Pharmacist Case Finding and Intervention for Vascular Prevention Trial

NCT06405880 | Active Not Recruiting

• 1 other identifier: Pro00139142
• Study Type: interventional
• Target: 1,003
• Locations: 1 country
• Sites: 1

Brief Summary

Heart disease is a common and serious medical condition which causes nearly one in every three deaths worldwide every year. The factors which increase people's risk for heart disease are well-known, but there needs to be more support given to people to reduce their risk of heart disease. Pharmacists are front line primary healthcare providers who see patients more frequently than any other healthcare provider and can help people reduce their risk of heart disease. This research project aims to see whether a pharmacist-led intervention can help people reduce their risk of heart disease. The potential impact of this project is to empower people to understand how to reduce their risk of heart disease and reduce the burden of heart disease on the community.

Conditions

Cardiovascular Risk Factors; Blood Pressure; Cardiovascular Disease; Diabetes; Dyslipidemia

Keywords

cardiovascular; blood pressure; diabetes; dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Estimated cardiovascular risk

  The primary outcome is the difference in change in estimated CV risk (calculated using the EPI·RxISK™ calculator: https://www.epicore.ualberta.ca/epirxisk/) from baseline to the end of the study (up to six months) between the intervention and control groups.

  Up to 6 months.

Secondary Outcomes (12)

• A1c in those who have diabetes

  Up to 6 months.

• Blood pressure

  Up to 6 months.

• LDL Cholesterol Concentration

  Up to 6 months.

• Tobacco use or vaping

  Up to 6 months.

• Yield of enrolment approaches

  Up to 6 months.

Study Arms (2)

Pharmacist-led care pathway

EXPERIMENTAL

Participants in the intervention arm will receive the care using a shared decision-making pharmacist-led care pathway designed to guide the cardiovascular (CV) risk reduction process. The pharmacist-led care pathway is modelled after the largest CV risk reduction randomized controlled trial in a community pharmacy setting (RxEACH Study), and based upon the latest CV risk reduction guidelines, such as C-CHANGE. This pathway will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to calculate the participant's estimated CV risk. The participant and pharmacist will be guided by the care pathway to review the participant's estimated CV risk and contributing CV risk factors and engage in shared decision-making to manage the participant's CV risk factors using lifestyle changes and/or pharmacological treatment as clinically appropriate.

Other: Pharmacist-led care pathway

Usual Care

NO INTERVENTION

The control group will involve facilitated relay of information to participants' family physician. Participants in the control group will have their pharmacist collect information informing the patient's CV risk. Participants will then be given a letter that contains their values for CV risk factors (including blood pressure, HbA1c, and lipid panel), and they will be advised to present it to their family physician. No specific suggestions for CV risk reduction will be detailed in the letter. In the case where the patient does not have a family physician, they can be referred to a physician walk-in clinic. A follow-up appointment in 6-months' time will be booked for with all participants in the control group.

Interventions

Pharmacist-led care pathway OTHER

Participants in the intervention arm will receive the care using a shared decision-making pharmacist-led care pathway designed to guide the cardiovascular (CV) risk reduction process. The pharmacist-led care pathway is modelled after the largest CV risk reduction randomized controlled trial in a community pharmacy setting (RxEACH Study), and based upon the latest CV risk reduction guidelines, such as C-CHANGE. This pathway will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to calculate the participant's estimated CV risk. The participant and pharmacist will be guided by the care pathway to review the participant's estimated CV risk and contributing CV risk factors and engage in shared decision-making to manage the participant's CV risk factors using lifestyle changes and/or pharmacological treatment as clinically appropriate.

Pharmacist-led care pathway

Eligibility Criteria

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

You may qualify if:

• Adults (18 years or older)
• Clinical diagnosis of at least one of the following conditions:
• Diabetes,
• Chronic kidney disease,
• Chronic inflammatory condition (e.g., rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, systemic lupus erythematosus or psoriasis),
• Atherosclerotic vascular disease,
• Hypertension,
• Obesity (defined as body mass index greater than 30),
• Current tobacco or vape use

You may not qualify if:

• Unwilling to participate/sign consent form;
• Unwilling or unable to participate in regular follow-up visits; or
• Pregnant

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

The University of Alberta

Edmonton, Alberta, Canada

Location

Related Publications (1)

• Liu S, Tsuyuki RT, Graham MM, Nelson D, Semeniuk G, Al Hamarneh YN. Implementation of Pharmacist Case-Finding and Care Pathway Intervention for Vascular Prevention (PRxOACT): Protocol for a Randomized Controlled Trial. CJC Open. 2025 Mar 20;7(6):821-831. doi: 10.1016/j.cjco.2025.03.011. eCollection 2025 Jun.

  PMID: 40586019 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus; Dyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Study Officials

• Ross Tsuyuki

  University of Alberta

  STUDY DIRECTOR

• Yazid Al Hamarneh

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 9, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CA (1)