Clinical trial NCT05468281: RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrial Flutter
Keywords: Safety
Emergency Department
Management guidelines
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 1108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presenting to the emergency department with Atrial Fibrillation (AF) or Atrial Flutter (AFL).

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.


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.

Primary outcomes:
measure: Improve the quality and safety of ED management of AF and AFL
timeFrame: 14 day
Secondary outcomes:
measure: Use of cardioversion (chemical or electrical) in the ED
timeFrame: Duration of the ED visit, approximately 4-12 hours.
measure: use of rate control and the final heart rate at disposition
timeFrame: Duration of the ED visit, approximately 4-12 hours.
measure: prescription of OAC on discharge
timeFrame: Duration of the ED visit, approximately 4-12 hours.
measure: consultations done in the ED by cardiology
timeFrame: Duration of the ED visit, approximately 4-12 hours.
measure: Adverse events attributable to medical management
timeFrame: Duration of the ED visit, approximately 4-12 hours.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Ian Stiell, MD
role: PRINCIPAL_INVESTIGATOR
References: