NCT07111624

Brief Summary

Fenice has proposed a new indicator to measure the level of crowding in the ER. The aim of this study is to evaluate, in a national multicenter context, the degree of agreement between the Fenice indicator and the perception of crowding of the ER operators and to compare this agreement with that between NEDOCS and the perception of the operators.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
828

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Oct 2025

Geographic Reach
1 country

52 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

July 23, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

July 23, 2025

Last Update Submit

May 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of variation in the ED staff perceived crowding level that is explained by the Fenice crowding score.

    The outcome will be measured using the coefficient of determination (referred to as R2) of the linear model regressing the perceived level of crowding on the Fenice score.

    September 2025 - December 2025

Secondary Outcomes (1)

  • Proportion of variation in the ED staff perceived crowding level that is explained by the NEDOCS score, measured using the coefficient of determination (R2) of the linear model regressing the perceived level of crowding on the NEDOCS score.

    September 2025 - December 2025

Study Arms (1)

Elegible population

All patients arrived in ED during the year 2024 and patientes arrived in the period of active monitoring of the perception of crowding.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients arriving in the emergency department at the time of the survey.

You may qualify if:

  • Patients that are in EDs at the time of the survey

You may not qualify if:

  • Patients that are in EDs, but not at the time of the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

Spedali civili

Brescia, BS, Italy

Location

IRCCS San Martino

Genova, GE, Italy

Location

Ospedale Santa Maria delle Croci

Ravenna, RA, Italy

Location

Azienda Ospedaliera San Camillo Forlanini

Roma, RM, Italy

Location

Presidio Osped. Riunito

Cirié, TO, Italy

Location

AOU San Luigi Gonzaga

Orbassano, TO, Italy

Location

P.O. Sant'Andrea

Vercelli, VC, Italy

Location

AOU SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Ospedale Regionale Umberto Parini

Aosta, Italy

Location

Ospedale San Bassiano

Bassano del Grappa, Italy

Location

Humanitas Gavazzeni

Bergamo, Italy

Location

Ospedale Papa Giovanni XXIII

Bergamo, Italy

Location

Ospedale Maggiore "CA Pizzardi"

Bologna, Italy

Location

Policlinico Sant'Orsola Malpighi

Bologna, Italy

Location

AOU Policlinico San Marco-PO Gaspare Rodolico

Catania, Italy

Location

AOU Policlinico San Marco-PO San Marco

Catania, Italy

Location

Ospedale Civico

Chivasso, Italy

Location

ASST Nord Milano P.O. Bassini

Cinisello Balsamo, Italy

Location

PO di Codogno

Codogno, Italy

Location

Ospedale Valduce

Como, Italy

Location

Ospedale G. B. Grassi

Lido di Ostia, Italy

Location

Ospedale Maggiore

Lodi, Italy

Location

Ospedale Carlo Poma

Mantua, Italy

Location

Ospedale Madonna delle Grazie

Matera, Italy

Location

ASST Ca' Granda Niguarda

Milan, Italy

Location

ASST Fatebenefratelli Sacco, P.O. Luigi Sacco

Milan, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Italy

Location

Ospedale Fatebenefratelli e Oftalmico

Milan, Italy

Location

Ospedale San Paolo

Milan, Italy

Location

Policlinico di Milano Ospedale Maggiore

Milan, Italy

Location

Policlinico di Monza

Monza, Italy

Location

AOU Maggiore della Carità

Novara, Italy

Location

Ospedale E. Agnelli

Pinerolo, Italy

Location

Ospedale Santa Maria degli Angeli

Pordenone, Italy

Location

Ospedale Santa Maria delle Grazie

Pozzuoli, Italy

Location

Ospedale Infermi

Rimini, Italy

Location

Ospedale degli Infermi

Rivoli, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

Location

Policlinico Tor Vergata

Roma, Italy

Location

Presidio Ospedaliero San Filippo Neri

Roma, Italy

Location

Ospedale Città del Piave

San Donà di Piave, Italy

Location

Ospedale Santa Maria dei Battuti

San Vito al Tagliamento, Italy

Location

Ospedale Savigliano e Saluzzo

Savigliano, Italy

Location

Ospedale Città di Sesto San Giovanni

Sesto San Giovanni, Italy

Location

Ospedale di Spilimbergo

Spilimbergo, Italy

Location

Presidio Ospedaliero S'Antonio Abate

Tolmezzo, Italy

Location

AO Ordine Mauriziano

Torino, Italy

Location

Humanitas Gradenigo

Torino, Italy

Location

Ospedale Molinette

Torino, Italy

Location

Ospedale San Giovanni Bosco

Torino, Italy

Location

Ospedale Santa Chiara

Trento, Italy

Location

Ospedale di Circolo

Varese, Italy

Location

MeSH Terms

Conditions

EmergenciesCrowding

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Study Officials

  • Giovanni Nattino

    Istituto di Ricerche Farmacologiche Mario Negri IRCSS

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2025

First Posted

August 8, 2025

Study Start

October 15, 2025

Primary Completion

December 13, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

May 20, 2026

Record last verified: 2026-05

Locations