A Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,050
- 试验地点
- 2
- 主要终点
- Incidence of CRBSI
研究概览
简要总结
The goal of this type of study is to construct the continuous quality promotion project "ICU-NO CRBSI(Catheter-Related Bloodstream Infection , CRBSI)" based on improvement science, and to verify its effect in the prevention of central venous catheter-related bloodstream infection and continuous quality improvement in ICU ( Intensive Care Unit , ICU) through multi-center implementation and two rounds of improvement.
The main question[s] it aims to answer are:
What is the incidence of catheter-related bloodstream infection in the ICU of participating units? How compliant are health care providers in the ICU with evidence-based sensory control practices for the prevention of catheter-associated bloodstream infection?
Participants will be provided with the hospital's routine CVC (Central Venous Catheter ,CVC) care practices and CVC quality improvement measures based on evidence-based guidelines What technical and cultural support is needed to implement quality and safety improvement measures?
详细描述
A multicenter, cluster-randomized controlled trial was conducted to verify the effect of the intervention scheme and the improvement strategy.
A continuous sample was taken based on subjects that met the inclusion criteria. This study was a multicenter cluster randomized controlled trial involving 23 research centers/medical institutions, including the Evidence-Based Nursing Center of Fudan University and Zhongshan Hospital affiliated to Fudan University. Co-led by the Pediatric Hospital Affiliated to Fudan University, a total of 23,000 catheter days (about 8050 people) were included, and each center planned to include 1,000 catheter days (about 350 people). Patients admitted to ICU from October to December 2023 were taken as baseline study objects, and ICU patients from January to March 2024 were entered into the control phase of the study experiment. ICU patients from April 2024 to June 2024 were included in the continuous observation group, and from July 2024 to September 2024 were included in the continuous observation period.
According to the study design characteristics, the intervention will be performed on the control group after the randomized controlled trial phase and the sustainability of the initial intervention group after 3 months will be assessed. The intervention group started in January 2024, implemented the validated intervention protocol and quality promotion implementation strategy, and entered the second phase three months later (April 2024), and the control group became the second intervention group after the intervention in April 2024. In Phase I (the randomized controlled trial phase, January 2024 to March 2024), the effect of the intervention and the improvement strategy was examined by comparing the change in BSI at baseline between the two groups. The control group started the intervention (January 2024) and began reporting bloodstream infection data. In the second phase (April 2024 to June 2024), both groups received the intervention and were followed up until September 2024. Therefore, it is possible to observe the first intervention group for 9 months and also to verify whether the results of the second intervention group (the phase I control group) can be replicated.
Control group: According to hospital catheterization, maintenance and central venous catheter extraction routine care.
Intervention group: On the basis of routine care, the "evidence-based intervention Program for the Prevention of Catheter Related bloodstream infection (CRBSI) in ICU patients" was implemented for intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Hospitals were divided into different groups, and the subjects and effect evaluators were blinded because they could not hide the assignment and the implementers were blinded. The main outcome indicators were laboratory objective indicators of CRBSI diagnosis
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ICU stay over 48 hours
- •CVC was placed for more than 24 hours
排除标准
- •Pregnant patients
- •Patients with a history of CRBSI infection
- •Patients with central venous catheterization were brought in from other hospitals
结局指标
主要结局
Incidence of CRBSI
时间窗: 1year
CRBSI incidence ratio
时间窗: 1 year
Ratio of CRBSI incidence per quarter (IRR)
次要结局
- Related Mortality(1 year)
- ICU hospitalization cost(1 year)
- Length of ICU stay(1 year)
研究者
ChunLei Li
graduate student
Fudan University