A Deployment Focused Pragmatic Trial of Optimal Stepped Care Intervention Targeting PTSD and Comorbidity for Acutely Hospitalized Injury Survivors Treated in US Trauma Care Systems

摘要 危及生命的创伤暴露需要被送往急救医疗机构是地方病 美国在新冠肺炎大流行、武器扩散和极端天气事件的时代，并构成 这既是个人痛苦的重要来源，也是公共卫生的重大负担。每年在美国， 超过3000万人在受伤后前往急救医疗机构接受治疗，约250万人 个人伤势严重，需要住院治疗。的首要目标是 创伤幸存者结局和支持(TSOS)R01调查是为了促进可持续交付 针对不同损伤的高质量创伤中心心理健康筛查、干预和转诊程序 幸存者。在过去的二十年里，TSOS研究团队包括研究科学家、创伤外科 政策制定者、患者和一线临床医生已经建立了使用来自 NIH直接针对美国外科医师学会创伤委员会的务实试验 监管政策。TSOS R01调查将提炼和测试最佳阶梯式护理干预策略 对于不同的创伤幸存者，在急诊医疗环境中出现创伤后应激障碍和相关的共病。 这项单一的创伤中心现场务实试验调查将分别随机抽取424名患者(212名 干预和212对照)到简单的阶梯式护理干预与大学所需的筛查和 推荐控制条件。阶梯式护理干预包括前瞻性护理管理以及 针对创伤后应激障碍和共病的药物和心理治疗元素。在3-3的时候盲目跟踪采访， 受伤后6个月和12个月将评估所有患者的创伤后应激障碍和相关并发症的症状。这个 急诊科卫生信息交换将用于捕获人口层面的自动化 急诊科/住院病人对意向治疗样本的利用数据。R01旨在测试主要的 假设干预患者将显著减少创伤后应激障碍症状和 与对照患者相比，急诊科/住院患者的利用率。调查还将 探索直接针对可操作的国家干预治疗效果的调解人和调解人 创伤中心的质量有所提高。一种混合法快速评估程序--知情临床 人种志实施过程评估将有助于将研究结果纳入国家 学院政策要求、指导方针和验证标准。一项国家创伤中心调查将阐明 美国所有I级和II级创伤的创伤后应激障碍和共病筛查、干预和转诊的进展 中锋。结束学习的大学政策峰会将利用务实的试验数据为美国的能力提供信息 创伤中心将为不同患者提供高质量的急性护理医疗心理健康服务 人口。

ABSTRACT Life-threatening traumatic exposures requiring presentation to acute care medical settings are endemic in the US in the era of the COVID-19 pandemic, firearm proliferation, and extreme weather events, and constitute both a substantial source of individual suffering and a significant public health burden. Each year in the US, over 30 million individuals present to acute care medical settings after injury, and approximately 2.5 million individuals are so severely injured that they require inpatient hospital admissions. The overarching goal of the Trauma Survivors Outcomes and Support (TSOS) R01 investigation is to advance the sustainable delivery of high quality trauma center mental health screening, intervention and referral procedures for diverse injury survivors. Over the past two decades, the TSOS study team that includes research scientists, trauma surgical policymakers, patients, and frontline clinicians has established a track record of using evidence derived from NIH pragmatic trials to directly target American College of Surgeons Committee on Trauma (College) regulatory policy. The TSOS R01 investigation will refine and test optimal stepped care intervention strategies for diverse injury survivors presenting to acute care medical settings with PTSD and associated comorbidity. This single trauma center site pragmatic trial investigation will individually randomize 424 patients (212 intervention and 212 control) to a brief stepped care intervention versus College required screening and referral control conditions. The stepped care intervention consists of proactive care management, as well as medications and psychotherapy elements targeting PTSD and comorbidity. Blinded follow-up interviews at 3-, 6-, and 12-months post-injury will assess the symptoms of PTSD and related comorbidity for all patients. The emergency department health information exchange will be used to capture population-level automated emergency department/inpatient utilization data for the intent-to-treat sample. The R01 aims to test the primary hypotheses that intervention patients will demonstrate significant reductions in PTSD symptoms and emergency department/inpatient utilization when compared to control patients. The investigation will also explore mediators and moderators of intervention treatment effects that directly address actionable national trauma center quality improvements. A mixed method Rapid Assessment Procedure-Informed Clinical Ethnography implementation process assessment will facilitate the integration of study results into national College policy requirements, guidelines, and verification criteria. A national trauma center survey will elucidate the progression of PTSD and comorbidity screening, intervention and referral for all US level I and II trauma centers. An end-of-study College policy summit will harness pragmatic trial data to inform the capacity for US trauma centers to implement high quality acute care medical mental health services for diverse patient populations.