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

Quality Improvement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06085690
• Other study ID #: B2023-212R
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: February 2024
• Source: Fudan University
• Contact: CHUNLEI Li
• Phone: 15800488689
• Email: 21211170023[@]m.fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8050
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Central Line Infection
• Central Venous Catheter Associated Bloodstream Infection
• Central Venous Catheter Related Bloodstream Infection
• CLABSI - Central Line Associated Bloodstream Infection
• Communicable Diseases
• Infections
• Quality Improvement
• Sepsis

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.

Locations

Country	Name	City	State
China	ZhongShan Hospital Affilicated to Fudan University	Shanghai	Shanghai

Sponsors (24)

Lead Sponsor

Collaborator

Fudan University

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

Country where clinical trial is conducted

China, 

References & Publications (14)

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, Prono — View Citation

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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. — View Citation

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):3 — View Citation

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. — View Citation

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 — View Citation

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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. — View Citation

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- — View Citation

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, — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CRBSI		1year
Primary	CRBSI incidence ratio	Ratio of CRBSI incidence per quarter (IRR)	1 year
Secondary	Length of ICU stay	Length of ICU stay	1 year
Secondary	Related Mortality	ICU CRBSI-related mortality	1 year
Secondary	ICU hospitalization cost		1 year