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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients

Conditions
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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

Intervention / Treatment
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* Genetic: Pharmacogenetic testing
* Other: Software-based drug & gene interaction risk analysis
* Other: MTM


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Controls (no analysis or testing)<br>MTM alone (i.e. Treatment As Usual) | Other: MTM<br>* Medication Therapy Management<br>|
| Experimental: Group 1<br>MTM + software-based drug & gene interaction risk analysis + pharmacogenetic testing | Genetic: Pharmacogenetic testing<br>* Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms<br>* Other names: YouScript(R) Personalized Prescribing System;Other: Software-based drug & gene interaction risk analysis<br>* 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.<br>Other: MTM<br>* Medication Therapy Management<br>|
| Active Comparator: Group 2<br>MTM + software-based drug & gene interaction risk analysis only | Other: Software-based drug & gene interaction risk analysis<br>* 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.<br>Other: MTM<br>* Medication Therapy Management<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Drug Therapy Problems (DTPs) | Tabulation of the number of drug therapy problems identified by drug & gene interaction risk analysis, with and without genetic testing. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse drug reactions | Tabulation of adverse drug reactions. | 8 months | 
| Quality of Life | Assessment of quality of life score via SF-12. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CYP3A4, CYP3A5, Drug-drug interactions, Drug-gene interactions, Drug-drug-gene interactions, Adverse Drug Reactions, Activities of Daily Living, Polypharmacy, Chronic conditions, Drug Therapy Problems, Medication Therapy Management, Medication-Related Problems