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临床试验/NCT07546071
NCT07546071已完成不适用

Randomized Controlled Trial Comparing the Safety and Efficiency of a Virtual-Hybrid Emergency Department Model Versus Standard Emergency Department Management in Non-Urgent Patients

Sheba Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Emergency Department Length of Stay

研究概览

简要总结

Background:

Emergency department (ED) overcrowding is a growing challenge worldwide and is associated with prolonged length of stay (LOS), reduced patient satisfaction, and increased burden on healthcare systems. New approaches are needed to improve how patients are evaluated and treated.

Telemedicine has been increasingly integrated into ED care and has shown feasibility and benefits in various settings. Existing models have demonstrated improvements in patient flow, reduced length of stay, and high patient satisfaction. However, despite the growing use of telemedicine in emergency medicine, there is a lack of randomized controlled trials evaluating its effectiveness and safety, particularly in models involving early remote physician assessment prior to ED evaluation.

Purpose:

This study aims to evaluate whether a video consultation with a senior emergency physician before entering the ED can improve the efficiency and quality of care. The study also examines whether physicians can accurately identify which patients need ED evaluation based on a remote assessment, while maintaining patient safety.

Methods:

A total of 200 adults who arrived at the ED were assigned to one of two groups. In the study group, participants had a video consultation with a physician before continuing with standard ED care.

In the control group, participants received standard ED care only.

During the video consultation, the physician performed an initial clinical assessment and could order tests or specialist consultations. The physician was also asked what their recommendation would have been if the participant had been assessed from home. Three possible decisions were recorded:

  • Immediate ED presentation
  • Scheduled ED presentation at a later time
  • Continued care in the community without ED presentation

Outcomes:

The primary outcomes focus on the effectiveness of the intervention. These include:

  • ED length of stay
  • Patient satisfaction
  • The ability of physicians to accurately identify participants who require ED evaluation The secondary outcome is safety, assessed by return visits to the ED within one week for the same complaint.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older
  • Presentation to the emergency department during study recruitment hours
  • Ability to provide written informed consent

排除标准

  • Pregnancy
  • Arrival by ambulance
  • Severe pain, defined as a Visual Analogue Scale (VAS) score of 8 or higher
  • Emergency Severity Index (ESI) level 1 or 2
  • Language barriers or technological difficulties without an accompanying person able to assist
  • Isolated orthopedic complaints with suspected fracture or dislocation
  • Repeat emergency department visit for the same complaint within the previous 72 hours

研究组 & 干预措施

Control Group

No Intervention

Participants receive standard emergency department care without a prior video consultation.

Study Group / Telemedicine Group

Experimental

Participants undergo an initial video consultation with a senior emergency physician prior to continuing with standard emergency department care.

干预措施: Telemedicine-Based Remote Physician Assessment (Behavioral)

结局指标

主要结局

Emergency Department Length of Stay

时间窗: From emergency department registration to the final decision regarding discharge or hospital admission during the index visit, up to 24 hours.

Emergency department length of stay, defined as the time from emergency department registration to discharge or hospital admission during the index visit, measured in hours. Data will be extracted from the hospital electronic medical record one week after the visit.

次要结局

  • Return Visits to the Emergency Department(Within one week after the ED visit)
  • Accuracy of Physician Assessment for ED Referral(From the baseline physician assessment at the initial video consultation, to the final clinical outcome at the end of the index visit (discharge or hospital admission), up to 24 hours.)
  • Patient Satisfaction(One week after the ED visit)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Avi Epstein

MD

Sheba Medical Center

研究点 (1)

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