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

NCT05468281 | Completed

• 1 other identifier: 3875
• Study Type: observational
• Target: 1,108
• Locations: 1 country
• Sites: 1

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

Keywords

Safety; Emergency Department; Management guidelines

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  Duration of the ED visit, approximately 4-12 hours.

• consultations done in the ED by cardiology

  Duration of the ED visit, approximately 4-12 hours.

• Adverse events attributable to medical management

  Duration of the ED visit, approximately 4-12 hours.

Study Arms (2)

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

Interventions

Checklist implementation 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.

After Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• The study will exclude patients who have any of:
• permanent AF;
• deemed unstable and required immediate electrical cardioversion; or
• primary presentation was for another condition rather than arrhythmia.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (1)

• 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.

  PMID: 38331027 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Emergencies

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ian Stiell, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2022
• First Posted: July 21, 2022
• Study Start: September 1, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

CA (1)