Clinical trial NCT05378568: Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children
Official title: Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children: a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children,Hospitalized
Vascular Access Devices
Keywords: pediatric
implementation study
peripheral venous access devices
selection
effect evaluation
appropriateness
randomised trial
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 4652
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a stepped wedge cluster randomized trial design. The object is to evaluate the influence on patient outcomes, medical staff's evidence-based practice behavior and hospital context after implementation of the selection scheme of venous access devices comes from" Evidence-based guidelines for clinical practice of intravenous infusion therapy in children". This study sought to compare the appropriateness of peripheral venous access device selection, to compare the incidence of infiltration and extravasation and the cost of venous infusion consumables before and after the implementation of the scheme.

Detailed description: This study aimed to improve the standardization and suitability of device use and reduce complications associated with intravenous fluids by implementing best practice evidence for intravenous fluid device selection in children. In 2021, the Chinese Journal of Evidence-Based Pediatrics released the " Evidence-based guidelines for clinical practice of intravenous infusion therapy in children". The researchers used the evidence in this guideline as a standard to understand the current status of clinical intravenous infusion device selection and the gap between the current situation and the evidence. The evidence tailor, baseline review, develop implementation plan, conduct implementation research. A stepped wedge cluster randomized trial divided into 5 steps, 10 clusters(units), and the step size was one month. Each included ward of a tertiary first-class pediatric hospital was regarded as a group, and each step was included into randomized two groups, and the observation was maintained for one month until all units were included in the intervention in the fifth month, with a total of 6 research periods. Given the practicality of the study design, limited additional inclusion and exclusion criteria will be added.

Eligibility criteria: Inclusion Criteria for nurses:

* Nurses have been working in the siting more than 1 year
* Nurses who can independently perform nursing operations (complete the contents related to intravenous infusion in the standardized training of hospital and pass the examination)

Inclusion Criteria for patients:

* Patients receiving intravenous infusion
* Hospitalized patients aged 28 days to 18 years

Exclusion Criteria for nurses:

* Nurses who has not obtained the practicing qualification certificate
* Nurses refused to participate in the study

Exclusion Criteria for patients:

* The indwelling time is less than 24h
* Patients who were put into intravenous catheter at admission and did not receive new catheter during hospitalization
* Patients with only one stat(st) order for intravenous infusion during hospitalization
* Patients refused to participate in the study

Primary outcomes:
measure: Error rate in peripheral intravenous infusion device selection
timeFrame: 6 months
Secondary outcomes:
measure: The knowledge level of nurses' intravenous infusion device selection
timeFrame: 6 months
measure: Compliance of evidence-based practice behavior of nurses
timeFrame: 6 months
measure: Incidence of infiltration and/or extravasation
timeFrame: 6 months
measure: The cost of intravenous infusion consumables
timeFrame: 6 months
measure: Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Gu, doctor
role: STUDY_CHAIR
References: