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

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

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 " .

Study Overview

• Status: Terminated
• Conditions: Infections; Infusion; Children,Hospitalized
• Intervention / Treatment: Other: Infusion management scheme

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Provincial Children's Hospital
  • Fujian
    • Xiamen, Fujian, China
      • Xiamen Children's Hospital
  • Guangxi
    • Nanning, Guangxi, China
      • First Affiliated Hospital of Guangxi Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital
  • Hunan
    • Changsha, Hunan, China
      • Hunan Children's Hospital
  • Jiangsu
    • Qidong, Jiangsu, China
      • Qidong Women's and Children's Health
  • Liaoning
    • Dalian, Liaoning, China
      • Dalian Women and Children's Medical Group
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Women's and Children's Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Infusion management scheme; To implement infusion management scheme, then observe the continuous changes.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): November 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: pediatric; implementation study; effect evaluation; management of infusion nursing
• Other Study ID Numbers: FNDGJ202110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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