Trial of Precision Medicine in Emergency Departments (TOPMEDs)

University of Florida

Status: Enrolling

Conditions: Pharmacogenomic Drug Interaction

Treatments: Diagnostic Test: Panel-based pharmacogenetic genotyping

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06448091

IRB202301675

R01HG013416 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Experimental: Immediate panel-based pharmacogenetic genotyping

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Panel-based pharmacogenetic genotyping

Delayed panel-based pharmacogenetic genotyping

No Intervention group

Description:

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).