Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care PHARMACY PRACTICE RESEARCH GRANTS

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1 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care PHARMACY PRACTICE RESEARCH GRANTS GUILD/GOVERNMENT COMMUNITY PHARMACY AGREEMENT FUNDING Final Report Project Title: Project Director: Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care. Mr Jeff Hughes Name of Organisation of the Project Director: School of Pharmacy Curtin University of Technology Project Number

2 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care TABLE OF CONTENTS Page Executive summary 4 Authors 8 Introduction 10 Literature Review 11 Methodology 15 Evaluation Methodology 19 Actual versus propose Methodology: Reasons for Deviation 20 Results 21 Discussion 44 Conclusion 54 Recommendations 55 References 58 Appendices 64 Project Number

3 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care INDEX TO APPENDICES Appendix 1 Patient self administered health assessment 2 QOL survey - SF36 3 Patient initial review and assessment, checklist, patient results 4 Patient follow up review and assessment, checklist, patient results 5 Withdrawal forms 6 Unscheduled contact forms 7 Diary care plans 8 Diary educational material 9 Other educational resource material 10 Recruitment Flyers 11 Media Release 12 Direct Mailing to Doctors 13 Division of General Practice Newsletter 14 ABC radio interview report 15 Patient questionnaire and responses Project Number

4 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Background EXECUTIVE SUMMARY Drug therapy of hypertension is proven to reduce blood pressure and the risk of associated adverse cardiovascular events, however these benefits cannot be realized unless patients actually comply with prescribed drug therapy and blood pressure is optimally reduced. In patients receiving antihypertensive drugs rates of blood pressure control have been shown to be inadequate. In addition, the rate of adherence of these patients to pharmacological and nonpharmacological therapies is also sub-optimal. Several studies in overseas settings have shown the potential benefits of pharmacist interventions to improve blood pressure control and adherence rates. This study aimed to assess the effectiveness of a community pharmacy-based hypertension disease state management program on improving blood pressure control, patient adherence, quality of life, lifestyle modification rates, and diminishing cardiac risk and cardiovascular disease events. Further the study sought to assess the impact of the program on health care resource consumption and health costs. Methodology A recruitment target of 300 patients was set to provide adequate power to detect significant differences from the intervention. Eligible patients were aged over 18 years and newly commenced on antihypertensive drug therapy. Patients were excluded if they did not speak English or were pregnant. Subjects were recruited from six community pharmacy in metropolitan Perth, Western Australia. Subjects were randomized using a block design and assigned to Control, or Low or High intervention groups and followed for a period of 12 months. Control subjects received standard pharmacy care. Subjects in the Low intervention group received 3 monthly follow-ups and those in the High intervention group received monthly follow-ups using the disease state management model. The disease state management model consisted of regular blood pressure monitoring, patient education and support, cardiovascular risk factor management, lifestyle modification promotion, medication management and adherence assessment. The disease state management program and blood pressure monitoring was administered at each site pharmacists who had received 2 full days advanced hypertension management training. At initial consultations blood pressure, patient demographics, medical history, drug history, cardiac risk factors, lifestyle factors (weight, smoking, alcohol consumption, physical activity levels and salt intake), attitudes towards drug treatment and understanding of hypertension and their drugs were assessed. A quality of life assessment was also performed using SF 36 Short Form. A diary was issued to all intervention subjects to record health issues, lifestyle target achievements, compliance problems and drug-related issues Project Number

5 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care encountered during the study. At subsequent visits intervention group participants had their blood pressure measured, diary reviewed as well as an assessment of progress with lifestyle modification, drug compliance and drug related problems. Health events, doctor visits and hospital visits were also recorded. At completion of the study period all patient groups had a repeat quality of life assessment and were asked to complete a satisfaction survey. Results Thirty-four patients were enrolled into the study and 21 completed the study follow-up period. There were seven patients in each of the study groups. Initial recruitment based on prospective identification of patients having an antihypertensive medication dispensed for the first time proved more difficult than expected. In response to this, various strategies to improve enrolment were tried which including; extensive signage and advertising, newspaper notices, radio interviews, direct mailing to GPs, involvement of GP practice divisions. Further the study entry criteria were also relaxed to include any patient within 3 months of commencing antihypertensive medication. Although these strategies improved recruitment none was particularly successful. The small number of patients recruited limited the probability of detecting statistically significant differences between the Control and Intervention groups. It also contributed groups not being matched at baseline in terms of age, sex distribution or baseline blood pressure. Both diastolic and systolic blood pressures were significant reduced in all groups after commencement of drug therapy, with the largest decline seen in the Control group. This is to be expected as the Control group had the highest baseline blood pressures. Differences in decline in blood pressures over the duration of the study between the Control and Intervention groups did not achieve statistical significance. The results were encouraging from the perspective that patients in the Intervention groups had lower average systolic and diastolic blood pressures and a larger proportion had achieved target blood pressures. These trends were more evident in the High intervention group. Both intervention groups showed a numerical trend towards better adherence compared to controls, however due to small number of subjects the difference did not achieve statistical significance (p = 0.482). Similarly, results related to health events, QOL assessments and lifestyle modifications did not show a clear benefit from the pharmacist intervention. Pharmacists demonstrated competence in detecting adverse drug reactions and over-treatment of hypertension, and successfully resolved these drug related problems. Results from the patient satisfaction survey demonstrated that participants valued the services offer, in particular education, personal contact and the attention of the pharmacist. Patient feedback and the higher drop out rate from the High intervention suggested that a service based on 3 monthly follow-up may be preferable by community pharmacy clients. Project Number

6 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Because of the small study cohort and failure to demonstrate any differences in crude measures of health care consumption (doctor visits and hospitalization) an economic evaluation was deemed unlikely to provide detectable differences and hence was not undertaken. Conclusions The interpretation of the results is limited by the small patient cohort, and therefore further research is required to determine benefits of a pharmacybased hypertension disease state management program. In this study the patient numbers were too small to demonstrate finite improvements in outcomes; however trends suggest regular pharmacist disease state management interventions lead to improvements in achievement of target blood pressure and adherence rates which warrant further study. Further, pharmacists may have also have helped to improve or maintain lifestyle modifications. Certainly, the study demonstrated that pharmacists did intervene to resolve drug-related problems which may otherwise have gone undetected. The pharmacist intervention programs did not significantly improve patients quality of life assessment, but at the same time no detriment was seen either. Patient satisfaction with the disease state management program was high, although the amount they were prepared to pay for such a service was quite low, $5-$20 per consultation. It is important to reiterate, given the very limited statistical inference that can be made on the results we consider that the study should only be viewed as a pilot program for disease state management in hypertension, but believe that its supports the need for further research in this area. Before programs such as this can be translated to general pharmacy practice consideration should be given to the pharmacist time and resources required to provide such advanced services, patient willingness pay for these services and the exact demand for disease monitoring and medicines management among antihypertensive medicine users. Recommendations Reasons for poor recruitment are of consideration. From the results of this study we recommend: Possible inducements for pharmacists to recruit (i.e. payment above their base salary) Possible inducements for patients to participate (e.g. provision of a blood pressure monitor) Site pharmacists with dedicated to the study and unconnected to normal pharmacy business services (this removes barriers related to need to service customers, rather than focusing on recruiting and following up trial participants) Increased numbers, mix and locations of study sites with smaller individual recruitment targets. Project Number

7 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Comments from pharmacists and patients suggested that study design and methodology could be improved. Based on this feedback we would suggest: Shorter consultations (not greater than 15 minutes) Simplified interventions and paperwork, possibly using IT decision support Reduced frequency of interventions (i.e. not more frequent than 3 monthly) Increased patient involvement in the intervention and monitoring process Review of the cost versus time ratio required of intervention reviews Questions raised but not answered by this study for consideration of future research include: What do patients really want from their pharmacist in regards to hypertension, and is it disease state management? Does the public understand what disease state management activities are and do they value them? Do patients value time and relationship with the pharmacist more than disease state management services? What amount of time spent on disease state management services would meet patient expectations? How can an economically sustainable model of disease state management and cognitive services for hypertension be developed for industry-wide application? Project Number

8 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care AUTHORS Chief Investigator Title and Name Mr Jeffery Hughes Qualifications and B Pharm (Distinction), Grad Dip Appointments Pharm (Distinction), M Pharm, Consultant Pharmacist AACP Senior Lecturer, Clinical Pharmacy Partner, Home and Hospital Pharmacy Services, Medical Clinic, SJOG Hospital Murdoch, WA Institution and Address School of Pharmacy, Curtin University of Technology, GPO Box U1987, Perth, WA, 6845 Business Phone Business Fax Mobile J.D.Hughes@curtin.edu.au Project Officer Title and Name Mr Neil Keen Qualifications and Appointments BPharm, MPS Senior Pharmacist Institution and Address Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, Western Australia 6009 Business Phone Business Fax Mobile Neil.Keen@health.gov.wa.au Project Number

9 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Co-Researchers Title and Name Mr Michael Dillon Qualifications and B Sci (Pharm), MPS Appointments Proprietor Pharmacy 777 Institution and Address Locked Bag 2 Applecross WA 6153 Business Phone Business Fax Mobile mad@pharm777.com.au Title and Name Mr Tony Maricic Qualifications and B Pharm, MPS Appointments Proprietor Midland Gate Pharmacy Institution and Address Midland Gate Pharmacy Shop Midland Gate Shopping Centre Brockman Road Midland WA 6056 Business Phone Business Fax Mobile tony@flyartgallery.com Project Number

10 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Objectives INTRODUCTION This study aims to evaluate a hypertension disease management model (DMM) for community pharmacists. Outcomes This study represented the first Australian community pharmacy based hypertension disease management program. It was expected that the program would result in the following health benefits: improved patients adherence rates with drug and non-drug interventions higher rates of achievement of target blood pressures (BP < 140/90 mm Hg non-diabetic patients, BP < 130/85 mm Hg for diabetics) reduced incidence of adverse drug reactions reduced CV complications (myocardial infarction, heart failure, transient ischaemic attacks or stroke, renal disease, death) improved quality of life reduction in health care expenditure (cost of medications and cost of doctors visits, attendances at emergency departments and hospital admissions) Project Number

11 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Significance of the Research Issue LITERATURE REVIEW Presented below are some key points from a report by Australian Institute of Health and Welfare In Australia, cardiovascular disease kills more people than any other disease and creates enormous costs for the health care system. These issues are expected to become more acute over the next decades with the growing number of elderly Australians, among whom cardiovascular disease is most common. In terms of deaths: Cardiovascular disease was the leading cause of death among Australians in 1998, accounting for 50,797 deaths (40% of all deaths). Coronary heart disease (mainly heart attacks) was the leading single cardiovascular cause of death, accounting for 27,825 deaths (22% of all deaths) in Australia in Stroke was Australia s second greatest single killer after coronary heart disease, claiming 11,982 lives in 1998 (9% of all deaths). It is the leading cause of long-term disability in adults. hospitalisations In , there were 437,717 hospitalizations where cardiovascular disease was the principal diagnosis (7% of all hospitalizations). In term of health care costs to the community: Cardiovascular disease is the most costly disease for the health system in Australia. It was responsible for 12% ($3.9 billion) of total recurrent health expenditure in Cardiovascular conditions consuming most health system resources were coronary heart disease ($894 million), high blood pressure ($831 million) and stroke ($630 million). As pointed out in the report much of the burden of cardiovascular disease is preventable through appropriate management of risk factors, such as obesity, smoking, elevated cholesterol, lack of physical activity and hypertension. In , almost three million Australians (aged 25 and over) had high blood pressure or were on medication for that condition. High blood pressure increases the risk of cardiovascular disease by two to four times. 1 Whilst, the number of Australian with raised blood pressure has declined over recent years, it still remains a significant health problem. Community pharmacists can assist patients to achieve the best possible outcome from their antihypertensive therapy through the process of disease state management. 2 Project Number

12 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Pharmacists can be involved in: Stage of treatment Treatment Plan Implementation Clinical Outcome Action Verify: Patient s health beliefs, educational needs, understanding of disease, treatment goals, lifestyle modifications and non-drug therapy Social/clinical factors complication patient care Risk factors (eg. Diabetes, smoking, dyslipidaemia, obesity) Diastolic/systolic BP stage of hypertension Target organ damage (eg. Heart, kidney, brain) Drug choice and conformity with recognised guidelines Drugs exacerbating hypertension are avoided, including OTC and complimentary medications Co-morbidity which may affect choice of therapy Monitor: Laboratory marker: plasma urea/creatinine, electrolytes, uric acid, glucose Clinical symptoms of over/under-treatment Patient compliance; need to reinforce health messages Dose: adjusted to optimise response to each antihypertensive agent Medication timings: synchronise to once or twice daily where possible. Confirm and respond to: Achievement of blood pressure goal Symptoms of toxicity Documentation of adverse effects Indications for treatment plan revisions to produce satisfactory control Indications to step down treatment There are a number of studies that have demonstrated that pharmacists have a role in the management of patients with hypertension Cheng and others set out to compare doctors compliance with medication usage guidelines published by the US Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. 7 Using pharmacy externs they assessed patients filling prescriptions in 102 New York Pharmacies, and enrolled 821 patients. They used pharmacy students given a 2 hour training tutorial to administer blood pressure readings and conduct questionnaires. The primary finding was that doctors complied with best practice in medication selection in 85% of cases initially. This Project Number

13 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care decreased to 64% by the end of the study. They also investigated adherence in these patients. Only 37% of patients were consistently compliant with their drugs. Six percent of patients understood why they were taking specific agents and 45% knew their blood pressure readings at diagnosis. These findings suggest that there is still much room for improvement in treatment of hypertension, education of patients and drug compliance. Park et al reported that through the process of monthly BP and heart rate monitoring and patient counselling in the community pharmacy setting they were able to significantly enhance compliance rates and achievement of target blood pressures in 27 intervention patients compared to 26 controls. 8 Using different methods Godley et al reviewed 23,316 health insurance records to determine blood pressure control. 9 The eligible sample of 374 patients had controlled blood pressure in 66% of cases. They suggested that there was a large potential for improvement and that pharmacists could influence this through education, evaluation of control, evaluation of medication use and recommendations for improvement. They then went on to apply such an intervention. Over six months three clinical pharmacists provided academic detailing to physicians. This resulted in a change in blood pressure control from 37.2% to 49.2% (p = ). Chabot et al explored the effects of an intervention program in pharmacies. They reasoned that most pharmaceutical care requires an appointment to be made and access to extra patient medical information. 10 They used computerised decision support tool in four pharmacies and compared this to five control pharmacies. The tool prompted blood pressure readings to be taken and information to be entered. Pharmacists received 2 hours training on the tool use and taking blood pressures. They were paid $ 4 Canadian for each blood pressure and $ 5 Canadian for each intervention. One hundred patients (of 348 approached) completed the study. They reported an improvement in systolic blood pressure (-7.8 vs 0.5 mm Hg, p =0.01) in interventions subjects versus controls, but only for patients with high incomes. The program also had a positive impact on adherence. Erickson and others studied patients at a US University health clinic, where pharmacists reviewed patients who had elevated blood pressures after routine consultations with the medical staff. 3 Several pharmacy residents provided comprehensive pharmaceutical care services, particularly education and adherence advice. Patients were followed for 5 months. Differences noted in blood pressure between the two groups were significant in the systolic pressures only (12 vs 2.7 mm Hg, p = 0.05). There was no difference seen in quality of life from pharmacist interventions as measured using SF36. Carcao et al attempted pharmaceutical care in a population of semiliterate hypertensive patients in rural Portugal. 11 The study site was one private pharmacy that serviced eight villages. Eighty two patients were randomly assigned to intervention or control. Patients were followed for 6 months. Intervention patients had blood pressure taken, were given educational advice, encouraged to apply non-pharmacological activities. Therapy was assessed and changes recommended to one of two prescribers by phone or letter. At the end of 6 months the level of uncontrolled blood pressure decreased by 77%.4 (p < 0.001) in the intervention group and 10.3 % (p = Project Number

14 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care 0.48) in the control group. Twenty nine antihypertensive drug related problems were detected in this population. Dong et al studied a hypertensive population in a US teaching hospital. Patients were selected from a hypertension clinic run by non-medical staff established 17 years previously. 6 In this clinic specialist pharmacist staff initiates, maintains and modifies patients antihypertensive drug treatment. The primary aim of this trial was to apply disease screening investigations and detect associated medical conditions. They audited 159 patients; 117 pharmacist managed and 42 nursing staff managed. Blood pressure control (defined as < 150/90) was 79.5% versus 59.5% in favour of pharmacist managed patients. While difficult to compare to other blood pressure control studies (no physician control and higher target blood pressure) the pharmacists showed at least equivalent control to other series, suggesting that pharmacists can competently manage monitoring and medicines management. Research suggests that up to 50% of patients will cease taking their antihypertensive medications after 1 year, and that of those who continue treatment a significant number will not achieve target blood pressures leaving them at significant risk of cardiovascular events Yasin, writing in the Australian Family Physician stated: Despite the proven benefits of hypertension control, fewer that 50% of those treated for hypertension have their blood pressure adequately controlled. The major reason for this is poor compliance with treatment. 21 An Australian survey of 269 patients taking long-term hypertensive medications revealed that 27.8% of patients missed doses. 22 Project Number

15 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care METHODOLOGY Setting The study was undertaken at six community pharmacies located in the Perth metropolitan area. The community pharmacy sites used in the study were either owned by or affiliated with the collaborating co-researchers. Contact was made with the general practitioners to explain the aims and structure of the project, and to enlist their cooperation. Patients Each pharmacy was be responsible for recruiting 50 newly diagnosed patients with hypertension commencing drug therapy for the first time. A total of 300 patients were to be enrolled into the study. Patients eligible for the study were those 25 years or older. Patients were recruited at the time of presentation of their first prescription for an antihypertensive medication. At this time the aims and structure of the study was explained to the patients and they were invited to become a participant. If they agreed to participate in the study they were asked to give written informed consent, which included permission to contact their general practitioners to discuss their progress and obtain relevant clinical and laboratory data, and to access the Medicare records through the Health Insurance Commission. They were informed that they might withdraw from the study at any time without penalty and their data will be destroyed. Sample Size The sample size was been calculated to allow the detection of a 20% change in adherence rates and achievement of target blood pressures at the 95% confidence interval. Randomisation Patients will be allocated into one of three groups (Control, high, Low) defined below using a table of random numbers. Study Groups Control Group: Patients receive Standard care Review 1. (Day of Enrolment) After giving informed written consent patients were asked to self-complete a specifically designed medical / medication history questionnaire and a quality of life questionnaire (originally planned to use Health Outcomes Institute, Hypertension/Lipids disorders; TyPE Specification, however this was replaced by the SF36 short form) at home. They then returned this to the pharmacist via mail. Patients were then interviewed to confirm the medical history provided in the questionnaire. The following data recorded: patient Project Number

16 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care demographics; social, medical and medication histories; history of drug allergies and lifestyle modifications suggested by their general practitioner. The patient s BP and weight were measured and recorded. Based on the patient s past medical history and history of drug allergies a review of the appropriateness of the antihypertensive prescribed was undertaken. Where this review identified a more appropriate antihypertensive the prescriber was contacted and the merits of the alternative therapy discussed. The controls patient were offered counseling on their medications and lifestyle modification, by providing Self-care fact sheets were appropriate and addressing specific queries. This level of care was distinct from the written information, intensive comprehensive counseling and written care plans provided to all intervention patients. Control patients were asked to return for a follow-up review in 12 months. Review 2. At 12 months Prior to the due date of their 12-month follow-up all patients were contacted by telephone to arrange an appointment time. During this appointment the patient s BP and weight was re-measured. They were administered a standardized review by interview to assess their level of adherence with drug therapy and recommended life-style changes. The patient s dispensing history was used as an objective marker of their adherence. The patient s drug history was recorded, as was a history of visits to their general practitioner and hospital attendances and reasons for these. Medicare data was to be obtained to allow quantification of health resource usage. The QOL assessment was repeated. Where appropriate, patients were to be referred to their general practitioner for further review based on predetermined guidelines. Low Group (Intervention Group 1: Patients to receive intensive patient education, regular monitoring of BP and weight, progress assessment, identification of and interventions to overcome barriers to adherence. three monthly follow- ups over 12 months) Review 1. (Day of Enrolment) After giving informed written consent patients were asked to self-complete a specifically designed medical / medication history questionnaire and a quality of life questionnaire (originally planned to use Health Outcomes Institute, Hypertension/Lipids disorders; TyPE Specification, however this was replaced by the SF36 short form) at home. They then returned this to the pharmacist via mail. Patients were then interviewed to confirm past medical and medication history and the following data recorded: patient demographics; social, medical and medication histories, history of drug allergies, and lifestyle modifications suggested by their general practitioner. The patient s BP and weight were measured and recorded. Based on the patient s past medical history, history of drug allergies the suitability of the antihypertensive medication prescribed was assessed and if necessary the patient s GP contacted to discuss possible alternatives. Patients received intensive counselling about hypertension and its management and were provided with written study specific educational materials. An assessment of cardiovascular Project Number

17 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care risk was undertaken and strategies to address identified risk factors (e.g. obesity, smoking) were discussed and an action plan agreed upon. Wherever appropriate the patient was referred back to their general practitioner. The patients were then provided with a diary which included written information on hypertension and its management, their medication regimen, dates for prescription refills (complemented with telephone reminders), lifestyle modification targets, dates for follow-up visits and doctors' appointments. Patients were asked to record any symptoms they experienced in their diary, life-style modifications (including exercise undertaken), missed medication doses, and unscheduled visits to their doctor or hospital attendances. Reviews 2, 3 and 4. (Months 3, 6 and 9) Patients were contacted by telephone prior to their next scheduled review to arrange an appointment time. At each of these reviews the patient s BP and weight was re-measured. The patient was interviewed to assess achievement life-style modifications targets. Where issues affecting adherence with drug and/or non-drug measures were identified the patient s management plan was reviewed and modified accordingly. Where appropriate measures to enhance adherence were instituted. If necessary, patients were referred to their general practitioner based on predetermined guidelines. Review 5. At 12 months As per the Control Group. High Group (Intervention Group 2: Patients to receive intensive patient education, regular monitoring of BP and weight, progress assessment, identification of and interventions to overcome barriers to adherence. Monthly follow-ups over 12 months) Review Process: As per Low (Intervention: Group 1) except reviews will be repeated at monthly intervals. All intervention pharmacists attended a 2 day advanced hypertension study day run by the authors at Sir Charles Gairdner Hospital. The training covered: methods of blood pressure measurement, hypertension, drug treatment, cardiac risk, lifestyle modification, pharmaceutical care, recruitment, study methodology, record keeping, patient education, adherence and compliance, and workshops of real case studies. Materials for visit reviews were developed by modifying existing care plan reviews. Reviews were designed to facilitate data collection and to provide a structured, uniform, disease state management review for hypertension and cardiovascular risk factors. These were developed with the assistance of site pharmacists. Assessment and recording instrument material for reviews, diary and educational material are documented in attached appendixes; 1 through 9. Project Number

18 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Guidelines for Practice The Pharmaceutical Society of Australia Guidelines for Blood Pressure Measurement and Assessment will be used when recording patient s blood pressure and as a guide for referral of patients to their General Practitioners. Patient education material was based on pamphlets produced by the National Health Foundation of Australia and Self-care; and the JNC IV Guidelines, Cardiovascular Guidelines published by Therapeutic Guidelines Limited, and the National Prescribing Service. A Cardiologist reviewed the educational material contained in the patient hypertension diaries before they were printed. Project Number

19 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Clinical EVALUATION METHODOLOGY The clinical success of the DM program was to be evaluated by comparing the level of adherence with therapy, frequency of attainment of target BP and the mean change in BP, incidence of complications and medication adverse effects, QOL assessment scores and rates to medical practitioners visits and hospital attendances/admissions, and death rates between intervention groups and the control group. Comparison of the results from the two intervention groups was undertaken to assess whether the intensity of the service provision (i.e. monthly versus 3 monthly) influenced clinical outcomes. Statistical analysis was undertaken using SPSS software package. Economic The economic impact of the service was to be evaluated by comparison of the health resource consumption costs between groups. Health resource costs were to be calculated from HIC data and to include: cost of medications, cost of doctor visits, diagnostic investigations, attendances at emergency departments and hospital admissions. The cost effectiveness of the program was to be evaluated by comparing the difference between actual healthcare consumption costs between groups. The disease state management program would have been deemed to be cost effective if the cost of providing the program was less than the cost savings achieved through providing the service. After estimation of relative risk of developing a major hypertension complication for patients in the intervention groups compared with controls it would be possible to further evaluate the cost-benefit of the program based on the service provision cost associated with the prevention specific complications of hypertension. This analysis would be based on outcome data obtained during the study, and extrapolated from epidemiological data. It could be expected that for any intervention that results in larger number of patients achieving optimal management of their BP should significantly reduce the financial burden of cardiovascular and cerebrovascular disease. Project Number

20 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care ACTUAL VERSUS PROPOSED METHODOLOGY: REASONS FOR DEVIATION There were two major deviations from the proposed study method. The first involved patient entry and eligibility criteria. The second involved use of the Quality of Life scoring tool initially nominated. Entry Criteria Eligibility for the study included those patients who had presented at the pharmacy for dispensing of their first prescription. This was based on assumptions made from review of the literature regarding patient adherence with antihypertensive medications. It was assumed that patients captured later than this would be those that had made a conscious decision to continue their blood pressure lowering medications and therefore their inclusion would be selecting a group that had high medication adherence, thus reducing the possibility of detecting a difference in outcomes. In addition based on evidence that early control is important in the decision to continue therapy 23 it was considered that the patients who had cease treatment early would be those most likely to benefit from education and improved control medicated by the pharmacist. The difficulty identifying and capturing these patients prospectively during such a small window of opportunity in a busy, uncontrolled environment forced these entry criteria to be altered. To make the window of opportunity larger patients who had commenced medical therapy for hypertension within the last 3 months were considered eligible. This was justified by necessity and some evidence from research that suggesting that median time to cessation is beyond 3 months 24. Relaxation of these criteria did markedly increase recruitment rate from baseline but still not enough to achieve targets. Quality Of Life Tool The Quality of life tool intended for use was the Health Outcomes Institute, Hypertension/Lipids disorders; TyPE Specification. We were not successful in purchasing this tool. Investigations suggested that as the tool was an older assessment method that it was no longer available and further was no longer supported. 25 In response to unavailability of this tool the Short Form 36 (SF36) quality of life tool was substituted. The SF36 is a generic tool that assesses general health across 8 domains. It is a very commonly used tool, accounting for the majority of all published QOL assessments in the medical literature. It has proven sensitivity and has been validated in numerous settings including measurement of cardiovascular health. 26 In addition other pharmacy based hypertension and intervention studies have utilized the SF36 tool. 3,27 Project Number

21 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care Statistical analysis RESULTS Results were entered into a Microsoft Access database and then exported into Statistical Package for Social Sciences (SPSS) software, Version 11.5 for Windows for data analysis. Data was analyzed with the assistance of Jennifer Lalor, the SPSS Advisor for the Learning Support Network (LSN), Curtin University of Technology. Due to the small sample size assumption of normal distribution for groups was deemed inappropriate. For this reason both parametric and non-parametric analysis of results was performed. Differences were considered to be statistically significant at the 0.05 level. Patient Enrolment Recruitment fell well short of the target 300 subjects required for predicted power to detect a significant difference between groups. Initially 6 months was allowed for subject recruitment based on a national Australian hypertension prevalence of 30% 28 and a local Western Australian hypertension prevalence of 22.7 to 28% 29, equating to a total of 209,017 patients. Each site was projected to recruit approximately one patient per week. In response to this initial slow enrolment the recruitment period was extended for a further 6 months. Initially promotion of the study was via in-pharmacy posters and through personal subject identification and invitation of eligible subjects. When evident that this was insufficient numerous extra strategies were implemented. These strategies included: Flyers Hundreds of short recruitment flyers (see Appendix 10) were printed and distributed to each recruitment site. These were placed in prominent locations around each store and inserted into script bags. Pharmacy displays Each site developed an attractive display in front of the dispensing counter using hypertension education resources, blood pressure monitors and study literature. Local community paper advertising Local community newspapers were approached and asked to provide advertising space (see Appendix 11). Response from this initiative was limited. Direct mailing to local doctors The top 40 doctors in the local area at each site were determined by prescription volume through the site pharmacy, dispensing records. An explanatory letter (see Appendix 12) was posted with a copy of the Project Number

22 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care abridged proposal and patient consent, seeking assistance in patient recruitment. In addition combined medical practices located close to each site were approached directly. Extra in-store signage Outside store signage Large, distinctive A-frame signs were designed and professionally printed for use in front of each pharmacy. Approach to local Divisions of general practice Regional divisions of general practice were approached for support. Several divisions agreed to promote the study to their member GP s. In consultation with these divisions promotional literature was developed (see Appendix 13) and distributed. Support of the study was also advertised in the Divisions of General Practice newsletters. Increasing on-site staff able to recruit Initially only the primary site pharmacist who had attended the advanced training day was authorised to recruit. When unsuccessful this was extended to all pharmacists, pre-registration trainees and pharmacy students. The study coordinator provided extra on-site recruitment education for these staff. In addition dispensary assistants were enlisted to help identify potential subjects and refer these to the pharmacist. Extension of entry criteria Anecdotal evidence from site pharmacists suggested that recruiting patients at the time of first dispensing after diagnosis with hypertension was difficult. The original entry criteria for the study only included patients who had been on antihypertensive medication for one month or less. This restriction was considered necessary to ensure that patients with good adherence did not self select for enrolment. In response to the slow enrolment the entry criteria was relaxed to include patients taking antihypertensive medications for 3 months or less. This was based on evidence that median cessation time for antihypertensive drugs is approximately 3 months 24 independent of drug class, dose or other factors. Radio interview An interview was conducted with ABC statewide talkback radio. This produced a good initial response with many phone enquiries; however few respondents progressed to enrollment. (See Appendix 14). Enrolment was ceased after 12 months with a final cohort of 34 patients (11.3% of projected). Excluding inadequate advertising as a cause, poor enrolment may reflect either lack of incentive for patients to participate or possibly failures or obstacles regarding the recruiting pharmacists. Project Number

23 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care The study was primarily promoted as offering free blood pressure testing and the potential of better health from interaction with the pharmacist. This may have simply been insufficient inducement in a market where the pharmacist is already readily accessible without appointment to anyone wishing to ask for free medical, health or medicines advice. The limited value that patients may place on blood pressure testing is evident in the low number who remembered their reading from the GP on diagnosis (only 47.6%) and also from comments regarding payment for services, such as I get bulk billed so my doctor will take my blood pressure for free. Further to this the perceptions of pharmacists, services offered and the value of pharmaceutical care has been studies by several authors, 30,31 who contend that patient participation in these programs has developed more slowly than the anticipated need to provide these services. One suggested cause is patient inexperience with pharmaceutical care, where patients do not perceive an immediate potential benefit from participation and therefore assign such services a low personal value. Patients are known to judge the benefits of a preventative behaviour on the basis of ability to reduce the threat of the personally relevant health problem. Nau et al 30 assert that to see the potential of pharmaceutical care as a preventative measure, pharmacists must first show patients how they may develop health and medication related problems. In keeping with this theory, patient education regarding cardiovascular risk and the link to hypertension was an objective of this study. However pharmacists perceptions of what patients require and value differ from what patients themselves expect and want from pharmaceutical care services This is supported by the ambivalent response to initial expectations of the study reported in the final patient assessment questionnaires. Poor enrolment demonstrated in this study argues in favour of a concerted promotional strategy by the entire pharmacy profession for patient education regarding pharmaceutical care and disease management services. The ability of patients to determine the technical competence of their pharmacist seems less important than the personal relationship they have with the pharmacist. 32 This may be relevant for the patients eligible for this study, initially diagnosed with hypertension who do not routinely use medications or access pharmacy services, and also for some of the larger busier study sites located in high traffic shopping centers. Other additional barriers to patient recruitment may have included extra time involved and lack of choice over treatment assignment. These have been well recognized as trial recruitment barriers. 35 Twenty to thirty minutes was allocated per visit and patients were clearly informed of their potential time commitment before enrolment. This amount of time was felt necessary to complete all the required tasks at each visit: diary review, data collection, dispensing, tablet counts, blood pressure measurements, interventions with doctors, counseling and education, appointment scheduling, recording of results and care plans. To conform with National Guidelines 21 patients were asked to rest for at least 5 minutes prior to blood pressure measurements being performed, and between measurements, this requirement also contributed to prolonging the consultation time. Both patients and pharmacists commented on the time required for these interviews and cited this as a reason for discontinuation. It was envisaged that as the study pharmacists became more proficient, the time required for follow-up appointment would fall. Unfortunately, the low number of subjects prepared to participate in the Project Number

24 Hypertension: Improving patient compliance and clinical outcomes through community pharmacist managed care study did not provide the opportunity for the pharmacists to refine their skills as anticipated. Some patients expressed disappointment at assignment to the Control group, while others declined to enter study upon explanation that they might be assigned to a Control group. Other recognized barriers to recruitment 35 on the part of the pharmacist were also reported. All site pharmacists cited lack of time as the primary personal barrier to recruitment. It is acknowledged that pharmaceutical care 31 activities detract from time that is required for other activities that provide real revenue from business such as dispensing. Experience with this study suggests that all future pharmaceutical care style interventions may require a dedicated pharmacist on site who is either independent of the normal running of the study site pharmacy or does not have competing dispensing duties. Although the time of each pharmacist spent on reviews was reimbursed to the pharmacy there was no personal reward or payment. This should also be considered in further research but would add to trial costs significantly. Loss to Follow Up Of the 34 patients enrolled, 13 were lost to follow up (see Table 1). The final retention rate was 62%. This number is lower but not inconsistent with retention rates of approximately 70 to 80% in some other pharmaceutical care studies treating hypertension. 11,36 Other studies have used different methods and were much shorter in duration, 3,10,36,37 the majority averaging 5 to 6 months follow up versus 12 months in this study. Duration of the study may well be significant, particularly for patients in the High-level intervention group. Time required to schedule and complete the disease management intervention was alluded to by several subjects in the active arm on study completion. The recognized low adherence rate with antihypertensive drugs should also be considered when assessing drop out in this cohort; many studies document rates below 50%. 24,38,39 Table 1: Patient withdrawals Study Groups Control Low Level Intervention High Level Intervention (3 monthly follow-up) (1 monthly follow-up) Withdrawals Cited reasons Moved house, untraceable or unwilling to continue 1 extended travelling 2 unwilling to continue 2 ceased medications 1 Moved 3 unwilling to continue A certain loss from the Control group was anticipated. None of the control patients lost to follow had continued dispensing histories at the site pharmacies. They are therefore assumed to be non-compliant. Patients lost to follow up are not included in the final analysis as there is no post intervention data for comparison. It could be argued that lack of intervention was the reason these patients withdrew or ceased medication and their inclusion in analysis would produce more favourable result towards the disease management model. Project Number