Trial of Precision Medicine in Emergency Departments

ConditionPharmacogenomic Drug Interaction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40+

SponsorUniversity of Florida

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

Panel-based pharmacogenetic genotyping

Treatment groups

1,200 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Florida

Lead sponsor

National Human Genome Research Institute (NHGRI)

Collaborator

Source ClinicalTrials.gov