Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cytochrome P450 CYP2D6 Enzyme Deficiency
- Sponsor
- Genelex Corporation
- Enrollment
- 341
- Locations
- 1
- Primary Endpoint
- Number of Drug Therapy Problems (DTPs)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Number of Drug Therapy Problems (DTPs)
Time Frame: Baseline
Tabulation of the number of drug therapy problems identified by drug \& gene interaction risk analysis, with and without genetic testing.
Secondary Outcomes
- Number of adverse drug reactions(8 months)
- Quality of Life(3 months)