ORD's Health Services Research and Development (HSR&D) and Genomic Medicine Implementation programs recently funded a groundbreaking study, entitled PRIME Care (PRecision medicine In MEntal health Care) to Dr. David Oslin, MD and a multidisciplinary team of investigators throughout the VA. The study will be hosted at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, PA where Dr. Oslin is Director of the VISN 4 Mental Illness Research, Education and Clinical Center and Core Investigator with the HSRD Center for Health Equity Research and Promotion. PRIME Care is based on ORD's Clinical Precision Medicine in Mental Health initiative and is in response to the VA Quality Enhancement Research Initiative (QUERI) Evidence Synthesis Program Scientific Review which strongly suggested the need for more research on genomic testing implementation in the clinical care setting. After a call for proposals this summer, HSR&D awarded funding to PRIME Care (PI: Dr. Oslin), which will begin in October 2016 and break new ground by determining optimal approaches to using genomic information to better treat depression in Veterans. PRIME Care focuses on the effectiveness of pharmacogenomics - how genes personally affect a person's response to treatment, and may help shorten time to optimal treatment by predicting how well an individual will tolerate or respond to an antidepressant.
For the first time in VA mental healthcare, genomic test results will be returned to providers and patients to determine if pharmacogenetics test tresults can influence treatment choice. PRIME Care includes several cores (Discovery, Knowledge Translation, Implementation) looking at the most effective way to return these results with the ultimate goal of better treating Veterans. The initiative focuses on the conduct of a randomized clinical trial comparing returning pharmacogenetic results at the time of randomization or six months later (delayed results). Outcomes will focus on whether patients and providers use the pharmacogenetic test results in medication choice and if that choice ultimately impacts treatment outcome. The study will be conducted at 20 VA facilities nationally. PRIME Care could serve as a primer for similar studies going forward. ORD's Genomic Medicine Implementation program's goal is to improve Veteran health through large-scale genetic testing, and is focused on research and implementation of best processes and methodologies that enable genomic research-to-practice tests to become sufficiently validated, and ultimately implemented within routine care settings. PRIME Care is an important step in achieving this goal and through an interdisciplinary group of researchers and VA clinical operations partners will inform development of novel approaches to evaluate and implement genomic testing in health care in order to improve the mental health of our Veterans. Other ORD and VA clinical initiatives encompassing this goal that strive to realize the potential of clinical precision medicine include the Precision Oncology Program and other efforts to leverage and analyze large-scale data as maintained within the Million Veteran Program.