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NCT Number: NCT04956978

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location contact

Larry Jackson

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Decision Support Tool

Other

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.

Primary outcomes

  1. Proportion of patients willing to consent as measured by enrollment log

    Time frame: End of Study, 12 months

  2. Proportion of patients willing to participate as measured by enrollment log

    Time frame: End of Study, 12 months

  3. 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)

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

    Time frame: End of Study, 12 months

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

    Time frame: 1 week post clinic visit

Secondary outcomes

  1. Decision Quality measured by use of the decision conflict scale

    Time frame: Clinical Day, up to 1 day

  2. Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.

    Time frame: Clinical Day, up to 1 day

Study contacts

Contact information is provided by the study sponsor or research team.

Larry Jackson, MD

CONTACT

[email protected]

919-684-5948

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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