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



Status:Completed
Conditions:Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:65 - Any
Updated:2/24/2017
Start Date:February 2015
End Date:February 2017

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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

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.

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.

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.
We found this trial at
1
site
Salt Lake City, Utah 84109
Principal Investigator: Jonathan W Magness, PharmD
Phone: 801-433-6230
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mi
from
Salt Lake City, UT
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