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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-02-28

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.

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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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Controls (no analysis or testing)

MTM alone (i.e. Treatment As Usual)

Group Type OTHER

MTM

Intervention Type OTHER

Medication Therapy Management

Group 1

MTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing

Group Type EXPERIMENTAL

Pharmacogenetic testing

Intervention Type GENETIC

Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms

Software-based drug & gene interaction risk analysis

Intervention Type OTHER

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.

MTM

Intervention Type OTHER

Medication Therapy Management

Group 2

MTM + software-based drug \& gene interaction risk analysis only

Group Type ACTIVE_COMPARATOR

Software-based drug & gene interaction risk analysis

Intervention Type OTHER

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.

MTM

Intervention Type OTHER

Medication Therapy Management

Interventions

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Pharmacogenetic testing

Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms

Intervention Type GENETIC

Software-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.

Intervention Type OTHER

MTM

Medication Therapy Management

Intervention Type OTHER

Other Intervention Names

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YouScript(R) Personalized Prescribing System

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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No