Canadian Community Utilization of Stroke Prevention Study - Emergency Department

Stroke Clinical Trial

— C-CUSP ED  

Official title:

Canadian Community Utilization of Stroke Prevention Study - Emergency Department

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02358655
• Other study ID #: C-CUSP ED
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: March 8, 2018

Study information

• Verified date: October 2018
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: March 8, 2018
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Emergencies
• Stroke

Intervention

Other:
• Retrospective review of OAC prescription

• Prescription of OAC in ED

• Community AF clinic

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety related to OAC, as measured by rates of adverse events related to OAC including major bleeding and minor bleeding	Rates of adverse events related to OAC including major bleeding and minor bleeding will be assessed	6 months
Primary	New OAC Prescription (Phase 1 and 3 comparison)		Up to 72 hrs
Secondary	New OAC Prescription (Phase 1 and 2 comparison)		Up to 72 hrs
Secondary	New OAC Prescription (Phase 2 and 3 comparison)		Up to 72 hrs
Secondary	OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)		30 days
Secondary	OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)		6 months
Secondary	Uptake of study interventions	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.	6 months