A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Patients With Traumatic Brain Injury and Their Families
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Change in patient SF-36 (36-item Short Form Survey) score
研究概览
简要总结
Despite poor outcomes for adults with traumatic brain injury (TBI), there are no U.S. standards for TBI transitional care for patients discharged home from acute hospital care. To enhance the standard of care, we will examine the efficacy of our existing intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), a patient- and family-centered TBI transitional care intervention, compared to usual care, among adults with TBI and families. The knowledge generated will drive improvements in outcomes for adults with TBI and families, resulting in improved health of the public.
详细描述
Patients with TBI (age 18 and older) with mild-to-severe traumatic brain injury (TBI) face high incidence and hospitalization rates, and poor cognitive, physical, behavioral, and emotional impairments <12 months post-discharge. These impairments affect patients' abilities to independently manage their health, wellness, and activities of daily living, resulting in dependence on family. 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 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. The paucity of theory-driven, evidence-based TBI transitional care interventions led our team to develop an 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 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 adults with TBI and families. Thus, the purpose of this study is to examine the efficacy of BETTER (vs. usual care) among adults with TBI 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 drive advancements to enhance the standard of care for adults with TBI and families.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with TBI, regardless of insurance status, will be eligible if they are/have:
- •age 18 years or older;
- •diagnosed with mild, moderate, or severe TBI [admission Glasgow Coma Scale score of 3-15];
- •admitted to a Duke University Hospital inpatient acute care unit;
- •plans to be discharged directly home from Duke University Hospital without inpatient rehabilitation or transfer to other settings (community discharge);
- •sufficient cognitive functioning to participate (i.e., able to follow 2-step commands), as determined by the Galveston Orientation and Amnesia Test (score >76 eligible);
- •English- or Spanish-speaking (self-report);
- •access to a phone or computer with internet capabilities for study participation
- •Patients with TBI will be excluded if they have/are:
- •Pre-injury neurologic conditions/disorder(s):
- •The following neurological conditions/disorders are excluded:
- •untreated ADHD, cerebral palsy, stroke, multiple sclerosis, Parkinson's disease); pre-injury cognitive impairments (e.g., Alzheimer's disease and related dementias); and developmental disorders (e.g., autism, down's syndrome).
- •The following neurological conditions are not being excluded:
- •transient ischemic attack, small vessel disease; essential tremor; concussion (maximum 2 prior concussions with no prior history of post-concussion syndrome); myasthenia gravis; dysautonomia; foot drop; degenerative disc disease; spine reticulopathy; bell's palsy + other cranial nerve palsy; neurogenic bladder (if in isolation); and epilepsy [patients with epilepsy are eligible to participate if they had no hospital admissions or emergency department visit for seizures in the last 6 months]
- •Severe psychiatric diagnosis (i.e., untreated schizophrenia, untreated bipolar 1 or 2, any indication of psychosis or acute psychotic events occurring) that are untreated with no psychiatric provider on record, which would preclude patients from having capacity to consent
- •Admitted from settings or locations other than home
- •Family members will include patient-identified biological relatives and friends and are eligible if they are/have:
- •associated with a patient meets all above-listed patient criteria;
- •age 18 years or older;
- •an anticipated primary caregiver after discharge (i.e., plans to live in same home as patient or have direct contact with patient >10 hours/week);
- •English- or Spanish-speaking (self-report);
- •access to a phone or computer with internet capabilities for study participation.
- •Family members will be excluded if the associated patient is not eligible or declines participation.
排除标准
- 未提供
研究组 & 干预措施
BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention
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.
干预措施: BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) (Behavioral)
Usual Care
In alignment with U.S. usual care for patients with TBI (Traumatic Brain Injury), usual care arm activities for younger adults with TBI and their family caregivers will includes usual care discharge planning process and follow up (e.g., verbal and written discharge instructions, with guidance on medications, outpatient therapy, and follow-up appointments).
干预措施: Usual Care (Other)
结局指标
主要结局
Change in patient SF-36 (36-item Short Form Survey) score
时间窗: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
The SF-36 is a quality of life (QOL) measurement with a score range of 0 to 100, where a higher score indicates a better outcome.
次要结局
- Change in patient cognitive function (Neuro-QOL, Cognitive functioning)(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient participation [Participation Assessment with Recombined Tools-Objective (PART-O)](8-, 16-, and 24-weeks post-discharge)
- Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)](8-, 16-, and 24-weeks post-discharge)
- Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)](8-, 16-, and 24-weeks post-discharge)
- Change in patient and caregiver quality of life / health status (Euro Qol, 5 Item [EQ-5D-5L]) + VAS (visual analog scale) + Cognitive domain (C)(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient and caregiver multi-dimensional interpersonal processes of care in the clinical encounter [Interpersonal Processes of Care (IPC) short-form](baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient and caregiver depressive symptoms [PHQ-9 (Patient Health Questionnaire-9)](baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient and caregiver Self-Efficacy for Management of Chronic Conditions Scale(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in patient and caregiver alcohol and substance abuse (CAGE-AID Substance Abuse Screening Tool)(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Score on patient and family personal health literacy (Self-Reported Health Literacy Questions)(baseline (24-72 hours pre-discharge))
- Number and type of healthcare services utilized(8-, 16-, and 24-weeks post-discharge)
- Change in caregiver Modified Caregiver Strain Index (MCSI)(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in caregiver Preparedness for Caregiving Scale(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Score on Pittsburgh Rehabilitation Participation Scale (PRPS)(weekly from 1- to 16-weeks post-discharge)
- Time spent caregiving and caregiving responsibilities(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)
- Change in Patient Activation Measure (PAM-10) for patients and caregivers.(baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge)