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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Atrial Fibrillation
• Intervention / Treatment: Drug: Oral anticoagulant

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Roopinder K Sandhu, MD; Phone Number: 424-315-4519; Email: roopinder.sandhu@cshs.org
• Study Contact Backup: Name: Ciantel Adair Blyler, PharmD; Phone Number: 310-425-2904; Email: ciantel.blyler@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Ciantel Adair Blyler, PharmD; Phone Number: 310-425-2904; Email: ciantel.blyler@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Oral anticoagulant; Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines; Other Names: warfarin; novel oral anticoagulants
Active Comparator: Enhanced Usual Care Control Arm; Pharmacist to notify primary care provider that patient has 'actionable' atrial fibrillation and provide current medication list.	Drug: Oral anticoagulant; Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines; Other Names: warfarin; novel oral anticoagulants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal OAC Therapy	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.	At 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Stroke; Atrial Fibrillation; Oral Anticoagulants; Pharmacist Case Management
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Warfarin; Anticoagulants
• Other Study ID Numbers: 00000850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes