Children,HospitalizedNCT05152446
Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals
A study testing Infusion management scheme in people with Children,Hospitalized and Infusion, run by Children's Hospital of Fudan University at 9 sites in China.
Trial summary
This study is a multi-center before-after trial design. The object is to observe whether the incidence of central line associated blood stream infection(CLABSI) will tend to descend compared with retrospective electronic medical record data after implementation of an infusion management scheme which comes form "… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Children,Hospitalized, Infusion, Infections
- What is being tested?
- Infusion management scheme
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 9 sitesChina
- Study dates
- 7 Mar 2022to 1 Nov 2024
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A tertiary children's hospital with more than 300 beds
- The vice president in charge of nursing affairs, the director of nursing department and the director of hospital infection control department all agree in participating in this study with written permission, which include total acceptance of infusion management scheme and outcome indicators report as required
- To obtain the approval from Ethics Committee of the hospital
- Hospitalized children aged 0~18 years
- Catheterization and maintenance in the same center
- The indwelling time is longer than 48h
Who cannot join
- The vice president in charge of nursing affairs or the director of nursing department inform the researcher to withdraw from this study with written form and should clear reasons
- The number of cases for suspected CLABSI sample actually submitted for inspection / The number of cases for suspected CLABSI sample should submitted for inspection<0.9
- The awareness rate of infusion management scheme in clinical nurses is less than 90% and the qualification rate of the practice examination in clinical nurses is less than90% during inspection
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Hunan Children's Hospital
Changsha, Hunan
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
Dalian women and children's medical group
Dalian, Liaoning
Anhui Provincial Children's Hospital
Hefei, Anhui
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Qidong Women's and Children's Health
Qidong, Jiangsu
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Tongji Hospital
Wuhan, Hubei
Xiamen Children's Hospital
Xiamen, Fujian
About this study
Official title: Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals：A Multi-center Before-afer Trial
This study is a multi-center before-after trial design. The object is to observe whether the incidence of central line associated blood stream infection(CLABSI) will tend to descend compared with retrospective electronic medical record data after implementation of an infusion management scheme which comes form " Clinical Practice Guideline on Infusion Therapy in Children " .
Read the detailed description
Infusion therapy is an important part in pediatric ward. Most hospitalized children need indwelling vascular access devices to receive infusion therapy. Much attention has been paid to possible serious or fatal complications due to immature immune system, poor communication ability and cognitive disorder in children during catheter placement, use and maintenance. Reducing the complications related to central venous catheter has become the focus of the global health care system. Studies have shown that the technical level of operators is in connection with the incidence of CLABSI, and an intravenous infusion team (IV Team) is the key to preventing CLABSI, which may fundamentally improve the clinical outcomes of pediatric patients. From December 2021 to April 2023, taking Children's Hospital of Fudan University as the leading center, Xiamen Children's Hospital, Anhui Provincial Children's Hospital, Dalian Municipal Women and Children's Medical Group, Tongji Hospital, First Affiliated Hospital of Guangxi Medical University, Qidong Women's and Children's Health, Chengdu Women's and Children's Central Hospital, Hunan Children's Hospital as the cooperation centers. A retrospective review of electronic medical record data will be collected first. The intervention is composed of setting up a pediatric intravenous infusion team; carrying out a quality improvement in collecting and sending suspected CLABSI samples; providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy.
- Conditions
- Children,Hospitalized, Infusion, Infections
- Being tested
- Infusion management scheme
- Keywords
- implementation study, pediatric, effect evaluation, management of infusion nursing
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion management schemeOther
- To set up a pediatric intravenous infusion team;
- To form standardized procedures by carrying out a quality improvement program in collecting and sending samples for inspection once suspected CLABSI occurs (1 month for training and 3 months for continuous improvement ); providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy( 6-month implementation);
- To observe the continued daily infusion practice in 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Infusion management scheme | Experimental | To implement infusion management scheme, then observe the continuous changes. Receives: Other: Infusion management scheme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CLABSI
CLABSI diagnostic criteria requires that a central line is in situ at the time of or within 48 hours; children with a central line have fever (over 38℃), chills, hypotension or mental state changes; there is no alternate source of bloodstream infection. Apart from the above three necessary requirements, CLABSI diagnosis could be accompanied by two positive blood cultures drawn from a peripheral vein and a CVAD, two positive blood cultures drawn from different CVADs, one positive blood culture from a CVAD with a planned specific antimicrobial therapy or common skin contamination bacteria cultured (eg. Coagulase-negative Staphylococci, diphtheroids, Bacillus or Micrococcus).
Incidence of CLABSI = (case numbers of CLABSI)/(Catheter Days per Month)×1000‰.
Measured: During the 6-month implementation
Secondary outcomes (3)
Changes of Inspection rate of suspected CLABSI samples
When there are suspected cases of CLABSI, the physician will prescribe blood culture and the nurse will draw blood within 1 hour and send them for inspection (if antibiotics are needed, blood should be drawn before administration).
Suspected CLABSI samples inspection rate= (documented samples for inspection )/(Required samples for inspection)×100%.
Measured: From baseline to the end of the 6-month implementation
Incidece of infiltration (of Grade2 or higher) and/or extravasation
Incidence of infiltration (of Grade2 or higher) and extravasation: The bedside nurses document PIV infiltration and extravasation using "Pediatric PIV Infiltration Scale" during fluid infusing and every shift.
Incidence of infiltration (of Grade2 or higher) and/or extravasation = (case numbers of infiltration (of Grade2 or higher) and/or extravasation)/(Catheter Days per Month)×1000‰.
Measured: During the 6-month implementation
Changes of the scores of readiness of internal context
10% of nurses in every participant center will be randomly drawn to complete the investigation questionnaire for the readiness of internal context using self-made "Assessment Tool of Organizational Internal Context (6 items) " and "Assessment Tool of Local Internal Context ( 9 items)".The purpose of the survey is to evaluate the internal context of evidence-based practice in each participant center. The score of each item is based on Likert 5 grades rating levels from 1 (lowest) to 5 (highest).
Measured: From baseline to the end of the 6-month implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start7 Mar 2022
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Why it stopped: COVID-19
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Xiamen Children's Hospital, Anhui Provincial Children's Hospital, Dalian Women and Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Qidong Women's and Children's Health, Chengdu Women's and Children's Central Hospital, Hunan Children's Hospital, Tongji Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152446
- Sponsor's protocol ID
- FNDGJ202110
- Status last verified
- Oct 2024
- First submitted
- 26 Nov 2021
- Last updated
- 4 Nov 2024
- 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 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of an Infusion Management Scheme to Improve Patient Outcome in Tertiary Children's Hospitals：A Multi-center Before-afer Trial
- ClinicalTrials.gov ID
- NCT05152446
- Acronym / sponsor ID
- FNDGJ202110
- Conditions
- Children,Hospitalized, Infusion, Infections
- Keywords
- implementation study, pediatric, effect evaluation, management of infusion nursing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Xiamen Children's Hospital, Anhui Provincial Children's Hospital, Dalian Women and Children's Medical Center, First Affiliated Hospital of Guangxi Medical University, Qidong Women's and Children's Health, Chengdu Women's and Children's Central Hospital, Hunan Children's Hospital, Tongji Hospital
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 9 Dec 2021 (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 multi-center before-after trial design. The object is to observe whether the incidence of central line associated blood stream infection(CLABSI) will tend to descend compared with retrospective electronic medical record data after implementation of an infusion management scheme which comes form " Clinical Practice Guideline on Infusion Therapy in Children " .
Detailed description
Infusion therapy is an important part in pediatric ward. Most hospitalized children need indwelling vascular access devices to receive infusion therapy. Much attention has been paid to possible serious or fatal complications due to immature immune system, poor communication ability and cognitive disorder in children during catheter placement, use and maintenance. Reducing the complications related to central venous catheter has become the focus of the global health care system. Studies have shown that the technical level of operators is in connection with the incidence of CLABSI, and an intravenous infusion team (IV Team) is the key to preventing CLABSI, which may fundamentally improve the clinical outcomes of pediatric patients. From December 2021 to April 2023, taking Children's Hospital of Fudan University as the leading center, Xiamen Children's Hospital, Anhui Provincial Children's Hospital, Dalian Municipal Women and Children's Medical Group, Tongji Hospital, First Affiliated Hospital of Guangxi Medical University, Qidong Women's and Children's Health, Chengdu Women's and Children's Central Hospital, Hunan Children's Hospital as the cooperation centers. A retrospective review of electronic medical record data will be collected first. The intervention is composed of setting up a pediatric intravenous infusion team; carrying out a quality improvement in collecting and sending suspected CLABSI samples; providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infusion management scheme | Experimental | Other: Infusion management schemeTo implement infusion management scheme, then observe the continuous changes. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- A tertiary children's hospital with more than 300 beds
- The vice president in charge of nursing affairs, the director of nursing department and the director of hospital infection control department all agree in participating in this study with written permission, which include total acceptance of infusion management scheme and outcome indicators report as required
- To obtain the approval from Ethics Committee of the hospital
- Hospitalized children aged 0~18 years
- Catheterization and maintenance in the same center
Key exclusion criteria (3 listed)
- The vice president in charge of nursing affairs or the director of nursing department inform the researcher to withdraw from this study with written form and should clear reasons
- The number of cases for suspected CLABSI sample actually submitted for inspection / The number of cases for suspected CLABSI sample should submitted for inspection<0.9
- The awareness rate of infusion management scheme in clinical nurses is less than 90% and the qualification rate of the practice examination in clinical nurses is less than90% during inspection
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 |
|---|---|---|
| Infusion management scheme* To set up a pediatric intravenous infusion team; * To form standardized procedures by carrying out a quality improvement program in collecting and sending samples for inspection once suspected CLABSI occurs (1 month for training and 3 months for continuous improvement ); providing infusion training curriculums to nurses in forms of lectures, group discussions, operation demonstrations, and scenario simulations, holding practice review meeting with them; providing elements to caregivers of educational leaflet, nurse-provided education during patients' infusion therapy( 6-month implementation); * To observe the continued daily infusion practice in 6 months. | Other | Infusion management scheme |
Primary outcome
Incidence of CLABSI
Time frame: During the 6-month implementation
CLABSI diagnostic criteria requires that a central line is in situ at the time of or within 48 hours; children with a central line have fever (over 38℃), chills, hypotension or mental state changes; there is no alternate source of bloodstream infection. Apart from the above three necessary requirements, CLABSI diagnosis could be accompanied by two positive blood cultures drawn from a peripheral vein and a CVAD, two positive blood cultures drawn from different CVADs, one positive blood culture from a CVAD with a planned specific antimicrobial therapy or common skin contamination bacteria cultured (eg. Coagulase-negative Staphylococci, diphtheroids, Bacillus or Micrococcus). Incidence of CLABSI = (case numbers of CLABSI)/(Catheter Days per Month)×1000‰.
3 secondary outcomes
Changes of Inspection rate of suspected CLABSI samples
Time frame: From baseline to the end of the 6-month implementation
Incidece of infiltration (of Grade2 or higher) and/or extravasation
Time frame: During the 6-month implementation
Changes of the scores of readiness of internal context
Time frame: From baseline to the end of the 6-month implementation
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infusion management scheme in people with Children,Hospitalized and Infusion, run by Children's Hospital of Fudan University at 9 sites 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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Incidence of CLABSI (time frame: During the 6-month implementation). 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 4 Nov 2024.