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

NCT ID: NCT04956978

Last Updated: 2025-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-01

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.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patient Decision Support Tool

Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation.

Group Type EXPERIMENTAL

Patient Decision Support Tool

Intervention Type 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.

Usual Healthcare Counseling

Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Larry Jackson

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Larry Jackson, MD

Role: CONTACT

919-684-5948

Facility Contacts

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Larry Jackson

Role: primary

Other Identifiers

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Pro00108334

Identifier Type: -

Identifier Source: org_study_id

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