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

Primary Purpose

Atrial Fibrillation, Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Retrospective review of OAC prescription
Prescription of OAC in ED
Community AF clinic
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Oral anticoagulant, Knowledge translation, Emergency department

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lions Gate Hospital
  • Dr. Georges-L.-Dumont University Hospital Centre
  • Dartmouth General Hospital
  • Cobequid Community Health Centre
  • Halifax Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Phase 1: Retrospective Chart Review

Phase 2: Low-Intensity Intervention

Phase 3: High-Intensity Intervention

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

New OAC Prescription (Phase 1 and 3 comparison)

Secondary Outcome Measures

New OAC Prescription (Phase 1 and 2 comparison)
New OAC Prescription (Phase 2 and 3 comparison)
OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)
OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)
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.

Full Information

First Posted
January 6, 2015
Last Updated
October 4, 2018
Sponsor
Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02358655
Brief Title
Canadian Community Utilization of Stroke Prevention Study - Emergency Department
Acronym
C-CUSP ED
Official Title
Canadian Community Utilization of Stroke Prevention Study - Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
March 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
Oral anticoagulant, Knowledge translation, Emergency department

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 1: Retrospective Chart Review
Arm Type
Other
Arm Description
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.
Arm Title
Phase 2: Low-Intensity Intervention
Arm Type
Other
Arm Description
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.
Arm Title
Phase 3: High-Intensity Intervention
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Retrospective review of OAC prescription
Intervention Type
Other
Intervention Name(s)
Prescription of OAC in ED
Intervention Type
Other
Intervention Name(s)
Community AF clinic
Primary Outcome Measure Information:
Title
New OAC Prescription (Phase 1 and 3 comparison)
Time Frame
Up to 72 hrs
Secondary Outcome Measure Information:
Title
New OAC Prescription (Phase 1 and 2 comparison)
Time Frame
Up to 72 hrs
Title
New OAC Prescription (Phase 2 and 3 comparison)
Time Frame
Up to 72 hrs
Title
OAC use in eligible patients at 30 days (Phase 2 and 3 comparison)
Time Frame
30 days
Title
OAC use in eligible patients at 6 months (Phase 2 and 3 comparison)
Time Frame
6 months
Title
Uptake of study interventions
Description
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 Pre-specified Outcome Measures:
Title
Safety related to OAC, as measured by rates of adverse events related to OAC including major bleeding and minor bleeding
Description
Rates of adverse events related to OAC including major bleeding and minor bleeding will be assessed
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ratika Parkash, MD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lions Gate Hospital
City
North Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Dr. Georges-L.-Dumont University Hospital Centre
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Dartmouth General Hospital
City
Dartmouth
State/Province
Nova Scotia
Country
Canada
Facility Name
Cobequid Community Health Centre
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30502307
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.
Results Reference
derived

Learn more about this trial

Canadian Community Utilization of Stroke Prevention Study - Emergency Department

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