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

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ClinicalTrials.gov Identifier: NCT02358655
Recruitment Status : Completed
First Posted : February 9, 2015
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

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 Not Applicable

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  (Clinical Trial)
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 : June 1, 2015
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : March 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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
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



Primary Outcome Measures :
  1. New OAC Prescription (Phase 1 and 3 comparison) [ Time Frame: Up to 72 hrs ]

Secondary Outcome Measures :
  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 [ 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02358655


Locations
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada
Canada, New Brunswick
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick, Canada
Canada, Nova Scotia
Dartmouth General Hospital
Dartmouth, Nova Scotia, Canada
Cobequid Community Health Centre
Halifax, Nova Scotia, Canada
Halifax Infirmary
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
Population Health Research Institute
Investigators
Principal Investigator: Ratika Parkash, MD Dalhousie University

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02358655     History of Changes
Other Study ID Numbers: C-CUSP ED
First Posted: February 9, 2015    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018

Keywords provided by Population Health Research Institute:
Oral anticoagulant
Knowledge translation
Emergency department

Additional relevant MeSH terms:
Stroke
Atrial Fibrillation
Emergencies
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Disease Attributes
Anticoagulants