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OpenTrials
Completed

NCT Number: NCT02358655

Canadian Community Utilization of Stroke Prevention Study - Emergency Department

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Attributes Emergencies Heart Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lions Gate Hospital, North Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective review of OAC prescription

Other

Prescription of OAC in ED

Other

Community AF clinic

Other

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

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Acronym: C-CUSP ED

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Feb 9, 2015
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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