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NCT Number: NCT07822971

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR Metz-Thionville, Hôpital de Mercy

Metz, 57085, France

Location status: Recruiting

Location contact

Mathieu LLORENS, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

No intervention

Other

Data Collection

Primary outcomes

  1. Change in the incidence density of intensive care unit-acquired healthcare-associated infections between the pre-intervention and post-intervention periods

    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)

    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

  1. Change in alcohol-based hand rub consumption 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

    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

  2. Change in hand hygiene compliance 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

    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

  3. Association between cumulative SimRéa training coverage and changes in infection prevention indicators

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Mélanie JUNKE

CONTACT

[email protected]

0033387179886

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

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

Acronym: SIMRéa

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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