Personalized Medicine Decision-Making in a Virtual Clinical Setting

Deep Vein Thrombosis Clinical Trial

Official title:

Medical Decision-Making in a Virtual Clinical Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108041
• Other study ID #: 999914075
• Secondary ID: 14-HG-N075
• Status: Completed
• Est. completion date: October 8, 2020

Study information

• Verified date: January 8, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

-How people respond to drugs depends in part on their genes. For some drugs, doctors can use an individuals genetic background to help in dosing the drug. Researchers want to know how doctors incorporate personalized or genomic medicine into clinical practice.

Objective:

-To study how physicians make personalized treatment decisions

Eligibility:

-Healthy adult primary care physicians who are internal (or family) medicine residents.

Design:

• Participants will complete a screening form.

• Participants will put on a headset, called a head-mounted display, showing a virtual reality environment.

• The environment will contain an exam room and the virtual patient.

• After interacting with the virtual patient, participants will complete a series of survey measures.

• Participation will last for about 60 minutes. The virtual patient interaction and follow-up questions will be audio taped.

Description:

This study will examine factors related to primary care physicians clinical decision-making. Using a virtual clinical interaction experiment, we aim to better understand physicians decision-making processes and to explore their communication behaviors toward patients in the clinical encounter. Physician participants will enter a virtual exam room where they will be asked to respond to a virtual patient, acting as her primary care physician in a follow-up visit to evaluate her for depression. Various aspects of physician communication in the virtual clinic and self-report measures related to decision-making will be analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: October 8, 2020
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

• INCLUSION CRITERIA:

• All physicians will be healthy adult volunteers who are medical residents in the internal medicine specialty.

EXCLUSION CRITERIA:

1. persons with seizure or vestibular disorders;

2. persons who are highly prone to motion sickness;

3. those without normal or normal to corrected vision or hearing;

4. all current and past employees and contractors of NHGRI; and

5. persons who have received information about the study purpose or procedure from a past participant.

NHGRI employees are excluded for this protocol because they are likely to have specialized genomic knowledge and may think differently about genomics in the clinical interaction.

Related Conditions & MeSH terms

• Blood Clots
• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	Harvard School of Public Health	Boston	Massachusetts
United States	University of Oregon	Eugene	Oregon
United States	Michigan State University	Flint	Michigan
United States	Columbia University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Human Genome Research Institute (NHGRI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Armstrong K. Genomics and health care disparities: the role of statistical discrimination. JAMA. 2012 Nov 21;308(19):1979-80. doi: 10.1001/2012.jama.10820. No abstract available. — View Citation

Green AR, Carney DR, Pallin DJ, Ngo LH, Raymond KL, Iezzoni LI, Banaji MR. Implicit bias among physicians and its prediction of thrombolysis decisions for black and white patients. J Gen Intern Med. 2007 Sep;22(9):1231-8. doi: 10.1007/s11606-007-0258-5. Epub 2007 Jun 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore how physicians use genetic testing for anticoagulant (warfarin) dosage in patients of different racial/ethnic and SES backgrounds	To explore how physicians use genetic testing for anticoagulant (warfarin) dosage in patients of different racial /ethnic and SES backgrounds	Outcome measurements are assessed on the same date of the study visit.