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

N/ANot Yet RecruitingNCT04956978

Duke University40 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Patient Decision Support ToolOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

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)

Measured by RedCap (all questionnaires will be distributed through 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 Outcomes

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

Central Contacts

Larry Jackson, MD

CONTACT

919-684-5948 larry.jackson@duke.edu

Data from ClinicalTrials.gov

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