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

NCT05378568 | Completed

• 1 other identifier: FNF202112
• Study Type: interventional
• Target: 4,652
• Locations: 1 country
• Sites: 1

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.

Conditions

Children,Hospitalized; Vascular Access Devices

Keywords

pediatric; implementation study; peripheral venous access devices; selection; effect evaluation; appropriateness; randomised trial

Outcome Measures

Primary Outcomes (1)

• Error rate in peripheral intravenous infusion device selection

  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%.

  6 months

Secondary Outcomes (5)

• The knowledge level of nurses' intravenous infusion device selection

  6 months

• Compliance of evidence-based practice behavior of nurses

  6 months

• Incidence of infiltration and/or extravasation

  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

Study Arms (2)

the selection scheme of peripheral venous access devices

EXPERIMENTAL

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.

Other: the selection scheme of peripheral venous access devices

the existing nursing routine

ACTIVE COMPARATOR

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

Other: the existing nursing routine

Interventions

the selection scheme of peripheral venous access devices 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 selection scheme of peripheral venous access devices

the existing nursing routine 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.

the existing nursing routine

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Study Officials

• Ying Gu, doctor

  Children's Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: May 18, 2022
• Study Start: May 30, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: February 22, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)