CClinicalTrials.gg
CompletedNCT02358655C-CUSP EDUpdated Oct 9, 2018

Canadian Community Utilization of Stroke Prevention Study - Emergency Department

An interventional study of Retrospective review of OAC prescription and Prescription of OAC in ED in Atrial Fibrillation and Stroke, sponsored by Population Health Research Institute. Completed at 5 sites in Canada. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Population Health Research Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Non-randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atrial Fibrillation
  • Stroke

Keywords

  • Oral anticoagulant
  • Knowledge translation
  • Emergency department
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 360 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
360 participants (actual)

Study arms

  • 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

Interventions

  • OtherRetrospective review of OAC prescription
  • OtherPrescription of OAC in ED
  • OtherCommunity AF clinic
06

What researchers measure

Primary outcomes

  1. New OAC Prescription (Phase 1 and 3 comparison)

    Time frame: Up to 72 hrs

Secondary outcomes

  1. New OAC Prescription (Phase 1 and 2 comparison)

    Time frame: Up to 72 hrs

  2. New OAC Prescription (Phase 2 and 3 comparison)

    Time frame: Up to 72 hrs

  3. OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)

    Time frame: 30 days

  4. OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)

    Time frame: 6 months

  5. 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.

    Time frame: 6 months

Other outcomes

  1. 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

    Time frame: 6 months

07

Study locations

5 sites
  • Lions Gate Hospital
    North Vancouver, British Columbia, Canada
  • Dr. Georges-L.-Dumont University Hospital Centre
    Moncton, New Brunswick, Canada
  • Dartmouth General Hospital
    Dartmouth, Nova Scotia, Canada
  • Cobequid Community Health Centre
    Halifax, Nova Scotia, Canada
  • Halifax Infirmary
    Halifax, Nova Scotia, Canada
08

References and documents

Publications

  • 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. PubMed 30502307 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02358655
Lead sponsor
Population Health Research Institute
Responsible party
Sponsor
First posted
Feb 9, 2015
Start date
Jun 1, 2015
Primary completion
Oct 31, 2016
Completion
Mar 8, 2018
Last update
Oct 9, 2018

Study contacts

Ratika Parkash, MD
principal investigator · Dalhousie University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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