Clinical trial NCT02746393: SFGH Health Advocates Stage II Study
Official title: San Francisco General Hospital (SFGH) Health Advocates Phase II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions Influencing Health Status
Social Determinants of Health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-04-21
Enrollment: 1278
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL)
timeFrame: Baseline and 6 months
measure: Change in Families' Social Needs Using Staff Administered Social Needs Screener
timeFrame: Baseline & 6 months
Secondary outcomes:
measure: Change in caregiver depression using self-report PHQ
timeFrame: Baseline and 6 months
measure: Change in caregiver health using PROMIS-10 measures
timeFrame: Baseline and 6 months
measure: Change in Perceived Social Stress using self-report Perceived Stress Scale
timeFrame: Baseline and 6 Months
measure: Change in hair cortisol in children and caregivers
timeFrame: Baseline and 6 Months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
Study officials:
affiliation: University of California, San Francisco
name: Laura M Gottlieb, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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