Atrial FibrillationAF SWCRT-CDSNCT05341986
Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool
A study testing Clinical Decision Support (CDS) tool in people with Atrial Fibrillation, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Atrial fibrillation (AF) is the most common arrhythmia in the world, with significant morbidity and mortality. With appropriate oral anticoagulation, the risk of stroke due to atrial fibrillation decreases by 64%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Clinical Decision Support (CDS) tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- A diagnosis of atrial fibrillation or paroxysmal atrial fibrillation (ICD-10 I48.0, I48.1, I48.9) during an ED visit with start dates between 1/11/2022 and 08/30/2026 within the patient's age ≥18 years.
Who cannot join
- Valvular disease, pregnancy, large esophageal varices, thrombocytopenia, severe or uncontrolled bleeding, severe liver or kidney disease, major surgery within 72 hours; OR
- Recent brain, eye or spinal cord injury or surgery; OR
- ED stroke, death or hospitalization at index visit; OR
- Patient transferred from another hospital (to ensure availability of index ED visit data); OR
- Left against medical advice; OR
- Evidence of non-OAC naïve patient:
Show all 9Show fewer
- OAC prescribed in the prior 3mo to index ED visit; OR
- Being managed by an anticoagulation clinic (ACC);
- Inclusion/Exclusion Criteria (Clinicians): All ED clinicians (board certified or eligible) interfacing with patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University (OHSU)
Portland, Oregon, 97239
About this study
Official title: Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool: A Stepped-Wedge Cluster Randomized Trial Design
Atrial fibrillation (AF) is the most common arrhythmia in the world, with significant morbidity and mortality. With appropriate oral anticoagulation, the risk of stroke due to atrial fibrillation decreases by 64%. Although atrial fibrillation is commonly diagnosed and treated in the Emergency Department (ED), oral anticoagulation is significantly underprescribed. Underprescribing has been attributed to a lack of empowerment and deferral of prescribing to longitudinal care clinicians.
Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of a clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.
Read the detailed description
OBJECTIVES:
AIM 1: Compare the magnitude of change of appropriate OAC prescribing over time at each ED with EHR-Based CDS tool implementation.
H1a. A CDS tool will increase the prescribing of OACs at ED discharge in patients with new AF.
H1b. The highly-integrated EHR-based CDS tool with a trigger will have a greater impact on the volume of prescribing compared to a less integrated web-based portal.
AIM 2: Evaluate clinician experiences with factors that influence the CDS tool implementation through a qualitative approach.
H2a. Clinicians will have high acceptability of the tool and be open to additional CDS tools.
H2b. Health system resources, such as the ability to refer patients to an anticoagulation clinic or primary care, will facilitate ED tool utilization.
AIM 3 (Exploratory): Determine patient satisfaction and engagement with ED visits across the three steps of CDS tool implementation and explore patient-clinician stories as mini-case studies (dyads) related to the recall of their experiences.
AIM 1 addresses whether a CDS tool can increase clinician prescribing-thereby improving long-term outcomes for patients. AIM 2 will address clinician facilitators and barriers to the CDS tool. AIM 3 (exploratory) will allow the exploration of a patient-centered approach for the future development of a scalable and generalizable strategy for large-scale dissemination. Through a convergent parallel quantitative-qualitative study, we will capitalize on a missed opportunity to change the trajectory of care and outcomes of newly ED-diagnosed AF patients.
- Conditions
- Atrial Fibrillation
- Being tested
- Clinical Decision Support (CDS) 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.
Clinical Decision Support (CDS) toolOther
Implementation of an EHR-based CDS tool for providers to use.
| Study group | Role | What they receive |
|---|---|---|
| Link-Out | Other | Clinicians will be trained on the web-based portal of the CDS tool and shown where the Link to the tool will be available in the EHR. Receives: Other: Clinical Decision Support (CDS) tool |
| BPA + Link-out | Other | Clinicians will be trained on how a BPA is triggered when a patient is diagnosed with AF. The alert will pop up within the EHR with the Link-out to the web portal. Receives: Other: Clinical Decision Support (CDS) tool |
| BPA + FHIR | Other | Instead of a link to the web-based portal, the BPA will contain a link to the FHIR-integrated CDS tool portal. FHIR will automatically pull EHR data about the patient into the CDS tool portal. Data include demographic information, comorbidities in the active problem list, past medical and surgical history, and social history. Clinicians will also receive training before the implementation of this step. Receives: Other: Clinical Decision Support (CDS) tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients appropriately prescribed OACs after CDS tool implementation.
The primary outcome is the number of patients appropriately prescribed OACs after CDS tool implementation.
Measured: through study completion, up to 4 years
Secondary outcomes (1)
Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.
Secondary outcomes include the clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.
Measured: through study completion, up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start11 Jan 2022
- Primary completion30 Aug 2026
- Study completion1 May 2027 (estimated)
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 Oregon Health and Science UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of an electronic health record (EHR) clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke, in three ED settings with different practice patterns and culture, patient populations, and organizational readiness. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bory Kea, Oregon Health and Science University
- Investigators
- Bory Kea, MD, MCR, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341986
- Sponsor's protocol ID
- STUDY00022471
- Acronym
- AF SWCRT-CDS
- Status last verified
- Oct 2026
- First submitted
- 13 Apr 2022
- Last updated
- 16 Oct 2026
- 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Stroke Prophylaxis of Acute Atrial Fibrillation With an Electronic Clinical Decision Support Tool: A Stepped-Wedge Cluster Randomized Trial Design
- ClinicalTrials.gov ID
- NCT05341986
- Acronym / sponsor ID
- AF SWCRT-CDS / STUDY00022471
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 22 Apr 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.
Atrial fibrillation (AF) is the most common arrhythmia in the world, with significant morbidity and mortality. With appropriate oral anticoagulation, the risk of stroke due to atrial fibrillation decreases by 64%. Although atrial fibrillation is commonly diagnosed and treated in the Emergency Department (ED), oral anticoagulation is significantly underprescribed. Underprescribing has been attributed to a lack of empowerment and deferral of prescribing to longitudinal care clinicians.
Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of a clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.
Detailed description
OBJECTIVES:
AIM 1: Compare the magnitude of change of appropriate OAC prescribing over time at each ED with EHR-Based CDS tool implementation.
H1a. A CDS tool will increase the prescribing of OACs at ED discharge in patients with new AF.
H1b. The highly-integrated EHR-based CDS tool with a trigger will have a greater impact on the volume of prescribing compared to a less integrated web-based portal.
AIM 2: Evaluate clinician experiences with factors that influence the CDS tool implementation through a qualitative approach.
H2a. Clinicians will have high acceptability of the tool and be open to additional CDS tools.
H2b. Health system resources, such as the ability to refer patients to an anticoagulation clinic or primary care, will facilitate ED tool utilization.
AIM 3 (Exploratory): Determine patient satisfaction and engagement with ED visits across the three steps of CDS tool implementation and explore patient-clinician stories as mini-case studies (dyads) related to the recall of their experiences.
AIM 1 addresses whether a CDS tool can increase clinician prescribing-thereby improving long-term outcomes for patients. AIM 2 will address clinician facilitators and barriers to the CDS tool. AIM 3 (exploratory) will allow the exploration of a patient-centered approach for the future development of a scalable and generalizable strategy for large-scale dissemination. Through a convergent parallel quantitative-qualitative study, we will capitalize on a missed opportunity to change the trajectory of care and outcomes of newly ED-diagnosed AF patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Using a convergent parallel quantitative-qualitative design (mixed-methods), we propose a stepped-wedge cluster randomized trial design with the implementation of an electronic health record (EHR) clinical decision support (CDS) tool in adults with new-onset AF that are OAC-naïve and at significant risk for stroke, in three ED settings with different practice patterns and culture, patient populations, and organizational readiness. In parallel, we will use qualitative approaches to evaluate clinician facilitators and barriers to tool utilization as well as patient satisfaction and engagement with the tool.
| Arm | Type | Receives |
|---|---|---|
| Link-Out | Other | Other: Clinical Decision Support (CDS) toolClinicians will be trained on the web-based portal of the CDS tool and shown where the Link to the tool will be available in the EHR. |
| BPA + Link-out | Other | Other: Clinical Decision Support (CDS) toolClinicians will be trained on how a BPA is triggered when a patient is diagnosed with AF. The alert will pop up within the EHR with the Link-out to the web portal. |
| BPA + FHIR | Other | Other: Clinical Decision Support (CDS) toolInstead of a link to the web-based portal, the BPA will contain a link to the FHIR-integrated CDS tool portal. FHIR will automatically pull EHR data about the patient into the CDS tool portal. Data include demographic information, comorbidities in the active problem list, past medical and surgical history, and social history. Clinicians will also receive training before the implementation of this step. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A diagnosis of atrial fibrillation or paroxysmal atrial fibrillation (ICD-10 I48.0, I48.1, I48.9) during an ED visit with start dates between 1/11/2022 and 08/30/2026 within the patient's age ≥18 years.
Key exclusion criteria (9 listed)
- Valvular disease, pregnancy, large esophageal varices, thrombocytopenia, severe or uncontrolled bleeding, severe liver or kidney disease, major surgery within 72 hours; OR
- Recent brain, eye or spinal cord injury or surgery; OR
- ED stroke, death or hospitalization at index visit; OR
- Patient transferred from another hospital (to ensure availability of index ED visit data); OR
- Left against medical advice; OR
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 |
|---|---|---|
| Clinical Decision Support (CDS) toolImplementation of an EHR-based CDS tool for providers to use. | Other | BPA + FHIR, BPA + Link-out, Link-Out |
Primary outcome
Number of patients appropriately prescribed OACs after CDS tool implementation.
Time frame: through study completion, up to 4 years
The primary outcome is the number of patients appropriately prescribed OACs after CDS tool implementation.
1 secondary outcome
Clinician and patient feedback on acceptability and identification of barriers and facilitators to use of the tool.
Time frame: through study completion, up to 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Bory Kea, MD, MCR principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support (CDS) tool in people with Atrial Fibrillation, run by Oregon Health and Science University at 1 site 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 9 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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 appropriately prescribed OACs after CDS tool implementation. (time frame: through study completion, up to 4 years). 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 16 Oct 2026.