Clinical trial NCT03627143: Decreasing Hospital Admissions From the ED for AAFF
Official title: Decreasing Hospital Admissions From the Emergency Department for Acute Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Cardiac Arrhythmia Network of Canada
First posted: 2018-08-13
Enrollment: 846
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicentre Behaviour Intervention Trial using a Stepped Wedge Cluster Randomized Design
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: length of stay in ED in minutes
timeFrame: a 100 minute reduction in ED length of stay (or a relative reduction of approximately 25%)
Secondary outcomes:
measure: Use of rhythm control in the ED
timeFrame: 13 months
measure: Use of rate control and the final heart rate at disposition
timeFrame: 13 months
measure: Appropriate prescription of anticoagulants on discharge
timeFrame: 1 day
measure: Adverse events
timeFrame: 30 days from discharge from the ED
measure: Return ED visits and admission
timeFrame: 30 days
Other outcomes:
Locations:
city: Moncton
country: Canada
facility: Dr. Georges-L. - Dumont University Hospital
state: New Brunswick
city: Dartmouth
country: Canada
facility: Dartmouth General Hospital
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Joseph's Health Center
state: Ontario
city: Montreal
country: Canada
facility: Hopital Du Sacre-Coeur
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Charles-Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Hôpital de l'Enfant-Jésus
state: Quebec
city: Québec
country: Canada
facility: Hôtel-Dieu de Lévis
state: Quebec
city: Regina
country: Canada
facility: Regina General Hospital
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Ian Stiell, MD
role: PRINCIPAL_INVESTIGATOR
References: