Implementation of Pharmacist Case-Finding and Care Pathway Intervention for Vascular Prevention (PRxOACT): Protocol for a Randomized Controlled Trial

Cardiovascular (CV) disease (CVD) is the leading cause of death worldwide. The risk factors contributing to CVD development have been well known for decades, but treatment gaps persist. Pharmacists are frontline primary healthcare providers whose interventions to lower CV risk are supported by rigorous evidence. However, efforts to support the widespread implementation of pharmacist interventions to reduce CV risk are needed. To support such implementation, we developed an electronic tool (the “Care Pathway”) for guideline-directed assessment, prescription, and follow-up for CVD risk reduction that incorporates shared decision-making. The aim of this trial is to determine the impact of the pharmacist-led Care Pathway intervention on participants’ estimated risk for major CV events. This investigator-initiated, multicentre, open-label, randomized controlled trial will include 982 patients (aged ≥ 18 years) with ≥ 1 risk factor for CVD. Patients will be randomized in a 1:1 ratio to receive either a pharmacist-led Care Pathway intervention or usual care. Participants’ estimated CV risk will be calculated at baseline and at a 6-month follow-up evaluation. The primary outcome is the difference in change in estimated CV risk from baseline to the 6-month follow-up evaluation between the groups. Pharmacist-led assessment and management of patients’ CV risk factors may serve as an effective intervention to reduce patients’ estimated risk for major CV events. Formal evaluation of widespread implementation of a Care Pathway intervention will be conducted for the first time in a pharmacy practice CV risk–reduction trial.

Clinical Trial Registration

The University of Alberta Human Research Ethics Board (Pro00139142). NCT06405880.