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

February 20, 2023 updated by: Children's Hospital of Fudan University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4652

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201102
        • Children's Hospital of Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

4 weeks to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria for nurses:

  • 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)

Inclusion Criteria for patients:

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

Exclusion Criteria for nurses:

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

Exclusion Criteria for patients:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
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.
Active Comparator: the existing nursing routine
Follow the existing nursing routine of intravenous infusion and the selection of peripheral venous access devices.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Error rate in peripheral intravenous infusion device selection
Time Frame: 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%.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The knowledge level of nurses' intravenous infusion device selection
Time Frame: 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.
6 months
Compliance of evidence-based practice behavior of nurses
Time Frame: 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%
6 months
Incidence of infiltration and/or extravasation
Time Frame: 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‰.
6 months
The cost of intravenous infusion consumables
Time Frame: 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.
6 months
Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Fudan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ying Gu, doctor, Children's Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FNF202112

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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