Trial of Precision Medicine in Emergency Departments (TOPMEDs)

May 9, 2025 updated by: University of Florida
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Not yet recruiting
        • UF Health Emergency Department
        • Contact:
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • UF Health Jacksonville Downtown Emergency Department
        • Principal Investigator:
          • Sophia Sheikh, MD
        • Contact:
      • Jacksonville, Florida, United States, 32218
        • Recruiting
        • UF Health Jacksonville North Emergency Department
        • Principal Investigator:
          • Sophia Sheikh, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Diagnostic test: 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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to 6 months
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.
Return of Results to 6-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Collaborators

National Human Genome Research Institute (NHGRI)

Investigators

  • Principal Investigator: Julio D Duarte, Pharm.D., Ph.D., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

February 1, 2029

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB202301675
  • R01HG013416 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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