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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Active Assistance by Navigators
Other interventionParticipants 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 interventionParticipants 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Rate of emergency department (ED) visits or readmissions
Whether child had an emergency department visit or readmission after discharge between baseline and follow-up.
Change in number of social risks
Change in the number of caregiver-endorsed social risk factors between baseline and follow-up.
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: