Implementation ScienceNCT06512805
Implementation Study of Intra-hospital Transfer of Pediatric Inpatients
A study testing Routine transport and Post-guideline transfer in people with Implementation Science and Transportation of Patients, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
This study implemented the "Clinical Practice Guidelines for In-hospital Transfer of Pediatric Inpatients (2023 edition)" released by the research team in June 2023 in real clinical settings. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Implementation Science, Transportation of Patients
- What is being tested?
- Routine transport and Post-guideline transfer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2024to 31 Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Those who had worked in the study site for more than 1 year;
- Those who can carry out intra-hospital transport independently;
- Staff on duty during the study period
Who cannot join
- Those who have not obtained a practicing qualification certificate;
- Refusal to participate in the study；
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation Study of Intra-hospital Transfer of Pediatric Inpatients Based on the EPIS Model
This study implemented the "Clinical Practice Guidelines for In-hospital Transfer of Pediatric Inpatients (2023 edition)" released by the research team in June 2023 in real clinical settings. It employed an effectiveness-implementation hybrid research design to evaluate the process and effects of the guidelines in clinical practice. The research objectives include the following aspects:
Identifying barriers to the implementation of the guidelines in clinical practice.
Read more
Constructing implementation strategies to facilitate the application of the guidelines based on identified barriers.
Evaluating the impact of implementation strategies on clinical healthcare personnel and the clinical environment.
Assessing the effect of in-hospital transfer of pediatric inpatients based on the guidelines on reducing adverse events related to in-hospital transfers and other clinical outcomes.
Participants will:
In the control group, healthcare personnel conduct transfers according to the routine management and working mode of the emergency department and pediatric intensive care unit (PICU).
In the intervention group, nurses receive implementation strategies developed during the preparation phase. These strategies are aimed at modifying the behavior of healthcare personnel through implementation, thereby conducting in-hospital transfers for pediatric patients based on the guidelines.
Read the detailed description
The demand for in-hospital transfers is high, and their occurrence rate is frequent, making them an unavoidable routine in hospital settings due to emergency patients, postoperative patients, and those highly dependent on specialized medical equipment. Research statistics indicate that out of 371 patients admitted to the neonatal ward, there were 1402 transfers, while 506 emergency department patients accounted for 2715 in-hospital transfers. Additionally, 43.5% of patients in the intensive care unit required repeated transfers, with 45% of them needing two or more transfers. According to a systematic review by Haydar et al., adverse event rates during in-hospital pediatric transfers ranged from 0.11% to 75%, with the most common events being hypoxemia (13%-21%), hypotension (3.3%-37.5%), chest compressions (7.5%), dislodgement/accidental removal of catheters (3.8%), and interruption of vasopressor infusions (5%). Therefore, ensuring the safety of in-hospital transfers for pediatric patients is a crucial aspect of healthcare workers' responsibilities. Standardizing the in-hospital transfer process to minimize adverse events is vital for the well-being of pediatric patients.
Thus, this study focuses on in-hospital transfers of pediatric patients, aiming to identify current clinical issues and implement strategies based on the "Clinical Practice Guidelines for In-hospital Transfer of Pediatric Inpatients (2023 edition)." Conducted at the Children's Hospital affiliated with Fudan University, the research aims to develop implementation strategies and evaluate the impact of evidence and implementation strategies on pediatric inpatients, the evidence-based practice behavior of clinical healthcare personnel, and changes in the hospital organizational environment. The goal is to alter current clinical practices, standardize the in-hospital transfer process for pediatric patients, and further reduce adverse events associated with in-hospital transfers.
- Conditions
- Implementation Science, Transportation of Patients
- Being tested
- Routine transport, Post-guideline transfer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine transportBehavioural
- Before the transfer of the patient: ① The doctor determines the destination of the patient based on the patient's condition and issues transfer orders.
- The responsible nurse assesses the patient's consciousness, circulation, respiration, etc., and fills out the "Transfer Patient Handover Record" in the transferring department section.
- The responsible nurse prepares the equipment, medications, and patient's belongings required for the transfer.
- During the transfer: Monitor the patient's vital signs.
- Upon arrival at the receiving department:
- Place the patient with the receiving department nurse. ② Verbally hand over the patient's condition to the receiving department nurse and hand over the patient's belongings and medications.
- The responsible nurse of the receiving department completes the remaining part of the "Transfer Patient Handover Record."
Post-guideline transferBehavioural
In the intervention group, nurses receive implementation strategies developed during the preparation phase. These strategies aim to modify the behavior of healthcare personnel through implementation, thereby conducting evidence-based (based on the guidelines) in-hospital transfer interventions for pediatric patients.The interventions received by pediatric patients are derived from the recommended practices evaluated for evidence availability in the guidelines. These include specific transfer procedures, the "Transfer Risk Level Classification Criteria," "Personnel Qualifications, Equipment, and Medications Allocation Based on Transfer Risk Level," "Transfer Preparation Checklist," and "Transfer Handover Checklist 2.0."
| Study group | Role | What they receive |
|---|---|---|
| Routine transport group | Active comparator | During the period from April 2024 to June 2024, pediatric patients transferred from the emergency department to the pediatric intensive care unit (PICU), and from the PICU to general wards will serve as the control group. They will undergo the hospital's current in-hospital transfer process. Receives: Behavioral: Routine transport |
| Post-guideline transfer group | Experimental | During the period from September 2024 to November 2024, pediatric patients transferred from the emergency department to the pediatric intensive care unit (PICU), and from the PICU to general wards will undergo the in-hospital transfer process based on the "Clinical Practice Guidelines for In-hospital Transfer of Pediatric Inpatients (2023 edition)." Receives: Behavioral: Post-guideline transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The compliance of healthcare personnel with evidence-based practice.
The compliance of each review indicator = (Number of times the indicator was correctly executed / Total number of times the indicator was reviewed) * 100%.
Measured: Three months before and three months after the intervention
Intra-hospital transfer time
The in-hospital transfer time = Time when the transfer team leaves the receiving department - Time when the transfer team leaves the transferring department.
Measured: Three months before and three months after the intervention
Bedside handover time
Departure time of the transfer team from the receiving department - Start time of the handover.
Measured: Three months before and three months after the intervention
Completeness of information handover
The ratio of completed items in the handover checklist to the total items in the handover checklist
Measured: Three months before and three months after the intervention
Rate of adverse events during in-hospital transfers
Adverse event rate = Number of patients experiencing adverse events during transfer / Total number of patients transferred during the study period
Measured: Three months before and three months after the intervention
Healthcare personnel's knowledge level of in-hospital transfers
"In-hospital Transfer Knowledge Level Questionnaire for Healthcare Personnel"
Measured: One month before and one month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implementation ScienceStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 214 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 director, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512805
- Sponsor's protocol ID
- CHFudanU1218
- Status last verified
- Jan 2025
- First submitted
- 27 Jun 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Yang Y, Hu J, Wang W, Jin Y, Shen W, Zhang Y, Zhou Y, Cheng Y, Latour JM, Gu Y. Effect of implementing an evidence-based clinical practice intra-hospital transport guideline for hospitalized children: a type III hybrid implementation-effectiveness study. Implement Sci Commun. 2026 Jun 6. doi: 10.1186/s43058-026-00962-7. Online ahead of print.
PubMed 42251453
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Study of Intra-hospital Transfer of Pediatric Inpatients Based on the EPIS Model
- ClinicalTrials.gov ID
- NCT06512805
- Acronym / sponsor ID
- CHFudanU1218
- Conditions
- Implementation Science, Transportation of Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 22 Jul 2024 (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 implemented the "Clinical Practice Guidelines for In-hospital Transfer of Pediatric Inpatients (2023 edition)" released by the research team in June 2023 in real clinical settings. It employed an effectiveness-implementation hybrid research design to evaluate the process and effects of the guidelines in clinical practice. The research objectives include the following aspects:
Identifying barriers to the implementation of the guidelines in clinical practice.
Constructing implementation strategies to facilitate the application of the guidelines based on identified barriers.
Evaluating the impact of implementation strategies on clinical healthcare personnel and the clinical environment.
Assessing the effect of in-hospital transfer of pediatric inpatients based on the guidelines on reducing adverse events related to in-hospital transfers and other clinical outcomes.
Participants will:
In the control group, healthcare personnel conduct transfers according to the routine management and working mode of the emergency department and pediatric intensive care unit (PICU).
In the intervention group, nurses receive implementation strategies developed during the preparation phase. These strategies are aimed at modifying the behavior of healthcare personnel through implementation, thereby conducting in-hospital transfers for pediatric patients based on the guidelines.
Detailed description
The demand for in-hospital transfers is high, and their occurrence rate is frequent, making them an unavoidable routine in hospital settings due to emergency patients, postoperative patients, and those highly dependent on specialized medical equipment. Research statistics indicate that out of 371 patients admitted to the neonatal ward, there were 1402 transfers, while 506 emergency department patients accounted for 2715 in-hospital transfers. Additionally, 43.5% of patients in the intensive care unit required repeated transfers, with 45% of them needing two or more transfers. According to a systematic review by Haydar et al., adverse event rates during in-hospital pediatric transfers ranged from 0.11% to 75%, with the most common events being hypoxemia (13%-21%), hypotension (3.3%-37.5%), chest compressions (7.5%), dislodgement/accidental removal of catheters (3.8%), and interruption of vasopressor infusions (5%). Therefore, ensuring the safety of in-hospital transfers for pediatric patients is a crucial aspect of healthcare workers' responsibilities. Standardizing the in-hospital transfer process to minimize adverse events is vital for the well-being of pediatric patients.
Thus, this study focuses on in-hospital transfers of pediatric patients, aiming to identify current clinical issues and implement strategies based on the "Clinical Practice Guidelines for In-hospital Transfer of Pediatric Inpatients (2023 edition)." Conducted at the Children's Hospital affiliated with Fudan University, the research aims to develop implementation strategies and evaluate the impact of evidence and implementation strategies on pediatric inpatients, the evidence-based practice behavior of clinical healthcare personnel, and changes in the hospital organizational environment. The goal is to alter current clinical practices, standardize the in-hospital transfer process for pediatric patients, and further reduce adverse events associated with in-hospital transfers.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine transport group | Active comparator | Behavioral: Routine transportDuring the period from April 2024 to June 2024, pediatric patients transferred from the emergency department to the pediatric intensive care unit (PICU), and from the PICU to general wards will serve as the control group. They will undergo the hospital's current in-hospital transfer process. |
| Post-guideline transfer group | Experimental | Behavioral: Post-guideline transferDuring the period from September 2024 to November 2024, pediatric patients transferred from the emergency department to the pediatric intensive care unit (PICU), and from the PICU to general wards will undergo the in-hospital transfer process based on the "Clinical Practice Guidelines for In-hospital Transfer of Pediatric Inpatients (2023 edition)." |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Those who had worked in the study site for more than 1 year;
Key exclusion criteria (2 listed)
- Those who have not obtained a practicing qualification certificate;
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 |
|---|---|---|
| Routine transport1. Before the transfer of the patient: ① The doctor determines the destination of the patient based on the patient's condition and issues transfer orders. * The responsible nurse assesses the patient's consciousness, circulation, respiration, etc., and fills out the "Transfer Patient Handover Record" in the transferring department section. * The responsible nurse prepares the equipment, medications, and patient's belongings required for the transfer. 2. During the transfer: Monitor the patient's vital signs. 3. Upon arrival at the receiving department: * Place the patient with the receiving department nurse. ② Verbally hand over the patient's condition to the receiving department nurse and hand over the patient's belongings and medications. * The responsible nurse of the receiving department completes the remaining part of the "Transfer Patient Handover Record." | Behavioural | Routine transport group |
| Post-guideline transferIn the intervention group, nurses receive implementation strategies developed during the preparation phase. These strategies aim to modify the behavior of healthcare personnel through implementation, thereby conducting evidence-based (based on the guidelines) in-hospital transfer interventions for pediatric patients.The interventions received by pediatric patients are derived from the recommended practices evaluated for evidence availability in the guidelines. These include specific transfer procedures, the "Transfer Risk Level Classification Criteria," "Personnel Qualifications, Equipment, and Medications Allocation Based on Transfer Risk Level," "Transfer Preparation Checklist," and "Transfer Handover Checklist 2.0." | Behavioural | Post-guideline transfer group |
Primary outcome
The compliance of healthcare personnel with evidence-based practice.
Time frame: Three months before and three months after the intervention
The compliance of each review indicator = (Number of times the indicator was correctly executed / Total number of times the indicator was reviewed) * 100%.
Intra-hospital transfer time
Time frame: Three months before and three months after the intervention
The in-hospital transfer time = Time when the transfer team leaves the receiving department - Time when the transfer team leaves the transferring department.
Bedside handover time
Time frame: Three months before and three months after the intervention
Departure time of the transfer team from the receiving department - Start time of the handover.
Completeness of information handover
Time frame: Three months before and three months after the intervention
The ratio of completed items in the handover checklist to the total items in the handover checklist
Rate of adverse events during in-hospital transfers
Time frame: Three months before and three months after the intervention
Adverse event rate = Number of patients experiencing adverse events during transfer / Total number of patients transferred during the study period
Healthcare personnel's knowledge level of in-hospital transfers
Time frame: One month before and one month after the intervention
"In-hospital Transfer Knowledge Level Questionnaire for Healthcare Personnel"
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 17 Jan 2025.
- Derived from this study: PubMed 42251453Li Y, Yang Y, Hu J, Wang W, Jin Y, Shen W, Zhang Y, Zhou Y, Cheng Y, Latour JM, Gu Y. Effect of implementing an evidence-based clinical practice intra-hospital transport guideline for hospitalized children: a type III hybrid implementation-effectiveness study. Implement Sci Commun. 2026 Jun 6. doi: 10.1186/s43058-026-00962-7. Online ahead of print.
- 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 director
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 Routine transport and Post-guideline transfer in people with Implementation Science and Transportation of Patients, 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 3 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: finished, as of the sponsor's last update on 17 Jan 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?
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?
The compliance of healthcare personnel with evidence-based practice. (time frame: Three months before and three months after the intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06512805, which also lists 1 linked publication.
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 17 Jan 2025.