Infusions, IntravenousNCT07184489
Validation of the Effectiveness of the CFIR - ERIC Matching Tool in Implementation Research
A study testing implementation strategies in people with Infusions, Intravenous and Implementation Science, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
The goal of this implementation study is to learn if the CFIR-ERIC matching tool is effective indeveloping implementation strategies for pediatric nurse. The evidence practised in this study is the pediatric venous access device selection decision tree from clinical practice guideline on infusion therapy in children. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infusions, Intravenous, Implementation Science
- What is being tested?
- implementation strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having worked at the research site for ≥ 1 year;
- Being able to independently perform nursing operations (having completed the content related to intravenous infusion in the standardized training of this hospital and passed the assessment).
Who cannot join
- Not having obtained the nurse practice license;
- Refusing to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, 201102
Ying Gu, Doctor, +86 13816881726, guying0128@aliyun.com
About this study
Official title: Validation of the Effectiveness of the CFIR - ERIC Matching Tool in Implementation Research of Pediatric Venous Access Device Selection
The goal of this implementation study is to learn if the CFIR-ERIC matching tool is effective indeveloping implementation strategies for pediatric nurse. The evidence practised in this study is the pediatric venous access device selection decision tree from clinical practice guideline on infusion therapy in children. The main questions it aims to answer are:
- Does the implementation strategies developed by CFIR-ERIC matching tool improve nurses knowledge in venous access devices selection.
- Does the implementation strategies developed by CFIR-ERIC matching tool lower the error rate of appropriate venous access device selection.
Read more
Researchers will compare the CFIR-ERIC group to a blank group to see if CIFR-ERIC matching tool works to improve nurses knowleged and lower the error rate of venous access device selection.
Participants will:
- Receive the implementation strategies made by CFIR-ERIC matching tool.
- Using the pediatric venous access device selection decision trees in daily catheterization.
- Record their venous access device selection informantion, consumables usage and pediatric patients' outcome.
Read the detailed description
Currently，the evidence-based practice research often isolates barrier assessment from implementation strategy development. At tne same time, many implementation science models being overly complex for clinicians. In Chinese, certain studies still neglect barrier assessment, demonstrate inconsistent conceptualization of implementation strategies, and rarely classify developed strategies.
As a tool for matching and selecting implementation strategies, the CFIR - ERIC matching tool has the characteristics of strong pertinence, repeatability, structuring, systematization, and simple and convenient operation compared with other models. Researchers can identify barrier factors through CFIR and use the CFIR - ERIC matching tool to match strategies to promote the implementation of clinical intervention measures.
This implementation study adopted a pre-post design using the CFIR-ERIC Matching Tool to analyze barriers and develop strategies. Grounded in the "Pediatric Venous Access Device Selection Decision Tree" from the 2021 clinical practice guideline on infusion therapy in children, the intervention was rolled out across 21 wards at the Children's Hospital of Fudan University.
The implementation process of the evidence was evaluated from four aspects using the RE-AIM framework , including the evaluation indicators corresponding to each dimension of patient reach, intervention efficacy, medical adoption, and guideline implementation.
- Conditions
- Infusions, Intravenous, Implementation Science
- Being tested
- implementation strategies
- Keywords
- implementation strategy, CFIR-ERIC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implementation strategiesOther
Also called pediatric venous access device selection decision tree
- Analysis of barrier factors: A focus group interview will be conducted. Purposive sampling was used to include senior nurses in the ward, members of the evidence-based group, and doctors for the analysis of barrier factors. Then the CFIR-ERIC matching tool will be used to develop implementation strategies based on the barrier factors.
- The best - worst scaling method will be used to generate relatively reliable and valid preference evidence of stakeholders for implementation strategies from CFIR-ERIC matching tool.
- The implementation strategies will be developed specifically by an expert group. This group includes nursing managers and experts in evidence-based practice.
- Implement the strategies.
| Study group | Role | What they receive |
|---|---|---|
| CFIR-ERIC group | Experimental | Develop implementation strategies for applying evidence to clinical practice using CFIR - ERIC matching tool. Receives: Other: implementation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
error rate of appropriate venous access device selection
According to the recommendations in the guidelines, selecting the infusion device is considered correct, while failing to select according to the recommendations is considered incorrect. Error rate = Number of incorrect selections / Total number of catheter insertions by nurses
Measured: 6 months
Secondary outcomes (5)
Score of nurses' knowledge questionaire of venous access device selection
The knowledge questionnaire is divided into three dimensions: device-related knowledge, access-related knowledge, and selection-related knowledge, with a total score of 100. The higher the score, the better the nurses' mastery of knowledge about venous device selection. The online knowledge questionnaire will be distributed to nurses before and after the intervention, and nurses are required to finish it during the morning shift handover. The researchers will conduct statistics on the questionnaire scores.
Measured: The third and sixth months of the research.
Nurses' compliance with evidence-based practice behaviors
Develop review indicators based on the evidence from applications, and review whether nurses have achieved the corresponding indicators in clinical practice.
Measured: 6 months
Complication rate
Statistically analyze the incidence of catheter-related complications in children after nurses select intravenous infusion devices.
Measured: 6 months
The cost of venous access device consumables
Including venous access device (including the total number of catheters consumed by successful or failed placement), dressing, central venous maintenance kits, infusion connectors, and flushing or locking solution.
Measured: 6 months
Implementing process evaluated 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 course; 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 nurse 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 posted19 Sep 2025
- Study start20 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infusions, IntravenousStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 394 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184489
- Sponsor's protocol ID
- CHFudanU0814
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 19 Sep 2025
- 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 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Effectiveness of the CFIR - ERIC Matching Tool in Implementation Research of Pediatric Venous Access Device Selection
- ClinicalTrials.gov ID
- NCT07184489
- Acronym / sponsor ID
- CHFudanU0814
- Conditions
- Infusions, Intravenous, Implementation Science
- Keywords
- implementation strategy, CFIR-ERIC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2025 (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.
The goal of this implementation study is to learn if the CFIR-ERIC matching tool is effective indeveloping implementation strategies for pediatric nurse. The evidence practised in this study is the pediatric venous access device selection decision tree from clinical practice guideline on infusion therapy in children. The main questions it aims to answer are:
- Does the implementation strategies developed by CFIR-ERIC matching tool improve nurses knowledge in venous access devices selection.
- Does the implementation strategies developed by CFIR-ERIC matching tool lower the error rate of appropriate venous access device selection.
Researchers will compare the CFIR-ERIC group to a blank group to see if CIFR-ERIC matching tool works to improve nurses knowleged and lower the error rate of venous access device selection.
Participants will:
- Receive the implementation strategies made by CFIR-ERIC matching tool.
- Using the pediatric venous access device selection decision trees in daily catheterization.
- Record their venous access device selection informantion, consumables usage and pediatric patients' outcome.
Detailed description
Currently，the evidence-based practice research often isolates barrier assessment from implementation strategy development. At tne same time, many implementation science models being overly complex for clinicians. In Chinese, certain studies still neglect barrier assessment, demonstrate inconsistent conceptualization of implementation strategies, and rarely classify developed strategies.
As a tool for matching and selecting implementation strategies, the CFIR - ERIC matching tool has the characteristics of strong pertinence, repeatability, structuring, systematization, and simple and convenient operation compared with other models. Researchers can identify barrier factors through CFIR and use the CFIR - ERIC matching tool to match strategies to promote the implementation of clinical intervention measures.
This implementation study adopted a pre-post design using the CFIR-ERIC Matching Tool to analyze barriers and develop strategies. Grounded in the "Pediatric Venous Access Device Selection Decision Tree" from the 2021 clinical practice guideline on infusion therapy in children, the intervention was rolled out across 21 wards at the Children's Hospital of Fudan University.
The implementation process of the evidence was evaluated from four aspects using the RE-AIM framework , including the evaluation indicators corresponding to each dimension of patient reach, intervention efficacy, medical adoption, and guideline implementation.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CFIR-ERIC group | Experimental | Other: implementation strategiesDevelop implementation strategies for applying evidence to clinical practice using CFIR - ERIC matching tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having worked at the research site for ≥ 1 year;
- Being able to independently perform nursing operations (having completed the content related to intravenous infusion in the standardized training of this hospital and passed the assessment).
Key exclusion criteria (2 listed)
- Not having obtained the nurse practice license;
- Refusing to participate in this study.
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 |
|---|---|---|
| implementation strategiesAlso: pediatric venous access device selection decision tree1. Analysis of barrier factors: A focus group interview will be conducted. Purposive sampling was used to include senior nurses in the ward, members of the evidence-based group, and doctors for the analysis of barrier factors. Then the CFIR-ERIC matching tool will be used to develop implementation strategies based on the barrier factors. 2. The best - worst scaling method will be used to generate relatively reliable and valid preference evidence of stakeholders for implementation strategies from CFIR-ERIC matching tool. 3. The implementation strategies will be developed specifically by an expert group. This group includes nursing managers and experts in evidence-based practice. 4. Implement the strategies. | Other | CFIR-ERIC group |
Primary outcome
error rate of appropriate venous access device selection
Time frame: 6 months
According to the recommendations in the guidelines, selecting the infusion device is considered correct, while failing to select according to the recommendations is considered incorrect. Error rate = Number of incorrect selections / Total number of catheter insertions by nurses
5 secondary outcomes
Score of nurses' knowledge questionaire of venous access device selection
Time frame: The third and sixth months of the research.
Nurses' compliance with evidence-based practice behaviors
Time frame: 6 months
Complication rate
Time frame: 6 months
The cost of venous access device consumables
Time frame: 6 months
Implementing process evaluated based on "Reach*Efficacy(RE)-Adoption, Implementation, and Maintenance(AIM)" framework
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing implementation strategies in people with Infusions, Intravenous and Implementation Science, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 19 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaliuhui WANG (+86 18085293862, ylhwang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
error rate of appropriate venous access 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 19 Sep 2025.