Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals

Infections Clinical Trial

Official title:

Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals：A Multi-center Before-afer Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05152446
• Other study ID #: FNDGJ202110
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: August 7, 2024

Study information

• Verified date: February 2024
• Source: Children's Hospital of Fudan University
• Contact: Ying Gu
• Phone: 8618017590969
• Email: guying0128[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multi-center before-after trial design. The object is to observe whether the incidence of central line associated blood stream infection(CLABSI) will tend to descend compared with retrospective electronic medical record data after implementation of an infusion management scheme which comes form " Clinical Practice Guideline on Infusion Therapy in Children " .

Description:

Infusion therapy is an important part in pediatric ward. Most hospitalized children need indwelling vascular access devices to receive infusion therapy. Much attention has been paid to possible serious or fatal complications due to immature immune system, poor communication ability and cognitive disorder in children during catheter placement, use and maintenance. Reducing the complications related to central venous catheter has become the focus of the global health care system. Studies have shown that the technical level of operators is in connection with the incidence of CLABSI, and an intravenous infusion team (IV Team) is the key to preventing CLABSI, which may fundamentally improve the clinical outcomes of pediatric patients. From December 2021 to April 2023, taking Children's Hospital of Fudan University as the leading center, Xiamen Children's Hospital, Anhui Provincial Children's Hospital, Dalian Municipal Women and Children's Medical Group, Tongji Hospital, First Affiliated Hospital of Guangxi Medical University, Qidong Women's and Children's Health, Chengdu Women's and Children's Central Hospital, Hunan Children's Hospital as the cooperation centers. A retrospective review of electronic medical record data will be collected first. The intervention is composed of setting up a pediatric intravenous infusion team; carrying out a quality improvement in collecting and sending suspected CLABSI samples; providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12568
• Est. completion date: August 7, 2024
• Est. primary completion date: August 7, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 18 Years

Eligibility

Inclusion Criteria for centers:

• A tertiary children's hospital with more than 300 beds

• The vice president in charge of nursing affairs, the director of nursing department and the director of hospital infection control department all agree in participating in this study with written permission, which include total acceptance of infusion management scheme and outcome indicators report as required

• To obtain the approval from Ethics Committee of the hospital

Inclusion Criteria for patients:

• Hospitalized children aged 0~18 years

• Catheterization and maintenance in the same center

• The indwelling time is longer than 48h

Exclusion Criteria:

• The vice president in charge of nursing affairs or the director of nursing department inform the researcher to withdraw from this study with written form and should clear reasons

• The number of cases for suspected CLABSI sample actually submitted for inspection / The number of cases for suspected CLABSI sample should submitted for inspection<0.9

• The awareness rate of infusion management scheme in clinical nurses is less than 90% and the qualification rate of the practice examination in clinical nurses is less than90% during inspection

Related Conditions & MeSH terms

• Infections

Intervention

Other:
• Infusion management scheme
To set up a pediatric intravenous infusion team; To form standardized procedures by carrying out a quality improvement program in collecting and sending samples for inspection once suspected CLABSI occurs (1 month for training and 3 months for continuous improvement ); providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy( 6-month implementation); To observe the continued daily infusion practice in 6 months.

Locations

Country	Name	City	State
China	Hunan Children's Hospital	Changsha	Hunan
China	Chengdu Women's and Children's Central Hospital	Chengdu	Sichuan
China	Dalian women and children's medical group	Dalian	Liaoning
China	Anhui Provincial Children's Hospital	Hefei	Anhui
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Qidong Women's and Children's Health	Qidong	Jiangsu
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Tongji Hospital	Wuhan	Hubei
China	Xiamen Children's Hospital	Xiamen	Fujian

Sponsors (9)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University	Anhui Provincial Children's Hospital, Chengdu Women's and Children's Central Hospital, Dalian women and children's medical group, First Affiliated Hospital of Guangxi Medical University, Hunan Children's Hospital, Qidong Women's and Children's Health, Tongji Hospital, Xiamen Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CLABSI	CLABSI diagnostic criteria requires that a central line is in situ at the time of or within 48 hours; children with a central line have fever (over 38?), chills, hypotension or mental state changes; there is no alternate source of bloodstream infection. Apart from the above three necessary requirements, CLABSI diagnosis could be accompanied by two positive blood cultures drawn from a peripheral vein and a CVAD, two positive blood cultures drawn from different CVADs, one positive blood culture from a CVAD with a planned specific antimicrobial therapy or common skin contamination bacteria cultured (eg. Coagulase-negative Staphylococci, diphtheroids, Bacillus or Micrococcus).; Incidence of CLABSI = (case numbers of CLABSI)/(Catheter Days per Month)×1000‰.	During the 6-month implementation
Secondary	Changes of Inspection rate of suspected CLABSI samples	When there are suspected cases of CLABSI, the physician will prescribe blood culture and the nurse will draw blood within 1 hour and send them for inspection (if antibiotics are needed, blood should be drawn before administration).; Suspected CLABSI samples inspection rate= (documented samples for inspection )/(Required samples for inspection)×100%.	From baseline to the end of the 6-month implementation
Secondary	Incidece of infiltration (of Grade2 or higher) and/or extravasation	Incidence of infiltration (of Grade2 or higher) and extravasation: The bedside nurses document PIV infiltration and extravasation using "Pediatric PIV Infiltration Scale" during fluid infusing and every shift.; Incidence of infiltration (of Grade2 or higher) and/or extravasation = (case numbers of infiltration (of Grade2 or higher) and/or extravasation)/(Catheter Days per Month)×1000‰.	During the 6-month implementation
Secondary	Changes of the scores of readiness of internal context	10% of nurses in every participant center will be randomly drawn to complete the investigation questionnaire for the readiness of internal context using self-made "Assessment Tool of Organizational Internal Context (6 items) " and "Assessment Tool of Local Internal Context ( 9 items)".The purpose of the survey is to evaluate the internal context of evidence-based practice in each participant center. The score of each item is based on Likert 5 grades rating levels from 1 (lowest) to 5 (highest).	From baseline to the end of the 6-month implementation