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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05929833
• Other study ID #: Pro00112309
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 26, 2024
• Est. completion date: January 31, 2027

Study information

• Verified date: October 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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)

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics	Age, sex, race/ethnicity, education, pre-injury occupation, insurance status, annual income	baseline (24-72 hours pre-discharge)
Other	Clinical Factors	TBI severity, length of stay, comorbidities (via chart review)	baseline (24-72 hours pre-discharge)
Primary	Change in patient SF-36 (36-item Short Form Survey) score	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient cognitive function (Neuro-QOL, Cognitive functioning)	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient physical functioning (Neuro-QOL, Upper & Lower extremity functioning)	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient sleep disturbance (NeuroQOL Sleep Disturbance, short-form)	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient TBI-related symptoms (Rivermead Post-concussion questionnaire)	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	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient participation [Participation Assessment with Recombined Tools-Objective (PART-O)]	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	8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient process of care transition [Care Transitions Measure-3 (CTM-3)]	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	8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient and caregiver difficulty accessing services [Service Obstacles Scale (SOS)]	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	8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient and caregiver quality of life / health status (Euro Qol, 5 Item [EQ-5D-5L]) + VAS (visual analog scale) + Cognitive domain (C)	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient and caregiver multi-dimensional interpersonal processes of care in the clinical encounter [Interpersonal Processes of Care (IPC) short-form]	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient and caregiver depressive symptoms [PHQ-9 (Patient Health Questionnaire-9)]	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient and caregiver Self-Efficacy for Management of Chronic Conditions Scale	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in patient and caregiver alcohol and substance abuse (CAGE-AID Substance Abuse Screening Tool)	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	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Score on patient and family personal health literacy (Self-Reported Health Literacy Questions)	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.	baseline (24-72 hours pre-discharge)
Secondary	Number and type of healthcare services utilized	Measured by patient and/or caregiver proxy report of patient transitional health care utilization, using a survey developed by the team.	8-, 16-, and 24-weeks post-discharge
Secondary	Change in caregiver Modified Caregiver Strain Index (MCSI)	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Change in caregiver Preparedness for Caregiving Scale	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.	baseline (24-72 hours pre-discharge); 8-, 16-, and 24-weeks post-discharge
Secondary	Score on Pittsburgh Rehabilitation Participation Scale (PRPS)	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.	weekly from 1- to 16-weeks post-discharge