Impact of an On-site Simulation-based Training Programme on Adherence to Standard Precautions and Healthcare-associated Infections in Adult Intensive Care

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Régional Metz-Thionville

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Retrospective

Treatments tested in this trial

  • Simulation-based training programme

    Other 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

  • No intervention

    Other intervention

    Data Collection

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Phase I : Pre-intervention period1 intervention
Group B: Phase II : Intervention period1 intervention
Group C: Phase III : Post-intervention period1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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
2

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
3

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)

Other outcomes

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