- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02108041
Personalized Medicine Decision-Making in a Virtual Clinical Setting
Medical Decision-Making in a Virtual Clinical Setting
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins School of Medicine
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Harvard School of Public Health
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Michigan
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Flint, Michigan, United States
- Michigan State University
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New York
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New York, New York, United States, 10032-3784
- Columbia University
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Oregon
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Eugene, Oregon, United States
- University of Oregon
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- All physicians will be healthy adult volunteers who are medical residents in the internal medicine specialty.
EXCLUSION CRITERIA:
- persons with seizure or vestibular disorders;
- persons who are highly prone to motion sickness;
- those without normal or normal to corrected vision or hearing;
- all current and past employees and contractors of NHGRI; and
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To explore how physicians use genetic testing for anticoagulant (warfarin) dosage in patients of different racial/ethnic and SES backgrounds
Time Frame: Outcome measurements are assessed on the same date of the study visit.
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To explore how physicians use genetic testing for anticoagulant (warfarin) dosage in patients of different racial /ethnic and SES backgrounds
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Outcome measurements are assessed on the same date of the study visit.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Susan J Persky, Ph.D., National Human Genome Research Institute (NHGRI)
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999914075
- 14-HG-N075
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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