Brain Injury Education and Outpatient Navigation for Hispanic Children and Their Caregivers-1stBIEN
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- Receipt of follow-up care in centralized Hospital and community
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children Inclusion criteria:
- •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
- •Parent Inclusion Criteria:
- •Hispanic ethnicity
- •Being the primary caregiver for the child (For longitudinal follow-up purposes)
排除标准
- •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)
- •Inability to be contacted by phone
研究组 & 干预措施
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.
干预措施: Bilingual Brain Injury Education and outpatient Navigation for Hispanic families (Behavioral)
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.
结局指标
主要结局
Receipt of follow-up care in centralized Hospital and community
时间窗: 6 months after discharge.
Percentage of attended appointments at hospital, primary care and therapies
Child's Health Related Quality of Life
时间窗: 1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.
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.
次要结局
- 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 Anxiety symptoms(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.)
- Receipt of School support programs(1 Year before the injury and 1 year after the injury)
- Child's Pain Interference(1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.)
- Child's Self-care Skills(1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.)
- Child's Physical Function-Upper Extremity(1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.)
- Child's Academic Performance(1 Year before the injury and 1 year after the injury)
- Child's Fatigue(1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge)
- Child's Depressive Symptoms(1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.)
- Child's Mobility(1 month before injury, 24 hours before discharge from the hospital and 3,6, and 12 months after hospital discharge.)
研究者
Nathalia Jimenez MD, MPH
Associate Professor Anesthesiology and Pain Medicine
Seattle Children's Hospital