Personalized Medicine Decision-Making in a Virtual Clinical Setting
- 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.
- To study how physicians make personalized treatment decisions
- Healthy adult primary care physicians who are internal (or family) medicine residents.
- 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.
Deep Vein Thrombosis
|Study Design:||Time Perspective: Cross-Sectional|
|Official Title:||Medical Decision-Making in a Virtual Clinical Setting|
- 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 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02108041
|Contact: Vence L Bonham, J.D.||(301) firstname.lastname@example.org|
|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|
|New York, New York, United States, 10032-3784|
|Principal Investigator:||Vence L Bonham, J.D.||National Human Genome Research Institute (NHGRI)|