Personalized Medicine Decision-Making in a Virtual Clinical Setting

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier:
NCT02108041
First received: April 5, 2014
Last updated: July 19, 2014
Last verified: July 2014
  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 manage a mock patient in an immersive virtual environment. They will get Emergency Department discharge data about a 27-year-old virtual patient.
  • Participants will put on a helmet. This will have a head-mounted display showing a virtual reality environment.
  • The environment will contain an exam room and a virtual patient to interact with.
  • Participation will last for about 60 minutes. The virtual patient interaction will be audio taped.

Condition
Deep Vein Thrombosis
Blood Clots

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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • To examine how physicians make decisions about pharmacogenetic testing related to anticoagulant (warfarin) response for patients. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Study Start Date: March 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Detailed Description:

This study will examine factors related to primary care physicians decision making around pharmacogenetic testing for warfarin response. Warfarin is a commonly prescribed anticoagulant (blood thinner) medication and it is one of the few drugs in primary care practice for which genotype-guided drug dosing is available in clinical practice. Warfarin is also difficult for primary care physicians to manage, as the dose necessary to remain in a therapeutic range of anticoagulation varies widely. Patients responses to warfarin are affected by several variables, including age, sex, diet, and genetic makeup. Pharmacogenetic testing for warfarin response is one tool to help primary care physicians better manage warfarin dose. This kind of testing is not widely used in clinical practice due to a lack of scientific evidence that primary clinical outcomes are improved, although there are ongoing clinical trials examining this issue. As a result, the decision of whether or not to order warfarin pharmacogenetic testing is currently left to individual primary care physicians. This study will use a virtual clinical interaction experiment to assess primary care physicians knowledge of the clinical utility of genotype guided dosing of warfarin and the current research in its effectiveness. The study will also explore how physicians interact with and make decisions about pharmacogenetic testing warfarin dosing in patients of diverse racial and socioeconomic (SES) groups. We will assess whether physicians believe this pharmacogenetic test is useful. Physicians will be asked to respond to a virtual patient who presents with concerns about taking warfarin after she experienced a deep venous thrombosis (DVT). Primary care physicians will be randomized to one of six four possible combinations of racial and SES groups for the virtual patient. Physicians implicit and explicit biases related to race and SES will be assessed as possible independent variables that may be correlated with their decisions about ordering genotype-guided drug dosing. Self-report measures will also be used to assess physicians knowledge and beliefs about racial groups and human genetic variation. These variables will all be examined as possible factors that might impact physicians decision making around warfarin pharmacogenetic testing. The central aim of this study is to assess how physicians make decisions about warfarin-related pharmacogenetic testing.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
University of Michigan, School of Public Health Recruiting
Ann Arbor, Michigan, United States, 48109-2029
United States, New York
Columbia University Recruiting
New York, New York, United States, 10032-3784
Sponsors and Collaborators
Investigators
Principal Investigator: Vence L Bonham, J.D. National Human Genome Research Institute (NHGRI)
  More Information

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
ClinicalTrials.gov Identifier: NCT02108041     History of Changes
Other Study ID Numbers: 999914075, 14-HG-N075
Study First Received: April 5, 2014
Last Updated: July 19, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Physicians
Pharmacogenetic Testing
Implicit Bias

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

ClinicalTrials.gov processed this record on August 25, 2014