Browsing by Author "Cavanaugh, Kerri L."

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    Design and Rationale of GUARDD-US: A pragmatic, randomized trial of genetic testing for APOL1 and pharmacogenomic predictors of antihypertensive efficacy in patients with hypertension
    (Elsevier, 2022) Eadon, Michael T.; Cavanaugh, Kerri L.; Orlando, Lori A.; Christian, David; Chakraborty, Hrishikesh; Steen-Burrell, Kady-Ann; Merrill, Peter; Seo, Janet; Hauser, Diane; Singh, Rajbir; Maynor Beasley, Cherry; Fuloria, Jyotsna; Kitzman, Heather; Parker, Alexander S.; Ramos, Michelle; Ong, Henry H.; Elwood, Erica N.; Lynch, Sheryl E.; Clermont, Sabrina; Cicali, Emily J.; Starostik, Petr; Pratt, Victoria M.; Nguyen, Khoa A.; Rosenman, Marc B.; Calman, Neil S.; Robinson, Mimsie; Nadkarni, Girish N.; Madden, Ebony B.; Kucher, Natalie; Volpi, Simona; Dexter, Paul R.; Skaar, Todd C.; Johnson, Julie A.; Cooper-DeHoff, Rhonda M.; Horowitz, Carol R.; GUARDD-US Investigators; Medicine, School of Medicine
    Rationale and objective: APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease. Study design: Multicenter, pragmatic, randomized controlled clinical trial. Setting and participants: 6650 individuals with African ancestry and hypertension from 13 health systems. Intervention: APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use. Outcomes: Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months. Results: To date, the trial has enrolled 3423 participants. Conclusions: The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record.
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    Multi-Institutional Implementation of Clinical Decision Support for APOL1, NAT2, and YEATS4 Genotyping in Antihypertensive Management
    (MDPI, 2021-05-27) Schneider, Thomas M.; Eadon, Michael T.; Cooper-DeHoff, Rhonda M.; Cavanaugh, Kerri L.; Nguyen, Khoa A.; Arwood, Meghan J.; Tillman, Emma M.; Pratt, Victoria M.; Dexter, Paul R.; McCoy, Allison B.; Orlando, Lori A.; Scott, Stuart A.; Nadkarni, Girish N.; Horowitz, Carol R.; Kannry, Joseph L.; Medical and Molecular Genetics, School of Medicine
    (1) Background: Clinical decision support (CDS) is a vitally important adjunct to the implementation of pharmacogenomic-guided prescribing in clinical practice. A novel CDS was sought for the APOL1, NAT2, and YEATS4 genes to guide optimal selection of antihypertensive medications among the African American population cared for at multiple participating institutions in a clinical trial. (2) Methods: The CDS committee, made up of clinical content and CDS experts, developed a framework and contributed to the creation of the CDS using the following guiding principles: 1. medical algorithm consensus; 2. actionability; 3. context-sensitive triggers; 4. workflow integration; 5. feasibility; 6. interpretability; 7. portability; and 8. discrete reporting of lab results. (3) Results: Utilizing the principle of discrete patient laboratory and vital information, a novel CDS for APOL1, NAT2, and YEATS4 was created for use in a multi-institutional trial based on a medical algorithm consensus. The alerts are actionable and easily interpretable, clearly displaying the purpose and recommendations with pertinent laboratory results, vitals and links to ordersets with suggested antihypertensive dosages. Alerts were either triggered immediately once a provider starts to order relevant antihypertensive agents or strategically placed in workflow-appropriate general CDS sections in the electronic health record (EHR). Detailed implementation instructions were shared across institutions to achieve maximum portability. (4) Conclusions: Using sound principles, the created genetic algorithms were applied across multiple institutions. The framework outlined in this study should apply to other disease-gene and pharmacogenomic projects employing CDS.