Propensity to Hospitalize Patients From the ED in European Centers. (eCREAM-UC1)

Propensity to Hospitalize Patients From the ED in European Centers.An Observational Retrospective Quality-of-care Study

The peer-to-peer comparison means center-to-center comparison, which requires adjusting for possible differences among centers to be fair and convincing. The first step to reach this goal is to develop a predictive model that accurately estimates each patient's probability of being admitted, starting from clinical conditions and boundary variables. Such a model would make it possible to calculate, for each ED, the expected hospitalization rate; that is, the hospitalization rate that would have been observed if the ED had behaved like the average of the EDs that provided the data to build the model itself. Comparing the observed hospitalization rate in the single ED with the expected rate derived from the model provides a rigorous method of comparing the department with the average performance, taking into account the characteristics of the patients treated and the conditions under which the ED operated. In other words, the predictive model represents the benchmark against which each ED is evaluated.

Study Overview

• Status: Recruiting
• Conditions: Emergency Medicine
• Intervention / Treatment: Other: no intervention

• Study Type: Observational
• Enrollment (Estimated): 162000

Contacts and Locations

• Study Contact: Name: Chiara Pandolfini; Phone Number: 0039 02 39014 253; Email: chiara.pandolfini@marionegri.it
• Study Contact Backup: Name: Giulia Ghilardi; Phone Number: 0039 035 4535 389; Email: giulia_irene.ghilardi@marionegri.it

Study Locations

• Italy
  • Torino, Italy
    • Recruiting
    • Ospedale San Giovanni Bosco
    • Contact: Franco Aprà; Phone Number: +39 011.2402210; Email: franco.apra@aslcittaditorino.it
  • Vercelli, Italy
    • Recruiting
    • Ospedale Sant'Andrea
    • Contact: Sergio Tartaglia; Phone Number: +39 0161 593111; Email: srtartaglia@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

All adult patients who arrived at participating emergency departments between January 1, 2021 and December 31, 2023

Description

Inclusion Criteria:

• Adult
• Arrived at emergency department between 1 January 2021 and 31 December 2023

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults who attended the emergency department	Other: no intervention; no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Create two separate databases	To create two separate databases (one for each of the two subgroups considered) on all patients who presenteding to the participating EDs over a defined period, containing the information considered important to study both the propensity to hospitalize these patients and their 30-day mortality	September 2024 - September 2025
Multivariable models	To develop two multivariable models that predict the probability that patients presenting to the ED with dyspnea (first model) or after a TLoC (second model) will be admitted to the hospital	September 2025 - September 2026
Adjusted comparison	To provide the participating EDs with an adjusted comparison of the hospitalization rates for the patients with selected symptoms, to improve the quality of care.	September 2025 - September 2026

Collaborators and Investigators

• Sponsor: Mario Negri Institute for Pharmacological Research
• Collaborators: Centre Hospitalier Universitaire Vaudois; Fondazione Bruno Kessler; Astir s.r.l.; Orobix Life S.r.l.
• Investigators: Principal Investigator: Guido Bertolini, MD, Istituto Di Ricerche Farmacologiche Mario Negri

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 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; Emergencies
• Other Study ID Numbers: 8780-UC1

Plan for Individual participant data (IPD)

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

IPD Plan Description

eCREAM-UCI1 will join the MIP (Medical Informatics Platform), developed in the Human Brain Project (HBP), to federate clinical data. The MIP is an open-source, GDPR-compliant, privacy-aware platform, enabling remote and federated analyses from datasets physically distributed in various hospitals, research centers, and biobanks, without moving the data outside their original storage site to a central repository. Patient identification data will be deleted from the databases before these are uploaded to the MIP platform, and no pseudo-identifier will be available.

See https://mip.ebrains.eu/ for more details on the MIP.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

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