Brain Injury Education and Outpatient Navigation-1stBIEN

NCT ID: NCT05261477

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2026-12-31

Brief Summary

Traumatic brain injury (TBI) is a significant problem for U.S. Hispanic children. Compared to non-Hispanic children, Hispanic children have higher long-term disability and lower health related quality of life, even though differences are not present at hospital discharge. Rehabilitation decreases disability, but needs timely initiation, and long treatments in hospitals, community healthcare facilities and schools. Parents play a key role in their child's recovery. Hispanic parents face additional barriers to initiate and maintain outpatient treatments. They report knowledge gaps in TBI-education, community, and school support systems; language and health literacy barriers. The investigators developed, a bilingual bicultural theory-based program for Hispanic families consisting of Brain Injury Education and outpatient care Navigation (1st BIEN). It integrates in-person education enriched by video content delivered through mobile phones, with navigation during transitions to outpatient care and school return. The pilot established feasibility and acceptability of the program. This randomized control trial will determine efficacy to maintain long-term adherence to rehabilitation and reduce disability. It will enroll 150 parent-child dyads: children (6-17 y), with mild-complicated, moderate-severe TBI in 5 centers in Washington, Texas, Dallas, Utah and Oregon and their parents. Intervention group parents receive: One in-person education session, plus bi-weekly videos tailored to the child's TBI and therapies; and, 3-months of bilingual outpatient care navigation. Attention control parents receive one in person-education session, monthly well-child texts and usual institutional follow up care. Primary outcome is treatment adherence at 6 months post-discharge measured by percentage of follow-up appointments attended during the prescribed time at hospitals, and community care facilities. Secondary outcomes are functional status of the child using PROMIS parental report measures; and parental health literacy, self-efficacy, and mental health at 3, 6, and 12 months after discharge. Child's academic performance will be assessed using school records. The study evaluates a flexible and scalable intervention using mobile phones to aid transitions of care, improve treatment adherence and TBI outcomes. It addresses the needs of an understudied population and can serve as a model for TBI family centered care for at risk groups.

Detailed Description

TBI is a major cause of acquired disability in children. Approximately 60% of children with moderate to severe TBI have long-term cognitive, emotional, or physical deficits. Compared to non-Hispanic children, Hispanic children have higher disability 3 years after TBI, even though differences are not present at hospital discharge. Known risk factors for poor TBI outcomes in children such as underinsurance, low socioeconomic status, and limited parental education are highly prevalent among Hispanics, especially among immigrants from Central America and Mexico. Barriers for receipt of outpatient rehabilitation for Hispanic children are multiple including gaps in understanding of TBI and treatments, limited availability of culturally and linguistically relevant educational resources; and barriers to access services due to transportation, and under-insurance.

Education and navigation programs are efficacious in improving adherence to treatment for children with chronic conditions but have not been tested in children with TBI, despite the need for long-term outpatient rehabilitation. The investigators developed and pilot tested the 1st intervention designed for Hispanic children with TBIs and their families consisting of Brain Injury Education and outpatient Navigation (1st BIEN). The 1st BIEN intervention proposes the novel use of telephone based, culturally relevant patient navigation and education for Hispanic parents of children with TBI. It aims to improve access and adherence to treatment to decrease disability in this high-risk and understudied population. In the 1st BIEN pilot, the investigators established feasibility and acceptability for the program. Now the investigators propose a multicenter randomized controlled trial to test the efficacy of 1st BIEN to maintain long-term adherence to rehabilitation and determine its effect on child's functional outcomes.

Specific aims:

Aim 1. Test the efficacy of the 1st BIEN intervention to improve receipt of overall 1 year follow-up care and outpatient rehabilitation after a TBI among children and adolescents of Hispanic families.

Hypothesis 1a. Intervention group children will have higher attendance at follow-up appointments and higher initiation and attendance at outpatient therapies 6 months after discharge, compared to control children.

Aim 2. Determine the effect of the 1st BIEN intervention on functional outcomes and social participation at 3, 6 and 12 months after TBI hospital discharge among children and adolescents of Hispanic families.

Hypothesis 2a. Intervention group children will have higher adaptive functioning, health related quality of life, better physical, and emotional function, at 3, 6 and 12 months after hospital discharge, compared to control children.

Hypothesis 2b. Intervention group children will have higher levels of social participation measured by earlier school reintegration, receipt of educational resources, and participation in extracurricular activities.

Exploratory Aim 3. Test possible moderators and mediators of 1st BIEN intervention effects. Exploratory analyses will test possible moderators of intervention effects (i.e. pre-injury parental acculturation and education) and possible mediators (i.e. post-intervention parental knowledge, self-efficacy, mental health).

Study design:

Multi-center randomized control trial, enrolling 150 parent-child dyads; Hispanic children 3-17 years of age, hospitalized with a mild, moderate or severe TBI and their primary caregiver parent from 5 centers in Washington, Texas, Dallas, Utah and Oregon. All parents will receive in person education and linguistically and culturally tailored written TBI materials. Intervention parents additionally receive 3 months of Patient Navigation (PN) to support transitions of care and video education through mobile phone devices to promote TBI advocacy skills and reinforce essential TBI knowledge. Control group parents will receive well-child texts once a month to control for attention and follow up per institutional standard of care. Control parents do not receive patient navigation or video education.

Randomization will be done in a 1:1 ratio at each participating institution using a computer-generated random assignment sequence prepared by the study biostatistician and stratified by injury severity (mild complicated; moderate-severe) and age (3-5; 6-11;12-17).

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. The written information given to the attention control group does not equal the amount (dosage) given to the intervention group but provides consistent information to all participants.

Considering that acute processes of care can influence outpatient adherence to treatment and patient outcomes, the investigators will measure institutional and patient level quality indicators of acute rehabilitation care. At the individual level the investigators will measure receipt of inpatient physical, occupational, and speech therapy evaluations and rehabilitation consults; and indicators of family centered care such as assistance with identified needs, telephone counseling services and provision of a contact person for questions after discharge.

Reliability of the intervention will be ensured through meticulous in-person training prior to intervention implementation and monitoring of strict adherence to elements of the intervention. Education of PNs follows a pre-determined curriculum that includes screening and recruitment procedures, inform consent procedures, education of parents using the written materials and using lay language. Training on how to conduct baseline evaluations, scales and forms. After the training PNs should demonstrate proficiency in all procedures, in two case scenarios including use of problem-solving skills during follow-up patient navigation calls, delivery of initial education and delivery of individualized video content education. These tasks will also be monitored on a regular basis via weekly conference calls and complemented by site visits once a year. the investigators will audit twenty percent of PN calls to check for protocol adherence using a standardized checklist. the investigators will audit calls during the first month of implementation of the intervention and then randomly over the 2-year period, following adherence checklists.

Conditions

Brain Injuries, Traumatic; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Intervention group

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 Type: EXPERIMENTAL

Bilingual Brain Injury Education and outpatient Navigation for Hispanic families

Intervention Type: BEHAVIORAL

1st BIEN was informed by Hispanic parents and clinical providers working with them. It considers their specific needs including lack of familiarity with shared decision models and of knowledge about patient rights and eligibility for community and school services. Based on principles of Social Cognitive Theory, 1st BIEN provides TBI education, teaches problem-solving skills to promote self-efficacy and advocacy; and provides outpatient navigation that allows for observational and experiential learning while supporting access to services in a timely manner. Central to the development of our intervention is the recognition of heterogeneity in individuals' level of readiness to adopt a health behavior according to their level of self-efficacy, expectations, and environment. The 1stBIEN intervention flexibly reduces barriers to access care, and simultaneously improves parental knowledge, health literacy, and self-efficacy to optimize outcomes.

Attention Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bilingual Brain Injury Education and outpatient Navigation for Hispanic families

1st BIEN was informed by Hispanic parents and clinical providers working with them. It considers their specific needs including lack of familiarity with shared decision models and of knowledge about patient rights and eligibility for community and school services. Based on principles of Social Cognitive Theory, 1st BIEN provides TBI education, teaches problem-solving skills to promote self-efficacy and advocacy; and provides outpatient navigation that allows for observational and experiential learning while supporting access to services in a timely manner. Central to the development of our intervention is the recognition of heterogeneity in individuals' level of readiness to adopt a health behavior according to their level of self-efficacy, expectations, and environment. The 1stBIEN intervention flexibly reduces barriers to access care, and simultaneously improves parental knowledge, health literacy, and self-efficacy to optimize outcomes.

Intervention Type: BEHAVIORAL

Other Intervention Names

1stBIEN

Eligibility Criteria

Inclusion Criteria

1. Children 3 to 17 years of age,

2. Hispanic ethnicity

3. Diagnosis of mild, moderate or severe TBI.

4. Hospitalization at one of the 5 academic institutions participating in this trial,

5. Treatment requiring at least one type of rehabilitation therapy as outpatient

1. Hispanic ethnicity

2. Being the primary caregiver for the child (For longitudinal follow-up purposes)

Exclusion Criteria

Child:

1. Prior neurological deficits,

2. Acquired brain injuries secondary to other conditions different from trauma.

3. Traumatic brain injuries secondary to abusive trauma.

Parent:

1. Loss of custody of the child (i.e. abusive head trauma)

2. Inability to be contacted by phone

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nathalia Jimenez MD, MPH

Associate Professor Anesthesiology and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathalia Jimenez, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

Children's Hospital Colorado

Colorado Springs, Colorado, United States

Site Status: RECRUITING

Oregon Health & Science University

Portland, Oregon, United States

Site Status: ACTIVE_NOT_RECRUITING

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status: RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status: WITHDRAWN

Harborview Medical Center - University of Washington

Seattle, Washington, United States

Site Status: RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Maria A Oliva, MS

Role: CONTACT

Andrea.Oliva@seattlechildrens.org

206 884 2506

Facility Contacts

Alison Colbert, PhD

Role: primary

Alison.Colbert@childrenscolorado.org

Michael Dichiaro, MD

Role: backup

Mike.Dichiaro@childrenscolorado.org

Robert Rinaldi, MD FAAPMR

Role: primary

Robert.Rinaldi@UTSouthwestern.edu

214-648-2733

Maria A Oliva, MS

Role: primary

andrea.oliva@seattlechildrens.org

206-884-2506

Maria A Oliva, MS

Role: primary

andrea.oliva@seattlechildrens.org

206-884-2506

References

Jimenez N, Fuentes M, Virtue A, Alonso-Gonzalez L, Lopez E, Zhou C, Crawley D, Apkon S, Johnston B, Rivara F. Feasibility and Acceptability of a Telephone-Based Intervention for Hispanic Children to Promote Treatment Adherence After Traumatic Brain Injury: A Pilot Study. J Head Trauma Rehabil. 2021 Jul-Aug 01;36(4):274-281. doi: 10.1097/HTR.0000000000000658.

Reference Type: BACKGROUND

PMID: 33656480 (View on PubMed)

Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

Reference Type: DERIVED

PMID: 39382077 (View on PubMed)

Jimenez N, Williams CN, Keenan H, Rinaldi R, Fuentes M, Woodward D, Rivara FP, Zhou C, Ko LK, Bell K. 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. Contemp Clin Trials. 2023 Dec;135:107362. doi: 10.1016/j.cct.2023.107362. Epub 2023 Oct 16.

Reference Type: DERIVED

PMID: 37852531 (View on PubMed)

Other Identifiers

R01HD103700-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003331

Identifier Type: -

Identifier Source: org_study_id