Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing (PIAAFRx)

University of Alberta

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation; Stroke

Treatments: Drug: Anticoagulants

Study type: Interventional

Funder types: Other

Identifiers

NCT03126214

0024466

Details and patient eligibility

About

The purpose of this study is to compare the effectiveness of prescribing oral anticoagulation therapy by pharmacist intervention compared to enhanced usual care in participants with unrecognized AF and/or known AF but not taking blood thinners.

Full description

Background:

AF is the most common arrhythmia and the leading cause of stroke. Despite robust evidence oral anticoagulation (OAC) therapy is effective and safe for stroke prevention in patients with AF; there is a lack of real-world application. Alternative strategies to deliver stroke prevention therapy need to be explored. Although pharmacists' prescribing of antihypertensive and lipid lowering drug therapy has been shown to increase adherence to guideline-based targets and warfarin management improve control of international normalized ratios in anticoagulation clinics, the role of pharmacist initiation of OAC therapy compared to usual care in AF patients for stroke prevention in a community setting is unclear.

In this study, the investigators will screen participants presenting to community pharmacies to identify participants with unrecognized AF and/or known AF but not taking blood thinners or not on optimal OAC therapy and randomize care to either the pharmacist or enhanced usual care (family physician notification by pharmacist).

Enrollment: 79 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 65 years with one additional stroke risk factor (hypertension, diabetes, heart failure history of or left ventricular ejection fraction <0.40), previous stroke or transient ischemic attack).
• Atrial fibrillation and not on oral anticoagulation (OAC) therapy but eligible
• Atrial fibrillation on sub-optimal OAC

Exclusion criteria

• Uncontrolled hypertension (defined as average SBP ≥ 160 mmHg [2 readings taken at time of screening]).
• End stage renal disease (CrCl < 15 ml/min)
• Valvular Heart Disease including those with prosthetic valve, mitral stenosis (moderate to severe) or valve repair.
• Excess alcohol intake (males: ≥ 28 units/week, females: ≥ 21 units/week. One unit of alcohol = 8 oz beer, 1 oz hard liquor or 4 oz wine).
• Intracranial bleed at any point.
• History of "Major Bleeding" at any point (defined as overt bleeding at a critical site including intracranial, intraspinal, intraocular, pericardial, or retroperitoneal; or bleed requiring hospitalization).
• Foreshortened life-expectancy or severe comorbidities precluding study follow-up period
• Unable to read/understand English
• Severe cognitive impairment (defined as score ≥ 5 on the Short Portable Mental Status Questionnaire)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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79 participants in 2 patient groups

Active Pharmacist Arm

Experimental group

Description:

OAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation.

Treatment:

Drug: Anticoagulants

Enhanced Usual Care Arm

Active Comparator group

Description:

Pharmacist will be refer participants to their physician in regards to OAC therapy for atrial fibrillation. The pharmacist will provide a current medication list to the physician as well as notification of a new diagnosis of atrial fibrillation

Treatment:

Drug: Anticoagulants