A Trial of Pharmacist Management of Oral Anticoagulation THerapy Versus Enhanced Usual CARe in the communitY for AF (APOTHECARY AF Study)
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Optimal OAC Therapy
Study Overview
Brief Summary
This is a prospective, single-arm, feasibility pilot study of 20 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) recruited from a total of 4 retail and outpatient community pharmacies. Eligible participants will be enrolled in a 3-month active intervention of pharmacist-led OAC management. Participants will be passively followed for an additional 9 months to determine safety endpoints.
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, single-arm, feasiblity pilot study the investigators intend to enroll 20 participants (aged 60 years or older, with additional stroke risk factors and 'actionable' undertreated AF) from a total of 4 retail and outpatient community pharmacies in Los Angeles. Eligible participants will be enrolled in a 3-month active intervention of pharmacist-led OAC management. Participants will be passively followed for an additional 9 months to determine safety endpoints.
The primary objective(s) will be to determine the prevalence of 'actionable' AF in the community and the proportion of patients receiving guideline concordant OAC therapy at 3 months. Secondary outcomes include: patient satisfaction with pharmacist services (at 3 months), pharmacists' perspective on study implementation (at 1 month and 3 months), OAC adherence (at 12 months), and healthcare utilization (at 12 months).
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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.
Intervention: Oral anticoagulant (Drug)
Outcomes
Primary Outcomes
Optimal OAC Therapy
Time Frame: At 3 months and 12 months
To determine the proportion of patients with 'actionable AF' receiving optimal OAC therapy at 3 months.
Secondary Outcomes
- Medication Adherence (NOAC)(At 12 months)
- Medication Adherence (Warfarin)(At 12 months)
- Patient Satisfaction with Pharmacist Services(At 3 months)
- Healthcare Utilization(At 12 months)
- 'Actionable' AF Prevalence(At 12 months)
- Qualitative Review of Program Implementation(At 1 month and 3 months post-implementation)
Investigators
Roopinder Sandhu
Principal Investigator
Cedars-Sinai Medical Center