Trial of Precision Medicine in Emergency Departments
TOPMEDs
2 other identifiers
interventional
1,200
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2024
CompletedFirst Posted
Study publicly available on registry
June 7, 2024
CompletedStudy Start
First participant enrolled
March 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2029
May 11, 2025
May 1, 2025
3.9 years
May 31, 2024
May 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
ED recidivism
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.
Baseline to 6 months
Rate of Clinician review of PGx results
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.
Return of Results to 6-months
Study Arms (2)
Experimental: Immediate panel-based pharmacogenetic genotyping
EXPERIMENTALSubjects 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.
Delayed panel-based pharmacogenetic genotyping
NO INTERVENTIONSubjects assigned to delayed panel-based pharmacogenetic genotyping will not be tested until after their participation in the study has ended (6 months after enrollment).
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
UF Health Emergency Department
Gainesville, Florida, 32610, United States
UF Health Jacksonville Downtown Emergency Department
Jacksonville, Florida, 32209, United States
UF Health Jacksonville North Emergency Department
Jacksonville, Florida, 32218, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Julio D Duarte, Pharm.D., Ph.D.
University of Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2024
First Posted
June 7, 2024
Study Start
March 18, 2025
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Last Updated
May 11, 2025
Record last verified: 2025-05