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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Decision Support Tool | Experimental | Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation. |
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| Usual Healthcare Counseling | No Intervention | Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Decision Support Tool | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Larry Jackson, MD | Contact | 919-684-5948 | larry.jackson@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Larry Jackson | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |