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Completed

NCT Number: NCT02746393

SFGH Health Advocates Stage II Study

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Advocates Program

Other

Provided services and support to address identified social needs from health advocate navigators.

211 Information Sheet

Other

Receive a printed list of community resources to address social needs.

Primary outcomes

  1. Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL)

    Time frame: Baseline and 6 months

    Collected at baseline and 6 month follow up

  2. Change in Families' Social Needs Using Staff Administered Social Needs Screener

    Time frame: Baseline & 6 months

    Collected at baseline and 6 month follow up

Secondary outcomes

  1. Change in caregiver depression using self-report PHQ

    Time frame: Baseline and 6 months

    measured at baseline and 6 months

  2. Change in caregiver health using PROMIS-10 measures

    Time frame: Baseline and 6 months

    Collected at baseline and 6 month follow up

  3. Change in Perceived Social Stress using self-report Perceived Stress Scale

    Time frame: Baseline and 6 Months

    Collected at baseline and 6 month follow up

  4. Change in hair cortisol in children and caregivers

    Time frame: Baseline and 6 Months

    Collected at baseline and 6 month follow up

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Apr 21, 2016
Registry last updated
Oct 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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