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

NCT ID: NCT05152446

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-07

Study Completion Date

2024-11-01

Brief Summary

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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 " .

Detailed Description

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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.

Conditions

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Children,Hospitalized Infusion Infections

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Infusion management scheme

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

Group Type EXPERIMENTAL

Infusion management scheme

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiamen Children's Hospital

OTHER

Sponsor Role collaborator

Anhui Provincial Children's Hospital

OTHER

Sponsor Role collaborator

Dalian women and children's medical group

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Guangxi Medical University

OTHER

Sponsor Role collaborator

Qidong Women's and Children's Health

UNKNOWN

Sponsor Role collaborator

Chengdu Women's and Children's Central Hospital

OTHER

Sponsor Role collaborator

Hunan Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Tongji Hospital

OTHER

Sponsor Role collaborator

Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anhui Provincial Children's Hospital

Hefei, Anhui, China

Site Status

Xiamen Children's Hospital

Xiamen, Fujian, China

Site Status

First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status

Tongji Hospital

Wuhan, Hubei, China

Site Status

Hunan Children's Hospital

Changsha, Hunan, China

Site Status

Qidong Women's and Children's Health

Qidong, Jiangsu, China

Site Status

Dalian women and children's medical group

Dalian, Liaoning, China

Site Status

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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FNDGJ202110

Identifier Type: -

Identifier Source: org_study_id

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