Pharmacist Enhanced Service for Cardiovascular Risk Reduction

Study Overview
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Brief Summary
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Pharmacist services such as medication review, counselling and treatment adherence clinics can improve clinical, health related quality of life and economic outcomes. To prove this hypothesis a step-wedge, cluster randomized controlled trial will be held in primary care centers of the public health system of Malaysia. Participants who have a high risk of cardiovascular risk factors currently seeking care in primary care will be recruited. Control group will receive usual care and the intervention arm will be seen by a pharmacist prior to their follow-up, with a comprehensive medication review, counselling and dietary advice consultations every month for three months. Participating pharmacist will be trained in cardiovascular prevention pharmacotherapy, interview skills, educational techniques, and develop personalized plan for every participant. The investigators plan to randomize up to 2100 participants who are currently receiving care in the primary care clinics in the district of Petaling by modifying the current workflow in primary care, whereby the investigators aim to get participants who are at high risk to undergo counselling as well as a medication review with proper pharmaceutical care delivered to them prior to seeking their medical doctor to receive care.

Official Title
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Pharmacist Enhanced Service in Primary Care for CArdiovascular Risk Reduction (PxES-CAR2+) Project: A Multi-centre Pragmatic, Step-wedge Cluster Randomized Controlled Trial

Conditions
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Cardiovascular Risk Factor

Intervention / Treatment
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* Other: Enhanced pharmacist service
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with diabetes Patients with chronic kidney disease (eGFR <60ml/min/1.73m2) Patients with established atherosclerotic vascular disease (via patient health records or selfreport) including cerebrovascular disease (prior stroke or transient ischemic attack), cardiovascular disease (myocardial infarction, acute coronary syndrome, stable angina, or revascularization), or peripheral arterial disease (symptomatic and/or ankle brachial index <0.9) Primary prevention patients with multiple risk factors and Framingham risk score >30% Exclusion Criteria: Unwilling to participate/sign consent form Unwilling or unable to participate in regular follow-up visits Pregnancy Undergoing existing medication therapy adherence clinic conducted by the Pharmacy Unit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced pharmacist service<br>The advanced care group will be undergo a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA) with the pharmacist | Other: Enhanced pharmacist service<br>* Calculation of cardiovascular risk by an online tool for discussion on the CVD risk. Pharmacist will also provide ducation on cardiovascular risk factors and healthy lifestyle. Any prescription adaptation(s), and/or recommendations where necessary to meet lipid, blood pressure and glycemic control targets and smoking cessation will be initiated<br>|
| Active Comparator: Usual care<br>Patients in the usual care arm will receive their usual care which they will obtain care from their doctor,nurse and pharmacist where appropriate | Other: Usual care<br>* Participants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiovascular risk scores | The difference from baseline to 3 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiovascular risk scores | The difference from baseline to 6 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale | 6 months | 
| Change in cardiovascular risk scores | The difference from baseline to 12 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale | 12 months | 
| Change in cardiovascular risk scores | The difference from baseline to 24 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale | 24 months | 
| Achievement of recommended cholesterol, blood pressure and glycemic control targets | Number of individual achieving target cholesterol, blood pressure and glycemic control target | 3 months | 
| Proportion of patients receiving appropriate medication | Number of patients receiving appropriate BP, cholesterol and diabetes medication | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, pharmacist service