A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF — APOTHECARYAF  

Stroke Clinical Trial

Official title: A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF (APOTHECARY AF Study)

Status Recruiting

Clinical Trial Summary

This is a prospective, open-label, cluster-randomized controlled trial of 400 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 40 retail and outpatient community pharmacies. Participants will be randomized (by pharmacy) to either to an intervention arm of pharmacist-led OAC management versus an enhanced usual care arm, wherein physicians receive notification of 'actionable' AF and patients are advised to schedule a physician clinic visit. The primary objective will be to determine the difference in proportion of patients with 'actionable AF' receiving guideline concordant OAC therapy at 3 months in those randomized to intervention arm versus control arm.

Clinical Trial Description

Oral anticoagulation therapy for stroke prevention in AF is safe and effective but under-utilized. Optimal delivery of existing therapies would prevent AF-related stroke. Therefore alternative strategies to increase adherence to current guidelines for OAC use for AF stroke prevention should be explored.

Accumulating data indicate that pharmacist-led or pharmacist-collaborative care in cardiovascular disease monitoring, risk factor control, and medication optimization leads to greater adherence to guideline-directed targets and improved outcomes.

In this prospective, open-label, cluster-randomized controlled trial the investigators intend to enroll 400 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 40 retail and outpatient community pharmacies in Los Angeles. Participants will be randomized (by pharmacy) to either to an intervention arm of pharmacist-led OAC management versus an enhanced usual care arm, wherein physicians receive notification of 'actionable' AF and patients are advised to schedule a physician clinic visit. The primary objective will be to determine the difference in proportion of patients with 'actionable AF' receiving guideline concordant OAC therapy at 3 months in those randomized to intervention arm versus control arm. Secondary outcomes include: patient satisfaction with pharmacist services (at 3 months), pharmacists' perspective on study implementation (at study end), and OAC adherence (at 1 year). In an exploratory aim, the investigators will assess healthcare utilization and clinical outcomes at 1 year.

This research will generate new knowledge on an innovative, and potentially sustainable stroke prevention strategy to increase evidence-based use of OAC therapy in patients with AF. ;

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

• NCT number: NCT04907825
• Study type: Interventional
• Source: Cedars-Sinai Medical Center
• Contact: Roopinder K Sandhu, MD
• Phone: 424-315-4519
• Email: roopinder.sandhu@cshs.org
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2023
• Completion date: August 31, 2024