Pharmacist Enhanced Service for Cardiovascular Risk Reduction
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Enhanced pharmacist service 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
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
|
| Active Comparator: Usual care 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
Participants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice
|
Outcome Measures
Primary Outcome Measures
- Change in cardiovascular risk scores [3 months]
The difference from baseline to 3 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
Secondary Outcome Measures
- Change in cardiovascular risk scores [6 months]
The difference from baseline to 6 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
- Change in cardiovascular risk scores [12 months]
The difference from baseline to 12 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
- Change in cardiovascular risk scores [24 months]
The difference from baseline to 24 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale
- Achievement of recommended cholesterol, blood pressure and glycemic control targets [3 months]
Number of individual achieving target cholesterol, blood pressure and glycemic control target
- Proportion of patients receiving appropriate medication [3 months]
Number of patients receiving appropriate BP, cholesterol and diabetes medication
Other Outcome Measures
- Efficiency of screening [3 months]
Number of high risk patients screened for cardiovascular risk
- Change in participant quality of life [3 months]
Change in quality of life assessed using EuroQoL-5D from baseline to end of intervention (range 0-1)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with diabetes
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Patients with chronic kidney disease (eGFR <60ml/min/1.73m2)
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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)
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Primary prevention patients with multiple risk factors and Framingham risk score >30%
Exclusion Criteria:
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Unwilling to participate/sign consent form
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Unwilling or unable to participate in regular follow-up visits
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Pregnancy
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Undergoing existing medication therapy adherence clinic conducted by the Pharmacy Unit
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shaun Lee | Subang Jaya | Selangor | Malaysia | 47500 |
Sponsors and Collaborators
- Monash University
- Klinik Kesihatan Puchong
- Klinik Kesihatan Kelana Jaya
- Klinik Kesihatan Shah Alam Seksyen 7
- Klinik Kesihatan Shah Alam Seksyen 9
- Klinik Kesihatan Taman Medan
- Klinik Kesihatan Seri Kembangan
Investigators
- Principal Investigator: Shaun Lee, Monash University Malaysia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PxES-CAR2+