Trial of Precision Medicine in Emergency Departments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- ED recidivism
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
- •Prisoners, wards of the state, or patients being held under the Baker Act or Marchman Act
- •Life expectancy less than 6 months
研究组 & 干预措施
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).
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.
干预措施: Panel-based pharmacogenetic genotyping (Diagnostic Test)
结局指标
主要结局
ED recidivism
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点