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

Sponsor

Genelex Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT02428660

Collaborator

(none)

341

Enrollment

Location

Arms

Actual Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Genetic: Pharmacogenetic testing Other: Software-based drug & gene interaction risk analysis Other: MTM	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

341 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients

Actual Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Feb 1, 2017

Actual Study Completion Date :

Feb 1, 2017

Arms and Interventions

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	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. Other: MTM Medication Therapy Management
Active Comparator: Group 2 MTM + software-based drug & gene interaction risk analysis only	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. Other: MTM Medication Therapy Management

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

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.

Other: MTM

Medication Therapy Management

Active Comparator: Group 2

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

Other: Software-based drug & gene interaction risk analysis

Other: MTM

Medication Therapy Management

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.