NCT05378568

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

Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children: a Stepped Wedge Cluster Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4,652 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 28 Days – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Children,Hospitalized
• Vascular Access Devices

Interventions

Type	Name	Description
OTHER	the selection scheme of peripheral venous access devices	Based on the "Facilitator Toolkit" of the promoting action on research implementation in health services integrated framework(i-PARIHS), the implementation plan of peripheral intravenous infusion device selection in hospitalized children was formulated and applied, so as to change the practice behavior of nurses in the intervention group. The specific process mainly includes: tailoring evidence; baseline review; situational analysis; promotion and implementation strategy like lectures, group discussions, operation demonstrations, and scenario simulations.
OTHER	the existing nursing routine	To choose infusion device according to nurse's working experience. First, nurse placed a peripheral intravenous catheter. The patients and family decide whether to place the central intravenous infusion device according to the recommendation of the medical staff.

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-10-30
• Completion: 2022-10-30
• First posted: 2022-05-18
• Last updated: 2023-02-22

Locations

1 site across 1 country: China