Pharmacist Enhanced Service for Cardiovascular Risk Reduction

NCT04220788 | Withdrawn

• 1 other identifier: PxES-CAR2+
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Risk Factor

Keywords

cardiovascular disease; pharmacist service

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in cardiovascular risk scores

  6 months

• Change in cardiovascular risk scores

  12 months

• 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

Other Outcomes (2)

• Efficiency of screening

  3 months

• Change in participant quality of life

  3 months

Study Arms (2)

Enhanced pharmacist service

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Interventions

Enhanced pharmacist service 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

Enhanced pharmacist service

Usual care OTHER

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

Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Monash University: lead
• Klinik Kesihatan Puchong: collaborator
• Klinik Kesihatan Kelana Jaya: collaborator
• Klinik Kesihatan Shah Alam Seksyen 7: collaborator
• Klinik Kesihatan Shah Alam Seksyen 9: collaborator
• Klinik Kesihatan Taman Medan: collaborator
• Klinik Kesihatan Seri Kembangan: collaborator

Study Sites (1)

Shaun Lee

Subang Jaya, Selangor, 47500, Malaysia

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Shaun Lee

  Monash University Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 7, 2020
• Study Start: March 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)