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

NCT ID: NCT05468281

Last Updated: 2023-11-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-07-30

Brief 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.

Conditions

Atrial Fibrillation; Atrial Flutter

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Before Period

The before period (12 months) serves as the control period prior to implementation; data will be collected by health records review.

No interventions assigned to this group

After Period

The after period (12 months) will be when patients are prospectively enrolled, and outcomes assessed.

Checklist implementation

Intervention Type: OTHER

. 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian Stiell, MD

Role: PRINCIPAL_INVESTIGATOR

Ottawa Hospital Research Institute

Locations

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Countries

Canada

References

Stiell IG, Taljaard M, Beanlands R, Johnson C, Golian M, Green M, Kwok E, Brown E, Nemnom MJ, Eagles D. RAFF-5 Study to Improve the Quality and Safety of Care for Patients Seen in the Emergency Department With Acute Atrial Fibrillation and Flutter. Can J Cardiol. 2024 Sep;40(9):1554-1562. doi: 10.1016/j.cjca.2024.01.037. Epub 2024 Feb 7.

Reference Type: DERIVED

PMID: 38331027 (View on PubMed)

Other Identifiers

3875

Identifier Type: -

Identifier Source: org_study_id