NCT05929833

BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)

A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Patients With Traumatic Brain Injury and Their Families

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	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)

Timeline

• Start date: 2024-01-26
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2023-07-03
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States