跳至主要内容
临床试验/NCT06846879
NCT06846879招募中不适用

Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations: Validation of an Algorithm Based on Computerized Hospital Databases

Mario Negri Institute for Pharmacological Research8 个研究点 分布在 1 个国家目标入组 240,000 人开始时间: 2026年1月5日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240,000
试验地点
8
主要终点
Qualitative validation and first refinement of the classification algorithm

研究概览

简要总结

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

详细描述

The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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 patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.

排除标准

  • All patients under 18 years of age arriving at participating centers between January 1, 2023 and December 31, 2024 and all patients arriving at participating centers outside the time frame January 1, 2023 - December 31, 2024.

研究组 & 干预措施

Elegible population

All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.

结局指标

主要结局

Qualitative validation and first refinement of the classification algorithm

时间窗: From August 2025 to November 2025

In this first phase of the project, representatives of doctors and nurses from participating hospitals will be asked to express their opinion on content validity. This refers to the accuracy with which a measurement tool covers all aspects of the construct under examination. Its measurement is generally based on the judgment of experts in the field, who are asked to provide feedback on how closely the measurement tool corresponds to the different domains associated with the construct. The evaluation will be conducted according to the consensus conference approach, an approach that reduces the risk of excessive subjectivity, intrinsic to content validity. This evaluation will lead to a possible refinement of the individual criteria that make up the algorithm.

Quantitative validation and second refinement of the classification algorithm

时间窗: From September 2025 to October 2026

In this second phase, the criterion validity of the algorithm developed in the previous phase will be examined. Criterion validity measures the relationship between the results obtained with the test in question and those obtained with a consolidated reference standard (the criterion, or gold standard) that measures the same construct.

Application of the algorithm to all eligible patients

时间窗: From November 2026 to Dicember 2026

Once perfected, the algorithm will be applied to all eligible patients arriving at the ER of participating hospitals within a 24-month period (from January 2023 to December 2024). This means that, for all hospitalized patients, it will be possible to obtain data on the appropriateness of this choice and monitor the evolution of this data over time.

Feasibility of assessing the appropriateness of discharge from the emergency room

时间窗: From November 2026 to June 2027

In this phase, an attempt will be made to obtain the data necessary to evaluate the appropriateness of discharges from the ED for eligible patients who were discharged between January 2023 and December 2024. Data will be collected on all accesses in the period considered in order to identify any multiple patient accesses (return visits) and the related presentation tables.

次要结局

未报告次要终点

研究者

发起方
Mario Negri Institute for Pharmacological Research
申办方类型
Other
责任方
Sponsor

研究点 (8)

Loading locations...

相似试验