跳至主要内容
临床试验/NCT05882435
NCT05882435招募中不适用

Intelligence for the Interpretation of Bone Standard X-rays Prescribed by the Emergency Department

Assistance Publique - Hôpitaux de Paris6 个研究点 分布在 1 个国家目标入组 8,400 人开始时间: 2023年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
8,400
试验地点
6
主要终点
Diagnostic error rate

研究概览

简要总结

The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone standard X-rays prescibed by the ED.

详细描述

"The study evaluates, in 3 emergency departments (ED) and on randomized alternate periods, the use of SmartUrgences®, Augmented Intelligence (AI) software to help the interpretation of bone radiographs prescibed by the ED.

The primary objective of the organizational study is to evaluate, compared to the current organization for the interpretation of standard bone radiographs requested by the ED, the impact of an organization incorporating the Milvue solution, on the reduction of the patient diagnostic error rate.

A cost-consequence study is carried out, comparing from the point of view of the community (production costs according to the HAS recommendations), the radiological diagnosis within the framework of an organization with the Milvue solution, to that within the framework of the current organization without the use of the Milvue solution.

The economic study will follow the scheme of the organizational study, comparing the periods with and without the Milvue solution and analyzing the costs and consequences, by period and by patient.

This is an open-label randomized cluster multiple period cross-over study with 6 alternate periods (3 with AI, 3 with usual organization) of 1 month in each ED. The choice of the intervention for the first period will be randomized."

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

  • All adult referred by the ED for a conventional X-rays of all or part of the appendicular skeleton and/or pelvis and/or costal gril
  • Not opposed to participate"

排除标准

  • 未提供

结局指标

主要结局

Diagnostic error rate

时间窗: Through patient's discharge from the emergency department, an average of 1 day

A diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED. A diagnostic error is defined as a final consensus diagnosis that differs from the diagnosis documented in the medical record by the emergency physician prior to patient's discharge from the ED.

次要结局

  • Time between x-ray and first diagnostic(Through patient's discharge from the emergency department, an average of 1 day)
  • Time between x-ray and first diagnostic by the emergency physician(Through patient's discharge from the emergency department, an average of 1 day)
  • Number of X-rays with a report by a radiologist at 30 days(30 days)
  • Total cost from the hospital viewpoint(30 days)
  • Rate of X-rays interpretation by radiologist without delay(1 hour)
  • Time spent in the ED by the patient(Through patient's discharge from the emergency department, an average of 1 day)
  • 30 days morbidity(30 days)
  • Time between x-ray and final diagnostic by the emergency physician(30 days)
  • Number of all radiological exam per patient prescribed by the ED(Through patient's discharge from the emergency department, an average of 1 day)
  • Number of patients invited to come back in the ED(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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