BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
- Conditions
- Traumatic Brain Injury
- Interventions
- Behavioral: BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery)Other: Usual Care
- Registration Number
- NCT05929833
- Lead Sponsor
- Duke University
- Brief Summary
Despite racial/ethnic disparities in outcomes for younger 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, the investigators will examine the efficacy of the existing intervention named BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery), a culturally-tailored, patient- and family-centered TBI transitional care intervention, compared to usual care, among younger adults with TBI and families. The knowledge generated will drive improvements in health equity for younger adults with TBI of various races/ethnicities and families, resulting in improved health of the public.
- Detailed Description
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 the 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 the 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 the 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) 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. Usual Care 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).
- Primary Outcome Measures
Name Time Method Change in patient SF-36 (36-item Short Form Survey) score 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.
- Secondary Outcome Measures
Name Time Method 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 The PHQ-9 assesses degree of depression severity via questionnaire. It has a score range of 0 to 27, where a higher score indicates greater depression.
Change in patient cognitive function (Neuro-QOL, Cognitive functioning) baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge The Neuro-QOL is a self-report of health related quality of life for individuals with neurological disorders. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10.
Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning) baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge The Neuro-QOL is a self-report of health related quality of life for individuals with neurological disorders. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10.
Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form) baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge The Neuro-QOL is a self-report of health related quality of life for individuals with neurological disorders. Raw scores are converted to T-scores with a mean of 50 and standard deviation of 10.
Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire) baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge The Rivermead Post-concussion questionnaire is a self-reported measures of TBI-related symptoms. Scores on the first 3 items of the RPQ can range from 0 to 12, with higher scores indicated higher severity of early symptom clusters of post-concussive symptoms; scores on items 4 to 16 can range from 0 to 52, with higher scores indicating higher severity of later post-concussive symptoms
Change in patient participation [Participation Assessment with Recombined Tools-Objective (PART-O)] 8-, 16-, and 24-weeks post-discharge Participation will be measured using the Participation Assessment with Recombined Tools-Objective (PART-O), an objective measure of societal participation developed for patients with TBI with 24-items, with higher scores indicating higher levels of participation
Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)] 8-, 16-, and 24-weeks post-discharge The process of care transitions will be measured by the Care Transitions Measure-3, a 3-item scale with scores ranging from 0 to 100, with higher scores indicating less challenges with the transitional care process
Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)] 8-, 16-, and 24-weeks post-discharge Difficulty accessing services will be measured by the Service Obstacles Scale, a 6-item scale with scores ranging from 7 to 42, with higher scores indicating more difficulty accessing services
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 The EQ-5D-5L is a patient reported outcome consisting of 5 items asking about quality of life. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state. The VAS (visual analog scale) captures self-rated health. Patients with TBI will also complete the cognitive domain of the EuroQol (EQ-5D-5L+C), to capture condition specific issues, but caregivers will not.
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 Multi-dimensional interpersonal processes in the clinical encounter, particularly discrimination in the clinical encounter, will be measured using the Interpersonal Processes of Care survey (short-form). The measure, which contains 18-items, has 7 domains using a 1 to 5 scale, with scores ranging from 18 to 90. Higher scores indicate a higher frequency of interpersonal challenges and discrimination in the clinical encounter.
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 The Self-Efficacy to Manage Chronic Disease Scale is made up of 6 items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). The total score range is 6 to 60, where a higher score indicates greater confidence.
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 Alcohol and substance use will be measured using the CAGE-AID Substance Use Screening Tool, a 5-item measure with scores ranging from 0 to 4, with higher scores indicating higher possibility of substance use disorder and need for possible testing
Score on patient and family personal health literacy (Self-Reported Health Literacy Questions) baseline (24-72 hours pre-discharge) Health literacy will be measured using the Self-Reported Health Literacy Questions, a 3-item measure with scores ranging from 3-15, with higher scores indicating lower self-reported health literacy.
Number and type of healthcare services utilized 8-, 16-, and 24-weeks post-discharge Measured by patient and/or caregiver proxy report of patient transitional health care utilization, using a survey developed by the team.
Change in caregiver Modified Caregiver Strain Index (MCSI) baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge The MCSI can quickly screen for caregiver strain in long-term caregivers. Scoring is 2 points for each 'yes', 1 point for each 'sometimes', and 0 for each 'no' response. The total score ranges from 0 to 26, where a higher score indicates a higher level of caregiver strain.
Change in caregiver Preparedness for Caregiving Scale baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge The Preparedness for Caregiving Scale is a caregiver self-rated instrument that consists of eight items that asks caregivers how well prepared they believe they are for multiple domains of caregiving. Responses are rated on a 5 point scale with scores ranging from 0 (not at all prepared) to 4 (very well prepared). The scale is scored by calculating the mean of all items answered with a score range of 0 to 4. The higher the score the more prepared the caregiver feels for caregiving.
Score on Pittsburgh Rehabilitation Participation Scale (PRPS) weekly from 1- to 16-weeks post-discharge The interventionist/transitional care manager will rate the patient and the caregiver on the Pittsburgh Rehabilitation Participation Scale (PRPS) to capture their level of engagement in Brain Injury Coping Skills (BICS) sessions. The PRPS is a clinician-rated instrument designed to assess a patient's participation in therapy. The PRPS will only be used for treatment arm participants.
Time spent caregiving and caregiving responsibilities baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge Time spent caregiving and caregiving responsibilities will be measured using 3 items created by the study team.
Change in Patient Activation Measure (PAM-10) for patients and caregivers. baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge The Patient Activation measure will that assesses a patient's and caregiver's ability to manage their health and healthcare. Insignia Health's proprietary survey scoring algorithm produces a PAM Score along an empirical, interval-level scale from 0-100 that correlates to one of four levels of patient activation. PAM Levels 1 and 2 indicate lower patient activation, while PAM Levels 3 and 4 indicate higher patient activation.
Trial Locations
- Locations (1)
Duke University Hospital
🇺🇸Durham, North Carolina, United States