Pharmacist Enhanced Service for Cardiovascular Risk Reduction

NCT ID: NCT04220788

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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Cardiovascular Risk Factor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Enhanced pharmacist service

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Participants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice

Interventions

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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

Intervention Type OTHER

Usual care

Participants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinik Kesihatan Puchong

UNKNOWN

Sponsor Role collaborator

Klinik Kesihatan Kelana Jaya

UNKNOWN

Sponsor Role collaborator

Klinik Kesihatan Shah Alam Seksyen 7

UNKNOWN

Sponsor Role collaborator

Klinik Kesihatan Shah Alam Seksyen 9

UNKNOWN

Sponsor Role collaborator

Klinik Kesihatan Taman Medan

UNKNOWN

Sponsor Role collaborator

Klinik Kesihatan Seri Kembangan

UNKNOWN

Sponsor Role collaborator

Monash University

OTHER

Sponsor Role lead

Responsible Party

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Shaun Lee Wen Huey

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaun Lee

Role: PRINCIPAL_INVESTIGATOR

Monash University Malaysia

Locations

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Shaun Lee

Subang Jaya, Selangor, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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PxES-CAR2+

Identifier Type: -

Identifier Source: org_study_id

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