A Prospective Trial to Assess Cost and Clinical Outcomes of a Clinical Pharmacogenomic Program

Completed · Not applicable

Conditions studied: Adverse Drug Reaction

In brief

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.

Key facts

Study ID

NCT02297126

Run by

Indiana University

People needed

4465

Starts

2015-03-01

Expected to finish

2019-05-03

Last updated by the study team

2021-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be eligible for inclusion if they are prescribed one of the 27 index medications for the first time, defined as there being no recorded prescription in the Eskenazi, Indiana University Health or Indiana Patient Care (INPC) system over the past year. The inclusion criteria that will be adhered to will be:
• Able and willing consent to participation in the trial;
• Adults aged 18 and over;
• Receiving care at Eskenazi Health or Indiana University Health Systems for 1 year or more;
• Prescribed an index medication.
• No documented prescription of the index medication for the past year.
• The study limit of enrollment (500) for that medication has not been reached
• A single tube of whole blood can be obtained, and
• Able to follow study procedures. -

You may not qualify if…

• No subject will be excluded from the study on the basis of ethnicity or race. We will include all minorities.
• Patients will be excluded if they:
• Cannot or do not consent to participate;
• are unable to provide 5cc of whole blood, or it cannot be obtained;
• if they are an employee or student under the supervision of any of the investigators.

Where it is running

• Eskenazi Health System — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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