Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMario Negri Institute for Pharmacological Research

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

240,000 Participants
are grouped into 1 trial group
Group A: Elegible population

Trial outcomes

Primary outcomes

1

Qualitative validation and first refinement of the classification algorithm

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.

Time frame
From August 2025 to November 2025
2

Quantitative validation and second refinement of the classification algorithm

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.

Time frame
From September 2025 to October 2026
3

Application of the algorithm to all eligible patients

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.

Time frame
From November 2026 to Dicember 2026
4

Feasibility of assessing the appropriateness of discharge from the emergency room

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.

Time frame
From November 2026 to June 2027

Secondary outcomes

Other outcomes

Sponsors and contacts

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