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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Controls (no analysis or testing) | Other | MTM alone (i.e. Treatment As Usual) |
|
| Group 1 | Experimental | MTM + software-based drug & gene interaction risk analysis + pharmacogenetic testing |
|
| Group 2 | Active Comparator | MTM + software-based drug & gene interaction risk analysis only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenetic testing | Genetic | Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse drug reactions | Tabulation of adverse drug reactions. | 8 months |
| Quality of Life | Assessment of quality of life score via SF-12. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance of recommendations by pharmacists | Proportion of recommendations deemed clinically relevant by local pharmacists. | Baseline |
| Major event risk reduction | Tabulation of major health events avoided (e.g. stroke, heart attack, and other events requiring hospitalization). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan W Magness, PharmD | VRx Pharmacy Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VRx Pharmacy Services | Salt Lake City | Utah | 84109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30479202 | Derived | 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. |
| Label | URL |
|---|---|
| Demo of YouScript(R) Personalized Prescribing System | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 27, 2019 | |
| Reset | Oct 18, 2019 |
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| 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 |
|
| 3 months |
| 8 months |
| Acceptance of recommendations by clinician providers | Proportion of recommendations resulting in medication or dose changes. | 8 months |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 27, 2019 | Oct 18, 2019 |
| ID | Term |
|---|---|
| C563835 | Drug Metabolism, Poor, CYP2D6-Related |
| C563703 | Drug Metabolism, Poor, CYP2C19-Related |
| D002908 | Chronic Disease |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| D000071185 | Pharmacogenomic Testing |
| ID | Term |
|---|---|
| D005820 | Genetic Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
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