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