SFGH Health Advocates Stage II Study

Study Overview
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Brief Summary
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The San Francisco General Hospital (SFGH) Health Advocate Staff II Study is a Randomized Controlled Trial (RCT) that collects survey data and non-invasive biological data from caregivers and children visiting a pediatric urgent care center. Families will be randomized according to a pre-determined randomization schedule into one of two social needs-focused interventions (the Health Advocates Program or a 211 Information active comparator arm). All patients in the study will be followed over a six month period to capture information about changes in social needs, health and health care utilization.

Detailed Description
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Adverse social circumstances like hunger and food insecurity can have dramatic, negative impacts on the health of vulnerable children. In safety-net settings, the prevalence of these adverse social circumstances are high. The investigators are proposing an RCT on an intervention based in a large urban pediatric urgent care setting that addresses patients' social circumstances. In an earlier RCT conducted in a similar setting, this intervention helped decrease total social needs and parent reported child health on a single item measure. In this study, the investigators will collect a more robust set of survey data including detailed measures of child health and non-invasive biological data from children and caregivers accompanying those children. Families will be randomized according to a pre-determined randomization schedule into the social needs-focused intervention. In one arm, the investigators will offer the intervention, which involves in-person navigation around available social and legal resources; in the other, the investigators will offer written information to participants on available community resources. All patients in both arms will be followed over a six month period to capture information about changes in participants' social needs, health and health care utilization.

Official Title
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San Francisco General Hospital (SFGH) Health Advocates Phase II Study

Conditions
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Conditions Influencing Health Status, Social Determinants of Health

Intervention / Treatment
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* Other: Health Advocates Program
* Other: 211 Information Sheet


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Child/Parent-Legal Guardian Caregiver Dyad; Child is SFGH Pediatric Urgent Care Clinic Patient between 0 and 17 years of age; Parent or Legal Guardian Caregiver over or equal to 18 years old; English or Spanish speaking Parent or Legal Guardian Caregiver; Both reside in San Francisco County. Exclusion Criteria: Non-English or non-Spanish speaking Parent or Legal Guardian Caregiver; Parent or legal guardian caregiver under age 18; Parent or legal guardian caregiver accompanying patient is not familiar with the child's living situation; Family participated in study previously; Non-San Francisco County resident; Foster child or child in clinic for a child protective clearance exam.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Health Advocates Program | Other: Health Advocates Program<br>* Provided services and support to address identified social needs from health advocate navigators.<br>|
| Active Comparator: 211 Arm<br>211 Information Sheet | Other: 211 Information Sheet<br>* Receive a printed list of community resources to address social needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL) | Collected at baseline and 6 month follow up | Baseline and 6 months | 
| Change in Families' Social Needs Using Staff Administered Social Needs Screener | Collected at baseline and 6 month follow up | Baseline & 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in caregiver depression using self-report PHQ | measured at baseline and 6 months | Baseline and 6 months | 
| Change in caregiver health using PROMIS-10 measures | Collected at baseline and 6 month follow up | Baseline and 6 months | 
| Change in Perceived Social Stress using self-report Perceived Stress Scale | Collected at baseline and 6 month follow up | Baseline and 6 Months | 
| Change in hair cortisol in children and caregivers | Collected at baseline and 6 month follow up | Baseline and 6 Months |