Improving Stroke Prevention in Atrial Fibrillation Through Pharmacist Prescribing: Program for the Identification of 'Actionable' AF (PIAAF) Rx Study
Overview
- Phase
- Phase 4
- Intervention
- Anticoagulants
- Conditions
- Atrial Fibrillation
- Sponsor
- University of Alberta
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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).
Investigators
Eligibility Criteria
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)
Arms & Interventions
Active Pharmacist Arm
OAC therapy will be initiated/adjusted by the community pharmacist in accordance to the Canadian Cardiovascular Society Guidelines for the Management of Atrial Fibrillation.
Intervention: Anticoagulants
Enhanced Usual Care Arm
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
Intervention: Anticoagulants
Outcomes
Primary Outcomes
Optimal Oral Anticoagulant (OAC) Therapy for Atrial Fibrillation Stroke Prevention
Time Frame: 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 Outcomes
- Healthcare Utilization(One year)
- Prevalence of AF(Through study completion, an average of 1 year)
- Patient Satisfaction with Pharmacists Services(3 months)
- Qualitative Assessment of Implementation by Pharmacist(Through study completion, an average of 1 year)