Brain Injury Education and Outpatient Navigation-1stBIEN

ConditionsBrain Injuries, Traumatic Rehabilitation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age3+

SponsorSeattle Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Prior neurological deficits,

Acquired brain injuries secondary to other conditions different from trauma.

Traumatic brain injuries secondary to abusive trauma.

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

Trial design

Design model

Parallel

Treatments tested in this trial

Bilingual Brain Injury Education and outpatient Navigation for Hispanic families
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.

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Intervention groupExperimental treatment 1 intervention

Group B: Attention Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Receipt of follow-up care in centralized Hospital and community

Percentage of attended appointments at hospital, primary care and therapies

Time frame

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.

Time frame

1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.

Secondary outcomes

Child's Functional Independence

Functional independence measures (FIM) FIM (8+ years) and WeeFIM (3-7 years);18 items (mobility 5 items, self-care 8 items and cognition 5 items) objective functional measures of independence. Every item is scored from"1" (dependent) to "7" (independent).The possible total score ranges from 18 (lowest) to 126 (highest) level of independence. For each item Scores of 1 (total assistance) and 2 (maximal assistance) belong to the "Complete Dependence" category. Scores of 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belong to the "Modified Dependence" category. Scores of 6 (modified independence) and 7 (complete independence) belong to the "Independent" category.

Time frame

24 hours before hospital discharge and through study completion an average of 6 months

Child's Communication

Adaptive Behavior Assessment System Third Edition (ABAS 3) -Communication subscale. A norm referenced measurement designed to assess adaptive skills. For both subscales, the mean and standard deviation values for healthy individuals are 10 mean and 3SD; higher scores indicate better functioning, and lower scores ,indicate below-average functioning.

Time frame

1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.

Child's Social Skills

Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy-Peer Relationships (SF7a).Symptoms are rated on a 5-point scale and converted to standard scores. The general population mean is 50 SD 10. Higher scores denote better outcomes.

Time frame

1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.

Child's Anxiety symptoms

Patient-Reported Outcomes Measurement Information System (PROMIS) Parent Proxy-Anxiety (SF8a) symptoms. Short version of PROMIS parental report pediatric measures of anxiety (8 items). Symptoms are rated on a 5-point scale and converted to standard scores. The general population mean is 50 SD 10. Higher scores denote better outcomes.

Time frame

1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.

Other outcomes

Parent's Anxiety symptoms

Patient-Reported Outcomes Measurement Information System PROMIS Anxiety (SF8b).Symptoms are rated on a 5-point scale and converted to standard scores. The general population mean is 50 SD 10. Higher scores denote better outcomes.

Time frame

24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.

Caregiver Self efficacy

The Caregiver Self efficacy (CSE) scale. 7 items scale that measures caregivers' confidence in caring and advocating for patients with brain injuries.

Time frame

24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.

Navigation evaluation

Family Experiences with Coordination of Care (FECC) measurement. A 20-item list of quality indicators of care coordination and engagement with patient navigators for children with medical complexity.

Time frame

12 months after discharge from the hospital

Engagement with video education materials

Google-analytics

Time frame

ongoing tracking (from enrollment - 12 months follow-up)