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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Emergency Department; Evaluation; Quality of Care; Appropriateness

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 240000

Contacts and Locations

• Study Contact: Name: Guido Bertolini, MD; Phone Number: +39 035 4535389; Email: guido.bertolini@marionegri.it

Study Locations

• Italy
  • Alessandria, Italy
    • Recruiting
    • AOU SS. Antonio e Biagio e Cesare Arrigo
    • Contact: Riccardo Boverio; Phone Number: 0131 206111; Email: rboverio@ospedale.al.it
  • Cuneo, Italy
    • Not yet recruiting
    • A.O. S. Croce e Carle
    • Contact: Giuseppe Lauria; Phone Number: 0171 641337; Email: lauria.g@ospedale.cuneo.it
  • Novara, Italy
    • Not yet recruiting
    • Ospedale Maggiore della Carita
    • Contact: Mattia Bellan; Phone Number: 0321 3733673; Email: mattia.bellan@med.uniupo.it
  • Novi Ligure, Italy
    • Not yet recruiting
    • Ospedale S. Giacomo
    • Contact: Roberta Virtuani; Phone Number: 0143 332215; Email: rvirtuani@aslal.it
  • Orbassano, Italy
    • Not yet recruiting
    • Ospedale San Luigi Gonzaga
    • Contact: Adriana Boccuzzi; Email: a.boccuzzi@sanluigi.piemonte.it
  • Rivoli, Italy
    • Not yet recruiting
    • Ospedale degli Infermi
    • Contact: Paola Molino; Phone Number: 011 9551040; Email: paola.molino@aslto3.piemonte.it
  • Torino, Italy
    • Not yet recruiting
    • Ospedale San Giovanni Bosco
    • Contact: Franco Aprà; Phone Number: 0112402349; Email: franco.apra@aslcittaditorino.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elegible population; All patients aged 18 years and over who arrived at participating centres between 1 January 2023 and 31 December 2024.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 26, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies
• Other Study ID Numbers: STAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No