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

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Anticoagulants; Warfarin

Criteria

Inclusion Criteria:

1. Age > 65 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

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