Brain Injury Education and Outpatient Navigation-1stBIEN
1st-BIEN
2 other identifiers
interventional
300
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedStudy Start
First participant enrolled
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 13, 2026
January 1, 2026
4 years
January 24, 2022
January 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Receipt of follow-up care in centralized Hospital and community
Percentage of attended appointments at hospital, primary care and therapies
6 months after discharge.
Child's Health Related Quality of Life
Pediatric Quality of Life Inventory-PedsQL. A 23-item questionnaire extensively used in TBI outcomes studies. It assesses physical, emotional, social and school functioning. Items on the PedsQL are reverse scored and transformed to a 0-100 scale. Higher scores indicate better health related quality of life, a clinically meaningful difference is 4.5 points. Minimum score is 0 maximum score is 100.
1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
Secondary Outcomes (12)
Child's Functional Independence
24 hours before hospital discharge and through study completion an average of 6 months
Child's Communication
1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
Child's Social Skills
1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
Child's Anxiety symptoms
1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
Child's Pain Interference
1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
- +7 more secondary outcomes
Other Outcomes (7)
Parent's Anxiety symptoms
24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
Caregiver Self efficacy
24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
Navigation evaluation
12 months after discharge from the hospital
- +4 more other outcomes
Study Arms (2)
Intervention group
EXPERIMENTALIntervention 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.
Attention Control group
NO INTERVENTIONAttention 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
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.
Eligibility Criteria
You may qualify if:
- Children 3 to 17 years of age,
- Hispanic ethnicity
- Diagnosis of mild, moderate or severe TBI.
- Hospitalization at one of the 5 academic institutions participating in this trial,
- Treatment requiring at least one type of rehabilitation therapy as outpatient
- Hispanic ethnicity
- Being the primary caregiver for the child (For longitudinal follow-up purposes)
You may not qualify if:
- Child:
- Prior neurological deficits,
- Acquired brain injuries secondary to other conditions different from trauma.
- Traumatic brain injuries secondary to abusive trauma.
- Parent:
- Loss of custody of the child (i.e. abusive head trauma)
- Inability to be contacted by phone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Children's Hospital Colorado
Colorado Springs, Colorado, 80920, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Harborview Medical Center - University of Washington
Seattle, Washington, 98104, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Related Publications (3)
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.
PMID: 33656480BACKGROUNDLalji 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.
PMID: 39382077DERIVEDJimenez 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.
PMID: 37852531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathalia Jimenez, MD, MPH
Seattle Children's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- All families enrolled in the trial will receive follow-up telephone assessments at 3-, 6-, and 12-months after discharge from the hospital. Follow-up interviews will be conducted by research assistants from the Social Development Research Group, who will be blinded to participant's study group.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor Anesthesiology and Pain Medicine
Study Record Dates
First Submitted
January 24, 2022
First Posted
March 2, 2022
Study Start
July 7, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After last subject enrollment and all follow up procedures have been completed, the 1stBIEN collaborative data coordinating center at the Seattle Children's Research Institute will prepare a final study database for the trial, which will then be used for statistical analyses and publication of findings from the trial. Our preliminary plan is to release the de-identified underlying primary database at the time of publication of the primary manuscript.
- Access Criteria
- Access to the releasable database will be in accordance with procedures and regulations of the NIH policy on Sharing Research Data. Release of data will be reviewed by the 1stBIEN collaborative and determined by the scientific merit of the proposal; feasibility, scientific rationale, qualifications and analysis plan; data security protections, and IRB oversight.
The 1st BIEN collaborative research group understands and agrees to comply with the NIH policy on Sharing Research Data. The PI and co-investigators from Seattle Children's Research Institute, University of Texas Southwestern Medical Center, Oregon Health and Science University, University of Washington and University of Utah; acknowledge their willingness to share de-identified data from this grant upon request to outside researchers. The database will be produced and will be completely de-identified in accordance with the definitions provided in the Health Insurance Portability and Accountability Act. The Data coordinating center at Seattle Children's will also prepare a data dictionary that provides a brief definition of every data element in the database so that individual investigators will be able to effectively use the data. After approval of 1stBIEN collaborative investigators, IRB and funding agency, controlled access to data will be granted following a data sharing agreement.