Trial Summary
What is the purpose of this trial?
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.
Research Team
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Larry Jackson
Principal Investigator
Duke University
Eligibility Criteria
This trial is for Black and White adults over 18 with non-valvular atrial fibrillation (NVAF) who have a CHA2DS2-VASc score of at least 2, indicating a higher risk of stroke. They must be new patients at primary care or cardiology clinics considering starting oral anticoagulation but cannot participate if they can't speak English or provide informed consent.Inclusion Criteria
I am starting oral anticoagulation treatment at a primary care or cardiology clinic.
I have been diagnosed with non-valvular atrial fibrillation.
I am an adult aged 18 or older.
See 1 more
Exclusion Criteria
I am unable to understand or sign the consent form.
Unable to speak English
Treatment Details
Interventions
- Patient Decision Support Tool (Behavioural Intervention)
Trial OverviewThe study tests whether a patient decision support tool can improve the quality of decisions made by patients regarding the use of oral anticoagulants to prevent strokes in NVAF. It aims to see if this tool helps, especially among Black patients, and will assess its feasibility and acceptability.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Patient Decision Support ToolExperimental Treatment1 Intervention
Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation.
Group II: Usual Healthcare CounselingActive Control1 Intervention
Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Trials
2495
Patients Recruited
5,912,000+
National Institutes of Health (NIH)
Collaborator
Trials
2896
Patients Recruited
8,053,000+