Recruiting

Precision Medicine

Sponsor:

University of Florida

Code:

NCT06448091

Conditions

Pharmacogenomic Drug Interaction

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Panel-based pharmacogenetic genotyping

Study Details

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.

Conditions

Pharmacogenomic Drug Interaction

Study ID

NCT06448091

Start date

Mar 18, 2025

Status verified date

Jun, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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).

Interventions

Panel-based pharmacogenetic genotyping

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 outcome measure

  • ED recidivism [ Time Frame: Baseline to 6 months ]
  • Rate of Clinician review of PGx results [ Time Frame: Return of Results to 6-months ]

Central Contacts and Locations

Central contacts

Erica N Elwood, MHA

3522736007erica.elwood@cop.ufl.edu

Locations

UF Health Jacksonville Downtown Emergency Department

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Morgan Henson, MPH

904-244-4234morgan.henson@jax.ufl.edu

Principal Investigator:

Sophia Sheikh, MD

UF Health Jacksonville North Emergency Department

Recruiting

Jacksonville, Florida, United States, 32218

Contacts

Morgan Henson, MPH

904-244-4234morgan.henson@jax.ufl.edu

Principal Investigator:

Sophia Sheikh, MD

More Information

Sponsor

University of Florida

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-10.