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
Conditions
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
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.
Interventions
GENETICPharmacogenetic testing
Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms
OTHERSoftware-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.
OTHERMTM
Medication Therapy Management
Sponsors
Genelex Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Drug Therapy Problems (DTPs) | Baseline | Tabulation of the number of drug therapy problems identified by drug & gene interaction risk analysis, with and without genetic testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse drug reactions | 8 months | Tabulation of adverse drug reactions. |
| Quality of Life | 3 months | Assessment of quality of life score via SF-12. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptance of recommendations by pharmacists | Baseline | Proportion of recommendations deemed clinically relevant by local pharmacists. |
| Major event risk reduction | 8 months | Tabulation of major health events avoided (e.g. stroke, heart attack, and other events requiring hospitalization). |
| Acceptance of recommendations by clinician providers | 8 months | Proportion of recommendations resulting in medication or dose changes. |
Countries
United States
Outcome results
None listed