Decreasing Hospital Admissions From the ED for AAFF

NCT ID: NCT03627143

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 846 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-10-30

Brief Summary

Acute atrial fibrillation and flutter (AAFF) is characterized by rapid heart rates with onset less than seven days. It's the most common type of palpitation treated in the Emergency Department (ED). Some Canadian ED's will discharge 95% of AAFF patients whereas others admit up to 40%. With hospital and ED crowding, discharge is the most optimal, effective and safe strategy. Our aim is to improve the care and reduce the length of stay (LOS) of ED AAFF patients, while decreasing unnecessary hospitalizations. First, the investigators must understand the local barriers. In the previous study, the investigators conducted interviews of emergency physicians, cardiologists and AAFF patients. In Project 1b, the investigators created the CAEP ED AAFF Guidelines Checklist to assist physicians to manage AAFF more efficiently and safely. The Guidelines are comprised of two algorithms and four sets of checklists for ED assessment and management. They have been endorsed by CAEP and are published in CJEM.

The investigators are now planning Project 2 in which the investigators will conduct a cluster [group] randomized trial at 11 Canadian EDs and enroll 1,300 patients over thirteen months. The investigators are not randomizing individual patients or doctors; instead the investigators are randomizing the start date of individual hospitals. Our goal is to introduce the new Guidelines into these hospitals to improve the care of AAFF patients. The investigators hope to improve AAFF management, leading to a significant decrease in hospital admissions and ED LOS. Central to our plans will be engagement of our two patient partners. Our behaviorally optimized intervention will be developed using state-of-the-art implementation science approaches informed by the results of Project 1a. The investigators will also undertake within-project and end-of-project knowledge translation and implementation (KTI) strategies to facilitate scale up and roll out of our program to ED departments in small, medium, and large hospitals across Canada (future Project 3). Ultimately the investigators expect to improve ED practices and decrease AAFF admissions and LOS, without increasing visits.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Local implementation of AAFF guidelines

The study intervention will support local implementation of the CAEP AAFF Guidelines during the intervention periods of the trial. The investigators will identify behaviour change techniques and organization/system level strategies that could likely address identified barriers or enhance enablers.

Group Type: OTHER

KTI activities

Intervention Type: OTHER

The Investigators also plan the following activities to encourage adherence to the guidelines, with an ultimate goal of rhythm or rate control and discharge home for most patients.

1. Selection of one or more local physician champions from both the ED as well as the cardiology group;

2. Review and discussion of the goals of the study, as well as perceived barriers and enablers, by the ED and cardiology physician groups;

3. Formal introduction of the CAEP AAFF Guidelines to the ED physicians and residents by means of presentations at rounds and staff meetings, emails, online video, and web-based resources;

4. Development of local action plan addressing local barriers to implementation;

5. Provision of the free Smartphone App to be developed for the guidelines;

6. Regular reminders provided by the local research staff;

7. Audit and feedback charts of site compliance

Interventions

KTI activities

The Investigators also plan the following activities to encourage adherence to the guidelines, with an ultimate goal of rhythm or rate control and discharge home for most patients.

1. Selection of one or more local physician champions from both the ED as well as the cardiology group;

2. Review and discussion of the goals of the study, as well as perceived barriers and enablers, by the ED and cardiology physician groups;

3. Formal introduction of the CAEP AAFF Guidelines to the ED physicians and residents by means of presentations at rounds and staff meetings, emails, online video, and web-based resources;

4. Development of local action plan addressing local barriers to implementation;

5. Provision of the free Smartphone App to be developed for the guidelines;

6. Regular reminders provided by the local research staff;

7. Audit and feedback charts of site compliance

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• stable patients presenting with an episode of acute atrial fibrillation or flutter (AAFF) of at least 3 hours duration, where symptoms require ED management by rhythm or rate control.
• patients with a history of prior episodes of AAFF, or those with previous presentations during the study periods.

Exclusion Criteria

• have permanent (chronic) AF
• are deemed unstable and require immediate cardioversion: i) systolic blood pressure <90 mmHg; ii) rapid ventricular pre-excitation (Wolff-Parkinson-White syndrome); iii) acute coronary syndrome - ongoing severe chest pain and marked ST depression (>2mm) on ECG despite therapy; or iv) pulmonary edema - severe dyspnea requiring immediate IV diuretic, nitrates, or BIPAP;
• the primary presentation was for another condition rather than arrhythmia
• convert spontaneously to sinus rhythm prior to receiving physician-initiated therapy; or
• die while in the ED from non-AAFF related causes.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cardiac Arrhythmia Network of Canada

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Stiell, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Dr. Georges-L. - Dumont University Hospital

Moncton, New Brunswick, Canada

Dartmouth General Hospital

Dartmouth, Nova Scotia, Canada

Ottawa Hospital

Ottawa, Ontario, Canada

St. Joseph's Health Center

Toronto, Ontario, Canada

Hopital Du Sacre-Coeur

Montreal, Quebec, Canada

Hôpital Charles-Lemoyne

Montreal, Quebec, Canada

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Hôtel-Dieu de Lévis

Québec, Quebec, Canada

Regina General Hospital

Regina, Saskatchewan, Canada

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Countries

Canada

Other Identifiers

20180367-01T

Identifier Type: -

Identifier Source: org_study_id