Children,HospitalizedNCT05378568
Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children
A study testing the selection scheme of peripheral venous access devices and the existing nursing routine in people with Children,Hospitalized and Vascular Access Devices, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Children,Hospitalized, Vascular Access Devices
- What is being tested?
- the selection scheme of peripheral venous access devices and the existing nursing routine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,652 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2022to 30 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: 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.
Read the 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
- Being tested
- the selection scheme of peripheral venous access devices, the existing nursing routine
- Keywords
- pediatric, implementation study, peripheral venous access devices, selection, effect evaluation, appropriateness, randomised trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the selection scheme of peripheral venous access devicesOther
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 routineOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: the existing nursing routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 6 months
Secondary outcomes (5)
The knowledge level of nurses' intravenous infusion device selection
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.
Measured: 6 months
Compliance of evidence-based practice behavior of nurses
compliance of each review indicator = (the number of correct implementation of this indicator by nurses)/(the total number of reviews of this indicator) *100%
Measured: 6 months
Incidence of infiltration and/or extravasation
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‰.
Measured: 6 months
The cost of intravenous infusion consumables
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.
Measured: 6 months
Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start30 May 2022
- Primary completion30 Oct 2022
- Study completion30 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children,HospitalizedStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,652 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ying Gu, doctor, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378568
- Sponsor's protocol ID
- FNF202112
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2022
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of the Selection Scheme of Peripheral Venous Infusion Devices for Hospitalized Children: a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05378568
- Acronym / sponsor ID
- FNF202112
- Conditions
- Children,Hospitalized, Vascular Access Devices
- Keywords
- pediatric, implementation study, peripheral venous access devices, selection, effect evaluation, appropriateness, randomised trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,652 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Oct 2022 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the selection scheme of peripheral venous access devices | Experimental | Other: the selection scheme of peripheral venous access devicesTo 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. |
| the existing nursing routine | Active comparator | Other: the existing nursing routineFollow the existing nursing routine of intravenous infusion and the selection of peripheral venous access devices. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the selection scheme of peripheral venous access devicesBased 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 selection scheme of peripheral venous access devices |
| the existing nursing routineTo 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. | Other | the existing nursing routine |
Primary outcome
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%.
5 secondary outcomes
The knowledge level of nurses' intravenous infusion device selection
Time frame: 6 months
Compliance of evidence-based practice behavior of nurses
Time frame: 6 months
Incidence of infiltration and/or extravasation
Time frame: 6 months
The cost of intravenous infusion consumables
Time frame: 6 months
Implementation process evaluation based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ying Gu, doctor study chair
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the selection scheme of peripheral venous access devices and the existing nursing routine in people with Children,Hospitalized and Vascular Access Devices, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Error rate in peripheral intravenous infusion device selection (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.