Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: PGx panel test.
- Who it may be relevant to
- Registry conditions: Pharmacogenomic Drug Interaction, Side Effect of Drug, Ineffective Drug Action, Drug Metabolism, Poor, CYP2D6-Related. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-gene Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice: Open-label, Mayo Clinic Multisite (Mayo Clinic Health System-Rochester Primary Care), Controlled, Implementation Study Taking the Results of the PREPARE Study Into Minnesota (PREPARE-Mayo)
Overview
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 test PGx 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.
Primary outcome measures
- Adverse Drug Reaction (ADR) [Time frame: 48 weeks]
Secondary outcome measures (2)
- PREPARE-MAYO Clinicians' and pharmacists' Questionnaire. [Time frame: 48 weeks]
- Patient-Reported Outcomes Measurement Information System (PROMIS-10) Global Health Questionnaire [Time frame: 48 weeks]
Eligibility criteria
Inclusion criteria
- Inclusion Criteria:
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Subject must be ≥ 18 years old
- 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.
- Subject is able and willing to take part and willing to be followed up on for 48 weeks
- Subject is able to donate saliva
- Subject has signed informed consent
- Subject meets requirement for computer access implying computer literacy as measured by active use of the patient portal or their email
Exclusion criteria
- 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
- Pregnant or lactating (to be verbally confirmed with the patient)
- Life expectancy estimated to be less than three months as determined by patient receiving hospice care
- Duration of index drug total treatment length is planned to be less than seven consecutive days.
- Current inpatients
- Unable to consent to the study
- Unwilling to take part
- Subject has no permanent address
- Subject has no current primary care provider
- Subject is, in the opinion of the study coordinator after discussion with participating clinician/pharmacist/investigator, not suitable to participate in the study
- Patient has a diagnosis of stage 4 or 5 chronic kidney disease (CKD) or is receiving dialysis
- Patients with advanced liver failure (stage Child-Pugh C) or a diagnosis of liver cirrhosis
- History of a liver transplant or an allogeneic hematopoietic stem cell transplant
- DNA sample collected that requires retesting in the event that DNA collected was not sufficient for testing as determined by the laboratory
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Mayo Clinic — Rochester
Identifiers
NCT: NCT06322238 · 23-008706