Trial of Precision Medicine in Emergency Departments

Not Applicable

Recruiting

• Conditions: Pharmacogenomic Drug Interaction
• Interventions: Diagnostic Test: Panel-based pharmacogenetic genotyping

• Registration Number: NCT06448091
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-31
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-07
• Study Start: 2025-03-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Primary Completion: 2029-02-01
• Study Completion: 2029-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Adults 40 years or older presenting to a participating ED
2. 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.
3. Documentation of at least 2 prior ED or urgent care visits within the past 12 months

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Immediate panel-based pharmacogenetic genotyping	Panel-based pharmacogenetic genotyping	Subjects assigned to the immediate pharmacogenetic genotyping group will be tested and have their results both entered into their electronic health record as well as provided to them within 2-4 weeks from randomization.

Primary Outcome Measures

Name	Time	Method
ED recidivism	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	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.

Trial Locations

Locations (3)

UF Health Emergency Department; 🇺🇸 Gainesville, Florida, United States

UF Health Jacksonville Downtown Emergency Department; 🇺🇸 Jacksonville, Florida, United States

UF Health Jacksonville North Emergency Department; 🇺🇸 Jacksonville, Florida, United States