RecruitingNot ApplicableNCT06448091

Trial of Precision Medicine in Emergency Departments

Sponsor

University of Florida

Enrollment

1,200 participants

Start Date

Mar 18, 2025

Study Type

INTERVENTIONAL

Conditions

Pharmacogenomic Drug Interaction

Summary

The objectives of this study are to (1) test the feasibility of the clinical implementation of preemptive pharmacogenetic (PGx) testing in the emergency department (ED) and (2) determine if PGx testing (with appropriate decision support) decreases ED return visits and hospitalizations. We will conduct a randomized, controlled, pragmatic clinical trial assessing both the real-world effectiveness as well as implementation outcomes using a targeted PGx testing panel in several UF Health EDs.

Eligibility

Min Age: 40 Years

Inclusion Criteria3

Adults 40 years or older presenting to a participating ED
Receipt of a new order/prescription for a selected PGx medication (Appendix 1), with a duration greater than 7 days, during the current ED visit or within 30 days prior.
Documentation of at least 2 prior ED or urgent care visits within the past 12 months

Exclusion Criteria6

Prior clinical pharmacogenetic test results within the EHR for genes relevant for this study (Appendix 1).
History of hepatic or renal transplant
History of severe liver disease (stage Child-Pugh C) or renal disease eGFR \<15 ml/min.
Any medical condition that would prohibit the ability to complete the study
Prisoners, wards of the state, or patients being held under the Baker Act or Marchman Act
Life expectancy less than 6 months

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Interventions

DIAGNOSTIC_TESTPanel-based pharmacogenetic genotyping

After consent and randomization into the immediate PGx testing, participants' results will (10-14 days after randomization) go into their EHR and be returned via a laminated results card