A Trial of Pharmacist Management of Oral Anticoagulation THerapy in the communitY for AF

Cedars-Sinai Medical Center14 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation Stroke

Interventions

Oral anticoagulantDRUG

Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Outcomes

Primary Outcomes

Optimal OAC Therapy

To determine the proportion of patients with 'actionable AF' receiving optimal OAC therapy at 3 months.

Time frame: At 3 months and 12 months

Secondary Outcomes

'Actionable' AF Prevalence

To determine the prevalence of patients with 'actionable AF'

Time frame: At 12 months

Medication Adherence (NOAC)

To assess OAC adherence (i.e. proportion of days covered (PDC) for NOACS)

Time frame: At 12 months

Medication Adherence (Warfarin)

To assess OAC adherence (i.e. time in the therapeutic range (TTR) for warfarin)

Time frame: At 12 months

Patient Satisfaction with Pharmacist Services

To assess patient satisfaction with pharmacist services using 22-item questionnaire

Time frame: 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

Time frame: At 1 month and 3 months post-implementation

Healthcare Utilization

To assess healthcare utilization (i.e. the number of physician visits, specialist visits, ED visits, and hospitalizations)

Time frame: At 12 months

Data from ClinicalTrials.gov

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