Using a Multi-gene Pharmacogenetic Panel to Reduce Adverse Drug Reactions in Primary Care An Open-label Mayo Clinic Multisite Study Based on PREPARE Results

What this Trial Is About

Researchers are evaluating whether using a pre-emptive pharmacogenomic PGx panel test to guide drug dose and selection for 39 commonly prescribed medications can reduce the number of adverse drug reactions linked to initial prescriptions in primary care. This study is a phase 2, open-label, controlled implementation trial conducted by Mayo Clinic across multiple sites. It aims to apply findings from the PREPARE study to a real-world primary care setting. Participants receive either immediate PGx testing or delayed testing as part of a non-randomized, step-wedge design. The PGx panel test analyzes a set of clinically relevant genetic markers following established guidelines to help tailor prescriptions. The study compares outcomes between those who have PGx results to guide treatment and those who do not during the initial phase. During the 48-week follow-up, participants are assessed for adverse drug reactions related to their initial drug. Researchers also collect feedback from clinicians and pharmacists through questionnaires and measure patient health using the PROMIS-10 Global Health questionnaire. Participants provide saliva samples for genetic testing and must have computer access for follow-up. The study monitors safety and patient-reported outcomes over the study period.

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