Pharmacist Enhanced Service in Primary Care for CArdiovascular Risk Reduction (PxES-CAR2+) Project: A Multi-centre Pragmatic, Step-wedge Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in cardiovascular risk scores
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •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
结局指标
主要结局
Change in cardiovascular risk scores
时间窗: 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
次要结局
- Change in cardiovascular risk scores(24 months)
- Achievement of recommended cholesterol, blood pressure and glycemic control targets(3 months)
- Proportion of patients receiving appropriate medication(3 months)
研究者
Shaun Lee Wen Huey
Associate Professor
Monash University