Clinical trial NCT02358655: Canadian Community Utilization of Stroke Prevention Study - Emergency Department
Official title: Canadian Community Utilization of Stroke Prevention Study - Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Stroke
Keywords: Oral anticoagulant
Knowledge translation
Emergency department
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
First posted: 2015-02-09
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: New OAC Prescription (Phase 1 and 3 comparison)
timeFrame: Up to 72 hrs
Secondary outcomes:
measure: New OAC Prescription (Phase 1 and 2 comparison)
timeFrame: Up to 72 hrs
measure: New OAC Prescription (Phase 2 and 3 comparison)
timeFrame: Up to 72 hrs
measure: OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)
timeFrame: 30 days
measure: OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)
timeFrame: 6 months
measure: Uptake of study interventions
timeFrame: 6 months
Other outcomes:
measure: Safety related to OAC, as measured by rates of adverse events related to OAC including major bleeding and minor bleeding
timeFrame: 6 months
Locations:
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Moncton
country: Canada
facility: Dr. Georges-L.-Dumont University Hospital Centre
state: New Brunswick
city: Dartmouth
country: Canada
facility: Dartmouth General Hospital
state: Nova Scotia
city: Halifax
country: Canada
facility: Cobequid Community Health Centre
state: Nova Scotia
city: Halifax
country: Canada
facility: Halifax Infirmary
state: Nova Scotia
Study officials:
affiliation: Dalhousie University
name: Ratika Parkash, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parkash R, Magee K, McMullen M, Clory M, D'Astous M, Robichaud M, Andolfatto G, Read B, Wang J, Thabane L, Atzema C, Dorian P, Kaczorowski J, Banner D, Nieuwlaat R, Ivers N, Huynh T, Curran J, Graham I, Connolly S, Healey J. The Canadian Community Utilization of Stroke Prevention Study in Atrial Fibrillation in the Emergency Department (C-CUSP ED). Ann Emerg Med. 2019 Apr;73(4):382-392. doi: 10.1016/j.annemergmed.2018.09.001. Epub 2018 Oct 26.