跳至主要内容
临床试验/NCT05378568
NCT05378568已完成不适用

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

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 4,652 人开始时间: 2022年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,652
试验地点
1
主要终点
Error rate in peripheral intravenous infusion device selection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
28 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Error rate in peripheral intravenous infusion device selection

时间窗: 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%.

次要结局

  • Compliance of evidence-based practice behavior of nurses(6 months)
  • The cost of intravenous infusion consumables(6 months)
  • Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework(6 months)
  • The knowledge level of nurses' intravenous infusion device selection(6 months)
  • Incidence of infiltration and/or extravasation(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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