Pediatric Emergency Agitation Care Enhancement: Protocol for a Prospective Mixed Methods Study.

Background: Children and adolescents presenting to emergency departments (EDs) with mental and behavioral health (MBH) concerns frequently exhibit agitation, which poses safety risks for patients and staff and strains ED resources. Validated tools for agitation risk stratification in pediatric MBH populations are lacking, and evidence-based, risk-informed management strategies remain underdeveloped. Addressing these gaps is critical to reducing the need for emergent interventions, enhancing safety, and optimizing care delivery. Objective: This study aims to (1) evaluate the predictive ability of a brief pediatric agitation risk prediction tool, a 5-item version of the Brief Rating of Aggression by Children and Adolescents (BRACHA-S), and (2) codevelop an associated risk-based management plan bundle. Methods: This is a single-center prospective mixed methods study. First, we conducted a prospective cohort study enrolling children and adolescents aged 5 to 18 years who presented to the ED with MBH concerns. At ED triage, nurses completed the BRACHA-S risk assessment tool. The primary outcome, agitation requiring intervention, was defined as the use of pharmacologic agents, physical restraints, or mechanical restraints for events of agitation or aggression, as extracted from the electronic health record and confirmed through chart review. Second, we will use qualitative participatory methodologies, including key informant interviews, group-level assessments, and participatory design workshops, to codevelop a multifaceted, tiered, risk-based management plan designed to mitigate agitation and aggression in pediatric ED patients. Insights will be gathered from diverse stakeholders, including patients, parents or guardians, and members of the care team. Results: Funding was secured in July 2024. Initial data collection commenced in October 2024 and is projected to conclude in 2026. For aim 1, enrollment was completed on November 1, 2025, achieving the targeted sample size of 472 participants. We hypothesize that the BRACHA-S will demonstrate strong predictive validity (area under the curve >0.70) for agitation requiring intervention. Data collection for aim 2 began in October 2025, with analysis and results anticipated by June 2026. As of April 2026, 10 patients and parents/guardians were enrolled for key informant interviews, 30 staff members were enrolled for group-level assessment sessions, and 9 participants were enrolled for participatory design workshops. For this aim, we will codevelop a stakeholder-informed, tiered, risk-based agitation management pathway aligned with BRACHA-S risk strata. Conclusions: This study outlines a pragmatic approach to early agitation risk identification and the management of agitation in pediatric ED settings. If BRACHA-S demonstrates predictive validity and is paired with a stakeholder-informed, tiered management pathway, this strategy could fill critical gaps in validated tools and structured workflows, ultimately enabling timely, least-restrictive interventions and improving patient and staff safety.