C-CUSP ED: Canadian Community Utilization of Stroke Prevention Study - Emergency Department

Sponsor

Population Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02358655

Collaborator

(none)

360

Enrollment

Locations

Arms

33.2

Actual Duration (Months)

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation Stroke	Other: Retrospective review of OAC prescription Other: Prescription of OAC in ED Other: Community AF clinic	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Canadian Community Utilization of Stroke Prevention Study - Emergency Department

Actual Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Oct 31, 2016

Actual Study Completion Date :

Mar 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Phase 1: Retrospective Chart Review 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.	Other: Retrospective review of OAC prescription
Other: Phase 2: Low-Intensity Intervention 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.	Other: Prescription of OAC in ED
Other: Phase 3: High-Intensity Intervention 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.	Other: Prescription of OAC in ED Other: Community AF clinic

Arm

Intervention/Treatment

Other: Phase 1: Retrospective Chart Review

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.

Other: Retrospective review of OAC prescription

Other: Phase 2: Low-Intensity Intervention

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.

Other: Prescription of OAC in ED

Other: Phase 3: High-Intensity Intervention

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.

Other: Prescription of OAC in ED

Other: Community AF clinic

Outcome Measures

Primary Outcome Measures

New OAC Prescription (Phase 1 and 3 comparison) [Up to 72 hrs]

Secondary Outcome Measures

New OAC Prescription (Phase 1 and 2 comparison) [Up to 72 hrs]
New OAC Prescription (Phase 2 and 3 comparison) [Up to 72 hrs]
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.

Other Outcome Measures

Safety related to OAC, as measured by rates of adverse events related to OAC including major bleeding and minor bleeding [6 months]
Rates of adverse events related to OAC including major bleeding and minor bleeding will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Lions Gate Hospital	North Vancouver	British Columbia	Canada
2	Dr. Georges-L.-Dumont University Hospital Centre	Moncton	New Brunswick	Canada
3	Dartmouth General Hospital	Dartmouth	Nova Scotia	Canada
4	Cobequid Community Health Centre	Halifax	Nova Scotia	Canada
5	Halifax Infirmary	Halifax	Nova Scotia	Canada