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

63
Monitor

Trial Health Score

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

Enrollment
828

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
not yet 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 Progress68%
Sep 2025Aug 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
24 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

August 8, 2025

Status Verified

May 1, 2025

Enrollment Period

12 months

First QC Date

July 23, 2025

Last Update Submit

August 7, 2025

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 (10)

Spedali civili

Brescia, BS, Italy

Location

IRCCS San Martino

Genova, GE, Italy

Location

Ospedale Santa Maria delle Croci

Ravenna, RA, Italy

Location

Ospedali riuniti di Anzio e Nettuno

Anzio, RM, 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 Maggiore della Carità

Novara, Italy

Location

Ospedale Santa Maria delle Grazie

Pozzuoli, 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

Central Study Contacts

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

September 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

August 8, 2025

Record last verified: 2025-05

Locations