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

Primary Purpose

Atrial Fibrillation

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Patient Decision Support Tool

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Oral Anticoagulation, Health Disparities

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patient Decision Support Tool

Usual Healthcare Counseling

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportion of patients willing to consent as measured by enrollment log

Proportion of patients willing to participate as measured by enrollment log

Rate of completion of questionnaire measures as measured by Research Electronic Data Capture (REDCAP)

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

Percent of patients who stated that the intervention was acceptable as measured by patient and provider interviews.

Secondary Outcome Measures

Decision Quality measured by use of the decision conflict scale

Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.

Full Information

NCT ID

NCT04956978

First Posted

June 25, 2021

Last Updated

August 11, 2023

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

1. Study Identification

Unique Protocol Identification Number

NCT04956978

Brief Title

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

Official Title

Shared Decision Making to Address Racial Disparities in Oral Anticoagulation Use in Patients With Non-valvular Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2024 (Anticipated)

Primary Completion Date

August 1, 2025 (Anticipated)

Study Completion Date

August 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

Keywords

Oral Anticoagulation, Health Disparities

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patient Decision Support Tool

Arm Type

Experimental

Arm Description

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

Arm Title

Usual Healthcare Counseling

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Patient Decision Support Tool

Intervention Description

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 Measure Information:

Title

Proportion of patients willing to consent as measured by enrollment log

Time Frame

End of Study, 12 months

Title

Proportion of patients willing to participate as measured by enrollment log

Time Frame

End of Study, 12 months

Title

Rate of completion of questionnaire measures as measured by Research Electronic Data Capture (REDCAP)

Description

Measured by RedCap (all questionnaires will be distributed through RedCap)

Time Frame

End of Study, 12 months

Title

Rate of Patient Decision Support tool delivery and data capture as measured by web based data capture

Time Frame

End of Study, 12 months

Title

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 Measure Information:

Title

Decision Quality measured by use of the decision conflict scale

Time Frame

Clinical Day, up to 1 day

Title

Decision to initiate systemic oral anticoagulation measured and documented by physician of record during clinic visit.

Time Frame

Clinical Day, up to 1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Larry Jackson, MD

Phone

919-684-5948

larry.jackson@duke.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Larry Jackson

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Larry Jackson

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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