RecruitingNot Applicable

Trial of Precision Medicine in Emergency Departments

United States1,200 participantsStarted 2025-03-18

Plain-language 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.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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 criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ED recidivism

Timeframe: Baseline to 6 months

Rate of Clinician review of PGx results

Timeframe: Return of Results to 6-months

Trial details

NCT IDNCT06448091

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-02-01

Contact for this trial

Erica N Elwood, MHA

3522736007 erica.elwood@cop.ufl.edu

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