Comparing Two Social Needs Assistance Interventions to Improve Health Among Hospitalized Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,880
- 试验地点
- 6
- 主要终点
- Mean Change in Caregiver-rated Child Global Health using the National Survey of Children's Health Health Status Measure
研究概览
简要总结
The goal of this clinical trial is to determine the best way to help families access social and economic support services in order to improve children's health for hospitalized children and their families/caregivers.
The main question it aims to answer is, does providing active assistance from navigators to connect families to social/economic resources lead to greater improvements in child global health compared to providing passive referrals to resources among hospitalized children?
All families will receive a tailored information sheet with referrals to community resources to address their social/economic needs and an introduction to how to search for resources using an online program. Researchers will compare families who receive these resources with families who also receive support from trained navigators, people with knowledge about local resources trained to connect families with resources. The study will examine whether the addition of navigator support improves families' access to services and children's health outcomes.
详细描述
This multi-center randomized clinical trial (RCT) will compare the effectiveness of two interventions that help families connect with community-based resources to address social and economic needs (e.g., food insecurity, housing instability) on the health of hospitalized children: 1) passive referral (providing information to families about community-based organizations [CBOs] that can help address their social/economic needs and an introduction to an online resource to search for resources; vs. 2) active assistance by navigators -additionally providing the support of trained navigators to help connect families to CBOs both during and after enrollment.
The study's Specific Aims are:
AIM 1 (RCT): Conduct a multicenter, pragmatic, RCT among hospitalized children to determine the comparative effectiveness of passive referral versus active assistance by navigators on long-term, child health outcomes.
H1: Both interventions will lead to improvements, but active assistance by navigator (the higher intensity intervention) will lead to significantly more improvement in health among hospitalized children.
Aim 1B: Explore how intervention effects vary by child and family characteristics using heterogeneity of treatment (HTE) effect analyses HTE hypothesis: Children with high social needs will experience greater benefit with active assistance by navigators.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aim 1 - Caregiver-Child Dyads Sample
- •Caregiver-child dyads will be eligible to participate in the study if they meet the following criteria assessed during the recruitment and enrollment process:
- •children are hospitalized on the general pediatric/pediatric hospital medicine (PHM) team/service
- •the child is between the ages of 0-17
- •the child's caregiver is >17 years-old
- •the caregiver speaks English or Spanish
- •the family lives in the same county as the hospital or in a neighboring county to the hospital
- •the child is not in Child Protective Services custody
- •the family has not previously been enrolled in the study
- •the caregiver screens positive for >=1 of the following social risks: food insecurity, housing instability, housing quality concerns, transportation needs, utilities needs, child care needs, or financial strain
- •the family is not enrolled in another social needs assistance-related research study (e.g., another social needs navigation study)
- •Aim 2 - Caregiver and Community-based Organization (CBO) Qualitative Interviews Sample Caregivers of children enrolled in Aim 1 will be eligible for study interviews.
- •CBO staff will be eligible to participate if they are:
- •> 17 years old
- •speak English or Spanish
- •work at a CBO serving the area in which patients at the study sites live
排除标准
- •Aim 1 - Caregiver-Child Dyads Sample
- •Participants will be excluded from participation if they are:
- •not hospitalized or hospitalized outside of general/PHM SERVICE
- •children are 18 years of age or older
- •caregiver/guardians are under the age of 18 years of age
- •caregivers are do not speak English or Spanish
- •the family does not live in the same or neighboring county of the recruitment hospital
- •the child is under the care of Child Protective Services custody
- •the family has already been previously enrolled in the study
- •the caregiver does not screen positive for any of the following social risks: food insecurity, housing instability, housing quality concerns, transportation needs, utilities needs, child care needs, or financial strain
- •the family is already enrolled in a social needs assistance-related research study (e.g., another social needs navigation study)
- •Aim 2 - Caregiver and CBO qualitative interviews Caregivers of children not enrolled in Aim 1 will not be eligible to participate study interviews.
- •CBO staff will not be eligible to participate if they are:
- •under 18 years of age
- •do not speak English or Spanish
- •do not work at a CBO serving the recruitment site areas
结局指标
主要结局
Mean Change in Caregiver-rated Child Global Health using the National Survey of Children's Health Health Status Measure
时间窗: Baseline and 6 months after recruitment
Child global health will be assessed using the caregiver-rated child health status item from the National Survey of Children's Health. Caregivers rate the child's overall health on a 5-point ordinal scale: Excellent, Very Good, Good, Fair, or Poor. Responses will be assigned numeric values from 1 to 5 for analysis (Excellent = 1, Very Good = 2, Good = 3, Fair = 4, Poor = 5). Scores range from 1 to 5, with lower scores indicating better child global health and higher scores indicating worse child global health. Mean change from baseline to 6 months will be reported.
次要结局
- Mean Change in Caregiver-rated Child Quality of Life using the Pediatric Quality of Life Inventory (PedsQL)/PedsQL Short Form(Baseline and 6 months after recruitment)
- Rate of emergency department (ED) visits or readmissions(Between baseline and 6 months after recruitment)
- Change in number of social risks(Between baseline and 6 months after recruitment)