Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children

Not Applicable

Completed

• Conditions: Children,Hospitalized; Vascular Access Devices
• Interventions: Other: the existing nursing routine; Other: the selection scheme of peripheral venous access devices

• Registration Number: NCT05378568
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-18
• Study Start: 2022-05-30
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-20
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4652

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the existing nursing routine	the existing nursing routine	Follow the existing nursing routine of intravenous infusion and the selection of peripheral venous access devices.
the selection scheme of peripheral venous access devices	the selection scheme of peripheral venous access devices	To implement the selection scheme of peripheral venous access devices, based on the Clinical Practice Guideline on Infusion Therapy in Children. Then observe the appropriateness of peripheral venous access devices selection.

Primary Outcome Measures

Name	Time	Method
Error rate in peripheral intravenous infusion device selection	6 months	The selection is made according to the recommendation of the guidelines. Those who conform to the recommendation are correct, those who do not conform are wrong. Calculation method: the error rate = (the number of cases with wrong peripheral intravenous infusion device selection)/(the total number of cases using peripheral intravenous infusion device)\* 100%.

Secondary Outcome Measures

Name	Time	Method
Compliance of evidence-based practice behavior of nurses	6 months	compliance of each review indicator = (the number of correct implementation of this indicator by nurses)/(the total number of reviews of this indicator) \*100%
The cost of intravenous infusion consumables	6 months	including intravenous infusion devices (including the total number of catheters consumed by successful catheter placement and failed puncture), dress, central venous maintenance kits, infusion connectors, and tees.
Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework	6 months	including Reach, Efficacy, Adoption, Implementation, and Maintenance. Reach refers to the participation rate of training courses; Efficacy refers to the change of knowledge level and compliance of evidence-based practice behavior of nurses in the intervention group; Adoption refers to the proportion of evidence actually adopted by nurses in the intervention group and the changes of context; Implementation refers to the completion rate of each training plan in the implementation strategy；Maintenance refers to evaluating the maintenance of the selection scheme.
The knowledge level of nurses' intravenous infusion device selection	6 months	The questionnaire has a total of 50 questions, 24 choice questions, 12 judgment questions, and 14 fill-in-the-blank questions, each with 2 points, and the total score is 100 points. Before and after the implementation of the program, the evaluation will be conducted, a score of less than 60 is considered a failure, and a score of more than 80 is considered excellent.
Incidence of infiltration and/or extravasation	6 months	The bedside nurses document the number of incidents of peripheral venous infiltration and extravasation using "Pediatric Peripheral Venous Infiltration Scale". The incidence of infiltration and/or extravasation = (case numbers of infiltration and/or extravasation)/(Catheter Days per Month)×1000‰.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China