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Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science

Primary Purpose

CRBSI - Catheter Related Bloodstream Infection, Evidence-based Nursing Practice, Central Venous Catheter Related Bloodstream Infection

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
evidence-based intervention Plan for the Prevention of CRBSI in ICU patients
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for CRBSI - Catheter Related Bloodstream Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Existing central venous catheters in the hospital or ICU maintain routine care procedures

    evidence-based intervention Plan for the Prevention of CRBSI in ICU patients

    Arm Description

    According to the hospital or ICU catheterization, maintenance and removal of central venous catheter routine care

    On the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention.

    Outcomes

    Primary Outcome Measures

    Incidence of CRBSI
    CRBSI incidence ratio
    Ratio of CRBSI incidence per quarter (IRR)

    Secondary Outcome Measures

    Length of ICU stay
    Length of ICU stay
    Related Mortality
    ICU CRBSI-related mortality
    ICU hospitalization cost

    Full Information

    First Posted
    October 10, 2023
    Last Updated
    October 16, 2023
    Sponsor
    Fudan University
    Collaborators
    Fudan University Evidence-based Nursing Center, Shanghai Zhongshan Hospital, Children's Hospital of Fudan University, Shanghai Public Health Clinical Center, Shandong First Medical University affiliated Provincial Hospital, Affiliated Hospital of Nantong University, Hospital of Obstetrics and Gynecology affiliated to Fudan University, Fudan University is affiliated with Shanghai Fifth People's Hospital, Shengjing hospital affiliated to China Medical University, The First Affiliated Hospital of University of South China, East China Hospital Affiliated to Fudan University, The First Affiliated Hospital of Dali University, Xinjiang Bayingoleng Mongolian Autonomous Prefecture People's Hospital, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Cancer Hospital of Chinese Academy of Medical Sciences Shanxi Hospital, Shanghai Minhang Central Hospital, Xi 'an children's hospital, Huashan Hospital, The First Affiliated Hospital of Xi 'an Jiaotong University, Affiliated Hospital of Guizhou Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen Third People's Hospital, Shanghai Dongfang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06085690
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    October 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fudan University
    Collaborators
    Fudan University Evidence-based Nursing Center, Shanghai Zhongshan Hospital, Children's Hospital of Fudan University, Shanghai Public Health Clinical Center, Shandong First Medical University affiliated Provincial Hospital, Affiliated Hospital of Nantong University, Hospital of Obstetrics and Gynecology affiliated to Fudan University, Fudan University is affiliated with Shanghai Fifth People's Hospital, Shengjing hospital affiliated to China Medical University, The First Affiliated Hospital of University of South China, East China Hospital Affiliated to Fudan University, The First Affiliated Hospital of Dali University, Xinjiang Bayingoleng Mongolian Autonomous Prefecture People's Hospital, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Cancer Hospital of Chinese Academy of Medical Sciences Shanxi Hospital, Shanghai Minhang Central Hospital, Xi 'an children's hospital, Huashan Hospital, The First Affiliated Hospital of Xi 'an Jiaotong University, Affiliated Hospital of Guizhou Medical University, Affiliated Hospital of Southwest Medical University, Shenzhen Third People's Hospital, Shanghai Dongfang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    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
    Allocation
    Randomized
    Enrollment
    8050 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Existing central venous catheters in the hospital or ICU maintain routine care procedures
    Arm Type
    No Intervention
    Arm Description
    According to the hospital or ICU catheterization, maintenance and removal of central venous catheter routine care
    Arm Title
    evidence-based intervention Plan for the Prevention of CRBSI in ICU patients
    Arm Type
    Experimental
    Arm Description
    On the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    evidence-based intervention Plan for the Prevention of CRBSI in ICU patients
    Intervention Description
    On the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention.
    Primary Outcome Measure Information:
    Title
    Incidence of CRBSI
    Time Frame
    1year
    Title
    CRBSI incidence ratio
    Description
    Ratio of CRBSI incidence per quarter (IRR)
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Length of ICU stay
    Description
    Length of ICU stay
    Time Frame
    1 year
    Title
    Related Mortality
    Description
    ICU CRBSI-related mortality
    Time Frame
    1 year
    Title
    ICU hospitalization cost
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    CHUNLEI Li
    Phone
    15800488689
    Email
    21211170023@m.fudan.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    YuXia Zhang
    Email
    Yuxiazhang@zs-hospital.sh.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yan Hu
    Organizational Affiliation
    School of Nursing, Fudan University; Center for Evidence-based Nursing, Fudan University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    YuXia Zhang
    Organizational Affiliation
    Department of Nursing, Zhongshan Hospital Affiliated to Fudan University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Ying Gu
    Organizational Affiliation
    Center for Evidence-based Nursing, Fudan University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    The research institute shares research data and results according to the plan. The materials and data involved in the study are for the research group only. The final interpretation belongs to the research group
    IPD Sharing Time Frame
    The materials and data involved in the study are available for five years from the start of the study to the end of the study, and the results of the study are agreed to be used for the study itself.
    IPD Sharing Access Criteria
    Provide access to the head of each research branch or PI
    Citations:
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    23265289
    Citation
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    Multicenter Clinical Translational Study of "ICU-NO CRBSI" Based on Improvement Science

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