Canadian Community Utilization of Stroke Prevention Study - Emergency Department

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Other: Retrospective review of OAC prescription; Other: Prescription of OAC in ED; Other: Community AF clinic

• Registration Number: NCT02358655
• Lead Sponsor: Population Health Research Institute

Brief Summary

Atrial fibrillation (AF) is a common heart condition, and increases the risk of stroke by six times. There are several medications (blood thinners) that can prevent strokes in AF patients. Many AF patients present to the emergency department, but about half of AF patients leave without prescription of a blood thinner. The study aims to evaluate if adding options like giving a patient education kit, encouraging emergency room physicians to prescribe a blood thinner and providing a specialized AF clinic to patients will increase the number patients receiving blood thinners to prevent strokes.

Detailed Description

This is a knowledge translation study will occur in three consecutive phases: Phase 1 is a retrospective chart review of all patients who presented to the emergency department (ED) with ECG documented AF during 1 year prior to study commencement. The main purpose of Phase 1 is to determine if oral anticoagulants (OACs) were prescribed for eligible AF patients at ED discharge. In Phase 2 a low-intensity intervention will be applied in the ED during 6 months, involving physician education, distribution of an AF patient education package, short-term OAC prescription, and a follow-up letter to the patient's family physician. After a one month transition phase, a high intensity intervention will be applied during 6 months in Phase 3. Phase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF.

Study Timeline

• Study First Submitted: 2015-01-06
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-09
• Study Start: 2015-06-01
• Primary Completion: 2016-10-31
• Study Completion: 2018-03-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-04
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients who present to the emergency department with electrocardiographically documented atrial fibrillation on a 12 lead ECG

Exclusion Criteria

• Prosthetic or mechanical mitral or aortic valve
• Known rheumatic heart disease
• Unable to provide informed consent
• Will be admitted to hospital
• Life expectancy of < 6 months
• Metastatic malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 1: Retrospective Chart Review	Retrospective review of OAC prescription	Retrospective chart review of all patients who presented to the emergency department (ED) with ECG-documented AF during 1 year prior to study commencement. The main purpose of Phase 1 is to determine if oral anticoagulants were prescribed for eligible AF patients at ED discharge.
Phase 3: High-Intensity Intervention	Community AF clinic	Phase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF.
Phase 2: Low-Intensity Intervention	Prescription of OAC in ED	Low-intensity intervention will be applied in the ED during 6 months, involving physician education, distribution of an AF patient education package, short-term oral anticoagulant prescription, and a follow-up letter to the patient's family physician.
Phase 3: High-Intensity Intervention	Prescription of OAC in ED	Phase 3 incorporates the Phase 2 intervention, and adds immediate follow-up (within 48-72 hours) in a community AF clinic run by a nurse/pharmacist who is supervised by a specialist in AF.

Primary Outcome Measures

Name	Time	Method
New OAC Prescription (Phase 1 and 3 comparison)	Up to 72 hrs

Secondary Outcome Measures

Name	Time	Method
OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)	30 days
OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)	6 months
Uptake of study interventions	6 months	This outcome measure is meant to determine feasibility for a larger community cluster RCT. This will be measured by the uptake of the interventions described in this study, including: patient use of the AF educational kit, patient use of AF clinic, attendance at educational presentations for patients, family doctors and emergency physicians, patient use of automated text or email reminders for OACs.
New OAC Prescription (Phase 1 and 2 comparison)	Up to 72 hrs
New OAC Prescription (Phase 2 and 3 comparison)	Up to 72 hrs

Trial Locations

Locations (5)

Cobequid Community Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Dr. Georges-L.-Dumont University Hospital Centre; 🇨🇦 Moncton, New Brunswick, Canada

Dartmouth General Hospital; 🇨🇦 Dartmouth, Nova Scotia, Canada

Halifax Infirmary; 🇨🇦 Halifax, Nova Scotia, Canada

Lions Gate Hospital; 🇨🇦 North Vancouver, British Columbia, Canada