Atrial FibrillationNCT04956978
Shared Decision Making to Address Racial Disparities in Oral Anticoagulation in NVAF
A study testing Patient Decision Support Tool in people with Atrial Fibrillation, run by Duke University at 1 site in United States.
Trial summary
The study is a pilot analysis using a decision on the risk and benefits of oral anticoagulation for stroke reduction for patients with non-valvular atrial fibrillation. This study is a feasibility and acceptability analysis but will also measure preliminary effectiveness measures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Patient Decision Support Tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 1 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Black and White adults greater than or equal to 18 years of age
- Clinical diagnosis of NVAF
- CHA2DS2-VASc score greater than or equal to 2
- New patient visit for initiation of oral anticoagulation at primary care and cardiology clinics
Who cannot join
- Unable to speak English
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
Larry Jackson
About this study
Official title: Shared Decision Making to Address Racial Disparities in Oral Anticoagulation Use in Patients With Non-valvular Atrial Fibrillation
The study is a pilot analysis using a decision on the risk and benefits of oral anticoagulation for stroke reduction for patients with non-valvular atrial fibrillation. This study is a feasibility and acceptability analysis but will also measure preliminary effectiveness measures.
The investigator hypothesizes that a patient decision support tool will increase decision quality and secondarily increase the use of oral anticoagulation in Black patients with non-valvular atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Patient Decision Support Tool
- Keywords
- Oral Anticoagulation, Health Disparities
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Decision Support ToolOther
Patient decision support tool is a web based educational material that informs a patient on the risk and benefits of oral anticoagulation. In addition, such a tool aims to assess patient values and preferences in the decision making process for oral anticoagulation for stroke reduction.
| Study group | Role | What they receive |
|---|---|---|
| Patient Decision Support Tool | Experimental | Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation. Receives: Other: Patient Decision Support Tool |
| Usual Healthcare Counseling | No intervention | Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients willing to consent as measured by enrollment log
Measured: End of Study, 12 months
Proportion of patients willing to participate as measured by enrollment log
Measured: End of Study, 12 months
Rate of completion of questionnaire measures as measured by Research Electronic Data Capture (REDCAP)
Measured by RedCap (all questionnaires will be distributed through RedCap)
Measured: End of Study, 12 months
Rate of Patient Decision Support tool delivery and data capture as measured by web based data capture
Measured: End of Study, 12 months
Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews.
Measured: 1 week post clinic visit
Secondary outcomes (2)
Decision Quality measured by use of the decision conflict scale
Measured: Clinical Day, up to 1 day
Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.
Measured: Clinical Day, up to 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start15 Oct 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion1 Jul 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 Duke 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Larry Jackson, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956978
- Sponsor's protocol ID
- Pro00108334
- Status last verified
- Sep 2026
- First submitted
- 25 Jun 2021
- Last updated
- 9 Sep 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making to Address Racial Disparities in Oral Anticoagulation Use in Patients With Non-valvular Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04956978
- Acronym / sponsor ID
- Pro00108334
- Conditions
- Atrial Fibrillation
- Keywords
- Oral Anticoagulation, Health Disparities
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 9 Jul 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.
The study is a pilot analysis using a decision on the risk and benefits of oral anticoagulation for stroke reduction for patients with non-valvular atrial fibrillation. This study is a feasibility and acceptability analysis but will also measure preliminary effectiveness measures.
The investigator hypothesizes that a patient decision support tool will increase decision quality and secondarily increase the use of oral anticoagulation in Black patients with non-valvular atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Decision Support Tool | Experimental | Other: Patient Decision Support ToolPatient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation. |
| Usual Healthcare Counseling | No intervention | –Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Black and White adults greater than or equal to 18 years of age
- Clinical diagnosis of NVAF
- CHA2DS2-VASc score greater than or equal to 2
- New patient visit for initiation of oral anticoagulation at primary care and cardiology clinics
Key exclusion criteria (2 listed)
- Unable to speak English
- Unable to provide informed consent
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 |
|---|---|---|
| Patient Decision Support ToolPatient decision support tool is a web based educational material that informs a patient on the risk and benefits of oral anticoagulation. In addition, such a tool aims to assess patient values and preferences in the decision making process for oral anticoagulation for stroke reduction. | Other | Patient Decision Support Tool |
Primary outcome
Proportion of patients willing to consent as measured by enrollment log
Time frame: End of Study, 12 months
Proportion of patients willing to participate as measured by enrollment log
Time frame: End of Study, 12 months
Rate of completion of questionnaire measures as measured by Research Electronic Data Capture (REDCAP)
Time frame: End of Study, 12 months
Measured by RedCap (all questionnaires will be distributed through RedCap)
Rate of Patient Decision Support tool delivery and data capture as measured by web based data capture
Time frame: End of Study, 12 months
Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews.
Time frame: 1 week post clinic visit
2 secondary outcomes
Decision Quality measured by use of the decision conflict scale
Time frame: Clinical Day, up to 1 day
Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.
Time frame: Clinical Day, up to 1 day
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 9 Sep 2026.
- Individual participant dataSharing planned: No
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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.
Larry Jackson principal investigator
Duke 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 Patient Decision Support Tool in people with Atrial Fibrillation, run by Duke 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 9 Sep 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?
Contact Larry Jackson, MD (919-684-5948, larry.jackson@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients willing to consent as measured by enrollment log (time frame: End of Study, 12 months). The study lists 5 primary outcomes in all. 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 9 Sep 2026.