Back to resultsDrug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
Primary Purpose
Cytochrome P450 CYP2D6 Enzyme Deficiency, Poor Metabolizer Due to Cytochrome P450 CYP2D6 Variant, Ultrarapid Metabolizer Due to Cytochrome P450 CYP2D6 Variant
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharmacogenetic testing
Software-based drug & gene interaction risk analysis
MTM
Sponsored by
About this trial
This is an interventional screening trial for Cytochrome P450 CYP2D6 Enzyme Deficiency focused on measuring 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
Eligibility 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.
Sites / Locations
- VRx Pharmacy Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Experimental
Active Comparator
Arm Label
Controls (no analysis or testing)
Group 1
Group 2
Arm Description
MTM alone (i.e. Treatment As Usual)
MTM + software-based drug & gene interaction risk analysis + pharmacogenetic testing
MTM + software-based drug & gene interaction risk analysis only
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of adverse drug reactions
Tabulation of adverse drug reactions.
Quality of Life
Assessment of quality of life score via SF-12.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02428660
Brief Title
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
Official Title
Medication Therapy Management Combined With Drug and Gene Interaction Software and Cytochrome DNA Testing Among a Population of Polypharmacy Medicare Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genelex Corporation
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
341 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Controls (no analysis or testing)
Arm Type
Other
Arm Description
MTM alone (i.e. Treatment As Usual)
Arm Title
Group 1
Arm Type
Experimental
Arm Description
MTM + software-based drug & gene interaction risk analysis + pharmacogenetic testing
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
MTM + software-based drug & gene interaction risk analysis only
Intervention Type
Genetic
Intervention Name(s)
Pharmacogenetic testing
Other Intervention Name(s)
YouScript(R) Personalized Prescribing System
Intervention Description
Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms
Intervention Type
Other
Intervention Name(s)
Software-based drug & gene interaction risk analysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
MTM
Intervention Description
Medication Therapy Management
Primary Outcome Measure Information:
Title
Number of Drug Therapy Problems (DTPs)
Description
Tabulation of the number of drug therapy problems identified by drug & gene interaction risk analysis, with and without genetic testing.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Number of adverse drug reactions
Description
Tabulation of adverse drug reactions.
Time Frame
8 months
Title
Quality of Life
Description
Assessment of quality of life score via SF-12.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Acceptance of recommendations by pharmacists
Description
Proportion of recommendations deemed clinically relevant by local pharmacists.
Time Frame
Baseline
Title
Major event risk reduction
Description
Tabulation of major health events avoided (e.g. stroke, heart attack, and other events requiring hospitalization).
Time Frame
8 months
Title
Acceptance of recommendations by clinician providers
Description
Proportion of recommendations resulting in medication or dose changes.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W Magness, PharmD
Organizational Affiliation
VRx Pharmacy Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
VRx Pharmacy Services
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30479202
Citation
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.
Results Reference
derived
Links:
URL
http://youscript.com/demo/
Description
Demo of YouScript(R) Personalized Prescribing System
Learn more about this trial
Drug & Gene Interaction Risk Analysis With & Without Genetic Testing Among Patients Undergoing MTM
We'll reach out to this number within 24 hrs