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

Not Applicable

Completed

• Conditions: CYP2D6 Polymorphism; Cytochrome P450 CYP2C9 Enzyme Deficiency; Drug Metabolism, Poor, CYP2D6-RELATED; Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant; Drug Metabolism, Poor, CYP2C19-RELATED; Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant; Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant; Cytochrome P450 CYP2D6 Enzyme Deficiency; Cytochrome P450 CYP2C19 Enzyme Deficiency
• Interventions: Genetic: Pharmacogenetic testing; Other: Software-based drug & gene interaction risk analysis; Other: MTM

• Registration Number: NCT02428660
• Lead Sponsor: Genelex Corporation

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-04-21
• Study First Submitted QC: 2015-04-28
• Study First Posted: 2015-04-29
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Pharmacogenetic testing	MTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing
Group 1	Software-based drug & gene interaction risk analysis	MTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing
Group 1	MTM	MTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing
Group 2	Software-based drug & gene interaction risk analysis	MTM + software-based drug \& gene interaction risk analysis only
Group 2	MTM	MTM + software-based drug \& gene interaction risk analysis only
Controls (no analysis or testing)	MTM	MTM alone (i.e. Treatment As Usual)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

VRx Pharmacy Services; 🇺🇸 Salt Lake City, Utah, United States