Trial of Precision Medicine in Emergency Departments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-18

Study Completion Date

2029-02-01

Brief Summary

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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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Detailed Description

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Conditions

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Pharmacogenomic Drug Interaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental: Immediate panel-based pharmacogenetic genotyping

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.

Group Type EXPERIMENTAL

Panel-based pharmacogenetic genotyping

Intervention Type 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

Delayed panel-based pharmacogenetic genotyping

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes