About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients who, after being informed, objected to the use of their health data for this research
Trial population
Patients hospitalized in the adult intensive care unit at CHR Metz-Thionville during the study period
Trial design
Other
Retrospective
Treatments tested in this trial
Simulation-based training programme
Other interventionSimRéa 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
No intervention
Other interventionData Collection
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.