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

Duke University

Status: Not yet enrolling

Conditions: Atrial Fibrillation

Treatments: Other: Patient Decision Support Tool

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04956978

Pro00108334

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Patient Decision Support Tool

Experimental group

Description:

Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation.

Treatment:

Other: Patient Decision Support Tool

Usual Healthcare Counseling

No Intervention group

Description:

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