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SFGH Health Advocates Stage II Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02746393
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : October 6, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Conditions Influencing Health Status Social Determinants of Health Other: Health Advocates Program Other: 211 Information Sheet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: San Francisco General Hospital (SFGH) Health Advocates Phase II Study
Actual Study Start Date : July 2016
Actual Primary Completion Date : March 2019
Actual Study Completion Date : July 2020

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746393


Locations
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United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Laura M Gottlieb, MD, MPH University of California, San Francisco
Publications:
Hanson M, Lawton E. Between a rock and a hard place: The prevalence and severity of unmet legal needs in the pediatric emergency department setting. Medical Legal Partnership for Children. 2007.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02746393    
Other Study ID Numbers: 15-18305
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No