A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Diverse Patients with Traumatic Brain Injury and Their Families

BETTER（一种过渡性护理干预措施）针对不同脑外伤患者及其家人的随机对照试验

• 批准号: 10630498
• 负责人: Tolu O. Oyesanya
• 金额: $ 72.78万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-19 至 2028-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10630498
• 关键词: 2 arm randomized control trial; Activities of Daily Living; Acute; Address; Affect; Age; Area; Behavior Therapy; Behavioral; Black race; Brain Injuries; Caring; Clinical; Clinical Skills; Cognitive; Communities; Complex; Coping Skills; Cost Analysis; Dependence; Education; Effectiveness; Emotional; Enrollment; Ensure; Equity; Ethnic Origin; Ethnic Population; Event; Face; Family; Future; Goals; Health; Health Services Accessibility; Health system; Healthcare; Home; Hour; Impairment; Incidence; Individual; Inequity; Insurance; Intervention; Interview; Knowledge; Language; Latino; Linguistics; Location; Manuals; Myocardial Infarction; Names; Outcome; Participant; Patient Care; Patient Discharge; Patient Transfer; Patient-Focused Outcomes; Patients; Persons; Pilot Projects; Process; Protocols documentation; Provider; Public Health; Quality of life; Race; Randomized; Randomized, Controlled Trials; Recovery; Reduce health disparities; Research; Research Methodology; Research Personnel; Resources; SF-36; Self Management; Services; Site; Stroke; Structure; Symptoms; TBI Patients; Time; Training; Training and Education; Transitional Care Planning; Traumatic Brain Injury; Traumatic Brain Injury recovery; United States National Institutes of Health; acceptability and feasibility; arm; bilingualism; budget impact; care coordination; care costs; caregiver strain; clinical encounter; clinical practice; cost; design; efficacy evaluation; ethnic disparity; ethnic minority; evidence base; family management; health care service; health equity; hospital care; hospital readmission; hospitalization rates; improved; minority communities; multi-site trial; preference; primary outcome; racial disparity; racial minority; racial population; recruit; secondary outcome; sex; standard of care; theories; treatment as usual; young adult

ABSTRACT Black and Latino younger adults (age 18-64) with mild-to-severe traumatic brain injury (TBI) face inequities in TBI-related consequences, demonstrated by higher incidence and hospitalization rates, and worse cognitive, physical, behavioral, and emotional impairments <12 months post-discharge compared to Whites. These impairments affect patients’ abilities to independently manage their health, wellness, and activities of daily living, resulting in dependence on family, particularly for racial/ethnic minorities. The complexity of needs combined with the fragmentation of healthcare services creates the perfect storm for low patient quality of life (QOL), mismanaged symptoms, rehospitalizations, and increased caregiver strain. Lack of insurance or access to care, as well as language barriers, aggravate these ongoing issues. Despite complex health needs, there are no U.S. standards for transitional care for patients with TBI. Transitional care is defined as actions in the clinical encounter designed to ensure the coordination and continuity of healthcare for patients transferring between different locations or levels of care (e.g., acute hospital care to home). In other patient groups with acute events (e.g., stroke, myocardial infarction), transitional care interventions have led to improved patient QOL and health outcomes. Yet, few TBI transitional care interventions exist, and these existing interventions do not equitably address needs of racial/ethnic minorities. The prevailing racial/ethnic disparities in TBI outcomes and the paucity of theory-driven, evidence-based TBI transitional care interventions led our team to develop a culturally-tailored intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery). Based on the Individual and Family Self-Management Theory (IFSMT), BETTER is a patient- and family-centered, behavioral intervention for younger adults with TBI discharged home from acute hospital care and families. The goal is to improve patients’ QOL (change in SF-36 total score, primary outcome) by 16-weeks post-discharge, as this timeframe includes high rates of unmet patient/family needs and preventable clinical events. Skilled clinical interventionists follow a manualized intervention protocol to address patient/family needs; establish goals; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills <16 weeks post-discharge. Findings from our NIH R03 pilot study showed BETTER significantly improved patients’ physical QOL by 31.36 points (p = 0.006) and that the intervention was feasible and acceptable with younger adults with TBI and families. Thus, the purpose of this study is to examine the efficacy of BETTER (vs. usual care) among younger adults with TBI of various races/ethnicities who are discharged home from acute hospital care and families. Findings will guide our team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to ultimately enhance the standard of care for younger adults with TBI and families. The new knowledge generated will drive advancements in health equity among younger adults with TBI of various races/ethnicities and families.

摘要 患有轻度至重度创伤性脑损伤（TBI）的黑人和拉丁裔年轻人（18-64岁）在以下方面面临不平等： TBI相关后果，表现为发病率和住院率较高，认知能力较差， 与白人相比，出院后<12个月的身体、行为和情感障碍。这些 损伤影响患者独立管理其健康、健康和日常生活活动的能力， 导致对家庭的依赖，特别是对少数种族/族裔而言。需求的复杂性 随着医疗保健服务的分散，为低患者生活质量（QOL）创造了完美的风暴， 症状处理不当，再次住院，以及护理人员压力增加。缺乏保险或护理， 以及语言障碍，加剧了这些持续存在的问题。尽管健康需求复杂，但美国没有 TBI患者的过渡护理标准。过渡期护理的定义是在临床 旨在确保患者之间转移的医疗保健协调和连续性的会面 不同的位置或护理水平（例如，急性病医院护理到家）。在发生急性事件的其他患者组中 (e.g.,中风、心肌梗死），过渡性护理干预导致患者生活质量和健康改善 结果。然而，很少有TBI过渡性护理干预措施存在，这些现有的干预措施并不公平。 满足少数民族/种族的需求。TBI结果中普遍存在的种族/民族差异以及 理论驱动的，以证据为基础的TBI过渡性护理干预导致我们的团队开发了一个文化定制的 更好的干预（脑损伤，教育，培训和治疗，以提高恢复）。基于 个人和家庭自我管理理论（IFSMT），BETTER是一个以病人和家庭为中心， 对从急性医院护理和家庭出院的年轻TBI患者进行行为干预。的 目标是在出院后16周内改善患者的QOL（SF-36总分变化，主要结局）， 因为这一时间框架包括高比率的未满足的患者/家庭需求和可预防的临床事件。技术 临床干预人员遵循手动干预协议，以满足患者/家庭的需求;建立目标; 协调出院后的护理、服务和资源;并提供患者/家庭自我教育和培训， 和家庭管理和应对技能<16周后出院。我们的NIH R 03试点研究的结果 显示BETTER显著改善患者的身体QOL 31.36分（p = 0.006）， 对于患有TBI的年轻人和家庭来说，干预是可行且可接受的。因此， 一项研究旨在检查BETTER（与常规护理相比）在各种TBI的年轻成人中的疗效。 从急性医院护理和家庭出院回家的种族/民族。研究结果将指导我们的团队 在设计未来的多中心试验，以传播和实施更好地进入临床实践， 提高TBI患者和家庭的护理标准。产生的新知识将推动 促进不同种族/族裔和家庭的年轻TBI患者的健康公平性。