- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06512805
Implementation Study of Intra-hospital Transfer of Pediatric Inpatients
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Shanghai, China, 201102
- Children's Hospital of Fudan University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
Those who have not obtained a practicing qualification certificate;
- Refusal to participate in the study;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Routine transport group
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.
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|
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Experimental: Post-guideline transfer group
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)."
|
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."
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The compliance of healthcare personnel with evidence-based practice.
Time Frame: Three months before and three months after the intervention
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The compliance of each review indicator = (Number of times the indicator was correctly executed / Total number of times the indicator was reviewed) * 100%.
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Three months before and three months after the intervention
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Intra-hospital transfer time
Time Frame: Three months before and three months after the intervention
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The in-hospital transfer time = Time when the transfer team leaves the receiving department - Time when the transfer team leaves the transferring department.
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Three months before and three months after the intervention
|
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Bedside handover time
Time Frame: Three months before and three months after the intervention
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Departure time of the transfer team from the receiving department - Start time of the handover.
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Three months before and three months after the intervention
|
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Completeness of information handover
Time Frame: Three months before and three months after the intervention
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The ratio of completed items in the handover checklist to the total items in the handover checklist
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Three months before and three months after the intervention
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Rate of adverse events during in-hospital transfers
Time Frame: Three months before and three months after the intervention
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Adverse event rate = Number of patients experiencing adverse events during transfer / Total number of patients transferred during the study period
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Three months before and three months after the intervention
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Healthcare personnel's knowledge level of in-hospital transfers
Time Frame: One month before and one month after the intervention
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"In-hospital Transfer Knowledge Level Questionnaire for Healthcare Personnel"
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One month before and one month after the intervention
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Collaborators and Investigators
Investigators
- Study Director: Ying Gu, Doctor, Children's Hospital of Fudan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CHFudanU1218
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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