INGENIOUS

The INGenious trial planed to 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 27 targeted index medication will receive pharmacogenomic testing using a custom micro-array measuring 43 Single nucleotide polymorphisms in 14 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.]]>
Subjects 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 13 months. The inclusion criteria that will be adhered to will be: 1) Able and willing consent to participation in the trial; 2) Adults aged 18 and over; 3) Receiving care at Eskenazi Health or Indiana University Health Systems for 1 year or more; 4) Prescribed an index medication; 5) No documented prescription of the index medication for the past 13 months; 6) The study limit of enrollment (500) for that medication has not been reached; 7) A single tube of whole blood or 2 ml of saliva can be obtained; and 8) Able to follow study procedures. Patients will be excluded if they: 1) Cannot or do not consent to participate; 2) Are unable to provide 7cc of whole blood, or 2 ml of saliva, or it cannot be obtained; and 3) If they are an employee or student under the supervision of any of the investigators.]]>
Study period: 09/05/2014 through 06/30/2018 Recruitment began 05/01/2015 Added $25.00 compensation for subject recruitment 12/2015 Increased subject recruitment compensation to $50.00 03/2016 Added saliva as approved sample type for Eskenazi Health 03/08/2016 Added Indiana University Health 01/01/2017 Recruitment ended 05/03/2018 Administrative Supplement received funding study through 04/30/2019 ]]>