Shared Decision Making to Address Racial Disparities in Oral Anticoagulation in NVAF
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Patient Decision Support Tool.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Shared Decision Making to Address Racial Disparities in Oral Anticoagulation Use in Patients With Non-valvular Atrial Fibrillation
Overview
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
- 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.
Primary outcome measures
- Proportion of patients willing to consent as measured by enrollment log [Time frame: End of Study, 12 months]
- Proportion of patients willing to participate as measured by enrollment log [Time frame: End of Study, 12 months]
- Rate of completion of questionnaire measures as measured by Research Electronic Data Capture (REDCAP) [Time frame: End of Study, 12 months]
- Rate of Patient Decision Support tool delivery and data capture as measured by web based data capture [Time frame: End of Study, 12 months]
- Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews. [Time frame: 1 week post clinic visit]
Secondary outcome measures (2)
- Decision Quality measured by use of the decision conflict scale [Time frame: Clinical Day, up to 1 day]
- Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit. [Time frame: Clinical Day, up to 1 day]
Eligibility 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke University Medical Center — Durham
Identifiers
NCT: NCT04956978 · Pro00108334