Emergency DepartmentNCT07111624
A New Crowding Indicator in the Emergency Department
An observational study of Emergency Department and Crowding, run by Mario Negri Institute for Pharmacological Research at 52 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency Department, Crowding
- How many people
- 828 participants
- Where
- 52 sitesItaly
- Study dates
- 15 Oct 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients arriving in the emergency department at the time of the survey.
Who may be able to join
- Patients that are in EDs at the time of the survey
Who cannot join
- Patients that are in EDs, but not at the time of the survey
Trial locations and contacts
52 sites in 1 country.
52 sites in 1 country
Italy52 sites
AOU SS. Antonio e Biagio e Cesare Arrigo
Alessandria
Ospedale Regionale Umberto Parini
Aosta
Ospedale San Bassiano
Bassano del Grappa
Humanitas Gavazzeni
Bergamo
Ospedale Papa Giovanni XXIII
Bergamo
Ospedale Maggiore "CA Pizzardi"
Bologna
Policlinico Sant'Orsola Malpighi
Bologna
Spedali civili
Brescia, BS
AOU Policlinico San Marco-PO Gaspare Rodolico
Catania
AOU Policlinico San Marco-PO San Marco
Catania
Ospedale Civico
Chivasso
ASST Nord Milano P.O. Bassini
Cinisello Balsamo
Presidio Osped. Riunito
Cirié, TO
PO di Codogno
Codogno
Ospedale Valduce
Como
IRCCS San Martino
Genova, GE
Ospedale G. B. Grassi
Lido di Ostia
Ospedale Maggiore
Lodi
Ospedale Carlo Poma
Mantua
Ospedale Madonna delle Grazie
Matera
ASST Ca' Granda Niguarda
Milan
ASST Fatebenefratelli Sacco, P.O. Luigi Sacco
Milan
IRCCS Ospedale San Raffaele
Milan
Ospedale Fatebenefratelli e Oftalmico
Milan
Ospedale San Paolo
Milan
Policlinico di Milano Ospedale Maggiore
Milan
Policlinico di Monza
Monza
AOU Maggiore della Carità
Novara
AOU San Luigi Gonzaga
Orbassano, TO
Ospedale E. Agnelli
Pinerolo
Ospedale Santa Maria degli Angeli
Pordenone
Ospedale Santa Maria delle Grazie
Pozzuoli
Ospedale Santa Maria delle Croci
Ravenna, RA
Ospedale Infermi
Rimini
Ospedale degli Infermi
Rivoli
Azienda Ospedaliera San Camillo Forlanini
Roma, RM
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma
Policlinico Tor Vergata
Roma
Presidio Ospedaliero San Filippo Neri
Roma
Ospedale Città del Piave
San Donà di Piave
Ospedale Santa Maria dei Battuti
San Vito al Tagliamento
Ospedale Savigliano e Saluzzo
Savigliano
Ospedale Città di Sesto San Giovanni
Sesto San Giovanni
Ospedale di Spilimbergo
Spilimbergo
Presidio Ospedaliero S'Antonio Abate
Tolmezzo
AO Ordine Mauriziano
Torino
Humanitas Gradenigo
Torino
Ospedale Molinette
Torino
Ospedale San Giovanni Bosco
Torino
Ospedale Santa Chiara
Trento
Ospedale di Circolo
Varese
P.O. Sant'Andrea
Vercelli, VC
About this study
Official title: Comparison Between a New Crowding Indicator and the Perception of Healthcare Workers in the Emergency Department
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.
Read the detailed description
The NEDOCS (National Emergency Department OverCrowding Study) is currently the most widely used indicator in Italy to measure the level of crowding in Emergency Departments (EDs). However, despite its widespread use, it presents several critical issues. First of all, it was developed in a context very different from the current Italian one, since it was built on data collected in 2002 in 8 medium-large US university EDs. It is therefore not possible to take for granted that this indicator can accurately describe the current crowding conditions of Italian EDs. Furthermore, the factors that make up the NEDOCS are often calculated differently by the various hospital facilities, compromising the comparability of the estimates.
Fenice has proposed a new indicator to measure the level of crowding in EDs. The indicator was developed to measure one of the objective consequences of crowding in EDs, namely the increase in waiting time for patients with a problem classified as minor urgency or deferrable to triage (codes 3 and 4). In parallel, the Fenice study has shown that NEDOCS is not very sensitive to this objective consequence of crowding.
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 operators of the ER and to compare this agreement with that between NEDOCS and the perception of the operators.
- Conditions
- Emergency Department, Crowding
- Medical subject headings
- Emergencies, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: September 2025 - December 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start15 Oct 2025
- Primary completion13 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency DepartmentStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 828 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Nattino, Study chair, Istituto di Ricerche Farmacologiche Mario Negri IRCSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111624
- Sponsor's protocol ID
- CAOS
- Status last verified
- May 2026
- First submitted
- 23 Jul 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between a New Crowding Indicator and the Perception of Healthcare Workers in the Emergency Department
- ClinicalTrials.gov ID
- NCT07111624
- Acronym / sponsor ID
- CAOS
- Conditions
- Emergency Department, Crowding
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 828 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 13 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The NEDOCS (National Emergency Department OverCrowding Study) is currently the most widely used indicator in Italy to measure the level of crowding in Emergency Departments (EDs). However, despite its widespread use, it presents several critical issues. First of all, it was developed in a context very different from the current Italian one, since it was built on data collected in 2002 in 8 medium-large US university EDs. It is therefore not possible to take for granted that this indicator can accurately describe the current crowding conditions of Italian EDs. Furthermore, the factors that make up the NEDOCS are often calculated differently by the various hospital facilities, compromising the comparability of the estimates.
Fenice has proposed a new indicator to measure the level of crowding in EDs. The indicator was developed to measure one of the objective consequences of crowding in EDs, namely the increase in waiting time for patients with a problem classified as minor urgency or deferrable to triage (codes 3 and 4). In parallel, the Fenice study has shown that NEDOCS is not very sensitive to this objective consequence of crowding.
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 operators of the ER and to compare this agreement with that between NEDOCS and the perception of the operators.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients arriving in the emergency department at the time of the survey.
Key inclusion criteria (1 listed)
- Patients that are in EDs at the time of the survey
Key exclusion criteria (1 listed)
- Patients that are in EDs, but not at the time of the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of variation in the ED staff perceived crowding level that is explained by the Fenice crowding score.
Time frame: September 2025 - December 2025
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.
1 secondary outcome
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.
Time frame: September 2025 - December 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanni Nattino study chair
Istituto di Ricerche Farmacologiche Mario Negri IRCSS
52 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Department and Crowding, run by Mario Negri Institute for Pharmacological Research at 52 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of variation in the ED staff perceived crowding level that is explained by the Fenice crowding score. (time frame: September 2025 - December 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.