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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 341
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • VRx Pharmacy Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Controls (no analysis or testing); MTM alone (i.e. Treatment As Usual)	Other: MTM; Medication Therapy Management
EXPERIMENTAL: Group 1; MTM + software-based drug & gene interaction risk analysis + pharmacogenetic testing	Other: MTM; Medication Therapy Management; Genetic: Pharmacogenetic testing; Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms; Other Names: YouScript(R) Personalized Prescribing System; Other: 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.
ACTIVE_COMPARATOR: Group 2; MTM + software-based drug & gene interaction risk analysis only	Other: MTM; Medication Therapy Management; Other: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance of recommendations by pharmacists	Proportion of recommendations deemed clinically relevant by local pharmacists.	Baseline
Major event risk reduction	Tabulation of major health events avoided (e.g. stroke, heart attack, and other events requiring hospitalization).	8 months
Acceptance of recommendations by clinician providers	Proportion of recommendations resulting in medication or dose changes.	8 months

Collaborators and Investigators

• Sponsor: Genelex Corporation
• Investigators: Principal Investigator: Jonathan W Magness, PharmD, VRx Pharmacy Services

Publications and helpful links

General Publications

• Kim K, Magness JW, Nelson R, Baron V, Brixner DI. Clinical Utility of Pharmacogenetic Testing and a Clinical Decision Support Tool to Enhance the Identification of Drug Therapy Problems Through Medication Therapy Management in Polypharmacy Patients. J Manag Care Spec Pharm. 2018 Dec;24(12):1250-1259. doi: 10.18553/jmcp.2018.24.12.1250.

Helpful Links

• Demo of YouScript(R) Personalized Prescribing System

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2015
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): February 1, 2017

Study Registration Dates

• First Submitted: April 21, 2015
• First Submitted That Met QC Criteria: April 28, 2015
• First Posted (ESTIMATE): April 29, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 22, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Polypharmacy; Activities of Daily Living; Medication Therapy Management; CYP3A4; CYP3A5; Adverse Drug Reactions; Drug-drug interactions; Chronic conditions; Drug Therapy Problems; Medication-Related Problems; Drug-gene interactions; Drug-drug-gene interactions
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors
• Other Study ID Numbers: Genelex 2014-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED