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

University of Alberta

Status: Active, not recruiting

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

Treatments: Other: Pharmacist-led care pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT06405880

Pro00139142

Details and patient eligibility

About

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.

Enrollment: 1,003 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,003 participants in 2 patient groups

Pharmacist-led care pathway

Experimental group

Description:

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.

Treatment:

Other: Pharmacist-led care pathway

Usual Care

No Intervention group

Description:

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.