Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
Completed · Not applicable
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT02428660
- Run by
- Genelex Corporation
- People needed
- 341
- Starts
- 2015-02-01
- Expected to finish
- 2017-02-01
- Last updated by the study team
- 2017-02-23
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 65 or over and enrolled in a Medicare Part-D Prescription Drug Plan.
- Currently prescribed ≥6 chronic medications.
- Have ≥3 chronic disease states including osteoarthritis, rheumatoid arthritis, heart failure, diabetes, dyslipidemia, hypertension, asthma, chronic obstructive pulmonary disease, atrial fibrillation, and coronary artery disease.
- Participant incurred the Medicare-mandated dollar amount in medication-related costs in the previous quarter.
You may not qualify if…
- Inability to perform MTM encounter due to living situation (e.g. patient is enrolled in hospice, or is in long term care facility).
- Patient is unable to perform MTM encounter due to metal health barriers as described by Brief Interview for Mental Status (BIMS) score of <13 points.
- Patient identifies themselves as being unable to perform the oral swab function of the genetic test.
- Patient had a known MTM session within the preceding 12 months.
Where it is running
- VRx Pharmacy Services — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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