Clinical trial NCT04220788: Pharmacist Enhanced Service for Cardiovascular Risk Reduction
Official title: Pharmacist Enhanced Service in Primary Care for CArdiovascular Risk Reduction (PxES-CAR2+) Project: A Multi-centre Pragmatic, Step-wedge Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Risk Factor
Keywords: cardiovascular disease
pharmacist service
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Klinik Kesihatan Puchong
name: Klinik Kesihatan Kelana Jaya
name: Klinik Kesihatan Shah Alam Seksyen 7
name: Klinik Kesihatan Shah Alam Seksyen 9
name: Klinik Kesihatan Taman Medan
name: Klinik Kesihatan Seri Kembangan
First posted: 2020-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in cardiovascular risk scores
timeFrame: 3 months
Secondary outcomes:
measure: Change in cardiovascular risk scores
timeFrame: 6 months
measure: Change in cardiovascular risk scores
timeFrame: 12 months
measure: Change in cardiovascular risk scores
timeFrame: 24 months
measure: Achievement of recommended cholesterol, blood pressure and glycemic control targets
timeFrame: 3 months
measure: Proportion of patients receiving appropriate medication
timeFrame: 3 months
Other outcomes:
measure: Efficiency of screening
timeFrame: 3 months
measure: Change in participant quality of life
timeFrame: 3 months
Locations:
city: Subang Jaya
country: Malaysia
facility: Shaun Lee
state: Selangor
Study officials:
affiliation: Monash University Malaysia
name: Shaun Lee
role: PRINCIPAL_INVESTIGATOR
References: