Decreasing Hospital Admissions From the ED for AAFF (RAFF-3)

Decreasing Hospital Admissions From the Emergency Department for Acute Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Other: KTI activities

• Study Type: Interventional
• Enrollment (Actual): 846
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • Dr. Georges-L. - Dumont University Hospital
  • Nova Scotia
    • Dartmouth, Nova Scotia, Canada
      • Dartmouth General Hospital
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital
    • Toronto, Ontario, Canada
      • St. Joseph's Health Center
  • Quebec
    • Montreal, Quebec, Canada
      • Hopital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada
      • McGill University Health Centre
    • Montreal, Quebec, Canada
      • Hopital Du Sacre-Coeur
    • Montreal, Quebec, Canada
      • Hopital Charles-LeMoyne
    • Québec, Quebec, Canada
      • Hôpital de l'Enfant-Jésus
    • Québec, Quebec, Canada
      • Hotel-Dieu De Levis
  • Saskatchewan
    • Regina, Saskatchewan, Canada
      • Regina General Hospital
    • Saskatoon, Saskatchewan, Canada
      • Royal University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Appropriate prescription of anticoagulants on discharge	anticoagulation prescription in compliance with the AAFF Guidelines	1 day
Adverse events	measuring adverse events within 30 days of discharge from the emergency department	30 days from discharge from the ED
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

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Cardiac Arrhythmia Network of Canada

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: 20180367-01T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No