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

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05929833

Collaborator

(none)

500

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Behavioral: BETTER (Brain Injury, Education, Training, and Therapy to Enhance Recovery) Other: Usual Care	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2027

Anticipated Study Completion Date :

Mar 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention 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.	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.
Placebo Comparator: 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).	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)

Arm

Intervention/Treatment

Experimental: BETTER TBI (Traumatic Brain Injury) Transitional Care Intervention

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.

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.

Placebo Comparator: 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).

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)

Outcome Measures

Primary Outcome Measures

Change in 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

Change in 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 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 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 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 caregiver SF-36 [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.
Number of participants utilizing transitional care [16 weeks post-discharge]
Measured by patient and/or caregiver proxy report of patient transitional health care utilization.
Change in 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 Preparedness for Caregiving Scale (CPS) [baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge]
The CPS 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with TBI of any race/ethnicity, regardless of insurance status, will be eligible if they are: a) age 18-64 years; b) diagnosed with mild, moderate, or severe TBI [admission Glasgow Coma Scale score of 3-14];110 c) admitted to a DUH inpatient acute care unit; d) plans to be discharged directly home from DUH without inpatient rehabilitation or transfer to other settings (community discharge); e) 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);111 f) English- or Spanish-speaking (self-report), and g) access to a phone (cell or landline) for study participation.
Family members will include patient-identified biological relatives and friends112 and are eligible if they: a) are 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);113 b) age >18; c) English- or Spanish-speaking (self-report), and d) access to a phone (cell or landline) for study participation. All participants must be able to consent to participate. Patients and families will be recruited as a dyad.

Exclusion Criteria:

Patients with TBI will be excluded if they are 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.