Clinical trial NCT05929833: BETTER (Brain Injury Education, Training, and Therapy to Enhance Recovery)
Official title: A Randomized Controlled Trial of BETTER, A Transitional Care Intervention, for Diverse Patients With Traumatic Brain Injury and Their Families
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: transitional care
patients
family caregivers
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Patients with TBI of any race/ethnicity, 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

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.

Patients with TBI will be excluded if they have/are:

* prior neurologic condition/disorder(s) (e.g., epilepsy, neuropathy, migraine, stroke, neurologically related spinal conditions, ADHD, MS, Parkinson's disease) or pre-injury cognitive impairments, early dementia, or Alzheimer's disease
* 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;
* unable to identify a family member to participate with them in the study.

Family members will be excluded if the associated patient is not eligible or declines participation.

Primary outcomes:
measure: Change in patient SF-36 (36-item Short Form Survey) score
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary outcomes:
measure: Change in patient cognitive function (Neuro-QOL, Cognitive functioning)
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient participation [Participation Assessment with Recombined Tools-Objective (PART-O)]
timeFrame: 8-, 16-, and 24-weeks post-discharge
measure: Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)]
timeFrame: 8-, 16-, and 24-weeks post-discharge
measure: Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)]
timeFrame: 8-, 16-, and 24-weeks post-discharge
measure: Change in patient and caregiver quality of life / health status (Euro Qol, 5 Item [EQ-5D-5L]) + VAS (visual analog scale) + Cognitive domain (C)
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient and caregiver multi-dimensional interpersonal processes of care in the clinical encounter [Interpersonal Processes of Care (IPC) short-form]
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient and caregiver depressive symptoms [PHQ-9 (Patient Health Questionnaire-9)]
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient and caregiver Self-Efficacy for Management of Chronic Conditions Scale
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in patient and caregiver alcohol and substance abuse (CAGE-AID Substance Abuse Screening Tool)
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Score on patient and family personal health literacy (Self-Reported Health Literacy Questions)
timeFrame: baseline (24-72 hours pre-discharge)
measure: Number and type of healthcare services utilized
timeFrame: 8-, 16-, and 24-weeks post-discharge
measure: Change in caregiver Modified Caregiver Strain Index (MCSI)
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in caregiver Preparedness for Caregiving Scale
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Score on Pittsburgh Rehabilitation Participation Scale (PRPS)
timeFrame: weekly from 1- to 16-weeks post-discharge
measure: Time spent caregiving and caregiving responsibilities
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
measure: Change in Patient Activation Measure (PAM-10) for patients and caregivers.
timeFrame: baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Other outcomes:
measure: Demographics
timeFrame: baseline (24-72 hours pre-discharge)
measure: Clinical Factors
timeFrame: baseline (24-72 hours pre-discharge)
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Tolu O Oyesanya, PhD, Rn
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. PLoS One. 2024 Feb 23;19(2):e0296083. doi: 10.1371/journal.pone.0296083. eCollection 2024.