A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

与政策相关的美国创伤护理系统针对创伤后应激障碍 (PTSD) 和合并症的实用试验

• 批准号: 9178219
• 负责人: DOUGLAS F ZATZICK
• 金额: $ 21.98万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-23 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9178219
• 关键词: Accident and Emergency department; Acute; Alcohol abuse; Alcohol consumption; American; American College of Surgeons; Behavior; Brain; Caring; Chronic; Chronic Disease; Clinical; Cluster randomized trial; Colorado; Community Services; Comorbidity; Computerized Medical Record; Coronary Arteriosclerosis; Development; Diabetes Mellitus; Disease Clusterings; Documentation; Drug usage; Elements; Ensure; Event; Evidence based treatment; Face; Feeling suicidal; Funding; Goals; Guidelines; Health; Health Status; Healthcare Systems; Home environment; Hospitalization; Hospitals; Hypertension; Individual; Information Technology; Injury; Inpatients; Institutes; Institutional Review Boards; Integrated Health Care Systems; Interdisciplinary Study; Intervention; Investigation; Lung diseases; Manuals; Measures; Medical; Medicare/Medicaid; Medication Management; Mental Depression; Modeling; National Institute of Mental Health; National Institute on Alcohol Abuse and Alcoholism; Operative Surgical Procedures; Pain; Patient Care; Patients; Phase; Physical Function; Physically Handicapped; Pilot Projects; Policies; Post-Traumatic Stress Disorders; Practice Guidelines; Pragmatic clinical trial; Primary Health Care; Procedures; Process; Protocols documentation; Psychotherapy; Qualitative Research; Randomized; Randomized Clinical Trials; Recommendation; Recruitment Activity; Research; Research Methodology; Research Personnel; Secure; Series; Services; Site; Staging; Supervision; Survivors; Symptoms; Time; Trauma; Traumatic Brain Injury; Uninsured; United States; United States National Institutes of Health; Washington; Work; care systems; collaboratory; college; computerized; cost; depressive symptoms; effective care management; evidence base; functional disability; group intervention; health economics; improved; injured; injury burden; innovation; member; multiple chronic conditions; novel; patient population; pragmatic trial; prevent; safety net; screening; support tools; symposium; systems research; trauma care; trauma centers; treatment effect

DESCRIPTION (provided by applicant): Each year over 30 million Americans present to trauma centers, emergency departments, and other acute care medical settings (i.e., trauma care systems) for the treatment of physical injuries. Multiple chronic conditions including Posttraumatic Stress Disorder (PTSD), alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptoms, and pre-existing chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Enduring PTSD and comorbidity are associated with marked functional impairments and societal costs. Evidence-based treatments for PTSD and comorbidity exist, but have yet to be broadly implemented throughout trauma care systems. The challenges presented by this constellation of PTSD and comorbid conditions in survivors of TBI and non-TBI related injury, require novel research approaches that cut across the traditional domains of multiple NIH institutes. The overarching goal of this UH2-UH3 proposal is to work synergistically with the NIH HCS Research Collaboratory to efficiently develop and implement an innovative large scale, pragmatic clinical trial that directly informs national trauma care system policy. The study team is proposing a 20 trauma center cluster randomized trial that incorporates Collaboratory-informed state-of-the art assessments and information technology innovations. The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries; the intervention also aims to mitigate the impact of the acute injury event on symptom exacerbations in the large subpopulation of patients who already carry a substantial pre-injury burden of multiple chronic medical conditions. The intervention utilizes a computerized decision support tool to flexibly target � 3 chronic conditions and includes care management, medication, and psychotherapy elements. At each of the 20 sites an electronic medical record screen will be used to recruit 40 patients with the chronic disease cluster of PTSD and comorbidity for a total of 800 inpatients to be followed over the course of the 12 months after injury hospitalization. The hypotheses are that intervention group patients will demonstrate significant reductions in the symptoms of PTSD, alcohol use, depression, and improved physical function, and that the intervention will be equally effective among injury survivors with and without TBI and with and without chronic medical conditions. Secondary analyses will evaluate the implementation of the intervention using the RE-AIM model augmented by health economic, organizational behavior, and qualitative research methods. Simultaneously, as the investigation is being conducted, the study team will be actively developing an American College of Surgeons' summit agenda targeting the broader aim of engaging trauma care systems nationwide in the research by using pragmatic trial results to directly impact policy mandates and practice guidelines for real-time, work-flow integrated screening, intervention, and quality documentation procedures for PTSD and related comorbidities.

描述（由申请人提供）：每年有超过3000万美国人前往创伤中心、急诊科和其他急性护理医疗机构（即，创伤护理系统）用于治疗身体损伤。多种慢性疾病，包括创伤后应激障碍（PTSD），酒精和药物使用问题，抑郁症和相关的自杀意念，疼痛和躯体症状，以及预先存在的慢性医疗条件是有和没有创伤性脑损伤（TBI）的身体创伤幸存者的地方病。持久的PTSD和合并症与明显的功能障碍和社会成本有关。PTSD和合并症的循证治疗是存在的，但尚未在整个创伤护理系统中广泛实施。创伤后应激障碍和共病条件的TBI和非TBI相关损伤的幸存者，这种星座所提出的挑战，需要新的研究方法，跨越传统领域的多个NIH研究所。UH 2-UH 3提案的总体目标是与NIH HCS研究合作实验室协同工作，有效地开发和实施一项创新的大规模，实用的临床试验，直接告知国家创伤护理系统政策。该研究小组提出了一项20个创伤中心的随机分组试验，该试验结合了协作通知的最新评估和信息技术创新。该干预措施旨在预防TBI和非TBI损伤幸存者的慢性PTSD和抑郁症状，酒精使用问题和持久身体残疾的发展;该干预措施还旨在减轻急性损伤事件对大量亚群患者症状恶化的影响，这些患者已经承受了大量的多种慢性疾病的损伤前负担。该干预利用计算机化的决策支持工具，灵活地针对3种慢性疾病，包括护理管理，药物治疗和心理治疗元素。在20个研究中心中的每个研究中心，将使用电子病历屏幕招募40名患有慢性疾病集群PTSD和合并症的患者，共计800名住院患者，在受伤住院后的12个月内进行随访。的 假设是干预组患者将表现出PTSD症状、酒精使用、抑郁和身体功能改善的显著减少，并且干预在有和没有TBI以及有和没有慢性医学状况的损伤幸存者中同样有效。二次分析将使用由卫生经济学、组织行为学和定性研究方法增强的RE-AIM模型评估干预措施的实施情况。同时，随着调查的进行，研究小组将积极制定美国外科医生学会的峰会议程，目标是通过使用务实的试验结果直接影响政策授权和实践指南，使全国范围内的创伤护理系统参与研究，实时，工作流程综合筛查，干预和创伤后应激障碍及相关并发症的质量记录程序。