Atrial Fibrillation and FlutterNCT05009225
Clinical Decision Support for Atrial Fibrillation and Flutter
An observational study of Atrial Fibrillation and Flutter, run by Kaiser Permanente at 16 sites in United States.
Trial summary
Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation and Flutter
- What is being tested?
- Comprehensive ED AF management tool
- How many people
- 4,000 participants
- Where
- 16 sitesUnited States
- Study dates
- 1 Oct 2021to 30 Jun 2024
- 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: Adult patients presenting to KPNC emergency departments with eligibility criteria
Who may be able to join
- Adult (≥18y) KPNC members presenting to the ED with a primary ED diagnosis of atrial fibrillation/flutter (AF/FL). Subjects who meet criteria will be identified electronically within the CDSS tool in the electronic health record.
Who cannot join
- Children (<18y).
- Non-members of KPNC.
- Patients who were prisoners, pregnant, receiving hospice or palliative care, or who left against medical advice at the index encounter for AF/FL.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Kaiser Permanente Antioch Emergency Department
Antioch, California, 94531
Kaiser Permanente Fremont Emergency Department
Fremont, California, 94538
Kaiser Permanente Manteca Medical Center
Manteca, California, 95337
Kaiser Permanente Modesto Medical Center
Modesto, California, 95356
Kaiser Permanente Oakland Emergency Department
Oakland, California, 94611
Kaiser Permanente Richmond Emergency Department
Richmond, California, 94801
Kaiser Permanente Roseville Emergency Department
Roseville, California, 95661
Kaiser Permanente South Sacramento Emergency Department
Sacramento, California, 95823
Kaiser Permanente Sacramento Emergency Department
Sacramento, California, 95825
Kaiser Permanente San Francisco Emergency Department
San Francisco, California, 94115
Kaiser Permanente San Jose Emergency Department
San Jose, California, 95119
Kaiser Permanente San Leandro Emergency Department
San Leandro, California, 94577
Kaiser Permanente San Rafael Emergency Department
San Rafael, California, 94903
Kaiser Permanente Santa Clara Emergency Department
Santa Clara, California, 95051
Kaiser Permanente South San Francisco Emergency Department
South San Francisco, California, 94080
Kaiser Permanente Walnut Creek Medical Center
Walnut Creek, California, 94596
About this study
Official title: Reducing Variation in Hospitalization and Processes of Care in Emergency Department Patients With Atrial Fibrillation: A Stepped Wedge Cluster Randomized Trial
Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. AF is a common reason for presenting to emergency departments (ED) in Kaiser Permanente Northern California (KPNC) and is associated with frequent hospitalization. Additionally, inter-facility hospitalization rates for AF vary across KPNC. Improvements in modifiable components of ED AF care could potentially reduce low-yield hospitalizations and the associated costs, patient inconveniences, and complications that can ensue. Real-time clinical decision support systems (CDSS) can transform entrenched physician practices and improve patient outcomes. The investigators will conduct a stepped-wedge cluster randomized trial of a CDSS intervention across 13 KPNC EDs for the comprehensive management of acute AF with the following three aims: 1) To evaluate the impact of the CDSS intervention on index hospitalization rates; 2) To evaluate the impact of the CDSS intervention on ED AF rate and rhythm control process-of-care metrics; and 3) To evaluate the impact of the CDSS intervention on AF stroke prevention actions for eligible participants at the time of ED discharge. The investigators hypothesize that the CDSS intervention will safely reduce index hospitalization rates, improve rate and rhythm control process-of-care metrics, and increase stroke prevention actions for eligible participants at ED discharge and within 30 days.
- Conditions
- Atrial Fibrillation and Flutter
- Being tested
- Comprehensive ED AF management tool
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive ED AF management toolOther
Managing atrial fibrillation (AF) patients in the emergency department (ED) is complex, often requiring many separate decisions: How to best reduce the heart rate? Should emergency physicians attempt cardioversion? If so, how? Does this patient need stroke prevention? The investigators' CDSS provides emergency physicians with a one-stop, evidence-based resource that addresses all aspects of ED AF management.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who were hospitalized
Measured: Through emergency department visit, an average of 8 hours
Number of patients who received sustained rate-reduction medications
Measured: Through emergency department visit, an average of 8 hours
Number of patients who received stroke prevention interventions
Measured: Through emergency department visit, an average of 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Oct 2021
- Primary completion30 Apr 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation and FlutterStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05009225
- Sponsor's protocol ID
- 1279670
- Status last verified
- Mar 2024
- First submitted
- 10 Aug 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vinson DR, Warton EM, Durant EJ, Mark DG, Ballard DW, Hofmann ER, Sax DR, Kene MV, Lin JS, Poth LS, Ghiya MS, Ganapathy A, Whiteley PM, Bouvet SC, Rauchwerger AS, Zhang JY, Shan J, DiLena DD, Kea B, Pai AP, Loyles JB, Solomon MD, Go AS, Reed ME. Decision Support Intervention and Anticoagulation for Emergency Department Atrial Fibrillation: The O'CAFE Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443097. doi: 10.1001/jamanetworkopen.2024.43097.
PubMed 39504024Vinson DR, Rauchwerger AS, Karadi CA, Shan J, Warton EM, Zhang JY, Ballard DW, Mark DG, Hofmann ER, Cotton DM, Durant EJ, Lin JS, Sax DR, Poth LS, Gamboa SH, Ghiya MS, Kene MV, Ganapathy A, Whiteley PM, Bouvet SC, Babakhanian L, Kwok EW, Solomon MD, Go AS, Reed ME; Kaiser Permanente CREST Network. Clinical decision support to Optimize Care of patients with Atrial Fibrillation or flutter in the Emergency department: protocol of a stepped-wedge cluster randomized pragmatic trial (O'CAFE trial). Trials. 2023 Mar 31;24(1):246. doi: 10.1186/s13063-023-07230-2.
PubMed 37004068
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Variation in Hospitalization and Processes of Care in Emergency Department Patients With Atrial Fibrillation: A Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05009225
- Acronym / sponsor ID
- 1279670
- Conditions
- Atrial Fibrillation and Flutter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 17 Aug 2021 (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.
Atrial fibrillation (AF) is a major public health problem: it impairs quality of life and independently heightens the risks of ischemic stroke, heart failure and all-cause mortality. AF is a common reason for presenting to emergency departments (ED) in Kaiser Permanente Northern California (KPNC) and is associated with frequent hospitalization. Additionally, inter-facility hospitalization rates for AF vary across KPNC. Improvements in modifiable components of ED AF care could potentially reduce low-yield hospitalizations and the associated costs, patient inconveniences, and complications that can ensue. Real-time clinical decision support systems (CDSS) can transform entrenched physician practices and improve patient outcomes. The investigators will conduct a stepped-wedge cluster randomized trial of a CDSS intervention across 13 KPNC EDs for the comprehensive management of acute AF with the following three aims: 1) To evaluate the impact of the CDSS intervention on index hospitalization rates; 2) To evaluate the impact of the CDSS intervention on ED AF rate and rhythm control process-of-care metrics; and 3) To evaluate the impact of the CDSS intervention on AF stroke prevention actions for eligible participants at the time of ED discharge. The investigators hypothesize that the CDSS intervention will safely reduce index hospitalization rates, improve rate and rhythm control process-of-care metrics, and increase stroke prevention actions for eligible participants at ED discharge and within 30 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients presenting to KPNC emergency departments with eligibility criteria
Key inclusion criteria (1 listed)
- Adult (≥18y) KPNC members presenting to the ED with a primary ED diagnosis of atrial fibrillation/flutter (AF/FL). Subjects who meet criteria will be identified electronically within the CDSS tool in the electronic health record.
Key exclusion criteria (3 listed)
- Children (<18y).
- Non-members of KPNC.
- Patients who were prisoners, pregnant, receiving hospice or palliative care, or who left against medical advice at the index encounter for AF/FL.
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 |
|---|---|---|
| Comprehensive ED AF management toolManaging atrial fibrillation (AF) patients in the emergency department (ED) is complex, often requiring many separate decisions: How to best reduce the heart rate? Should emergency physicians attempt cardioversion? If so, how? Does this patient need stroke prevention? The investigators' CDSS provides emergency physicians with a one-stop, evidence-based resource that addresses all aspects of ED AF management. | Other | – |
Primary outcome
Number of patients who were hospitalized
Time frame: Through emergency department visit, an average of 8 hours
Number of patients who received sustained rate-reduction medications
Time frame: Through emergency department visit, an average of 8 hours
Number of patients who received stroke prevention interventions
Time frame: Through emergency department visit, an average of 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 39504024Vinson DR, Warton EM, Durant EJ, Mark DG, Ballard DW, Hofmann ER, Sax DR, Kene MV, Lin JS, Poth LS, Ghiya MS, Ganapathy A, Whiteley PM, Bouvet SC, Rauchwerger AS, Zhang JY, Shan J, DiLena DD, Kea B, Pai AP, Loyles JB, Solomon MD, Go AS, Reed ME. Decision Support Intervention and Anticoagulation for Emergency Department Atrial Fibrillation: The O'CAFE Stepped-Wedge Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2443097. doi: 10.1001/jamanetworkopen.2024.43097.
- Derived from this study: PubMed 37004068Vinson DR, Rauchwerger AS, Karadi CA, Shan J, Warton EM, Zhang JY, Ballard DW, Mark DG, Hofmann ER, Cotton DM, Durant EJ, Lin JS, Sax DR, Poth LS, Gamboa SH, Ghiya MS, Kene MV, Ganapathy A, Whiteley PM, Bouvet SC, Babakhanian L, Kwok EW, Solomon MD, Go AS, Reed ME; Kaiser Permanente CREST Network. Clinical decision support to Optimize Care of patients with Atrial Fibrillation or flutter in the Emergency department: protocol of a stepped-wedge cluster randomized pragmatic trial (O'CAFE trial). Trials. 2023 Mar 31;24(1):246. doi: 10.1186/s13063-023-07230-2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
16 sites 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 Flutter, run by Kaiser Permanente at 16 sites in United States.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. 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?
Results are not available in the source record.
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?
Number of patients who were hospitalized (time frame: Through emergency department visit, an average of 8 hours). The study lists 3 primary outcomes in all. 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 NCT05009225, which also lists 2 linked publications.
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 6 Mar 2024.