Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

Noch keine Rekrutierung

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

Beobachtungs

Einschreibung (Geschätzt)

650000

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

      • Alessandria, Italien
        • Ospedale Civile SS.Antonio e Biagio
        • Hauptermittler:
          • Riccardo Boverio

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients aged 18 years and older presenting to participating Emergency Departments during the period from 1 January 2023 to 31 December 2025.

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

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Eligible population
Adult patients (age >18 years) who presented to the participating Emergency Departments between 1/1/2023 and 31/12/2025.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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
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.
July 2026 - November 2026
Change in quality-of-care indicator rates over the three-year study period
Zeitfenster: 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.
December 2026 - March 2027
Rate of adherence to quality-of-care indicators per participating emergency department
Zeitfenster: 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.
April 2027 - July 2027
Proportion of patients managed in accordance with predefined quality-of-care indicators per participating emergency department
Zeitfenster: 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.
December 2026 - March 2027
Number of improvement signals per quality-of-care indicator under simulated continuous monitoring
Zeitfenster: 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.
December 2026 - March 2027

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

15. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Mai 2026

Zuerst gepostet (Tatsächlich)

26. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • PRIME

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Notfallabteilungen

Abonnieren