Recruiting

Outpatient Navigation

Sponsor:

Seattle Children's Hospital

Code:

NCT05261477

Conditions

Brain Injuries, Traumatic

Rehabilitation

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Interventions

Bilingual Brain Injury Education and outpatient Navigation for Hispanic families

Study Details

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.

Conditions

Brain Injuries, Traumatic

Rehabilitation

Study ID

NCT05261477

Start date

Jul 7, 2022

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3+

Healthy Volunteers: Not accepted

Children 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

Parent Inclusion Criteria:

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

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.

Primary outcome measure

  • Receipt of follow-up care in centralized Hospital and community [ Time Frame: 6 months after discharge. ]
  • Child's Health Related Quality of Life [ Time Frame: 1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge. ]

Central Contacts and Locations

Central contacts

Maria A Oliva, MS

206 884 2506Andrea.Oliva@seattlechildrens.org

Locations

Children's Hospital Colorado

Recruiting

Colorado Springs, Colorado, United States, 80920

Contacts

Alison Colbert, PhD

Alison.Colbert@childrenscolorado.org

Michael Dichiaro, MD

Mike.Dichiaro@childrenscolorado.org

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Robert Rinaldi, MD FAAPMR

214-648-2733Robert.Rinaldi@UTSouthwestern.edu

Principal Investigator:

Robert Rinaldi, MD

Harborview Medical Center - University of Washington

Recruiting

Seattle, Washington, United States, 98104

Contacts

Maria A Oliva, MS

206-884-2506andrea.oliva@seattlechildrens.org

Principal Investigator:

Frederick P Rivara, MD

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Maria A Oliva, MS

206-884-2506andrea.oliva@seattlechildrens.org

Principal Investigator:

Nathalia Jimenez, MD, MPH

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Jan 13, 2026

Last verified

Jan, 2026

Keywords

  • Hispanic or Latino
  • Child
  • Brain Injuries, Traumatic
  • Patient Navigation
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-01-13.