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