RecruitingPhase 2NCT06322238

Pharmacogenetic Panel to Prevent Adverse Drug Reactions in Daily Primary Care Practice:

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)

Sponsor

Mayo Clinic

Enrollment

66 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Side Effect of Drug Pharmacogenomic Drug Interaction Ineffective Drug Action Drug Metabolism, Poor, CYP2D6-Related Drug Metabolism, Poor, CYP2C19-Related

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').

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria14

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

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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.