Clinical trial NCT06085690: Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science
Official title: A Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CRBSI - Catheter Related Bloodstream Infection
Evidence-based Nursing Practice
Central Venous Catheter Related Bloodstream Infection
Central Venous Catheter Associated Bloodstream Infection
Central Line Infection
CLABSI - Central Line Associated Bloodstream Infection
Quality Improvement
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Fudan University Evidence-based Nursing Center
name: Shanghai Zhongshan Hospital
name: Children's Hospital of Fudan University
name: Shanghai Public Health Clinical Center
name: Shandong First Medical University affiliated Provincial Hospital
name: Affiliated Hospital of Nantong University
name: Hospital of Obstetrics and Gynecology affiliated to Fudan University
name: Shengjing Hospital
name: The First Affiliated Hospital of University of South China
name: East China Hospital Affiliated to Fudan University
name: The First Affiliated Hospital of Dali University
name: Xinjiang Bayingoleng Mongolian Autonomous Prefecture People's Hospital
name: Wuhan Union Hospital, China
name: Chinese Academy of Medical Sciences
name: Shanghai Minhang Central Hospital
name: Xi 'an children's hospital
name: Huashan Hospital
name: The First Affiliated Hospital of Xi 'an Jiaotong University
name: Affiliated Hospital of Guizhou Medical University
name: Affiliated Hospital of Southwest Medical University
name: Shenzhen Third People's Hospital
name: Shanghai Dongfang Hospital
First posted: 2023-10-17
Enrollment: 8050
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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?

Detailed description: 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.

Primary outcome: incidence of CRBSI, ratio of CRBSI incidence (quarterly comparison) Secondary outcome ：length of stay in ICU, BSI-related mortality in ICU, hospitalization cost in ICU, knowledge and practice score of adherence to evidence-based sensory control in ICU, adherence to evidence-based practice of central venous catheter placement, maintenance and extubation.

Eligibility criteria: Inclusion Criteria:

* ICU stay over 48 hours
* CVC was placed for more than 24 hours

Exclusion Criteria:

* Pregnant patients
* Patients with a history of CRBSI infection
* Patients with central venous catheterization were brought in from other hospitals

Primary outcomes:
measure: Incidence of CRBSI
timeFrame: 1year
measure: CRBSI incidence ratio
timeFrame: 1 year
Secondary outcomes:
measure: Length of ICU stay
timeFrame: 1 year
measure: Related Mortality
timeFrame: 1 year
measure: ICU hospitalization cost
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ZhongShan Hospital Affilicated to Fudan University
state: Shanghai
Study officials:
affiliation: School of Nursing, Fudan University; Center for Evidence-based Nursing, Fudan University
name: Yan Hu
role: STUDY_CHAIR
affiliation: Department of Nursing, Zhongshan Hospital Affiliated to Fudan University
name: YuXia Zhang
role: STUDY_DIRECTOR
affiliation: Center for Evidence-based Nursing, Fudan University
name: Ying Gu
role: STUDY_DIRECTOR
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