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

NCT04956978 | Not Yet Recruiting

• 1 other identifier: Pro00108334
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Oral Anticoagulation; Health Disparities

Outcome Measures

Primary Outcomes (5)

• Proportion of patients willing to consent as measured by enrollment log

  End of Study, 12 months

• Proportion of patients willing to participate as measured by enrollment log

  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)

  End of Study, 12 months

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

  End of Study, 12 months

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

  1 week post clinic visit

Secondary Outcomes (2)

• 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 Arms (2)

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.

Other: Patient Decision Support Tool

Usual Healthcare Counseling

NO INTERVENTION

Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation

Interventions

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.

Patient Decision Support Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to speak English
• Unable to provide informed consent

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Larry Jackson

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larry Jackson, MD

CONTACT

919-684-5948; larry.jackson@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: July 9, 2021
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)