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Completed

NCT Number: NCT05468281

RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Improve the quality and safety of ED management of AF and AFL

    Time frame: 14 day

    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.

Secondary outcomes

  1. Use of cardioversion (chemical or electrical) in the ED

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

  2. use of rate control and the final heart rate at disposition

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

  3. prescription of OAC on discharge

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

    Whether or not they were given an outpatient prescription for oral anticoagulants in accordance with the 2021 CAEP Checklist

  4. consultations done in the ED by cardiology

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

    Whether or not the patient had an (unnecessary) consultation done in the ED by cardiology

  5. Adverse events attributable to medical management

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

    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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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

Acronym: RAFF5

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 21, 2022
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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