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， 在美国每年至少有69万名儿童。AHT在30%的头部受伤者中被遗漏或未被识别 儿童和超过25%的未被识别的AHT儿童遭受额外的伤害。十 患有未被识别的AHT的儿童中有10%随后死亡或被杀害-其中80%可能是 8一个有缺陷的决定，启动一个虐待评估可以增加父母的 压力，使儿童面临额外的风险，延长住院时间，并增加医疗保健费用。 照顾创伤的年轻受害者的人必须做出重要的决定， 当与头部受伤的儿童。这些决定可能很困难，而且风险很大。 高不幸的是，医生们通常很难定义滥用的“合理怀疑”， 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。的 主要研究者（Hymel）概念化、设计并指导了序贯多中心研究， 并以临床决策规则（CDR）的形式验证有效的AHT筛查工具-基于证据的 专门开发的工具，用于指导连续AHT护理中的离散决策。虽然CDR 在初步研究中显示出希望，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试验将证明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 评价。我们将在美国8个儿科重症监护中心进行一项分层整群随机试验（SCRT）， 随机分配到干预（n = 4）或对照（n = 4）条件下的PICU。SCRT将比较 AHT筛查的准确性后，积极部署多方面的实施战略，旨在 促进CDR在干预部位的接受、利用和准确性（目标1）。此外，SCRT将 确定是否有任何研究中心、提供者和患者特定因素预测PICU环境中的CDR应用 (Aim 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，以确定其相对重要性， 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 医生的固有偏见和实践差异的负面影响，显着增加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 医疗费用。最重要的是，CDR将挽救生命--否则将遭受痛苦的儿童的生命 如果/当他们的AHT被遗漏或未被识别时，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.