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

NCT07822971 | Recruiting

• 1 other identifier: 2026-04-Obs-CHRMT
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cross Infection

Keywords

Cross Infection; Infection Control; Universal Precautions; Intensive Care Units; Simulation Training; Patient Safety

Outcome Measures

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

  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 (3)

• Change in alcohol-based hand rub consumption 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

  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

  From the beginning to the end of the study period (month 1 to month 18)

Study Arms (3)

Phase I : Pre-intervention period

Baseline period for data collection prior to the implementation of the SimRéa programme

Other: No intervention

Phase II : Intervention period

Gradual roll-out of the SimRéa training programme to resuscitation professionals: doctors, nurses and nursing assistants.

Other: Simulation-based training programme

Phase III : Post-intervention period

An evaluation period designed to measure the impact of the intervention following the end of its roll-out.

Other: No intervention

Interventions

Simulation-based training programme OTHER

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 II : Intervention period

No intervention OTHER

Data Collection

Phase I : Pre-intervention period; Phase III : Post-intervention period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in the adult intensive care unit at CHR Metz-Thionville during the study period

You may qualify if:

• 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

You may not qualify if:

• Patients who, after being informed, objected to the use of their health data for this research

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville, Hôpital de Mercy

Metz, 57085, France

RECRUITING

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Mathieu LLORENS, MD

  CHR Metz-Thionville, Hôpital de Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mélanie JUNKE

CONTACT

0033387179886; projet-recherche-clinique@chr-metz-thionville.fr

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2026
• First Posted: September 16, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

FR (1)