Clinical trial NCT02108041: Personalized Medicine Decision-Making in a Virtual Clinical Setting
Official title: Medical Decision-Making in a Virtual Clinical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Vein Thrombosis
Blood Clots
Keywords: Physicians
Genomics
Internal Medicine
Warfarin
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2014-04-09
Enrollment: 196
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Internal medicine and family medicine residents will be recruited from diverse national sites for the study, and the virtual reality environment will be brought to them through the use of a head-mounted display and laptop

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.

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.

Eligibility criteria: * 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.

Primary outcomes:
measure: To explore how physicians use genetic testing for anticoagulant (warfarin) dosage in patients of different racial/ethnic and SES backgrounds
timeFrame: Outcome measurements are assessed on the same date of the study visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
city: Flint
country: United States
facility: Michigan State University
state: Michigan
city: New York
country: United States
facility: Columbia University
state: New York
city: Eugene
country: United States
facility: University of Oregon
state: Oregon
Study officials:
affiliation: National Human Genome Research Institute (NHGRI)
name: Susan J Persky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.