Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

NIH RePORTER · NIH · U01 · $409,209 · view on reporter.nih.gov ↗

Abstract

The IGNITE (Implementing Genomics in Practice) Consortium was created to enhance the use of genomic medicine by supporting the development of methods for incorporating genomic information into clinical care and exploration of the methods for effective implementation, diffusion and sustainability in diverse clinical settings. The IGNITE II grant was designed to establish the foundation for selected pragmatic clinical trials. As part of the network funding, the Indiana University Clinical Group is recruiting participants into both the ADOPT-PGx (A Depression and Opioid Pragmatic Trial in Pharmacogenetics) and GUARDD-US (Genetic Testing to Understand and Address Renal Disease Disparities across the United States) clinical trials. GUARDD-US: This trial aims to recruit African Americans with hypertension, with or without chronic kidney disease, randomized to immediate versus delayed return of APOL1 genetic testing results. In those who are APOL1 negative, we will also conduct a pilot study to test the impact of pharmacogenetic testing on systolic blood pressure. Secondary outcomes include 6-month systolic blood pressure in chronic kidney disease patients, medications ordered, renal diagnosis and testing, patient psycho-behavioral outcomes, cost effectiveness, and the effect of pharmacogenetic-guided hypertension management on systolic blood pressure. ADOPT-PGx: This randomized pragmatic genotype-guided clinical trial tests the effect of genotype-guided therapy in three scenarios of patients: acute post-surgical pain, chronic pain, and depression. For each scenario, participants are randomized to genotype-guided drug therapy versus usual approaches to drug therapy selection. Changes in patient reported outcomes representing pain and depression control using standard PROMIS scales define the primary endpoints. Secondary analyses include safety endpoints, changes in overall well-being, and economic impact represented by differences in healthcare utilization. The Administrative Supplement supports the continuation and conclusion of GUARDD-US and ADOPT-PGx.

Key facts

NIH application ID
11073201
Project number
3U01HG010245-05S2
Recipient
INDIANA UNIVERSITY INDIANAPOLIS
Principal Investigator
Paul Dexter
Activity code
U01
Funding institute
NIH
Fiscal year
2024
Award amount
$409,209
Award type
3
Project period
2018-09-19 → 2025-06-30