Brain Injury Education and Navigation for Traumatic Brain Injury

(1st-BIEN Trial)

Recruiting at 4 trial locations

Overseen By Maria A Oliva, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Prior neurological deficits, abusive trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Hispanic children with traumatic brain injuries (TBIs) and their families in managing recovery after hospital discharge. It tests a bilingual program called Bilingual Brain Injury Education and Outpatient Navigation for Hispanic families, which provides education and support to help parents navigate outpatient care and school transitions. Videos and personalized support from bilingual navigators deliver this program. The trial seeks Hispanic children who have experienced a mild to severe TBI and require outpatient rehabilitation, along with their primary caregiver. The goal is to determine if this program improves long-term adherence to rehabilitation and reduces disability for these children. As an unphased trial, this study offers families a unique opportunity to access innovative support tailored to their needs.

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 prior data suggests that this program is safe for Hispanic families dealing with TBI?

Research has shown that the bilingual Brain Injury Education and outpatient Navigation program, known as 1st BIEN, has been tested for effectiveness and usability. Early results from past studies suggest that participants manage this program well. It includes in-person education, mobile phone videos, and support from a bilingual Patient Navigator. These components aim to help families of children with traumatic brain injuries manage care and improve recovery.

The initial study found that families considered the program easy to use and helpful. Although specific safety details are not mentioned, the program's progression beyond early testing suggests reasonable safety. No reports of negative effects from the educational content or support have emerged, indicating the program is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it offers a comprehensive, bilingual approach to supporting Hispanic families dealing with traumatic brain injury (TBI). Unlike traditional care, which typically involves standard post-injury follow-up, this trial includes personalized education through the 1stBIEN booklet and weekly video sessions tailored to each family's needs. A bilingual Patient Navigator (PN) provides hands-on support, helping families navigate the healthcare system and interact with schools, which is not commonly offered in standard care. This method aims to enhance self-efficacy and ensure smoother transitions to outpatient care, potentially leading to better outcomes for patients and their families.

What evidence suggests that the Bilingual Brain Injury Education and outpatient Navigation program is effective for improving treatment adherence and TBI outcomes in Hispanic children?

Research has shown that the bilingual Brain Injury Education and outpatient Navigation program, known as 1st BIEN, assists Hispanic families dealing with traumatic brain injury (TBI). In this trial, participants in the intervention group will receive personalized education and support via mobile phones. Studies have found that this method improves parents' understanding of health information, which is crucial for managing their child's recovery after a TBI. The program aids families in following rehabilitation plans and reducing long-term disability. Early results suggest that by offering personalized education and guidance, the program helps parents overcome language and system barriers. This approach is expected to enhance children's ability to function and succeed in school over time. ^{1 6 7 8 9}

Who Is on the Research Team?

Nathalia Jimenez, MD, MPH

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

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.

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)

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Bilingual Brain Injury Education and outpatient Navigation for Hispanic families

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention group Experimental Treatment 1 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 group Active Control 1 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

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A study involving 152 patients and family members showed that both interactive iBook and pamphlet educational interventions significantly improved self-reported knowledge about traumatic brain injury (TBI) or concussion (P < .01).

Patients who used the interactive iBook performed better on knowledge assessments compared to those who received pamphlets, indicating that engaging educational tools may enhance understanding and potentially improve compliance with medical recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive iBook-Based Patient Education in a NeuroTrauma Clinic. Sahyouni, R., Mahmoodi, A., Mahmoodi, A., et al.[2018]

The telephone-based education and navigation program for Hispanic parents of children with traumatic brain injury (TBI) was highly feasible, with 82% recruitment and 100% completion rates among the 14 participating parent-child dyads.

The program was well-received, with 90% of parents satisfied and significant improvements in their caregiving self-efficacy and adherence to follow-up rehabilitation appointments, indicating potential benefits for both parents and children in managing TBI care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of a Telephone-Based Intervention for Hispanic Children to Promote Treatment Adherence After Traumatic Brain Injury: A Pilot Study. Jimenez, N., Fuentes, M., Virtue, A., et al.[2023]

An interactive iBook-based educational intervention significantly improved understanding of traumatic brain injury (TBI) and concussion among 273 neurotrauma patients and their families, regardless of their native language or cultural background, with a notable increase in comprehension scores after using the tool.

The study highlighted disparities in baseline and post-intervention scores among different ethnic groups, indicating that while the intervention was effective overall, Caucasian participants scored higher than other ethnicities, suggesting a need for tailored educational approaches to address these differences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Linguistic Validation of Interactive Educational Interventions in Neurologic Trauma. Sahyouni, R., Mahmoodi, A., Tran, DK., et al.[2021]

75% of Spanish-speaking school professionals surveyed knew what traumatic brain injury (TBI) is, but only 18% had experience with a student who had TBI, indicating a gap between knowledge and practical experience.

Only a small percentage of participants could identify common short- and long-term effects of TBI, highlighting the need for improved training and education on TBI for these professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School professionals' knowledge about pediatric traumatic brain injury: an international study. Olabarrieta-Landa, L., Ramos-Usuga, D., Benito-Sánchez, I., et al.[2023]

In a study of 1128 TBI patients in a predominantly Hispanic region, it was found that Hispanic patients were significantly less likely to be discharged to rehabilitation facilities compared to non-Hispanic patients, even when controlling for factors like injury severity and insurance status.

Despite similar levels of injury severity and insurance coverage, the study highlights a concerning ethnic disparity in posthospitalization care referrals, indicating that systemic factors may influence discharge decisions for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ethnic disparities in traumatic brain injury care referral in a Hispanic-majority population. Budnick, HC., Tyroch, AH., Milan, SA.[2021]

The Trabajadora de Salud intervention, which involved in-home support from bilingual lay health workers, was well-accepted and showed improvements in functional abilities, depression, and somatic symptoms for Latina/o patients with traumatic brain injuries (TBIs) compared to a control group.

Caregivers also experienced reduced somatic symptoms and caregiver burden, indicating that the intervention not only benefits patients but also supports their caregivers, highlighting its potential effectiveness in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of Trabajadora de salud, a lay health worker intervention for Latinas/os with traumatic brain injuries and their caregivers. Linton, KF., Kim, BJ.[2021]

The 1st BIEN intervention, which combines bilingual education and outpatient navigation for Hispanic families after traumatic brain injury (TBI), aims to improve long-term treatment adherence and functional outcomes for children, addressing a significant gap in care for this high-risk population.

This pilot study uses a randomized controlled trial design to evaluate the intervention's effectiveness, measuring outcomes such as treatment adherence and children's functional status at multiple time points post-discharge, highlighting its potential as a scalable model for family-centered TBI interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Jimenez, N., Williams, CN., Keenan, H., et al.[2023]

A nine-minute educational video significantly improved healthcare navigation and engagement knowledge among 79 Spanish-speaking Latino parents of infants, with a p-value of less than 0.001 indicating strong efficacy.

Participants preferred the video format over written materials for receiving health education, highlighting its effectiveness in delivering culturally and linguistically tailored information, especially for those at risk for limited health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leaving Paper Behind: Improving Healthcare Navigation by Latino Immigrant Parents Through Video-Based Education. Valenzuela-Araujo, D., Godage, SK., Quintanilla, K., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40152401/

Implementation of a bilingual and bicultural navigation ... This study examined factors that facilitate or hinder the implementation of a bilingual and bicultural navigation program for caregivers of Hispanic children ...

2. tandfonline.com tandfonline.com/doi/full/10.1080/02699052.2025.2479824?scroll=top&needAccess=true

Implementation of a bilingual and bicultural navigation ... 1st BIEN is a culturally and linguistically appropriate brain injury education and navigation intervention, aimed to improve parental health literacy and self- ...

3. trialstoday.org trialstoday.org/trial/NCT05261477

Brain Injury Education and Outpatient Navigation-1stBIEN This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423002859

A study focus on recruitment of Hispanic children with ... We developed and pilot tested a bilingual/bicultural intervention informed by Hispanic families consisting of Brain Injury Education and outpatient Navigation ( ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37852531/

Bilingual randomized controlled trial design, of a telephone ... Our study evaluates a novel, flexible and scalable approach using mobile phone devices to aid transitions of care, increase treatment adherence and improve TBI ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10990393/

Bilingual randomized controlled trial design, of a telephone ... The present randomized controlled trial aims to evaluate the first Brain Injury Education and outpatient Navigation (1st BIEN) program; a culturally and ...

7. researcherprofiles.seattlechildrens.org researcherprofiles.seattlechildrens.org/nathalia.jimenez/publications

Nathalia Jimenez | Publications ... Brain Injury Education and outpatient Navigation (1st BIEN). It integrates bilingual in-person education enriched by video content delivered through mobile ...

8. reporter.nih.gov reporter.nih.gov/search/NlLJJjMKJ0mL7TJEWfpI1Q/project-details/10299443

RePORT RePORTER - National Institutes of Health (NIH) | Based on Social Cognitive theory, 1st BIEN integrates in-person education enriched by video content delivered through mobile phone devices, with outpatient ...

9. withpower.com withpower.com/trial/phase-wounds-and-injuries-2-2022-0eebb

Brain Injury Education and Navigation for Traumatic ... This trial tests a bilingual program called 1st BIEN for Hispanic children with traumatic brain injuries. The program includes education through videos and ...