Emergency DepartmentsPRIMENCT07606209
Emergency and Urgent Care Indicators in Piedmont
An observational study of Emergency Departments, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
The Emergency Department represents the main entry point to the hospital and a key setting for the management of urgent healthcare needs in the population. To date, the assessment of care quality has mainly focused on organizational aspects, with limited structured tools to systematically measure clinical and care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Departments
- How many people
- 650,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2027to 1 Jul 2028
- 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: Adult patients aged 18 years and older presenting to participating Emergency Departments during the period from 1 January 2023 to 31 December 2025.
Who may be able to join
- Adult patients (age >18 years) who presented to the participating Emergency Departments between 1/1/2023 and 31/12/2025.
Who cannot join
- All patients under 18 years.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Project on Indicators for Emergency and Urgent Care Services in the Piedmont Region
The Emergency Department represents the main entry point to the hospital and a key setting for the management of urgent healthcare needs in the population. To date, the assessment of care quality has mainly focused on organizational aspects, with limited structured tools to systematically measure clinical and care processes.
Overcrowding and limited resources make dedicated data collection unsustainable; therefore, it is necessary to rely on data already available from routine healthcare information systems. In this context, the study aims to assess the feasibility of using these data to construct quality indicators, as well as to evaluate their availability and reliability across participating centers.
The study will also analyze variability in indicators among participating Emergency Departments, with the goal of identifying differences in care processes and potential areas for improvement.
Read the detailed description
The Emergency Department (ED) is the primary gateway to the hospital system, yet its quality has traditionally been measured only by organizational efficiency rather than clinical care.
This study introduces a program to monitor the quality of assistance through standardized indicators, shifting the focus toward clinical and care appropriateness. Because Italian EDs face chronic overcrowding and resource shortages, the study is designed to be sustainable by using data already collected during routine clinical practice (current data flows) instead of requiring new, active data collection by staff.
The main goal of this pilot study is to build a reliable monitoring system. First, it verifies if the necessary data are actually available and accurate within existing hospital databases. Second, it measures the quality of care provided by participating centers to identify significant variations in clinical processes.
Finally, it aims to provide centers with detailed reports to help them interpret these findings and identify areas for improvement.
This is a multicenter, retrospective, observational cohort study involving at least 10 EDs. The study analyzes all patient visits over a three-year period, from January 2023 to December 2025, to account for seasonal trends and the evolution of care over time.
A total of 13 indicators are evaluated:
- Mandatory Indicators: These focus on critical issues like "boarding" (the time spent waiting for a hospital bed), overall overcrowding, wait times for clinical visits, and the management of time-dependent conditions like sepsis.
- Optional Indicators: These explore aspects such as the re-evaluation of patients in the waiting room, the use of "fast-track" assignments, and safety metrics like the frequency of falls among elderly patients.
Data are extracted from hospital information systems and transferred via secure protocols for analysis. All information is pseudonymized at the source to protect patient privacy. The analysis assesses the reliability of the data and uses statistical tests to compare performance between different centers and over time. As a pilot project, this study serves to identify which indicators are robust enough to be included in a permanent, large-scale quality improvement framework.
- Conditions
- Emergency Departments
- 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 |
|---|---|---|
| Eligible population | Adult patients (age >18 years) who presented to the participating Emergency Departments between 1/1/2023 and 31/12/2025. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To verify the availability and reliability of data for the construction of indicators on the quality of care in Emergency Departments (EDs) in the hospital databases of the participating centers.
Data availability for calculating quality-of-care indicators in emergency departments will be assessed without statistical analyses. Data reliability will be evaluated by a multidisciplinary working group (statisticians, emergency physicians, nurses, and hospital information/management staff), considering clinical relevance, missing or incomplete data, and internal consistency. This approach will document potential limitations in data quality across participating hospital databases.
Measured: July 2026 - November 2026
Rate of adherence to quality-of-care indicators per participating emergency department
Quality-of-care indicators will be calculated and, for each of them, 95% confidence intervals will be reported to quantify estimation uncertainty. Differences across participating emergency departments will be assessed using descriptive statistics (means, standard deviations, medians, interquartile ranges, boxplots, and histograms) and inferential tests appropriate to the indicator type: ANOVA and Kruskal-Wallis tests for quantitative indicators, and proportion difference tests for indicators expressed as percentages.
Measured: April 2027 - July 2027
Change in quality-of-care indicator rates over the three-year study period
Temporal trends in quality-of-care indicators will be analyzed across the three-year data collection period (2023-2025) to quantify variations observed over time within and across participating emergency departments.
Measured: December 2026 - March 2027
Proportion of patients managed in accordance with predefined quality-of-care indicators per participating emergency department
Quality-of-care indicators will be calculated according to predefined criteria, with 95% confidence intervals to quantify estimation uncertainty. Variability across participating emergency departments will be assessed using descriptive methods (means, standard deviations, medians, interquartile ranges, boxplots, and histograms) and inferential statistics, including ANOVA, Kruskal-Wallis tests, and proportion tests as appropriate. Temporal trends over the three-year study period will be analyzed. A retrospective application of the methodology will be performed to evaluate potential improvement signals under continuous monitoring conditions.
Measured: December 2026 - March 2027
Number of improvement signals per quality-of-care indicator under simulated continuous monitoring
A retrospective application of the continuous monitoring methodology will be performed to evaluate the number of improvement signals that would have been detected had the monitoring system been continuously active across participating emergency departments during the study period.
Measured: December 2026 - March 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Jul 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency DepartmentsStudies 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
- 650,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606209
- Sponsor's protocol ID
- PRIME
- Acronym
- PRIME
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project on Indicators for Emergency and Urgent Care Services in the Piedmont Region
- ClinicalTrials.gov ID
- NCT07606209
- Acronym / sponsor ID
- PRIME / PRIME
- Conditions
- Emergency Departments
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 650,000 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 1 Jul 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 26 May 2026 (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 Emergency Department represents the main entry point to the hospital and a key setting for the management of urgent healthcare needs in the population. To date, the assessment of care quality has mainly focused on organizational aspects, with limited structured tools to systematically measure clinical and care processes.
Overcrowding and limited resources make dedicated data collection unsustainable; therefore, it is necessary to rely on data already available from routine healthcare information systems. In this context, the study aims to assess the feasibility of using these data to construct quality indicators, as well as to evaluate their availability and reliability across participating centers.
The study will also analyze variability in indicators among participating Emergency Departments, with the goal of identifying differences in care processes and potential areas for improvement.
Detailed description
The Emergency Department (ED) is the primary gateway to the hospital system, yet its quality has traditionally been measured only by organizational efficiency rather than clinical care.
This study introduces a program to monitor the quality of assistance through standardized indicators, shifting the focus toward clinical and care appropriateness. Because Italian EDs face chronic overcrowding and resource shortages, the study is designed to be sustainable by using data already collected during routine clinical practice (current data flows) instead of requiring new, active data collection by staff.
The main goal of this pilot study is to build a reliable monitoring system. First, it verifies if the necessary data are actually available and accurate within existing hospital databases. Second, it measures the quality of care provided by participating centers to identify significant variations in clinical processes.
Finally, it aims to provide centers with detailed reports to help them interpret these findings and identify areas for improvement.
This is a multicenter, retrospective, observational cohort study involving at least 10 EDs. The study analyzes all patient visits over a three-year period, from January 2023 to December 2025, to account for seasonal trends and the evolution of care over time.
A total of 13 indicators are evaluated:
- Mandatory Indicators: These focus on critical issues like "boarding" (the time spent waiting for a hospital bed), overall overcrowding, wait times for clinical visits, and the management of time-dependent conditions like sepsis.
- Optional Indicators: These explore aspects such as the re-evaluation of patients in the waiting room, the use of "fast-track" assignments, and safety metrics like the frequency of falls among elderly patients.
Data are extracted from hospital information systems and transferred via secure protocols for analysis. All information is pseudonymized at the source to protect patient privacy. The analysis assesses the reliability of the data and uses statistical tests to compare performance between different centers and over time. As a pilot project, this study serves to identify which indicators are robust enough to be included in a permanent, large-scale quality improvement framework.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible population | – | –Adult patients (age >18 years) who presented to the participating Emergency Departments between 1/1/2023 and 31/12/2025. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years and older presenting to participating Emergency Departments during the period from 1 January 2023 to 31 December 2025.
Key inclusion criteria (1 listed)
- Adult patients (age >18 years) who presented to the participating Emergency Departments between 1/1/2023 and 31/12/2025.
Key exclusion criteria (1 listed)
- All patients under 18 years.
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
To verify the availability and reliability of data for the construction of indicators on the quality of care in Emergency Departments (EDs) in the hospital databases of the participating centers.
Time frame: July 2026 - November 2026
Data availability for calculating quality-of-care indicators in emergency departments will be assessed without statistical analyses. Data reliability will be evaluated by a multidisciplinary working group (statisticians, emergency physicians, nurses, and hospital information/management staff), considering clinical relevance, missing or incomplete data, and internal consistency. This approach will document potential limitations in data quality across participating hospital databases.
Rate of adherence to quality-of-care indicators per participating emergency department
Time frame: April 2027 - July 2027
Quality-of-care indicators will be calculated and, for each of them, 95% confidence intervals will be reported to quantify estimation uncertainty. Differences across participating emergency departments will be assessed using descriptive statistics (means, standard deviations, medians, interquartile ranges, boxplots, and histograms) and inferential tests appropriate to the indicator type: ANOVA and Kruskal-Wallis tests for quantitative indicators, and proportion difference tests for indicators expressed as percentages.
Change in quality-of-care indicator rates over the three-year study period
Time frame: December 2026 - March 2027
Temporal trends in quality-of-care indicators will be analyzed across the three-year data collection period (2023-2025) to quantify variations observed over time within and across participating emergency departments.
Proportion of patients managed in accordance with predefined quality-of-care indicators per participating emergency department
Time frame: December 2026 - March 2027
Quality-of-care indicators will be calculated according to predefined criteria, with 95% confidence intervals to quantify estimation uncertainty. Variability across participating emergency departments will be assessed using descriptive methods (means, standard deviations, medians, interquartile ranges, boxplots, and histograms) and inferential statistics, including ANOVA, Kruskal-Wallis tests, and proportion tests as appropriate. Temporal trends over the three-year study period will be analyzed. A retrospective application of the methodology will be performed to evaluate potential improvement signals under continuous monitoring conditions.
Number of improvement signals per quality-of-care indicator under simulated continuous monitoring
Time frame: December 2026 - March 2027
A retrospective application of the continuous monitoring methodology will be performed to evaluate the number of improvement signals that would have been detected had the monitoring system been continuously active across participating emergency departments during the study period.
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: 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.
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 Emergency Departments, 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 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: opening soon, 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 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?
Contact Giovanni Nattino (+39 0354535351, giovanni.nattino@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To verify the availability and reliability of data for the construction of indicators on the quality of care in Emergency Departments (EDs) in the hospital databases of the participating centers. (time frame: July 2026 - November 2026). The study lists 5 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.