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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• Age \> 60 years

• Men (CHADS-VASc score ≥2) AND Women (CHADS-VASc score ≥3)

• AF and not on OAC therapy but eligible

• AF and on sub-optimal or inappropriate OAC therapy

• Written informed consent

Locations
United States
California
Cedars-Sinai Medical Center
RECRUITING
Los Angeles
Contact Information
Primary
Roopinder K Sandhu, MD
roopinder.sandhu@cshs.org
424-315-4519
Backup
Ciantel Adair Blyler, PharmD
ciantel.blyler@cshs.org
310-425-2904
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 400
Treatments
Experimental: Pharmacist Intervention Arm
Pharmacist to prescribe/monitor/manage oral anticoagulation therapy for atrial fibrillation stroke prophylaxis (under collaborative practice agreement with participants primary care provider) in accordance with ACC/AHA/HRS Guidelines.
Active_comparator: Enhanced Usual Care Control Arm
Pharmacist to notify primary care provider that patient has 'actionable' atrial fibrillation and provide current medication list.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: Cedars-Sinai Medical Center

This content was sourced from clinicaltrials.gov