- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07606209
Emergency and Urgent Care Indicators in Piedmont (PRIME)
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Giovanni Nattino
- Telefonnummer: +39 0354535351
- E-Mail: giovanni.nattino@marionegri.it
Studienorte
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Alessandria, Italien
- Ospedale Civile SS.Antonio e Biagio
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Hauptermittler:
- Riccardo Boverio
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Adult patients (age >18 years) who presented to the participating Emergency Departments between 1/1/2023 and 31/12/2025.
Exclusion Criteria:
- All patients under 18 years.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Eligible population
Adult patients (age >18 years) who presented to the participating Emergency Departments between 1/1/2023 and 31/12/2025.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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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.
Zeitfenster: July 2026 - November 2026
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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.
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July 2026 - November 2026
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Change in quality-of-care indicator rates over the three-year study period
Zeitfenster: December 2026 - March 2027
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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.
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December 2026 - March 2027
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Rate of adherence to quality-of-care indicators per participating emergency department
Zeitfenster: April 2027 - July 2027
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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.
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April 2027 - July 2027
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Proportion of patients managed in accordance with predefined quality-of-care indicators per participating emergency department
Zeitfenster: December 2026 - March 2027
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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.
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December 2026 - March 2027
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Number of improvement signals per quality-of-care indicator under simulated continuous monitoring
Zeitfenster: December 2026 - March 2027
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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.
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December 2026 - March 2027
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PRIME
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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