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Personalized Medicine Decision-Making in a Virtual Clinical Setting

This study is currently recruiting participants.
Verified May 30, 2017 by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02108041
First Posted: April 9, 2014
Last Update Posted: October 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
  Purpose

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
Deep Vein Thrombosis Blood Clots

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Medical Decision-Making in a Virtual Clinical Setting

Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):

Primary Outcome Measures:
  • To examine how physicians make treatment plan decisions for patients with DVT. [ Time Frame: Ongoing ]

Estimated Enrollment: 260
Study Start Date: April 5, 2014
Estimated Study Completion Date: July 31, 2018
Estimated Primary Completion Date: July 31, 2018 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108041


Contacts
Contact: Vence L Bonham, J.D. (301) 594-3973 bonhamv@nhgri.nih.gov

Locations
United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Harvard School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Michigan State University Recruiting
Flint, Michigan, United States
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032-3784
United States, Oregon
University of Oregon Recruiting
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)
  More Information

Publications:
Responsible Party: National Human Genome Research Institute (NHGRI)
ClinicalTrials.gov Identifier: NCT02108041     History of Changes
Other Study ID Numbers: 999914075
14-HG-N075
First Submitted: April 5, 2014
First Posted: April 9, 2014
Last Update Posted: October 19, 2017
Last Verified: May 30, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) ):
Physicians
Pharmacogenetic Testing
Decision-Making
Communicative Behaviors

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases