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Pharmacist Enhanced Service for Cardiovascular Risk Reduction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04220788
Recruitment Status : Withdrawn (No enrollment due to difficulty in recruitment of study sites)
First Posted : January 7, 2020
Last Update Posted : September 2, 2020
Sponsor:
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
Information provided by (Responsible Party):
Shaun Lee Wen Huey, 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Other: Enhanced pharmacist service Other: Usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
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
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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




Primary Outcome Measures :
  1. Change in cardiovascular risk scores [ Time Frame: 3 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 :
  1. Change in cardiovascular risk scores [ Time Frame: 6 months ]
    The difference from baseline to 6 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale

  2. Change in cardiovascular risk scores [ Time Frame: 12 months ]
    The difference from baseline to 12 months in the estimated cardiovascular risk between advanced care and usual care groups assessed using the Framingham scale

  3. Change in cardiovascular risk scores [ Time Frame: 24 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

  4. Achievement of recommended cholesterol, blood pressure and glycemic control targets [ Time Frame: 3 months ]
    Number of individual achieving target cholesterol, blood pressure and glycemic control target

  5. Proportion of patients receiving appropriate medication [ Time Frame: 3 months ]
    Number of patients receiving appropriate BP, cholesterol and diabetes medication


Other Outcome Measures:
  1. Efficiency of screening [ Time Frame: 3 months ]
    Number of high risk patients screened for cardiovascular risk

  2. Change in participant quality of life [ Time Frame: 3 months ]
    Change in quality of life assessed using EuroQoL-5D from baseline to end of intervention (range 0-1)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220788


Locations
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Malaysia
Shaun Lee
Subang Jaya, Selangor, Malaysia, 47500
Sponsors and Collaborators
Monash University
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
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Principal Investigator: Shaun Lee Monash University Malaysia
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Responsible Party: Shaun Lee Wen Huey, Associate Professor, Monash University
ClinicalTrials.gov Identifier: NCT04220788    
Other Study ID Numbers: PxES-CAR2+
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shaun Lee Wen Huey, Monash University:
cardiovascular disease
pharmacist service