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

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04907825

Collaborator

(none)

380

Enrollment

Location

Arms

Anticipated Duration (Months)

15.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, open-label, cluster-randomized controlled trial of 380 participants (aged 65 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 38 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Stroke	Drug: Oral anticoagulant	Phase 4

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 380 participants (aged 65 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 38 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 Design

Study Type:

Interventional

Anticipated Enrollment :

380 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, open-label, cluster-randomized controlled trialProspective, open-label, cluster-randomized controlled trial

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

'Actionable' AF Prevalence [Through study completion, an average of 1 year]
To determine the prevalence of patients with 'actionable AF'
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)
Patient Satisfaction with Pharmacist Services [At 3 months]
To assess patient satisfaction with pharmacist services using 22-item questionnaire
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
Healthcare Utilization [At 12 months]
To assess healthcare utilization (i.e. the number of physician visits, specialist visits, ED visits, and hospitalizations)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age > 65 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

Exclusion Criteria:

AF on optimal OAC therapy
OAC required for other conditions (i.e. DVT/PE, PCI in prior year, left ventricular thrombus, etc.)
Currently taking two antiplatelet agents
Uncontrolled hypertension (defined as SBP ≥160 mmHg x 2 BP readings measured at screening)
End-stage renal disease (CrCl <15 ml/min or dialysis)
Major surgery in prior month (defined as surgery requiring general anesthesia and overnight inpatient hospital stay)
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)
Excess alcohol intake (≥8 alcoholic drinks/week)
Inability to read or understand English
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
Severe cognitive impairment (≥5 errors on the Short Portable Mental Status Questionnaire)
Pregnant women