CompletedNot Applicable

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

United States341 participantsStarted 2015-02

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

Number of Drug Therapy Problems (DTPs)

Timeframe: Baseline

Trial details

NCT IDNCT02428660

SponsorGenelex Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-02