Conditions Influencing Health StatusNCT02746393
SFGH Health Advocates Stage II Study
A study testing Health Advocates Program and 211 Information Sheet in people with Conditions Influencing Health Status and Social Determinants of Health, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status, Social Determinants of Health
- What is being tested?
- Health Advocates Program and 211 Information Sheet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,278 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: 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.
Read the 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.
- Being tested
- Health Advocates Program, 211 Information Sheet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Advocates ProgramOther
Provided services and support to address identified social needs from health advocate navigators.
211 Information SheetOther
Receive a printed list of community resources to address social needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Health Advocates Program Receives: Other: Health Advocates Program |
| 211 Arm | Active comparator | 211 Information Sheet Receives: Other: 211 Information Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL)
Collected at baseline and 6 month follow up
Measured: Baseline and 6 months
Change in Families' Social Needs Using Staff Administered Social Needs Screener
Collected at baseline and 6 month follow up
Measured: Baseline & 6 months
Secondary outcomes (4)
Change in caregiver depression using self-report PHQ
measured at baseline and 6 months
Measured: Baseline and 6 months
Change in caregiver health using PROMIS-10 measures
Collected at baseline and 6 month follow up
Measured: Baseline and 6 months
Change in Perceived Social Stress using self-report Perceived Stress Scale
Collected at baseline and 6 month follow up
Measured: Baseline and 6 Months
Change in hair cortisol in children and caregivers
Collected at baseline and 6 month follow up
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Conditions Influencing Health StatusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,278 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura M Gottlieb, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746393
- Sponsor's protocol ID
- 15-18305
- Status last verified
- Oct 2020
- First submitted
- 1 Dec 2015
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19499315Wood 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.
PubMed 12197971Cook 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.
PubMed 12090835Frank 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.
PubMed 17079530Meyers 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.
PubMed 15939854Garg 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.
PubMed 18566347Lawton 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.
PubMed 10670622Hanson 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.
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.
PubMed 17545363Garg 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.
PubMed 17766528Bikson 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.
PubMed 20182986Keller 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.
PubMed 18644550Black 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.
PubMed 15231924Jones 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.
PubMed 12912784Cook 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.##.
PubMed 15173408
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- San Francisco General Hospital (SFGH) Health Advocates Phase II Study
- ClinicalTrials.gov ID
- NCT02746393
- Acronym / sponsor ID
- 15-18305
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,278 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Health Advocates ProgramHealth Advocates Program |
| 211 Arm | Active comparator | Other: 211 Information Sheet211 Information Sheet |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Advocates ProgramProvided services and support to address identified social needs from health advocate navigators. | Other | Intervention |
| 211 Information SheetReceive a printed list of community resources to address social needs. | Other | 211 Arm |
Primary outcome
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
Change in Families' Social Needs Using Staff Administered Social Needs Screener
Time frame: Baseline & 6 months
Collected at baseline and 6 month follow up
4 secondary outcomes
Change in caregiver depression using self-report PHQ
Time frame: Baseline and 6 months
Change in caregiver health using PROMIS-10 measures
Time frame: Baseline and 6 months
Change in Perceived Social Stress using self-report Perceived Stress Scale
Time frame: Baseline and 6 Months
Change in hair cortisol in children and caregivers
Time frame: Baseline and 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Background: PubMed 19499315Larson 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.
- Background: PubMed 12197971Wood 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.
- Background: PubMed 12090835Cook 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.
- Background: PubMed 17079530Frank 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.
- Background: PubMed 15939854Meyers 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.
- Background: PubMed 18566347Garg 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.
- Background: PubMed 10670622Lawton 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.
- BackgroundHanson 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: PubMed 17545363Fleegler 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.
- Background: PubMed 17766528Garg 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.
- Background: PubMed 20182986Bikson 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.
- Background: PubMed 18644550Keller 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.
- Individual participant dataSharing planned: No
Related trials for Conditions Influencing Health Status
Active, not recruiting
Comparing the Reliability of Expressed Prostatic Secretion (EPS) and Post Massage Urine (PMU) for the Prediction of Prostate Cancer Biopsy Outcome
Conditions Influencing Health Status, Healthy
Not yet recruiting
The Social Needs Assistance for Hospitalized Kids Trial
Social Needs, Health-Related Social Needs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Gottlieb, MD, MPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Advocates Program and 211 Information Sheet in people with Conditions Influencing Health Status and Social Determinants of Health, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Caregiver Report of Child Health Status Using Pediatric Quality of Life Inventory (Peds QL) (time frame: Baseline and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02746393, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2020.