Pharmacogenomic Drug Interaction
Conditions
Brief summary
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_TESTPanel-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
Sponsors
University of Florida
National Human Genome Research Institute (NHGRI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ED recidivism | 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. |
| Rate of Clinician review of PGx results | 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. |
Countries
United States
Contacts
CONTACTErica N Elwood, MHA
PRINCIPAL_INVESTIGATORJulio D Duarte, Pharm.D., Ph.D.
University of Florida
Outcome results
None listed