Clinical trial NCT02428660: Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
Official title: Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Keywords: Polypharmacy
Chronic conditions
Drug Therapy Problems
Medication Therapy Management
Medication-Related Problems
CYP3A4
CYP3A5
Drug-drug interactions
Drug-gene interactions
Drug-drug-gene interactions
Adverse Drug Reactions
Activities of Daily Living
Lead sponsor: Genelex Corporation
Sponsor class: INDUSTRY
First posted: 2015-04-29
Enrollment: 341
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Drug Therapy Problems (DTPs)
timeFrame: Baseline
Secondary outcomes:
measure: Number of adverse drug reactions
timeFrame: 8 months
measure: Quality of Life
timeFrame: 3 months
Other outcomes:
measure: Acceptance of recommendations by pharmacists
timeFrame: Baseline
measure: Major event risk reduction
timeFrame: 8 months
measure: Acceptance of recommendations by clinician providers
timeFrame: 8 months
Locations:
city: Salt Lake City
country: United States
facility: VRx Pharmacy Services
state: Utah
Study officials:
affiliation: VRx Pharmacy Services
name: Jonathan W Magness, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim K, Magness JW, Nelson R, Baron V, Brixner DI. Clinical Utility of Pharmacogenetic Testing and a Clinical Decision Support Tool to Enhance the Identification of Drug Therapy Problems Through Medication Therapy Management in Polypharmacy Patients. J Manag Care Spec Pharm. 2018 Dec;24(12):1250-1259. doi: 10.18553/jmcp.2018.24.12.1250.