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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in the incidence density of intensive care unit-acquired healthcare-associated infections between the pre-intervention and post-intervention periods
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who, after being informed, objected to the use of their health data for this research
研究组 & 干预措施
Phase II : Intervention period
Gradual roll-out of the SimRéa training programme to resuscitation professionals: doctors, nurses and nursing assistants.
干预措施: Simulation-based training programme (Other)
Phase III : Post-intervention period
An evaluation period designed to measure the impact of the intervention following the end of its roll-out.
干预措施: No intervention (Other)
Phase I : Pre-intervention period
Baseline period for data collection prior to the implementation of the SimRéa programme
干预措施: No intervention (Other)
结局指标
主要结局
Change in the incidence density of intensive care unit-acquired healthcare-associated infections between the pre-intervention and post-intervention periods
时间窗: 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
次要结局
- 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))