Atrial FibrillationRAFF-3NCT03627143
Decreasing Hospital Admissions From the ED for AAFF
A study testing KTI activities in people with Atrial Fibrillation and Atrial Flutter, run by Ottawa Hospital Research Institute at 12 sites in Canada.
Trial summary
Acute atrial fibrillation and flutter (AAFF) is characterized by rapid heart rates with onset less than seven days. It's the most common type of palpitation treated in the Emergency Department (ED). Some Canadian ED's will discharge 95% of AAFF patients whereas others admit up to 40%. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Atrial Flutter
- What is being tested?
- KTI activities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 846 participants
- Where
- 12 sitesCanada
- Study dates
- 1 Sep 2018to 30 Oct 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- stable patients presenting with an episode of acute atrial fibrillation or flutter (AAFF) of at least 3 hours duration, where symptoms require ED management by rhythm or rate control.
- patients with a history of prior episodes of AAFF, or those with previous presentations during the study periods.
- Exclusion Criteria: We will exclude patients who have any of the reasons listed below.
- have permanent (chronic) AF
- are deemed unstable and require immediate cardioversion: i) systolic blood pressure <90 mmHg; ii) rapid ventricular pre-excitation (Wolff-Parkinson-White syndrome); iii) acute coronary syndrome - ongoing severe chest pain and marked ST depression (>2mm) on ECG despite therapy; or iv) pulmonary edema - severe dyspnea requiring immediate IV diuretic, nitrates, or BIPAP;
- the primary presentation was for another condition rather than arrhythmia
- convert spontaneously to sinus rhythm prior to receiving physician-initiated therapy; or
- die while in the ED from non-AAFF related causes.
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Canada12 sites
Dartmouth General Hospital
Dartmouth, Nova Scotia
Dr. Georges-L. - Dumont University Hospital
Moncton, New Brunswick
Hopital Du Sacre-Coeur
Montreal, Quebec
Hôpital Charles-Lemoyne
Montreal, Quebec
Hôpital Maisonneuve-Rosemont
Montreal, Quebec
McGill University Health Centre
Montreal, Quebec
Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Hôpital de l'Enfant-Jésus
Québec, Quebec
Hôtel-Dieu de Lévis
Québec, Quebec
Regina General Hospital
Regina, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan
St. Joseph's Health Center
Toronto, Ontario
About this study
Official title: Decreasing Hospital Admissions From the Emergency Department for Acute Atrial Fibrillation
Acute atrial fibrillation and flutter (AAFF) is characterized by rapid heart rates with onset less than seven days. It's the most common type of palpitation treated in the Emergency Department (ED). Some Canadian ED's will discharge 95% of AAFF patients whereas others admit up to 40%. With hospital and ED crowding, discharge is the most optimal, effective and safe strategy. Our aim is to improve the care and reduce the length of stay (LOS) of ED AAFF patients, while decreasing unnecessary hospitalizations. First, the investigators must understand the local barriers. In the previous study, the investigators conducted interviews of emergency physicians, cardiologists and AAFF patients. In Project 1b, the investigators created the CAEP ED AAFF Guidelines Checklist to assist physicians to manage AAFF more efficiently and safely. The Guidelines are comprised of two algorithms and four sets of checklists for ED assessment and management. They have been endorsed by CAEP and are published in CJEM.
The investigators are now planning Project 2 in which the investigators will conduct a cluster [group] randomized trial at 11 Canadian EDs and enroll 1,300 patients over thirteen months. The investigators are not randomizing individual patients or doctors; instead the investigators are randomizing the start date of individual hospitals. Our goal is to introduce the new Guidelines into these hospitals to improve the care of AAFF patients. The investigators hope to improve AAFF management, leading to a significant decrease in hospital admissions and ED LOS. Central to our plans will be engagement of our two patient partners. Our behaviorally optimized intervention will be developed using state-of-the-art implementation science approaches informed by the results of Project 1a. The investigators will also undertake within-project and end-of-project knowledge translation and implementation (KTI) strategies to facilitate scale up and roll out of our program to ED departments in small, medium, and large hospitals across Canada (future Project 3). Ultimately the investigators expect to improve ED practices and decrease AAFF admissions and LOS, without increasing visits.
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Being tested
- KTI activities
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KTI activitiesOther
The Investigators also plan the following activities to encourage adherence to the guidelines, with an ultimate goal of rhythm or rate control and discharge home for most patients.
- Selection of one or more local physician champions from both the ED as well as the cardiology group;
- Review and discussion of the goals of the study, as well as perceived barriers and enablers, by the ED and cardiology physician groups;
- Formal introduction of the CAEP AAFF Guidelines to the ED physicians and residents by means of presentations at rounds and staff meetings, emails, online video, and web-based resources;
- Development of local action plan addressing local barriers to implementation;
- Provision of the free Smartphone App to be developed for the guidelines;
- Regular reminders provided by the local research staff;
- Audit and feedback charts of site compliance
| Study group | Role | What they receive |
|---|---|---|
| Local implementation of AAFF guidelines | Other | The study intervention will support local implementation of the CAEP AAFF Guidelines during the intervention periods of the trial. The investigators will identify behaviour change techniques and organization/system level strategies that could likely address identified barriers or enhance enablers. Receives: Other: KTI activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay in ED in minutes
Length of stay in ED in min. from time of arrival to time of discharge or admission.
Measured: a 100 minute reduction in ED length of stay (or a relative reduction of approximately 25%)
Secondary outcomes (5)
Use of rhythm control in the ED
attempts at chemical or electrical cardioversion, as well as the success of these attempts (we believe these attempts facilitate ED discharge); compliance with the AAFF Guidelines will be assessed on criteria to be determined a priori by the investigators;
Measured: 13 months
Use of rate control and the final heart rate at disposition
compliance with the AAFF Guidelines will be assessed on criteria to be determined a priori by the investigators;
Measured: 13 months
Appropriate prescription of anticoagulants on discharge
anticoagulation prescription in compliance with the AAFF Guidelines
Measured: 1 day
Adverse events
measuring adverse events within 30 days of discharge from the emergency department
Measured: 30 days from discharge from the ED
Return ED visits and admission
for AAFF or related cardiovascular problems (stroke, CHF, AAFF, ACS or death), in the subsequent 30 days via a Health record reivew
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicentre Behaviour Intervention Trial using a Stepped Wedge Cluster Randomized Design
- Masking
- None (open label)
- Enrolment
- 846 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Responsible party
- Sponsor
- Investigators
- Ian Stiell, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627143
- Sponsor's protocol ID
- 20180367-01T
- Acronym
- RAFF-3
- Status last verified
- Jun 2021
- First submitted
- 19 Jul 2018
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decreasing Hospital Admissions From the Emergency Department for Acute Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03627143
- Acronym / sponsor ID
- RAFF-3 / 20180367-01T
- Conditions
- Atrial Fibrillation, Atrial Flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 846 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Cardiac Arrhythmia Network of Canada
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 13 Aug 2018 (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 and flutter (AAFF) is characterized by rapid heart rates with onset less than seven days. It's the most common type of palpitation treated in the Emergency Department (ED). Some Canadian ED's will discharge 95% of AAFF patients whereas others admit up to 40%. With hospital and ED crowding, discharge is the most optimal, effective and safe strategy. Our aim is to improve the care and reduce the length of stay (LOS) of ED AAFF patients, while decreasing unnecessary hospitalizations. First, the investigators must understand the local barriers. In the previous study, the investigators conducted interviews of emergency physicians, cardiologists and AAFF patients. In Project 1b, the investigators created the CAEP ED AAFF Guidelines Checklist to assist physicians to manage AAFF more efficiently and safely. The Guidelines are comprised of two algorithms and four sets of checklists for ED assessment and management. They have been endorsed by CAEP and are published in CJEM.
The investigators are now planning Project 2 in which the investigators will conduct a cluster [group] randomized trial at 11 Canadian EDs and enroll 1,300 patients over thirteen months. The investigators are not randomizing individual patients or doctors; instead the investigators are randomizing the start date of individual hospitals. Our goal is to introduce the new Guidelines into these hospitals to improve the care of AAFF patients. The investigators hope to improve AAFF management, leading to a significant decrease in hospital admissions and ED LOS. Central to our plans will be engagement of our two patient partners. Our behaviorally optimized intervention will be developed using state-of-the-art implementation science approaches informed by the results of Project 1a. The investigators will also undertake within-project and end-of-project knowledge translation and implementation (KTI) strategies to facilitate scale up and roll out of our program to ED departments in small, medium, and large hospitals across Canada (future Project 3). Ultimately the investigators expect to improve ED practices and decrease AAFF admissions and LOS, without increasing visits.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentre Behaviour Intervention Trial using a Stepped Wedge Cluster Randomized Design
| Arm | Type | Receives |
|---|---|---|
| Local implementation of AAFF guidelines | Other | Other: KTI activitiesThe study intervention will support local implementation of the CAEP AAFF Guidelines during the intervention periods of the trial. The investigators will identify behaviour change techniques and organization/system level strategies that could likely address identified barriers or enhance enablers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- stable patients presenting with an episode of acute atrial fibrillation or flutter (AAFF) of at least 3 hours duration, where symptoms require ED management by rhythm or rate control.
- patients with a history of prior episodes of AAFF, or those with previous presentations during the study periods.
- Exclusion Criteria: We will exclude patients who have any of the reasons listed below.
- have permanent (chronic) AF
- are deemed unstable and require immediate cardioversion: i) systolic blood pressure <90 mmHg; ii) rapid ventricular pre-excitation (Wolff-Parkinson-White syndrome); iii) acute coronary syndrome - ongoing severe chest pain and marked ST depression (>2mm) on ECG despite therapy; or iv) pulmonary edema - severe dyspnea requiring immediate IV diuretic, nitrates, or BIPAP;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| KTI activitiesThe Investigators also plan the following activities to encourage adherence to the guidelines, with an ultimate goal of rhythm or rate control and discharge home for most patients. 1. Selection of one or more local physician champions from both the ED as well as the cardiology group; 2. Review and discussion of the goals of the study, as well as perceived barriers and enablers, by the ED and cardiology physician groups; 3. Formal introduction of the CAEP AAFF Guidelines to the ED physicians and residents by means of presentations at rounds and staff meetings, emails, online video, and web-based resources; 4. Development of local action plan addressing local barriers to implementation; 5. Provision of the free Smartphone App to be developed for the guidelines; 6. Regular reminders provided by the local research staff; 7. Audit and feedback charts of site compliance | Other | Local implementation of AAFF guidelines |
Primary outcome
length of stay in ED in minutes
Time frame: a 100 minute reduction in ED length of stay (or a relative reduction of approximately 25%)
Length of stay in ED in min. from time of arrival to time of discharge or admission.
5 secondary outcomes
Use of rhythm control in the ED
Time frame: 13 months
Use of rate control and the final heart rate at disposition
Time frame: 13 months
Appropriate prescription of anticoagulants on discharge
Time frame: 1 day
Adverse events
Time frame: 30 days from discharge from the ED
Return ED visits and admission
Time frame: 30 days
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 21 Jun 2021.
- Individual participant dataSharing planned: No
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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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KTI activities in people with Atrial Fibrillation and Atrial Flutter, run by Ottawa Hospital Research Institute at 12 sites 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 8 inclusion and 0 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 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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?
length of stay in ED in minutes (time frame: a 100 minute reduction in ED length of stay (or a relative reduction of approximately 25%)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2021.