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INGENIOUS

 

INdiana GENomics Implementation: an Opportunity for the UnderServed

Project Description:

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. 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 significant inequalities of care.

 

                                                             

                                                      

 

Study Aims:

 

Aim 1: 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.
Aim2: 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.

 

Principal Investigators:
David A. Flockhart, MD, PhD; Paul Dexter, MD
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, Pharm D; Marc Rosenman MD; Todd Skaar PhD; Desta Zeruesenay PhD; Lang Li PhD; Vicky Pratt PhD, FACMG; Ann Holmes PhD; Michael Eadon MD; Program Manager: Kenneth Levy PhD, MBA

 

Indiana Institute for Personalized Medicine: /iipm