The Social Needs Assistance for Hospitalized Kids Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of California, San Francisco

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Active Assistance by Navigators

    Other intervention

    Participants will receive the same resources as in the passive referral group as well as support from navigators for up to 3 months after enrollment. Navigators will review resources with caregivers, assist with completion of intake applications when applicable, and provide support related to accessing social services.

  • Passive Referral

    Other intervention

    Participants in this group will receive a list of local resources to address social needs based on the social risks for which they screen positive and where they live. Research staff will use Findhelp, an online platform that helps identify social resources (e.g., food assistance, housing support) based on zip code, to inform creation of the lists. In addition, families will receive a brief introduction on how to access and use Findhelp.

Treatment groups

1,880 Participants
are divided into 2 treatment groups
Group A: Active Assistance by NavigatorsExperimental treatment 1 intervention
Group B: Passive ReferralActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean Change in Caregiver-rated Child Global Health using the National Survey of Children's Health Health Status Measure

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.

Time frame
Baseline and 6 months after recruitment

Secondary outcomes

1

Mean Change in Caregiver-rated Child Quality of Life using the Pediatric Quality of Life Inventory (PedsQL)/PedsQL Short Form

Child quality of life will be assessed using caregiver-rated child quality of life measures from the Pediatric Quality of Life Inventory (PedsQL)/PedsQL Short For. The PedsQL includes 4 domains with 5-point Likert items that are averaged to create a single score for each domain: physical functioning, emotional functioning, social functioning, and cognitive/school functioning. It has versions that vary by age group (0-12 months, 13-23 months, 2-4 years, 5-7 years, 8-12 years, and 13-18 years). We will use the Short Form for age groups for which it is available. Mean change from baseline to 6 months will be reported for each domain.

Time frame
Baseline and 6 months after recruitment
2

Rate of emergency department (ED) visits or readmissions

Whether child had an emergency department visit or readmission after discharge between baseline and follow-up.

Time frame
Between baseline and 6 months after recruitment
3

Change in number of social risks

Change in the number of caregiver-endorsed social risk factors between baseline and follow-up.

Time frame
Between baseline and 6 months after recruitment

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

The University of Texas Health Science Center, Houston

Collaborator

Baylor University

Collaborator

Children's Hospital of Philadelphia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: