Trial of Precision Medicine in Emergency Departments
ConditionPharmacogenomic Drug Interaction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Panel-based pharmacogenetic genotyping
Diagnostic testAfter 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
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Experimental: Immediate panel-based pharmacogenetic genotypingExperimental treatment 1 intervention
Group B: Delayed panel-based pharmacogenetic genotypingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
ED recidivism
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.
Time frame
Baseline to 6 months2
Rate of Clinician review of PGx results
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.
Time frame
Return of Results to 6-monthsSponsors and contacts
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University of Florida
Lead sponsor
National Human Genome Research Institute (NHGRI)
Collaborator
Source ClinicalTrials.gov