BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), Usual Care.
- Кому может быть актуально
- Состояния в реестре: Traumatic Brain Injury. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Patients With Traumatic Brain Injury and Their Families
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery)
The six components of BETTER include: 1) assessment of patient/family needs and referral to community-based resources; 2) patient goal setting and review of goals; 3) health care coordination; 4) availability of clinical interventionist to patient/family; 5) training on self- and family-management and brain injury coping skills; and 6) warm hand off/referral to the state-affiliated Brain Injury Association at the end of the intervention for additional resources. - Другое Usual Care
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)
Первичные конечные точки
- Change in patient SF-36 (36-item Short Form Survey) score [Срок оценки: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge]
Вторичные конечные точки (12)
- Change in patient cognitive function (Neuro-QOL, Cognitive functioning) [Срок оценки: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge]
- Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning) [Срок оценки: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge]
- Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form) [Срок оценки: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge]
- Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire) [Срок оценки: 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)] [Срок оценки: 8-, 16-, and 24-weeks post-discharge]
- Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)] [Срок оценки: 8-, 16-, and 24-weeks post-discharge]
- Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)] [Срок оценки: 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) [Срок оценки: 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] [Срок оценки: 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)] [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge]
Критерии участия
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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 1 центр
- Duke University Hospital — Durham
Публикации
- Oyesanya TO, Ibemere SO, You H, Emerson MM, Pan W, Palipana A, Kandel M, Ingram D, Soto M, Pioppo A, Albert B, Walker-Atwater T, Hawes J, Komisarow J, Ramos K, Byom L, Gonzalez-Guarda R, Van Houtven CH, Agarwal S, Prvu Bettger J. Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial. PL PMID 38394279
Идентификаторы
NCT: NCT05929833 · Pro00112309