Shared Decision Making to Address Racial Disparities in Oral Anticoagulation in NVAF
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
| No Intervention: Usual Healthcare Counseling Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation |
Outcome Measures
Primary Outcome Measures
- 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) [End of Study, 12 months]
Measured by RedCap (all questionnaires will be distributed through RedCap)
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Larry Jackson, Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00108334