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.

抽象的 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）面临不平等 TBI 相关后果表现为发病率和住院率较高以及认知能力较差， 与白人相比，出院后 12 个月内出现身体、行为和情绪障碍。 损伤影响患者独立管理自己的健康、保健和日常生活活动的能力， 导致对家庭的依赖，特别是对于少数族裔而言 需求的复杂性相结合。 医疗服务的碎片化导致患者生活质量（QOL）低下， 症状处理不当、再次住院以及护理人员的压力增加，缺乏保险或获得护理的机会， 尽管存在复杂的健康需求，但语言障碍加剧了这些持续存在的问题。 TBI 患者的过渡护理标准被定义为临床行动。 旨在确保患者之间转移的医疗保健的协调性和连续性 不同地点或级别的护理（例如，在发生急性事件的其他患者群体中进行紧急医院护理）。 （例如，中风、心肌梗死），过渡性护理干预措施改善了患者的生活质量和健康状况 然而，TBI 过渡护理干预措施很少，而且这些现有干预措施并不公平。 解决少数种族/族裔的需求。 TBI 结果中普遍存在的种族/族裔差异和稀缺性。 理论驱动、基于证据的 TBI 过渡护理干预措施引导我们的团队开发了一种适合文化的方法 名为 BETTER 的干预措施（基于脑损伤、教育、培训和治疗以促进康复）。 个人和家庭自我管理理论（IFSMT），BETTER是以患者和家庭为中心， 对患有 TBI 的年轻人从紧急医院护理和家庭出院进行行为干预。 目标是在出院后 16 周改善患者的 QOL（SF-36 总分的变化，主要结果）， 因为此时间范围内未满足患者/家庭需求和可预防的临床事件的比例很高。 临床干预专家遵循手动干预方案来满足患者/家庭的需求； 协调出院后护理、服务和资源；并提供患者/家属自我教育和培训 出院后 16 周内的家庭管理和应对技能 NIH R03 试点研究的结果。 显示 BETTER 显着改善了患者的身体 QOL 31.36 分 (p = 0.006)，并且 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，本次干预的目的是。 研究的目的是检验 BETTER（与常规护理相比）对患有各种类型 TBI 的年轻人的疗效 从紧急医院护理和家庭出院的种族/民族调查结果将为我们的团队提供指导。 设计未来的多中心试验，将 BETTER 传播并实施到临床实践中，最终 提高患有 TBI 的年轻人和家庭的护理标准。产生的新知识将推动。 不同种族/民族和家庭的患有 TBI 的年轻人的健康公平性取得了进展。