STRATIFIED CLUSTER RANDOMIZED TRIAL (SCRT) OF A CLINICAL DECISION RULE (CDR) FOR ABUSIVE HEAD TRAUMA (AHT)

虐待性头部创伤(AHT)是儿童早期创伤性死亡和残疾的主要原因，影响 在美国，每年至少有69万名儿童。30%的颅脑损伤患者遗漏或未识别AHT 患有未被识别的AHT的儿童和超过25%的儿童遭受额外的伤害。十 患有未被识别的AHT的儿童中有80%后来死亡或死亡--其中80%可能是 通过更早地认识到虐待行为而节省下来。8启动虐待评估的错误决定可能会增加父母 压力，使孩子面临更多的风险，延长住院时间，增加医疗费用 谁照顾创伤的年轻受害者必须做出重要决定，要么开始，要么放弃虐待儿童 当与头部受伤的儿童一起展示时，评估。这些决定可能很困难，而且事关重大 很高。不幸的是，医生经常很难定义虐待的“合理怀疑”，并有 表现出与儿童年龄、种族、婚姻状况和社会经济地位有关的固有偏见。这个 首席研究员(Hymel)概念化、设计并指导顺序多中心研究以得出 并以临床决策规则(CDR)的形式验证有效的AHT筛查工具-循证 专门为指导AHT护理连续统一体中的离散决策而开发的工具。尽管CDR已经 在初步研究中显示出了希望，但尚未进行正式的随机试验，这是 这个项目的目的。拟议的CDR试验将展示CDR对AHT筛查的影响 准确性，假设CDR应用将增加AHT检测并减少不必要的滥用 评估。我们将在8个美国儿科重症监护室进行分层整群随机试验(SCRT) 单位(PICU)随机分配到干预组(n=4)或对照组(n=4)。SCRT将比较 部署积极的多方面实施战略后的AHT筛查准确率旨在 在干预地点促进CDR的接受度、利用率和准确性(目标1)。此外，小贩管理处将会 确定地点、提供者和患者特定的因素预测CDR在PICU设置中的应用情况(如果有的话) (目标2)。一旦SCRT结束，我们将在干预地点进行为期12个月的可持续性试验， 系统地逐一废除执行战略，以辨别其相对重要性 可持续性(探索性目标3)。我们预计，这种简单、廉价和可靠的CDR将减少 医生固有的偏见和实践差异的负面影响，显著增加了AHT 检测，减少不必要的滥用评估(及其相关风险)，并减少与AHT相关的 医疗保健成本。最重要的是，CDR将拯救生命--否则将遭受苦难的儿童的生命。 如果/当他们的AHT未命中或无法识别时，会造成额外的致命伤害。

Abusive head trauma (AHT) is the leading cause of traumatic death and disability in early childhood, affecting at least 690,000 children annually in the United States. AHT is missed or unrecognized in 30% of head-injured children and more than 25% of children with unrecognized AHT suffered additional inflicted injuries. Ten percent of children with unrecognized AHT subsequently died or were killed—80% of whom could have been saved by earlier recognition of abuse.8 A flawed decision to launch an abuse evaluation can increase parental stress, expose the child to additional risks, prolong hospital stays, and increase health care costs.9,10 Doctors who care for young victims of trauma must make important decisions to launch or forgo child-abuse evaluations when presented with head-injured children. These decisions can be difficult, and the stakes are high. Unfortunately, doctors routinely struggle to define a “reasonable suspicion” of abuse and have demonstrated inherent biases related to child age, race, marital status, and socioeconomic status. The principal investigator (Hymel) conceptualized, designed, and directed sequential multicenter studies to derive and validate an effective AHT screening tool in the form of a clinical decision rule (CDR)—an evidence-based tool developed specifically to guide a discrete decision in the continuum of AHT care. Though the CDR has shown promise in preliminary studies, it has not yet been subjected to a formal randomized trial, which is the purpose of this project. The proposed CDR trial will demonstrate the CDR's impact on AHT screening accuracy, hypothesizing that CDR application will increase AHT detection and reduce unnecessary abuse evaluations. We will conduct a stratified cluster randomized trial (SCRT) at eight US pediatric intensive care units (PICUs) randomly assigned to intervention (n = 4) or control (n = 4) conditions. The SCRT will compare AHT screening accuracy after the deployment of active multifaceted implementation strategies designed to promote CDR acceptance, utilization, and accuracy at the intervention sites (Aim 1). In addition, the SCRT will determine what—if any—site-, provider-, and patient-specific factors predict CDR application in PICU settings (Aim 2). Once the SCRT has concluded, we will conduct a 12-month sustainability trial at intervention sites, systematically repealing the implementation strategies one by one to discern their relative importance to sustainability (Exploratory Aim 3). We anticipate that this simple, inexpensive, and reliable CDR will decrease the negative impacts of physicians' inherent biases and practice disparities, significantly increase AHT detection, decrease unnecessary abuse evaluations (and their associated risks), and reduce AHT-associated healthcare costs. Most importantly, the CDR will save lives—the lives of children who will otherwise suffer additional fatal inflicted injuries if/when their AHT is missed or unrecognized.