RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter (RAFF5)

RAFF5 Proposal: Project to Improve the Quality and Safety of the Immediate and Subsequent Care of Patients Seen in the Emergency Department With Acute Atrial Fibrillation and Flutter

Acute atrial fibrillation (AF) and flutter (AFL) are the most common arrhythmias requiring management in the emergency department (ED). They are characterized by sudden onset of a rapid heart rate which may be irregular (AF) or regular (AFL). Our focus is on episodes of acute AF or AFL which are usually less than 48 hours in duration and are highly symptomatic, requiring rapid treatment in the ED. Management guidelines for acute AF/AFL have changed substantially in recent years with several recent revisions published by the Canadian Cardiovascular Society (CCS) and the Canadian Association of Emergency Physicians (CAEP). The 2021 CAEP Acute Atrial Fibrillation/Flutter Best Practices Checklist (CAEP Checklist) was very recently published to assist ED physicians in Canada and elsewhere manage patients who present to the ED with acute AF/AFL (Figure 1).

The overall goal of this project is to improve the quality and safety of the immediate and subsequent care of patients seen in the ED with acute AF and AFL by implementing the principles of the CAEP Checklist at both The Ottawa Hospital (TOH) EDs and by working with TOH cardiologists to provide rapid cardiology follow-up processes for patients discharged from the ED. The Investigators propose a before-after cohort study using an interrupted time series design to evaluate implementation involving 720 patients at the two TOH EDs over a 24-month period.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Atrial Flutter
• Intervention / Treatment: Other: Checklist implementation

• Study Type: Observational
• Enrollment (Actual): 1108

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1Y 4E9
      • Ottawa Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All patients presenting to the emergency department with Atrial Fibrillation (AF) or Atrial Flutter (AFL).

Description

Inclusion Criteria:

• include all eligible patient visits to the participating EDs during the study period regardless of how they are managed.
• include stable patients aged 18 and over,
• presenting with an episode of acute AF or AFL of at least 3 hours duration,
• where symptoms require ED management by rhythm or rate control.

Exclusion Criteria:

• The study will exclude patients who have any of:

  1. permanent AF;
  2. deemed unstable and required immediate electrical cardioversion; or
  3. primary presentation was for another condition rather than arrhythmia.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before Period; The before period (12 months) serves as the control period prior to implementation; data will be collected by health records review.
After Period; The after period (12 months) will be when patients are prospectively enrolled, and outcomes assessed.	Other: Checklist implementation; . Our strategies will include a) selection of local physician champions from the ED and cardiology; b) discussion of the goals of the study with the local physician groups; c) formal introduction of the CAEP Checklist to the physicians and nurses by means of presentations at staff meetings, emails, and an online video; d) development of an action plan to address local barriers to implementation; e) creation of a free smartphone application; f) regular reminders; and g) and distribution of charts of site compliance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improve the quality and safety of ED management of AF and AFL	the quality and safety of ED management based upon the CAEP Checklist management. best practices. The study team will use a score sheet which will identify specific managements for AF and AFL that are 1) optimal; 2) suboptimal; 3) unsafe.	14 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of cardioversion (chemical or electrical) in the ED		Duration of the ED visit, approximately 4-12 hours.
use of rate control and the final heart rate at disposition		Duration of the ED visit, approximately 4-12 hours.
prescription of OAC on discharge	Whether or not they were given an outpatient prescription for oral anticoagulants in accordance with the 2021 CAEP Checklist	Duration of the ED visit, approximately 4-12 hours.
consultations done in the ED by cardiology	Whether or not the patient had an (unnecessary) consultation done in the ED by cardiology	Duration of the ED visit, approximately 4-12 hours.
Adverse events attributable to medical management	adverse events including: i) conduction problems; ii) dysrhythmias; iii) hypotension requiring treatment; iv) respiratory events; f) admission to a hospital unit; and g) use of the rapid referral process.	Duration of the ED visit, approximately 4-12 hours.

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Investigators: Principal Investigator: Ian Stiell, MD, Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Emergency Department; Management guidelines
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Emergencies; Atrial Fibrillation; Atrial Flutter
• Other Study ID Numbers: 3875

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Plan to share data at the end of the study will be reviewed on a case by case basis.

Drug and device information, study documents

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