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

Genelex

Status: Completed

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

Treatments: Other: MTM; Genetic: Pharmacogenetic testing; Other: Software-based drug & gene interaction risk analysis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02428660

Genelex 2014-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 341 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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341 participants in 3 patient groups

Controls (no analysis or testing)

Other group

Description:

MTM alone (i.e. Treatment As Usual)

Treatment:

Other: MTM

Group 1

Experimental group

Description:

MTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing

Treatment:

Other: Software-based drug & gene interaction risk analysis

Other: MTM

Genetic: Pharmacogenetic testing

Group 2

Active Comparator group

Description:

MTM + software-based drug \& gene interaction risk analysis only

Treatment:

Other: Software-based drug & gene interaction risk analysis

Other: MTM