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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627143
Recruitment Status : Active, not recruiting
First Posted : August 13, 2018
Last Update Posted : April 10, 2020
Sponsor:
Collaborator:
Cardiac Arrhythmia Network of Canada
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Atrial Flutter Other: KTI activities Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 846 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Multicentre Behaviour Intervention Trial using a Stepped Wedge Cluster Randomized Design
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Decreasing Hospital Admissions From the Emergency Department for Acute Atrial Fibrillation
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

  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




Primary Outcome Measures :
  1. length of stay in ED in minutes [ Time Frame: a 100 minute reduction in ED length of stay (or a relative reduction of approximately 25%) ]
    Length of stay in ED in min. from time of arrival to time of discharge or admission.


Secondary Outcome Measures :
  1. Use of rhythm control in the ED [ Time Frame: 13 months ]
    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;

  2. Use of rate control and the final heart rate at disposition [ Time Frame: 13 months ]
    compliance with the AAFF Guidelines will be assessed on criteria to be determined a priori by the investigators;

  3. Appropriate prescription of anticoagulants on discharge [ Time Frame: 1 day ]
    anticoagulation prescription in compliance with the AAFF Guidelines

  4. Adverse events [ Time Frame: 30 days from discharge from the ED ]
    measuring adverse events within 30 days of discharge from the emergency department

  5. Return ED visits and admission [ Time Frame: 30 days ]
    for AAFF or related cardiovascular problems (stroke, CHF, AAFF, ACS or death), in the subsequent 30 days via a Health record reivew



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627143


Locations
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Canada, New Brunswick
Dr. Georges-L. - Dumont University Hospital
Moncton, New Brunswick, Canada
Canada, Nova Scotia
Dartmouth General Hospital
Dartmouth, Nova Scotia, Canada
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
St. Joseph's Health Center
Toronto, Ontario, Canada
Canada, Quebec
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
Canada, Saskatchewan
Regina General Hospital
Regina, Saskatchewan, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Ottawa Hospital Research Institute
Cardiac Arrhythmia Network of Canada
Investigators
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Principal Investigator: Ian Stiell, MD Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03627143    
Other Study ID Numbers: 20180367-01T
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes