Trial of Precision Medicine in Emergency Departments

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pharmacogenomic Drug Interaction

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health Emergency Department, Gainesville, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
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

Treatment and study plan

Panel-based pharmacogenetic genotyping

Diagnostic Test

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

Primary outcomes

ED recidivism

Time frame: Baseline to 6 months

The primary effectiveness outcome for the trial will be ED recidivism between participants assigned to PGx testing (intervention) compared to those assigned to delayed genotyping (usual care) within 6 months. Specifically, the rate of return visits related to their prior medical problem, identified through a matching primary diagnosis code or clinical impression abstracted from the EHR.
Rate of Clinician review of PGx results

Time frame: Return of Results to 6-months

The primary implementation outcome will be the rate at which clinicians review the PGx results. This will include both viewing of CDS alerts within the UF Health EHR or viewing individualized PGx recommendations routed from patient PGx results cards.

Study contacts

Contact information is provided by the study sponsor or research team.

Erica N Elwood, MHA

CONTACT

[email protected]

3522736007

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

National Human Genome Research Institute (NHGRI)

Registry information

Acronym: TOPMEDs

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Jun 7, 2024
Registry last updated: Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting