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

Atrial Fibrillation Clinical Trial

— RAFF5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468281
• Other study ID #: 3875
• Status: Completed
• Start date: September 1, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: November 2023
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1108
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Emergencies

Intervention

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.

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Use of cardioversion (chemical or electrical) in the ED		Duration of the ED visit, approximately 4-12 hours.
Secondary	use of rate control and the final heart rate at disposition		Duration of the ED visit, approximately 4-12 hours.
Secondary	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.
Secondary	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.
Secondary	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.