Atrial FibrillationRAFF5NCT05468281
RAFF5 Proposal: Improve the Quality and Safety of Patients Seen in the Emergency Department for Acute Atrial Fibrillation and Flutter
An observational study of Atrial Fibrillation and Atrial Flutter, run by Ottawa Hospital Research Institute at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Checklist implementation
- How many people
- 1,108 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2022to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting to the emergency department with Atrial Fibrillation (AF) or Atrial Flutter (AFL).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Checklist implementation
- Keywords
- Safety, Emergency Department, Management guidelines
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Checklist implementationOther
. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Checklist implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 day
Secondary outcomes (5)
Use of cardioversion (chemical or electrical) in the ED
Measured: Duration of the ED visit, approximately 4-12 hours.
use of rate control and the final heart rate at disposition
Measured: Duration of the ED visit, approximately 4-12 hours.
prescription of OAC on discharge
Whether or not they were given an outpatient prescription for oral anticoagulants in accordance with the 2021 CAEP Checklist
Measured: Duration of the ED visit, approximately 4-12 hours.
consultations done in the ED by cardiology
Whether or not the patient had an (unnecessary) consultation done in the ED by cardiology
Measured: Duration of the ED visit, approximately 4-12 hours.
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.
Measured: Duration of the ED visit, approximately 4-12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Sep 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Stiell, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468281
- Sponsor's protocol ID
- 3875
- Acronym
- RAFF5
- Status last verified
- Nov 2023
- First submitted
- 25 May 2022
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to share data at the end of the study will be reviewed on a case by case basis.
Publications
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.
PubMed 38331027
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05468281
- Acronym / sponsor ID
- RAFF5 / 3875
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Keywords
- Safety, Emergency Department, Management guidelines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,108 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Checklist implementationThe after period (12 months) will be when patients are prospectively enrolled, and outcomes assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting to the emergency department with Atrial Fibrillation (AF) or Atrial Flutter (AFL).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- The study will exclude patients who have any of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | After Period |
Primary outcome
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.
5 secondary outcomes
Use of cardioversion (chemical or electrical) in the ED
Time frame: Duration of the ED visit, approximately 4-12 hours.
use of rate control and the final heart rate at disposition
Time frame: Duration of the ED visit, approximately 4-12 hours.
prescription of OAC on discharge
Time frame: Duration of the ED visit, approximately 4-12 hours.
consultations done in the ED by cardiology
Time frame: Duration of the ED visit, approximately 4-12 hours.
Adverse events attributable to medical management
Time frame: Duration of the ED visit, approximately 4-12 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Derived from this study: PubMed 38331027Stiell 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.
- Individual participant dataSharing planned: Undecided. Plan to share data at the end of the study will be reviewed on a case by case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Stiell, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Flutter, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve the quality and safety of ED management of AF and AFL (time frame: 14 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468281, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.