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

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ClinicalTrials.gov Identifier: NCT02428660
Recruitment Status : Completed
First Posted : April 29, 2015
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428660


Locations
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United States, Utah
VRx Pharmacy Services
Salt Lake City, Utah, United States, 84109
Sponsors and Collaborators
Genelex Corporation
Investigators
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Principal Investigator: Jonathan W Magness, PharmD VRx Pharmacy Services

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Genelex Corporation
ClinicalTrials.gov Identifier: NCT02428660     History of Changes
Other Study ID Numbers: Genelex 2014-02
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Genelex Corporation:
Chronic conditions
Polypharmacy
Drug Therapy Problems
Medication Therapy Management
Medication-Related Problems
CYP3A4
CYP3A5
Drug-drug interactions
Drug-gene interactions
Drug-drug-gene interactions
Adverse Drug Reactions
Activities of Daily Living
Additional relevant MeSH terms:
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Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases