# Implementing a genomics-enabled Learning Health System across Indiana

> **NIH NIH U01** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $658,448

## Abstract

The goals of this project are to identify strategies to improve the integration of genomic testing, reporting, and
use into the clinical workflow of patient care. Over the last decade, we have acquired the infrastructure and
expertise to support genetic testing, reporting, alerting, educating, and returning results. We will now leverage
our past accomplishments and our genomics-enabled learning health system (gLHS) to share implementation
strategies, conduct two selected intervention projects network-wide and evaluate their impact, and share gLHS
tools and resources that can be broadly adopted. To facilitate this work, we are proposing two pragmatic
randomized stepped wedge clinical trials: one focused on implementing DPYD testing and one on APOL1
testing. In patients receiving fluoropyrimidine chemotherapies, DPYD testing and genetic-guided dose
adjustments reduce the severe toxicities caused by these drugs. In many other countries, DPYD testing is
standard of care; in the US, it is beginning to be used in some clinics, but needs additional leadership and
effective strategies to overcome the barriers and facilitate broad adoption. APOL1 variants contribute to the
development and progression of chronic kidney disease and disparate outcomes in patients with African
ancestry. APOL1 testing, together with joint decision making with the patient and provider, helps to manage risk
factors that contribute to poor chronic kidney disease outcomes. These trials represent two distinct genetic tests
and disciplines of medicine, are tests that are ready for broad implementation, can be implemented in most
health care systems, and address disparate healthcare outcomes. The two proposed clinical trials will serve as
a platform to implement innovative solutions to drive genomic medicine uptake. We propose that an initial set of
solutions would reasonably include EHR-based clinical decision support, educating providers, simplifying genetic
test ordering, and streamlining processes to improve insurance reimbursement rates. Following the initial
implementation, we will evaluate the success of the strategies and refine and integrate additional improvements
in two subsequent rounds of iterative implementation. In order to fully accommodate the selected projects, our
implementation team includes experts in genetics, counseling, informatics, pharmacology, bioethics, learning
health systems, economics, implementation science and many disciplines of medicine that have a productive
track record of working together. Our previous implementation work has led to the identification and resolution
of many barriers to genomic medicine. The insights gained from our learning health system, provider and patient
feedback, informatics analyses, workflow logistics, and laboratory challenges provide initial basis for our initial
interventions; they will also provide immediate strategies for other health care systems to learn from our
experience. Upon completion of these trials, we expe...

## Key facts

- **NIH application ID:** 10980962
- **Project number:** 1U01HG013770-01
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Paul Dexter
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $658,448
- **Award type:** 1
- **Project period:** 2024-09-23 → 2030-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10980962

## Citation

> US National Institutes of Health, RePORTER application 10980962, Implementing a genomics-enabled Learning Health System across Indiana (1U01HG013770-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10980962. Licensed CC0.

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