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Browsing by Author "Wiisanen, Kristin"
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Item Best-worst scaling methodology to evaluate constructs of the Consolidated Framework for Implementation Research: application to the implementation of pharmacogenetic testing for antidepressant therapy.(BMC, 2022-05-14) Salloum, Ramzi G.; Bishop, Jeffrey R.; Elchynski, Amanda L.; Smith, D. Max; Rowe, Elizabeth; Blake, Kathryn V.; Limdi, Nita A.; Aquilante, Christina L.; Bates, Jill; Beitelshees, Amber L.; Cipriani, Amber; Duong, Benjamin Q.; Empey, Philip E.; Formea, Christine M.; Hicks, J. Kevin; Mroz, Pawel; Oslin, David; Pasternak, Amy L.; Petry, Natasha; Ramsey, Laura B.; Schlichte, Allyson; Swain, Sandra M.; Ward, Kristen M.; Wiisanen, Kristin; Skaar, Todd C.; Van Driest, Sara L.; Cavallari, Larisa H.; Tuteja, SonyBACKGROUND: Despite the increased demand for pharmacogenetic (PGx) testing to guide antidepressant use, little is known about how to implement testing in clinical practice. Best-worst scaling (BWS) is a stated preferences technique for determining the relative importance of alternative scenarios and is increasingly being used as a healthcare assessment tool, with potential applications in implementation research. We conducted a BWS experiment to evaluate the relative importance of implementation factors for PGx testing to guide antidepressant use. METHODS: We surveyed 17 healthcare organizations that either had implemented or were in the process of implementing PGx testing for antidepressants. The survey included a BWS experiment to evaluate the relative importance of Consolidated Framework for Implementation Research (CFIR) constructs from the perspective of implementing sites. RESULTS: Participating sites varied on their PGx testing platform and methods for returning recommendations to providers and patients, but they were consistent in ranking several CFIR constructs as most important for implementation: patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and identification of champions. CONCLUSIONS: This study demonstrates the feasibility of using choice experiments to systematically evaluate the relative importance of implementation determinants from the perspective of implementing organizations. BWS findings can inform other organizations interested in implementing PGx testing for mental health. Further, this study demonstrates the application of BWS to PGx, the findings of which may be used by other organizations to inform implementation of PGx testing for mental health disorders.Item 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, SimonaPURPOSE: 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.Item Implementing a pragmatic clinical trial to tailor opioids for acute pain on behalf of the IGNITE ADOPT PGx investigators.(Wiley, 2022-07-28) Cavallari, Larisa H.; Cicali, Emily; Wiisanen, Kristin; Fillingim, Roger B.; Chakraborty, Hrishikesh; Myers, Rachel A.; Blake, Kathryn V.; Asiyanbola, Bolanle; Baye, Jordan F.; Bronson, Wesley H.; Cook, Kelsey J.; Elwood, Erica N.; Gray, Chancellor F.; Gong, Yan; Hines, Lindsay; Kannry, Joseph; Kucher, Natalie; Lynch, Sheryl; Nguyen, Khoa A.; Obeng, Aniwaa Owusu; Pratt, Victoria M.; Prieto, Hernan A.; Ramos, Michelle; Sadeghpour, Azita; Singh, Rajbir; Rosenman, Marc; Starostik, Petr; Thomas, Cameron D.; Tillman, Emma; Dexter, Paul R.; Horowitz, Carol R.; Orlando, Lori A.; Peterson, Josh F.; Skaar, Todd C.; Van Driest, Sara L.; Volpi, Simona; Voora, Deepak; Parvataneni, Hari K.; Johnson, Julie A.Opioid prescribing for postoperative pain management is challenging because of inter-patient variability in opioid response and concern about opioid addiction. Tramadol, hydrocodone, and codeine depend on the cytochrome P450 2D6 (CYP2D6) enzyme for formation of highly potent metabolites. Individuals with reduced or absent CYP2D6 activity (i.e., intermediate metabolizers [IMs] or poor metabolizers [PMs], respectively) have lower concentrations of potent opioid metabolites and potentially inadequate pain control. The primary objective of this prospective, multicenter, randomized pragmatic trial is to determine the effect of postoperative CYP2D6-guided opioid prescribing on pain control and opioid usage. Up to 2020 participants, age ≥8 years, scheduled to undergo a surgical procedure will be enrolled and randomized to immediate pharmacogenetic testing with clinical decision support (CDS) for CYP2D6 phenotype-guided postoperative pain management (intervention arm) or delayed testing without CDS (control arm). CDS is provided through medical record alerts and/or a pharmacist consult note. For IMs and PM in the intervention arm, CDS includes recommendations to avoid hydrocodone, tramadol, and codeine. Patient-reported pain-related outcomes are collected 10 days and 1, 3, and 6 months after surgery. The primary outcome, a composite of pain intensity and opioid usage at 10 days postsurgery, will be compared in the subgroup of IMs and PMs in the intervention (n = 152) versus the control (n = 152) arm. Secondary end points include prescription pain medication misuse scores and opioid persistence at 6 months. This trial will provide data on the clinical utility of CYP2D6 phenotype-guided opioid selection for improving postoperative pain control and reducing opioid-related risks.Item Multisite evaluation of institutional processes and implementation determinants for pharmacogenetic testing to guide antidepressant therapy.(Wiley, 2022-02) Tuteja, Sony; Salloum, Ramzi G.; Elchynski, Amanda L.; Smith, D. Max; Rowe, Elizabeth; Blake, Kathryn V.; Limdi, Nita A.; Aquilante, Christina L.; Bates, Jill; Beitelshees, Amber L.; Cipriani, Amber; Duong, Benjamin Q.; Empey, Philip E.; Formea, Christine M.; Hicks, J. Kevin; Mroz, Pawel; Oslin, David; Pasternak, Amy L.; Petry, Natasha; Ramsey, Allyson; Swain, Sandra M.; Ward, Kristen M.; Wiisanen, Kristin; Skaar, Todd C.; Van Driest, Sara L.; Cavallari, Larisa H.; Bishop, Jeffrey R.There is growing interest in utilizing pharmacogenetic (PGx) testing to guide antidepressant use, but there is lack of clarity on how to implement testing into clinical practice. We administered two surveys at 17 sites that had implemented or were in the process of implementing PGx testing for antidepressants. Survey 1 collected data on the process and logistics of testing. Survey 2 asked sites to rank the importance of Consolidated Framework for Implementation Research (CFIR) constructs using best-worst scaling choice experiments. Of the 17 sites, 13 had implemented testing and four were in the planning stage. Thirteen offered testing in the outpatient setting, and nine in both outpatient/inpatient settings. PGx tests were mainly ordered by psychiatry (92%) and primary care (69%) providers. CYP2C19 and CYP2D6 were the most commonly tested genes. The justification for antidepressants selected for PGx guidance was based on Clinical Pharmacogenetics Implementation Consortium guidelines (94%) and US Food and Drug Administration (FDA; 75.6%) guidance. Both institutional (53%) and commercial laboratories (53%) were used for testing. Sites varied on the methods for returning results to providers and patients. Sites were consistent in ranking CFIR constructs and identified patient needs/resources, leadership engagement, intervention knowledge/beliefs, evidence strength and quality, and the identification of champions as most important for implementation. Sites deployed similar implementation strategies and measured similar outcomes. The process of implementing PGx testing to guide antidepressant therapy varied across sites, but key drivers for successful implementation were similar and may help guide other institutions interested in providing PGx-guided pharmacotherapy for antidepressant management.Item Multisite investigation of strategies for the clinical implementation of pre-emptive pharmacogenetic testing(Elsevier, 2021) Duarte, Julio D.; Dalton, Rachel; Elchynski, Amanda L.; Smith, D. Max; Cicali, Emily J.; Lee, James C.; Duong, Benjamin Q.; Petry, Natasha J.; Aquilante, Christina L.; Beitelshees, Amber L.; Empey, Philip E.; Johnson, Julie A.; Obeng, Aniwaa Owusu; Pasternak, Amy L.; Pratt, Victoria M.; Ramsey, Laura B.; Tuteja, Sony; Van Driest, Sara L.; Wiisanen, Kristin; Hicks, J. Kevin; Cavallari, Larisa H.; IGNITE Network Pharmacogenetics Working Group; Medical and Molecular Genetics, School of MedicinePurpose: The increased availability of clinical pharmacogenetic (PGx) guidelines and decreasing costs for genetic testing have slowly led to increased utilization of PGx testing in clinical practice. Pre-emptive PGx testing, where testing is performed in advance of drug prescribing, is one means to ensure results are available at the time of prescribing decisions. However, the most efficient and effective methods to clinically implement this strategy remain unclear. Methods: In this report, we compare and contrast implementation strategies for pre-emptive PGx testing by 15 early-adopter institutions. We surveyed these groups, collecting data on testing approaches, team composition, and workflow dynamics, in addition to estimated third-party reimbursement rates. Results: We found that while pre-emptive PGx testing models varied across sites, institutions shared several commonalities, including methods to identify patients eligible for testing, involvement of a precision medicine clinical team in program leadership, and the implementation of pharmacogenes with Clinical Pharmacogenetics Implementation Consortium guidelines available. Finally, while reimbursement rate data were difficult to obtain, the data available suggested that reimbursement rates for pre-emptive PGx testing remain low. Conclusion: These findings should inform the establishment of future implementation efforts at institutions considering a pre-emptive PGx testing program.