An observational study in Cross Infection, sponsored by Centre Hospitalier Régional Metz-Thionville. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational
This is a prospective, single-centre, quasi-experimental before-and-after study conducted over 18 months in an adult ICU. The study includes a 6-month pre-intervention period, a 6-month intervention period during which healthcare professionals participate in repeated in situ simulation sessions, and a 6-month post-intervention period.
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.
285 studies on the registry are indexed under Cross Infection; 48 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 351 across 115 observational studies indexed under Cross Infection.
Browse Cross Infection studies →Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 123 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients hospitalized in the adult intensive care unit at CHR Metz-Thionville during the study period
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Exclusion Criteria:
Baseline period for data collection prior to the implementation of the SimRéa programme
Other: No intervention
Gradual roll-out of the SimRéa training programme to resuscitation professionals: doctors, nurses and nursing assistants.
Other: Simulation-based training programme
An evaluation period designed to measure the impact of the intervention following the end of its roll-out.
Other: No intervention
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
Data Collection
Change in the incidence density of intensive care unit-acquired healthcare-associated infections between the pre-intervention and post-intervention periods
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
Time frame: 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)
Change in alcohol-based hand rub consumption between the pre-intervention and post-intervention 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
Time frame: 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
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
Time frame: 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
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
Time frame: From the beginning to the end of the study period (month 1 to month 18)
Started Mar 2026 (actual). Primary completion is estimated for Aug 2027, 17 months after the start.
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