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

NCT02428660 | Completed

• 1 other identifier: Genelex 2014-02
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Polypharmacy; Chronic conditions; 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of adverse drug reactions

  8 months

• Quality of Life

  3 months

Other Outcomes (3)

• Acceptance of recommendations by pharmacists

  Baseline

• Major event risk reduction

  8 months

• Acceptance of recommendations by clinician providers

  8 months

Study Arms (3)

Controls (no analysis or testing)

OTHER

MTM alone (i.e. Treatment As Usual)

Other: MTM

Group 1

EXPERIMENTAL

MTM + software-based drug \& gene interaction risk analysis + pharmacogenetic testing

Genetic: Pharmacogenetic testing; Other: Software-based drug & gene interaction risk analysis; Other: MTM

Group 2

ACTIVE COMPARATOR

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

Other: Software-based drug & gene interaction risk analysis; Other: MTM

Interventions

Pharmacogenetic testing GENETIC

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

Also known as: YouScript(R) Personalized Prescribing System

Group 1

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.

Group 1; Group 2

MTM OTHER

Medication Therapy Management

Controls (no analysis or testing); Group 1; Group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genelex Corporation: lead

Study Sites (1)

VRx Pharmacy Services

Salt Lake City, Utah, 84109, United States

Location

Related Publications (1)

• 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.

  PMID: 30479202 DERIVED

Related Links

• Demo of YouScript(R) Personalized Prescribing System

MeSH Terms

Conditions

Drug Metabolism, Poor, CYP2D6-Related; Drug Metabolism, Poor, CYP2C19-Related; Chronic Disease; Drug-Related Side Effects and Adverse Reactions

Interventions

Pharmacogenomic Testing

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Jonathan W Magness, PharmD

  VRx Pharmacy Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: April 29, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)