Clinical trial NCT05152446: Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals
Official title: Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals：A Multi-center Before-afer Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Children,Hospitalized
Infusion
Infections
Keywords: implementation study
pediatric
effect evaluation
management of infusion nursing
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Xiamen Children's Hospital
name: Anhui Provincial Children's Hospital
name: Dalian women and children's medical group
name: First Affiliated Hospital of Guangxi Medical University
name: Qidong Women's and Children's Health
name: Chengdu Women's and Children's Central Hospital
name: Hunan Children's Hospital
name: Tongji Hospital
First posted: 2021-12-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 " .

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of CLABSI
timeFrame: During the 6-month implementation
Secondary outcomes:
measure: Changes of Inspection rate of suspected CLABSI samples
timeFrame: From baseline to the end of the 6-month implementation
measure: Incidece of infiltration (of Grade2 or higher) and/or extravasation
timeFrame: During the 6-month implementation
measure: Changes of the scores of readiness of internal context
timeFrame: From baseline to the end of the 6-month implementation
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Xiamen
country: China
facility: Xiamen Children's Hospital
state: Fujian
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Qidong
country: China
facility: Qidong Women's and Children's Health
state: Jiangsu
city: Dalian
country: China
facility: Dalian women and children's medical group
state: Liaoning
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
Study officials:
References: