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

NCT ID: NCT05378568

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4652 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-10-30

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.

Conditions

Children,Hospitalized; Vascular Access Devices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

the selection scheme of peripheral venous access devices

Intervention Type: OTHER

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.

the existing nursing routine

Follow the existing nursing routine of intravenous infusion and the selection of peripheral venous access devices.

Group Type: ACTIVE_COMPARATOR

the existing nursing routine

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

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

Exclusion Criteria

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

• 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

• Minimum Eligible Age: 28 Days
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ying Gu, doctor

Role: STUDY_CHAIR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FNF202112

Identifier Type: -

Identifier Source: org_study_id