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Pharmacist Enhanced Service for Cardiovascular Risk Reduction

Not Applicable
Withdrawn
Conditions
Cardiovascular Risk Factor
Interventions
Other: Enhanced pharmacist service
Other: Usual care
Registration Number
NCT04220788
Lead Sponsor
Monash University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
Enhanced pharmacist serviceEnhanced pharmacist serviceThe advanced care group will be undergo a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA) with the pharmacist
Usual careUsual carePatients in the usual care arm will receive their usual care which they will obtain care from their doctor,nurse and pharmacist where appropriate
Primary Outcome Measures
NameTimeMethod
Change in cardiovascular risk scores3 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
NameTimeMethod
Change in cardiovascular risk scores24 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 targets3 months

Number of individual achieving target cholesterol, blood pressure and glycemic control target

Proportion of patients receiving appropriate medication3 months

Number of patients receiving appropriate BP, cholesterol and diabetes medication

Trial Locations

Locations (1)

Shaun Lee

🇲🇾

Subang Jaya, Selangor, Malaysia

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