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

CYP2D6 Polymorphism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428660
• Other study ID #: Genelex 2014-02
• Status: Completed
• Phase: N/A
• First received: April 21, 2015
• Last updated: February 22, 2017
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Genelex Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 341
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CYP2D6 Polymorphism
• Cytochrome P450 CYP2C19 Enzyme Deficiency
• Cytochrome P450 CYP2C9 Enzyme Deficiency
• Cytochrome P450 CYP2D6 Enzyme Deficiency
• Drug Metabolism, Poor, CYP2C19-RELATED
• Drug Metabolism, Poor, CYP2D6-RELATED
• Extensive Metabolizer Due to Cytochrome P450 CYP2D6 Variant
• Metabolism, Inborn Errors
• Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant
• Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant

Intervention

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

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.
• MTM
Medication Therapy Management

Locations

Country	Name	City	State
United States	VRx Pharmacy Services	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Genelex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptance of recommendations by pharmacists	Proportion of recommendations deemed clinically relevant by local pharmacists.	Baseline
Other	Major event risk reduction	Tabulation of major health events avoided (e.g. stroke, heart attack, and other events requiring hospitalization).	8 months
Other	Acceptance of recommendations by clinician providers	Proportion of recommendations resulting in medication or dose changes.	8 months
Primary	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	Number of adverse drug reactions	Tabulation of adverse drug reactions.	8 months
Secondary	Quality of Life	Assessment of quality of life score via SF-12.	3 months

External Links

•   Demo of YouScript(R) Personalized Prescribing System