Shared Decision Making to Address Racial Disparities in Oral Anticoagulation in NVAF

September 2, 2026 updated by: Duke University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
        • Contact:
          • Larry Jackson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Decision Support Tool
Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation.
Other: Patient Decision Support Tool
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.
No Intervention: Usual Healthcare Counseling
Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients willing to consent as measured by enrollment log
Time Frame: End of Study, 12 months
End of Study, 12 months
Proportion of patients willing to participate as measured by enrollment log
Time Frame: End of Study, 12 months
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)
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
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
1 week post clinic visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Decision Quality measured by use of the decision conflict scale
Time Frame: Clinical Day, up to 1 day
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
Clinical Day, up to 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Larry Jackson, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2026

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 25, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00108334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe