Pharmacist Enhanced Service for Cardiovascular Risk Reduction

Cardiovascular Risk Factor Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04220788
• Other study ID #: PxES-CAR2+
• Status: Withdrawn
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2020
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

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

Locations

Country	Name	City	State
Malaysia	Shaun Lee	Subang Jaya	Selangor

Sponsors (7)

Lead Sponsor	Collaborator
Monash University	Klinik Kesihatan Kelana Jaya, Klinik Kesihatan Puchong, Klinik Kesihatan Seri Kembangan, Klinik Kesihatan Shah Alam Seksyen 7, Klinik Kesihatan Shah Alam Seksyen 9, Klinik Kesihatan Taman Medan

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficiency of screening	Number of high risk patients screened for cardiovascular risk	3 months
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Achievement of recommended cholesterol, blood pressure and glycemic control targets	Number of individual achieving target cholesterol, blood pressure and glycemic control target	3 months
Secondary	Proportion of patients receiving appropriate medication	Number of patients receiving appropriate BP, cholesterol and diabetes medication	3 months