Propensity to Hospitalize Patients From the ED in European Centers.

NCT06354764 | Not Yet Recruiting

• 1 other identifier: 8780-UC1
• Study Type: observational
• Target: 162,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Emergency Medicine

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Adults who attended the emergency department

Other: no intervention

Interventions

no intervention OTHER

no intervention

Adults who attended the emergency department

Eligibility Criteria

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

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Astir S.r.l.: collaborator
• Centre Hospitalier Universitaire Vaudois: collaborator
• Orobix Life S.r.l.: collaborator
• Fondazione Bruno Kessler: collaborator

Study Officials

• Guido Bertolini, MD

  Istituto Di Ricerche Farmacologiche Mario Negri

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chiara Pandolfini

CONTACT

0039 02 39014 253; chiara.pandolfini@marionegri.it

Giulia Ghilardi

CONTACT

0039 035 4535 389; giulia_irene.ghilardi@marionegri.it

Study Design

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

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 9, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL