Impact of an On-site Simulation-based Training Programme on Adherence to Standard Precautions and Healthcare-associated Infections in Adult Intensive Care (SIMRéa)
Impact of an On-site Simulation-based Training Programme on Adherence to Standard Precautions and Healthcare-associated Infections in Adult Intensive Care : Prospective Quasi-experimental Before-and-after Study
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Healthcare-associated infections (HAIs) remain a major patient safety concern in intensive care units (ICUs), despite the widespread availability of evidence-based infection prevention and control (IPC) recommendations. Standard precautions (SPs) are the cornerstone of IPC, yet their implementation remains inconsistent in routine clinical practice. Beyond knowledge and technical proficiency, maintaining reliable implementation of standard precautions in ICUs requires healthcare professionals to manage interruptions, cognitive workload, competing priorities and teamwork in a complex clinical environment.
SIMREA is an implementation strategy based on in situ simulation, designed to strengthen three complementary competencies required for the reliable implementation of standard precautions: knowledge, technical skills and non-technical skills. Simulation scenarios reproduce routine ICU situations and integrate contextual challenges encountered in daily practice, allowing healthcare professionals to apply infection prevention measures under realistic working conditions.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Arpiné EL NAR, PhD
- Telefonnummer: 0033387557766
- E-Mail: projet-recherche-clinique@chr-metz-thionville.fr
Studieren Sie die Kontaktsicherung
- Name: Mélanie JUNKE
- Telefonnummer: 0033387179886
- E-Mail: projet-recherche-clinique@chr-metz-thionville.fr
Studienorte
-
-
-
Metz, Frankreich, 57085
- Rekrutierung
- CHR Metz-Thionville, Hôpital de Mercy
-
Hauptermittler:
- Mathieu LLORENS, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
Inclusion Criteria:
- Patients hospitalized in the adult intensive care unit at CHR Metz-Thionville during the study period
- Patients aged 18 years or older
- Patients with a length of stay in the intensive care unit of 48 hours or more
- Patients for whom the data necessary to assess the outcome measures are available in the electronic health record and/or hospital surveillance databases
- Patients who have been informed about the use of their health data for research purposes, in accordance with the procedures established by the institution
Exclusion Criteria:
- Patients who, after being informed, objected to the use of their health data for this research
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Phase I : Pre-intervention period
Baseline period for data collection prior to the implementation of the SimRéa programme
|
Data Collection
|
|
Phase II : Intervention period
Gradual roll-out of the SimRéa training programme to resuscitation professionals: doctors, nurses and nursing assistants.
|
SimRéa programme is based on low-fidelity simulation scenarios that replicate common resuscitation situations, deliberately incorporating human factors that may affect the application of standard precautions (task interruptions, cognitive load, interprofessional demands). Data collection |
|
Phase III : Post-intervention period
An evaluation period designed to measure the impact of the intervention following the end of its roll-out.
|
Data Collection
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in the incidence density of intensive care unit-acquired healthcare-associated infections between the pre-intervention and post-intervention periods
Zeitfenster: Continuously assessed throughout the 18-month study period (Months 1-18), with the primary analysis comparing the pre-intervention period (Months 1-6) and the post-intervention period (Months 13-18)
|
The primary outcome will be the incidence density of healthcare-associated infections acquired in the intensive care unit, expressed as the number of infections per 1,000 patient-days. An infection will be considered ICU-acquired if it meets the CTINILS 2007 diagnostic criteria and occurs at least 48 hours after admission to the intensive care unit. The infections under surveillance will include, in particular, healthcare-associated pneumonia, bloodstream infection, and healthcare-associated urinary tract infection. The incidence density will be calculated as follows: Number of ICU-acquired healthcare-associated infections / Total number of patient-days × 1,000 |
Continuously assessed throughout the 18-month study period (Months 1-18), with the primary analysis comparing the pre-intervention period (Months 1-6) and the post-intervention period (Months 13-18)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in alcohol-based hand rub consumption between the pre-intervention and post-intervention periods
Zeitfenster: Assessed monthly throughout the 18-month study period (Months 1-18). The primary analysis will compare the pre-intervention (Months 1-6) and post-intervention (Months 13-18) periods
|
Alcohol-based hand rub consumption will be assessed using the French ICSHA (Hydroalcoholic Solution Consumption Index) indicator and expressed as the percentage achievement of the standardized national consumption target. Monthly ICSHA values will be compared between the pre-intervention and post-intervention periods |
Assessed monthly throughout the 18-month study period (Months 1-18). The primary analysis will compare the pre-intervention (Months 1-6) and post-intervention (Months 13-18) periods
|
|
Change in hand hygiene compliance between the pre-intervention and post-intervention periods
Zeitfenster: Assessed monthly throughout the 18-month study period (Months 1-18). The primary analysis will compare the pre-intervention (Months 1-6) and post-intervention (Months 13-18) periods
|
Hand hygiene compliance will be assessed through direct observation using the standardized Hand Hygiene Australia observation tool, based on the World Health Organization's "My 5 Moments for Hand Hygiene" framework. Compliance will be expressed as: Number of compliant hand hygiene actions / Total number of observed hand hygiene opportunities × 100 |
Assessed monthly throughout the 18-month study period (Months 1-18). The primary analysis will compare the pre-intervention (Months 1-6) and post-intervention (Months 13-18) periods
|
|
Association between cumulative SimRéa training coverage and changes in infection prevention indicators
Zeitfenster: From the beginning to the end of the study period (month 1 to month 18)
|
The cumulative proportion of trained healthcare professionals will be calculated monthly as: Number of eligible healthcare professionals who have attended at least one SimRéa training session / Total number of eligible healthcare professionals in the unit × 100. The cumulative training coverage will be examined in relation to the following monthly indicators: a) hand hygiene compliance rate [% : Number of compliant opportunities / Total number of opportunities observed × 100] ; b) alcohol-based hand rub consumption measured using the ICSHA indicator [% : Percentage of achievement of the standardised national target for the use of hydroalcoholic solutions] ; c) incidence density [Number] of ICU-acquired healthcare-associated infections, expressed per 1,000 patient-days. This exploratory analysis will assess the presence of an organisational dose-response relationship between increasing training coverage and changes in infection prevention outcomes |
From the beginning to the end of the study period (month 1 to month 18)
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Dr. Mathieu LLORENS, MD, CHR Metz-Thionville, Hôpital de Mercy
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
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
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-04-Obs-CHRMT
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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 .