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SaVeBRAIN.Kids-study protocol for a cluster-randomized stepped-wedge trial to reduce hospitalizations for mild
Nora Bruns1,2, Pia Brensing3,4, Linda von der Heiden3,4
1Department of Pediatrics I, Neonatology, Pediatric Intensive Care Medicine, Pediatric Neurology, and Pediatric Infectious Diseases, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Nora.bruns@uk-essen.de.
Insights
The SaVeBRAIN.Kids trial tests a new care pathway to reduce hospitalizations for pediatric mild traumatic brain injury (TBI) in Germany. This approach aims to improve patient safety and healthcare efficiency.
Area of Science:
- Pediatric neurology
- Emergency medicine
- Health services research
Background:
- Traumatic brain injury (TBI) is a significant global pediatric health concern.
- Germany experiences higher hospitalization rates for mild TBI compared to similar healthcare systems.
- Current management may lead to unnecessary hospitalizations.
Purpose of the Study:
- To implement and evaluate a novel care pathway (nCP) for pediatric mild TBI.
- To reduce hospitalizations for children with mild TBI in Germany.
- To assess the safety and cost-effectiveness of the nCP.
Main Methods:
- Cluster-randomized stepped-wedge design across multiple centers.
- Inclusion criteria: age 3 months to <18 years, head injury within 48h, GCS ≥ 14, no risk factors.
- Co-primary outcomes: hospitalization risk and unplanned re-visits within 72h.
Main Results:
- The study is ongoing; results are pending.
- The trial aims to recruit 1390 patients over 12 months.
- Statistical power calculated for non-inferiority testing.
Conclusions:
- The SaVeBRAIN.Kids trial addresses a critical need in pediatric TBI management in Germany.
- The nCP has the potential to decrease unnecessary hospitalizations and optimize resource allocation.
- Successful implementation could enhance patient safety and healthcare system efficiency.
Background:
Traumatic brain injury (TBI) is one of the most important pediatric conditions worldwide. In Germany, hospitalization rates for mild TBI drastically exceed hospitalization rates from similar healthcare systems.
Methods:
The SaVeBRAIN.Kids trial will implement and test a novel care pathway (nCP) for evidence-based standardized risk assessment, structured observation in the emergency department (ED) for several hours, and technology-supported home monitoring with the aim to reduce hospitalizations. This non-inferiority multicenter study will be carried out using a cluster-randomized stepped-wedge design, with all centers starting in the control phase and sequentially transitioning to the intervention. Eligible participants (age ≥ 3 months and < 18 years) must present within 48 h of head injury, have minimal symptoms (Glasgow coma scale ≥ 14), and no risk factors for intracranial complications. The co-primary outcomes are the relative risk of hospitalization and the proportion of unplanned re-visits within 72 h of presentation to the ED for ambulatory cases. Secondary outcomes include clinical safety measures, cost-effectiveness, and process evaluation. Based on power calculations (α = 0.05, power = 0.9), 1390 patients will be recruited over 12 months.
Discussion:
The SaVeBRAIN.Kids trial addresses a relevant healthcare challenge by testing a new approach to pediatric mild TBI management in Germany. It aligns with current evidence while accounting for the country's specific healthcare context. If successful, the intervention could substantially reduce unnecessary hospitalizations and free inpatient capacities while preserving patient safety.
Trial Registration:
German Clinical Trials Registry (DRKS00035623). Registered on January 21, 2025.
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