Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing

Phase 4

Completed

Brief Summary: 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.

Detailed 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).

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Active Pharmacist Arm	Anticoagulants	OAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation.
Enhanced Usual Care Arm	Anticoagulants	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

Primary Outcome Measures

Name	Time	Method
Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention	3 months	Proportion of participants receiving optimal OAC therapy in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation in the early intervention arm compared to the delayed intervention arm. Optimal defined as a new prescription for OAC in a previously untreated AF or known AF who should be on an OAC or adjustment of an existing OAC prescription.

Secondary Outcome Measures

Name	Time	Method
Healthcare Utilization	One year	To determine the number of laboratory testing performed related to oral anticoagulation therapy
Prevalence of AF	Through study completion, an average of 1 year	To determine the prevalence of participants with unrecognized AF eligible for OAC therapy and those with AF who should be on OAC therapy but are either not on or their existing OAC prescriptions; require adjustment due to contraindications, or sub-optimal levels (hereafter referred to those with "actionable" AF)
Patient Satisfaction with Pharmacists Services	3 months	Assessed using the validated Participant Satisfaction with Pharmacists Services Questionnaire (consists of 22 questions with 4 point Likert scale).
Qualitative Assessment of Implementation by Pharmacist	Through study completion, an average of 1 year	Assessed using the questionnaire developed by the SEARCH-AF study