Brain Injury Education and Outpatient Navigation-1stBIEN (1st-BIEN)
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|ClinicalTrials.gov Identifier: NCT05261477|
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : October 27, 2022
|First Submitted Date ICMJE||January 24, 2022|
|First Posted Date ICMJE||March 2, 2022|
|Last Update Posted Date||October 27, 2022|
|Actual Study Start Date ICMJE||July 7, 2022|
|Estimated Primary Completion Date||June 2025 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures
|Original Other Pre-specified Outcome Measures||Same as current|
|Brief Title ICMJE||Brain Injury Education and Outpatient Navigation-1stBIEN|
|Official Title ICMJE||Brain Injury Education and Outpatient Navigation for Hispanic Children and Their Caregivers-1stBIEN|
|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.|
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.
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).
Multi-center randomized control trial, enrolling 150 parent-child dyads; Hispanic children 6-17 years of age, with a mild-complicated, 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 (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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Intervention group will receive one in-person education session, bi-weekly video reviews tailored to the child's injury and therapies; and, 3 months of bilingual outpatient navigation, using three way calls to model and coach problem solving skills, with parents as active participants. Attention control group will receive one in person-education session, monthly non-TBI (Well-child) texts and usual institutional follow up care. Participants in the control group do not receive video education or patient navigation.Masking: Single (Outcomes Assessor)
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.Primary Purpose: Health Services Research
|Intervention ICMJE||Behavioral: 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.
Other Name: 1stBIEN
|Study Arms ICMJE||
|Publications *||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.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||March 2026|
|Estimated Primary Completion Date||June 2025 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
Children Inclusion criteria:
Parent Inclusion Criteria:
|Ages ICMJE||6 Years and older (Child, Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT05261477|
|Other Study ID Numbers ICMJE||STUDY00003331
R01HD103700-01A1 ( U.S. NIH Grant/Contract )
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||
|Current Responsible Party||Nathalia Jimenez MD, MPH, Seattle Children's Hospital|
|Original Responsible Party||Same as current|
|Current Study Sponsor ICMJE||Seattle Children's Hospital|
|Original Study Sponsor ICMJE||Same as current|
|Collaborators ICMJE||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|PRS Account||Seattle Children's Hospital|
|Verification Date||October 2022|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP