Drug Metabolism, Poor, CYP2C19-Related, Drug Metabolism, Poor, CYP2D6-Related, Ineffective Drug Action, Pharmacogenomic Drug Interaction, Side Effect of Drug
Conditions
Keywords
pharmacogenomics, PGx, CPIC, primary care, drug metabolism, side effects, ineffectiveness, PREPARE-Mayo
Brief summary
The purpose of this study is to determine whether the implementation of pre-emptive pharmacogenomic (PGx) testing of a panel of clinically relevant PGx markers, to guide the dose and drug selection for 39 commonly prescribed drugs, will result in an overall reduction in the number of clinically relevant drug-genotype associated ADRs which are causally related to the initial drug of inclusion (referred to as 'index drug').
Interventions
DIAGNOSTIC_TESTPGx panel test
In this prospective, non-randomized, step-wedge design controlled clinical study (PREPARE-MAYO Rochester, Mayo Clinic Health System), pre-emptive genotyping of a panel of clinically relevant PGx-markers, for which CPIC guidelines are available.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1. Subject must be ≥ 18 years old 2. Subject must receive a 1st prescription (meaning no known prescription for this drug in the preceding 12 months) for a drug included in Table 1, which is prescribed to them in routine primary care. 3. Subject is able and willing to take part and willing to be followed up on for 48 weeks 4. Subject is able to donate saliva 5. Subject has signed informed consent 6. Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email
Exclusion criteria
1. For the investigational arm only: Previous (direct-to-consumer, or clinical) pharmacogenomic testing that includes any of the genes included in the Focused Pharmacogenomics Panel 2. Pregnant or lactating (to be verbally confirmed with the patient) 3. Life expectancy estimated to be less than three months as determined by patient receiving hospice care 4. Duration of index drug total treatment length is planned to be less than seven consecutive days. 5. Current inpatients 6. Unable to consent to the study 7. Unwilling to take part 8. Subject has no permanent address 9. Subject has no current primary care provider 10. Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study 11. Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis 12. Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis 13. History of a liver transplant or an allogeneic hematopoietic stem cell transplant 14. DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reaction (ADR) | 48 weeks | The count of participants who experience any of the following ADR's: muscle aches, falling, tripping, fainting, palpations, emotional changes, or physical changes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PREPARE-MAYO Clinicians' and pharmacists' Questionnaire. | 48 weeks | The 29-item PREPARE-MAYO Clinicians' and pharmacists' Questionnaire measures the Experience and Attitude, Knowledge, Knowledge testing and Needs assessment of clinicians and pharmacists. Each item is scored from 1 (disagree) to 4 (agree). Total possible scores range from 29 to 116, with lower scores indicating less knowledge and higher scores indicating more knowledge. |
| Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire | 48 weeks | The 10-item PROMIS Global Health measures general, physical, mental and social health. Each item is scored from 1 (poor health) to 5 (excellent health). Total possible scores range from 10 to 50, with lower scores indicating worse state of health and higher scores indicating greater state of health. |
Countries
United States
Outcome results
None listed