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

针对美国创伤护理系统中接受治疗的急性住院损伤幸存者的创伤后应激障碍 (PTSD) 和合并症的最佳阶梯式护理干预的以部署为重点的务实试验

• 批准号: 10506526
• 负责人: EILEEN M BULGER
• 金额: $ 79.02万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10506526
• 关键词: Accident and Emergency department; Acute; Address; Alcohol abuse; Alcohol consumption; American College of Surgeons; Blinded; COVID-19 pandemic; Caring; Clinical; Data; Development; Disease; Drug usage; Elements; Ethnography; Event; Feeling suicidal; Firearms; Goals; Guidelines; Health; Health Services Research; Hospitalization; Individual; Injury; Inpatients; Intervention; Interview; Investigation; Latinx; Life; Mediator of activation protein; Medical; Mental Depression; Mental Health Services; National Institute of Mental Health; Operative Surgical Procedures; Outcome; Patients; Pharmaceutical Preparations; Policies; Population; Post-Traumatic Stress Disorders; Procedures; Process; Process Assessment; Protocols documentation; Psychotherapy; Public Health; Quality of Care; Randomized; Research; Sampling; Science; Scientist; Series; Site; Site Visit; Source; Surveys; Survivors; Symptoms; Testing; Trauma; Traumatic injury; United States National Institutes of Health; acute care; alcohol intervention; alcohol screening; care systems; collaboratory; college; comorbidity; extreme weather; follow-up; health care delivery; health service use; high risk; implementation process; injured; mental health center; patient population; patient screening; post-traumatic symptoms; pragmatic trial; psychologic; rapid technique; reduce symptoms; screening; severe injury; symposium; systems research; trauma care; trauma centers; trauma exposure; treatment effect

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.

摘要 需要紧急护理医疗环境的危及生命的创伤暴露在美国是一种地方病， 美国在COVID-19大流行、枪支扩散和极端天气事件的时代， 这既是个人痛苦的主要来源，也是重大的公共卫生负担。每年在美国， 超过3000万人在受伤后进入急诊医疗机构， 有些人受伤严重，需要住院治疗。的首要目标 创伤幸存者结局和支持（TSOS）R 01调查旨在促进 高质量创伤中心心理健康筛查、干预和转诊程序，用于各种伤害 幸存者在过去的二十年里，TSOS研究团队，包括研究科学家，创伤外科医生， 政策制定者、患者和一线临床医生已经建立了使用来自以下方面的证据的跟踪记录： NIH务实试验直接针对美国外科医生学会创伤委员会（学院） 监管政策。TSOS R 01调查将完善和测试最佳的阶梯式护理干预策略 对于不同的创伤幸存者提出的急性护理医疗设置与创伤后应激障碍和相关的合并症。 这一单一创伤中心现场务实的试验研究将单独随机化424例患者（212 干预和212对照），以简短的分步护理干预与大学要求的筛选， 转介控制条件分级护理干预包括积极主动的护理管理，以及 针对创伤后应激障碍和并发症的药物和心理治疗元素。3点进行盲法后续采访， 伤后6个月和12个月将评估所有患者的PTSD症状和相关合并症。的 急诊科健康信息交换将用于获取人口水平的自动化 意向治疗样本的急诊科/住院患者使用数据。R 01旨在测试主要的 假设干预患者将表现出PTSD症状的显着减少， 与对照组患者相比，急诊科/住院患者的利用率。调查还将 探索直接解决可采取行动的国家干预治疗效果的中介者和调节者 提高创伤中心的质量一种混合方法快速评估程序-通知临床 民族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。国家创伤中心的调查将阐明 所有美国I级和II级创伤的PTSD和合并症筛查、干预和转诊进展 中心.一个研究结束学院政策峰会将利用务实的试验数据，以告知美国的能力 创伤中心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。