Canadian Community Utilization of Stroke Prevention Study - Emergency Department

NCT02358655 | Completed

• 1 other identifier: C-CUSP ED
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 5

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.

Conditions

Atrial Fibrillation; Stroke

Keywords

Oral anticoagulant; Knowledge translation; Emergency department

Outcome Measures

Primary Outcomes (1)

• New OAC Prescription (Phase 1 and 3 comparison)

  Up to 72 hrs

Secondary Outcomes (5)

• New OAC Prescription (Phase 1 and 2 comparison)

  Up to 72 hrs

• New OAC Prescription (Phase 2 and 3 comparison)

  Up to 72 hrs

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

  30 days

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

  6 months

• Uptake of study interventions

  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

  6 months

Study Arms (3)

Phase 1: Retrospective Chart Review

OTHER

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

OTHER

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

OTHER

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

Retrospective review of OAC prescription OTHER

Phase 1: Retrospective Chart Review

Prescription of OAC in ED OTHER

Phase 2: Low-Intensity Intervention; Phase 3: High-Intensity Intervention

Community AF clinic OTHER

Phase 3: High-Intensity Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (5)

Lions Gate Hospital

North Vancouver, British Columbia, Canada

Location

Dr. Georges-L.-Dumont University Hospital Centre

Moncton, New Brunswick, Canada

Location

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Location

Cobequid Community Health Centre

Halifax, Nova Scotia, Canada

Location

Halifax Infirmary

Halifax, Nova Scotia, Canada

Location

Related Publications (1)

• 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.

  PMID: 30502307 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Stroke; Emergencies

Condition Hierarchy (Ancestors)

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

Study Officials

• Ratika Parkash, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2015
• First Posted: February 9, 2015
• Study Start: June 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: March 8, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CA (5)