This is a single-center, prospective, mixed methods study, funded by the Place Outcomes Research Award grant. The study period spans July 2024 to July 2026. Reporting of the quantitative cohort for aim 1 will follow the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines and incorporate relevant items from the Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement [29,30]. Reporting of the qualitative participatory aim 2 will follow the Standards for Reporting Qualitative Research (SRQR) [31].

This study was approved by Cincinnati Children’s Hospital Institutional Review Board (2024-0413) and conducted in compliance with institutional review board and HIPAA regulations [47]. This study involves minimal risk to patients, families, and participating clinicians.

For aim 1, enrollment was conducted under a waiver of informed consent and HIPAA authorization. Electronic medical records were used to screen for eligibility. Identifiable data (eg, medical record number, visit time, demographics, and clinical data), agitation risk assessments (BRACHA-S, BVC, or STAMP), and linked staff injuries were stored in a REDCap (Research Electronic Data Capture) research database. No study-specific procedures altered clinical management, and interactions related to data collection occurred only with the treating team. Staff injury surveys were voluntary, and responses were recorded without personal identifiers other than clinical role. No compensation was provided for participation in aim 1.

For aim 2, written or electronic informed consent and, when applicable, assent will be obtained from patient and parent or guardian participants before the start of KI interviews. Health care team members and parents or guardians involved in GLA and PDW activities will participate under a waiver of documented consent. They receive a study information sheet and provide verbal consent or assent before study procedures. At the start of each group session, facilitators will review ground rules emphasizing confidentiality, respectful discussion, and voluntary participation. Participants may decline to answer any question or withdraw at any time without impact on clinical care or employment. Each participant will receive up to US $40 per session.

All study data, including EHR extracts, survey responses, and staff injury reports, will be stored in accordance with HIPAA and institutional data security policies [48]. Data will be entered into secure, password-protected REDCap databases or other approved institutional systems with role-based access. Identifiers will be removed or replaced with unique study codes at the earliest possible time, and linkage files will be stored separately in restricted-access locations. Only authorized study personnel will have access to identifiable data, and all reports and publications will present aggregate, deidentified results.

This study protocol outlines a mixed methods approach to enhance care for children and adolescents presenting to the ED with MBH concerns by prospectively evaluating the predictive performance of the BRACHA-S tool at triage and developing a tiered, risk-based management plan. With completion of this study, and assuming adequate predictive performance, the results are expected to support BRACHA-S as an early risk-stratification tool for agitation in the ED for patients with MBH concerns and to yield a stakeholder-derived, tiered management plan ready for testing in future implementation studies. This risk-stratified approach has the potential to reduce reliance on emergent pharmacologic and physical interventions, improve patient and staff safety, and enhance operational efficiency through early recognition of elevated risk, more strategic allocation of ED resources, and more targeted interventions.

Evidence supporting brief agitation or violence risk tools in ED settings remains limited. Literature syntheses of studies conducted in adult EDs identify more than 10 brief violence risk tools and conclude that, although these instruments appear feasible for short-term risk stratification, psychometric evidence is sparse, heterogeneous, and insufficient to support recommending any single tool [49-52]. In the pediatric ED setting, far fewer instruments have been studied [53]. Studies on the Pediatric Violence/Aggression Assessment Tool [54] and the Dynamic Appraisal of Situational Aggression, Youth Version [55] suggest that higher scores are associated with increased aggression and greater restraint use in the ED; however, external validation is limited, and outcome definitions (eg, aggression events, restraint use, and medication use) vary across studies. These gaps underscore the need for rigorous testing of agitation risk tools such as BRACHA-S within real-world pediatric ED workflows. This study will also generate exploratory data on the BVC and STAMP framework in pediatric emergency care. BVC is validated for short-term aggression prediction in psychiatric units and has been implemented in adult EDs as part of workplace violence initiatives; however, pediatric ED performance data remain sparse [16,56,57]. STAMP, developed from qualitative observation in adult EDs, is widely cited in violence-prevention resources but lacks formal validity and reliability testing and has not been evaluated as a predictive tool in pediatric ED populations. Collecting these measures alongside BRACHA-S and ARI will provide comparative estimates to inform future validation studies and potential refinement of ED-specific agitation risk tools for children and adolescents.

Staff injury related to patient aggression is a central occupational safety concern in pediatric ED agitation care. National survey data show that 96% of pediatric emergency physicians have experienced workplace violence, and 10% have sustained injuries requiring medical attention or time off, with approximately half of the incidents unreported [58]. In pediatric inpatient settings, a high-risk flag identified a small subgroup that accounted for a disproportionate share of staff injuries [59], supporting exploration of whether ED risk stratification aligns with occupational risk. Furthermore, quality improvement work in inpatient settings suggests that staff injuries may be reduced through system-level responses, such as behavioral response teams for children and adolescents at risk of aggression [60]. Accordingly, this protocol will explore linkages among agitation risk scores and staff injury surveillance in the ED to inform future prevention strategies.

Current best-practice recommendations for management of agitated children or adolescents emphasize early, least-restrictive strategies, including verbal de-escalation, environmental modification, and proactive engagement of behavioral health resources, with stepwise escalation to medication and restrictive interventions only when needed to maintain safety [19,61,62]. Standardized pathways and order sets may reduce variation by clarifying roles, aligning team communication, and supporting timely selection of nonpharmacologic and pharmacologic options [9]. However, the evidence base remains heterogeneous and largely single-site, and few approaches explicitly integrate prospective risk stratification at triage to tailor the intensity of response. Results from this study may address this gap by pairing early risk identification with standardized, risk-appropriate actions in a pediatric ED setting.

Prior qualitative and mixed methods studies of pediatric behavioral emergencies describe persistent barriers to delivering least-restrictive care in ED settings, including variable staff training and confidence with de-escalation, unclear roles and communication during escalation, environmental constraints, and staff safety concerns [17,20,63]. Most published pediatric ED agitation pathways have been developed by multidisciplinary clinical teams, with limited description of patient or caregiver co-design [9]. Parent-inclusive stakeholder processes have been used to define pediatric ED agitation quality measures, demonstrating the feasibility and value of incorporating patient and caregiver perspectives in this domain [64]. In this protocol, participatory design methods extend this literature by incorporating stakeholder perspectives on risk and selection of management strategies to build a tiered approach for caring for agitated children and adolescents in pediatric ED settings.

The integration of both quantitative and qualitative methodologies will provide a comprehensive understanding of predictive accuracy and contextual implementation needs. A key strength of this study is its pragmatic design, which evaluates the BRACHA-S tool in real-world ED settings using frontline nursing staff. This enhances the generalizability and potential scalability of the findings. The prospective cohort design supports robust evaluation of the predictive validity of the tool, while the participatory design methods ensure that the resulting care plan bundle is informed by the lived experiences and insights of diverse stakeholders, including patients, families, and care providers.

This study has several limitations. It is conducted within a single pediatric health system, which may limit generalizability. Aim 1 uses a convenience sample during predefined screening windows, and nurse refusal to complete BRACHA-S, BVC, or STAMP may introduce selection bias. ARI is ascertained from electronic orders and documentation, so incomplete recording of behaviors, brief holds, or de-escalation efforts may lead to outcome misclassification. Additional de-escalation interventions were not systematically recorded, limiting understanding of how agitation risk scores operate within the broader spectrum of agitation management. Exploratory analyses of BVC and STAMP are not powered for precise estimates of predictive performance. For aim 2, qualitative findings rely on an English-speaking, self-selected sample from a single institution, which may limit transferability to other settings.

Early identification and intervention are critical for managing agitation and aggression in pediatric MBH patients; however, practical tools and workflows in emergency settings remain limited. This study positions BRACHA-S as a brief, nurse-administered triage tool for early quantification of agitation risk among children and adolescents presenting to the ED with MBH concerns. Paired with a stakeholder-informed, tiered management pathway, it establishes a structured foundation for safer, more consistent, and patient-centered agitation care in pediatric emergency settings.