SFGH Health Advocates Stage II Study

NCT02746393 | Completed

• 1 other identifier: 15-18305
• Study Type: interventional
• Target: 1,278
• Locations: 1 country
• Sites: 1

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.

Conditions

Conditions Influencing Health Status; Social Determinants of Health

Outcome Measures

Primary Outcomes (2)

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

  Collected at baseline and 6 month follow up

  Baseline and 6 months

• Change in Families' Social Needs Using Staff Administered Social Needs Screener

  Collected at baseline and 6 month follow up

  Baseline & 6 months

Secondary Outcomes (4)

• Change in caregiver depression using self-report PHQ

  Baseline and 6 months

• Change in caregiver health using PROMIS-10 measures

  Baseline and 6 months

• Change in Perceived Social Stress using self-report Perceived Stress Scale

  Baseline and 6 Months

• Change in hair cortisol in children and caregivers

  Baseline and 6 Months

Study Arms (2)

Intervention

EXPERIMENTAL

Health Advocates Program

Other: Health Advocates Program

211 Arm

ACTIVE COMPARATOR

211 Information Sheet

Other: 211 Information Sheet

Interventions

Health Advocates Program OTHER

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

Intervention

211 Information Sheet OTHER

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

211 Arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (23)

• Larson K, Halfon N. Family income gradients in the health and health care access of US children. Matern Child Health J. 2010 May;14(3):332-42. doi: 10.1007/s10995-009-0477-y. Epub 2009 Jun 5.

  PMID: 19499315 BACKGROUND

• Wood PR, Smith LA, Romero D, Bradshaw P, Wise PH, Chavkin W. Relationships between welfare status, health insurance status, and health and medical care among children with asthma. Am J Public Health. 2002 Sep;92(9):1446-52. doi: 10.2105/ajph.92.9.1446.

  PMID: 12197971 BACKGROUND

• Cook JT, Frank DA, Berkowitz C, Black MM, Casey PH, Cutts DB, Meyers AF, Zaldivar N, Skalicky A, Levenson S, Heeren T. Welfare reform and the health of young children: a sentinel survey in 6 US cities. Arch Pediatr Adolesc Med. 2002 Jul;156(7):678-84. doi: 10.1001/archpedi.156.7.678.

  PMID: 12090835 BACKGROUND

• Frank DA, Neault NB, Skalicky A, Cook JT, Wilson JD, Levenson S, Meyers AF, Heeren T, Cutts DB, Casey PH, Black MM, Berkowitz C. Heat or eat: the Low Income Home Energy Assistance Program and nutritional and health risks among children less than 3 years of age. Pediatrics. 2006 Nov;118(5):e1293-302. doi: 10.1542/peds.2005-2943.

  PMID: 17079530 BACKGROUND

• Meyers A, Cutts D, Frank DA, Levenson S, Skalicky A, Heeren T, Cook J, Berkowitz C, Black M, Casey P, Zaldivar N. Subsidized housing and children's nutritional status: data from a multisite surveillance study. Arch Pediatr Adolesc Med. 2005 Jun;159(6):551-6. doi: 10.1001/archpedi.159.6.551.

  PMID: 15939854 BACKGROUND

• Garg A, Butz AM, Dworkin PH, Lewis RA, Serwint JR. Screening for basic social needs at a medical home for low-income children. Clin Pediatr (Phila). 2009 Jan;48(1):32-6. doi: 10.1177/0009922808320602. Epub 2008 Jun 19.

  PMID: 18566347 BACKGROUND

• Lawton E, Leiter K, Todd J, Smith L. Welfare reform: advocacy and intervention in the health care setting. Public Health Rep. 1999 Nov-Dec;114(6):540-9. doi: 10.1093/phr/114.6.540.

  PMID: 10670622 BACKGROUND

• 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.

  BACKGROUND

• Fleegler EW, Lieu TA, Wise PH, Muret-Wagstaff S. Families' health-related social problems and missed referral opportunities. Pediatrics. 2007 Jun;119(6):e1332-41. doi: 10.1542/peds.2006-1505.

  PMID: 17545363 BACKGROUND

• Garg A, Butz AM, Dworkin PH, Lewis RA, Thompson RE, Serwint JR. Improving the management of family psychosocial problems at low-income children's well-child care visits: the WE CARE Project. Pediatrics. 2007 Sep;120(3):547-58. doi: 10.1542/peds.2007-0398.

  PMID: 17766528 BACKGROUND

• Bikson K, McGuire J, Blue-Howells J, Seldin-Sommer L. Psychosocial problems in primary care: patient and provider perceptions. Soc Work Health Care. 2009;48(8):736-49. doi: 10.1080/00981380902929057.

  PMID: 20182986 BACKGROUND

• Keller D, Jones N, Savageau JA, Cashman SB. Development of a brief questionnaire to identify families in need of legal advocacy to improve child health. Ambul Pediatr. 2008 Jul-Aug;8(4):266-9. doi: 10.1016/j.ambp.2008.04.004. Epub 2008 May 27.

  PMID: 18644550 BACKGROUND

• Black MM, Cutts DB, Frank DA, Geppert J, Skalicky A, Levenson S, Casey PH, Berkowitz C, Zaldivar N, Cook JT, Meyers AF, Herren T; Children's Sentinel Nutritional Assessment Program Study Group. Special Supplemental Nutrition Program for Women, Infants, and Children participation and infants' growth and health: a multisite surveillance study. Pediatrics. 2004 Jul;114(1):169-76. doi: 10.1542/peds.114.1.169.

  PMID: 15231924 BACKGROUND

• Jones SJ, Jahns L, Laraia BA, Haughton B. Lower risk of overweight in school-aged food insecure girls who participate in food assistance: results from the panel study of income dynamics child development supplement. Arch Pediatr Adolesc Med. 2003 Aug;157(8):780-4. doi: 10.1001/archpedi.157.8.780.

  PMID: 12912784 BACKGROUND

• Cook JT, Frank DA, Berkowitz C, Black MM, Casey PH, Cutts DB, Meyers AF, Zaldivar N, Skalicky A, Levenson S, Heeren T, Nord M. Food insecurity is associated with adverse health outcomes among human infants and toddlers. J Nutr. 2004 Jun;134(6):1432-8. doi: 10.1093/jn/134.6.##.

  PMID: 15173408 BACKGROUND

• Cook JT, Frank DA, Levenson SM, Neault NB, Heeren TC, Black MM, Berkowitz C, Casey PH, Meyers AF, Cutts DB, Chilton M. Child food insecurity increases risks posed by household food insecurity to young children's health. J Nutr. 2006 Apr;136(4):1073-6. doi: 10.1093/jn/136.4.1073.

  PMID: 16549481 BACKGROUND

• Staufenbiel SM, Penninx BW, Spijker AT, Elzinga BM, van Rossum EF. Hair cortisol, stress exposure, and mental health in humans: a systematic review. Psychoneuroendocrinology. 2013 Aug;38(8):1220-35. doi: 10.1016/j.psyneuen.2012.11.015. Epub 2012 Dec 17.

  PMID: 23253896 BACKGROUND

• Sharpley CF, McFarlane JR, Slominski A. Stress-linked cortisol concentrations in hair: what we know and what we need to know. Rev Neurosci. 2011 Dec 8;23(1):111-21. doi: 10.1515/RNS.2011.058.

  PMID: 22150070 BACKGROUND

• Steptoe A, Hamer M, Chida Y. The effects of acute psychological stress on circulating inflammatory factors in humans: a review and meta-analysis. Brain Behav Immun. 2007 Oct;21(7):901-12. doi: 10.1016/j.bbi.2007.03.011. Epub 2007 May 1.

  PMID: 17475444 BACKGROUND

• Weik U, Herforth A, Kolb-Bachofen V, Deinzer R. Acute stress induces proinflammatory signaling at chronic inflammation sites. Psychosom Med. 2008 Oct;70(8):906-12. doi: 10.1097/PSY.0b013e3181835bf3. Epub 2008 Sep 16.

  PMID: 18799429 BACKGROUND

• Garg A, Toy S, Tripodis Y, Silverstein M, Freeman E. Addressing social determinants of health at well child care visits: a cluster RCT. Pediatrics. 2015 Feb;135(2):e296-304. doi: 10.1542/peds.2014-2888. Epub 2015 Jan 5.

  PMID: 25560448 BACKGROUND

• Pantell MS, Silveira PP, de Mendonca Filho EJ, Wing H, Brown EM, Keeton VF, Pokhvisneva I, O'Donnell KJ, Neuhaus J, Hessler D, Meaney MJ, Adler NE, Gottlieb LM. Associations between Social Adversity and Biomarkers of Inflammation, Stress, and Aging in Children. Pediatr Res. 2024 May;95(6):1553-1563. doi: 10.1038/s41390-023-02992-6. Epub 2024 Jan 17.

  PMID: 38233512 DERIVED

• Gottlieb LM, Adler NE, Wing H, Velazquez D, Keeton V, Romero A, Hernandez M, Munoz Vera A, Urrutia Caceres E, Arevalo C, Herrera P, Bernal Suarez M, Hessler D. Effects of In-Person Assistance vs Personalized Written Resources About Social Services on Household Social Risks and Child and Caregiver Health: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e200701. doi: 10.1001/jamanetworkopen.2020.0701.

  PMID: 32154888 DERIVED

Study Officials

• Laura M Gottlieb, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: April 21, 2016
• Study Start: July 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: July 1, 2020
• Last Updated: October 6, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)