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.

抽象的 危及生命的创伤性暴露，需要向急性护理医疗机构进行介绍 我们在19号大流行，枪支扩散和极端天气事件的时代，构成 既是个人痛苦的重要来源，也是巨大的公共卫生负担。每年在美国， 受伤后，超过3000万人参加了急性护理医疗机构，约有250万人 个人受到严重伤害，以至于需要住院住院。总体目标 创伤幸存者的成果和支持（TSO）R01调查是为了提高可持续交付 高质量的创伤中心心理健康筛查，干预和转诊程序多种伤害 幸存者。在过去的二十年中，包括研究科学家，创伤手术的TSOS研究团队 决策者，患者和前线临床医生已经建立了使用源自证据的记录 NIH务实的试验直接针对美国外科医生学院创伤委员会（学院） 监管政策。 TSO R01调查将完善和测试最佳阶梯护理干预策略 对于各种伤害幸存者，与PTSD及其相关合并症一起出现在急性护理医疗环境中。 这个单个创伤中心现场务实的试验调查将分别随机化424名患者（212例 干预措施和212控制）进行简短的阶梯式护理干预措施与大学需要筛查和 转介控制条件。阶梯护理干预措施包括主动护理管理，以及 针对PTSD和合并症的药物和心理治疗元素。盲目的后续采访在3-， 6-和12个月后的伤害将评估所有患者的PTSD及相关合并症的症状。这 急诊室健康信息交换将用于捕获人群级自动化 意图对治疗样本的急诊科/住院使用数据。 R01旨在测试主要 假设干预患者将显示出PTSD症状和 与对照患者相比，急诊科/住院使用情况。调查也将 探索干预治疗效应的调解人和主持人，这些效果直接解决可行的国家 创伤中心质量改进。混合方法快速评估程序知识的临床 民族志实施过程评估将有助于将研究结果整合到国家 大学政策要求，准则和验证标准。国家创伤中心调查将阐明 美国全部I和II创伤的PTSD和合并症筛查，干预和转诊的进展 中心。学习结束的大学政策峰会将利用务实的试验数据，以告知我们的能力 创伤中心为多元化患者实施高质量的急性护理医疗心理健康服务 人群。