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Clinical Trials/NCT04956978
NCT04956978
Not yet recruiting
Not Applicable

Shared Decision Making to Address Racial Disparities in Oral Anticoagulation Use in Patients With Non-valvular Atrial Fibrillation

Duke University1 site in 1 country40 target enrollmentJune 1, 2026

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
Duke University
Enrollment
40
Locations
1
Primary Endpoint
Proportion of patients willing to participate as measured by enrollment log
Status
Not yet recruiting
Last Updated
last month

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2026
End Date
December 31, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Unable to speak English
  • Unable to provide informed consent

Outcomes

Primary Outcomes

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)

Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews.

Time Frame: 1 week post clinic visit

Proportion of patients willing to consent as measured by enrollment log

Time Frame: End of Study, 12 months

Rate of Patient Decision Support tool delivery and data capture as measured by web based data capture

Time Frame: End of Study, 12 months

Secondary Outcomes

  • Decision Quality measured by use of the decision conflict scale(Clinical Day, up to 1 day)
  • Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.(Clinical Day, up to 1 day)

Study Sites (1)

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