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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
1,200
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
UF Health Emergency Department
Gainesville, Florida, United States
NOT_YET_RECRUITINGUF Health Jacksonville Downtown Emergency Department
Jacksonville, Florida, United States
RECRUITINGUF Health Jacksonville North Emergency Department
Jacksonville, Florida, United States
RECRUITINGED 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 months
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-months
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