BETTER Program for Traumatic Brain Injury

Recruiting in Palo Alto (17 mi)

Overseen byTolu O Oyesanya, PhD, Rn

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

The BETTER trial is for younger adults aged 18-64 with mild to severe traumatic brain injury (TBI) who are being discharged home from acute hospital care. Participants must be able to follow commands, speak English or Spanish, and have phone access. Primary caregivers of the patients can also join if they're over 18 and meet similar language and phone requirements.

Inclusion Criteria

I plan to go home directly after being discharged from Duke University Hospital.

I have been diagnosed with a traumatic brain injury of any severity.

Patients with TBI of any race/ethnicity, regardless of insurance status, will be eligible if they are/have:

+8 more

Exclusion Criteria

Unable to identify a family member to participate with them in the study

My family member cannot join if I am not eligible or if I choose not to participate.

I do not have an untreated severe psychiatric condition that affects my ability to consent.

+3 more

Participant Groups

This study compares a special program called BETTER, which includes education, training, and therapy tailored for TBI patients and their families, against the usual care given after discharge from the hospital. It aims to improve recovery outcomes in racially diverse young adults with TBI.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BETTER TBI (Traumatic Brain Injury) Transitional Care InterventionExperimental Treatment1 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.

Group II: Usual CarePlacebo Group1 Intervention

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).