Atrial Fibrillation
Conditions
Keywords
Oral Anticoagulation, Health Disparities
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.
Interventions
OTHERPatient 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.
Sponsors
Duke University
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | 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 |
Countries
United States
Contacts
CONTACTLarry Jackson, MD
PRINCIPAL_INVESTIGATORLarry Jackson
Duke University
Outcome results
None listed