Emergency MedicineeCREAM-UC1NCT06354764
Propensity to Hospitalize Patients From the ED in European Centers.
An observational study of Emergency Medicine, run by Mario Negri Institute for Pharmacological Research at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine
- How many people
- 162,000 participants
- Where
- 2 sitesItaly
- Study dates
- 22 Sep 2025to Feb 2027
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: All adult patients who arrived at participating emergency departments between January 1, 2021 and December 31, 2023
Who may be able to join
- Adult
- Arrived at emergency department between 1 January 2021 and 31 December 2023
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Ospedale San Giovanni Bosco
Torino
Franco Aprà, +39 011.2402210, franco.apra@aslcittaditorino.it
- Recruiting
Ospedale Sant'Andrea
Vercelli
Sergio Tartaglia, +39 0161 593111, srtartaglia@gmail.com
About this study
Official title: 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.
- Conditions
- Emergency Medicine
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| Adults who attended the emergency department | Not described Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: September 2025 - September 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start22 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 162,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Sponsor type
- University, hospital or other
- Collaborators
- Astir s.r.l., Centre Hospitalier Universitaire Vaudois, Orobix Life S.r.l., Fondazione Bruno Kessler
- Responsible party
- Sponsor
- Investigators
- Guido Bertolini, MD, Principal investigator, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354764
- Sponsor's protocol ID
- 8780-UC1
- Acronym
- eCREAM-UC1
- Status last verified
- May 2026
- First submitted
- 3 Apr 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propensity to Hospitalize Patients From the ED in European Centers.An Observational Retrospective Quality-of-care Study
- ClinicalTrials.gov ID
- NCT06354764
- Acronym / sponsor ID
- eCREAM-UC1 / 8780-UC1
- Conditions
- Emergency Medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 162,000 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Astir s.r.l., Centre Hospitalier Universitaire Vaudois, Orobix Life S.r.l., Fondazione Bruno Kessler
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Apr 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults who attended the emergency department | – | Other: no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All adult patients who arrived at participating emergency departments between January 1, 2021 and December 31, 2023
Key inclusion criteria (2 listed)
- Adult
- Arrived at emergency department between 1 January 2021 and 31 December 2023
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | Adults who attended the emergency department |
Primary outcome
Create two separate databases
Time frame: September 2024 - September 2025
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
Multivariable models
Time frame: September 2025 - September 2026
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
Adjusted comparison
Time frame: September 2025 - September 2026
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.
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 9 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Guido Bertolini, MD principal investigator
Istituto Di Ricerche Farmacologiche Mario Negri
2 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 Medicine, run by Mario Negri Institute for Pharmacological Research at 2 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 2 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Contact Chiara Pandolfini (0039 02 39014 253, chiara.pandolfini@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Create two separate databases (time frame: September 2024 - September 2025). The study lists 3 primary outcomes in all. 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 9 Oct 2026.