Efficacy of BETTER transitional care intervention for diverse patients with traumatic brain injury and their families: Study protocol of a randomized controlled trial.

OBJECTIVE: The purpose of this study is to examine the efficacy of BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) vs. usual transitional care management among diverse adults with traumatic brain injury (TBI) discharged home from acute hospital care and families. METHODS: This will be a single-site, two-arm, randomized controlled trial (N = 436 people, 218 patient/family dyads, 109 dyads per arm) of BETTER, a culturally- and linguistically-tailored, patient- and family-centered, TBI transitional care intervention for adult patients with TBI and families. Skilled clinical interventionists will follow a manualized protocol to address patient/family needs. The interventionists will co-establish goals with participants; coordinate post-hospital care, services, and resources; and provide patient/family education and training on self- and family-management and coping skills for 16 weeks following hospital discharge. English- and Spanish-speaking adult patients with mild-to-severe TBI who are discharged directly home from the hospital without inpatient rehabilitation or transfer to other settings (community discharge) and associated family caregivers are eligible and will be randomized to treatment or usual transitional care management. We will use intention-to-treat analysis to determine if patients receiving BETTER have a higher quality of life (primary outcome, SF-36) at 16-weeks post-hospital discharge than those receiving usual transitional care management. We will conduct a descriptive, qualitative study with 45 dyads randomized to BETTER, using semi-structured interviews, to capture perspectives on barriers and facilitators to participation. Data will be analyzed using conventional content analysis. Finally, we will conduct a cost/budget impact analysis, evaluating differences in intervention costs and healthcare costs by arm. DISCUSSION: Findings will guide our team in designing a future, multi-site trial to disseminate and implement BETTER into clinical practice to enhance the standard of care for adults with TBI and families. The new knowledge generated will drive advancements in health equity among diverse adults with TBI and families. TRIAL REGISTRATION: NCT05929833.

The BETTER Traumatic Brain Injury Transitional Care Intervention: A Feasibility Study.

This study aimed to investigate the feasibility, acceptability, and clinical outcome measures of BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery), a culturally tailored traumatic brain injury (TBI) transitional care intervention, among diverse younger adult patients with TBI (age 18-64) and their caregivers. Trained clinical interventionists addressed patient/family needs; established goals; coordinated post-hospital care and resources; and provided patient/family training on self- and family-management coping skills. Fifteen dyads enrolled (N = 31, 15 patients, 16 caregivers). All completed baseline data; 74.2% (n = 23; 10 patients, 13 caregivers) completed 8-week data; 83.8% (n = 26; 13 each) completed 16-week data. Approximately 38% (n = 12, 3 patients, 9 caregivers) completed acceptability data, showing positive experiences (mean = 9.25, range 0-10; SD = 2.01). Overall and mental quality of life (QOL) scores did not differ over time but physical QOL scores did improve over time (baseline: 30.3, 8 weeks: 46.5, 16 weeks: 61.6; p = 0.0056), which was considered to be a suitable outcome measure for a future trial. BETTER is a promising intervention with implications to improve TBI care standards. Research is needed to determine efficacy in a randomized trial.

How Subjective and Objective Factors in Research and Practice May Perpetuate Health Disparities Among Patients With Traumatic Brain Injury.

ABSTRACT: Research shows disparities exist in traumatic brain injury (TBI)-related outcomes and are associated with objective and subjective factors. Objective factors (e.g., age, sex, race/ethnicity, health insurance status, and socioeconomic status) are defined as variables that are frequently measured, not easily modifiable, and not easily influenced by individual perceptions, opinions, or experiences. Conversely, subjective factors (e.g., personal health literacy, cultural competence, patient/family-clinician communication, implicit bias, and trust) are defined as variables that may be less frequently measured, more easily modifiable, and more easily influenced by individual perceptions, opinions, or experiences. The purpose of this analysis and perspective is to provide recommendations for further examination of subjective factors within TBI research and practice, with the overarching goal of reducing TBI-related disparities. Establishing reliable and valid measures of subjective factors is recommended to allow for further examination of the influence of both objective factors and subjective factors in the TBI population. Providers and researchers must also engage in education and training to recognize their biases and how bias influences decision making. The influence of subjective factors in practice and research must also be considered to ensure that knowledge needed to advance health equity is generated and disparities in outcomes for patients with TBI are reduced.

Design, methods, and baseline characteristics of the Brain Injury Education, Training, and Therapy to Enhance Recovery (BETTER) feasibility study: a transitional care intervention for younger adult patients with traumatic brain injury and caregivers.

OBJECTIVES: We developed a patient- and family-centered traumatic brain injury (TBI) transitional care intervention, called BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery), to improve quality of life (via SF-36) of younger TBI patients of different racial groups discharged home from acute hospital care and caregivers. We describe our design, methods, and baseline characteristics for our feasibility study. METHODS: We co-developed BETTER with input from key stakeholders (TBI patients and caregivers, healthcare providers, and interdisciplinary research team members). BETTER is guided by the Individual and Family Self-Management Theory, our team's prior research, as well as literature used to support, educate, and train patients and families recovering from TBI and other conditions. The intervention is delivered by trained clinical interventionists (transitional care managers), beginning 24-72 h pre-discharge to 16 weeks post-discharge. BETTER offers tailored transitional care support to patient/family dyads, including assessing needs; establishing goals; coordinating post-hospital care, services, and resources; and providing patient/family education and training on brain injury coping skills. The majority of the intervention is delivered remotely via phone and remote video conferencing platform (Clinicaltrials.gov: NCT04584554). RESULTS: We enrolled 15 dyads (N = 31, 15 patients, 16 caregivers) in this single arm, single center feasibility study. Most patients were men (n = 11, 73.33%), had a mean age of 39.07 (SD: 15.15), and were Black (n = 9, 60%), White (n = 5, 33.3%), or American Indian (n = 1, 0.66%). Injury severities were mild (n = 6, 40%), moderate (n = 4, 26.6%) or severe (n = 5, 33.33%). Most patients were insured (n = 10; 66.7%), had a high school education (n = 6; 40%); and earned $30,000 or less per year (n = 11; 73.3%). Most caregivers were married (n = 9, 56.25%) women (n = 14, 87.5%) with a mean age of 43.38 (SD: 10.45) and were Black (n = 8, 50%), White (n = 7, 43.75%), or American Indian (n = 1, 0.62%). Most caregivers identified as the spouse (n = 7; 43.75%) or parent (n = 6; 37.5%) of the patient. CONCLUSIONS: BETTER is among the first TBI transitional care intervention to address needs/preferences for younger TBI patients of different racial groups after discharge home from acute hospital care and families. Findings can be used to inform future work.