The Social Needs Assistance for Hospitalized Kids Trial

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.

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.

AIM 2 (Qualitative Interviews): Conduct interviews with caregivers who received resources and CBOs to identify barriers, facilitators, and mechanisms involved in connecting caregivers to CBOs and improving child health outcomes.

H1: Navigators' local knowledge of CBOs will be a key facilitator in addressing social needs.

H2: When social needs/competing demands are reduced, caregivers can focus more on their child's health.

For Aim 1, research staff will identify potentially eligible hospitalized patients through the electronic health record (EHR) and approach their caregivers about participation. Participants will first complete an eligibility screener and identify any social risks factors (e.g., food insecurity). If caregivers are deemed eligible, study staff will obtain informed consent from interested caregivers. All participating families will receive a tailored list of community resources to address their social needs informed by Findhelp, a web-based platform that helps individuals identify and connect with resources to address their social needs based on zip code. Families will also receive information on how to access and use Findhelp. Families will be randomly assigned to either: 1) the passive referral arm, for which no additional intervention activities will be provided, or 2) the active assistance by navigators arm, for which families will additionally receive hands-on support from a navigator, including follow-up contact every two weeks for three months, to help assist families in connecting with resources. The study will support both English- and Spanish-speaking families. Caregivers and their children will be followed over a 12-month period to assess health and social outcomes, with the primary outcome being assessed at 6 months after enrollment.

Aim 2 will involve interviewing a subset of caregivers who participated in Aim 1 and staff from CBOs serving recruitment site areas. Staff will conduct semi-structured interviews to explore perspectives on barriers and facilitators of connecting to CBOs to address social needs and mechanisms through which the interventions influence child health outcomes.