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

Phase 4

Recruiting

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Drug: Oral anticoagulant

• Registration Number: NCT04907825
• Lead Sponsor: Cedars-Sinai Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-06-01
• Study Start: 2023-01-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age > 60 years
2. Men (CHADS-VASc score ≥2) AND Women (CHADS-VASc score ≥3)
3. AF and not on OAC therapy but eligible
4. AF and on sub-optimal or inappropriate OAC therapy
5. Written informed consent

Exclusion Criteria

1. AF on optimal OAC therapy
2. OAC required for other conditions (i.e. DVT/PE, PCI in prior year, left ventricular thrombus, etc.)
3. Currently taking two antiplatelet agents
4. Uncontrolled hypertension (defined as SBP ≥160 mmHg x 2 BP readings measured at screening)
5. End-stage renal disease (CrCl <15 ml/min or dialysis)
6. Major surgery in prior month (defined as surgery requiring general anesthesia and overnight inpatient hospital stay)
7. History of "major bleeding" in prior year (defined as overt bleeding at critical site including intracranial, intraspinal, intraocular, pericardial, GI bleed, bleed requiring hospitalization, bleed resulting in ≥20 g/L drop in hemoglobin or requiring transfusion of ≥2 units packed cells)
8. Excess alcohol intake (≥8 alcoholic drinks/week)
9. Inability to read or understand English or Spanish
10. Participants considered unreliable by the Investigator or designated pharmacy team member concerning the requirements of follow-up, or those with foreshortened life expectancy precluding 3-month follow-up
11. Severe cognitive impairment (≥5 errors on the Short Portable Mental Status Questionnaire)
12. Pregnant women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacist Intervention Arm	Oral anticoagulant	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.
Enhanced Usual Care Control Arm	Oral anticoagulant	Pharmacist to notify primary care provider that patient has 'actionable' atrial fibrillation and provide current medication list.

Primary Outcome Measures

Name	Time	Method
Optimal OAC Therapy	At 3 months	To determine the difference in proportion of patients with 'actionable AF' receiving optimal OAC therapy at 3 months in those randomized to intervention arm versus control arm.

Secondary Outcome Measures

Name	Time	Method
Medication Adherence (NOAC)	At 12 months	To assess OAC adherence (i.e. proportion of days covered (PDC) for NOACS)
Medication Adherence (Warfarin)	At 12 months	To assess OAC adherence (i.e. time in the therapeutic range (TTR) for warfarin)
'Actionable' AF Prevalence	Through study completion, an average of 1 year	To determine the prevalence of patients with 'actionable AF'
Patient Satisfaction with Pharmacist Services	At 3 months	To assess patient satisfaction with pharmacist services using 22-item questionnaire
Healthcare Utilization	At 12 months	To assess healthcare utilization (i.e. the number of physician visits, specialist visits, ED visits, and hospitalizations)
Qualitative Review of Program Implementation	Through study completion, an average of 1 year	To perform a qualitative review of program implementation by surveying pharmacists about their experiences with 11-item questionnaire

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States