Cardiovascular Risk Factor
Conditions
Keywords
cardiovascular disease, pharmacist service
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.
Interventions
OTHEREnhanced 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
OTHERUsual care
Participants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice
Sponsors
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
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Efficiency of screening | 3 months | Number of high risk patients screened for cardiovascular risk |
Countries
Malaysia
Outcome results
None listed