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

Study Overview
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Brief Summary
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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.

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

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Other: Patient Decision Support Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Decision Support Tool<br>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<br>* 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.<br>|
| No Intervention: Usual Healthcare Counseling<br>Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Anticoagulation, Health Disparities