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

Primary Purpose

Atrial Fibrillation, Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
KTI activities
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dr. Georges-L. - Dumont University Hospital
  • Dartmouth General Hospital
  • Ottawa Hospital
  • St. Joseph's Health Center
  • Hopital Du Sacre-Coeur
  • Hôpital Charles-Lemoyne
  • Hôpital Maisonneuve-Rosemont
  • McGill University Health Centre
  • Hôpital de l'Enfant-Jésus
  • Hôtel-Dieu de Lévis
  • Regina General Hospital
  • Royal University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Local implementation of AAFF guidelines

Arm Description

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.

Outcomes

Primary Outcome Measures

length of stay in ED in minutes
Length of stay in ED in min. from time of arrival to time of discharge or admission.

Secondary Outcome Measures

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;
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;
Appropriate prescription of anticoagulants on discharge
anticoagulation prescription in compliance with the AAFF Guidelines
Adverse events
measuring adverse events within 30 days of discharge from the emergency department
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

Full Information

First Posted
July 19, 2018
Last Updated
June 18, 2021
Sponsor
Ottawa Hospital Research Institute
Collaborators
Cardiac Arrhythmia Network of Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03627143
Brief Title
Decreasing Hospital Admissions From the ED for AAFF
Acronym
RAFF-3
Official Title
Decreasing Hospital Admissions From the Emergency Department for Acute Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Cardiac Arrhythmia Network of Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Multicentre Behaviour Intervention Trial using a Stepped Wedge Cluster Randomized Design
Masking
None (Open Label)
Allocation
N/A
Enrollment
846 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Local implementation of AAFF guidelines
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
KTI activities
Intervention Description
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
Primary Outcome Measure Information:
Title
length of stay in ED in minutes
Description
Length of stay in ED in min. from time of arrival to time of discharge or admission.
Time Frame
a 100 minute reduction in ED length of stay (or a relative reduction of approximately 25%)
Secondary Outcome Measure Information:
Title
Use of rhythm control in the ED
Description
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;
Time Frame
13 months
Title
Use of rate control and the final heart rate at disposition
Description
compliance with the AAFF Guidelines will be assessed on criteria to be determined a priori by the investigators;
Time Frame
13 months
Title
Appropriate prescription of anticoagulants on discharge
Description
anticoagulation prescription in compliance with the AAFF Guidelines
Time Frame
1 day
Title
Adverse events
Description
measuring adverse events within 30 days of discharge from the emergency department
Time Frame
30 days from discharge from the ED
Title
Return ED visits and admission
Description
for AAFF or related cardiovascular problems (stroke, CHF, AAFF, ACS or death), in the subsequent 30 days via a Health record reivew
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Stiell, MD
Organizational Affiliation
Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Georges-L. - Dumont University Hospital
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Dartmouth General Hospital
City
Dartmouth
State/Province
Nova Scotia
Country
Canada
Facility Name
Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
St. Joseph's Health Center
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hopital Du Sacre-Coeur
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hôpital Charles-Lemoyne
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hôpital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Hôpital de l'Enfant-Jésus
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
Hôtel-Dieu de Lévis
City
Québec
State/Province
Quebec
Country
Canada
Facility Name
Regina General Hospital
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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Decreasing Hospital Admissions From the ED for AAFF

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