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| ID | Type | Description | Link |
|---|---|---|---|
| R01HG013416 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Human Genome Research Institute (NHGRI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Immediate panel-based pharmacogenetic genotyping | Experimental | 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. |
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| Delayed panel-based pharmacogenetic genotyping | No Intervention | 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panel-based pharmacogenetic genotyping | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Return of Results to 6-months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erica N Elwood, MHA | Contact | 3522736007 | erica.elwood@cop.ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Julio D Duarte, Pharm.D., Ph.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Health Emergency Department | Not yet recruiting | Gainesville | Florida | 32610 | United States |
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| UF Health Jacksonville Downtown Emergency Department | Recruiting | Jacksonville | Florida | 32209 | United States |
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| UF Health Jacksonville North Emergency Department | Recruiting | Jacksonville | Florida | 32218 | United States |
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