Cross InfectionSIMRéaNCT07822971
Impact of an On-site Simulation-based Training Programme on Adherence to Standard Precautions and Healthcare-associated Infections in Adult Intensive Care
An observational study of Cross Infection, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cross Infection
- What is being tested?
- Simulation-based training programme
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients hospitalized in the adult intensive care unit at CHR Metz-Thionville during the study period
Who may be able to join
- 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
Who cannot join
- Patients who, after being informed, objected to the use of their health data for this research
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHR Metz-Thionville, Hôpital de Mercy
Metz, 57085
Mathieu LLORENS, MD
Olfa EZZI, MD
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Cross Infection
- Being tested
- Simulation-based training programme, No intervention
- Keywords
- Cross Infection, Infection Control, Universal Precautions, Intensive Care Units, Simulation Training, Patient Safety
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based training programmeOther
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 interventionOther
Data Collection
| Study group | Role | What they receive |
|---|---|---|
| Phase I : Pre-intervention period | Baseline period for data collection prior to the implementation of the SimRéa programme Receives: Other: No intervention | |
| Phase II : Intervention period | Gradual roll-out of the SimRéa training programme to resuscitation professionals: doctors, nurses and nursing assistants. Receives: 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: 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
Measured: From the beginning to the end of the study period (month 1 to month 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Mar 2026
- Primary completion31 Aug 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cross InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Mathieu LLORENS, MD, Principal investigator, CHR Metz-Thionville, Hôpital de Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822971
- Sponsor's protocol ID
- 2026-04-Obs-CHRMT
- Acronym
- SIMRéa
- Status last verified
- Sep 2026
- First submitted
- 3 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07822971
- Acronym / sponsor ID
- SIMRéa / 2026-04-Obs-CHRMT
- Conditions
- Cross Infection
- Keywords
- Cross Infection, Infection Control, Universal Precautions, Intensive Care Units, Simulation Training, Patient Safety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I : Pre-intervention period | – | Other: No interventionBaseline period for data collection prior to the implementation of the SimRéa programme |
| Phase II : Intervention period | – | Other: Simulation-based training programmeGradual roll-out of the SimRéa training programme to resuscitation professionals: doctors, nurses and nursing assistants. |
| Phase III : Post-intervention period | – | Other: No interventionAn evaluation period designed to measure the impact of the intervention following the end of its roll-out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the adult intensive care unit at CHR Metz-Thionville during the study period
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who, after being informed, objected to the use of their health data for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based training programmeSimRéa 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 | Other | Phase II : Intervention period |
| No interventionData Collection | Other | Phase I : Pre-intervention period, Phase III : Post-intervention period |
Primary outcome
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
3 secondary outcomes
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Mathieu LLORENS, MD principal investigator
CHR Metz-Thionville, Hôpital de Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cross Infection, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mélanie JUNKE (0033387179886, projet-recherche-clinique@chr-metz-thionville.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.