Quality of CareNCT06345352
Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Admissions of Patients Accessing the Emergency Department (Fondazione IRCCS Ca' Granda Ospedale Maggione Policlinico)
An observational study of Quality of Care and Evaluation, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Care, Evaluation, Emergency Department
- How many people
- 1,200 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2020to Dec 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients entering Emergency Department represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.
Who may be able to join
- Adult patients
- Presentation in the Emergency Department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.
Who cannot join
- Voluntary removal of the patient;
- Sending home with instructions to return for further services
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano
Milan, MI, 20122
About this study
Official title: Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of the Admissions of Patients Accessing the PS: Construction and Validation of an Algorithm Based on Computerised Databases
The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.
Read the detailed description
The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.
- Conditions
- Quality of Care, Evaluation, Emergency Department, Appropriateness
- Medical subject headings
- Emergencies
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 adult patients presenting to the emergency department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm creation
To develop, for the types of patients taken into consideration, a classification algorithm of the appropriateness of admissions based on the files available at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (for simplicity: Policlinico hospital)
Measured: September 2020 - January 2024
Algorithm validation
To validate the classification algorithm on a sample of hospital medical records.
Measured: February 2024 - December 2024
Algorithm application
To apply the validated algorithm on patients referred to the PS of the Policlinico hospital over 36 months, to estimate the proportion of appropriate admissions.
Measured: January 2025 - December 2027
Appropriateness estimation
Provide, for the types of patients considered, an estimate of appropriate discharges for patients discharged and subsequently admitted to the Polyclinic, by drawing on the data available at the polyclinic itself. For all other patients, data on living status and admissions to other facilities in the metropolitan area (PS administrative flow and hospital discharge cards - SDOs), will be analysed using data provided by the ATS Milano Città Metropolitana.
Measured: January 2025 - December 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Sep 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of CareStudies 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
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345352
- Sponsor's protocol ID
- IRFMN_7520_PoliMI
- Status last verified
- May 2026
- First submitted
- 28 Mar 2024
- 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
- Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of the Admissions of Patients Accessing the PS: Construction and Validation of an Algorithm Based on Computerised Databases
- ClinicalTrials.gov ID
- NCT06345352
- Acronym / sponsor ID
- IRFMN_7520_PoliMI
- Conditions
- Quality of Care, Evaluation, Emergency Department, Appropriateness
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 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 aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.
Detailed description
The information normally recorded in the Emergency Department medical record will be used, as well as the available clinical and administrative databases. For reasons of feasibility, the investigators will also restrict the analysis to patients coming to the Emergency Department with non-specific manifestations in the pulmonary, cardiovascular and abdominal districts, represented by one or more of the following symptoms: dyspnoea, chest pain, transient loss of consciousness, abdominal pain.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elegible population | – | –All adult patients presenting to the emergency department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients entering Emergency Department represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.
Key inclusion criteria (2 listed)
- Adult patients
- Presentation in the Emergency Department with non-specific cardiopulmonary or abdominal manifestations, represented by one or more of the following symptoms: chest pain, abdominal pain, dyspnoea, transient loss of consciousness.
Key exclusion criteria (2 listed)
- Voluntary removal of the patient;
- Sending home with instructions to return for further services
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
Algorithm creation
Time frame: September 2020 - January 2024
To develop, for the types of patients taken into consideration, a classification algorithm of the appropriateness of admissions based on the files available at the Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (for simplicity: Policlinico hospital)
Algorithm validation
Time frame: February 2024 - December 2024
To validate the classification algorithm on a sample of hospital medical records.
Algorithm application
Time frame: January 2025 - December 2027
To apply the validated algorithm on patients referred to the PS of the Policlinico hospital over 36 months, to estimate the proportion of appropriate admissions.
Appropriateness estimation
Time frame: January 2025 - December 2027
Provide, for the types of patients considered, an estimate of appropriate discharges for patients discharged and subsequently admitted to the Polyclinic, by drawing on the data available at the polyclinic itself. For all other patients, data on living status and admissions to other facilities in the metropolitan area (PS administrative flow and hospital discharge cards - SDOs), will be analysed using data provided by the ATS Milano Città Metropolitana.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Care and Evaluation, run by Mario Negri Institute for Pharmacological Research at 1 site 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 2 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 1 site 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?
Algorithm creation (time frame: September 2020 - January 2024). The study lists 4 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 20 May 2026.