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

NCT05152446 | Terminated

• 1 other identifier: FNDGJ202110
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 9

Brief 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 " .

Conditions

Children,Hospitalized; Infusion; Infections

Keywords

implementation study; pediatric; effect evaluation; management of infusion nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Changes of Inspection rate of suspected CLABSI samples

  From baseline to the end of the 6-month implementation

• Incidece of infiltration (of Grade2 or higher) and/or extravasation

  During the 6-month implementation

• Changes of the scores of readiness of internal context

  From baseline to the end of the 6-month implementation

Study Arms (1)

Infusion management scheme

EXPERIMENTAL

To implement infusion management scheme, then observe the continuous changes.

Other: Infusion management scheme

Interventions

Infusion management scheme OTHER

* 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.

Infusion management scheme

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• Hospitalized children aged 0\~18 years
• Catheterization and maintenance in the same center
• The indwelling time is longer than 48h

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (9)

Anhui Provincial Children's Hospital

Hefei, Anhui, China

Location

Xiamen Children's Hospital

Xiamen, Fujian, China

Location

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

Tongji Hospital

Wuhan, Hubei, China

Location

Hunan Children's Hospital

Changsha, Hunan, China

Location

Qidong Women's and Children's Health

Qidong, Jiangsu, China

Location

Dalian women and children's medical group

Dalian, Liaoning, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: March 7, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)