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

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

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?

Study Overview

• Status: Recruiting
• Conditions: Quality Improvement; Central Venous Catheter Associated Bloodstream Infection; CLABSI - Central Line Associated Bloodstream Infection; Central Venous Catheter Related Bloodstream Infection; Central Line Infection; CRBSI - Catheter Related Bloodstream Infection; Evidence-based Nursing Practice
• Intervention / Treatment: Behavioral: evidence-based intervention Plan for the Prevention of CRBSI in ICU patients

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.

• Study Type: Interventional
• Enrollment (Estimated): 8050
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CHUNLEI Li; Phone Number: 15800488689; Email: 21211170023@m.fudan.edu.cn
• Study Contact Backup: Name: YuXia Zhang; Email: Yuxiazhang@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • ZhongShan Hospital Affilicated to Fudan University
      • Contact: CHUNLEI Li; Phone Number: 15800488689; Email: 21211170023@m.fudan.edu.cn
      • Principal Investigator: Yuxia Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Existing central venous catheters in the hospital or ICU maintain routine care procedures; According to the hospital or ICU catheterization, maintenance and removal of central venous catheter routine care
Experimental: evidence-based intervention Plan for the Prevention of CRBSI in ICU patients; On the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention.	Behavioral: evidence-based intervention Plan for the Prevention of CRBSI in ICU patients; On the basis of routine nursing, the "evidence-based intervention Plan for the Prevention of CRBSI in ICU patients" was implemented for intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CRBSI		1year
CRBSI incidence ratio	Ratio of CRBSI incidence per quarter (IRR)	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU stay	Length of ICU stay	1 year
Related Mortality	ICU CRBSI-related mortality	1 year
ICU hospitalization cost		1 year

Collaborators and Investigators

• Sponsor: Fudan University
• Collaborators: Shanghai Zhongshan Hospital; Huashan Hospital; Children's Hospital of Fudan University; Shanghai Public Health Clinical Center; The First Affiliated Hospital of University of South China; Shanghai Minhang Central Hospital; Affiliated Hospital of Nantong University; Shenzhen Third People's Hospital; Xi 'an children's hospital; Affiliated Hospital of Southwest Medical University; Affiliated Hospital of Guizhou Medical University; Fudan University Evidence-based Nursing Center; Shandong First Medical University affiliated Provincial Hospital; 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; 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; The First Affiliated Hospital of Xi 'an Jiaotong University; Shanghai Dongfang Hospital
• Investigators: Study Chair: Yan Hu, School of Nursing, Fudan University; Center for Evidence-based Nursing, Fudan University; Study Director: YuXia Zhang, Department of Nursing, Zhongshan Hospital Affiliated to Fudan University; Study Director: Ying Gu, Center for Evidence-based Nursing, Fudan University

Publications and helpful links

General Publications

• Parienti JJ, Mongardon N, Megarbane B, Mira JP, Kalfon P, Gros A, Marque S, Thuong M, Pottier V, Ramakers M, Savary B, Seguin A, Valette X, Terzi N, Sauneuf B, Cattoir V, Mermel LA, du Cheyron D; 3SITES Study Group. Intravascular Complications of Central Venous Catheterization by Insertion Site. N Engl J Med. 2015 Sep 24;373(13):1220-9. doi: 10.1056/NEJMoa1500964.
• Peng S, Lu Y. Clinical epidemiology of central venous catheter-related bloodstream infections in an intensive care unit in China. J Crit Care. 2013 Jun;28(3):277-83. doi: 10.1016/j.jcrc.2012.09.007. Epub 2012 Dec 21.
• Lindgren S, Pikwer A, Ricksten SE, Akeson J. Survey of central venous catheterisation practice in Sweden. Acta Anaesthesiol Scand. 2013 Nov;57(10):1237-44. doi: 10.1111/aas.12190. Epub 2013 Sep 16.
• Govindan S, Jobe A, O'Malley ME, Flanders SA, Chopra V. To PICC or not to PICC? A cross-sectional survey of vascular access practices in the ICU. J Crit Care. 2021 Jun;63:98-103. doi: 10.1016/j.jcrc.2021.02.004. Epub 2021 Feb 20.
• O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the prevention of intravascular catheter-related infections. Clin Infect Dis. 2011 May;52(9):e162-93. doi: 10.1093/cid/cir257. Epub 2011 Apr 1. No abstract available.
• Rosenthal VD, Maki DG, Mehta Y, Leblebicioglu H, Memish ZA, Al-Mousa HH, Balkhy H, Hu B, Alvarez-Moreno C, Medeiros EA, Apisarnthanarak A, Raka L, Cuellar LE, Ahmed A, Navoa-Ng JA, El-Kholy AA, Kanj SS, Bat-Erdene I, Duszynska W, Van Truong N, Pazmino LN, See-Lum LC, Fernandez-Hidalgo R, Di-Silvestre G, Zand F, Hlinkova S, Belskiy V, Al-Rahma H, Luque-Torres MT, Bayraktar N, Mitrev Z, Gurskis V, Fisher D, Abu-Khader IB, Berechid K, Rodriguez-Sanchez A, Horhat FG, Requejo-Pino O, Hadjieva N, Ben-Jaballah N, Garcia-Mayorca E, Kushner-Davalos L, Pasic S, Pedrozo-Ortiz LE, Apostolopoulou E, Mejia N, Gamar-Elanbya MO, Jayatilleke K, de Lourdes-Duenas M, Aguirre-Avalos G; International Nosocomial Infection Control Consortium. International Nosocomial Infection Control Consortium (INICC) report, data summary of 43 countries for 2007-2012. Device-associated module. Am J Infect Control. 2014 Sep;42(9):942-56. doi: 10.1016/j.ajic.2014.05.029. Erratum In: Am J Infect Control. 2015 Jul;43(7):779-81.
• Granger BB. Science of Improvement Versus Science of Implementation: Integrating Both Into Clinical Inquiry. AACN Adv Crit Care. 2018 Summer;29(2):208-212. doi: 10.4037/aacnacc2018757. No abstract available.
• Koczwara B, Stover AM, Davies L, Davis MM, Fleisher L, Ramanadhan S, Schroeck FR, Zullig LL, Chambers DA, Proctor E. Harnessing the Synergy Between Improvement Science and Implementation Science in Cancer: A Call to Action. J Oncol Pract. 2018 Jun;14(6):335-340. doi: 10.1200/JOP.17.00083. Epub 2018 May 14. No abstract available.
• Pronovost P, Needham D, Berenholtz S, Sinopoli D, Chu H, Cosgrove S, Sexton B, Hyzy R, Welsh R, Roth G, Bander J, Kepros J, Goeschel C. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-32. doi: 10.1056/NEJMoa061115. Erratum In: N Engl J Med. 2007 Jun 21;356(25):2660.
• Berenholtz SM, Lubomski LH, Weeks K, Goeschel CA, Marsteller JA, Pham JC, Sawyer MD, Thompson DA, Winters BD, Cosgrove SE, Yang T, Louis TA, Meyer Lucas B, George CT, Watson SR, Albert-Lesher MI, St Andre JR, Combes JR, Bohr D, Hines SC, Battles JB, Pronovost PJ; On the CUSP: Stop BSI program. Eliminating central line-associated bloodstream infections: a national patient safety imperative. Infect Control Hosp Epidemiol. 2014 Jan;35(1):56-62. doi: 10.1086/674384. Epub 2013 Nov 26.
• Marsteller JA, Sexton JB, Hsu YJ, Hsiao CJ, Holzmueller CG, Pronovost PJ, Thompson DA. A multicenter, phased, cluster-randomized controlled trial to reduce central line-associated bloodstream infections in intensive care units*. Crit Care Med. 2012 Nov;40(11):2933-9. doi: 10.1097/CCM.0b013e31825fd4d8.
• Blot K, Bergs J, Vogelaers D, Blot S, Vandijck D. Prevention of central line-associated bloodstream infections through quality improvement interventions: a systematic review and meta-analysis. Clin Infect Dis. 2014 Jul 1;59(1):96-105. doi: 10.1093/cid/ciu239. Epub 2014 Apr 9.
• Gorski LA. The 2016 Infusion Therapy Standards of Practice. Home Healthc Now. 2017 Jan;35(1):10-18. doi: 10.1097/NHH.0000000000000481.
• Septimus EJ. Society for Healthcare Epidemiology of America Compendium updates 2022. Curr Opin Infect Dis. 2023 Aug 1;36(4):263-269. doi: 10.1097/QCO.0000000000000926. Epub 2023 Jun 2.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: October 10, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 17, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 24, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Infections; Communicable Diseases
• Other Study ID Numbers: B2023-212R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No