SFGH Health Advocates Stage II Study

October 2, 2020 updated by: University of California, San Francisco

San Francisco General Hospital (SFGH) Health Advocates Phase 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1278

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • San Francisco General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

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)
Time Frame: Baseline and 6 months
Collected at baseline and 6 month follow up
Baseline and 6 months
Change in Families' Social Needs Using Staff Administered Social Needs Screener
Time Frame: Baseline & 6 months
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
Time Frame: Baseline and 6 months
measured at baseline and 6 months
Baseline and 6 months
Change in caregiver health using PROMIS-10 measures
Time Frame: Baseline and 6 months
Collected at baseline and 6 month follow up
Baseline and 6 months
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
Baseline and 6 Months
Change in hair cortisol in children and caregivers
Time Frame: Baseline and 6 Months
Collected at baseline and 6 month follow up
Baseline and 6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Laura M Gottlieb, MD, MPH, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 15-18305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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