A Practical Guide for Collaborative Partnerships Among Patients & Care Providers in IBD Health

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1 Overview A Practical Guide for Collaborative Partnerships Among Patients & Care Providers in IBD Health Patients with moderate-to-severe inflammatory bowel disease (IBD) face a life-long illness that, if not adequately controlled, can lead to hospitalizations, surgery, and reduced quality of life. This unique train-the-trainer program is designed to assist healthcare providers to engage their IBD patients in learning more about their disease, treatment options, and management goals through informal group education sessions. These group sessions provide a secure and interactive setting for providers and their patients to discuss key issues related to IBD self-care and treatment. During the session, providers lead their patients through conversations about IBD, setting goals for treatment, communicating effectively about symptoms, and engaging in decision-making on treatment options. The program focuses on patients with moderate-to-severe IBD, with the goal of empowering patients to engage in self-care behaviors and be active participants in their healthcare decisions. A patient education slide deck is provided to facilitate these programs. However, the format should be relaxed and informal. The healthcare professional leading the session should invite participants to ask questions throughout, striving to create a dialogue and tailor the information to the participants level of background knowledge. These discussions allow providers and their patients to talk about issues that may not be addressed in individual appointments due to time constraints, such as factors impacting treatment adherence and understanding about the disease. Patients have the opportunity to interact with and learn from each other, and to share their experiences and challenges with IBD. Insights from programs with similar design show that patients often feel more comfortable asking questions or raising concerns than they would during an individual appointment. In turn, providers are able to gain input from their patients, improve the patient experience, and deliver key messages in an efficient manner. Goals/Objectives Strengthen patient awareness and understanding of IBD causes and treatment options Define shared goals for IBD treatment and management Establish solutions for overcoming barriers to achieving remission through positive changes in patients personal health behaviors What s in the Trainthe-Trainer Toolkit? A slide deck to facilitate patient education and discussion A guide to using motivational interviewing strategies to promote positive behavior change Resources and tools for IBD clinical care, shared decision-making, and reporting on quality measures 2016 PRIME Education, LLC. All Rights Reserved.

2 There is no fee for this activity as it is sponsored by PRIME through independent educational grants from Takeda Pharmaceuticals U.S.A. Goals for Today s Program Gain a deeper understanding of inflammatory bowel disease (IBD) Learn more about: Setting treatment goals Discussing treatment options with your IBD care team How to track/monitor your IBD symptoms Signs that your IBD is uncontrolled Share your experiences, challenges, and successes with others 1

3 What questions or concerns do you have about your IBD? What do you want to get out of today s program? What Causes IBD? Diet Smoking Stress Antibiotics Aspirin Ibuprophen Naproxen Appendicitis Environmental Triggers Environment IBD Immune System Genes and Family History Scientific advances have led to better understanding of the underlying causes of IBD, resulting in more effective treatments 2

4 Inflammation and IBD Healthy Crohn s disease Ulcerative colitis Fat wrapping IBD involves inflammation of the lining of the gastrointestinal (GI) tract, but we still do not know exactly what triggers the body s immune response Ongoing inflammation causes ongoing gdamage! Increased muscle thickness Cobblestone appearance Fissures Ulceration By reducing inflammation, the tissue is healed, but the disease is still present Benefits of Controlling Inflammation in IBD Optimal Control of Inflammation Intestinal healing Reduce steroid use Prevent complications Reduce hospitalizations Reduce need for surgery Prevent osteoporosis Increase growth/ development in children/adolescents Reduce risk of blood clots Reduce cancer risk 3

5 IBD Symptoms Symptoms related to inflammation in GI tract Diarrhea Abdominal pain Rectal bleeding Urgent need to move bowels Sensation of incomplete evacuation General symptoms Fever Loss of appetite Weight loss Fatigue Night sweats Loss of normal menstrual cycle Each patient is unique in how their flares or symptoms present IBD Symptoms Are the Tip of the Iceberg Symptoms Blood Samples show signs of inflammation Endoscopy shows signs of inflammation Biopsy shows signs of inflammation Symptoms alone may not reflect the level of inflammation in IBD 4

6 Goals of IBD Treatment Achieve remission No symptoms or signs of inflammation Maintain remission No flare ups Improve quality of life Avoid repeated use of steroids Prevent complications (hospitalizations, surgery, etc) Balance risks (eg, side effects) and benefits of treatment What Are Your Goals for IBD Treatment? 5

7 Questions? Individualized Treatment for IBD IBD treatment must be tailored to each individual Factors that may influence the choice of treatment include: Disease severity Location of disease in GI tract Previous response to medication Side effects of medication Other medical conditions 6

8 IBD Treatment Options Aminosalicylates Mesalamine (Rowasa, Pentasa, Asacol, Delizicol, Canasa, Lialda, Apriso ), sulfasalazine (Azulfidine, Colazal, Dipentum ) Given either ih orally or rectally Work by decreasing inflammation without modifying the immune system Used primarily for ulcerative colitis Corticosteroids Predisone, budesonide (Entocort ) Given orally, rectally, or by infusion Effective for short term control of flares NOT recommended for long term use due to side effects (bone loss, weight gain, cataracts, mood swings, etc) Immunomodulators Azathioprine (Azasan, Imuran ), methotrexate, cyclosporine, 6 mercaptopurine (Purinethol ) Given orally or as a shot (methotrexate) Decreases inflammation by modifying the immune system IBD Treatment Options (cont.) Biologic therapies Most recently developed treatments for IBD Target the action of biologic molecules that cause inflammation Given as a shot or at an infusion center Target an inflammatory protein called tumor necrosis factor (TNF) Cimzia Humira Simponi Remicade Target inflammatory proteins called interleukin 12 and interleukin 23 Stelara Block certain types of immune cells from getting into inflamed tissues Entyvio Tysabri 7

9 Example: Understanding Benefits and Risks of IBD Treatment In clinical trials, for every 100 people with Crohn s disease who took Humira, 42 had relief of symptoms after 2 years In clinical trials, for every 100 people with Crohn s disease who took Humira, 7 had serious infections over 2 years Example: Understanding Benefits and Risks of IBD Treatment (cont.) In a clinical trial, for every 100 people with ulcerative colitis who took vedolizumab, 45 had relief of symptoms after 1 year Compared to ulcerative colitis patients who received placebo, how many who took vedolizumab had side effects? 100% of Patients in Remission (%) Percentage o 80% 60% 40% 20% 0% 16% Placebo 45% Vedolizumab Placebo Veolizumab Fatigue 5.3% Abdominal pain 5.6% Nausea 6.1% Serious infection 1.9% Cancer 0.2% 0% 20% 40% 60% 80% 100% Percentage of Patients with the Side Effect (%) 8

10 Shared Decision Making Shared decision making happens when patients and their healthcare providers discuss different treatment options together The conversation(s) typically include discussion on: The benefits and risks of different treatments The patient s preference for treatments Cost of the medications How the medications are taken (pills, injections, etc) The goal is for patients and providers to come to an agreement about which treatments would be best Sample Questions to Ask Your IBD Healthcare Provider Which treatment options may be right for me? What are the benefits and risks/side effects of these options? How long might it take before I see an improvement? What can I do to make sure I am getting the most from my medication? In addition to taking my medication, what else can I do to manage my IBD? 9

11 Let s Discuss What questions do you have about tthe benefits and risks of different IBD treatments? Are you satisfied with your IBD treatment? Do you feel you need a change in the way your IBD is treated? Monitoring IBD Regular follow up is essential to assess your response to your IBD medications and prevent complications! Regular endoscopy Clinic visits (every 3 6 months) Address your concerns Communicate with your IBD care team 10

12 Remember Your Medications! Taking your IBD medications as prescribed is crucial to achieving and maintaining remission Do NOT stop taking your IBD medications, even if you have been feeling better for a long time What you can do: Set up a reminder system Involve your family or significant others Be honest with your IBD care team: Let them know if you have concerns about your medications or have trouble taking them How Do You Manage and Monitor Your IBD? 11

13 Questions? Achieving Optimal Health Healthy lifestyle changes lead to better long term health, well being, and improved immune health Good Diet & Nutrition Mental Health Exercise 12

14 Stop Smoking In Crohn s disease, smoking makes IBD medications less effective and increases flares Talk with your healthcare provider if you need help quitting Diet: What Are Better Choices? Western Diet Higher in saturated fat Higher consumption of meats Lower consumption of fruits and vegetables Mediterranean Diet Lower in saturated fat Lower consumption of meats Higher consumption of fruits and vegetables A Mediterranean diet pattern is protective against several diseases associated with chronic inflammation The Mediterranean diet is an example of a healthy diet; there are additional healthy diets available for patients 13

15 How to Eat During a Flare Avoid Your trigger foods Certain high fiber foods Nuts, seeds, and popcorn High fat foods Caffeine Alcohol Spicy foods Raw fruits and vegetables (especially ones with skins) Prunes Beans Dairy products as tolerated Large food portions Fruit juices Choose Applesauce and bananas Bland, soft foods Plain cereals, white rice, and refined pastas Fully cooked vegetables and potatoes without skin Small, more frequent meals Nutritional supplements if loss of appetite Vitamins and mineral supplements Protein as tolerated, such as lean meats, fish, and soy When in remission, a balanced diet that includes plenty of whole grains, lean protein, and fresh fruits and vegetables is recommended Exercise and Immunity Moderate exercise protects and enhances the immune response and provides long lasting benefits for chronic inflammation Only 30 minutes of moderate exercise per week is needed: Walking Tai chi Aerobics Climbing stairs Exercise is beneficial in 3 5 minute bursts 14

16 Stress Affects the Immune System Chronic stress can cause harmful changes in the immune system Stress may increase susceptibility to infections, cause infections to be more severe, and reduce effectiveness of vaccinations Practicing mindfulness exercises (such as deep breathing) can help reduce stress What Works For You? What strategies for healthy living have you found helpful? 15

17 Questions? Wrap Up IBD is a complex and life long disease IBD treatments need to be tailored to each individual Communicate with your healthcare team about your symptoms, concerns, goals, and preferences Speak up for your health! Make your health a top priority Listen to your body and gut feelings Take your medications as prescribed Monitor your symptoms and share with your provider Ask for and seek more information about IBD and IBD medications 16

18 What Did You Learn Today? Questions? 17

19 IBD Conversation Guide Learning how to best manage your inflammatory bowel disease (IBD) starts with talking to your doctor or healthcare provider. Use this guide to help you talk with your IBD care team about your condition and get your questions answered. 1. Be prepared to ask questions and raise your concerns. Here are some questions you may want to ask: What tests will I need to have done? What will the results tell us? What symptoms should I watch for? How can I monitor my symptoms? What treatment options may be right for me? What are the benefits and risks/side effects of these options? How long might it take before I see an improvement? What can I do to make sure I am getting the most from my medication? In addition to taking my medication, what else can I do to manage my IBD? Are there any over-the-counter medicines, herbals, or supplements that I should avoid? Where can I find more information on IBD? Other: 2. Be prepared to tell your doctor about symptoms you may be experiencing. 3. Be prepared to tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. List all of the medicines (prescription and over-the-counter), vitamins, and herbal supplements that you take: 4. Express yourself you are your best advocate. Explain how IBD makes you feel. How does having IBD make you feel? How have things changed over time? Do you feel you need a change in the way your IBD is treated? 2016 PRIME Education, LLC. All Rights Reserved.

20 Tips for Promoting Positive Behavior Change Among IBD Patients: Strategies for Using Motivational Interviewing in Daily Practice Typical approaches to patient education and self-management often fail in patients who are not ready to change their behavior. Motivational interviewing (MI) is a goal-oriented conversational approach designed to strengthen a person s motivation and commitment to change. MI has been used successfully for several health behaviors, including medication adherence, dietary change, and exercise. 1 Patients with inflammatory bowel disease (IBD) frequently require long-term medication and lifestyle changes. Lack of patient adherence to IBD medications puts patients at risk for disease flares and can set patients on course for disabling disease. Key strategies to improve patient adherence focus on strengthening the therapeutic relationship between patients and the healthcare provider. 2 In this regard, studies in IBD show that brief MI interventions improve the patient experience and attitudes towards patient-provider communication. 3 Several concrete MI strategies can be briefly and easily implemented in daily clinical practice. 1 Examples of such strategies include setting an agenda, weighing the costs and benefits of change, and providing medical advice and health feedback. Below are some tips for incorporating MI into patient-provider communications. Remember open-ended questions, affirmations, reflective listening, and summary statements pen-ended O A R S questions ffirmations eflective listening ummary statements Open-ended questions encourage the patient to disclose more information. Examples: How are your medications working? How are you taking your medications? What problems are you having with your treatment plan? What do you expect from treatment? What symptoms are you experiencing? Affirmations are statements of appreciation to acknowledge patients efforts to change. Examples: I am impressed with how hard you are trying to quit smoking. With all the obstacles you have right now, it s amazing that you have been able to maintain your daily regimen. Restate the patient s thoughts or feelings to ensure understanding of the patient s perspective; emphasize positive statements about change; and diffuse resistance to change. Examples: What I hear you saying is It sounds like I get the sense that Recapitulate what the patient has said during the session to ensure understanding or to transition to another topic. Example: It sounds like you are concerned about your IBD because You also said that IBD is preventing you from doing the things you enjoy. Those seem like good reasons to follow your treatment plan PRIME Education, LLC. All Rights Reserved.

21 Setting an agenda The physician provides a menu of options for where to begin the discussion and then lets the patient decide. This approach increases the patient s participation and investment in the discussion. Example: Would you like to talk about taking your medication, monitoring symptoms, or avoiding triggers? Explore costs and benefits of change This strategy can help patients think about their reasons for adherence or nonadherence, and also to realize that their healthcare provider is interested in both sides of their reasoning. Encourage detailed answers. Example: The healthcare provider might first ask a patient what he or she thinks are the not so good things about taking medication. The provider could then ask, What about the other side? What are some good things about taking your medication? Strengthen intrinsic motivation by discussing how change is consistent with the patient s own values and goals Example: If the patient enjoys jogging, the healthcare provider asks how taking medication can help him/her run better. Provide medical advice and feedback using the elicit-provide-elicit approach Use this approach to engage patients in shared decision-making. First, elicit the patient s perspective of his or her condition. Then ask permission to provide education. Finally, elicit the patient s interpretation of the information to ensure understanding. Example: Elicit: What connection, if any, do you see between taking your medication and your IBD? Provide: Would you like to know more information about how medication can help your IBD? Elicit: What do you make of this information? References 1. Borrelli B, Riekert KA, Weinstein A, et al. Brief motivational interviewing as a clinical strategy to promote asthma medication adherence. J Allergy Clin Immunol. 2007;120(5): Bernick SJ. Improving adherence in inflammatory bowel disease. Pract Gastroenterol. 2010;34(2): Mocciaro F, Di Mitri R, Russo G, et al. Motivational interviewing in inflammatory bowel disease patients: a useful tool for outpatient counselling. Dig Liver Dis. 2014;46(10): PRIME Education, LLC. All Rights Reserved.

22 Resources for IBD Care and Patient Engagement IBD Clinical Care Pathways The American Gastroenterological Association (AGA) provides guidance and resources for inflammatory bowel disease (IBD) clinical care and patient management. In recent years, the AGA has developed evidence-based Clinical Care Pathways for both Crohn s disease and ulcerative colitis. These clinical decision support tools show a practical approach to identifying patients at high risk for severe disease, selecting initial treatment, and switching therapy in patients who have lost response. The IBD Clinical Care Pathways can be found at: Low-Risk Patient Assess Inflammation Assess Disease Burden Assess Comorbitities and Complications Moderate/High-Risk Patient Initial Treatment Initial Treatment Treatment for Patient in Remission Treatment for Patient Not in Remission Treatment for Patient in Remission Treatment for Patient Not in Remission Patient Education and Shared Decision-Making Resources The Crohn s and Colitis Foundation (CCFA) provides a broad range of patient education materials, covering IBD treatments, diet, complications, and more. Interactive tools such as the GI Buddy help patients keep track of their disease and communicate with their healthcare providers. These can be found at: To facilitate shared decision-making, the Agency for Healthcare Research and Quality (AHRQ) has developed the 5-step SHARE approach and accompanying tools, including reference guides, posters, and other resources to support implementation of shared decision-making. These tools can be found at: curriculum-tools/shareddecisionmaking/ index.html The SHARE Approach to Healthcare Decision-Making Seek your patient s participation Help your patient explore and compare treatment options Assess your patient s values and preferences Reach a decision with your patient Evaluate your patient s decision 2016 PRIME Education, LLC. All Rights Reserved.

23 Stepwise Approach to PQRS Reporting for IBD Quality Measures Overview Established as part of the Affordable Care Act, the National Quality Strategy (NQS) serves to guide the healthcare industry in providing better, more affordable care for individuals and the community. Stemming from this initiative, the Centers for Medicare and Medicaid Services (CMS) implemented the Physician Quality Reporting System (PQRS). In this program, eligible providers (EPs) report data on quality measures for covered Physician Fee Schedule services furnished to Medicare Part B Fee-for- Service (FFS) beneficiaries. In 2015, PQRS implemented a negative payment adjustment of 2% to EPs who do not satisfactorily report data on quality measures for covered professional services. Reporting Requirements Each PQRS measure aligns with 1 of 6 NQS domains (Effective Clinical Care; Patient Safety; Communication and Care Coordination; Person and Caregiver-Centered Experiences and Outcomes; Efficiency and Cost Reduction; and Community/Population Health). These domains represent the Department of Health and Human Services (DHHS) priorities for healthcare quality improvement. To satisfy the PQRS reporting requirements and avoid payment adjustments, EPs must: 1. Report on at least 9 PQRS measures across 3 NQS domains 2. Each measure must be reported for at least 50% of applicable Medicare Part B FFS patients 3. New in 2015, if an EP has a face-to-face encounter with a Medicare patient, the EP must report on 1 cross-cutting measure. The CMS defines a face-to-face encounter as an instance in which the EP billed for services that are associated with face-to-face encounters under the Medicare Physician Fee Schedule (MPFS). This includes general office visits, outpatient visits and surgical procedure codes, but not telehealth visits. Refer to the 2016 Cross-Cutting Measures List for applicable measures and the 2016 PQRS List of Face-to-Face Encounter Codes for a complete list of billable codes that identify face-to-face encounters. Reporting Requirements As an alternative to the reporting of individual measures, EPs may choose to report a PQRS Measures Group. A Measures Group consists of 6 to 10 individual measures with a common theme (eg, Preventive Care, IBD, etc). For 2016, 25 Measures Groups have been established, including an IBD Measures Group. To report a Measures Group, all applicable measures within the selected group must be reported for at least 20 patients who meet the patient sample criteria for the Measures Group. Additionally, a majority of the patient sample (at least 11 patients) must be Medicare Part B FFS patients. For further specifications on Measures Groups, refer to the 2016 PQRS Measures Groups Specifications Manual. Reporting Methods EPs may participate in PQRS as individuals or as part of a group practice under the Group Practice Reporting Option (GPRO). There are multiple ways to report measures for PQRS, which include: Medicare Part B Claims Individual Measures via Traditional Registry Measures Group via Traditional Registry Direct Electronic Health Records (EHR) using Certified HER Technology (CEHRT) CEHRT via Data Submission Vendor Qualified Clinical Data Registry (QCDR) GPRO via GPRO Web Interface GPRO via Registry and EHR Note that Measures Groups can only be reported via registry and cannot be used for group reporting under the GPRO PRIME Education, LLC. All Rights Reserved.

24 2016 PQRS Measures for IBD Listed below are the individual PQRS measures specific to IBD and corresponding quality domains and reporting options. Cross-cutting measure is denoted with an asterisk (*). The individual PQRS measures that constitute the IBD Measures Group (G-code G8899) are: PQRS Measure # 110* 111* 226* PQRS IBD Quality Measures Measure Description Preventive Care and Screening: Influenza Immunization: Percentage of patients aged 6 months and older seen for a visit between October 1 and March 31 who received an influenza immunization OR who reported previous receipt of an influenza immunization. Pneumonia Vaccination Status for Older Adults: Percentage of patients 65 years of age and older who have ever received a pneumococcal vaccine. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention: Percentage of patients aged 18 years and older who were screened for tobacco use 1 or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. IBD: Preventive Care: Corticosteroid Sparing Therapy: Percentage of patients aged 18 years and older with a diagnosis of IBD who have been managed by corticosteroids 10 mg/day of prednisone equivalents for 60 or greater consecutive days or a single prescription equating to 600 mg prednisone or greater for all fills that have been prescribed corticosteroid sparing therapy within the last 12 months. IBD: Preventive Care: Corticosteroid Related Iatrogenic Injury Bone Loss Assessment: Percentage of patients aged 18 years and older with an IBD encounter who were prescribed prednisone equivalents 10 mg/day for 60 or greater consecutive days or a single prescription equating to 600 mg prednisone or greater for all fills and were documented for risk of bone loss once during the reporting year or the previous calendar year. IBD: Testing for Latent Tuberculosis (TB) Before Initiating Anti-TNF (Tumor Necrosis Factor) Therapy: Percentage of patients aged 18 years and older with a diagnosis of IBD for whom a TB screening was performed and results interpreted within 6 months prior to receiving a first course of anti-tnf therapy. NQS Domain Community/ Population Health Community/ Population Health Community/ Population Health Effective Clinical Care Effective Clinical Care Effective Clinical Care 275 IBD: Assessment of Hepatitis B Virus (HBV) Status Before Initiating Anti-TNF Therapy: Percentage of patients aged 18 years and older with a diagnosis of IBD who had HBV status assessed and results interpreted within 1 year prior to receiving a first course of anti-tnf therapy. Effective Clinical Care Reporting Requirements As an active participant in the National Quality Forum, the AGA developed and maintains guidelines-based quality measures that align with the requirements set forth by CMS and private payers. To assist practices in reporting on IBD quality measures, the AGA hosts its own clinical data registry and provides information and tools, including an implementation guide for registry-based reporting IBD Measures Group. These and other resources can be found at: practice-management/quality References 1. Centers for Medicare and Medicaid Services PQRS Implementation Guide. Accessed 8/15/ Centers for Medicare and Medicaid Services PQRS Measures Groups Specifications Manual. Accessed 8/15/ Centers for Medicare and Medicaid Services. PQRS: Measures Codes. Accessed 8/15/ PRIME Education, LLC. All Rights Reserved.

25 [ ] TO OBTAIN CREDIT FOR THIS PROGRAM, ACCESS PRIMEINC.ORG/65PR161 There is no fee for this activity as it is sponsored by PRIME through an educational grant from Takeda Pharmaceuticals U.S.A.

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