INtegrated combination Therapy, Electronic General practice support tool, phaRmacy led intervention And combination Therapy Evaluation (INTEGRATE): An integrated general practice and pharmacy-based intervention to promote the prescription and use of appropriate preventive medications among individuals at high cardiovascular risk

Using a randomised controlled trial design, 70 Australian General Practice and Pharmacy pairs (35 intervention and 35 control) will be recruited. Each GP/Pharmacy pair in the intervention group will be exposed to three interventions (HealthTracker, CVD polypills and PASS). Each GP/pharmacy pair in the intervention arm will be encouraged to continue with the intervention 18 months from the time the last practice is recruited (based on results from the TORPEDO study1). At the end of this period, data will be collected from the GP/Pharmacy pairs in both study arms. 1 Peiris D, Usherwood T, Panaretto K, Harris M, Hunt J, Redfern J, et al. Effect of a Computer-Guided, Quality Improvement Program for Cardiovascular Disease Risk Management in Primary Health Care: The Treatment of Cardiovascular Risk Using Electronic Decision Support Cluster-Randomized Trial. Circulation: Cardiovascular Quality and Outcomes. 2015; 8(1): 87-95. The integrated intervention comprises of the following three elements: (1) HealthTracker, (2) availability of the Polypills and (3)Pharmacy Adherence Support Service (PASS). (1) HealthTracker is an electronic decision support tool that aims to assist general practitioners in the management of cardiovascular disease (CVD) risk. It aims to promote best practice care by giving management advice to health care providers based on national guidelines. HealthTracker incorporates a single, extensively validated screening and management algorithm, based on a synthesis of recommendations from several guidelines for CVD, kidney disease and diabetes prevention and management. HealthTracker interfaces with Medical Director (MD) and Best Practice (BP), two clinical practice software systems that together comprise around 80% of general practice record systems in Australia. Data from the patient records in MD or BP pre-populate HealthTracker which then provides the GP point-of-care recommendations on optimal use of CVD risk preventive medications (including option of polypill), based on that patient’s absolute CVD risk estimate. (2). Eight CVD polypills will be available and they are: (i) Name: PolyPill Hydrotelmi; Components: Telmisartan (40mg) + hydrochlorothiazide (12.5mg) + rosuvastatin (10mg) (ii) Name: PolyPill Hydrotelmi Asp; Components: Telmisartan (40mg) + hydrochlorothiazide (12.5mg) + rosuvastatin (10mg) + aspirin (100mg) (iii) Name: PolyPill Amtelmi; Components: Telmisartan (40mg) + amlodipine (5mg) + rosuvastatin (10mg) (iv) Name: PolyPill Amtelmi Asp; Components: Telmisartan (40mg) + amlodipine (5mg) + rosuvastatin (10mg) + aspirin (100mg) (v) Name: PolyPill Perindap; Components: Perindopril (4mg) + indapamide (1.25mg) + atorvastatin (40mg (vi) Name: PolyPill Perindap Asp; Components: Perindopril (4mg) + indapamide (1.25mg) + atorvastatin (40mg) + aspirin (100mg) (vii) Name: PolyPill Peramlo; Components: Perindopril (4mg) + amlodipine (5mg) + atorvastatin (40mg) (viii) Name: PolyPill Peramlo Asp; Components:Perindopril (4mg) + amlodipine (5mg) + atorvastatin (40mg) + aspirin (100mg) (3) Pharmacy Adherence Support Service (PASS): This intervention involves supporting patients with their “medication journey” by a trained pharmacist. Patients who have been prescribed a Polypill or a new CVD preventative medication will be referred by the GP to a partner Pharmacist who will firstly administer the 7 item Adherence to Refills and Medications Scale (ARMS-7) for assessing medication adherence in patients presenting with new CVD preventative medication prescriptions. A score of greater than 7 indicates unsatisfactory adherence to their medication regimen and the patient is recommended to participate in PASS. PASS, is a customised adherence program which involves a structured clinical interview (approximately 20 minutes) focused on: (i) understanding how the patient actually ‘uses’ their medications; (ii) understanding patient beliefs about their medications; and (iii) capturing patient-reported barriers to adherence. The structured interview is based on a modified version of the Brief Medication Questionnaire 1 (BMQ1), which will be used to systematically review and collect adherence data. Depending on the individualised recommendations, pharmacists may see enrolled patients at approximately 2 weeks (telephone discussion, 5 minutes), and during scheduled pharmacy visits at approximately 1, 3, 6 and 12 months after enrolment, to coincide with prescription re-fills (patients may however present each month for a regular re-fill of their medications). Adherence issues and barriers to medication taking will be reviewed at each visit (10 minutes). An electronic software (PASS Application) has been developed to deliver the ARMS-7 and the PASS via a Tablet/Ipad provided to Pharmacists. The use of HealthTracker will be monitored centrally by the research team. The use of PASS will be monitored by Project Officers who will contact and visit pharmacies regularly. Fidelity measures (e.g. number of times a recommendation was clicked or the PASS intervention was delivered) will be collected throughout the study.