The INGenious trial will prospectively 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. It is randomized between an intervention arm and one that receives no intervention in order that the 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 after being prescribed a targeted medication. Patients randomized into the intervention arm that are prescribed one or more of the 24 targeted index medication will receive pharmacogenomic testing using a custom micro-array measuring 51 Single nucleotide polymorphisms in 16 genes. The study is being conducted by the Indiana University School of Medicine and the Indiana University Institute of Personalized Medicine in collaboration with the Eskenazi and Indiana University Health Systems and will evaluate the economic and clinical outcomes associated with embedding a pharmacogenomics program in a system that serves as the primary health care safety-net in Indianapolis, Indiana. By successfully implementing a pharmacogenomics program and integrating it with the Electronic Health Record and Clinical Decision Support system, physicians will be able to optimize patient care by delivering tailored therapeutic decisions based on the patient's individual genetics.
Indiana University School of Medicine and the Indiana University Institute of Personalized Medicine in collaboration with the Eskenazi Health and IUH Systems will be conducting a NIH funded randomized trial beginning in 2014. The study will evaluate the economic and clinical outcomes of associated with embedding a pharmacogenomics program in a system that serves as a health care safety-net in Indianapolis, Indiana, and 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 Clinical Laboratory Improvement Amendment 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 investigators will enroll subjects 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 Single nucleotide polymorphisms 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
4,465
In the design of this trial, pharmacogenetic testing will be triggered by the incident prescription of one or more of the targeted medications listed in the control arm. The pharmacogenetic array to be used incorporates 51 genetic variants for the following 16 genes/transporters: ATP-binding cassette sub-family C member 2, ATP-binding cassette, sub-family C, member 4, Cytochrome P450 2B6, Cytochrome P450 2C19, Cytochrome P450 2C9, Cytochrome P450 2D6, Cytochrome P450 3A4/3A5, Cytochrome P450 4F2, Dihydropyrimidine dehydrogenase, Glucose-6-Phosphate Dehydrogenase, Human Leukocyte antigen-B, I interleukin-28B, Inosine Triphosphatase, Solute Carrier Organic Anion Transporter Family, Member 1B, Thiopurine methyltransferase and V vitamin K epoxide reductase complex, subunit 1.
Eskenazi Health System
Indianapolis, Indiana, United States
Financial impact on the total cost of patient care resulting from implementation of a Pharmacogenetics testing program within a safety-net and Academic healthcare system
Analysis of cost of care (measured in U.S. dollars) data from the Eskenazi and Indiana University Health electronic medical records and billing systems for patients in the study. Charge data collected from monthly Eskenazi and IU Health System reports generated for the state hospital association. Categories of inpatient and outpatient charges include costs for medications, facility, laboratory, treatment, professional, and other sources. Data will be collected for each patient in the control and intervention arm beginning the day that the treating physician prescribes one or more targeted medication and will continue to be collected for 12 calendar months. Study enrollment period 2.5 years
Time frame: Study enrollment period of 2.5 years with individual patient data collection period of 12 month after one of more targeted medication is prescribed
Impact of implementing a Pharmacogenetics program on Clinical Outcomes (incidence and severity of adverse events, frequency of healthcare visits, length of hospital stay, and readmissions) within a safety-net and Academic healthcare system
For each patient in the study, investigators from the Regenstrief Institute will collect 12 months of data from the Eskenazi and IUH electronic medical records and informatics systems beginning when one or more targeted medications are prescribed. Outcome measures include: number of patient admissions, readmissions, number of emergency department visits, number of clinic visits and returns to clinic. Data collected includes reported adverse drug reactions related to the targeted medications (utilizing text in the physician notes section of the medical record and records entered using International Classification of Diseases coding convention
Time frame: Study enrollment period of 2.5 years with individual patient data collection period of 12 month after one of more targeted medication is prescribed
Impact of implementing a Pharmacogenetics program on prescribing patterns within a safety-net healthcare system
Prescribing data will be collected for each patient in the control and intervention arm beginning the day that the treating physician prescribes one or more targeted medication and will continue to be collected for 12 calendar months. Study enrollment period 2.5 years. Medication possession ratio for index medications used to determine whether a change in drug regimen was implemented for the intervention versus the control arm.
Time frame: Study enrollment period of 2.5 years with individual patient data collection period of 12 month after one of more targeted medication is prescribed
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