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

October 4, 2018 updated by: Population Health Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
New OAC Prescription (Phase 1 and 3 comparison)
Time Frame: Up to 72 hrs
Up to 72 hrs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New OAC Prescription (Phase 1 and 2 comparison)
Time Frame: Up to 72 hrs
Up to 72 hrs
New OAC Prescription (Phase 2 and 3 comparison)
Time Frame: Up to 72 hrs
Up to 72 hrs
OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)
Time Frame: 30 days
30 days
OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)
Time Frame: 6 months
6 months
Uptake of study interventions
Time Frame: 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.
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety related to OAC, as measured by rates of adverse events related to OAC including major bleeding and minor bleeding
Time Frame: 6 months
Rates of adverse events related to OAC including major bleeding and minor bleeding will be assessed
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Population Health Research Institute

Investigators

  • Principal Investigator: Ratika Parkash, MD, Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

March 8, 2018

Study Registration Dates

First Submitted

January 6, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-CUSP ED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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