Trial of Precision Medicine in Emergency Departments

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT06448091
Status
Recruiting
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Conditions

  • Pharmacogenomic Drug Interaction

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 18, 2025
Status verified
Jun 2026
Primary completion
Feb 1, 2029
Completion
Feb 1, 2029

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Experimental: Immediate 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.
  • No Intervention: Delayed panel-based pharmacogenetic genotyping
    Subjects assigned to delayed panel-based pharmacogenetic genotyping will not be tested until after their participation in the study has ended (6 months after enrollment).

Primary Outcome Measure

ED recidivism [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UF Health Emergency DepartmentGainesvilleFlorida32610
Erica Elwood, MHA
[email protected]
352-273-6007
UF Health Jacksonville Downtown Emergency DepartmentJacksonvilleFlorida32209
Morgan Henson, MPH
[email protected]
904-244-4234
Sophia Sheikh, MD (PRINCIPAL_INVESTIGATOR)
UF Health Jacksonville North Emergency DepartmentJacksonvilleFlorida32218
Morgan Henson, MPH
[email protected]
904-244-4234
Sophia Sheikh, MD (PRINCIPAL_INVESTIGATOR)

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UF Health Emergency Department· Gainesville, FLUF Health Jacksonville Downtown Emergency Department· Jacksonville, FLUF Health Jacksonville North Emergency Department· Jacksonville, FL

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