Indiana University School of Medicine and the Indiana University Institute for Personalized Medicine in collaboration with the Eskenazi Health System will be conducting a study to evaluate the economic and clinical outcomes associated with embedding a pharmacogenomics program in a system that serves as a health care safety-net in Indianapolis, Indiana.

Principal Investigators

Dexter_PaulPaul R. Dexter, MD

Indiana University School of Medicine
Associate Professor of Clinical Medicine
Research Scientist, Regenstrief Institute
Chief Medical Information Officer, Eskenazi Health

SkaarTodd Skaar, PhD

Indiana University School of Medicine
Associate Professor of Medicine

flockhartThe late Dave Flockhart, MD, PhD (1952-2015)
Former Chief of the Division of Clinical Pharmacology
and The Harry and Edith Gladstein Chair in Cancer Pharmacogenomics

A guiding force in the work of the INGENIOUS project and the IGNITE Network as the former Chair of the IGNITE Steering Committee

Project Description

ingenious_logo

The Eskenazi Health System handles over 1.2 million outpatient visits a year at its hospital and network of 10 community health centers. There are over 990,000 outpatient visits and 15,000 adult admissions annually, and the payor mix includes 45% uninsured, 26% Medicaid and 18% Medicare patients. This health care system has more than 40 years of experience in digital medical record implementation and a proven track record of innovation in medical informatics that is based in the Regenstrief Institute.

The goal of Personalized Medicine (PM) is to implement advances in biomarker pharmacology, molecular diagnostics and genomics to improve the health of patients afflicted by a wide range of medical conditions. Dramatic advances in genomics have identified numerous disease/therapeutic associations now placing this goal within sight. For the full benefits of personalized genomic medicine to be realized, it is now critical that progress made on a small scale be extended. The fruits of outstanding scientific discovery are often enjoyed by a small number of academic medical centers but are not scalable, and therefore not available to the masses of patients found in larger health care systems. In addition, such advances often bypass underserved populations, resulting in significant inequalities of care.

Project Goals

  • To test the hypothesis that a CLIA certified genotyping targeted at 24 widely used drugs is associated with significant reductions in hospital and outpatient economic costs incurred over 1 year.
  • To test whether pharmacogenetic testing is associated with significant improvements in clinical outcomes over 1 year.

The INGENIOUS trial will enroll a total of 6,000 patients, with 2,000 patients assigned to a pharmacogenetic testing arm and 4,000 to a control arm who will be followed, but not tested. The study is prospective since practice patterns change, and retrospective designs cannot be used to assess the impact of a prospective change.

It is randomized between an intervention arm and one that receives no intervention in order that a genotyped group can be compared with one in which undisturbed, routine clinical care is carried out in patients taking the same drugs. Both arms will be followed for a year. Subjects will be enrolled starting at 6 months into the funding period, and we will enroll for a total of 2 years, so that the last person enrolled will be at 2.5 years, and follow up will be completed at 3.5 years, allowing 6 months for analysis at the end of the study.

A pharmacogenetic test, involving 51 SNPs in 16 genes will be carried out at the beginning of the study in patients in the testing arm upon prompting by an index medication: one of 24 selected as being supported by validated guidelines.

Key Personnel

Principal Investigators

  • Paul R. Dexter, MD
  • Todd Skaar, PhD

Co-Investigators

  • Samir K. Gupta, MD
  • David M. Haas, MD
  • Raj Vuppalanchi, MD
  • Gail Vance, MD
  • Rolf Kreutz, MD
  • Thomas Callaghan, MD, PhD
  • Brian Decker, MD, PharmD
  • Marc Rosenman, MD
  • Desta Zeruesenay, PhD
  • Lang Li, PhD
  • Vicky Pratt, PhD, FACMG
  • Ann Holmes, PhD
  • Program Manager: Kenneth Levy, PhD, MBA