SFGH Health Advocates Stage II Study
- Conditions
- Conditions Influencing Health StatusSocial Determinants of Health
- Interventions
- Other: Health Advocates ProgramOther: 211 Information Sheet
- Registration Number
- NCT02746393
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1278
Not provided
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Health Advocates Program Health Advocates Program 211 Arm 211 Information Sheet 211 Information Sheet
- Primary Outcome Measures
Name Time Method Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL) Baseline and 6 months Collected at baseline and 6 month follow up
Change in Families' Social Needs Using Staff Administered Social Needs Screener Baseline & 6 months Collected at baseline and 6 month follow up
- Secondary Outcome Measures
Name Time Method Change in caregiver depression using self-report PHQ Baseline and 6 months measured at baseline and 6 months
Change in Perceived Social Stress using self-report Perceived Stress Scale Baseline and 6 Months Collected at baseline and 6 month follow up
Change in caregiver health using PROMIS-10 measures Baseline and 6 months Collected at baseline and 6 month follow up
Change in hair cortisol in children and caregivers Baseline and 6 Months Collected at baseline and 6 month follow up
Trial Locations
- Locations (1)
San Francisco General Hospital
🇺🇸San Francisco, California, United States