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

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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (估计的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Metz、法国、57085
        • 招聘中
        • CHR Metz-Thionville, Hôpital de Mercy
        • 首席研究员:
          • Mathieu LLORENS, MD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Phase I : Pre-intervention period
Baseline period for data collection prior to the implementation of the SimRéa programme
Data Collection
Phase II : Intervention period
Gradual roll-out of the SimRéa training programme to resuscitation professionals: doctors, nurses and nursing assistants.

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 III : Post-intervention period
An evaluation period designed to measure the impact of the intervention following the end of its roll-out.
Data Collection

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in the incidence density of intensive care unit-acquired healthcare-associated infections between the pre-intervention and post-intervention periods
大体时间: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

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)

次要结果测量

结果测量
措施说明
大体时间
Change in alcohol-based hand rub consumption between the pre-intervention and post-intervention periods
大体时间: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

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
大体时间: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

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
大体时间: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

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Dr. Mathieu LLORENS, MD、CHR Metz-Thionville, Hôpital de Mercy

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年3月1日

初级完成 (估计的)

2027年8月31日

研究完成 (估计的)

2028年3月1日

研究注册日期

首次提交

2026年9月3日

首先提交符合 QC 标准的

2026年9月10日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月10日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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