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

Not Applicable

Not yet recruiting

• Conditions: Atrial Fibrillation
• Interventions: Other: Patient Decision Support Tool

• Registration Number: NCT04956978
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-09
• Status Verified: 2024-07
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-03
• Study Start: 2025-01-01
• Primary Completion: 2025-08-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

• Unable to speak English
• Unable to provide informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Decision Support Tool	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.

Primary Outcome Measures

Name	Time	Method
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)	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.	1 week post clinic visit
Proportion of patients willing to consent as measured by enrollment log	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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States