Decreasing Hospital Admissions From the ED for AAFF

Atrial Fibrillation Clinical Trial

— RAFF-3  

Official title:

Decreasing Hospital Admissions From the Emergency Department for Acute Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627143
• Other study ID #: 20180367-01T
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: June 2021
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 846
• Est. completion date: October 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

All eligible patients seen in the participating EDs during the study period will be included in the trial regardless of how they are managed.

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: We will exclude patients who have any of the reasons listed below.

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Other:
• 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. Selection of one or more local physician champions from both the ED as well as the cardiology group; Review and discussion of the goals of the study, as well as perceived barriers and enablers, by the ED and cardiology physician groups; 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; Development of local action plan addressing local barriers to implementation; Provision of the free Smartphone App to be developed for the guidelines; Regular reminders provided by the local research staff; Audit and feedback charts of site compliance

Locations

Country	Name	City	State
Canada	Dartmouth General Hospital	Dartmouth	Nova Scotia
Canada	Dr. Georges-L. - Dumont University Hospital	Moncton	New Brunswick
Canada	Hôpital Charles-Lemoyne	Montreal	Quebec
Canada	Hopital Du Sacre-Coeur	Montreal	Quebec
Canada	Hôpital Maisonneuve-Rosemont	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Ottawa Hospital	Ottawa	Ontario
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	St. Joseph's Health Center	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Cardiac Arrhythmia Network of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of stay in ED in minutes	Length of stay in ED in min. from time of arrival to time of discharge or admission.	a 100 minute reduction in ED length of stay (or a relative reduction of approximately 25%)
Secondary	Use of rhythm control in the ED	attempts at chemical or electrical cardioversion, as well as the success of these attempts (we believe these attempts facilitate ED discharge); compliance with the AAFF Guidelines will be assessed on criteria to be determined a priori by the investigators;	13 months
Secondary	Use of rate control and the final heart rate at disposition	compliance with the AAFF Guidelines will be assessed on criteria to be determined a priori by the investigators;	13 months
Secondary	Appropriate prescription of anticoagulants on discharge	anticoagulation prescription in compliance with the AAFF Guidelines	1 day
Secondary	Adverse events	measuring adverse events within 30 days of discharge from the emergency department	30 days from discharge from the ED
Secondary	Return ED visits and admission	for AAFF or related cardiovascular problems (stroke, CHF, AAFF, ACS or death), in the subsequent 30 days via a Health record reivew	30 days