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The success of The Human Genome Project gave rise to molecular medicine, representing a new branch of medicine focused on genetic markers. As a result, genetic testing is slowly finding its niche in drug therapy selection, which dovetails with a more precise approach to human health (Malsagova et al, 2020). Scientists in the field of pharmacogenomics study how specific variants in an individual’s genome sequence influence their response to medications (NIH National Genome Research Institute). For example, a pharmacogenetic test might predict an individual’s likelihood of experiencing an adverse event or not responding to a given drug at all.
The VA PHASER program is a national clinical program that is offering free, multi-gene pharmacogenomic (PGx) testing for up to 250,000 Veterans at approximately 50 VA healthcare sites over five years. This national clinical program is collaborating with Sanford Health to test 11 genes that impact 37 commonly prescribed medications. By providing guidance on optimizing the dose or type of medication prescribed, the PHASER program aims to enhance drug response outcomes for Veterans. These drug-gene interactions relate to therapies used to treat:
- Cardiovascular disease,
- Anxiety and depression,
- Opioid use disorders,
- Acute and chronic pain, and
- Selected malignancies, infections, and autoimmune disorders.
However, realizing the health benefits of PGx testing requires uptake by various stakeholders within the VA healthcare system, including patients, providers, and administrators.
Led by Corrine Voils, PhD, who is supported by an HSR&D Research Career Scientist Award and is affiliated with the William S. Middleton Memorial Veterans Hospital in Madison, WI, the PHASER QUERI Partnered Evaluation will enhance VA's capability to implement pharmacogenomic (PGx) testing nationwide. Thus far, the PHASER program has experienced lower-than-expected uptake by facilities, providers, and patients. This evaluation will use both qualitative and quantitative methods to assess current implementation strategies and provide actionable information to increase adoption in VA sites across the country.
PHASER QUERI is employing a multi-level mixed model design to the three evaluation aims. All program data are collected and managed by the VINCI (VA Informatics and Computing Infrastructure) Data Core for PHASER. Evaluation aims include identifying factors associated with:
- Facility adoption of PGx testing,
- Provider adoption of PGx testing, and
- Patient adoption and effectiveness of PGx testing.
Guided by the Consolidated Framework for Implementation Research, the PHASER QUERI team will conduct key stakeholder interviews at participating sites to help ascertain organizational determinants of facility adoption. Additionally, the team will apply the Theoretical Domains Framework as it employs VA administrative and provider interview data from low- and high-adopting sites to examine factors associated with provider ordering of PGx testing. Finally, data from electronic medical records, surveys, and interviews will be used to examine factors associated with patient participation in PGX testing and its impact on medication adherence.
The PHASER QUERI Partnered Evaluation project will facilitate the acceleration of PGx testing at VA healthcare centers nationwide. The pharmacogenomic testing results provided by the PHASER Program have the potential to impact patients over their lifetime by avoiding preventable adverse drug effects and improving medication response. This groundwork will create a blueprint to facilitate the implementation of future genomic medicine interventions and initiatives across the VA healthcare system, including implementation of PGx testing at VA when the PHASER program ends.
Implementing a clinical practice like pharmacogenomics is new territory for VA. We are looking forward to working with the QUERI team to learn how to optimize uptake at the patient, provider, and facility levels so that all Veterans can access and benefit from pharmacogenomics testing. –Deepak Voora, MD, Director, VA PHASER Program
This partnered evaluation will be conducted by investigators at three different facilities—William S Middleton Memorial Veterans Hospital, HSR&D’s Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT), and HSR&D’s Center of Innovation for Complex Chronic Healthcare (CINCCH)—with the following operations partners: