Disease Management for. Heart Failure

Transcription

1 Disease Management for Heart Failure

2 DISCLAIMER: The information contained in this annotated bibliography was obtained from the publications listed. The National Pharmaceutical Council (NPC) has worked to ensure that the annotations accurately reflect the information contained in the publications, but cannot guarantee the accuracy of the annotations or the publications. There are articles available on the treatment of heart failure that are not included in this bibliography and that may include relevant information not covered herein. The inclusion of any publication in this bibliography does not constitute an endorsement of that publication by NPC or an endorsement of the services, programs, treatments, or other information contained in such publication. This bibliography is designed for informational purposes only, and should not be construed as professional advice on any specific set of facts and circumstances. This bibliography is not intended to be a comprehensive source of disease management services or programs for the treatment of heart failure, or a substitute for informed medical advice. If medical advice or other expert assistance is required, readers are urged to consult a qualified health care provider or other professional. NPC is not responsible for any claims or losses that may arise from any errors or omissions in the information contained in this bibliography or in the listed publications, whether caused by NPC or originating in any of the listed publications, or any reliance thereon, whether in a clinical or other setting. October 2004 National Pharmaceutical Council, Inc.

3 Introduction The Disease Management Association of America defines disease management as a system of coordinated health care interventions and communications for populations with conditions in which patient self-care efforts are significant. 1 Disease management supports the clinician-patient relationship and plan of care, and emphasizes prevention of exacerbations and complications using evidence-based practice guidelines and patient empowerment strategies. 1 It also evaluates clinical, humanistic, and economic outcomes on an ongoing basis with the goal of improving overall health. 1 More specific goals of disease management include: 2 Improving patient self-care through means such as patient education, monitoring, and communication. Improving physician performance through feedback and/or reports on patient progress in compliance with protocols. Improving communication and coordination of services between the patient, the physician, the disease management organization, and other providers. Improving access to services, including prevention services and prescription drugs as needed. The following functions are components of disease management: 2 Identification of patient populations. Use of evidence-based practice guidelines. Support of adherence to evidence-based medical practice guidelines by providing medical treatment guidelines to physicians and other providers, reporting on the patient s progress in complying with protocols, and providing support services to assist the physician in monitoring the patient. Provision of services designed to enhance the patient s self-management and adherence to his or her treatment plan. Routine reporting and feedback. Communication and collaboration among providers and between the patient and his or her providers. Collection and analysis of process and outcomes measures. Disease management programs are widely used for asthma, diabetes mellitus, and heart failure. 3-5 Considerations in selecting a disease for disease management include: Availability of treatment guidelines with consensus about what constitutes appropriate and effective care. Presence of generally recognized problems in therapy that are well documented in the medical literature. Large practice variation and a range of drug treatment modalities. Large number of patients with the disease whose therapy could be improved. Preventable acute events that often are associated with the chronic disease (e.g., emergency department or urgent care visits). Outcomes that can be defined and measured in standardized and objective ways and that can be modified by application of appropriate therapy (e.g., decreased number of emergency department visits or hospitalizations). Potential for costs savings within a short period (e.g., less than 3 years). Three major not-for-profit organizations whose mission is to promote quality health care have recognized the contribution of disease management activities to quality health care by establishing disease management certification or accreditation programs. The Joint Commission on Accreditation of Healthcare Organizations, an independent, not-for-profit organization and the nation s predominant standards-setting and accrediting body in health care, offers disease-specific care program certification. Program certification is based on an assessment of compliance with consensus-based national standards, effective use of established clinical practice guidelines to manage and optimize care, and an organized approach to performance measurement and improvement activities. 6 The National Committee for Quality Assurance accredits disease management programs on the basis of standards that are patient oriented, practitioner oriented, or both. It also offers organizations certification for program design (i.e., content development), systems (i.e., clinical information and other support systems), or patient or practitioner contact (e.g., for nurse call centers and other organizations without comprehensive activities). 7 The Utilization Review Accreditation Commission (URAC), also known as the American Accreditation HealthCare Commission, establishes standards for the health care and insurance industries. URAC s goal is to Disease Management for Hear Failure [1]

4 Disease Management for Hear Failure [2] promote excellence among purchasers, providers, and patients through continuous improvement in the quality and efficiency of health care delivery. It achieves this goal by establishing standards, education and communication programs, and a process of accreditation. URAC has accreditation programs for disease management as well as case management, claims processing, core accreditation, credential verification, health call centers, health networks, health plans, health provider credentialing, health utilization management, health Web sites, Health Insurance Portability and Accountability Act privacy and security, independent review, and workers compensation utilization management. 8 Penetration And Trends The ultimate goal of disease management is to produce optimal health outcomes for patients. Therefore, virtually all stakeholders in health care want to be involved. Disease management is of interest to providers, patients, managed care organizations, insurance companies, government agencies, pharmacy benefit management (PBM) firms, and employer purchasing coalitions. 9 Most disease management programs are implemented through health maintenance organizations (HMOs), PBM firms, or Medicaid agencies. 4 Some organizations choose to hire a vendor and contract out disease management services, whereas others choose to develop their own programs. Each method has advantages and disadvantages; success often depends on the organization and its level of resources and commitment. Managed Care Organizations and Pharmacy Benefit Management Firms Managed care organizations and PBM firms were the first to implement disease management programs. PBM firms offer disease management programs and services to employers and managed care clients as part of their overall benefit management services. 10 The 1998 Novartis Pharmacy Benefit Report indicated that 75% of PBM pharmacy directors were expending resources to develop disease management programs for conditions that respond to or depend on pharmaceutical products and services. HMOs reported that 16% of their disease management programs were provided thorough a PBM. 10 Most employers reported using PBM firms to manage costs, and many employers used PBM firms to provide disease management services. 10 America s Health Insurance Plans (a trade association created by the joining of the American Association of Health Plans and the Health Insurance Association of America) represents more than 1300 HMOs, preferred provider organizations, and other network-based plans. Members of the association provide health care to more than 200 million Americans nationwide. In a 2000 survey of a random sample of association members, 99% of member health plans offered a disease management program. 5 State Medicaid Programs In the rapidly changing environment of Medicaid managed care, it is essential for Medicaid directors and their top managed care staff to remain abreast of innovations in organization and payment that are occurring to serve the special needs of the Medicaid population. Traditionally, state Medicaid programs either have retained insurance risk and paid on a fee-for-service basis or have outsourced risk and contracted with Medicaid HMOs. Disease management represents a method of managed care in the middle between traditional fee-for-service and HMOs. Four types of models are emerging: 1. Medicaid health outcomes partnerships are usually applied to an existing fee-for-service primary care case management program. Medicaid programs focus on high-priority diseases, offering a number of support systems to help existing Medicaid providers better serve the patients assigned to them Disease management organizations are outside contractors who are retained by the state to address particular diseases, either by supplementing existing Medicaid providers and their case management activities or by taking over responsibility for targeted patients. 3. Pay-for-performance approaches establish new rules for scope of practice or referrals and involve nontraditional providers in the care of patients with specific diseases. The nontraditional providers are paid a special fee contingent on improving health outcomes or lowering costs. 4. Centers of Excellence focus on particular disease episodes for high-cost, high-volume diseases and select a network of hospitals, physicians, and other providers who are already organized to receive a prospective, bundled payment per episode of care. To meet criteria for designation

5 as a center of excellence, an organization must provide written documentation of the quality and outcomes of care for a selected disease. Most states are actively involved in the disease management process. By far, the diseases most often focused on in these programs are asthma and diabetes. Other diseases and conditions included in state disease management programs are arthritis, heart failure, depression, gastrointestinal disease, hemophilia, HIV infection/aids, hyperkinetic activity, dyslipidemia, mental health, otitis media, pregnancy, smoking, ulcer, and upperrespiratory infections. Current information about state disease and case management activities is available on the Web at Why Focus on Heart Failure? Over the last decade, managed care organizations began an intense utilization review process to identify areas where cost control measures would be appropriate. 12 Heart failure was one of the first diseases selected because there is great opportunity to treat this disease more effectively and to develop programs that will help payers and plans manage the high costs associated with it. 12 Economic Impact In the United States, the direct and indirect costs of heart failure in 2004 are estimated at $25.8 billion. 13 This figure includes $23.7 billion in direct costs for expenses related to hospitalization, nursing home care, physicians and other health professionals, medications, and home health care. The indirect costs for lost productivity and earnings due to death from heart failure amount to $2.1 billion. Hospitalization is the largest component of the direct costs of heart failure, and the rate of hospitalization for heart failure has increased substantially over the past decade. 14,15 In 1999, Medicare payments to beneficiaries hospitalized with heart failure amounted to more than $5000 per patient discharged and a total of $3.6 billion. 13 Nearly 75% of the hospitalization expense is incurred within the first 48 hours of hospitalization (except for the daily room charge). 14 Annual expenditures for medications to treat heart failure amount to approximately $500 million. 15 Epidemiology An estimated 5 million Americans have heart failure, and approximately 550,000 new cases are diagnosed each year. 13 The prevalence of heart failure increases with age; it is approximately 1% at age 50 and 5% at age Four out of five cases of heart failure occur in persons 65 years of age or older. 17 Heart failure is the most common cause of hospitalization in this age group, and nearly half of elderly patients with a discharge diagnosis of heart failure are readmitted within 6 months. 17 Men are more likely to be affected by heart failure than are women, probably because the incidence of ischemic heart disease is greater in men than in women. 13,18 Roughly 9 out of 10 patients with a diagnosis of heart failure survive for 1 year. 19 However, only 5 out of 10 patients are alive 5 years after diagnosis, and the quality of life is impaired in many of these patients. 19 Approximately 39,000 Americans die from heart disease annually, and the disease contributes to the deaths of another 225,000 people each year. 16 Death is sudden in 40% of patients, suggesting that it is the result of serious ventricular arrhythmia. 18 Mortality from heart failure is twice as high for African Americans as it is for whites. 16 What Is Heart Failure? Heart failure is the result of dysfunction of the cardiac ventricles during diastole (filling), systole (contraction), or both. 18 This dysfunction may have a variety of causes, including hypertension (which increases the workload for the heart) and diseases of the cardiac valves, muscle, and pericardium (the sac surrounding the heart). Myocardial infarction is a common cause of decreased contractility; damage to heart muscle fibers due to an insufficient oxygen supply impairs the ability of the fibers to shorten during systole. Myocardial infarction also can increase the stiffness of the ventricles and restrict filling during diastole. In most cases, heart failure is characterized by dysfunction of the left ventricle during systole and a low cardiac output (the volume of blood pumped per minute) and ejection fraction (the portion of the left ventricle volume expelled during systole). 18 Common causes of left ventricular systolic dysfunction include hypertension, coronary artery disease, and idiopathic dilated cardiomyopathy. 18 Heart failure is a condition in which the heart cannot pump enough blood to meet the needs of the body s other organs. It can result from: Narrowed arteries that supply blood to the heart muscle (i.e., coronary artery disease). Disease Management for Hear Failure [3]

6 Disease Management for Hear Failure [4] A past heart attack, or myocardial infarction, with scar tissue that interferes with the heart muscle s normal work. High blood pressure. Heart valve disease due to past rheumatic fever or other causes. Primary disease of the heart muscle itself, called cardiomyopathy. Defects in the heart present at birth (i.e., congenital heart disease). Infection of the heart valves and/or heart muscle itself (i.e., endocarditis and/or myocarditis). The failing heart keeps working, but it doesn t work as efficiently as it should. People with heart failure cannot physically exert themselves because they become short of breath and fatigued. As blood flow out of the heart slows, blood returning to the heart through the veins often backs up, causing congestion in the tissues. Swelling (edema) results, most commonly in the lower legs, ankles, and feet, but possibly in other parts of the body as well. Sometimes fluid collects in the lungs and interferes with breathing, causing shortness of breath, especially when a person is lying down. Heart failure also affects the ability of the kidneys to excrete sodium and water. Water retention worsens the edema. Compensatory mechanisms involving the blood vessels, kidneys, nervous system, and hormones (e.g., the renin-angiotensin-aldosterone system) allow the cardiovascular system to temporarily adapt to underlying pathologic conditions, maintain a normal cardiac output, and forestall the onset of heart failure signs and symptoms. 18 These mechanisms include hypertrophy of the ventricles (an increase in muscle mass and wall thickness), dilatation of the ventricles (i.e., increased volume), and sympathetic nervous stimulation (to increase heart rate, contractility, and cardiac output). However, some compensatory mechanisms can worsen heart failure; these mechanisms are referred to as maladaptive responses. For example, low renal blood flow due to low cardiac output results in activation of the reninangiotensin-aldosterone system, which increases blood pressure and promotes sodium and water retention and volume overload. 18 Although sympathetic stimulation increases the heart rate, contractility, and cardiac output, it also increases blood pressure and oxygen demand on the heart. Heart failure signs and symptoms manifest when the maladaptive responses overwhelm the beneficial effects of compensatory mechanisms. 18 Maladaptive responses contribute to disease progression in patients with heart failure. Signs and symptoms of heart failure include fatigue, shortness of breath, difficulty breathing (especially at night, when lying down, or during physical exertion), cough, weight gain (from fluid retention), and swelling of the feet and ankles. 16,18 The New York Heart Association functional classification may be used to classify functional disability in patients with heart failure on the basis of the extent to which physical activity is limited because of symptoms. Class I is no impairment (i.e., symptoms only at levels of physical activity that limit normal persons), and Class IV is severe impairment (i.e., symptoms at rest). Table 1 lists commonly used authoritative guidelines for managing heart failure. Up-to-date information on treatment guidelines from various sources also is available from the National Guideline Clearinghouse ( The management of heart failure, based on information in the guidelines, is discussed in Appendix A. Table 2 provides a list of organizations with information about heart failure for patients. Health Goals in Patients with Heart Failure Some of the conditions that cause heart failure (e.g., diseased heart valves) can be corrected. However, in most cases, a cure is not possible. Nevertheless, lifestyle modifications and drug therapies may be used to manage chronic illness. The goals of treatment are to increase survival, reduce symptoms, and improve functional status and quality of life. 16 Review of Heart Failure Disease Management Literature A comprehensive search of the heart failure disease management literature was conducted in preparing this bibliography. The goal was to identify reports describing educational interventions or disease management programs designed to improve the management of heart failure. Thus, whereas some reports describe comprehensive disease management programs, others describe educational interventions directed at patients, health care providers, or both. MEDLINE is the National Library of Medicine s premier database. It contains more than 12 million citations and abstracts from more than 4800 biomedical journals

7 Table 1. Authoritative Guidelines for Managing Congestive Heart Failure a 1. American Heart Association Exercise and heart failure: a statement from the American Heart Association Committee on exercise, rehabilitation, and prevention. Available in print (Circulation. 2003;107: ) and online at: 2. Canadian Cardiovascular Society The Canadian Cardiovascular Society consensus guideline update for the diagnosis and management of heart failure. Available in print (Can J Cardiol. 2003;19: ). 3. Heart Failure Society of America Heart Failure Society of America guidelines for management of patients with heart failure caused by left ventricular systolic dysfunction: pharmacological approaches. Available in print (J Card Fail. 1999;5: , Pharmacotherapy. 2000;20: , or Congestive Heart Failure. 2000;6:11-39) and online at: Update in progress. 4. Institute for Clinical Systems Improvement Health care guidelines on (1) Inpatient Management of Heart Failure (2004) and (2) Heart Failure in Adults (2003). Available online at: 5. European Society of Cardiology Guidelines for the diagnosis and treatment of chronic heart failure. Available in print (Eur Heart J. 2001;22: ) and online at: a Clinical practice is subject to constant change, and the guidelines in this list may become outdated or be superseded by newer ones. The reader is encouraged to consult the National Guideline Clearinghouse ( a public resource for evidence-based clinical practice guidelines sponsored by the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research), in partnership with the American Medical Association and the American Association of Health Plans (now America s Health Insurance Plans), for the most current guidelines. published in the United States and 70 other countries. Topics span the fields of medicine, nursing, dentistry, veterinary medicine, the health care system, and the preclinical sciences. Earlier versions of this bibliography were based on searches of the MEDLINE database for the period from January 1985 to May 2002 using the search terms disease AND management AND congestive heart failure. In preparing this updated version of this bibliography, an additional search of the MEDLINE database was performed for the period from May 2002 through May 2004 using the search terms disease management AND heart failure to reflect changes to the National Library of Medicine s controlled vocabulary. This search was limited to clinical trials. The primary criteria for inclusion of a report in this analysis were: An educational intervention undertaken to improve the management of heart failure. Measurement of the impact of the intervention or program. Reports on 68 disease management programs met these criteria. Appendix B presents summaries of these reports, and Appendix C displays associated methodological information and outcome data in tabular form. Methodologies The educational interventions or disease management programs were targeted at adults, including a large percentage of patients more than 55 years of age. Aside from three studies with mixed patient populations (one study included patients with chronic obstructive pulmonary disease [COPD] or congestive heart failure [CHF], another included patients with CHF or cardiomyopathy, and a third included patients with CHF, COPD, or diabetes), all interventions and programs were targeted at individuals with heart failure, including the congestive state. The size of the patient population ranged from to 15 to nearly 5000 patients. Patient participants in the disease management programs and educational interventions were recruited Disease Management for Hear Failure [5]

8 Table 2. Organizations With Information About Congestive Heart Failure for Patients American Heart Association 7272 Greenville Avenue Dallas, TX AHA-USA-1 or Heart Failure Society of America Court International Suite 240 S 2550 University Avenue West Saint Paul, MN Heart Rhythm Society Six Strathmore Road Natick, MA National Heart, Lung, and Blood Institute P.O. Box Bethesda, MD Texas Heart Institute P.O. Box Houston, TX Disease Management for Hear Failure [6] from various sites, including hospitals, clinics, private medical groups, and special heart failure centers. Some interventions and programs focused on patients with specific risk factors for hospital readmission. For example, 14 interventions and programs were conducted with patients who were elderly or had severe heart failure, including 2 programs affiliated with heart transplantation centers. In one case, a medical claims database was used to identify all patients with a heart failure-based claim of more than $50 as well as a recent hospital admission or emergency department visit. Fifty-two of the educational interventions or disease management programs were specifically intended for patients; families of the patients were involved in nine cases. The program content typically included information about: Heart failure (e.g., pathophysiology, signs, symptoms). Appropriate diet, weight, activity level, and other lifestyle factors. Medications and the importance of treatment adherence. Self-monitoring techniques to facilitate the daily measurement and reporting of body weight, dietary intake, and evidence of acute heart failure exacerbation (e.g., weight gain, edema, shortness of breath). Various settings and formats were used to present the educational material, including individualized and smallgroup sessions held at a hospital, outpatient clinic, or the patient s home. Information presented orally usually was supplemented by audiovisual or printed materials (e.g., workbooks, medication calendars, brochures). Common methods to reinforce educational material and promote treatment adherence included home visits by a nurse and outpatient clinic visits by patients. Telemonitoring ranging from regular, provider-initiated telephone calls to the transmission of patient self-reported data via an automated telemanagement system was used in many interventions and programs. New technologies allow for the education of patients at home by health care professionals at a remote location. Some devices also provide for the measurement and transmittal of patient health data from the home to the remote location for review by a health care professional. The use of these technologies has reduced the need for frequent home visits by health care professionals and patient trips to a health care facility. Thirteen educational interventions or disease management programs were directed at both patients and health care professionals. In addition to offering patient education, these programs and interventions provided health care professionals (including physicians) with information about:

9 The program itself or patient status (i.e., patient self-monitoring data). The appropriate use of practice guidelines developed locally or nationally. Techniques for improving patient adherence. The early management of complications. Three interventions were directly solely at health care providers. These interventions involved the development and implementation of critical and clinical pathways for management of patients with heart failure. All or certain aspects (e.g., patient teaching, medication dosage adjustments, critical pathways) of 20 disease management programs or educational interventions were based on guidelines widely accepted in the medical community. These include guidelines issued by the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality), the American Heart Association, and the American College of Cardiology. Eighteen other interventions or programs relied on internally developed guidelines or critical pathways, or were based partly or entirely on: Unspecified protocols, guidelines, or critical pathways. Guidelines issued by federal agencies (e.g., Medicare), nursing agencies, or home health care agencies. Published research. For example, target angiotensin converting-enzyme (ACE) inhibitor dosages in one disease management program were based on the results from randomized clinical trials. Most of the educational interventions and disease management programs targeting patients were administered by specially trained nurses or pharmacists. Some interventions and programs were administered by a multidisciplinary team of providers, including physicians, nurses, pharmacists, dietitians, social workers, psychologists, and home health care workers. However, a nurse often coordinated the activities of these multidisciplinary teams. Physicians, working alone or in conjunction with another health care professional, often conducted interventions or programs directed at health care providers (i.e., the development and implementation of critical pathways). The studies included 27 randomized, controlled trials; 18 observational, pre- and post-intervention comparison studies; and 5 retrospective chart reviews. Outcomes were assessed over various periods after the intervention (e.g., 30 days, 90 days, 6 months), with 29 studies providing patient follow-up data for 1 year or longer. Outcomes A commonly measured outcome was the hospital admission or readmission rate (readmissions), reflecting the goal of most educational interventions and disease management programs to reduce resource utilization. These rates were measured over relatively short periods (e.g., 30 or 90 days) in some studies and over longer periods (e.g., 1 year) in others. Forty- nine of the 68 educational programs and disease management programs used hospital admission or readmission rate as a measure of effectiveness. Following the intervention, rates dropped in 39 studies, remained unchanged in 7 studies, and increased in 3 studies. Other common hospital-related outcome measures included total number of hospital days and average length of stay (LOS). The average LOS decreased among patients receiving the intervention in 13 of 14 studies in which LOS was assessed. These changes were paralleled by a decrease in the total number of hospital days in 17 of the 18 studies in which this outcome measure was evaluated. Other measures of resource utilization (e.g., emergency department visits) also showed similar improvements. Several studies evaluated the effect of the educational intervention or disease management program on patients emotional or physical status. Patient-related outcome measures in these studies included quality of life, mood, and functional status. Improvement in quality-of-life scores was found among patients participating in the intervention in 17 of the 22 studies in which this parameter was assessed; improved mood also was observed in 3 studies. In 12 studies that assessed functional status, significant improvements were noted among patients participating in the program or intervention compared with controls. Several studies focused on the effectiveness of the educational intervention or disease management program in improving the disease-related knowledge or selfmanagement behavior of patients with heart failure. For example, eight studies assessed patient knowledge of Disease Management for Hear Failure [7]

10 topics such as appropriate medication use, diet, and exercise; improvements attributed to the intervention were observed in seven of these studies. Eleven studies used objective measures of adherence to the medication regimen, dietary restrictions, and other aspects of treatment. All of these studies documented improved adherence among patients who participated in the educational intervention or disease management program. Knowledge of and compliance with practice guidelines among providers were indirectly measured by evaluating the appropriateness of medical management (e.g., appropriate use of an ACE inhibitor to reduce afterload in a patient with heart failure who can tolerate such therapy). Of the six studies that evaluated appropriate medical management, five documented improved care associated with the educational intervention or disease management program, including more appropriate use or dosing of ACE inhibitors in three studies. Health-related costs were evaluated or projected in 37 studies. Thirty-two reports described reduced healthrelated costs among patients who participated in the educational intervention or disease management program. The intervention had no impact on costs in one study. A cost savings was projected in another four reports. The Future of Disease Management Disease management can improve patient outcomes and quality of life while potentially reducing overall costs. It is an important approach to integrated care. As health care payers incorporate disease management principles into the delivery of care, they need to become more sophisticated in contracting with outside vendors for these services. The Disease Management Association of America works with potential customers to address issues associated with contracting, such as data contracting and risk sharing. Currently, the Disease Management Association of America has more than 100 corporate members that provide disease management services. Disease management vendors have begun using the Internet to reach out to target populations. The Internet allows two-way communication between clinicians and patients, as well as immediate and free access to educational materials. Compared with traditional office visits and postal mailings, the Internet may save time and money. Initially the Internet may be used to educate Medicaid physicians, nurses, pharmacists, and other providers about disease management. As more people gain access to personal computers and enter the information superhighway, the Internet will become an increasingly powerful tool. Disease management is a useful, efficient approach to health care. It will continue to gain widespread acceptance among health plans that provide care for patients with chronic disease. Disease Management for Hear Failure [8]

11 Appendix A. Management of Heart Failure Heart failure usually requires a treatment regimen that includes rest, proper diet, modified daily activities, and medications that include angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, digitalis, diuretics, and vasodilators. The various medications used to treat heart failure perform different functions. For example, ACE inhibitors and vasodilators expand blood vessels and decrease resistance, allowing blood to flow more easily and making the heart s work easier or more efficient. Beta-blockers can improve the function of the left ventricle. Digitalis increases the pumping action of the heart, while diuretics help the body eliminate excess salt and water. When a specific cause of heart failure is discovered, it should be treated or, if possible, corrected. For example, in some cases treating high blood pressure can ameliorate heart failure. Some patients are treated surgically by replacing abnormal heart valves. When the heart becomes so damaged that it cannot be repaired, a more drastic treatment such as a heart transplant may be considered. Most cases of mild or moderate heart failure are treatable. With proper medical supervision, people with heart failure need not become invalids. Nonpharmacologic Therapy Regular exercise is recommended for patients with stable heart failure because it may improve functional status and decrease symptoms. 15,20 Moderate restriction of dietary sodium intake is recommended. 18 Excessive fluid intake should be avoided, although fluid restriction is not necessary. Smoking cessation, restriction of dietary fat intake, and treatment of lipid disorders also may be recommended. 15 Alcohol and illicit drug use should be discouraged because they may increase the risk of heart failure. 15 Pharmacologic Therapy Diuretics, ACE inhibitors, beta-blockers, and digitalis are used to treat patients with heart failure. 15 Aldosterone antagonists (e.g., eplerenone), angiotensin receptor blockers (e.g., losartan), hydralazine, and isosorbide dinitrate may be considered for certain patients. 15,21 Diuretics. Diuretics are used to correct and prevent fluid retention. 15 They promote the elimination of sodium and water by the kidneys. Loop diuretics (e.g., furosemide) are the most widely used diuretics for heart failure. 18 Thiazide diuretics (e.g., hydrochlorothiazide) are weaker diuretics than loop diuretics, although they may be used in combination with loop diuretics. Adverse effects of loop and thiazide diuretics include the loss of excessive amounts of potassium, weakness, muscle cramps, joint pain, and impotence. 16 The potassium-sparing diuretic spironolactone acts as an aldosterone antagonist, which can be beneficial in patients with moderate to severe heart failure. 18 However, it can cause gynecomastia (breast pain) and hyperkalemia. Angiotensin-Converting Enzyme Inhibitors. ACE inhibitors are recommended for patients with left ventricular dysfunction (unless the patient has hyperkalemia, symptomatic hypotension, a history of adverse reactions to ACE inhibitors, or another contraindication to the use of ACE inhibitors). 15 ACE inhibitors reduce the conversion of angiotensin I to angiotensin II. Angiotensin II is a vasoconstrictor that increases sympathetic nervous activity and causes aldosterone release, which in turn promotes sodium and water retention by the kidneys. ACE inhibitors also may diminish local production of angiotensin II, which is thought to contribute to ventricular hypertrophy and dilatation in patients with heart failure. 22 ACE inhibitors reduce mortality from heart failure, delay the progression of the disease, improve functional status, and decrease the need for hospitalization. 23,24 These agents also are recommended for asymptomatic patients with moderately or severely impaired leftventricular systolic function (e.g., to prevent heart failure from developing after a myocardial infarction). 15 The use of ACE inhibitors reduces the risk of heart failure in these patients. 25 ACE inhibitors also are recommended for patients at high risk of developing heart failure (e.g., patients with a history of atherosclerotic vascular disease, diabetes mellitus, or hypertension and associated cardiovascular risk factors). 15 Agents that have been shown to reduce mortality in patients with heart failure (e.g., captopril, enalapril, lisinopril, quinapril, ramipril, trandolapril) are preferred over those without a documented survival benefit. 18 Cough is a common adverse effect from ACE inhibitor therapy. 16 Angiotensin receptor blockers may be an alternative for patients who are unable to tolerate ACE inhibitors. Beta-Blockers. In the past, clinicians were advised to use beta-blockers with care in patients with heart failure because of the negative inotropic effect of these drugs. 19 However, the use of beta-blockers for asymptomatic and symptomatic heart failure is now widely accepted because chronic sympathetic activation is thought to play an important role in heart failure. 15,18 Betablockers have been shown to slow the progression of heart failure and reduce hospitalization and mortality, possibly by blocking sympathetic stimulation. 26,27 Beta-blockers with intrinsic sympathomimetic activity (e.g., acebutolol, pindolol) should be avoided. Reductions in mortality have been demonstrated with bisoprolol, carvedilol, and metoprolol. 18 Small beta-blocker dosages should be used initially, and dosages should be increased gradually to avoid aggravating heart failure. 18 Digoxin. Digoxin is recommended (in conjunction with an ACE inhibitor and diuretic) for patients with symptomatic heart failure. 15 It is particularly useful for patients with certain arrhythmias. 18 Digoxin has a positive inotropic effect (i.e., it increases the force of contraction) and increases cardiac output. It also has antiarrhythmic activity and beneficial effects on nervous and hormonal mechanisms that contribute to heart failure. Digoxin reduces symptoms, improves physical function and quality of life, and decreases the rate of hospitalization in patients with heart failure, although it does not appear to affect mortality. 28 Adverse effects from digoxin include arrhythmias, anorexia, nausea, vomiting, diarrhea, confusion, vision disturbances, fatigue, and dizziness. 16,18 Nitrates and Hydralazine. Nitrates (e.g., isosorbide dinitrate) and hydralazine are vasodilators that may be used in patients who are unable to take ACE inhibitors because of contraindications or adverse effects. 18 Nitrates and hydralazine relax vascular smooth muscle and often are used in combination. 18 They reduce mortality from heart failure, although to a lesser extent than ACE inhibitors. 29 Headache is a common adverse effect from these agents. Disease Management for Hear Failure [9]

12 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure Disease Management for for Hear Failure [10] Humana Congestive Heart Failure program cuts costs, admissions. Anon. Healthcare Benchmarks. 1998;5: The effects of a disease management program on hospital admissions, hospital days, inpatient costs, and emergency department visits were studied in nearly 5000 members of the Humana Inc. health plan diagnosed with congestive heart failure (CHF). The program, offered by a private Illinois-based company (Cardiac Solutions), began with a home visit from a contracted home health agency to assess the patient s physical and psychosocial status, diet, and medication compliance. Patients then received a simple workbook that taught them how to manage the disease. Experienced cardiac nurses reviewed the material with patients individually by telephone using a script. The nurses also worked to establish a relationship with each patient, using frequent phone calls and postcards. Protocols for the program were based on guidelines from the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) and the American Heart Association. The nurses also followed protocols on laboratory, medication, lifestyle, and symptom management, and reported urgent patient problems or discrepancies between guidelines and treatments to attending physicians for clarification about treatment. The content of all nurse-patient and nurse-physician encounters was shared with physicians and patients. In a 2-year study of the program s effectiveness, the Humana Inc. health plan observed a 58% drop in hospital admissions for all diagnoses and a 61% reduction in inpatient health care costs over a 2-year period. Hospital admissions decreased from 7,795 in 1995 to 3,309 in the period between 1996 and The number of hospital days for CHF patients participating in the program decreased by 58%, and emergency department visits decreased by 49%. Health plan administrators concluded that the efficiency of telephone contacts and the personal touch of as-needed home visits improves care for CHF patients. DM programs take different roads to CHF success. Anon. Healthcare Demand & Disease Management Jun;6(6): [Also reported in Clinical Resource Management Feb;2(2):20-25.] A controlled study of a telephone case management system in which nurses provided congestive heart failure patients with education about the disease, symptoms, importance of measuring body weight daily, medications, and other aspects of disease management is described. The nurses had specialized training in cardiac care. Phone calls to patients were made weekly for 4 weeks, biweekly for another 4 weeks, and monthly thereafter. Scales were provided to patients who had none so that they could weigh themselves daily. The control group received usual care. After 6 months of the program, the New York Heart Association functional class and quality of life improved in a significant number of patients in the intervention group (i.e., patients enrolled in the telephone case management system). The annualized hospitalization rate and costs decreased by 49% and 64%, respectively, in the 6-month period after program enrollment compared with the 6- month period before enrollment (the reductions in rate and costs were 32% and 36%, respectively, for the control group). Emergency department visits increased by 10% in the control group and did not change in the intervention group. Total costs decreased by 68% and 44% in the intervention group and the control group, respectively, after program enrollment. Solid outcomes show e-health and chronically ill senior populations are compatible. Anon. Disease Management Advisor Jul;7(7): A 1-year randomized, controlled pilot study comparing the cardiac costs and rate and length of hospitalization associated with a computer-based disease management program, interactive voice response (IVR), and usual care in 69 elderly patients with moderate to severe congestive heart failure (CHF) is described. Patients in the computer group and the IVR group were taught to measure their own blood pressure using a blood pressure cuff, as well as measuring their pulse and their weight. These vital signs and various symptoms of worsening CHF were reported to a nurse via the Internet for the computer group or telephone for the IVR group (using voice response or the telephone key pad). In-home assistance with computer set up was provided for the computer group. There were 20 hospitalizations for a total of 149 days in the computer group and 39 hospitalizations for 258 days in the IVR group over a 1-year period. Hospitalization data were not reported for the usual care (control) group. Cardiac costs per patient per month decreased by $247 in the computer group and $265 in the IVR group and increased by $135 in the usual care group. Web-based educational effort for CHF patients boosts outcomes while cutting costs. Anon. Disease Management Advisor Jun;7(6): A computerized disease management program for 159 patients with congestive heart failure (CHF) is described. Computer software was developed to automatically sort Blue Cross/Blue Shield claims data by International Classification of Diseases, 9th Revision codes and utilization and pharmacy data using an algorithm. The software also stratified patients by risk (to facilitate prioritization by the program coordinator) and generated letters to all patients inviting them to enroll in the disease management program. Patients completed

13 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) questionnaires that assessed education level, readiness to change, and medical history; the forms were automatically read by computer and a plan of action was generated. Physicians completed questionnaires about patients medications, medical history, contraindications, heart failure classification, target weight, and adherence to medications and diet. Program coordinators used this information and the action plan to conduct telephone counseling sessions with patients 1 to 3 times per month. Patient education was provided in these sessions to improve patients self-management skills. Additional information was available on the Internet (on the program Web site and through links to Web sites with good information). Patients were advised to contact their physician if medical problems arose. Physicians received feedback about specific patients and data for their patients as a group (e.g., rates of flu vaccination, angiotensin-converting enzyme [ACE] inhibitor use). After 18 months, 93% of participants reported improved disease knowledge, 56% reported improved functional status, and 96% were satisfied with the program. ACE inhibitor use increased by more than 20% to 65%. Overall costs decreased by about 35% due to decreases in emergency department use, hospital admissions, and hospital length of stay. [see also the summary for Hinkle AJ. Disease management: a smart way to interact with patients. Health Management Technology. 2000;21:38.] DM programs take different roads to CHF success. Anon. Clinical Resource Management Feb;2(2): [Also reported in Healthcare Demand & Disease Management Jun;6(6):80-85.] The impact of a disease management program on angiotensinconverting enzyme (ACE) inhibitor and beta-blocker use, use of target dosages of these medications, clinic visit rate, hospitalization rate and length of stay, and costs for 117 patients with congestive heart failure (CHF) at Duke University Medical Center is described. The disease management program involved planning before hospital discharge, periodic follow-up and emergent care at a CHF clinic, telephone follow-up, and patient education about medications, diet, and what to do if symptoms of worsening CHF develop. The CHF team comprised attending physicians, nurse practitioners, a nurse specialist, a pharmacist, a social worker, and a nutritionist. The pharmacist ensured that drug therapy was appropriate and the risk of adverse drug reactions was minimized. Patients hospitalized for CHF within the previous 6 months with New York Heart Association functional class III or IV and an ejection fraction less than 20% (i.e., severe illness) were included. The use of ACE inhibitors did not change after implementation of the program, probably because most patients were receiving them before program implementation. However, the percentage of patients receiving the target dosage increased from 74% before program implementation to 97% after implementation. The percentage of patients receiving beta-blockers increased from 52% at baseline to 76% after program implementation, and the percentage of patients receiving the target dosage increased from 24% to 40% during that period. The average rate of hospitalization decreased from 1.86 times per patient per year at baseline to 1.21 times per patient per year after program implementation, and the average length of stay decreased from 7.67 days to 6.07 days during that period. The rate of clinic visits increased from 7.8 visits per patient year to 12.9 visits per patient year. The outpatient costs increased by 27%, and the inpatient costs decreased by 38%. The total cost of care decreased by $1.1 million for the 117 patients, which is a 37% decrease. Sacramento hospital boosts outcomes by focusing on highrisk CHF patients. Anon. Data Strategies & Benchmarks May;5(5): A software program called Health Hero was implemented in a hospital-based disease management program for patients with congestive heart failure (CHF). Patients responded at home to preprogrammed questions about general health, diet, and medications and transmitted their responses through an electronic appliance to a nurse case manager. The program compiled a report for the nurse case manager in which patients with potential problems are flagged. Health Hero also provided patient education and reminders to patients about diet and self-monitoring activities (e.g., measuring body weight). The monthly cost of the Health Hero program was about $30 to $60 per patient, but this cost was offset by savings in nursing time. The use of Health Hero did not affect hospitalizations or visits to the emergency department for CHF, but it reduced all-cause hospitalizations and emergency department visits by 23%. The total number of bed days for all causes was reduced by about 50%. The annual savings in direct costs for all causes amounted to $1,266 per patient. CHF managers make the case for home-monitoring technology. Anon. Disease Management Advisor Oct;8(10): , 145. The usefulness of a home health-monitoring device was evaluated in a 3-month pilot program involving 10 patients with congestive heart failure (CHF). The device was programmed to measure weight, blood pressure, heart rate, oxygen saturation, and temperature on a daily basis at a convenient time selected by the patient. [11]

14 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [12] A recorded voice was used to cue patients to take the measurements. The device had the capability to ask up to 10 questions. Data were transmitted by pager or modem to a central location for review by a nurse practitioner, who contacted the physician if changes in drug therapy were needed. The patient compliance rate with daily measurements was 97% on average. Hospitalizations and emergency department visits were eliminated during the 3-month pilot study. Patients experienced significant improvements in how they felt and in their understanding of the disease process. Most insurance plans did not pay for the device. Arranging for visiting nurses to install the device in patient homes and teach patients to use the device properly is a strategy that was used because insurance plans cover visiting nurse services. Individualized care in patients with chronic congestive heart failure. Bertel O, Conen D. Journal of Cardiovascular Pharmacology. 1987;2:S68 S72. The impact of a comprehensive treatment program for congestive heart failure (CHF) was evaluated in a nonrandomized, observational study of 25 patients with similar degrees of disease despite therapy. Program enrollees consisted of 25 consecutive patients referred to this university-based hospital in Switzerland because of severe CHF that was refractory to treatment. The program focused on three issues: (1) individualized medical therapy for CHF, (2) antiarrhythmic treatment and close follow-up visits, and (3) continuing education of patients and physicians to improve treatment compliance and facilitate the early management of complications. Medical treatment was based on diuretic and vasodilator therapy in all the patients, while positive inotropic substances were selectively administered. Patient education related to the problems and complications of CHF. Education also addressed necessary lifestyle adjustments (e.g., physical activity, reduction in salt intake), and patients were asked to keep a diary of daily body weight measurements, drug intake, and symptoms. All patients were followed at short intervals of 1 to 2 weeks, independent of their symptoms. However, daily visits were scheduled if symptoms increased. To minimize unnecessary changes in the treatment regimen, patients were consistently evaluated by the same physician. The outcomes of patients in the special-care program (intervention patients) were compared with those of 21 consecutive patients described in a previous study. Patients in the control group were also referred to the institution for severe CHF refractory to treatment, but were treated prior to development of the CHF program. After evaluation, patients in the control group were sent back to their family physicians, with a detailed letter containing treatment recommendations. They were then followed only by telephone calls from their treating physicians. Reported outcomes for this study consisted of survival rates, results of medical treatment for CHF, and results of medical treatment for arrhythmias. The 1-year survival of all intervention-group patients was 92%, which was significantly higher than the 1-year survival rate in the control group of only 43%. In addition, the 2- year survival rate for the intervention group was 83%, which reportedly compares favorably with previously reported survival rates. All patients received intensive diuretic and vasodilator therapy as medical treatment of CHF. Vasodilator treatment was started with prazosin in 22 patients and angiotensin-converting enzyme (ACE) inhibitors in 3 patients. However, 55% of the patients on prazosin had to be changed over to ACE inhibitors because of fading clinical efficacy. Digoxin was used effectively in 8 of the 25 patients to control heart rates and/or arrhythmias. These 8 patients remained in sinus rhythm after digoxin was withdrawn. Amiodarone was used as the first-line drug to treat two patients with symptomatic ventricular tachycardia and two survivors of ventricular fibrillation. Six of the 11 patients treated for ventricular arrhythmias remained free of symptoms from malignant ventricular arrhythmias. Effect of a pharmacist-led intervention on diuretic compliance in heart failure patients: a randomized controlled study. Bouvy ML, Heerdink ER, Urquhart J, et al. Journal of Cardiac Failure Oct;9(5): The effect of a pharmacist-led intervention on mediation compliance was evaluated in a randomized controlled trial involving 7 hospitals, 79 pharmacists, and 152 patients with congestive heart failure (CHF) that was treated with loop diuretics. Patients were randomized to the intervention or a control group that received usual care. The intervention involved an interview by the pharmacist in which the patient medication history and reasons for noncompliance were discussed. The pharmacist contacted the patient afterwards on a monthly basis for up to 6 months. Compliance with the prescribed loop diuretic was assessed in both groups by using a container with a microchip that recorded the time and date of opening. Medication compliance during the 6-month study was greater in the intervention group than in the control group. The intervention group had 140 days without loop diuretic use out of 7,556 days, and the control group had 337 days without loop diuretic use out of 6,196 days. There were two consecutive days of loop diuretic nonuse on 18 days out of 7,656 days in the intervention group and 46 days out of 6,196 days in the control group. There were no significant differences between the two groups in rehospitalization, mortality, or quality of life.

15 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Cost/utility ratio in chronic heart failure: comparison between heart failure management program delivered by day-hospital and usual care. Capomolla S, Febo O, Ceresa M, et al. Journal of the American College of Cardiology. 2002;40: The effectiveness of a heart failure (HF) management program delivered by a day hospital was compared with usual care in 234 chronic HF outpatients in a 12-month randomized controlled trial. Patients were randomized to the intervention or usual care. The intervention involved creation of a plan of care by a day hospitalbased multidisciplinary team comprising a cardiologist, nurses, physiotherapists, dietitian, psychologist, and social assistant. Cardiovascular risk stratification and tailoring of therapy according to evidence-based criteria were performed, and health care education and counseling were provided to the intervention group. After 12 months, significantly fewer patients in the intervention group had died than patients in the usual-care group. The hospital readmission rate was significantly lower in the intervention group (14%) than in the usual-care group (86%). In the intervention group, New York Heart Association (NYHA) functional class was improved in 23% of patients and it had worsened in 11% of patients, a difference that is significant. However, in the usual-care group, NYHA functional class was improved in 13% of patients and it had worsened in 16% of patients, a difference that is not significant. The intervention was cost-effective, with a cost of $19,462 for each quality-adjusted life-year saved. The cost/utility ratios for the intervention and usual- care groups were similar ($2,244 for the intervention group and $2,409 for the usual-care group). There was a cost savings of $1,068 for each quality-adjusted life-year gained by using the intervention instead of usual care. Hospital length of stay (LOS), cost of care, mortality, readmission statistics, and performance rates of processes of care were evaluated in a 12-month randomized retrospective study of 95 elderly patients with congestive heart failure (CHF) who were managed according to a clinical pathway. These data were compared with those from a historical cohort of 200 patients who had been treated for CHF in a traditional manner. Study participants consisted of patients who had been admitted to a tertiary-care teaching hospital in metropolitan Detroit for management of CHF. These patients were randomly admitted to medical wards, including two wards participating in the pathway for the study s duration. The CHF pathway had been developed as part of a quality enhancement and clinical resource management project designed to enhance care in the elderly and improve resource management. Health care providers were instructed to follow the clinical pathway, and a clinical nurse manager monitored all processes of care. Any variances in processes of care were reported to the attending physician for corrective action. The control group consisted of patients who had been hospitalized for CHF the year preceding the study, prior to pathway implementation. Randomization was achieved in the control population by retrieving every third chart from a computerized discharge log of patients with a primary diagnosis of CHF. All patients were older than 65 years of age, and there were no statistically significant differences between groups in terms of sex or New York Heart Association functional classification. Analysis of outcome data revealed a significant reduction in LOS, from 6.36 days for the prepathway group (controls) to 5.25 days for the pathway group. This reduction in LOS was accompanied by a significant reduction in variable cost of $776 per patient. The mortality rate during hospitalization remained unchanged at 3.5%. However, the rate of readmission (at 31 days) showed a significant increase, from 9.25% in the prepathway group to 13.5% for the pathway group. Significant improvements were noted in performance of three of the six processes of care evaluated (early discharge planning, patient education, and early patient mobilization); lesser improvements were documented for the three remaining processes (heparin prescription, recording of daily weights, use of echocardiography). The authors concluded that the lower costs of care in the pathway patients compared with the prepathway patients reflected the shorter LOS. The significant increase in hospital readmissions observed in the pathway patients was considered a matter for concern and is currently being investigated. Potential reasons for a higher admission rate include sicker patients, comorbid illnesses, premature discharges, and inadequate discharge plans. Assessing the efficacy of a clinical pathway in the management of older patients hospitalized with congestive heart failure. Cardozo L, Aherns S. Journal of Healthcare Quality. 1999;21: Development of a heart failure center: a medical center and cardiology practice join forces to improve care and reduce costs. Chapman DB, Torpy J. American Journal of Managed Care. 1997;3: The effectiveness of The Heart Failure Center s comprehensive outpatient program in reducing hospital admissions, number of hospital days, and average length of stay was evaluated in 67 patients with congestive heart failure (CHF). The Omaha-based Heart Institute s Heart Failure Center represented a partnership between a private-practice cardiology group and a tertiary-care medical center. Its program for CHF patients emphasized continuity of care and patient education. Patients were assigned to a clinician group that provided education and treatment using internally generated protocols and standardized clinic visit forms. These protocols were based on both the 1994 Cardiology Preeminence Report on CHF [13]

16 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [14] and a 2-day Cardiology Roundtable meeting. A medical director physician helped to implement the program (and protocols) by meeting with all department personnel and educating all staff members. A registered nurse, with experience in treating CHF, was the identified program coordinator. Patient education was provided by a multidisciplinary team (nurse, physician, pharmacist, dietician, nurse program coordinator). It addressed a variety of issues (pathophysiology, appropriate diet, medication compliance, weight loss). Patient education began with a formal one-on-one curriculum prior to hospital discharge and continued at later outpatient visits. Other elements of the program included outpatient infusions of inotropic agents (to help reduce hospital readmissions), electronic linkages between the clinic and the emergency department (to reduce unnecessary clinic patient admissions), and home health care visits by nurses. The latter were intended to detect signs of clinical decompensation between clinic visits. The nurses also saw the patients regularly at the clinic to reinforce the need for adherence to medications, diet, and office visits. The 67 patients in this study were followed for a minimum of 1 year before enrollment in the program and 16 months after enrollment. The mean age of the patients was 64.7 years, and 50% had advanced heart failure (New York Heart Association functional class III or class IV). Comparison of pre- and post-enrollment data revealed that hospital admissions dropped 30%, from 38 before program enrollment to 27 after implementation. In addition, the number of hospital days decreased by 42% from 202 to 118, and the average length of stay decreased from 5.3 days to 4.4 days (a decrease of 17%). The investigators also noted that a year of frequent visits to the center costs less than one hospital admission. Each year, the average patient was seen 15 to 20 times at the clinic for an average cost of $2,000; the average cost of a hospitalization was about $9,000. The authors concluded that an effective heart failure outpatient program can reduce the economic burden of CHF and improve the quality of patient care. Congestive heart failure clinical outcomes study in a private community medical group. Civitarese LA, DeGregorio N. Journal of the American Board of Family Practice. 1999;12: A 21-month, prospective study was conducted to assess whether congestive heart failure (CHF) clinical practice guidelines, implemented with a continuous quality improvement program, would optimize use of angiotensin-converting enzyme (ACE) inhibitors and, thus, decrease hospital admissions for systolic CHF. The recipients of the program included 10 family practitioners and 10 internists at an independent medical group. The patients consisted of all 275 patients admitted to the group s primary communitybased hospital during the study with a confirmed discharge diagnosis of CHF. The group physicians developed CHF guidelines by reviewing the literature and guidelines from other hospital systems and health plans. The new guidelines were presented to the group s physicians at a formal continuing medical education session at the study s outset. Physicians were provided an opportunity to modify the guidelines, and each physician endorsed the final version. The guidelines, available for reference at office and hospital sites, were then reinforced at monthly quality improvement meetings. Other points emphasized at each meeting included (1) assessment of left ventricular function to optimize treatment, (2) appropriate use of ACE inhibitors in patients with systolic CHF, and (3) instruction of patients to obtain daily weights and contact the physician to report a weight gain. Standardized inpatient orders were also developed to parallel the guidelines, and physicians reviewed their own performance data at quarterly meetings. Rates of classifying systolic and diastolic dysfunction remained unchanged during the study, and documentation of patient discharge instructions was suboptimal. However, use of ACE inhibitor therapy substantially improved for patients with systolic dysfunction. Pharmacy utilization data from Aetna U.S. Healthcare showed a 39% increase in ACE inhibitor use by patients cared for by participating physicians. By the study s end, 100% of these patients had been prescribed ACE inhibitors or had documentation that they met exclusion criteria for such therapy. There was also a 49% reduction in quarterly admissions for CHF due to systolic dysfunction during the study; patient admissions for diastolic dysfunction remained stable. Associated economic effects were not addressed. Thus, use of disease management guidelines, ongoing physician education, and review of performance data significantly reduce quarterly admissions for systolic dysfunction-based CHF and optimized the use of ACE inhibitors. Cost effective management programme for heart failure reduces hospitalisation. Cline CM, Israelsson BY, Willenheimer RB, Broms K, Erhardt LR. Heart. 1998;80: A 1-year prospective, randomized trial evaluated the effects of a heart failure (HF) management program on outcomes in 190 patients with HF. Patients age years who were hospitalized at a Swedish university hospital for HF were eligible to participate. Patients were randomly assigned to the intervention or control group. Control patients received standard care at the university cardiology department s outpatient clinic following discharge. Intervention-group patients underwent an educational program managed by registered nurses followed by treatment at a HF clinic.

17 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) The intervention began with two 30-minute hospital visits by a nurse, followed by a 1-hour informational visit for patients and families 2 weeks after discharge. Information about the pathophysiology and treatment of HF was presented, with emphasis on compliance with medications. Patients next received guidelines for the selfmanagement of diuretic therapy based on symptoms and signs of worsening HF and were asked to record such data in a diary. Finally, patients were followed at an easy-access, nurse-directed outpatient clinic, in which patients could call or be seen on short notice. Patients were also offered outpatient visits with doctors at 1 and 4 months after discharge and at the study nurse s discretion. Clinical assessment followed a protocol, but no guidelines for evaluation or treatment specific to the study were used. Data on hospitalization and outpatient visits were obtained from hospital records and questionnaires. All patients were followed for 1 year, and final results were obtained from 135 surviving patients. The 1-year survival rate did not differ significantly between groups. However, the mean number of days until readmission was significantly longer in the intervention group (141) than in the control group (106), and the number of days spent in the hospital by the intervention group tended to be fewer than those spent by the control group (4.2 vs. 8.2, respectively). There was also a trend toward fewer patients being hospitalized in the intervention group than in the control group, with a similar number of outpatient visits in the two groups. The mean cost of the intervention per patient was $208. Costs for doctors outpatient visits tended to be $55 less per patient in the intervention group compared with the control group. In addition, the mean cost per patient for hospital readmission tended to be lower in the intervention group ($1,628 vs. $3,081), which contributed to a mean annual reduction in overall costs of $1,300 per patient. Impact of a guideline-based disease management team on outcomes of hospitalized patients with congestive heart failure. Costantini O, Huck K, Carlson MD, et al. Archives of Internal Medicine. 2001;161: The impact of daily use of new guideline-based recommendations for treating congestive heart failure (CHF) by a care management team (a nurse care manager, faculty cardiologist, and physician representative from the part-time faculty) at a large university-based medical center was assessed. All participating patients were hospital inpatients. Care-managed patients were compared with noncare-managed patients who were not followed by the team and with baseline patients (i.e., patients hospitalized before implementation of the new care management approach). National guidelines were available during the baseline period, but care-managed patients were monitored daily by the care management team and recommendations consistent with the guidelines were made. Clinical measures of quality of care (the use of angiotensin-converting enzyme inhibitors, documentation of assessment of left ventricular function using echocardiography, and the consistent daily measurement of body weight) were significantly improved and hospital length of stay and costs were significantly reduced in caremanaged patients compared with non-care-managed patients and baseline. The median hospital length of stay was 3 days with care management and 5 days without care management. Care management was associated with a $2,204 reduction in hospital costs. The relationship between hospital readmissions of Medicare beneficiaries with chronic illnesses and home care nursing interventions. Dennis LI, Blue CL, Stahl SM, Benge ME, Shaw CJ. Home Healthcare Nurse. 1996;14: A 12-month retrospective audit of the charts of 62 Medicare patients with a diagnosis of congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD) was conducted to evaluate the relationship between various home health care nursing interventions and hospital readmissions. Criteria for patient selection included those who were (1) admitted with a primary diagnosis of CHF or COPD of given severity, (2) under the care of a visiting home health care nurse within a 1-year interval, (3) Medicare beneficiaries, and (4) receiving services provided by an agency that had Medicare reimbursement. Interventions for patients with CHF consisted of assessment of vital signs; lip, skin, and nail bed color; presence of edema; presence of chest pain; specific signs/symptoms of CHF; activity tolerance; and weight measurement. Patient educational interventions included the signs/symptoms of CHF, prevention of an exacerbation, components of a low-sodium diet, medication actions/side effects, and use of medications. Interventions (assessment and teaching) specific to COPD were also carried out. A home health care nurse documented each intervention, and the total number of hospital readmissions was determined in a convenience sample of 42 patients. Interventions were selected from agency nursing care plans and Medicare regulations appropriate for patients with CHF or COPD. Fifty-seven percent of the patients (n=24) had CHF versus 43% (n=18) with COPD. Sixty-four percent of the patients were never readmitted to a hospital during the study. Of those who were readmitted once (n=15), 20% were readmitted twice and another 29%, three times. No patients were readmitted more than three times during the interval studied. As the number of home health care nursing visits increased, hospital readmissions decreased. Hospital readmissions also decreased as the total number of assessment interventions implemented increased. Interventions most strongly related to readmission rates were assessment of lungs, cough, and respiratory rate. The teaching interventions were more weakly related to the hospitalization rate and were only implemented 29% of the time. [15]

18 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [16] Outcomes of an integrated telehealth network demonstration project. Dimmick SL, Burgiss SG, Robbins S, Black D, Jarnagin B, Anders M. Telemedicine Journal and E-Health Spring;9(1): A disease management program for congestive heart failure (CHF) was implemented for residents of a Tennessee county using an integrated telehealth/telemedicine network with home videoconferencing, telephone conversations, and remote monitoring of blood pressure, blood oxygen saturation, and pulse. The number of program participants varied over time because of deaths and dropouts. Weight control (a measure of medication and dietary compliance) was achieved by more than 50% of patients after program implementation. Sleep problems (a measure of mood) improved, although feelings of fatigue, depression, and loss of appetite increased. Only 14% of patients were hospitalized in the first 6 months after program implementation. The hospitalization rate decreased from 1.7 times per patient per year to 0.6 times per patient per year as a result of program implementation. The hospital length of stay decreased from a national benchmark of 6.2 days to 4 days. The cost per patient per year for the program included $2,353 for nursing labor and $833 for equipment. A reduction in annual costs for hospital care for CHF from $8 billion to $4.2 billion was projected on a national basis. Heart failure disease management: impact on hospital care, length of stay, and reimbursement. Discher CL, Klein D, Pierce L, Levine AB, Levine TB. Congestive Heart Failure Mar-Apr;9(2): A congestive heart failure (CHF) disease management program was developed for use in an inpatient setting. The program involved a treatment algorithm/clinical pathway for the time from hospital admission to discharge and inservice education programs for physicians, nurses, and other health care professionals. Patients were assigned to a managed group unless the physician objected or cognitive impairment or inadequate living conditions interfered with patient participation. Of 593 patients enrolled in the study, 396 patients were assigned to the managed group and 197 patients were assigned to an unmanaged group. The latter group did not participate in the program. Documentation of left ventricular ejection fraction improved significantly in the first quarter and throughout the first year after program implementation in the managed group but not in the unmanaged group. Documentation of angiotensin converting-enzyme (ACE) inhibitor use (or intolerance) increased significantly in both groups in the first quarter after program implementation, but the improvement was greater in the managed group than in the unmanaged group and further improvement in subsequent quarters was observed only in the managed group. The average hospital length of stay in the managed group decreased significantly from 6.1 days before program implementation to 3.9 days after implementation. There was no significant change in average length of stay over the course of the study in the unmanaged group. The average cost per patient after program implementation was lower for managed patients ($4,404) than unmanaged patients ($6,828), despite intensified involvement of nursing staff. Nurse satisfaction was high. Randomized, controlled trial of integrated heart failure management: The Auckland Heart Failure Management Study. Doughty RN, Wright SP, Pearl A, et al. European Heart Journal. 2002;23: The impact of an integrated heart failure (HF) management program on mortality, hospital readmissions, and quality of life was evaluated in 197 patients hospitalized with HF. General practitioners were randomized to the intervention group or a control group so that all of the patients treated by that practitioner were assigned to the same group as a cluster. The intervention involved clinical review at a hospital-based clinic shortly after hospital discharge, individual and group education sessions, a personal diary to record medication administration and body weight measurements, information booklets, and regular clinical follow-up alternating between the general practitioner and clinic. The control group received usual care. There was no significant difference between the two groups in the number of patients who died or were readmitted to the hospital during 12 months of follow up (68 patients in the intervention group and 61 patients in the control group). The number of first readmissions for HF and the number of hospital bed days for first readmissions were similar for the two groups. However, fewer subsequent readmissions for HF and fewer bed days during subsequent readmissions were associated with the intervention compared with the control group. Quality of life was markedly impaired at baseline in both groups. There was a significantly greater improvement in the physical-functioning component of quality of life in the intervention group than in the control group.

19 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Effects of an exercise adherence intervention on outcomes in patients with heart failure. Duncan K, Pozehl B. Rehabilitation Nursing Jul-Aug;28(4): The effectiveness of an intervention designed to facilitate patient adherence to an exercise regimen was tested in 16 patients with heart failure (HF). Patients were randomized to the intervention or an exercise-only (i.e., control) group. Both groups participated in a 12-week supervised exercise program (phase 1), which was followed by 12 weeks of unsupervised home exercise (phase 2). Goals were established for exercise frequency and duration for both groups. The adherence facilitation intervention involved the provision of graphic feedback about exercise frequency and duration, positive feedback when goals were achieved, and help with problem solving when goals were not achieved. Physiologic outcomes that were assessed include maximum oxygen consumption (a measure of exercise capacity), baseline dyspnea index (a measure of breathlessness), and level of fatigue. Functional status was evaluated using a 6-minute walk test. A validated questionnaire was used to assess quality of life. In phase 1, there was no significant difference between the two groups in adherence (i.e., the number of exercise sessions completed). Improvement in all physiologic outcomes and functional status but not in quality of life was observed in phase 1 in the intervention group. In the control group, improvement was observed only in functional status and level of fatigue in phase 1. In phase 2, quality of life and symptoms of dyspnea and fatigue improved and maximum oxygen consumption decreased in the intervention group, although all outcomes were better than at baseline at the end of phase 2. In the control group, maximum oxygen consumption, functional capacity, and qualify of life were worse and dyspnea and fatigue were improved at the end of phase 2 compared with baseline. Adherence during phase 2 was significantly higher in the intervention group than in the control group. Thus, the patient adherence intervention has the potential to improve physiologic, functional, and quality of life outcomes in patients with HF. Impact of a comprehensive heart failure management program on hospital readmission and functional status of patients with advanced heart failure. Fonarow GC, Stevenson LW, Walden JA, et al. Journal of the American College of Cardiology. 1997;30: The impact of a comprehensive heart failure (HF) management program on hospital admissions and functional status was assessed in 214 patients with HF in a nonrandomized observational study spanning 3 years. Subjects included patients referred to the Ahmanson-UCLA Cardiomyopathy Center as potential candidates for heart transplantation who met study inclusion criteria (i.e., candidates for transplantation with no contraindications; discharged, but not too well ). All patients were initially hospitalized for formal transplant evaluation, which included invasive testing, medication evaluation, and a review of all medical records. Intensive medical therapy was then initiated (or systematically adjusted) to control HF symptoms, optimize hemodynamics, and address concomitant conditions (e.g., angina, arrhythmias). Comprehensive patient education was also provided to patients and their families in accordance with Heart Failure Practice Guidelines. This included a review of diet, lifestyle factors, and exercise, as well as symptoms and signs of worsening HF and complications. This information was conveyed by a HF clinical nurse specialist and was reinforced with patient brochures. After discharge, patients were followed by HF cardiologists in conjunction with referring physicians. This follow-up included weekly visits to the HF center until the patient was clinically stable, followed by telephone calls and clinic visits at various intervals. At each visit, medications were adjusted and patient education was reinforced. Reassessment 6 months after the intervention revealed improved New York Heart Association functional classification and exercise tolerance (i.e., improved functional status). Hospitalization rates were significantly lower, with only 63 admissions for HF during the 6 months following the program compared with 429 admissions during the 6 months prior to the program (i.e., an 85% reduction). Ninety-two percent of the patients required hospitalization prior to the program, compared with 26% after the program. Qualitatively similar results were obtained when the analysis was confined to the 179 patients who completed 6 months of follow-up without death or transplantation. For the entire group, the cost of hospital readmission after the program was estimated at $578,000 compared with $3,937,000 prior to the program. After considering the cost of the initial hospitalization for management and cost of the nurse specialist s services during follow-up (estimated at $200 to $400 per patient), the net savings was estimated at about $9,800 per patient. Reduction in heart failure events by the addition of a clinical pharmacist to the heart failure management team: results of the Pharmacist in Heart Failure Assessment Recommendation and Monitoring (PHARM) Study. Gattis WA, Hasselblad V, Whellan DJ, O Connor CM. Archives of Internal Medicine. 1999;159: The effect of involving a clinical pharmacist in the management of outpatients with heart failure (HF) was evaluated in a controlled study. Of 1,568 patients with HF evaluated at a Duke University cardiology faculty clinic, 181 patients satisfied the enrollment criteria (e.g., presence of signs and symptoms of HF, an ejection fraction less than 45%) and agreed to participate. These patients were randomized to an intervention (n = 90) or control (n = 91) group. All patients answered questions about current drug treatment to assess the regimen, compliance, and any adverse effects. [17]

20 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [18] Patients in the intervention group underwent evaluation by a clinical pharmacist, including medication review, therapeutic recommendations to the attending physician, patient education, and follow-up telemonitoring. Therapeutic recommendations included increasing use of angiotensin-converting enzyme (ACE) inhibitors, raising ACE inhibitor dosages to target levels, and using alternative vasodilators in ACE-intolerant patients, in accordance with published results from clinical research. Patient education consisted of detailed information about the purpose of each drug, importance of adherence to the prescribed regimen, directions for use, and potential adverse effects. Patients were encouraged to ask questions and were given the pharmacist s telephone number for future contact. The pharmacist also provided telephone follow-up 2, 12, and 24 weeks after the initial clinic visit to identify problems, answer questions, and evaluate HF clinical events (i.e., emergency department visits, hospitalizations for HF). Pharmacists communicated information to physicians and referred patients for evaluation when appropriate. Control subjects received standard care and were assessed and educated by physicians, physician assistants, and/or nurse practitioners. Pharmacists contacted patients in the control group at 12 and 24 weeks to identify HF clinical events but provided no recommendations or education. The median follow-up interval was 6 months. All-cause mortality and HF events (emergency department visits, hospitalizations) were significantly lower in the intervention group compared with the control group (4 events vs. 16 events). At the 6-month follow-up, patients in the intervention group were also significantly closer to the target ACE inhibitor dosage, with higher rates of use of other vasodilators in ACE inhibitor intolerant patients (75% vs. 26%). No economic effects were assessed. The authors concluded that including a clinical pharmacist in the management of HF patients improved outcomes, possibly because of increased use of ACE inhibitors and closer follow-up care. Disease management hits home. Gilbert JA. Health Data Management. 1998;6:54-56, Crozer-Keystone Health System, a Springfield, Pennsylvania based integrated delivery system, developed a disease management program for patients with congestive heart failure (CHF). This program, called Heart Success, was a multidisciplinary program designed to monitor patients after hospital visits and provide them with education and support to keep them as healthy and independent as possible. Central to the Heart Success program was a personal computer-based, automated patient follow-up system, which made automatic telephone calls to certain patients to determine their condition. The system was designed to ask a series of customized questions when the patient answers the telephone. Patients used the keypad of their touch-tone telephone to respond to the questions. The patient also had the option of speaking with a nurse after answering the last question. In 1996, Crozer-Keystone compared hospital readmission rates for an unspecified number of patients enrolled in the Heart Success program with readmission rates among patients receiving traditional home care follow-up. Results of this 9-week pilot study showed that 76% of the patients receiving home care (home visits by nurses) were readmitted to the hospital within 3 to 4 weeks after discharge. In contrast, only 18% of the patients enrolled in the Heart Success program were readmitted after 9 weeks of monitoring. The program director concluded that telemanagement is effective because it keeps patients in contact with clinicians long after discharge and it also provides a cost-effective way of identifying the 20% of patients who require additional attention. Does encouraging good compliance improve patients clinical condition in heart failure? Goodyer LI, Miskelly F, Milligan P. British Journal of Clinical Practice. 1995;49: A prospective, randomized controlled trial was conducted to evaluate whether improving medication compliance in elderly patients with chronic stable heart failure (HF) would influence objective and subjective measures of HF severity. Patients (age >70 years) at a London clinic who (1) had a diagnosis of chronic stable HF, (2) supervised their own medication use, (3) required no medication changes, and (4) met no physical or mental exclusion criteria were invited to participate. Fifty elderly patients were randomly assigned to a 3-month, intensive medication counseling program carried out by a pharmacist. Instruction about the correct use of medications proceeded according to a standard written protocol using verbal communication, medication calendars, and informational brochures. Another 50 patients constituted a no-counseling (i.e., control) group. Tablet counts and patient questionnaires were completed at the beginning and end of the study to assess knowledge and compliance. Other measures recorded at the beginning and end of the study included results on a submaximal 6-minute exercise test, visual analogue scores of breathlessness, Nottingham Health Profile scores, and clinical signs of HF. Use of clinical practice guidelines was not specified. Baseline measures were similar in the two groups. Compliance improved significantly (by 32%) in the counseled group but remained unchanged for the control group. Medication knowledge improved only for the counseled patients. Results for the 6-minute exercise test improved by 20 meters for the counseled group but worsened by 22 meters for the control patients. Distance to breathlessness also improved for the counseled patients and worsened for patients in the control group. In contrast, body weights, jugular venous pressures, and Nottingham Health Profile scores did not change significantly for either group. Peripheral and pulmonary edema scores improved for the counseled group only, along with a

21 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) small improvement in the visual analogue scores. Associated economic effects were not assessed. The authors concluded that improved compliance attributed to intensive medication counseling had a small, but measurable, beneficial effect on objective measures of HF. However, the small nature of this benefit relative to the level of improved compliance led them to doubt whether improved compliance produces a clinically relevant benefit in older patients with HF. A disease management program for heart failure: collaboration between a home care agency and a care management organization. Gorski LA, Johnson K. Lippincott s Case Management Nov-Dec;8(6): The impact of a disease management program developed through a collaborative arrangement between a home health care agency and a care management organization on outcomes was assessed in 51 patients with heart failure (HF). A nurse employed by the care management organization coordinated the program, which emphasized patient self-management skills (e.g., daily weight measurements, medication management, diet, physical activity, depression and stress management, regular medical follow-up, and notification of the physician of changes in condition). The program involved patient education (e.g., regular telephone calls, mailings) and coordination and promotion of interdisciplinary patient care using community resources, newsletters, and referrals to a home health care program. There was a 35% decrease in the hospitalization rate from 22.6 per 1,000 enrollees to 14.6 per 1,000 enrollees within 9 months after implementation of the program. Assuming a hospitalization cost of $5,000, a cost savings of $165,000 from the reduced hospitalization of patients participating in the program was projected. Daily weight measurement was assessed as an outcome representing self-care behavior. The percentage of patients performing daily weight measurements increased significantly from less than 10% before program implementation to more than 60% after implementation. Patient satisfaction was good, very good, or excellent. Effect of a heart failure program on hospitalization frequency and exercise tolerance. Hanumanthu S, Butler J, Chomsky D, Davis S, Wilson JR. Circulation. 1997;96: An observational, pre- and post-intervention comparison study evaluated whether hospitalization rates and functional outcomes improve when patients with heart failure (HF) are managed by physicians with special HF expertise, working within a dedicated HF program. All 187 patients with HF who were referred to the Vanderbilt Heart Failure and Heart Transplantation Program between July 1994 and June 1995 were identified. Most (n = 138) were referred as outpatients, and some (n = 49) were transferred from other hospitals. The mean patient age was 52 years and the mean ejection fraction was 26%. The program consisted of long-term follow-up by three physicians who work exclusively with HF and heart transplantation patients. Two nurse coordinators assisted with patient management during hospitalizations and outpatient care; home health care agencies were involved in the care of 10% of patients. All patients underwent echocardiographic evaluation as well as cardiopulmonary exercise testing, when possible. These tests were performed by program staff at a nearby outpatient laboratory. Exercise testing was repeated 3 to 6 months after enrollment to monitor status. A subgroup of patients also completed the 21-question Minnesota Living with Heart Failure Questionnaire, which assessed emotional and physical impairment due to HF. Patient information and outcomes were maintained in a computerized database, and periodic meetings were held at the Vanderbilt Home Health Agency and local hospice care programs to integrate care. The program was evaluated by comparing annual hospitalization rates, peak exercise capacity, and medication use before and after referral among patients followed for more than 30 days. Of the 187 patients referred to the program, 134 (72%) were followed for at least 30 days. During the year prior to referral, 94% of the patients had been hospitalized (210 cardiovascular hospitalizations) versus 44% during the year after referral (104 hospitalizations), which is a 53% reduction. Hospitalizations for HF decreased from 164 to 60 for all patients (regardless of follow-up duration) and decreased from 97 to 30 (a 69% reduction) for patients followed for at least 1 year after referral. Survival was 83% after the 1-year follow up. Composite scores on the Minnesota Living with Heart Failure Questionnaire improved. The authors concluded that patients with HF have fewer HF-related hospitalizations and significantly better function when managed by HF specialists working in a dedicated HF program versus physicians with limited expertise in managing HF. [19]

22 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Quality of life of individuals with heart failure: a randomized trial of the effectiveness of two models of hospital-to-home transition. Harrison MB, Browne GB, Roberts J, Tugwell P, Gafni A, Graham ID. Medical Care. 2002;40: The impact of a transitional-care intervention designed to facilitate the transition from hospital to home for patients with congestive heart failure (CHF) was assessed in a 12-week, randomized controlled trial. The impact of transitional care on health-related quality of life and rates of hospital readmission and emergency department use was compared with that of usual care in patients hospitalized for CHF in one of two large urban teaching hospitals in Canada. The transitional-care intervention involved telephone outreach within 24 hours after hospital discharge and consultations between hospital nurses and home care nurses. Patient education and supportive care for self-management were provided. Patients in both groups were visited by community nurses twice in the first 2 weeks after discharge. After 12 weeks, health-related quality of life was significantly better in the transitional-care group than in the usual-care group. The hospital readmission rate was 23% in the transitional-care group and 31% in the usual-care group, a difference that is not significant. The number of emergency department visits was significantly lower in the transitional-care group than in the usual-care group (29% vs. 46%). The intervention consisted of patient education, daily self-monitoring, and physician notification of abnormal weight gain, vital signs, and symptoms. Each patient received weekly educational mailings describing 52 topics related to HF. These materials were based on Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) guidelines for patients with HF and were reinforced during weekly telephone calls by a nurse. Patients also received a digital scale and an automatic blood pressure cuff, and were instructed in the use of these items. The patients were then provided a toll-free number to use daily in transmitting blood pressure, pulse, weight, and symptom data to a computer. If data fell outside an established normal range, a nurse followed up with the patient and faxed the information to the physician. Patients could also contact the physician directly with any health concern. The patients were followed for a mean of 7.4 months. During this interval, there were 294 physician notifications of abnormal signs or symptoms in 53 patients; approximately 1 in 8 notifications resulted in a change in the patient s medical regimen. The average compliance with call-ins by patients was 85%. Quality-of-life measures did not change significantly over the course of the study. To further assess the impact of the intervention, average claims per year before the intervention were compared with claims per year during the intervention. In addition, claims by intervention-group patients were compared with those of a matched control group (n = 86 patients) to control for technological improvements or disease progression. Compared with the previous year, medical claims per year decreased in the intervention group ($8,500 to $7,400) but increased in the control group ($9,200 to $18,800). Similarly, hospital days per year significantly decreased from 8.6 to 4.8 in intervention patients, while increasing from 8.9 to 17 in control patients. The number of admissions per year did not differ significantly between the two groups. The program s effectiveness was unrelated to age, sex, or type of left ventricular dysfunction. The average cost of the program was estimated at $200 per patient per month. Considering this cost, the cost of care per year for intervention patients was $9,800 vs. $18,800 for control patients. Disease Management for for Hear Failure [20] Effect of a home monitoring system on hospitalization and resource use for patients with heart failure. Heidenreich PA, Ruggerio CM, Massie BM. American Heart Journal. 1999;138: The effect of a low-intensity monitoring program on outcomes, including hospitalizations and cost of care, were assessed in 68 patients with heart failure (HF) in this nonrandomized, matchedcontrol study. Eligible patients were identified from a claims database and included those with symptomatic HF who were cared for by one of 31 community physicians within a multidisciplinary medical group. Prospective evaluation of an outpatient heart failure management program. Hershberger RE, Ni H, Nauman DJ, et al. Journal of Cardiac Failure. 2001;7: The effects of a heart failure outpatient management program on clinical and cost outcomes of care were assessed in 108 patients with chronic, symptomatic CHF. The 6-month period before referral to the program was compared with the 6-month period after referral. The program involved the use of current practice guidelines for treating CHF, frequent telephone contact between nurses and patients, pre-emptive hospitalization (hospitalization for impending decompensation based on clinical assessment), patient educational needs assessment, and patient counseling, which were provided by a team of cardiologists, specially trained and experienced nurses, and a social worker. Patients self-care knowledge (e.g., the warning signs of heart failure progression, the importance of daily body weight measurement and dietary salt intake restriction) and the percentage of patients weighing themselves daily increased significantly after participation in the program, although patient adherence to the prescribed med-

23 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) ications and diet did not change (adherence at baseline was good). The severity of illness (New York Heart Association functional class) and need for emergency department visits and hospitalization for cardiovascular causes decreased significantly, and quality of life improved significantly. The hospitalization rate decreased from 56% before referral to the program to 27% after participation in the program. The corresponding before and after figures for emergency department use were 54% and 15%, respectively. The average estimated cost savings associated with reduced hospitalization was $4,307 per patient. Disease management: a smart way to interact with patients. Hinkle AJ. Health Management Technology. 2000;Apr. 21(4):38. Blue Cross and Blue Shield of New Hampshire used an Internetbased disease management program for patients with congestive heart failure (CHF) identified electronically through claims data. The Web-based program was designed to assess patients willingness to change, educate patients about CHF, and promote positive behavioral change. Enrollment in the program increased 125% over a 4-month period. Frustration with CHF decreased in more than 90% of patients, and knowledge of the disease increased in more than 82% of patients. Quality of life improved in at least half of patients. [See the summary of Anon. Web-based educational effort for CHF patients boosts outcomes while cutting costs. Disease Management Advisor Jun;7(6):92-96.] A randomized trial of telenursing to reduce hospitalization for heart failure: patient-centered outcomes and nursing indicators. Jerant AF, Azari R, Martinez C, Nesbitt TS. Home Health Care Services Quarterly. 2003;22(1):1-20. The impact on hospital readmission charges and emergency department visits of two types of telenursing (1) home telecare with real-time video interactions between patients and health care providers and (2) telephone calls was compared with usual care after hospitalization over a 180-day period in 37 patients with congestive heart failure (CHF). In-person visits were made by nurses to patient homes shortly after hospital discharge and about 60 days later for all treatment groups. Nurses made recommendations to primary care providers for changes in therapy as appropriate. Patient self-care teaching by nurses addressed the disease process, daily weight monitoring, sodium restriction, smoking cessation, moderation in alcohol intake, weight loss (for obese patients), aerobic exercise, and medication use and adherence. CHF-related readmission charges were more than 80% lower in the telenursing groups (i.e., home telecare group and telephone group) compared with the usual-care group. The number of emergency department visits was significantly lower with telenursing than with usual care. A randomized trial of the efficacy of multidisciplinary care in heart failure outpatients at high risk of hospital readmission. Kasper EK, Gerstenblith G, Hefter G, et al. Journal of the American College of Cardiology. 2002;39: A randomized controlled trial was conducted to compare the effects of an outpatient management program and usual care on hospital readmissions and mortality over a 6-month period in 200 patients hospitalized with congestive heart failure (CHF) who were at increased risk for readmission. Patients were judged at increased risk for readmission because of age greater than 70 years, left ventricular ejection fraction less than 35%, at least one additional CHFrelated hospital admission in the previous year, ischemic cardiomyopathy, peripheral edema at the time of hospital discharge, a weight loss of less than 3 kg while in the hospital, peripheral vascular disease, or a low cardiac index or high systolic or diastolic blood pressure or pulmonary capillary wedge pressure. The intervention was provided by a multidisciplinary team comprising a cardiologist, CHF nurse, telephone nurse coordinator, and the patient s primary physician. The intervention involved periodic follow-up telephone calls by the telephone nurse coordinator; development of an individualized treatment plan; patient visits with the CHF nurse, who followed a treatment algorithm for adjusting medications; and provision of a scale, low-sodium meals, telephone, and transportation if needed by the patient. Patients receiving usual care served as controls. There were significantly fewer hospital readmissions and deaths in the intervention group (43 readmissions and 7 deaths) than in the usual-care group (59 readmissions and 13 deaths) during the 6- month study. At the end of the study, patients were less symptomatic and quality of life had improved to a greater extent in the intervention group compared with the control group. There was no significant difference between the intervention group and the control group in inpatient or outpatient resource use. The cost per patient was similar with the intervention and usual care. [21]

24 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [22] Implementing a congestive heart failure disease management program to decrease length of stay and cost. Knox D, Mischke L. Journal of Cardiovascular Nursing. 1999;14: Beginning in 1995, Evanston Northwestern Healthcare (ENH) created a multidisciplinary disease management program for congestive heart failure (CHF) designed to decrease length of stay (LOS), reduce costs, prevent readmissions, and improve compliance with treatment. ENH is an integrated delivery system consisting of two teaching hospitals affiliated with Northwestern University. It has about 800 admissions for CHF per year. The program consisted of an integrated program of inpatient consultation and education, patient visits to an outpatient clinic, cardiac home care, and monitoring of compliance through an automated telemanagement program. The inpatient component consisted of a 5-day LOS pathway created by members of a multidisciplinary treatment team. This clinical pathway is based on the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) heart failure guidelines and financial information from the institution. Informational inservice educational conferences were presented to hospital personnel caring for CHF patients to ensure successful pathway implementation. The physician leader of the treatment team also introduced the pathway to attending physicians, and quarterly reports summarized clinical and financial outcomes following implementation. The core of the educational program embodied in the pathway was individualized patient education. The goal of such education was to explore reasons for treatment nonadherence, develop strategies for effective disease management, and encourage health promotion (i.e., allow patients to become comanagers of their disease). Material was presented to the patients in written and audio form. The outpatient clinic was designed to optimize medications and stratify patients by risk to allow more frequent visits for noncompliant and high-risk (end-stage CHF) patients. To reduce emergency visits, cardiac home care was also available. Lastly, compliance monitoring, via an automated telemanagement program (CHF Tel- Assurance program), was used to reinforce education, identify early warning signs, and reduce the likelihood of hospitalization. Patients called in their daily weights and answered CHF-related questions. They also received information about exercise and diet, their medical regimen, and the next clinic appointment. Advanced practical nurses monitored this system and communicated with patients and physicians as appropriate. Although this report does not define a specific population, it does provide some general outcome data for patients participating in the ENH CHF program. After 18 months, telemanagement participants compliance rate averaged 89.5%. Patient satisfaction surveys indicated a high level of satisfaction with the CHF Tel-Assurance program. CHF hospitalization rates with the program were 0.6 per patient per year at ENH, compared with the national benchmark of 1.7 per patient per year. The 30-day readmission rate for patients participating in the program was 2.3% (compared with 23% nationally) and the LOS was 4 days (compared with a national average of 6.2 days). Intensive home-care surveillance prevents hospitalization and improves morbidity rates among elderly patients with severe congestive heart failure. Kornowski R, Zeeli D, Averbuch M, et al. American Heart Journal. 1995;129: A nonrandomized, pre- and post-intervention comparison study evaluated the impact of intensive home care surveillance on morbidity of elderly patients with severe congestive heart failure (ejection fraction less than 40%, New York Heart Association functional class III or IV). Forty-two patients (mean age 78 years and ejection fraction 27%) who had completed 1 year of home surveillance were included in the study. All recruited patients had also been hospitalized at least once for cardiovascular complications during the year preceding program enrollment. The outcomes of program participants at the 12-month follow-up were compared with medical data for these same patients collected during the year prior to the intervention. The intervention consisted of weekly home visits by an internist affiliated with the Tel Aviv Medical Center. The visits included a history and physical examination, review of medications, laboratory studies and intravenous medications (as needed), and discussion of treatment plans for the coming week (i.e., patient education and planning). In addition, various therapies (e.g., physical therapy, oxygen, extra home visits) were available, and paramedical staff provided extra patient support. Evaluation at the end of the first year of home care surveillance revealed a significant decrease in the mean total hospitalization rate. The hospital length of stay also significantly decreased, and similar reductions were seen in cardiovascular admissions. The ability of patients to perform daily activities (i.e., functional status) also significantly improved, and drug therapy was modified at least once in all 42 patients. The authors concluded that an intensive home care program was associated with a marked decrease in the need for hospitalization and improved functional status of elderly patients with severe congestive heart failure. The authors suggested that such a service might offer a cost-effective advantage and have a major impact on health expenditures, although costs were not assessed in the study.

25 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Nonpharmacologic therapy improves functional and emotional status in congestive heart failure. Kostis JB, Rosen RC, Cosgrove NM, Shindler DM, Wilson AC. Chest. 1994;106: A 12-week, parallel-design randomized controlled trial was conducted to compare the effects of a multimodal nonpharmacologic intervention with both digoxin and placebo in patients with congestive heart failure (CHF) who were receiving background therapy with an angiotensin-converting enzyme (ACE) inhibitor. Twenty patients with New York Heart Association functional class II or III CHF and an ejection fraction <40% treated at the University of Medicine and Dentistry of New Jersey Robert Wood Johnson Medical School were randomized to one of three treatment groups: nonpharmacologic treatment (n = 7), digoxin therapy (n = 7), or placebo (n = 6). The 12-week nonpharmacologic treatment program included (1) graduated exercise training (e.g., walking, cycling, rowing) three to five times per week; (2) structured cognitive therapy and stress management twice weekly for 60 to 90 minutes; and (3) weekly dietary counseling and interventions aimed at salt reduction and weight reduction in overweight individuals. All three aspects of the program were provided in a group setting. Biomedical and behavioral assessments were completed before and after the program. The treatment with digoxin or matching placebo was initiated at a starting dose of mg, and the digoxin dosage was titrated to achieve a blood level between 0.8 and 2.0 ng/ml. Placebo and digoxin were both administered in a randomized, double-blind fashion. The authors concluded that nonpharmacologic therapy improved functional capacity, body weight, and mood in patients with CHF. In contrast, digoxin improved the ejection fraction without corresponding changes in exercise tolerance or quality of life. Randomized trial of an education and support intervention to prevent readmission of patients with heart failure. Krumholz HM, Amatruda J, Smith GL, et al. Journal of the American College of Cardiology. 2002;39: The impact of a targeted education and support intervention on the rate of hospital readmission or death and hospital costs was assessed in a 1-year, randomized controlled trial of 88 patients with congestive heart failure (CHF) who were at least 50 years old. Patients were randomized to an intervention group or a control group. In the intervention group, patient knowledge of each of five care domains for chronic illness (knowledge of the illness, relationship between medications and the illness, relationship between health behaviors and the illness, knowledge of early signs and symptoms of decompensation, and where and when to obtain assistance) was assessed to identify knowledge gaps. An experienced cardiac nurse provided patient education. Telephone calls were made to patients to reinforce the care domains. Recommendations for changes in treatment were not part of the telephone calls, although the nurse made recommendations to the patient to contact his or her physician as needed if the health status deteriorated. The control group received usual care. The percentage of patients who died or were readmitted to the hospital during the 1-year study was significantly lower in the intervention group (57%) than in the control group (82%). The total number of readmissions was 49 in the intervention group and 80 in the control group, representing a significant 39% reduction. The total estimated cost of the intervention was $530 per patient. Average hospital readmission costs were significantly lower in the intervention group ($14,420) than in the control group ($21,935). The net cost savings associated with the intervention was $6,985 per patient after taking into consideration the cost of the intervention. Comparison of Health Buddy with traditional approaches to heart failure management. LaFramboise LM, Todero CM, Zimmerman L, Agrawal S. Family & Community Health Oct-Dec;26(4): Four strategies for delivery of the education content of a heart failure (HF) disease management program were compared in a 2- month pilot study of 90 patients discharged from the hospital with a primary diagnosis of HF within the previous 6 months. Patients were randomized to one of four strategies: (1) telephonic case management, (2) five home visits for patient assessment and education (i.e., home care), (3) assessment and education by using a telehealth communication device (Health Buddy), and (4) a combination of home visits and the telehealth communication device. The telehealth communication device had a screen that displayed questions from the health care provider and allowed patients to respond. It also provided patients with education according to a script developed by the health care provider. Patient responses were automatically transmitted electronically to the health care provider for review. Follow-up phone calls were made to the patient if his or her responses suggested an exacerbation of the disease. Twenty (30%) of 66 patients assigned to use the telehealth communication device were unable to use it because of poor health, technical problems (e.g., lack of electrical outlets or telephone service), or poor eyesight. Self-efficacy (i.e., level of confidence in making lifestyle and behavioral changes related to HF management) worsened in the telephonic case management group and improved in the other three groups. There were no significant differences between the groups in measures of functional status, mood, or quality of life. At the end of the 2-month pilot study, functional status (i.e., performance in a [23]

26 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [24] 6-minute walk test) had improved from baseline to a significant extent in all four groups. More than half (52%) of patients improved their walking distance by 10%, and 45% improve their walking distance by 20%. At baseline, 29% of participants were depressed. Depression improved from baseline in all four groups, although the improvement from baseline was not significant. Quality of life improved significantly from baseline in all four groups. [See the summary of Todero CM, LaFramboise LM, Zimmerman LM. Symptom status and quality-of-life outcomes of home-based disease management program for heart failure patients. Outcomes Management Oct-Dec;6(4): ] Case management in a heterogeneous congestive heart failure population: a randomized controlled trial. Laramee AS, Levinsky SK, Sargent J, Ross R, Callas P. Archives of Internal Medicine. 2003;163: A randomized controlled trial was conducted to evaluate the effect of a hospital-based nurse case management program on hospital readmission rates in 287 patients with congestive heart failure (CHF). Patients with a primary or secondary diagnosis of CHF and a left ventricular ejection fraction less than 40% or radiologic evidence of pulmonary edema requiring diuresis (i.e., a heterogeneous patient population) were randomized to the intervention or a control group that received usual care. The intervention consisted of early discharge planning and coordination of care, individualized and comprehensive patient and family education, 12 weeks of telephone follow-up, and promotion of optimal CHF medications and doses based on consensus guidelines. A care manager coordinated these services. After 90 days there was no difference between the two groups in the hospital readmission rate (37%). Patients in the intervention group required fewer days of hospitalization than those in the control group (6.9 days vs. 9.5 days), but the difference was not significant. Patient adherence to the treatment plan was better in the intervention group than in the control group for daily weight measurements, checks for edema, and a low-salt diet, but both groups took medications as prescribed equally well. Patient satisfaction was significantly greater in the intervention group compared with the control group. The intervention reduced the total inpatient and outpatient median cost and the readmission median cost by 14% and 26%, respectively. The differences between the intervention group and control group were not significant, although the differences might be significant if the intervention was used for a larger number of patients. The effect of a nurse-managed CHF clinic on patient readmission and length of stay. Lasater M. Home Healthcare Nurse. 1996;14: A 1-year pre- and post-intervention comparison study was conducted to examine the impact of a nurse-managed clinic on hospital readmission rates for exacerbation of congestive heart failure (CHF) among 80 patients with CHF or cardiomyopathy managed at home. Beginning in July 1993, all patients from the tricounty area surrounding the South Carolina Medical Center with such a diagnosis were automatically enrolled in the clinic for care after hospital discharge. The clinic program focused on precautions to reduce or detect the signs and symptoms of CHF, including a complete cardiopulmonary assessment, daily weights, and patient education (medications, sodium-restricted diet). The expertise of physicians, dieticians, and social workers was used in collaboration with primary management by registered nurses. Follow-up care was scheduled at the nurse s discretion, and critical-path algorithms directed this care. Financial assistance was available to facilitate care and the procurement of medication or supplies. Prior to program implementation, the medical center observed a 25.6% readmission rate within 6 months among 39 patients with CHF or cardiomyopathy. The average length of stay (LOS) was 7.3 days. Reanalysis of these measures in a comparable patient population (n = 41) 6 months after program implementation showed a significant drop in the readmission rate to 21.9%; the average LOS had also significantly decreased to 5.7 days. Comparison of hospitalization charges preintervention ($6,898) and 1 year post-intervention ($6,404) further revealed a decrease in charges of almost $500 per patient. The decreased costs were thought to represent decreased severity of illness upon readmission. Improved patient knowledge of medications was also observed after the intervention. Assessment patients, chronic heart failure, and home care. Lazarre M, Ax S. Caring. 1997;16:20-22, 24. A study assessed the impact of a cardiac specialty program for home care developed by a private home health care agency (TGC Home Health Care Inc of Lakeland, FL) on outcomes in patients with heart failure (HF). In this program, nurses with a critical-care background provided targeted teaching to patients and families about disease pathophysiology, risk factors, and management of symptoms, diet, weight, and medications. Critical pathways were used to ensure clarity and consistency of information provided. Each patient was also assigned a cardiac nurse case manager who planned and delivered care and monitored patients for signs and symptoms of CHF exacerbation. Other members of the multidisciplinary treatment team included a home care aide, social worker, and physical or occupational therapist. Several types of assess-

27 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) ment and therapy were available, including comprehensive cardiopulmonary assessment, electrocardiographic monitoring, pulse oximetry, intravenous diuretic administration, and inotropic support. During the 7-month course of this study, 34 patients entered the program. Study inclusion criteria included admission to home health care with a primary or secondary diagnosis of HF and a diagnosis of HF as either an acute exacerbation or new onset. Staff measured hospital readmission rates in this population 30 and 90 days following enrollment and documented rates of 2.9% and 8.8%, respectively. These rates reflected 7 admissions among 6 of the 34 patients. The rates were significantly lower than the national average readmission rates of 16% (30 days) and 32% (90 days), as reported by the Cardiology Pre-eminenece Roundtable. No attempt was made to convert outcomes into potential savings. The authors concluded that a home care program featuring targeted teaching, close monitoring by cardiac-trained nurses, and early management of HF exacerbations may reduce hospital readmissions and translate into cost savings. A study of the relationship between home care services and hospital readmission of patients with congestive heart failure. Martens KH, Mellor SD. Home Healthcare Nurse. 1997;15: A retrospective chart audit was conducted to (1) explore the relationship between home care nursing services and hospital readmission rates in patients with a primary diagnosis of congestive heart failure (CHF) and (2) obtain descriptive information about home health care nurse interventions provided to patients with CHF by a specific hospital-based home care agency. The care provided to patients with CHF was audited because a fiscal report identified CHF as the most common admission diagnosis. By using the hospital s computerized medical records, all patients with CHF discharged from the hospital to the home over a 1-year interval were retrospectively identified and evaluated. Of the 1,176 CHF discharges during 1993 and 1994, 924 patients were discharged to home with or without a referral for home care services. Most discharges (79%) were to the home only, with only 247 patients referred to a home health agency. There were 219 readmissions to the hospital within 12 months after discharge among the 924 patients. This figure included admission of 162 patients who were readmitted between one and six times. Patients receiving home care services were readmitted to the hospital significantly less often within 90 days after discharge than the patients not receiving such services. This relationship approached significance after 35 days, but no significant relationship was found 14 or 28 days after discharge. Length of stay for the patients readmitted ranged from 1 to 56 days, with most staying 4-7 days. Of the 247 discharged patients with referral to a home health care agency, 120 (48%) patients were referred to the hospital-based home care agency involved in the study. Most referrals involved extended care, with an average of registered nurse visits per referral. Fifty-seven patients (48%) were readmitted to the hospital, with 50 (42%) readmissions occurring within 3 months. A quality assurance focused review of care for all patients admitted to home care with CHF for one quarter of the year (n = 32) revealed that 9 patients (28%) were readmitted to the hospital within 3 months. All of these readmissions occurred within 26 days, leading the authors to conclude that hospital readmission was related to the reason for initial hospitalization. To elicit possible variables related to hospital readmission, documentation of care provided to 31 members of a 32-patient subgroup was analyzed. These data consisted of three categories of information: areas of assessment (e.g., vital signs, heart and lung sounds, weight, medication compliance), assessment of findings (e.g., documentation of edema, weight gain, medical compliance), and patient teaching (i.e., documentation of instructions to patients about nutrition, medications, disease management). This focused review indicated that many areas were always assessed, with the exception of medication compliance. Most patients also received instructions, but documentation suggested instructions were not provided at each visit. Of the nine patients in this subgroup who were readmitted, the vital signs of four (44%) were outside normal limits; vital signs were also abnormal in seven (32%) of the 22 not readmitted. The difference between groups was not significant. Similarly, no significant difference was found between five patients readmitted for evidence of fluid overload and 12 patients with fluid overload who were not readmitted. Outcomes for patients with congestive heart failure in a nursing case management model. Morrison RS, Beckworth V. Nursing Case Management. 1998;3: A retrospective chart review was conducted to evaluate outcomes in patients with congestive heart failure (CHF) who received care according to a hospital-based nursing care management model developed at an acute-care hospital in the southeastern United States. The broad theoretical framework for this model was continuous quality improvement (CQI). Multidisciplinary CQI teams were established for specific case types, including CHF. A physician was designated team champion, and a case manager was named team facilitator. The function of each team was to identify the best practice, develop a critical pathway of care, and spearhead its approval and implementation. Once a critical pathway was implemented, the case manager assumed the role of consultant/auditor, including taking responsibility for patients whose care did not follow the critical pathway. Patients whose care followed the pathway were typically managed by the nursing unit registered nurses. CHF was the [25]

28 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [26] diagnosis with the highest volume and costs at this institution, so the critical pathway for CHF was developed first. The retrospective chart review yielded data for 50 randomly selected CHF patients who received care under the nursing care model approximately 5 years after it was first introduced. Outcomes assessed in these patients included length of stay (LOS), costs, physiologic status, physical functioning, health knowledge, and family caregiver status. The mean LOS in 1996 was 5.4 days compared with about 17 days in similar patients hospitalized in 1991, before implementation of the model. The mean fixed costs, variable costs, and total costs for the 50 patients were estimated as $2,491, $1,858, and $4,291, respectively. Whereas several significant correlations existed among various outcome measures, the only predictor of LOS identified via regression analysis was number of medications. Only 15 of 28 patients who met the criteria for use of angiotensin-converting enzyme inhibitor therapy in Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) guidelines were taking the medication at the time of discharge from the hospital. The authors concluded that further attention to compliance with such guidelines is needed, along with collection of more data about physiologic status during hospitalization, closer evaluation of a patient s health knowledge prior to discharge, and revision and further testing of the data collection instrument. Telemanagement of heart failure: a diuretic treatment algorithm for advanced practice nurses. Mueller TM, Vuckovic KM, Knox DA, Williams RE. Heart Lung Sep-Oct;31(5): Telemanagement (i.e., telephone contact between patients and health care providers) and a diuretic treatment algorithm with pharmacologic and nonpharmacologic interventions were used in an effort to prevent decompensation in 200 patients with heart failure (HF). Advanced-practice nurses contacted patients by telephone to identify problems and provide patient education, with the goal of reducing morbidity, clinic visits, and hospitalization. The diuretic treatment algorithm was based on evidence-based medicine and was designed to provide consistent care while allowing for flexibility in clinical judgment and implementation of an individualized plan of care. Patient compliance with the telephone calling program was high (90%). The 30-day hospital readmission rate decreased from 2.3% in to 0.7% in The hospitalization rate decreased by 50%, and hospital costs for treating HF decreased by 52% as a result of the intervention. Emerging information management technologies and the future of disease management. Nobel JJ, Norman GK. Disease Management Winter;6(4): The use of emerging information management technology involving a remote biometric measuring and monitoring device in the home setting was studied in patients with congestive heart failure (CHF). Patient data (body weight and symptoms) were automatically transmitted on a daily basis to a central call station that was monitored by cardiac nurses who analyzed trends and notified the physician if the data suggested a change in patient health status. Patients with a deteriorating condition were called and encouraged to seek same-day or emergency care. The device also allowed for interactive communication between patients and nurses, which helped patients adhere to the prescribed health regimen, including medications and weight management. The nurses assessed patient understanding of the disease, treatment, self-care skills, diet, and medication compliance. Two populations of health maintenance organization members (an elderly one more than 65 years of age and a younger one 65 years of age or younger) were compared before and 12 months after installation and use of the device. Comparisons also were made with control patients in each age group who did not participate in the intervention. Data were obtained for 78,038 member-months for the elderly group (including 66,297 member-months that served as a control) and 7,477 member-months for the younger group (including 6,408 member-months that served as a control). In the elderly population, the bed days per thousand members per year were reduced by 53% in the intervention group and by 0% in the control group; costs paid per member per month decreased by 50% in the intervention group and by 0% in the control group. In the younger group, the bed days per thousand members per year were reduced by 62% in the intervention group and by 9% in the control group; the costs paid per member per month were reduced by 60% in the intervention group and by 9% in the control group. Heart failure disease management in an indigent population. O Connell AM, Crawford MH, Abrams J. American Heart Journal. 2001;141: The effects of a multidisciplinary disease management program for outpatients on functional status (New York Heart Association functional class, which reflects severity of illness), hospitalization rate, and costs were assessed in a nonrandomized study of indigent patients admitted to a university hospital with heart failure. Group A was comprised of 14 patients with a hospital readmission rate of at least two times per year and an ejection fraction of 45% or less who were not candidates for transplantation. Group B was comprised of 21 patients referred by their primary care provider or the

29 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) hospital team at the time of hospital discharge because of a high likelihood of readmission due to financial, social, or nonadherence issues. The ejection fraction was 45% or less in group B. Patients enrolled in the multidisciplinary disease management program were frequently monitored in an outpatient clinic, with weekly telephone contact. Written information and individualized counseling about symptoms, diet, exercise, and medications were provided to patients. A medication consultation, with assessment for drug interactions, patient education, and medication adjustment in accordance with Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) guidelines, was performed by a cardiovascular pharmacist. Patients were referred as needed to a dietitian, diabetes case manager, and cardiac rehabilitation team. The intervention was the same for patients in group A and group B, but the two groups were analyzed separately because of different characteristics (e.g., greater severity of illness in group A). The 1-year period before program enrollment was compared with the 1-year period after enrollment. After 1 year, functional status improved significantly in both groups, possibly as a result of improved medication use. The need for hospitalization decreased from 33 and 9 admissions in group A and group B, respectively, in the year before program enrollment to 3 and 0 admissions, respectively, in the year after enrollment. The savings in hospital charges associated with the program for group A and group B were $167,000 and $50,000, respectively. The net savings when hospital and clinic charges were considered for both groups combined amounted to $4,600 per patient. Enhanced access to primary care for patients with congestive heart failure: Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission. Oddone EZ, Weinberger M, Giobbie-Hurder A, Landsman P, Henderson W. Effective Clinical Practice. 1999;2: A multisite, randomized controlled trial evaluated whether enhanced access to primary care affects the diagnostic evaluation, pharmacologic management, and health outcomes of patients hospitalized with congestive heart failure (CHF). Eligible patients included veterans hospitalized at one of nine Veterans Affairs medical centers with a diagnosis of CHF, among other conditions. These patients were randomly assigned to receive enhanced access to care (n = 222) or usual care (n = 221) and were followed for 6 months. The intervention (enhanced care) was delivered by a primary care physician/registered nurse team. Prior to discharge, the nurse educated each patient in obtaining daily weights and appropriate use of diuretics. Educational materials from the American Heart Association about living with heart failure also were reviewed. The physician and nurse visited the patient to review medications, establish a treatment plan, and provide contact information for follow-up outpatient care. Following discharge, the nurse telephoned the patient within 2 days to assess any problems and arranged follow-up appointments with the nurse and doctor within 1 week. The frequency of other visits and telephone calls was discretionary. Control patients received the usual care offered at their facility, which did not include access to a primary care nurse, supplemental education, or needs assessment. Of the 504 patients who entered the study, complete data were available for 443 patients. About 80% of patients in both groups underwent recommended evaluation of left ventricular ejection fraction. Among patients for whom an angiotensin-converting enzyme (ACE) inhibitor was recommended in accordance with Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) guidelines (i.e., those with an ejection fraction <40%), three quarters in both the enhanced-access and usualcare groups received the drug (75% and 73%, respectively). Enhanced access to primary care did not improve quality of life (assessed via survey). Patients with enhanced access to care averaged 1.5 readmissions in 6 months of follow-up compared with 1.1 readmissions for patients who received usual care, a difference that is significant. The authors concluded that compliance with recommended CHF testing and treatment was equally high in both study groups. They also observed that enhanced access to primary care did not improve patients self-reported health status and was associated with more frequent hospitalizations. Impact of a nurse-managed heart failure clinic: a pilot study. Paul S. American Journal of Critical Care. 2000;9: The clinical and economic effects of a nurse practitioner-managed, multidisciplinary outpatient heart failure clinic were evaluated in a 12-month nonrandomized study in which patients served as their own controls. The clinic was developed in 1995 at a southeastern university hospital to enhance the follow-up and management of patients with chronic congestive heart failure (CHF). After initial evaluation by a cardiologist at the clinic, patients and their families received additional evaluation and education from a nurse practitioner (about diet, exercise, body weight, and symptom management) and clinical pharmacist (about medications). The nurse practitioner then followed a protocol to determine the frequency and need for follow-up telephone calls and clinic visits. These calls and visits were used to reinforce education, assess patient needs, arrange tests, and adjust medication. At each clinic visit, the patient saw the physician, the nurse practitioner, and a clinical pharmacist, and had access to a dietitian and social worker as needed. The clinic offered flexibility in allowing the nurse practitioner to see patients on demand for evaluation and treatment that could reduce the risk for hospital readmission. [27]

30 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [28] The convenience study sample consisted of 15 patients with CHF who were referred to the clinic after admission to an affiliated university hospital. Data were retrieved from a computerized medical record system for the 6 months prior to and the 6 months following clinic enrollment (i.e., patients served as their own controls). The patients had a total of 38 hospital admissions (151 hospital days) in the 6 months before joining the clinic compared with 19 admissions (72 hospital days) in the 6 months afterward. These decreases in total number of hospital admissions and hospital days were significant. There were also nonsignificant decreases in mean length of stay (4.3 days vs. 3.8 days) and the number of emergency department visits (10 vs. 8). The mean inpatient hospital charges per patient admission decreased from $10,624 to $5,893, and reimbursements were $7,751 (a 73% collection rate) and $5,138 (a 87% collection rate), respectively. Mean charges for emergency department visits decreased from $390 before clinic enrollment to $284 afterward. The authors concluded that participation in the heart failure clinic appeared beneficial and that early management of CHF exacerbation may decrease readmissions and improve outcomes. The results of a randomized trial of a quality improvement intervention in the care of patients with heart failure. Philbin EF, Rocco TA, Lindenmuth NW, Ulrich K, McCall M, Jenkins PL. The MISCHF Study Investigators. American Journal of Medicine. 2000;109: The impact of a multifaceted quality improvement intervention on quality of care, hospital length of stay and charges, in-hospital and 6-month mortality, hospital readmissions, and quality of life of patients with heart failure was compared with that of usual care in a randomized controlled trial. Ten acute-care community hospitals were randomized to the intervention or usual care, and data were collected for a 9-month baseline period and a 9-month period after the intervention, including 6 months after hospital discharge for each patient. The intervention comprised use of inpatient, emergency department, and home care critical pathways, with diagnostic tests and treatments based on published clinical trial results, expert guidelines, and widely accepted practices. The emergency department pathway emphasized rapid diagnosis and initiation of treatment. Videotaped presentations to the hospital staff and teaching aids for patients and families were used to improve staff and patient knowledge. The intervention was managed by physicians, nurse leaders, and administrators responsible for quality management. Markers of quality of care included measurement of left ventricular systolic function, documentation of the primary cause of heart failure, proper dietary counseling, and prescribing of angiotensin-converting enzyme inhibitors. The changes from baseline in markers of quality of care were mixed and not significantly different for the intervention compared with usual care. Average hospital length of stay decreased from baseline by 1.8 days in the intervention group and by 0.7 days in the control group, a difference that is not significant. Hospital charges decreased slightly in the intervention group and increased slightly in the control group. The intervention produced small changes in mortality, hospital readmission, and quality of life that were not significantly different from those associated with usual care. A community hospital-based congestive heart failure program: impact on length of stay, admission and readmission rates, and cost. Rauh RA, Schwabauer NJ, Enger EL, Moran JF. American Journal of Managed Care. 1999;5: The impact of a multidisciplinary inpatient and outpatient congestive heart failure (CHF) program was evaluated in a retrospective analysis of patients hospitalized at a community-based hospital with a primary diagnosis of CHF. The control group comprised 407 patients treated during the year prior to program initiation. The intervention group consisted of 347 patients treated in the program for 1 year. A subset of the intervention group (n = 81) received outpatient inotropic therapy designed to address signs of CHF decompensation and avoid the need for hospital readmission. The program (intervention) used a multidisciplinary team approach based on Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) guidelines. Patients were managed in accordance with inpatient and outpatient treatment protocols established and implemented by team members. A 4-day inpatient heart failure clinical path addressed necessary consultations/tests, treatment, diet, activity, patient education, and discharge planning. Patients at high risk for decompensation upon discharge were referred to an outpatient, hospital-based CHF clinic for follow-up management, including the intermittent administration of intravenous inotropes. Team members were educated about the protocols, clinical paths, services for CHF patients, and patient education materials at the individual and group level. Patients and their families learned how to manage CHF via a nurse-directed educational program focusing on diet, compliance, and symptom recognition. After hospital discharge, patients received regular follow-up telephone calls to address problems and encourage compliance with the home CHF management regimen. The primary endpoint for the analysis was length of stay (LOS) for all CHF-related hospital admissions. Secondary endpoints were the primary admission rate for CHF management, the readmission rate within 90 days after discharge, and the per-case cost to the patient and provider for all CHF admissions. Compared with the control group, patients in the intervention group had a significantly reduced LOS (5.7 days vs. 7.3 days), significantly fewer admissions for CHF management (404 vs. 503), and a lower 90-day readmission rate (13% vs. 18%). The mean cost per admission was $6,719 in the control group and $5,601 in the program group, representing a 17% reduction in cost per admission. A 77% net reduction in non-

31 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) reimbursed (lost) hospital revenue ($718,468) was also noted after program implementation. The cost of operating the outpatient heart clinic was approximately $104,000, and revenue generated from the program was about $211,000. Data regarding the effectiveness of the outpatient inotropic therapy in avoiding readmission were not included in the report. Prevention of readmission in elderly patients with congestive heart failure: results of a prospective, randomized pilot study. Rich MW, Vinson JM, Sperry JC, et al. Journal of General Internal Medicine. 1993;8: The impact of a nurse-directed, nonpharmacologic, multidisciplinary intervention on hospital readmissions in elderly patients with congestive heart failure (CHF) was evaluated in a prospective, randomized controlled trial. Patients at least 70 years of age who were admitted to a secondary and tertiary teaching hospital over a 1- year interval were screened for CHF. Ninety-eight patients (mean age 79 years) who were considered at moderate-to-high risk for early hospital readmission were enrolled. The patients were stratified by risk and randomly assigned to receive conventional physician-directed care supplemented by a nurse-directed multidisciplinary team (n = 63) or conventional care by their usual physician (n = 35). The intervention consisted of (1) comprehensive education by an experienced geriatric cardiovascular nurse, (2) a detailed medication review with specific recommendations designed to improve compliance and reduce side effects, (3) social service consultations to facilitate discharge planning and the transition back to home, (4) individualized dietary teaching by a registered dietitian, and (5) enhanced follow-up care through home care and telephone contacts. The follow-up care consisted of regular home visits, in accordance with federal home care guidelines, and nurse-initiated telephone calls. Patients also received educational materials (including a patient guide to CHF), charts, and medication cards to facilitate appropriate dietary modification, medication compliance, and daily self-monitoring of weight. Patients in the control group received conventional care that could include social service evaluation, dietary and medication teaching, and home care; but this care was considered lower in intensity than the care provided to the intervention group. All patients were followed for 90 days after initial hospital discharge. The primary endpoints were rehospitalization within 90 days and the cumulative number of days hospitalized during follow-up. The 90-day readmission rate was 33% for the patients in the intervention group compared with 46% for the patients in the control group, a difference that is not significant. The mean number of hospital days was not significantly different in the two groups; it was 4.3 for the intervention group versus 5.7 for the control group. In a subgroup of 61 patients at intermediate risk for readmission, the intervention reduced readmissions by 42% (from 48% to 28%), and there was a trend toward reduction in the average number of hospital days (a change from 6.7 days to 3.2 days). The authors concluded that a comprehensive, multidisciplinary approach to reducing repetitive hospitalizations in elderly patients with CHF might lead to a reduction in readmissions and hospital days, particularly in patients at moderate risk for early rehospitalization. They felt that further evaluation of this treatment strategy in a larger trial, including an assessment of the cost-effectiveness, was warranted. Extrapolation of these data to all CHF patients discharged after short-stay hospitalization suggests a potential cost savings of $262.5 million per year, although no cost data were analyzed in the study. A multidisciplinary intervention to prevent the readmission of elderly patients with congestive heart failure. Rich MW, Beckham V, Wittenberg C, Leven CL, Freedland KE, Carney RM. New England Journal of Medicine. 1995;333: The effects of a nurse-directed, multidisciplinary intervention on rates of readmission, quality of life, and costs of care for high-risk elderly patients with congestive heart failure (CHF) were evaluated in a prospective, randomized controlled trial. Patients at least 70 years of age who were admitted to the Washington University Medical Center because of CHF were eligible to participate if they had at least one risk factor for early readmission. Of 282 eligible patients, 142 were randomly assigned to an intervention group and 140 were assigned to a control group. The intervention consisted of nurse-directed education about CHF for the patient and family, individualized dietary assessment and instruction, social-service consultation for discharge planning, medication review by a geriatric cardiologist, and intensive follow-up. The follow-up consisted of home care services supplemented by individualized home visits and telephone contact with members of the multidisciplinary treatment team. The goal of this follow-up was to reinforce education, ensure dietary and medication compliance, and identify CHF symptoms amenable to outpatient treatment. Patients in the control group received standard treatment and services ordered by their physicians. All patients were followed for 1 year, although the primary study endpoint was readmission-free survival after 90 days. That status was achieved in 91 patients (64%) in the intervention group compared with 75 patients (55%) in the control group, a difference that is not significant. However, when the analysis was limited to survivors of the first hospitalization, the difference between the two groups was significant. There were significantly fewer readmissions within 90 days for any reason in the intervention group (53 vs. 94 readmissions, which is a 44% reduction). Readmission for CHF was less frequent in the intervention group (24 vs. 54 readmissions, [29]

32 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [30] which is a 56% reduction). The total hospital days per patient also was reduced in the intervention group (3.9 vs. 6.2 days, which is a 37% reduction). The proportion of patients readmitted more than once in the 90-day follow-up interval was also significantly less (6% vs. 16%). In a subgroup of 126 patients who completed the Chronic Heart Failure Questionnaire, quality-of-life scores after 90 days were improved from baseline to a significantly greater extent in patients in the intervention group than in patients in the control group. The average cost of the intervention was $216 per patient. Caregiver costs and nonhospital costs did not differ significantly between the two groups, although the cost of hospital readmission was significantly higher in the control group ($3,236 vs. $2,178). The overall cost of care was estimated to be $460 less per patient in the intervention group because of the reduction in hospital admissions. Effect of a multidisciplinary intervention on medication compliance in elderly with congestive heart failure. Rich MW, Gray DB, Beckham V, Wittenberg C, Luther P. American Journal of Medicine. 1996;101: Medication compliance was evaluated in elderly patients with congestive heart failure (CHF) to identify factors associated with reduced compliance and to assess the effect of a multidisciplinary treatment approach on medication adherence. Patients in this prospective randomized controlled trial were a subset of patients at least 70 years old enrolled in a previous trial conducted at the Washington University Medical Center. The patients had been admitted to the hospital with CHF and satisfied study entry criteria. Prior to discharge, 156 eligible patients were randomly assigned to the intervention (n = 80) or conventional care (n = 76). The intervention began while the patients were still hospitalized. Patient education about CHF management was provided using a 15-page teaching guide prepared by the study team. A study nurse visited each patient daily to emphasize the importance of compliance with medications and diet. Each patient also received dietary instruction from a dietitian and discharge planning from a social service representative. Shortly prior to discharge, a geriatric cardiologist made specific recommendations regarding each patient s medication regimen. Following discharge, patients were visited by the hospital s home care department and were contacted regularly by the study nurse. Patients in the control group received conventional medical care including standard hospital services (i.e., dietary teaching, medication instructions). Detailed data on all prescribed medications were collected at the time of hospital discharge, and medication compliance was assessed by pill counts performed at the patient s home roughly 30 days later. The overall compliance rate during the first 30 days after discharge was 85%. Compliance was 88% for patients in the intervention group compared with 81% for patients in the control group, a difference that is significant. Eighty-five percent of patients in the intervention group achieved a compliance rate of 80% or greater versus 70% of patients in the control group. The difference is significant. Multivariate analysis showed that assignment to the intervention group was the strongest independent predictor of compliance, although Caucasian race and not living alone were also predictive of compliance. Hospital readmission rates were determined for the first 90 days following hospital discharge. During this interval, 22 control-group patients (29%) and 18 intervention-group patients (23%) were readmitted to the hospital 31 and 22 times, respectively. Total days of rehospitalization were 258 days for the control group and 188 days for the intervention group. Thus, readmissions per patient were reduced by 33% and hospital days were reduced by 31% in patients randomized to the intervention group. Independent predictors of readmission were low systolic blood pressure and high blood urea nitrogen concentration. There was a trend toward fewer readmissions in patients who were more than 90% compliant. The authors concluded that such a multidisciplinary treatment strategy appears to improve medication compliance in elderly CHF patients and may improve outcomes. Effect of a standardized nurse case-management telephone intervention on resource use in patients with chronic heart failure. Riegel B, Carlson B, Kopp Z, LePetri B, Glaser D, Unger A. Archives of Internal Medicine. 2002;162: A randomized controlled trial was conducted to assess the effects of a telephone congestive heart failure (CHF) case management intervention on resource use. Physicians were randomized to an intervention group or a usual-care control group so that the same approach was used for all patients treated by a particular physician. Patients were identified at the time of hospitalization and were followed for 6 months after discharge from the hospital. The intervention was based on a decision support software program designed to emphasize factors known to predict hospitalization in patients with CHF (i.e., patient nonadherence to medications and diet, lack of knowledge of the signs and symptoms of worsening illness). Printed education materials were mailed to patients in the intervention group monthly. Physicians in the intervention group received patient progress reports produced automatically by the software, using data collected by telephone. Physicians also received phone calls from case managers (registered nurses) about specific patient concerns as needed. Care for patients in the usual-care group was not standardized and presumably involved patient education before hospital discharge. After 6 months, the heart failure hospitalization rate in the intervention group was 48% lower than that in the usual-care group. The

33 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) average number of hospital days for CHF was 46% lower and the percentage of patients with multiple admissions was 43% lower in the intervention group compared with the usual-care group. Inpatient heart failure costs were 46% lower in the intervention group. All of these differences were significant. The intervention yielded cost savings even after the costs of the intervention were taken into consideration. There was no evidence of cost shifting from the inpatient setting to the outpatient setting. Patient satisfaction was greater in the intervention group than in the usual-care group. Disease management interventions to improve outcomes in congestive heart failure. Roglieri JL, Futterman R, McDonough KL, et al. American Journal of Managed Care. 1997;3: The impact of selected disease management interventions (e.g., post-hospitalization follow-up) on outcomes in patients with congestive heart failure (CHF) or a CHF-related diagnosis were studied in a managed care setting. The analysis was part of a 24-month, multicenter, longitudinal comparison study of a comprehensive CHF disease management program. Study subjects consisted of 149 patients enrolled in the CHF disease management program and all members of a managed care plan. The program participants were enrolled in the CHF program following physician or social worker referral or identification by review of medical claims. The larger population of health plan members corresponded to plan membership for the third quarters of 1995 (n = 139,922) and 1996 (n = 161,267). The program consisted of patient education, nurse-initiated telephone calls to patients (telemonitoring), a home visit by a nurse (post-hospitalization discharge intervention), and physician education (mailings and telephone calls to raise program awareness.) The telemonitoring and education-oriented interventions were available only to patients enrolled in the program, although all members of the health plan were eligible for the guideline-based clinical interventions. Guidelines directing treatment for patients with CHF and CHF-related diagnoses included those from the American Heart Association, the Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality), and NYLCare Health Plans. Review of hospital and emergency department utilization data provided information about utilization events, which were categorized as attributable to pure CHF or a CHF-related diagnosis. The effects of the program were then analyzed for pure CHF and CHF-related diagnoses, with outcomes for the third quarter of 1996 (post-intervention follow-up) compared with those for the third quarter of 1995 (pre-intervention baseline). Overall, the data demonstrated significantly reduced admission and readmission rates for patients with a pure CHF diagnosis. Among the entire CHF patient population, the third quarter admission rate declined 63%, and the 30-day and 90-day readmission rates declined 75% and 74%, respectively. Among program participants with a pure CHF diagnosis, the 30-day readmission rate was reduced to 0, and an 83% reduction occurred for both the thirdquarter admission and 90-day readmission rates. In addition, the average length of stay for patients with CHF-related diagnoses was significantly reduced among both plan participants and program participants. Reductions were seen in total hospital days and emergency department utilization. The authors concluded that a comprehensive disease management program can reduce health care utilization not only among CHF patients in the program, but also among an entire managed care plan population. A medication discharge planning program: measuring the effect on readmissions. Schneider JK, Hornberger S, Booker J, Davis A, Kralicek R. Clinical Nursing Research. 1993;2: The effect of a medication discharge-planning program on hospital readmissions among patients with congestive heart failure (CHF) in a quasi-experimental, after-only, randomized controlled study. Five nurses implemented the program for 54 patients with CHF who were admitted to a 600-bed nonprofit, Midwestern medical facility over a 5-month interval. All enrolled patients had the cognitive capability to self-administer medications and were taking one or more medications at the time of discharge from the hospital. These patients were randomly assigned to a control (n = 28) or an experimental group (n = 26). The experimental group participated in the medication discharge-planning program, and the control group received the usual informal discharge planning provided on the nursing unit. Five nurse investigators were trained by the principal investigator to follow a specific format for medical discharge planning based on Orem s theory of self-care. Training involved a review and practice of the discharge-planning format. Discharge planning was conducted prior to hospital discharge. It involved oral presentation of information about the prescribed medication by the nurse investigator. This information was consistent with printed medical information cards provided to the patient. The cards listed the purpose of each medication, side effects, whom and when to call with questions, and any medication-specific instructions. The nurse investigator also reinforced information and corrected any patient misunderstandings about medications. Family members, if present, were included in the program. The nurse investigator next inquired about the patient s daily routine and assisted him or her in scheduling medication administration times. Patients were then queried about problems with taking med- [31]

34 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [32] ications at home. If the patient identified no problems, the nurse investigator posed two potential problems (forgetfulness and limited budget) and discussed solutions to these problems. Finally, the nurse briefly reviewed the medication schedule and purpose of each medication. Subsequent reinforcement and instruction were provided as appropriate. Patients also were given a physician telephone number for any questions once they had left the medical center. The entire interaction took about 20 minutes. The two groups were similar with respect to all demographic data. The total number of medications at the time of hospital discharge ranged from 1 to 11. Eight (29%) of the 28 patients in the control group were readmitted within 31 days after discharge compared with 2 (8%) of the 26 patients in the experimental group. The difference is significant. The authors concluded that these findings confirm the importance of a medication discharge-planning program. Congestive Heart Failure Disease Management Study: a patient education intervention. Serxner S, Miyaji M, Jeffords J. Congestive Heart Failure. 1998;4: The effects of educational mailings and compliance aides on hospital readmissions, quality of life, and compliance were evaluated in a 6-month randomized controlled trial of 109 elderly patients hospitalized with congestive heart failure (CHF). The subjects were identified by selecting all patients with a diagnosis of CHF discharged from Columbia Good Samaritan Hospital and Columbia San Jose Medical Center within a 1-year interval. Study exclusion criteria consisted of CHF of noncardiac origin, inability to speak English, no telephone or residence, and discharge to a skilled nursing facility outside of the Columbia Hospital system. Patients were randomized to an education intervention (n = 55) or standard care (n = 54). The intervention consisted of mailings at 3- to 4-week intervals of a personalized letter and a wide range of educational materials (booklets, brochures, fact sheets, resource guide, video). These materials were accompanied by compliance aides (medication sheets and a weight chart). Patients in the control group received the customary hospital education but no special information after discharge. Trained nurse interviewers conducted telephone surveys before and after the intervention for all patients. The survey used was a unique instrument designed by a multidisciplinary CHF patient education task force that assessed CHF knowledge, attitudes, self-efficacy, and key outcome behaviors. The medical staff was informed about the study by mail to raise program awareness. Hospital records were used to monitor patient health care utilization related to CHF admissions and costs. No data were collected on admissions or emergency department visits to hospitals not within the system. Compliance, quality of life, and hospital readmissions were monitored for 6 months. In the control group, 27 (50%) of the patients were admitted at least once during this interval compared with 15 (27%) of the patients in the intervention group. The 44% reduction in readmissions was significant. Multiple readmissions were more common among patients in the control group than in the intervention group. Compared with the control group, the intervention group had a significantly lower (by 51%) total number of readmissions (21 vs. 43 in the control group). Post-test analysis revealed significant differences between the control and intervention groups on key behavioral and attitudinal measures (reduction in salt intake, change in cooking habits, weight monitoring). There also were significant differences between the two groups on frequency of forgetting medications (i.e., medication compliance), self-efficacy scores, and ratings of personal health. Compared with the control group, the intervention group reported better overall health status, greater confidence in self-management, and enhanced compliance with diet, medications, and weight monitoring. The cost of the educational program was $50 for patients, and the average cost of a CHF admission to the study medical facility at that time was $6,000. Based on the reduced readmission rate, the investigators estimated that the intervention reduced overall costs. A net return on the investment of $8:$1 for the hospital and $19:$1 for thirdparty payers was projected. Prevention of hospitalizations for heart failure with an interactive home monitoring program. Shah NB, Der E, Ruggerio C, Heidenreich PA, Massie BM. American Heart Journal. 1998;135: A 1-year observational pre- and post-intervention comparison study was conducted to determine whether a program less rigorous than some intensive multidisciplinary interventions could reduce hospitalizations in patients with moderate or severe congestive heart failure (CHF). A secondary aim of the study was to ascertain whether benefits associated with some inpatient programs directed at elderly patients with CHF would extend to younger individuals with the disease treated as outpatients. Twenty-seven patients (mean age 62 years) with class II IV CHF satisfied enrollment criteria and entered the study. These patients included patients referred to the Heart Failure Clinic at the San Francisco Veteran Affairs Medical Center after a recent hospitalization or while treated as stable outpatients. The intervention featured patient education and self-monitoring, automated reminders to improve compliance, and telephone communication with a nurse monitor. Educational materials relating to symptoms, medications, and management of CHF were mailed to participants weekly for the first 8 weeks of the study. Patients also received devices and instruction in obtaining daily weights and vital signs, and were given a pager through which they received reminders regarding medications and measurements. Patient clinical status was assessed and physiologic data were collected in

35 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) weekly telemonitoring phone calls by study nurses. Patients were also provided with 24-hour telephone access to a nurse to report changes in their condition, weight gain, or medical emergencies. Cardiologists reviewed physiologic data weekly and received immediate notification of patient changes in status. Nurses followed up any such notifications with the patient, and physicians reported any actions taken to the nurse. The primary endpoints were numbers of hospitalizations and hospital days during the mean follow-up period of 8.5 months compared with values during an equivalent period before the intervention. Overall, the number of hospitalizations per patient-year of follow-up after enrollment (0.4) did not differ significantly from the number prior to enrollment (0.8). However, cardiovascular hospitalization significantly decreased from 0.6 per patient-year to 0.2 per patientyear. All-cause and cardiovascular hospital days also decreased significantly from 9.5 to 0.8 per patient-year and 7.8 to 0.7 per patient-year, respectively. During the study, there were 52 physician notifications by the monitoring system for 65 reported problems (e.g., weight gain, shortness of breath, edema). This notification resulted in 19 physician interventions, 50% of which were to increase the dosage of diuretics or change other cardiac medications. Patient acceptance of the program was high, with 82% rating the program as useful or very useful. The treating physicians also found the program helpful in permitting medication adjustments by phone. No associated economic effects were reported. Effects of a home-based intervention among patients with congestive heart failure discharged from acute hospital care. Stewart S, Pearson S, Horowitz JD. Archives of Internal Medicine. 1998;158: The effect of a home-based intervention (HBI) on readmission and death among high-risk patients with congestive heart failure (CHF) was evaluated in a randomized controlled trial conducted at a tertiary referral hospital in Australia. Hospitalized patients with CHF/systolic dysfunction, exercise intolerance, and recurrent hospital admissions for acute CHF were eligible to participate. Ninety-seven patients were randomized to receive usual care (n = 48) or the HBI (n = 49). Before hospital discharge, HBI patients were visited by the study nurse and counseled about compliance with the treatment regimen and the need to report any signs of clinical deterioration. One week after discharge, these patients received a home visit by a nurse and pharmacist. The pharmacist assessed patient medication knowledge by questionnaire and medication compliance by pill count. Patients who demonstrated poor medication knowledge or noncompliance received remedial counseling, a daily medication reminder, a weekly medication container, incremental monitoring by caregivers, medical information/reminder cards, and referral to a community pharmacist. The nurse also evaluated patients for evidence of clinical deterioration or adverse effects from medications; patients were referred to their primary care physician as appropriate. The nurse also contacted patients primary care physicians to discuss the visit and arrange more intensive follow-up, as appropriate. Patients in the usual-care group received normal levels of postdischarge care, including follow-up physician appointments within 2 weeks after hospital discharge and home support in some cases (27%). Seven patients (14%) assigned to the HBI group received no home visit because of early readmission or study withdrawal. The home visit to the remaining patients revealed that 22 (52%) patients were noncompliant with medications and 38 (90%) patients had inadequate knowledge of the treatment regimen. Therefore, most HBI patients required remedial measures, including referral of nine patients to community pharmacists. In addition, 14 patients showed signs of clinical deterioration, prompting referral to the primary care physician. Patients were followed for 6 months after the intervention to evaluate the primary composite study endpoint (unplanned readmissions plus out-of-hospital deaths) and secondary endpoints (time until first endpoint, rate of unplanned readmission, total hospital days, emergency department visits, overall mortality, and costs). During follow-up, HBI patients had significantly fewer unplanned readmissions (36 vs. 63) and a trend toward fewer out-of-hospital deaths (1 vs. 5) than control patients. The composite primary endpoint was 0.8 vs. 1.4 events per patient assigned to HBI and usual care, respectively. The difference is significant. There were no significant differences between the two groups in time until primary endpoint, percentage of patients with unplanned admissions, or overall mortality. However, HBI patients had fewer days of hospitalization (261 vs. 452) and significantly fewer visits to the emergency department (48 vs. 87) than the control group. The mean cost of hospitalbased care for the HBI group averaged $3,200 versus $5,400 for the usual-care group. The estimated cost of the intervention was $190 (Australian dollars) per patient; outpatient costs for the two groups did not differ. Effects of a multidisciplinary, home-based intervention on unplanned readmissions and survival among patients with chronic congestive heart failure: a randomised controlled study. Stewart S, Marley JE, Horowitz JD. The Lancet. 1999;354: In a 6-month randomized controlled trial, 200 patients with chronic congestive heart failure (CHF) who were discharged home after acute hospital admission were randomly assigned to usual care (n = 100) or a multidisciplinary, home-based intervention (n = 100). Eligible patients included those who had been admitted to a tertiary referral hospital in Australia and (1) were 55 years old or older, (2) [33]

36 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [34] had New York Heart Association functional class II, III, or IV CHF, (3) had at least one prior hospital admission for acute CHF, and (4) met no study exclusion criteria. The study began with assessment of all patients immediately prior to discharge to obtain baseline demographic, clinical, and psychosocial data. Patients were then randomized to the intervention group or usual-care group, and existing norms for discharge planning were applied to all patients (including follow-up appointments within 2 weeks after discharge at an outpatient cardiac clinic). Patients assigned to the home-based intervention group then received a structured home visit by a cardiac nurse within 7 to 14 days after discharge. Nurse assessments included a physical examination, review of medication compliance, and evaluation of the patient s understanding of appropriate treatment for CHF (e.g., appropriate diet, exercise, symptom recognition). Based on this assessment, patients and their families (if appropriate) received a combination of remedial counseling, introduction of strategies to improve treatment compliance and response, incremental monitoring by caregivers, and referral to a primary care physician for urgent care, if appropriate. The nurse then sent a report to the patient s primary care physician and cardiologist detailing results of the assessment and any remedial actions. The nurse then arranged any changes in pharmacologic therapy and additional home visits, as appropriate, as well as follow-up telephone contacts after 3 and 6 months. The patients were followed for 6 months (the effective intervention duration). The primary composite study endpoint was frequency of unplanned readmissions plus out-of-hospital deaths within 6 months. Secondary endpoints included time to first endpoint (event-free survival), frequency of unplanned admissions alone, frequency of out-of-hospital deaths alone, days of unplanned readmissions, functional status and quality of life, and hospital and community-based health care costs. During 6 months of follow-up, there were 129 primary-endpoint events in the usual-care group and 77 events in the intervention group, a difference that is significant. Significantly more intervention-group patients than usual-care patients remained event free (51 vs. 38). There were also significantly fewer unplanned readmissions (68 vs. 118) and associated days in the hospital (460 vs. 1,173) among intervention-group patients. Whereas intervention-group patients had superior qualityof-life scores after 3 months of follow-up, scores did not differ significantly between the two groups after 6 months. Hospital-based costs amounted to $490,300 (Australian) for the intervention group and $922,600 for the usual-care group. Community-based health care costs were similar for the two groups. The mean cost of the intervention was $350 per patient. Home-based intervention in congestive heart failure: longterm implications on readmission and survival. Stewart S, Horowitz JD. Circulation. 2002;105: The long-term effects of a multidisciplinary, post-discharge, homebased intervention were evaluated in participants in two previously published studies (see the summaries of Stewart S, Pearson S, et al. Archives of Internal Medicine. 1998;158: and Stewart S, Marley JE, et al. Lancet. 1999;354: ), involving a total of 297 patients with congestive heart failure (CHF). The intervention involved home visits by nurses to optimize medication management, provide patient education, identify early signs of clinical deterioration, and intensify medical follow-up as appropriate. Patients were randomized to the intervention or usual care. After a median follow-up time of 4.2 years, there were significantly fewer unplanned hospital readmissions and deaths in the intervention group (0.21 events per patient per month) than in the usualcare group (0.37 events per patient per month). The median eventfree survival time was significantly longer in the intervention group (7 months) than in the usual-care group (3 months). The median cost (in Australian dollars) of unplanned readmissions was significantly lower in the intervention group ($325 per month per patient) than in the usual-care group ($660 per month per patient). Nurse-led heart failure clinics improve survival and self-care behaviour in patients with heart failure: results from a prospective, randomised trial. Stromberg A, Martensson J, Fridlund B, Levin LA, Karlsson JE, Dahlstrom U. European Heart Journal. 2003;24: The impact of a nurse-led heart failure (HF) clinic on morbidity, mortality, and self-care behavior was studied in a 12-month, randomized controlled study of 106 patients who were admitted to the hospital for HF. The intervention involved follow-up after hospitalization by trained cardiac nurses who made changes in medications according to protocol and provided education and social support to the patient and his or her family. The control group received usual care. The intervention group had significantly fewer deaths and hospital admissions and days, and scored significantly higher on a questionnaire about self-care behaviors (a high score reflects better behavior) than the control group. A 55% decrease in admissions per patient per month was associated with the intervention.

37 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Symptom status and quality-of-life outcomes of home-based disease management program for heart failure patients. Todero CM, LaFramboise LM, Zimmerman LM. Outcomes Management Oct-Dec;6(4): Changes in CHF symptom occurrence and characteristics and quality of life were evaluated over a 2-month period in 93 patients with CHF who had recently been discharged from the hospital and were referred by their physician to a home disease management program. Nurses visited the patients at home at baseline (approximately 1 month after hospital discharge) and again 2 months later to assess symptoms and collect data. The program included routine reminders to monitor symptoms and suggestions for symptom management. A patient education videotape explaining the disease and its management was shown, and patients were given an educational manual for reference. Patients were randomized to one of four strategies for delivery of the educational component of the program: (1) telephonic case management, (2) five home visits for patient assessment and education (i.e., home care), (3) assessment and education by using a telehealth communication device (Health Buddy), and (4) a combination of home visits and the telehealth communication device. However, because a preliminary analysis revealed that symptom status did not differ at baseline or the end of the study based on which group the patient was assigned to, the data for the four groups were combined. The most common symptoms at baseline were fatigue (86%) and shortness of breath (78%). The percentage of patients experiencing these and each of nine other symptoms was decreased from baseline at the end of the study. Shortness of breath was the most common symptom at the end of the study, affecting 75% of patients. Fatigue was the second most common symptom at the end of the study, affecting 70% of patients. The frequency, severity, amount of interference with physical activity, and the interference with enjoyment of life from shortness of breath improved over the 2-month study. Similarly, the frequency, severity, amount of interference with physical activity, and the interference with enjoyment of life from fatigue improved during this period. Improvements in quality of life also were reported. [See the summary of LaFramboise LM, Todero CM, Zimmerman L, Agrawal S. Comparison of Health Buddy with traditional approaches to heart failure management. Family & Community Health Oct-Dec;26(4): ] Heart failure collaborative care: an integrated partnership to manage quality and outcomes. Urden LD. Outcomes Management for Nursing Practice. 1998;2: Preliminary outcome information is reported about an integrated disease case management program for heart failure (HF) that was established at a hospital in response to the complexity and difficulty of treating patients with HF. First, an interdisciplinary team created an inpatient HF clinical pathway with the goals of decreasing length of stay (LOS) of hospitalized HF patients and eliminating or minimizing unnecessary readmissions and emergency department visits. Work was then begun to integrate this inpatient HF pathway with a home care HF pathway. The net result was the development of a HF service consisting of five overlapping components: (1) inpatient consultation with a nurse practitioner (NP) and cardiologist, pathway care, and comprehensive discharge planning and teaching; (2) regular outpatient follow up at a HF clinic with an NP, cardiologist, and nurse clinician; (3) intermittent outpatient intravenous infusion therapy, managed by a nurse clinician who was supervised by an NP and cardiologist; (4) ongoing outpatient telemanagement by a nurse clinician; and (5) linkage with appropriate community, home health, and referral services. Preliminary outcome data gathered for 108 patients seen on the service indicate that patients have been satisfied with the service, accessibility, timely response, and personalized care. However, because no baseline data about satisfaction with care were obtained, no conclusions about changes in satisfaction with care can be drawn. Early assessment also showed an increase in consultations (e.g., dietician and social service referrals) by more than 20%. Patient education (about HF medication, diet, and symptom management) was thought to be considerably improved. Significant improvements were noted in overall quality of life, emotional functioning, and physical functioning after 3 months of follow-up. The LOS for hospitalized HF patients decreased by 1.1 days since implementation of the HF inpatient pathway. Readmissions within 30 days after discharge decreased from 17% to 4%. The decrease in overall LOS resulted in $2,700 in cost savings per patient hospitalization. These emerging trends suggest that the HF service interventions will have additional positive fiscal outcomes. Pharmaceutical care of patients with congestive heart failure: interventions and outcomes. Varma S, McElnay JC, Hughes CM, Passmore AP, Varma M. Pharmacotherapy. 1999;19: The effects of a structured pharmaceutical care program for patients with congestive heart failure (CHF) on disease control, quality of life, and health care facility utilization were evaluated in a longitudinal, prospective, randomized controlled trial. Elderly patients who were hospitalized or attended an outpatient clinic in [35]

38 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Disease Management for for Hear Failure [36] one of three study sites in Northern Ireland were recruited. Eightythree patients with a confirmed diagnosis of CHF who (1) were more than 65 years old, (2) had an adequate cognitive status, and (3) met no exclusion criteria were restrictively randomized to an intervention group (n = 42) or a control group (n = 41). Groups were matched as well as possible for CHF severity, renal function, concomitant illness, and cognitive status. The intervention group received algorithm-based education from a research pharmacist about CHF, its treatment, and lifestyle changes for symptom control. Educational material was provided in written and oral form. Patients were also encouraged to monitor their symptoms and comply with prescribed drug therapy. This was reinforced by providing patients with monitoring diary cards that they were to show to their physicians and community pharmacists. Instructions for an extra dose of diuretic were provided in the event of a defined weight gain or symptoms. If necessary, dosage regimens were simplified in liaison with hospital physicians. The research pharmacist discussed the project with physicians and community pharmacists, and obtained information from community pharmacists about dispensed medications for evaluating medication compliance. The 41 patients in the control group received standard care, excluding education and counseling by the pharmacist, self-monitoring, or liaison among physicians and community pharmacists. The following outcome measures were assessed in all patients at baseline as well as after 3, 6, 9, and 12 months: 2- minute walk test, blood pressure, body weight, pulse, forced vital capacity (FVC), quality of life, knowledge of symptoms and drugs, compliance with therapy, and health care utilization. Body weight, pulse, and FVC did not differ between the two groups after the intervention. Patients in the intervention group tended to have higher blood pressures, with a significant difference between the two groups in diastolic pressures noted after 12 months. Patients in the intervention group showed improved compliance with drug therapy on some measures (drug use profile data but not self-reported data), which in turn improved aspects of their exercise capacity (distance walked) compared with patients in the control group. Education on management of symptoms, lifestyle changes, and dietary recommendations also benefited patients in the intervention group, as suggested by superior scores on quality-of-life, physical functioning, and emotional health assessments. Drug therapy knowledge improved significantly in the intervention group during the 12-month study compared with the control group. There were significantly fewer hospital admissions in the intervention group (14 vs. 27 in the control group). Although intervention-group patients tended to have more emergency department visits (15 vs. 7) and doctor emergency visits (38 vs. 35), there were no significant differences between the two groups in these measures. Specific costs were not determined. Does increased access to primary care reduce hospital readmissions? Veterans Affairs Cooperative Study Group on Primary Care and Hospital Readmission. Weinberger M, Oddone EZ, Henderson WG. New England Journal of Medicine. 1996;334: In a multicenter, randomized controlled trial conducted at nine Veterans Affairs (VA) Medical Centers, 1,396 veterans hospitalized with diabetes (n = 751), chronic obstructive pulmonary disease (n = 583), or congestive heart failure (n = 504) were randomized to a customary post-discharge care group or an intensive, primary care intervention group. Exclusion criteria included certain concomitant illnesses, plans for care from a skilled nursing facility, inability to speak English, lack of a telephone, and poor cognitive status. Baseline assessment showed that the patients were severely ill; two thirds were considered at medium or high risk for readmission. Half of those with congestive heart failure had New York Heart Association functional class III or IV disease. Baseline quality-of-life scores were poor. The intervention was delivered by a team consisting of a registered nurse and a primary care physician. The intervention was designed to increase access to primary care after hospital discharge, with the goals of reducing readmissions and emergency department visits and increasing patients quality of life and satisfaction with care. It involved close follow-up by the team, beginning before discharge and continuing for 6 months. Prior to discharge, patients in the intervention group were assessed by a primary care nurse and were given educational materials and a card with team member names and beeper numbers. The primary care physician also visited patients to review the hospital course, discharge plans, and medication regimens. The nurse then scheduled a follow-up clinic appointment within 1 week after discharge. The nurse telephoned patients within 2 days after discharge to assess potential problems and remind patients about their appointments. Additional reminders and protocols for missed appointments were implemented as necessary. Patients in the control group received customary post-discharge care, without primary care nurse access, supplemental education, or needs assessment. Patients were followed for 180 days after hospital discharge using a national database of VA hospitalization information and computer systems at local hospitals. Although patients in the intervention group received more intensive care, they had a significantly higher monthly readmission rate (0.19 vs 0.14) and more days of rehospitalization (10.2 vs. 8.8) than patients in the control group. Patients in the intervention group were more likely to be readmitted than patients in the control group (49% vs. 44%, respectively), and the readmission tended to occur sooner in intervention-group patients than in control-group patients. Intervention-group patients were significantly more satisfied with their care than were control-group patients, although quality-of-life scores did not differ between the two groups. The study lacked adequate power to permit subgroup

39 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) analysis, but no significant differences in outcomes were noted between the three disease strata. The authors concluded that the primary care intervention increased rather than decreased the rate of rehospitalization among patients discharged from VA hospitals, although the intervention was associated with greater patient satisfaction with care. A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization. West JA, Miller NH, Parker KM, et al. American Journal of Cardiology. 1997;79: The feasibility and safety of a physician-supervised, nurse-mediated, home-based system for heart failure (HF) management was evaluated in an observational study involving 51 patients with HF. This MULTIFIT system was designed to effectively implement consensus guidelines for pharmacologic and dietary therapy using a nurse manager to enhance compliance and monitor patient clinical status by telemonitoring. Patients recently hospitalized with HF at a Kaiser-Permanente medical center and outpatients referred by physicians with a diagnosis of HF were recruited for the study. Nurse case managers, who worked in conjunction with primary physicians, were primarily responsible for implementing the MULTI- FIT intervention. It consisted of an initial comprehensive nurse visit to the patient s home followed by regularly scheduled, nurse-initiated telephone calls. The frequency of these calls was predetermined but could be increased if symptoms progressed or after a recent event (e.g., emergency department visit, hospitalization). Nurse managers also educated patients about HF-related issues, including sodium restriction, pharmacotherapy, and symptom recognition. Behavioral techniques were introduced to improve compliance and foster self-monitoring skills. Physician consultation was available on an as-needed basis, and a primary physician retained overall responsibility for patient management. Patient management was directed by locally adapted guidelines consistent with the American College of Cardiology/American Heart Association consensus report, as well as Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality) clinical practice guidelines. One specific goal of implementing the guidelines was to optimize use of vasodilator therapy (i.e., angiotensin-converting enzyme [ACE] inhibitors, hydralazine). Local cardiologists assisted with developing guideline implementation goals consistent with the local environment. Monitoring of care by the nurse manager provided information about guideline compliance. Fifty-one patients with the clinical diagnosis of HF were followed for a mean of 138 days after program enrollment. Compared with the 6 months before program enrollment, medical resource utilization declined significantly after enrollment. For example, utilization rates for general medical visits, cardiology visits, HF-related emergency department visits, and total emergency department visits decreased by 23%, 31%, 67%, and 53%, respectively. Compared with the 12 months before enrollment, hospitalizations for HF decreased significantly (by 87% from 1.12 to 0.15 per year) and the total hospitalization rate decreased significantly (by 74% from 1.61 to 0.42 per year). Functional status, symptomatic status, and health-related quality of life also improved during the intervention as determined by the Duke Activity Status Index, New York Heart Association functional class, and the Short Form-36. The program also achieved pre-established pharmacologic and dietary goals, with significant increases in dosages of ACE inhibitors and hydralazine. For example, the percentage of patients taking target dosages of the ACE inhibitor lisinopril increased from 45% to 83%. For hydralazine, the percentage of patients taking target dosages increased from 10% to 70%. Self-reported use of dietary sodium significantly decreased. The total contact time between nurse managers and patients (including the initial 2-hour visit) averaged 7.0 hours. The authors concluded that the MULTIFIT system enhanced the effectiveness of pharmacologic and dietary therapy for HF in clinical practice, improving outcomes and compliance and reducing medical resource utilization. The benefit of implementing a heart failure disease management program. Whellan DJ, Gaulden L, Gattis WA, et al. Archives of Internal Medicine. 2001;161: The effects of a congestive heart failure (CHF) disease management program on medication use, hospitalization rate, number of clinic visits, and costs were evaluated in a randomized, prospective study of 117 patients with a recent hospitalization for CHF, an ejection fraction less than 20%, or symptoms consistent with New York Heart Association functional class III or IV. The program involved the use of treatment protocols, follow-up clinic visits and telephone calls, and a patient education manual. The mean enrollment time was 4.7 months. The use of angiotensin converting-enzyme inhibitors was high at baseline (78%) and did not change significantly as a result of the intervention (79%). The use of beta-blockers increased significantly from baseline (52%) to the end of enrollment (76%). As a result of the intervention, the hospitalization rate decreased significantly from 1.5 hospitalizations per patient-year to none, and the number of clinic visits increased significantly from 4.3 clinic visits per patient-year to 9.8 clinic visits per patient-year. The outpatient cost per patient-year increased by $659, and the inpatient cost per patient-year decreased by $6,963. The cost per discharge also decreased. A total cost savings of $8,571 per patient-year was associated with the intervention. [37]

40 Appendix B. Reports of the Impact of Disease Management Interventions on Treatment of Congestive Heart Failure (continued) Uptake of self-management strategies in a heart failure management programme. Wright SP, Walsh H, Ingley KM, et al. The European Journal of Heart Failure Jun;5(3): The effectiveness of an integrated outpatient heart failure (HF) management program was evaluated in a 12-month, randomized controlled trial involving 197 patients with a first diagnosis or exacerbation of HF who were admitted to a New Zealand hospital. The intervention entailed HF clinic visits every 6 weeks, with counseling by a nurse specialist and optimization of drug therapy; patient education sessions; telephone follow-up as required; provision of diaries for recording daily weights; and instructions on performing daily weight measurements. A control group received usual care without structured patient education, provision of a diary, or advice on self-management. Patients were encouraged to purchase scales for home use; the clinic did not purchase scales for use by patients. The intervention had no effect on deaths or hospital readmissions, but it decreased total bed days and multiple readmissions, and improved quality of life. Seventy-six of the 100 patients randomized to the intervention group used the diaries, and these patients tended to receive more medications, were more likely to attend patient education sessions and make clinic visits, and were less likely to die during the study than patients who did not use the diaries. Of the 76 patients who used the diaries, 51 patients weighed themselves regularly; these patients tended to own scales at home, attend education sessions, and experience fewer hospital admissions than patients who did not weigh themselves regularly. At the end of the study, knowledge of self-management was greater in the intervention group than in the control group. Disease Management for for Hear Failure [38]

41 [39]

42 Appendix C. Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Anon, 1998 Nearly 5,000 Not specified Home visit by Yes, Agency for Patients Cardiac nurses patients with home health Health Care Policy CHF agency nurse to and Research assess patient (now the Agency status, diet, for Healthcare medication Research and compliance; Quality), American patient workbook Heart Association for assistance guidelines with disease management; nurse visits and telephone contact Anon, patients Not specified Telephone case Not specified Patients Cardiac care with CHF management nurses system (patient education) Anon, elderly Claims data and Computer-based Not specified Patients Nurse (Disease patients with physician referrals (Internet) or Management moderate to telephone Advisor. 2001; severe CHF (interactive voice 7[7]: ) response) reporting by patients of selfmeasured blood pressure, pulse, weight, and CHF symptoms Anon, patients Monthly automated Patient education Not specified Patients Program (Disease with CHF review of claims primarily by coordinator Management data using an telephone Advisor. 2001; algorithm 7[6]:92-96) ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [40]

43 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Hospital admissions, 2 years Not specified, but no Inpatient health Health plan The intervention reduced inpatient costs, control group identified care costs members both hospital admissions hospital days, decreased 61% receiving home and hospital days by 58% ED visits care from and ED visits by 49%. contracted home health care agency New York Heart 6 months before Controlled pre-and Hospital and total Patient homes Functional class Association and after post-intervention costs decreased by quality of life improved. functional class, comparison 64% and 68%, The hospitalization quality of life, respectively rate decreased by 49%. hospital and ED ED use did not change. use, costs Hospitalizations, 1 year RCT Cardiac costs per Patient homes There were 20 hospital days, cardiac patient per month hospitalizations for a total costs decreased by $247 of 149 days in the in the computer computer group and 39 group and $265 in hospitalizations for 258 the interactive voice days in the interactive response group, voice response group. and increased by $135 in the usualcare (control) group Self-reported 18 months Pre- and post- Overall costs Patient homes Disease knowledge and disease knowledge intervention decreased by ~35% functional status and functional health; comparison due to decreases improved in 93% and 56% ACE inhibitor use; in ED use and of patients, respectively. ED use; hospital hospital admissions ACE inhibitor use increased admissions and LOS and LOS by more than 20% to 65%. [41]

44 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Anon, patients Hospitalization for Planning before Not specified Patients Attending physicians, (Clinical Resource with CHF CHF within past 6 hospital discharge; nurse practitioners, Management) months, New York clinic and nurse specialist, Heart Association telephone pharmacist, social functional class III follow-up; and worker, and or IV, and ejection patient education nutritionist fraction <20% about medications, diet, and care plan Anon, 2001 Not specified Not specified Software program Not specified Patients with CHF Nurse case managers (Data Strategies & and appliance for Benchmarks) use at home by patients to transmit health data to nurse case managers Anon, patients Inpatients judged Use of a home- Not specified Patients Nurse practitioner with CHF in need of extra based device to support and measure and reinforcement and electronically outpatients with transmit weight, poor understanding blood pressure, of disease and heart rate, oxygen frequent physician saturation, and or ED visits temperature to a central location on a daily basis Bertel O, 25 patients with Consecutive Special CHF Not specified Patients and Not specified Conen D, 1987 severe CHF patients referred to program focused physicians institution because on: of severe CHF (1) individualized refractory to medical therapy treatment for CHF, (2) antiarrhythmic treatment and close follow-up visits, and (3) continuous education of patients and physicians to improve treatment compliance and early management of complications ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [42]

45 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Use of target Not specified Pre- and post- Outpatient costs University Use of target dosages of dosages of ACE intervention increased by 27%, medical center ACE inhibitors and betainhibitors and comparison inpatient costs blockers increased. beta-blockers, clinic decreased by 38%, Hospitalization rate visits, hospitalization and total cost of decreased from 1.86 to rate and LOS care decreased by 1.21 times per patient per 37% year. Average LOS decreased from 7.67 to 6.07 days. Rate of clinic visits increased from 7.8 to 12.9 visits per patient year. Hospitalizations, Not specified Pre- and post- The savings in Patient homes Hospitalizations and ED ED visits, bed days intervention direct costs was visits decreased by 23%. comparison $1,266 per patient Total number of bed days per year decreased by 50%. Hospitalizations, 3 months Pilot study None Inpatient and Hospitalizations and ED ED visits, patient outpatient visits were eliminated and sense of well-being patient well-being and and understanding of understanding of the the disease disease were significantly improved. Survival, outcomes Not specified, but Nonrandomized None University-based The 1-year survival in the of medical treatment 1-year and 2-year observational with hospital in intervention group (92%) for CHF, outcomes survival rates were comparison with Switzerland was significantly higher of medical treatment provided for the pre-existing control than that in the control for arrhythmias intervention group group group (43%). The 2-year survival rate for the intervention group (83%) compares favorably with previously reported survival rates. [43]

46 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Bouvy ML, 152 patients Patients admitted Patient interviews Not specified Patients Pharmacist Heerdink ER, with CHF to the hospital or about medication et al., 2003 attending a compliance with specialist monthly follow-up outpatient CHF contact clinic Capomolla S, 234 patients Referral through an Cardiovascular Yes, American Patients Multidisciplinary Febo O, et al., 2002 with HF unspecified risk stratification, College of process creation of an Cardiology/American individualized Heart Association plan of care, and health care education and counseling Cardozo L, 290 elderly Random selection Implementation of Yes, internally Health care Clinical nurse Aherns S, 1999 patients with of patients (age internally developed clinical providers manager CHF >65 years) developed clinical pathway for CHF monitoring presenting to a pathway for CHF management processes of care; tertiary-care intended to variances in care teaching hospital improve care for reported to for CHF elderly patients attending physician management over and improve for corrective a 1-year interval resource utilization action Chapman DB, 67 patients Not specified Comprehensive Yes, internal Patients (education, Registered nurse Torpy J, 1997 with CHF outpatient protocols support, home with CHF program offering established by the health care); training (nurse standardized care, Heart Failure physicians coordinator) in patient education, Center based on (education about conjunction with outpatient infusion both the 1994 program and physician medical of inotropic agents, Cardiology protocols used) director and electronic linkages Preeminence administrator between clinic Report on CHF and ED, and and a 2-day home health care cardiology nurse visits roundtable meeting ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [44]

47 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Medication 6 months RCT None Outpatient clinic, Medication compliance compliance, hospital, and was greater in the rehospitalization, home intervention group than in mortality, and qualify the control (usual-care) of life group. There were no significant differences between the two groups in rehospitalization, mortality, or quality of life. Cardiac deaths, 12 months RCT There was a cost Day hospital and Cardiac deaths and hospital readmissions, savings of $1,068 community readmissions were New York Heart for each quality- significantly lower and Association functional adjusted life-year New York Heart Association class gained by using the functional class was more intervention instead likely to improve in the of usual care intervention group than in the control (usual-care) group. LOS, cost of care, 12 months Randomized Significant reduction Tertiary-care LOS decreased from 6.36 mortality, readmission retrospective pilot in variable cost of teaching hospital days (for controls) to 5.25 statistics, and study $776 per patient in metropolitan days (with pathway). performance rates of attributed to Detroit Performance of three of processes of care shorter LOS six processes of care improved. However, rate of readmission increased from 9.25% (in controls) to 13.5% (with pathway). Hospital admissions, 12 months before Observational pre- and Potential for Hospital at Hospital admissions, number of hospital and 16 months post-intervention decreased costs tertiary-care hospital days, and average days, average LOS after enrollment comparison due to less medical center LOS decreased by 30%, frequent followed by 42%, and 17%, hospitalization outpatient clinic respectively. (estimated cost of and home care 1 year of clinic treatment was $2,000 vs. $9,000 for average cost of single admission) [45]

48 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Civitarese LA, 20 physicians All patients of a Internally Yes, internally Physicians; Physicians DeGregorio N, in private private community developed clinical developed clinical patients as 1999 community medical group practice guideline practice guideline secondary medical group; admitted to the integrated with for treatment recipients 275 patients hospital during the monthly quality of CHF with CHF study interval with improvement a confirmed meetings discharge diagnosis of CHF (ICD-9 code 428) Cline CM, 190 adults Recruited from Education None for evaluation Patients and Registered nurses Israelsson BY, with HF patients admitted about HF or treatment families with experience et al., 1998 to university (pathophysiology, specific to the treating patients hospital for HF over treatment); study; patients with HF 2-year interval guidelines for received selfself-management management of diuretic therapy; guidelines for follow-up at diuretic therapy nurse-directed outpatient clinic Costantini O, 582 inpatients Hospital Care management, Care Patients Nurse care Huck K, et al., 2001 with CHF inpatients with daily use of recommendations manager, faculty new care were based on cardiologist, and guidelines national guidelines physician representative from part-time faculty Dennis LI, 24 Medicare Convenience Assessment and Use of agency Patients who were Home health Blue CL, et al., patients with sample drawn from patient teaching nursing care plans Medicare care nurses 1996 CHF and pool of Medicare interventions and Medicare beneficiaries 18 Medicare beneficiaries administered to regulations patients with receiving home patients by home appropriate for COPD health care for health care nurses patients with CHF CHF or COPD or COPD ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [46]

49 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Rates of classifying 21 months Prospective None Patients Rates of classifying systolic systolic and diastolic hospitalized at and diastolic dysfunction dysfunction, use of Pittsburgh medical remained unchanged. ACE inhibitors, groups primary ACE inhibitor use hospitalization rates, community-based increased by 39%. documentation of hospital Quarterly admissions for discharge instructions systolic dysfunction-based CHF decreased by 49%. Documentation of patient discharge instructions was suboptimal. 1-year survival rates, 1 year Prospective, Mean cost of Swedish university The intervention did not time until randomized trial intervention: $208 hospital clinic and affect 1-year survival rate, readmission, days in per patient (US); patient homes but it increased the number hospital, health care Mean annual of days until readmission costs reduction in overall (141 vs. 106 in control cost: $1,300 per group), and decreased the patient number of days in hospital (4.2 vs. 8.2). Quality of care 1 year Controlled pre- and Care management Large university Care management (use of inhibitors, post-intervention was associated with medical center improved quality of care documentation of comparison a $2,204 reduction and reduced median echocardiography, in hospital costs hospital LOS from 5 days daily weight to 3 days. measurement) and hospital LOS and costs Hospital readmission 12 months Retrospective chart None Patient homes A significant relationship rates review (nonexperimental was found between certain research design) interventions implemented by home health care nurses and hospital readmission rates among Medicare patients with CHF or COPD. Hospitalization readmission rates significantly decreased as the number of nurse visits and assessment-based interventions increased. [47]

50 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Dimmick SL, Not specified Recruited from Telehealth disease Not specified Patients Registered nurses Burgiss SG, et al., county residents management 2003 (videoconferencing, telephone conversations, and remote monitoring of blood pressure, blood oxygen saturation, and pulse) Discher CL, 593 patients Patients admitted Treatment Yes, Agency for Patients and health Nurse case Klein D, et al., 2003 with CHF to the hospital who algorithm/clinical Health Care Policy care professionals manager had physician pathway and and Research (now support, and education of the Agency for adequate cognitive health care Healthcare ability and living professionals and Research and conditions for patients Quality) program participation Doughty RN, 197 patients Patients admitted Clinical review at Yes, Agency for Patients Nurse Wright SP, et al., with HF to a hospital with a clinic, individual Health Care Policy 2002 a primary diagnosis and group and Research of HF education (now the Agency sessions, a for Healthcare personal diary to Research and record medication Quality) administration and body weight measurements, information booklets, and regular clinical follow-up ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [48]

51 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Weight control (a 13 months Not randomized or A reduction in cost Homes and Weight control was measure of controlled of care for CHF clinics achieved by more than 50% medication and hospitalizations of patients as a result of dietary compliance), from $8 billion the intervention. Sleep mood (sleep problems, to $4.2 billion was problems improved, fatigue, depression, projected annually although feelings of and appetite), and on a national basis fatigue, depression, and hospitalization rate loss of appetite increased. and costs The hospitalization rate decreased from 1.7 times per patient per year to 0.6 per patient per year, and the hospital LOS decreased from a national benchmark of 6.2 days to 4 days. Average hospital 1 year Pre- and post- There was a Community The intervention led to a LOS and costs, intervention significant reduction hospital significant reduction in documentation of left comparison in cost per patient average LOS from 6.1 ventricular ejection from $6,828 to days to 3.9 days, fraction and ACE $4,404 improvement in inhibitor use, and documentation of left nurse satisfaction ventricular ejection fraction and ACE inhibitor use, and high nurse satisfaction. Number of patients 12 months RCT None Hospital-based There was no significant who died or were clinic difference between the readmitted to the intervention group and the hospital, number of control (usual-care) group bed days, and quality in the number of patients of life who died or were readmitted to the hospital. The intervention was associated with fewer multiple readmissions and bed days, and greater improvement in the physical-functioning component of quality of life than usual care. [49]

52 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Duncan K, 16 patients Recruited from an Exercise plus Not specified Patients Research nurse Pozehl B, 2003 with HF HF clinic adherence involving individualized goal setting, graphic feedback on goals, and problem-solving support Fonarow GC, 214 heart Patients with HF Comprehensive Patients educated Patients and their Education by HF Stevenson LW, transplant presenting for heart management in accordance with families clinical nurse et al., 1997 candidates transplantation program by HF Heart Failure specialist; follow-up evaluation who met transplant team Practice Guidelines; care provided by eligibility featuring a systematic HF cardiologists requirements (i.e., systematic adjustment of stable for hospital approach to drug medications discharge; no therapy; patient described, but no contraindications; education (diet, specific guidelines not too well ) exercise, self- identified monitoring); and regular telephone and clinic follow-up with HF team after discharge Gattis WA, 181 adults with Patients with HF Evaluation by a Target dosages of Patients Clinical pharmacist Hasselblad V, et al., HF and left and left ventricular clinical pharmacist, ACE inhibitors 1999 ventricular dysfunction including used were in dysfunction (ejection fraction medication accordance with <45%) undergoing evaluation, those established evaluation at therapeutic by randomized university-affiliated recommendations controlled trial clinic to physician, patient education, and follow-up telemonitoring Gilbert JA, 1998 Unidentified Not specified Telephone-based Not specified Patients Not specified, but number of disease multidisciplinary patients with management team mentioned CHF system, designed to monitor patients after hospital visits and provide education and support ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [50]

53 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Maximum oxygen 24 weeks RCT None Cardiac All outcomes were better uptake (a measure of (12 weeks rehabilitation than at baseline in the exercise capacity), supervised and facility and home intervention group. dyspnea, fatigue, 12 weeks Adherence to the exercise walk-test unsupervised) regimen during the performance, unsupervised weeks was quality of life significantly better in the intervention group than in the control group. Functional status, 6 months before Nonrandomized, Estimated savings in Heart Functional status improved hospital readmissions, and at least observational (pre- hospital readmission transplantation and hospital readmission management costs 6 months after and post-intervention costs of $9,800 per center rate decreased by 85% intervention comparison) patient; estimated with the intervention. (3-year interval) cost of intervention: $200-$400 per patient Primary endpoints: 6 months (median Double-blind None Duke University, All-cause mortality and HF all-cause mortality patient follow-up randomized general cardiology clinical events decreased and nonfatal HF interval) controlled trial faculty clinic and ACE inhibitor use and clinical events (ED dosage improved with the visits or hospitalization intervention. for HF); secondary endpoints: ACE inhibitor use and dosage Hospital readmission 9 weeks Observational (pilot) None Patient homes Hospital readmission rates rates study (telemanagement decreased from 76% to through Crozer- 18% with the intervention. Keystone Health System, a Springfield, PAbased integrated delivery system) [51]

54 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Goodyer LI, 100 elderly All elderly patients 3 months of Patient instruction Patients Pharmacist Miskelly F, et al., patients with at a London clinic intensive based on protocol, 1995 chronic, stable who met inclusion medication but no specific HF criteria counseling by a guidelines were pharmacist identified Gorski LA, 51 patients Claims analysis, Education (regular Yes, American Patients Nurse Johnson K, 2003 with HF health risk telephone calls, College of assessment, and mailings) and Cardiology/American referrals from coordination and Heart Association utilization managers, promotion of case managers, interdisciplinary physicians, and patient care patients using community resources, newsletters, and referrals to a home health care program Hanumanthu S, 134 patients All patients Comprehensive Not specified Patients and Physicians who Butler J, et al., 1997 with HF referred to Heart management by providers (providers work exclusively Failure and Heart HF specialists/ participated in with HF and heart Transplantation transplant team, periodic meetings transplant patients; Program (by including medical with affiliated home assisted by nurse cardiologists) management, health agency and coordinators and during a 1-year cardiovascular hospice to home health care interval testing, and integrate patient agencies medication care) adjustments ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [52]

55 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Medication knowledge, 3 months Prospective RCT None Outpatient clinic Medication compliance medication compliance, for the elderly at increased by 32% and results on submaximal Charing Cross knowledge improved with 6-minute exercise Hospital, London the intervention. Results test, visual analogue for the 6-minute exercise scores of test improved by 20 breathlessness, meters for the intervention Nottingham Health group and worsened by Profile scores, 22 meters for the control clinical signs of HF patients. Nottingham (e.g., edema) Health Profile scores did not change for either group. Distance to breathlessness and peripheral and pulmonary edema scores improved only in the intervention group. Hospitalization rate, 9 months Pre- and post- A cost savings of Home The intervention led to a self-care behaviors, intervention $165,000 was substantial decrease in and patient satisfaction comparison projected hospitalization rate and an increase in self-care behavior, and patient satisfaction was good, very good, or excellent. Annual hospitalization Follow-up intervals Nonrandomized, None Vanderbilt Heart The intervention reduced rates, peak exercise ranging from observational pre- and Failure and Heart cardiovascular- and HFcapacity, and 30 days to 1 year post-intervention Transplantation related admissions by 53% medication use compared with comparison Program and 69%, respectively, and similar period improved functional status before intervention compared with earlier care. [53]

56 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Harrison MB, 200 patients Patients screened Transitional care Yes, Agency for Patients Nurses Browne GB, with CHF during (telephone Health Care Policy et al., 2002 hospitalization outreach within and Research 24 hours after (now the Agency discharge, for Healthcare consultations Research and between hospital Quality) guidelines and home care nurses, patient education, and supportive care for selfmanagement) Heidenreich PA, 68 patients Use of medical Multidisciplinary Patient educational Patients Nurses Ruggerio CM, with HF claims database program consisting materials based (education, selfet al., 1999 to identify patients of patient on Agency for monitoring with an HF claim education, daily Health Care techniques); >$50, a self-monitoring and Policy and physicians hospitalization for telephone Research (now (notification of HF, or recent ED transmission of the Agency for problems based visit for HF, with data, and Healthcare on results of subsequent contact physician Research and patient selfof patient s notification of Quality) monitoring) physician abnormal weight guidelines for gain, vital signs, patients with HF and symptoms Hershberger RE, 108 outpatients Referred because Use of current Yes, Agency for Patients Cardiologists, Ni H, et al., 2001 with CHF of chronic, practice guidelines Health Care Policy specially trained, symptomatic CHF for treating CHF, and Research experienced frequent telephone (now the Agency nurses, and a contact between for Healthcare social worker nurses and patients, Research and pre-emptive Quality) and hospitalization, American Heart patient education Association/ American College of Cardiology guidelines Hinkle AJ, 2000 Not specified Electronically Internet-based Not specified Patients Not specified identified from disease claims data management (assesses willingness to change, educates about CHF, promotes positive behavioral change) ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [54]

57 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Health-related quality 12 weeks RCT None Hospital and Health-related quality of life, rates of hospital patient homes of life was significantly readmission and better in the transitional- ED visits care group than in the usual-care group. The hospital readmission rate did not differ significantly (23% vs. 31%). ED visits were significantly lower in the transitional-care group (29% vs. 46%). Primary endpoints: Approximately Nonrandomized, Estimated cost of Community setting Hospital days per year total claims (costs) 1 year (mean matched-control study program was $200 (patient homes) significantly decreased per year, admissions follow-up 7.4 per patient per from 8.6 (in previous year) per year, hospital months) month; estimated to 4.8 in intervention days; secondary mean savings per patients, while increasing endpoints: patient year was $9,000 from 8.9 to 17 in control compliance with (difference in cost patients. Number of self-monitoring, between groups) admissions per year did number of physician not differ significantly notifications, between the two groups. quality of life Patient self-care 6 months before Pre- and post- Average estimated Outpatient setting Patient self-care knowledge and daily and 6 months intervention cost savings knowledge, daily weight weight measurement, after referral comparison associated with measurement, and quality severity of illness, ED reduced of life increased, and use, hospitalization, hospitalization was severity of illness and quality of life $4,307 per patient decreased. Hospitalization rate and ED use decreased from 56% and 54%, respectively, before referral to 27% and 15%, respectively, after the program. Frustration with CHF, Not specified Not applicable None Third-party Decreased frustration knowledge of CHF, insurer with CHF in >90% of quality of life patients, increased knowledge of CHF in >82% of patients, improved quality of life in >50% of patients. [55]

58 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Jerant AF, Azari R, 37 patients Patients admitted In-person nurse Yes, Visiting Patients Nurse et al., 2003 with CHF to a university visits shortly after Nurses hospital with a hospital discharge Association and primary diagnosis and after 60 days, Advisory Council of CHF plus telenursing to Improve (video-based Outcomes home telecare or Nationwide in telephone calls) Heart Failure Kasper EK, 200 patients Patients Outpatient Not specified Patients Multidisciplinary Gerstenblith G, with CHF hospitalized with program with et al., 2002 CHF who were periodic follow-up at increased risk telephone calls for readmission and visits, an individualized treatment plan, a treatment algorithm, and provision of a scale, low-sodium meals, telephone, and transportation if needed Knox D, Not specified Not specified Integrated Clinical pathway Patients and Multidisciplinary Mischke L, 1999 multidisciplinary for LOS based on providers team, with program of Agency for Health advanced inpatient Care Policy and practical nurse consultation and Research (now coordinating and education, patient the Agency for supervising outpatient clinic Healthcare compliance visits, cardiac Research and monitoring home care, and Quality) guidelines monitoring of compliance through automated telemanagement program ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [56]

59 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results CHF-related hospital 180 days Pre- and post- CHF-related Home The number of ED visits readmissions and intervention readmission was significantly lower with ED visits comparison charges were telenursing than with >80% lower with usual care. telenursing than with usual care Hospital 6 months RCT The cost per patient Home There were significantly readmissions, was similar with the fewer hospital mortality, symptoms, intervention and readmissions and deaths, and quality of life usual-care groups patients were less symptomatic, and quality of life improved to a greater extent in the intervention group compared with the usual-care group. Patient satisfaction, 18 months for Outcome data None Evanston Satisfaction was high and compliance with compliance; other presented, but not a Northwestern compliance rate averaged automated periods of tracking defined study Healthcare 89.5%. CHF telemanagement not indicated hospital and clinic, hospitalization rate was program, and patient 0.6 per patient per year hospitalization homes vs. national benchmark rate, 30-day of 1.7 per patient per readmission rate, year. The 30-day LOS readmission rate was 2.3% (vs. 23% nationally). LOS was 4 days (vs. national average of 6.2 days). [57]

60 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Kornowski R, 42 elderly Individuals Home Not specified Patients Internal medicine Zeeli D, et al., 1995 patients with participating in surveillance physicians; severe CHF home surveillance program collaboration with program for 1 year involving paramedical personnel who met other home visits by inclusion criteria internists and (history of paramedical hospitalization in personnel for preceding year, evaluation, ejection fraction recommendations <40%) to patient (i.e., education), and treatment Kostis JB, 20 patients Not specified Nonpharmacologic Not specified Patients Treatment team, Rosen RC, et al., with CHF treatment program, including physicians, 1994 consisting of psychotherapist, exercise, dietary dietician, and staff counseling, at cardiovascular cognitive therapy, rehabilitation facility and stress management Krumholz HM, 88 patients Patients at least Targeted education Not specified Patients Experienced Amatruda J, et al., with HF 50 years old who and support cardiac nurse 2002 were hospitalized intervention with with HF telephone follow-up LaFramboise LM, 90 patients Patients discharged Home visits, Yes, Agency for Patients Research nurse Todero CM, et al., with HF from the hospital telehealth Health Care Policy 2003 within the previous communication and Research 6 months with a device, or both (now the Agency primary diagnosis compared with for Healthcare of HF telephonic case Research and management Quality) ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [58]

61 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Total and 12 months before Nonrandomized, pre- None Home care A home surveillance cardiovascular-related and after and post-intervention surveillance program significantly hospital admissions, intervention comparison program in decreased total and hospital LOS, Tel Aviv cardiovascular-related functional status, hospital admissions and medication use hospital LOS in elderly patients with severe CHF, and significantly improved self-reported functional status. Ejection fraction, 12 weeks Randomized, None University of Compared with digoxin exercise tolerance, controlled, Medicine and therapy and placebo, the anxiety and parallel design Dentistry of nonpharmacologic depression scores New Jersey intervention resulted in (mood), weight loss Robert Wood significant improvements Johnson Medical in exercise tolerance, School weight control, and mood. In contrast, digoxin significantly improved ejection fraction but not exercise capacity or quality of life. Rate of hospital 1 year RCT The intervention Home The percentage of patients readmission or death reduced hospital who died or were readmission costs by readmitted to the hospital $6,985 per patient was significantly lower in the intervention group (57%) than in the control group (82%). The intervention reduced the total number of readmissions by 39%. Self-efficacy (i.e., 2 months Pilot RCT None Home Self-efficacy worsened in level of confidence in the telephonic case making lifestyle and management group and behavioral changes increased in the other related to HF three groups. Functional management), status, mood, and quality functional status, of life improved from mood, and quality baseline in all four groups; of life there were no significant differences between the groups in these measures. [59]

62 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Laramee AS, 287 patients Patients admitted Early discharge Yes, Agency for Patients Nurses Levinsky SK, with CHF to the hospital planning, patient Health Care Policy et al., 2003 with a primary or and family and Research secondary education, (now the Agency diagnosis of CHF 12 weeks for Healthcare and a left of telephone Research and ventricular ejection follow-up, and Quality), fraction <40% or promotion of American radiologic evidence optimal CHF College of of pulmonary medications Cardiology/American edema requiring Heart Association, diuresis Heart Failure Society of America Lasater M, patients All patients Program at Unidentified Patients Registered nurses; with CHF or hospitalized at nurse-managed critical-path collaboration by cardiomyopathy local medical CHF clinic algorithms directed physicians center for CHF emphasizing nurse-provided care (cardiologists), or cardiomyopathy precautions to dieticians, social were automatically reduce risk of workers enrolled in CHF hospital precautions clinic readmission for follow-up after (patient education, hospital discharge cardiopulmonary assessment, daily weights, assessment of medication compliance) Lazarre M, 34 patients All patients who Cardiac care Unidentified Patients and Nurses with a Ax S, 1997 with HF entered cardiac program for home critical pathways families critical-care care program care featuring used to guide background during 7-month targeted teaching, targeted teaching contracted by course of study close monitoring home health who also met by cardiac-trained care agency; inclusion criteria nurses, collaboration cardiovascular with assessment, and multidisciplinary early team management of HF exacerbations ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [60]

63 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results 90-day hospital 90 days RCT The total inpatient Hospital and The 90-day readmission readmission rate, and outpatient home rate was the same (37%) costs, and patient median cost and for both groups. adherence the readmission Adherence to the median cost were treatment plan was reduced by 14% and significantly better in the 26%, respectively intervention group than in the control group. Patient knowledge 1 year (6 months Nonrandomized, Comparison of Nurse-managed The intervention decreased of medications, before and after observational hospitalization CHF precautions hospital readmissions hospital readmission intervention) (pre- and post- charges after clinic associated (22% vs. 26%) and LOS rates, hospitalization intervention intervention ($6,404) with South (5.7 days vs. 7.3 days), costs comparison) vs. before Carolina Medical and improved patient intervention ($6,898) Center knowledge of medications. revealed a savings of almost $500 per patient Hospital readmission 7 months Nonrandomized, None Patients 30-day and 90-day rates 30 and 90 days partially controlled receiving home readmission rates after program (results compared with care according (2.9% and 8.8%, enrollment national averages) to a home health respectively) were lower care agency- than national averages sponsored (16% for 30 days and 32% cardiac program for 90 days). [61]

64 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Martens KH, 924 patients Use of Home health care Not specified Patients Home health Mellor SD, 1997 with CHF computerized nursing care nurses discharged to medical records to interventions home (study identify all CHF focused on patient aim #1); 120 patients in hospital assessment and patients with system who were teaching CHF and discharged to home, referral to with or without specific home referral to home health care health care, over agency (study a given interval aim #2) Morrison RS, 50 patients Random selection Hospital-based, Yes, institutional Care providers Nurse case Beckworth V, 1998 with CHF from patients nursing care critical pathways manager hospitalized within management developed by a a 6-month interval model involving continuous quality with a primary the development improvement team diagnosis of CHF and implementation (ICD-9 code 428) of a critical pathway for CHF care Mueller TM, 200 patients Not specified Telemanagement Yes, Heart Failure Patients Advanced-practice Vuckovic KM, with HF and a diuretic Society of America nurses et al., 2002 treatment and others algorithm Nobel JJ, 78,038 member Members of a Remote biometric Not specified Patients Cardiac nurses Norman GK, 2003 months with health maintenance measuring and age >65 years organization monitoring device, and 7,477 and interactive member months communication with age between nurses <65 years and patients ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [62]

65 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Hospital readmissions 3 months (follow-up Retrospective chart None Patient homes Patients who received within various 90 days after audit home health care nursing intervals, compliance intervention) services were readmitted with intervention to the hospital implementation significantly less often (28% vs. 42%) within 90 days after hospital discharge than patients not receiving such services. Hospital LOS, costs Calendar year Retrospective chart The estimated Acute-care Mean LOS in 1996 with (fixed, variable, 1996 review mean fixed, variable, hospital in the implementation of the total), physiologic and total costs for southeastern nursing care management status, physical 50 patients treated United States model was 5.4 days vs. functioning, health according to this ~17 days in 1991 before knowledge, and model were $2,491, implementation. family caregiver $1,858, and $4,291, Regression analysis status respectively identified number of medications as the only predictor of LOS. Guideline compliance was suboptimal. Patient compliance 2 years Not randomized or Hospital costs for Home Patient compliance was with telephone calling controlled treating HF high (90%). The 30-day program, 30-day decreased by 52% readmission rate hospital readmission decreased from 2.3% in rate, hospitalization to 0.7% in rate, and costs The hospitalization rate decreased by 50%. Hospital days per 12 months Controlled but not The intervention Home The intervention reduced thousand members randomized reduced the costs hospital days per thousand per year paid per member members per year by 53% per month by 50% in patients >65 years old in patients >65 and by 62% in patients years old and by <65 years old. 60% in patients <65 years old [63]

66 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention O Connell AM, 35 indigent Patients admitted Multidisciplinary Yes, Agency for Patients Cardiologists, Crawford MH, patients with to university disease Health Care Policy nurse practitioner et al., 2001 CHF not hospital with high management and Research with specialized eligible for hospitalization rate program (monitoring (now the Agency training and transplantation or referred by at clinic, telephone for Healthcare experience caring primary care contact, patient Research and for cardiac physician because education, Quality) guidelines patients, social of high risk of medication for medications worker, pharmacist, hospitalization consultation, dietitian, cardiac due to financial, referral to rehabilitation team social, or dietitians and nonadherence other specialists) issues Oddone EZ, 443 patients Random invitation Enhanced access Appropriate Patients Primary care Weinberger M, with CHF of CHF patients to primary care, utilization of ACE physician/registered et al., 1999 treated at one of including inhibitors assessed nurse team nine Veterans assignment to using Agency for Affairs medical primary care Health Care center study sites nurse and Policy and physician team, Research (now patient education, the Agency for increased Healthcare telephone contact, Research and and additional Quality) guidelines outpatient visits (guideline implementation not described); American Heart Association materials used for patient education Paul S, patients A convenience Nurse practitioner- Nurse practitioner Patients and their Nurse practitioner with CHF sample of patients managed, provided care in families in collaboration who were admitted multidisciplinary accordance with with multidisciplinary to a university- outpatient clinic unidentified clinic team affiliated clinic offering patient protocols education, assessment and treatment by a multidisciplinary team, frequent monitoring via nurse telephone calls and visits, and on-demand clinic visits for worsening signs of CHF ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [64]

67 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Functional status 1 year before and Nonrandomized, There was a net Clinic Functional status improved (severity of illness), year after pre- and post- savings of $4,600 and the need for hospitalization rate, 1enrollment intervention per patient hospitalization decreased. and hospital and comparison clinic costs Diagnostic evaluation, 6 months of Multisite RCT None Nine Veterans Compliance with pharmacologic follow-up after Affairs medical recommended CHF management, randomization centers (inpatient testing and treatment was health-related and clinic care) similar among the quality of life, and patient homes intervention and control hospital readmission groups. Enhanced access rates to primary care did not improve patients self-reported health status and was associated with more frequent hospitalizations (1.5 readmissions in 6 months vs. 1.1 in the control group). Total hospital 6 months before Nonrandomized Mean inpatient Nurse practitioner- Clinic enrollment readmissions, total and after selection with hospital charges managed, decreased hospital hospital days, mean intervention subjects serving as decreased from multidisciplinary admissions (and days) LOS, ED visits, (clinic enrollment) own controls $10,624 per patient outpatient clinic from 38 (151 hospital charges, and admission to $5,893; affiliated with days) to 19 (72 hospital reimbursement mean ED visit university hospital days). It also decreased charges decreased mean LOS (4.3 days vs. from $390 to $ days) and number of ED visits (10 vs. 8). [65]

68 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Philbin EF, 1,504 patients Selected based on Multifaceted quality Critical pathways Patients and health Physicians, nurse Rocco TA, et al., with HF at diagnosis-related improvement were based on care staff leaders, 2000 acute-care grouping (inpatient, ED, and expert guidelines administrators community home care critical responsible for hospitals pathways with quality recommended management diagnostic tests and treatments; staff and patient education) Rauh RA, 754 patients Patients at a Physician-directed, Yes, Agency for Patients and Nurses in Schwabauer NJ, with CHF community-based nurse-managed Health Care Policy families received collaborations et al., 1999 hospital with a inpatient and and Research patient education; with physicians, discharge diagnosis outpatient CHF (now the Agency members of dieticians, and of CHF (diagnosis- program, featuring for Healthcare multidisciplinary social workers related grouping intensive patient Research and treatment team 127) education, Quality) guidelines were educated treatment in for CHF about CHF accordance with management and protocols, and protocols at the aggressive individual and outpatient group level pharmacologic management Rich MW, 98 elderly Patients at least Comprehensive, Home visits were Patients Nurses working Vinson JM, et al., patients with 70 years of age nurse-directed in accordance with with a 1993 CHF admitted to a multidisciplinary federal home-care multidisciplinary secondary and approach to guidelines treatment team tertiary teaching reducing repeated hospital over a hospitalizations 1-year interval were including teaching, screened for CHF; medication and CHF patients at dietary intervention, moderate-to-high discharge planning, risk for early and enhanced hospital readmission, follow-up care who met no study exclusion criteria, were enrolled ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [66]

69 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Quality of care 9-month baseline RCT A slight reduction Hospital and The intervention had small (e.g., measurement and post- in hospital patient homes effects on outcomes that of left ventricular intervention periods, charges was were not significantly systolic function), including 6 months observed different from the effects hospital LOS and after hospital of usual care. Average charges, mortality, discharge hospital LOS decreased hospital readmissions, from baseline by 1.8 days quality of life in the intervention group and by 0.7 days in the control group. Primary endpoint: 1 year prior to Retrospective chart 17% ($1,118) Community-based Compared with control LOS for all CHF- program review reduction in cost per Illinois hospital group, intervention group related hospital implementation for admission; 77% (inpatient setting) had a significantly reduced admissions; controls; 1 year ($718,468) net and associated LOS (5.7 days vs. 7.3 secondary after program reduction in physician-directed, days), fewer admissions endpoints: primary implementation nonreimbursed nurse-managed for CHF management CHF admission for intervention hospital revenue; outpatient CHF (404 vs. 503), and a rate, readmission group cost of operating clinic (outpatient lower 90-day rate within 90 days outpatient heart setting) readmission rate (13% of discharge, per- clinic was about vs. 18%). case cost (to $104,000, and patient and program revenue provider) for all generated was CHF admissions $211,000 All-cause admissions 90-day Prospective RCT No actual cost data 550-bed The intervention did not and cumulative post-intervention were provided; secondary and significantly reduce number of hospital follow-up however, potential tertiary care readmissions or hospital days during 90-day annual savings university teaching days. The 90-day follow-up interval were estimated at hospital followed readmission rate was 33% $262.5 million if by patient homes for the intervention group data were vs. 46% for the control extrapolated to all group. The mean number patients with CHF of hospital days was 4.3 discharged from for the intervention group short-stay hospitals vs. 5.7 for the control group. [67]

70 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Rich MW, 282 elderly Patients A nurse-directed Not specified Patients and Nurses Beckman V, et al., patients with hospitalized at multidisciplinary their families collaborating with 1995 CHF treatment site intervention, multidisciplinary were invited to offering team participate if they comprehensive had risk factors for education, a readmission and prescribed diet, met no exclusion medication review, criteria social service support, and intensive follow-up (telephone contact and home visits) Rich MW, 156 elderly Subset of Comprehensive Not specified Patients Study nurse in Gray DB, et al., patients with patients in previous patient education, collaboration with 1996 CHF trial who had a dietary and social multidisciplinary diagnosis of CHF service team (physician, and who did not consultations, pharmacist, meet any exclusion medication review, dietician, social criteria and intensive worker, home postdischarge care workers) follow-up Riegel B, 358 patients Patients screened Telephone case Yes, Agency for Patients Case managers Carlson B, with CHF for eligibility when management to Health Care (registered nurses) et al., 2002 hospitalized provide patient Policy and education and Research (now collect and the Agency for document patient Healthcare progress data after Research and discharge Quality) and others ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [68]

71 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Primary outcome 4-year study with Prospective RCT Average cost of Hospital at Elderly patients with CHF measure: survival 1-year follow-up intervention was university medical participating in a for 90 days without (90 days during $216 per patient; center followed by nurse-directed hospital readmission; intervention and the cost of hospital patient homes multidisciplinary secondary endpoints: 9 months after readmission was intervention experienced all-cause readmissions, intervention $2,178 in the improved quality of life, CHF-related discontinuation) intervention group 44% fewer readmissions readmissions, vs. $3,236 in the within 90 days, 56% fewer cumulative days of control group hospital admissions for hospitalization after (P =.03); CHF, 37% fewer hospital follow-up, quality of estimated savings days, and lower medical life, medical costs of $460 per costs compared with patient control patients receiving standard care. Medication Medication Prospective RCT None Washington Compared with controls, compliance (by pill compliance University Medical overall compliance count), hospital assessed for Center improved and readmission rates 30 days, hospital (hospitalization) readmissions and hospital readmission rates followed by days decreased by 33% assessed for patient homes and 31%, respectively, in 90 days elderly patients with CHF who underwent a multidisciplinary treatment intervention aimed at improving medication compliance. HF hospitalization 6 months RCT Inpatient HF costs Hospital and The HF hospitalization rate, rate, number of HF were 46% lower in patient homes number of HF hospital hospital days, and the intervention days, and percentage of percentage of patients group patients with multiple with multiple readmissions were 48%, readmissions 46%, and 43% lower in the intervention group than in the usual-care control group. [69]

72 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Roglieri JL, All participants Referral by Patient education, Yes, American Patients Nurse for Futterman R, in a managed attending physician telemonitoring, Heart Association, (educational and telemonitoring et al., 1997 care plan, or hospital case post-hospitalization Agency for Health clinical interventions and patient including a manager, or discharge Care Policy and and telemonitoring) education; not subset of identified in review intervention Research (now and physicians specified who 149 patients of medical claims (home visit by the Agency for (education about managed who participated (ICD-9 codes) nurse), and Healthcare program, including physician in a CHF physician Research and review of CHF education disease education (practice Quality), and treatment management guidelines) NYLCare guidelines) program HealthPlans Schneider JK, 54 patients with Patients admitted Nurse-directed The medication Patients and Nurse Hornberger S, et al., CHF to medical facility medication discharge- families (when investigators 1993 over 5-month discharge planning planning program present) interval for CHF was based who met other on Orem s theory inclusion criteria of self-care; no (ability to specific guidelines self-administer were identified medications, taking one or more medications at discharge) Serxner S, 109 elderly CHF patients Low-cost Not specified Patients; providers Trained nurse Miyaji M, et al., patients with discharged from a educational also received interviewers 1998 CHF hospital system materials and mailed information over the course of compliance aids to raise program a year who had a mailed to awareness telephone, spoke patients at English, and had regular intervals CHF of cardiac (home-based origin educational intervention) ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [70]

73 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Third-quarter 24 months Longitudinal None Managed care Third-quarter admission admission rates, (12 months before comparison study health plan and rate and 30- and 90-day 30- and 90-day and after patient homes readmission rates declined readmission rates, intervention) 63%, 75%, and 74%, LOS, total hospital respectively, in patients days, and ED with any CHF-related utilization among diagnosis. In patients with patients with (1) a a pure CHF diagnosis, pure CHF 30-day readmission rate diagnosis and (2) decreased to 0, and any CHF-related third-quarter admission diagnosis and 90-day readmission rates both decreased 83%. Health care utilization (admissions, readmissions, LOS) also decreased in entire managed care plan population. Hospital readmission 1 month of Quasi-experimental, None A 600-bed, Participants in the rate 31 days after follow-up after after-only, randomized nonprofit medication dischargedischarge intervention controlled study Midwestern planning program had medical facility significantly lower readmission rates 31 days after discharge than patients who underwent standard discharge planning (8% vs. 29%). Quality of life, 6 months (3-month RCT Cost of program Patient homes The intervention reduced hospital intervention, with was $50 per patient; (recipients of hospital readmissions by readmissions, 6-month follow-up estimated net return home-based 51% and improved overall associated costs, after enrollment) on the investment program offered patient health status, compliance with of $8:$1 for the by Columbia confidence in medications, diet, hospital and $19: hospital system) self-management, and and daily weights $1 for third-party compliance with diet, payers medications, and weight monitoring among patients with CHF. [71]

74 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Shah NB, Der E, 27 patients with Patients referred to Mailed patient Not specified Patients; Nurses with et al., 1998 moderate or CHF clinic at education materials, physicians notified access to severe CHF Veterans Affairs automated of problems cardiologists medical center reminders for detected by patient during 6-month medication self-monitoring enrollment period compliance, selfwho met inclusion monitoring of criteria weights and vital signs, and facilitated telephone communication with a nurse monitor Stewart S, 97 patients Patients at tertiary Home visit by a Not specified Patients Home-based, Pearson S, et al., with CHF referral hospital nurse and nurse-pharmacist 1998 who had pharmacist to team CHF/systolic optimize medication dysfunction, management, exercise provide education intolerance, and (and remedial recurrent hospital counseling) about admissions for medications and acute CHF; who medication met no exclusion compliance, criteria; and who identify early agreed to clinical participate deterioration, and intensify medical follow-up, as appropriate Stewart S, 200 patients Patients Home visit and Not specified Patients and Home-based Marley JE, et al., with chronic discharged from telemonitoring by families cardiac nurse 1999 CHF a tertiary referral a cardiac nurse hospital in to optimize Australia with medication and (1) age 55 years, disease (2) New York Heart management, Association identify early functional class II, clinical deterioration, III, or IV CHF, and intensify medical (3) at least one follow-up, and prior hospital provide remedial admission for counseling acute CHF (patient teaching), as appropriate ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [72]

75 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Hospitalizations (all 1 year (mean Observational (pre- and None Patient homes No significant difference cause and follow-up interval post-intervention in number of cardiovascular), was 8.5 months comparison) hospitalizations per hospital days after intervention) patient-year before and (all cause and after the intervention (0.8 cardiovascular), and 0.4, respectively). physician notifications, Cardiovascular patient acceptance hospitalizations decreased from 0.6 per patient-year to 0.2 per patient-year. All-cause and cardiovascular hospital days decreased from 9.5 to 0.8 per patient-year and from 7.8 to 0.7 per patientyear, respectively. Primary endpoint: 6 months of RCT The mean cost Tertiary referral The intervention reduced frequency of follow-up after of hospital-based hospital in southern primary-endpoint events unplanned enrollment care for the Australia followed (0.8 vs. 1.4 per patient), readmissions plus (duration of intervention group by patient homes unplanned readmissions out-of-hospital intervention) averaged $3,200 (36 vs. 63), out-of-hospital deaths; secondary vs. $5,400 for the deaths (1 vs. 5), days of endpoints: event-free usual-care group hospitalization survival, percentage (not significant); (261 vs. 452), and visits of patients with the estimated to the ED (48 vs. 87). unplanned cost of the readmissions, total intervention was hospital days, number $190 (Australian) of ED visits, overall per patient; mortality, cost of outpatient costs hospital-based did not differ care between groups Primary endpoint: 6 months of RCT Hospital-based Tertiary referral The intervention reduced frequency of follow-up after costs were hospital in primary endpoint events unplanned enrollment Australian $490,300 Australia followed from 129 to 77, readmissions (duration of for the intervention by patient homes unplanned readmissions plus out-of-hospital intervention) group and Australian (118 vs. 68), and deaths; secondary $922,600 for the associated hospital days endpoints: event-free usual-care group (1,173 vs. 460) and survival, days of (P = 0.16); increased the number unplanned community-based of patients remaining readmissions, health care costs event-free (51 vs. 38). functional status were similar for both Quality-of-life scores did and quality of life, groups; mean cost not differ significantly hospital and of the intervention between the two groups community-based was Australian $350 after 6 months. health care costs per patient [73]

76 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Stewart S, 297 patients Screening of Postdischarge Not specified Patients and Multidisciplinary Horowitz JD, 2002 with CHF patients admitted home-based families to the cardiology intervention unit of a hospital (see the and active summaries of consultation with Stewart S, the admitting Pearson S, et al. physician Archives of Internal Medicine. 1998;158: and Stewart S, Marley JE, et al. Lancet. 1999;354: ) Stromberg A, 106 patients Patients Follow-up HF Not specified Patients Cardiac nurses Martensson J, with HF hospitalized for HF clinic where et al., 2003 medication changes were made by protocol, and patients and family members received education and social support Todero CM, 93 patients Referred by CHF disease Yes, Agency for Patients Nurses LaFramboise LM, with CHF physician to home management Health Care Policy et al., 2002 disease program with and Research management routine reminders (now the Agency program after to monitor for Healthcare hospital discharge symptoms, Research and for acute suggestions for Quality) exacerbation of symptom CHF management, and patient education ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [74]

77 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Unplanned hospital Median of 4.2 RCT The median cost of Tertiary referral There were significantly readmissions, years unplanned hospital in fewer unplanned deaths, and event- readmissions was Australia followed readmissions and deaths, free survival significantly lower by patient homes and the median event-free in the intervention survival was significantly group than in a longer in the intervention control group group than in the control receiving usual care group. Mortality, hospital 12 months RCT None Clinic The intervention group had admissions and significantly fewer deaths days, and self-care and hospital admissions behavior and days, and exhibited better self-care behavior than the control group. The percentage of 2 months Not randomized or None Home The percentage of patients patients with specific controlled with each CHF symptom HF symptoms; the decreased as a result of frequency, severity, the intervention. The and amount of frequency, severity, interference with amount of interference physical activity with physical activity, from the symptoms; and interference with and the interference enjoyment of life from with enjoyment of shortness of breath life from the and fatigue (the two symptoms most common symptoms) improved. [75]

78 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention Urden LD, patients Not specified Integrated disease Inpatient CHF Patients and Team consisting with CHF case management clinical pathway providers (clinical of a cardiologist program (service) developed pathway) medical director, for CHF featuring internally by team nurse practitioner, inpatient and and nurse clinician outpatient consultation, comprehensive education, outpatient treatment, and intensive home telephone contact, including monitoring and home intervention Varma S, 83 elderly Patients hospitalized Structured Use of previously Patients Research McElnay JC, et al., patients with or attending an pharmaceutical published pharmacist in 1999 CHF outpatient clinic in care program algorithm for liaison with one of three study for elderly CHF pharmaceutical community sites with: patients education, but no physicians and (1) confirmed specific practice community diagnosis of CHF, guidelines identified pharmacists (2) age >65 years, and (3) adequate cognitive score Weinberger M, 1,396 patients Patients Intensive Not specified Patients Primary care Oddone EZ, et al., with diabetes hospitalized at outpatient teams, consisting 1996 (n = 751), one of nine primary care by of one primary COPD (n = 583), Veterans Affairs a dedicated care nurse and or CHF (n = 504) hospitals with physician-nurse one primary CHF, COPD, or team following care physician diabetes inpatient assessment and provision of patient educational materials ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [76]

79 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Hospital LOS, Not specified, but Observational Decreased LOS Inpatient LOS decreased by 30-day readmission <1 year after resulted in $2,700 (community 1.1 days and 30-day rate, costs, program in savings per hospital in readmissions decreased patient satisfaction, implementation patient Michigan); from 17% to 4% after consultations, quality hospitalization outpatient (patient program implementation. of life, emotional and homes) Consultations increased physical functioning by >20%. Patient education, overall quality of life, emotional functioning, and physical functioning improved. 2-minute walk test, 12 months Longitudinal, Average cost of Three study sites Compared with controls, blood pressure, body prospective RCT medical ward (hospitals, clinics) program participants had weight, pulse, forced admission was in Northern Ireland better quality of life, vital capacity, vs for physical functioning, quality of life, ED visit and emotional health; knowledge of medication compliance; symptoms and and medication medications, knowledge; and fewer compliance with hospital admissions therapy, and use of (14 vs. 27). health care facilities Hospital 6 months after Multicenter RCT None Hospitals and Patients in the intervention readmissions, intervention clinics at nine group had a higher days of Veterans Affairs monthly readmission rate hospitalization, Medical Centers (0.19 vs. 0.14) and more quality of life, days of rehospitalization satisfaction with (10.2 vs. 8.8) despite care greater satisfaction than patients in the control group. [77]

80 Appendix C. (continued) Method of Identifying Population for Size of Whom Data Are Intervention Guideline Audience for Primary Manager Author(s) Population Evaluated Strategy Based? Intervention of Intervention West JA, 51 patients Recruitment of Physician- Management Patients and Nurse case Miller NH, et al., with HF patients hospitalized supervised, nurse- guidelines providers managers with 1997 at managed care mediated, home- adapted from and access to medical center for based HF consistent with supervising HF within past management American College physician 12 months, as well system (MULTIFIT) of Cardiology/ as referral of that implements American Heart outpatients by consensus practice Association physicians guidelines for consensus pharmacologic report and the and dietary Agency for Health therapy, and uses Care Policy and a nurse manager Research (now to promote the Agency for adherence and Healthcare carry out patient Research and telemonitoring Quality) clinical practice guidelines for CHF Whellan DJ, 117 patients Patients with a Disease Not specified Patients Nurse practitioner Gaulden L, et al., with CHF hospitalization for management or nurse specialist 2001 CHF, an ejection program with and pharmacist fraction <20%, or treatment symptoms protocols, consistent with follow-up clinic New York Heart visits and Association class telephone calls, III or IV and a patient education manual Wright SP, 197 patients Patients with first Clinic visits, Not specified Patients Nurse specialist Walsh H, et al., with HF diagnosis or patient education 2003 exacerbation of sessions, telephone HF admitted to the follow-up, and use hospital of diaries for recording daily weight measurements ACE = angiotensin-converting enzyme; CHF = congestive heart failure; COPD = chronic obstructive pulmonary disease; ED = emergency department; HF = heart failure; ICD-9 = International Classification of Diseases, Ninth Revision; LOS = length of stay; RCT = randomized controlled trial. [78]

81 Economic Outcomes Time Period Study/Evaluation Effects Measured Studied Design Assessed Setting Key Results Death, 10 months (mean Nonrandomized, pre- None Patient Quality of life, functional hospitalizations, patient follow-up and post-intervention homes (home- status, and compliance ED visits, clinic interval of 138 ± comparison based care with guidelines improved. visits, functional 44 days) system sponsored Medical visits, cardiology status, exercise by managed visits, HF-related ED capacity, self- care organization) visits, and total ED visits reported data decreased by 23%, 31%, (weights, dietary 67%, and 53%, compliance), respectively. functional status, Hospitalizations for HF health-related decreased by 87% from quality of life, 1.12 to 0.15/year, and compliance with total hospitalization rate guidelines decreased by 74% from 1.61 to 0.42/year. Medication use, Mean enrollment Randomized Outpatient costs Clinic Beta-blocker use and clinic hospitalization rate, time of 4.7 months prospective pre- and increased, but the visits increased and number of clinic postintervention cost per discharge significantly. The visits comparison and inpatient and hospitalization rate total costs per decreased significantly. patient-year decreased, resulting in a net savings of $8,571 per patient-year. Mortality, hospital 12 months RCT None Hospital, clinic, The intervention had no readmissions, bed and home effect on deaths or hospital days, quality of life, readmissions, but it and knowledge of decreased total bed days self-management and multiple readmissions, and improved quality of life. Knowledge of selfmanagement was greater in the intervention group than in a control group. [79]

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