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

NCT06846879 | Not Yet Recruiting

• 1 other identifier: START
• Study Type: observational
• Target: 240,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Quality of Care; Evaluation; Emergency Department; Appropriateness

Outcome Measures

Primary Outcomes (4)

• 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.

  From August 2025 to November 2025

• 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.

  From September 2025 to October 2026

• 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.

  From November 2026 to Dicember 2026

• 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.

  From November 2026 to June 2027

Study Arms (1)

Elegible population

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead

Study Sites (1)

Ospedale San Luigi Gonzaga

Orbassano, Italy

Location

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guido Bertolini, MD

CONTACT

+39 035 4535389; guido.bertolini@marionegri.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

IT (1)