Brain Injury Education and Navigation for Traumatic Brain Injury
(1st-BIEN Trial)
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Seattle Children's Hospital
Disqualifiers: Prior neurological deficits, abusive trauma, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial tests a bilingual program called 1st BIEN for Hispanic children with traumatic brain injuries. The program includes education through videos and in-person sessions, plus support to help families access outpatient care. It aims to improve treatment adherence and reduce long-term disability.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications. It is best to consult with the trial coordinators for specific guidance.
What data supports the effectiveness of the treatment Bilingual Brain Injury Education and outpatient Navigation for Hispanic families?
Research shows that a bilingual education and navigation program can be feasible and acceptable for Hispanic families dealing with traumatic brain injury (TBI). This approach, which includes bilingual education and support during care transitions, has been pilot tested and is designed to address the unique needs of Hispanic families, potentially improving outcomes for children with TBI.
12345Is the Brain Injury Education and Navigation program safe for humans?
The studies on the Brain Injury Education and Navigation program, including its versions for Hispanic families, have focused on its feasibility and acceptability, which suggests it is generally safe for use in humans.
12356How is the 1st BIEN treatment different from other treatments for traumatic brain injury?
The 1st BIEN treatment is unique because it provides bilingual education and navigation support specifically tailored for Hispanic families, using mobile phone video content and bilingual navigators to help with transitions of care and school return, addressing a gap in culturally relevant interventions for this population.
12378Eligibility Criteria
This trial is for Hispanic children aged 6-17 with mild to severe traumatic brain injury (TBI) who have been hospitalized for over 24 hours and need outpatient rehab therapy. It's also for their primary caregivers, who will help with the child's recovery.Inclusion Criteria
Hispanic ethnicity
Hospitalization for more than 24 hours at one of the 5 academic institutions participating in this trial
I need outpatient rehabilitation therapy.
+2 more
Exclusion Criteria
My child has a brain injury not caused by physical trauma.
Child: Prior neurological deficits
Parent: Loss of custody of the child (i.e. abusive head trauma)
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Education and Initial Intervention
Participants receive one in-person education session using the 1stBIEN booklet, followed by video education via mobile phones and care coordination from a bilingual Patient Navigator for 3 months.
3 months
1 in-person visit, weekly virtual follow-ups
Follow-up
Participants are monitored for treatment adherence and functional outcomes at 3, 6, and 12 months post-discharge.
12 months
Regular follow-ups at 3, 6, and 12 months
Long-term Monitoring
Ongoing assessment of child's academic performance and social participation using school records and PROMIS measures.
12 months
Participant Groups
The study tests a bilingual program called '1st BIEN' that combines in-person education and mobile video content with navigation support during transitions to outpatient care and school return, aiming to improve long-term adherence to rehabilitation.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Intervention group receives one in person education session using the 1stBIEN booklet, video education via mobile phones and care coordination from a bilingual Patient Navigator-PN for 3-months. PN follow up patients weekly for the first month and once a month for two months. Video education is done weekly. Videos cover problem solving training, brain injury concepts, rehabilitation treatments and school resources individualized to patient and family needs. PNs facilitate transition to outpatient care, follow-up with specialists and primary care providers; use of community resources; and communication with teachers and school administrators. PN provides observational and experiential learning opportunities for parents, using three way calls for scheduling of services and interactions with clinics and schools. PN calls use a problem-solving training format, to reinforce parental experiential learning and improve self-efficacy. Expert MD providers (Co-investigators) will supervise PNs.
Group II: Attention Control groupActive Control1 Intervention
Attention Control group receives one in person education session using the 1stBIEN booklet, monthly well-child texts and usual post-injury care including routine follow-up by specialists and primary care providers, per guidelines at each recruiting institution. Control patients have access to a list of community resources included in the 1stBIEN booklet. While education using the 1stBIEN booklet is not part of the current usual care at participating institutions, providing all families with initial education at the time of discharge addresses ethical and practical considerations. It standardizes discharge processes at participating institutions while delineating differences in the intensity of education and care coordination activities.
Bilingual Brain Injury Education and outpatient Navigation for Hispanic families is already approved in United States for the following indications:
🇺🇸 Approved in United States as 1st BIEN for:
- Traumatic Brain Injury (TBI) rehabilitation for Hispanic children
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Harborview Medical Center - University of WashingtonSeattle, WA
Seattle Children's HospitalSeattle, WA
Children's Hospital ColoradoColorado Springs, CO
Oregon Health & Science UniversityPortland, OR
More Trial Locations
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Who Is Running the Clinical Trial?
Seattle Children's HospitalLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Feasibility and Acceptability of a Telephone-Based Intervention for Hispanic Children to Promote Treatment Adherence After Traumatic Brain Injury: A Pilot Study. [2023]To assess the feasibility and acceptability of a telephone-based education and navigation program for Hispanic parents of children hospitalized with traumatic brain injury (TBI).
Bilingual randomized controlled trial design, of a telephone-based intervention to promote rehabilitation adherence; A study focus on recruitment of Hispanic children with traumatic brain injury. [2023]While Hispanic children experience large long-term disparities in disability after traumatic Brain Injury (TBI), there is a gap in evidenced-based interventions to improve outcomes among this rapidly growing and at high-risk population. We developed and pilot tested a bilingual/bicultural intervention informed by Hispanic families consisting of Brain Injury Education and outpatient Navigation (1st BIEN). It integrates bilingual in-person education enriched by video content delivered through mobile phone devices, with outpatient navigation by bilingual and bicultural navigators during transitions of care and school return.
A pilot study of Trabajadora de salud, a lay health worker intervention for Latinas/os with traumatic brain injuries and their caregivers. [2021]Latinas/os with traumatic brain injuries (TBIs) and their caregivers experience worse outcomes than others.
Ethnic disparities in traumatic brain injury care referral in a Hispanic-majority population. [2021]Functional outcomes after traumatic brain injury (TBI) can be significantly improved by discharge to posthospitalization care facilities. Many variables influence the discharge disposition of the TBI patient, including insurance status, patient condition, and patient prognosis. The literature has demonstrated an ethnic disparity in posthospitalization care referral, with Hispanics being discharged to rehabilitation and nursing facilities less often than non-Hispanics. However, this relationship has not been studied in a Hispanic-majority population, and thus, this study seeks to determine if differences in neurorehabilitation referrals exist among ethnic groups in a predominately Hispanic region.
Linguistic Validation of Interactive Educational Interventions in Neurologic Trauma. [2021]Neurological surgeons oftentimes educate patients and their families on complex medical conditions and treatment options. Time constraints and varied linguistic and cultural backgrounds limit the amount of information that can be disbursed. In this study, we assessed the linguistic validity of interactive educational interventions in non-English-speaking patients with traumatic brain injury (TBI) and concussion and their families.
Leaving Paper Behind: Improving Healthcare Navigation by Latino Immigrant Parents Through Video-Based Education. [2021]System barriers to effective healthcare engagement and navigation contribute to healthcare disparities among Latino children with immigrant parents in the US. We evaluated a nine-minute educational video supporting healthcare navigation and engagement skills of Spanish-speaking Latino parents of infants. Participants viewed the video at their child's 2-month well-visit, completed a pre-and post-video knowledge evaluation, and answered open-ended questions on video style. A paired t test was used to examine differences in knowledge and open-ended responses were coded using an iterative, consensus-based process. Of the 79 participants, 63.3% had an education level below high school diploma/GED and 84.8% were at risk for limited health literacy. There was a significant gain in healthcare navigation and engagement knowledge after watching the video (p
School professionals' knowledge about pediatric traumatic brain injury: an international study. [2023]To determine Spanish-speaking school professionals' level of knowledge and attitudes regarding pediatric TBI.
Interactive iBook-Based Patient Education in a NeuroTrauma Clinic. [2018]Traumatic brain injury (TBI) is a leading cause of death and disability in the United States. Educational interventions may alleviate the burden of TBI for patients and their families. Interactive modalities that involve engagement with the educational material may enhance patient knowledge acquisition when compared to static text-based educational material.