Pharmacist Enhanced Service for Cardiovascular Risk Reduction

Pharmacist Enhanced Service in Primary Care for CArdiovascular Risk Reduction (PxES-CAR2+) Project: A Multi-centre Pragmatic, Step-wedge Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Cardiovascular Risk Factor
• Intervention / Treatment: Other: Enhanced pharmacist service; Other: Usual care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Selangor
    • Subang Jaya, Selangor, Malaysia, 47500
      • Shaun Lee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiovascular risk scores	The difference from baseline to 3 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiovascular risk scores	The difference from baseline to 6 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale	6 months
Change in cardiovascular risk scores	The difference from baseline to 12 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale	12 months
Change in cardiovascular risk scores	The difference from baseline to 24 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale	24 months
Achievement of recommended cholesterol, blood pressure and glycemic control targets	Number of individual achieving target cholesterol, blood pressure and glycemic control target	3 months
Proportion of patients receiving appropriate medication	Number of patients receiving appropriate BP, cholesterol and diabetes medication	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency of screening	Number of high risk patients screened for cardiovascular risk	3 months
Change in participant quality of life	Change in quality of life assessed using EuroQoL-5D from baseline to end of intervention (range 0-1)	3 months

Collaborators and Investigators

• Sponsor: Monash University
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 5, 2020
• First Posted (Actual): January 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 31, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: cardiovascular disease; pharmacist service
• Other Study ID Numbers: PxES-CAR2+

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No