Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 233
- 试验地点
- 2
- 主要终点
- Time to Disposition
研究概览
简要总结
The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 21 years of age or older
- •Presenting to the BMC main ED or Urgent Care area with influenza-like illness
- •Physician ordered an influenza A/B diagnostic test
排除标准
- •Previously enrolled in the study
- •Any Influenza test result already available at the time approached by the ED RA
- •Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
- •Unable to give informed consent
结局指标
主要结局
Time to Disposition
时间窗: By the End of the ED visit (an average time of 4 hours)
The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record
次要结局
- Delivery of prescription or administration of antibiotics(by the end of ED visit (an average time of 4 hours))
研究者
Elissa Schechter-Perkins
Principal Investigator
Boston Medical Center