SFGH Health Advocates Stage II Study

Social Determinants of Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746393
• Other study ID #: 15-18305
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2020

Study information

• Verified date: October 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1278
• Est. completion date: July 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Conditions Influencing Health Status
• Social Determinants of Health

Intervention

Other:
• Health Advocates Program
Provided services and support to address identified social needs from health advocate navigators.
• 211 Information Sheet
Receive a printed list of community resources to address social needs.

Locations

Country	Name	City	State
United States	San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Epub 2007 May 1. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Families' Social Needs Using Staff Administered Social Needs Screener	Collected at baseline and 6 month follow up	Baseline & 6 months
Secondary	Change in caregiver depression using self-report PHQ	measured at baseline and 6 months	Baseline and 6 months
Secondary	Change in caregiver health using PROMIS-10 measures	Collected at baseline and 6 month follow up	Baseline and 6 months
Secondary	Change in Perceived Social Stress using self-report Perceived Stress Scale	Collected at baseline and 6 month follow up	Baseline and 6 Months
Secondary	Change in hair cortisol in children and caregivers	Collected at baseline and 6 month follow up	Baseline and 6 Months