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Completed

NCT Number: NCT02428660

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

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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Key information

Conditions

Cytochrome P450 CYP2D6 Enzyme Deficiency CYP2D6 Polymorphism Chemically-Induced Disorders Chronic Disease Cytochrome P450 CYP2C19 Enzyme Deficiency Cytochrome P450 CYP2C9 Enzyme Deficiency Disease Attributes Drug Metabolism, Poor, CYP2C19-Related Drug Metabolism, Poor, CYP2D6-Related Drug-Related Side Effects and Adverse Reactions Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant Pathologic Processes Pathological Conditions, Signs and Symptoms Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VRx Pharmacy Services

Salt Lake City, Utah, 84109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pharmacogenetic testing

Genetic

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

Other names: YouScript(R) Personalized Prescribing System

Software-based drug & gene interaction risk analysis

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

Other

Medication Therapy Management

Primary outcomes

  1. Number of Drug Therapy Problems (DTPs)

    Time frame: Baseline

    Tabulation of the number of drug therapy problems identified by drug & gene interaction risk analysis, with and without genetic testing.

Secondary outcomes

  1. Number of adverse drug reactions

    Time frame: 8 months

    Tabulation of adverse drug reactions.

  2. Quality of Life

    Time frame: 3 months

    Assessment of quality of life score via SF-12.

Other outcomes

  1. Acceptance of recommendations by pharmacists

    Time frame: Baseline

    Proportion of recommendations deemed clinically relevant by local pharmacists.

  2. Major event risk reduction

    Time frame: 8 months

    Tabulation of major health events avoided (e.g. stroke, heart attack, and other events requiring hospitalization).

  3. Acceptance of recommendations by clinician providers

    Time frame: 8 months

    Proportion of recommendations resulting in medication or dose changes.

Sponsors and collaborators

Lead sponsor

Genelex Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 29, 2015
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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