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

虐待性头部创伤 (AHT) 临床决策规则 (CDR) 的分层整群随机试验 (SCRT)

• 批准号: 10187609
• 负责人: Kent P Hymel
• 金额: $ 9.08万
• 依托单位: PENNSYLVANIA STATE UNIVERSITY, THE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-04-20 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10187609
• 关键词: Acute; Admission activity; Affect; Age; Bilateral; Caregivers; Caring; Cessation of life; Child; Child Abuse; Child Abuse and Neglect; Childhood Injury; Clinical; Clinical Trials; Closed head injuries; Cluster randomized trial; Collection; Contusions; Craniocerebral Trauma; Detection; Ear; Electronic Mail; Evaluation; Exposure to; Feedback; Health Care Costs; Household; Impact evaluation; Injury; Intervention; Length of Stay; Liquid substance; Marital Status; Minority; Multicenter Studies; Neck; Parietal; Patients; Pediatric Intensive Care Units; Physicians; Predictive Factor; Principal Investigator; Probability; Provider; Race; Randomized; Research; Risk; Screening procedure; Shaken baby syndrome; Single Parent; Site; Skull Fractures; Socioeconomic Status; Specificity; Stress; Subdural Hematoma; Testing; Time; Training; Trauma; United States; Universities; Visit; clinical application; clinical predictors; design; detection sensitivity; disability; early childhood; evidence base; handheld mobile device; high risk; implementation strategy; low socioeconomic status; minority children; older patient; randomized trial; respiratory; screening; tool; trauma care

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.

虐待头部创伤（AHT）是幼儿创伤性死亡和残疾的主要原因，影响 美国每年至少有690,000名儿童。在30％的头部受伤中，AHT被错过或未被认可 儿童和超过25％的未识别AHT的儿童遭受了额外的伤害。十 AHT未知的儿童随后死亡或丧生，其中80％可能是 通过早期认识虐待而得救。8有缺陷的决定发起虐待评估可以增加父母 压力，使孩子面临额外的风险，延长住院并增加医疗保健费用。9,10位医生 谁关心年轻的创伤惊喜必须做出重要的决定，以发射或忘记虐待儿童 评估与头部受伤的儿童一起进行。这些决定可能很困难，赌注是 高的。不幸的是，医生经常努力定义对虐待的“合理可疑”，并 表现出与儿童年龄，种族，婚姻状况和社会经济地位有关的继承偏见。 主要研究者（Hymel）概念化，设计和定向的顺序多中心研究，以得出 并以临床决策规则（CDR）的形式验证有效的AHT筛选工具 专门开发的工具是为了指导AHT护理连续性的离散决定。虽然CDR有 在初步研究中显示出希望，尚未接受正式的随机试验，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 评估。我们将在美国八个小儿重症监护 单位（PICU）随机分配给干预（n = 4）或对照（n = 4）条件。 SCRT将比较 部署主动多面实施策略后，AHT筛选精度 在干预地点促进CDR接受，利用和准确性（AIM 1）。此外，斯克将 确定什么（如果有的话），提供者 - 提供者和特定于患者的因素可以预测CDR在PICU设置中的应用 （目标2）。 SCRT结束后，我们将在干预地点进行12个月的可持续性试验， 系统地重复实施策略，以辨别其相对重要性 可持续性（探索目标3）。我们预计这种简单，廉价且可靠的CDR将减少 医生继承偏见和实践差异的负面影响，大大增加了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 医疗保健费用。最重要的是，CDR将挽救生命 - 儿童的生命，否则会遭受苦难 如果/当他们的AHT被错过或无法识别时，额外的致命受伤会造成伤害。