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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke, Atrial Fibrillation

Intervention / Treatment
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* Drug: Oral anticoagulant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 or Spanish 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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, open-label, cluster-randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial Fibrillation, Stroke, Oral Anticoagulants, Pharmacist Case Management