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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04956978
• Other study ID #: Pro00108334
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: July 2023
• Source: Duke University
• Contact: Larry Jackson, MD
• Phone: 919-684-5948
• Email: larry.jackson[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients willing to consent as measured by enrollment log		End of Study, 12 months
Primary	Proportion of patients willing to participate as measured by enrollment log		End of Study, 12 months
Primary	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
Primary	Rate of Patient Decision Support tool delivery and data capture as measured by web based data capture		End of Study, 12 months
Primary	Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews.		1 week post clinic visit
Secondary	Decision Quality measured by use of the decision conflict scale		Clinical Day, up to 1 day
Secondary	Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.		Clinical Day, up to 1 day