Browsing by Author "Ramos, Michelle A."

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    Establishing the value of genomics in medicine: the IGNITE Pragmatic Trials Network.
    (Springer, 2021-07) Ginsburg, Geoffrey S.; Cavallari, Larisa H.; Chakraborty, Hrishikesh; Cooper-DeHoff, Rhonda M.; Dexter, Paul R.; Eadon, Michael T.; Ferket, Bart S.; Horowitz, Carol R.; Johnson, Julie A.; Kannry, Joseph; Kucher, Natalie; Madden, Ebony B.; Orlando, Lori A.; Parker, Wanda; Peterson, Josh; Pratt, Victoria M.; Rakhra-Burris, Tejinder K.; Ramos, Michelle A.; Skaar, Todd C.; Sperber, Nina; Steen-Burrell, Kady-Ann; Van Driest, Sara L.; Voora, Deepak; Wiisanen, Kristin; Winterstein, Almut G.; Volpi, Simona
    PURPOSE: A critical gap in the adoption of genomic medicine into medical practice is the need for the rigorous evaluation of the utility of genomic medicine interventions. METHODS: The Implementing Genomics in Practice Pragmatic Trials Network (IGNITE PTN) was formed in 2018 to measure the clinical utility and cost-effectiveness of genomic medicine interventions, to assess approaches for real-world application of genomic medicine in diverse clinical settings, and to produce generalizable knowledge on clinical trials using genomic interventions. Five clinical sites and a coordinating center evaluated trial proposals and developed working groups to enable their implementation. RESULTS: Two pragmatic clinical trials (PCTs) have been initiated, one evaluating genetic risk APOL1 variants in African Americans in the management of their hypertension, and the other to evaluate the use of pharmacogenetic testing for medications to manage acute and chronic pain as well as depression. CONCLUSION: IGNITE PTN is a network that carries out PCTs in genomic medicine; it is focused on diversity and inclusion of underrepresented minority trial participants; it uses electronic health records and clinical decision support to deliver the interventions. IGNITE PTN will develop the evidence to support (or oppose) the adoption of genomic medicine interventions by patients, providers, and payers.
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    Strategies to Integrate Genomic Medicine into Clinical Care: Evidence from the IGNITE Network
    (MDPI, 2021-07-08) Sperber, Nina R.; Dong, Olivia M.; Roberts, Megan C.; Dexter, Paul; Elsey, Amanda R.; Ginsburg, Geoffrey S.; Horowitz, Carol R.; Johnson, Julie A.; Levy, Kenneth D.; Ong, Henry; Peterson, Josh F.; Pollin, Toni I.; Rakhra-Burris, Tejinder; Ramos, Michelle A.; Skaar, Todd C.; Orlando, Lori A.; Medicine, School of Medicine
    The complexity of genomic medicine can be streamlined by implementing some form of clinical decision support (CDS) to guide clinicians in how to use and interpret personalized data; however, it is not yet clear which strategies are best suited for this purpose. In this study, we used implementation science to identify common strategies for applying provider-based CDS interventions across six genomic medicine clinical research projects funded by an NIH consortium. Each project’s strategies were elicited via a structured survey derived from a typology of implementation strategies, the Expert Recommendations for Implementing Change (ERIC), and follow-up interviews guided by both implementation strategy reporting criteria and a planning framework, RE-AIM, to obtain more detail about implementation strategies and desired outcomes. We found that, on average, the three pharmacogenomics implementation projects used more strategies than the disease-focused projects. Overall, projects had four implementation strategies in common; however, operationalization of each differed in accordance with each study’s implementation outcomes. These four common strategies may be important for precision medicine program implementation, and pharmacogenomics may require more integration into clinical care. Understanding how and why these strategies were successfully employed could be useful for others implementing genomic or precision medicine programs in different contexts.