Trial of Precision Medicine in Emergency Departments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Panel-based pharmacogenetic genotyping.
- Who it may be relevant to
- Registry conditions: Pharmacogenomic Drug Interaction. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- ED recidivism [Time frame: Baseline to 6 months]
- Rate of Clinician review of PGx results [Time frame: Return of Results to 6-months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- UF Health Emergency Department — Gainesville
- UF Health Jacksonville Downtown Emergency Department — Jacksonville
- UF Health Jacksonville North Emergency Department — Jacksonville
Identifiers
NCT: NCT06448091 · IRB202301675 · R01HG013416