Personalized Medicine Decision-Making in a Virtual Clinical Setting

Sponsor
National Human Genome Research Institute (NHGRI) (NIH)
Overall Status
Completed
CT.gov ID
NCT02108041
Collaborator
(none)
196
5
39.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    196 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Medical Decision-Making in a Virtual Clinical Setting
    Actual Primary Completion Date :
    Oct 8, 2020
    Actual Study Completion Date :
    Oct 8, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Physicians that interact with the black/High SES avatar patien

    Medical residents will then be randomized to be exposed to a virtual patient with one of 4 race/SES profiles, this one being a female patient who is Upper-Middle Income and Black/African American.

    Physicians that interact with the black/Low SES avatar patient

    Medical residents will then be randomized to be exposed to a virtual patient with one of 4 race/SES profiles, this one being a female patient who is low-Middle Income and Black/African American.

    Physicians that interact with the white race/high SES avatar

    Medical residents will then be randomized to be exposed to a virtual patient with one of 4 race/SES profiles, this one being a female patient who is Upper-Middle Income White andCaucasian.

    Physicians that interact with the white race/low SES avatar p

    Medical residents will then be randomized to be exposed to a virtual patient with one of 4 race/SES profiles, this one being a female patient who is low Income White and Caucasian.

    Outcome Measures

    Primary Outcome Measures

    1. 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.]

      To explore how physicians use genetic testing for anticoagulant (warfarin) dosage in patients of different racial /ethnic and SES backgrounds

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins School of Medicine Baltimore Maryland United States 21205
    2 Harvard School of Public Health Boston Massachusetts United States 02115
    3 Michigan State University Flint Michigan United States
    4 Columbia University New York New York United States 10032-3784
    5 University of Oregon Eugene Oregon United States

    Sponsors and Collaborators

    • National Human Genome Research Institute (NHGRI)

    Investigators

    • Principal Investigator: Vence L Bonham, J.D., National Human Genome Research Institute (NHGRI)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Human Genome Research Institute (NHGRI)
    ClinicalTrials.gov Identifier:
    NCT02108041
    Other Study ID Numbers:
    • 999914075
    • 14-HG-N075
    First Posted:
    Apr 9, 2014
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Mar 3, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by National Human Genome Research Institute (NHGRI)
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 12, 2022