NCT02428660

Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM

Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Genelex Corporation · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial will evaluate whether the use of pharmacogenetic testing through a Medication Therapy Management (MTM) program has a beneficial impact on drug therapy problems. More specifically, cytochrome DNA testing, which provides information with regards to participant specific metabolism of medications, will be used in the evaluation of participant medication regimens. The overall aim of the project is to evaluate if the addition of genetic CYP testing to a standardized MTM Program provides increased clinical value. To answer this question, the investigators will look at the drug therapy problems (DTPs) identified by the genetic test compared to those DTPs discovered without the test.

Detailed description

All study participants will receive a Comprehensive Medication Review (CMR). One third will have standard MTM conducted. Another third of the participants will be randomized to MTM plus drug interaction risk analysis via YouScript software. The remaining third will be randomized to MTM along with drug interaction risk analysis via YouScript software and genetic testing. The software will identify polypharmacy patients who may benefit from pharmacogenetic testing based on their current medication regimen. Results of the testing will be mailed to both the participant and their provider. Participants who undergo testing will also receive a follow-up phone call. All participants, including those who receive MTM alone, will receive a contact 3 months later to assess quality of life.

Conditions

• Cytochrome P450 CYP2D6 Enzyme Deficiency
• Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
• Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant
• Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
• Cytochrome P450 CYP2C9 Enzyme Deficiency
• Cytochrome P450 CYP2C19 Enzyme Deficiency
• Drug Metabolism, Poor, CYP2D6-RELATED
• Drug Metabolism, Poor, CYP2C19-RELATED
• CYP2D6 Polymorphism

Interventions

Type	Name	Description
GENETIC	Pharmacogenetic testing	Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms
OTHER	Software-based drug & gene interaction risk analysis	By assessing a patient's medication list along with the frequencies of variant phenotypes in the population, YouScript is able to identify whether a patient might be at risk for an adverse drug event and suggest when testing might be appropriate.
OTHER	MTM	Medication Therapy Management

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-04-29
• Last updated: 2017-02-23

Locations

1 site across 1 country: United States