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; 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 黑人和拉丁裔年轻人（18-64岁），有轻度至重度创伤性脑损伤（TBI）面对询问 与TBI相关的后果，以较高的事件和住院率证明，认知较差， 与白人相比，分娩后12个月的身体，行为和情绪障碍<12个月。这些 障碍会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，特别是对于种族/族裔少数民族。需求的复杂性结合在一起 随着医疗保健服务的分裂，为低患者生活质量（QOL）创造了完美的风暴， 症状不善，复兴和护理人员菌株增加。缺乏保险或获得护理， 以及语言障碍，加剧了这些持续的问题。尽管健康需求复杂，但没有美国 TBI患者过渡护理标准。过渡护理被定义为临床的行动 旨在确保患者转移的医疗保健协调和连续性 不同的位置或护理水平（例如，急性医院护理到家）。在其他患有急性事件的患者组中 （例如，中风，心肌梗塞），过渡护理干预措施已改善患者QOL和健康 结果。但是，很少有TBI过渡护理干预措施，这些现有干预措施并不平等 满足种族/族裔少数民族的需求。 TBI成果和贫困的现行种族/种族差异 理论驱动的，基于证据的TBI过渡护理干预措施使我们的团队开发了一个经过文化的规定 干预措施提名更好（脑损伤，教育，培训和治疗以增强康复）。基于 个人和家庭自我管理理论（IFSMT），更好的是患者和家庭中心， 患有TBI的年轻人的行为干预从急性医院护理和家庭中出院。这 目的是通过16周放病后改善患者的QOL（SF-36总分的变化，主要结果）， 由于此时间表包括高未满足的患者/家庭需求和可预防的临床事件的高率。熟练 临床干预主义者遵循手动干预方案，以满足患者/家庭需求；建立目标； 协调院后护理，服务和资源；并提供患者/家庭教育和自我培训 以及分期收取后16周的家庭管理和应对技巧。我们的NIH R03试点研究的发现 显示出更好的改善，将患者的身体质量提高31.36点（p = 0.006），并且 对于有TBI和家庭的年轻人，干预是可行的，并且可以接受。那，目的 研究是为了检查患有各种TBI的年轻人的更好（与常规护理）的有效性 从急性医院护理和家庭出院的种族/民族。调查结果将指导我们的团队 在设计未来的多站点试验时，以更好地传播和实施临床实践，以最终 提高患有TBI和家庭的年轻人的护理标准。产生的新知识将驱动 具有各种种族/种族和家庭的TBI的年轻人的卫生公平进步。