Pharmacist Case Finding and Intervention for Vascular Prevention Trial (PRxOACT)

Implementation of Pharmacist Case Finding and Intervention for Vascular Prevention (PRxOACT) Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Disease; Diabetes; Dyslipidemia; Blood Pressure; Cardiovascular Risk Factors
• Intervention / Treatment: Other: Pharmacist-led care pathway

• Study Type: Interventional
• Enrollment (Actual): 1003
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • The University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pharmacist-led care pathway; 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; 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.
No Intervention: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1c in those who have diabetes	The difference in change in serum A1c in those who have diabetes from baseline to the end of the study (up to six months) between the intervention and control groups	Up to 6 months.
Blood pressure	The difference in change in blood pressure from baseline to the end of the study (up to six months) between the intervention and control groups	Up to 6 months.
LDL Cholesterol Concentration	The difference in change in serum LDL-cholesterol concentration from baseline to the end of the study (up to six months) between the intervention and control groups	Up to 6 months.
Tobacco use or vaping	The difference in the proportion of participants who report tobacco or vape use from baseline to the end of the study (up to six months) between the intervention and control groups.	Up to 6 months.
Yield of enrolment approaches	The yield from each enrolment approach used (active case-finding approach vs. passive approaches such as when the patient attends the pharmacy to collect a prescription medication or through patient self-identification)	Up to 6 months.
Yield of enrollment by pharmacy type	Yield of enrollment by clinic or non-clinic pharmacy type	Up to 6 months.
Shared-decision making uptake	Extent to which shared decision making was achieved in the intervention as measured by the validated Shared Decision Making 9-item Questionnaire (SDM-Q-9) tool. The minimum score is 0 and the maximum score is 45, where a higher score indicates a greater subjective level of shared decision making.	Up to 6 months.
Previous cardiovascular risk assessment	Proportion of participants who never had their cardiovascular risk assessed before the study.	Up to 6 months.
Proportion categorized as having high cardiovascular risk	Proportion of participants who are categorized as having high cardiovascular risk.	Up to 6 months.
Patient satisfaction	Patient satisfaction as measured by the Consultation Satisfaction Questionnaire. Minimum score is 18 and maximum score is 90, where a higher score indicates higher patient satisfaction.	Up to 6 months.
Types of intervention delivered by the pharmacist	Types of interventions provided by the pharmacists, such as education on lifestyle factors (tobacco cessation, diet, exercise), prescribing or changing the dose of medications, education on new or changed medications, education on adherence to medications and/or lifestyle recommendations.	Up to 6 months.
Quality of life reported by study participants	The difference in change in quality of life as measured using the validated EuroQoL 5 Dimensions 5 Levels (EQ-5D-5L) Scale between the intervention and control groups. The EQ-5D-5L will be scored by collecting individuals' health state index value, which will be converted into an EQ 5D summary value according to the preferences of the general population of a country/region.	Up to 6 months.

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Study Director: Ross Tsuyuki, University of Alberta; Principal Investigator: Yazid Al Hamarneh, University of Alberta

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 4, 2024
• First Posted (Actual): May 9, 2024

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: diabetes; blood pressure; cardiovascular; dyslipidemia
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Cardiovascular Diseases; Diabetes Mellitus; Dyslipidemias
• Other Study ID Numbers: Pro00139142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No