Social Needs ScreeningNCT05968716
Addressing Unmet Social Needs Among Hospitalized Children
A study testing Social needs screening protocol in people with Social Needs Screening and Caregiver-care Team Relationships, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Social Needs Screening, Caregiver-care Team Relationships, Social Needs Status
- What is being tested?
- Social needs screening protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2023to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregiver's child is hospitalized in the Transitional Care Unit (TCU) of Benioff Children's Hospital - San Francisco
- English or Spanish Speaking
- Parent/caregiver accompanying a patient hospitalized 0-17 years old
- Consenting adult over or equal to 18 years old
- Initially admitted to the TCU
- Caregiver's child is part of a service for which pediatric residents or advance practice providers provide care
Who cannot join
- Non-English or non-Spanish speaking caregiver
- Caregiver under age 18
- Family participated in study previously
- Caregiver's child was initially admitted to a unit besides the TCU
- Caregiver's child is NOT part of a service for which pediatric residents or advance practice providers provide care
Trial locations and contacts
1 site in 1 country.
United States1 site
Benioff Children's Hospital - San Francisco
San Francisco, California, 94158
About this study
The purpose of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol. The investigators will work with pediatric word healthcare team members to develop a social needs screening and intervention protocol. They will then compare preliminary health and social outcome measures between children hospitalized during the pre-intervention period (control group) vs. the post-intervention period (intervention group).
Read the detailed description
Millions of children in the US live in families with unmet social needs, and numbers increased during the COVID-19 pandemic. Children with unmet social needs are at increased risk of experiencing worse health and health care outcomes, and addressing unmet social needs can improve health and reduce health care utilization. Consequently, many professional organizations now endorse screening for and addressing social needs in clinical settings. However, despite social needs screening recommendations, there are no established best practices for clinical settings, and there has not been much focus on the pediatric inpatient setting. In order to understand whether identifying and addressing social needs in the pediatric inpatient setting positively impacts social and health outcomes, interventions must be developed and assessed that seek to accomplish this. Before launching large trials to assess such interventions, the feasibility and acceptability of implementing social needs interventions in the pediatric inpatient setting must determined. The objective of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol in this setting.
The investigators will utilize a before-and-after trial design to assess feasibility, acceptability, process, and preliminary outcome measures of implementing a social needs screening and intervention protocol in a tertiary children's hospital. Caregivers of hospitalized pediatric patients will be eligible to participate in surveys about screening acceptability and social and health outcomes if they are over 18 and their child is hospitalized on the transitional care general pediatrics unit within the 4 months prior to implementation of the protocol (control/pre-implementation group) or 4 months after the wash-in period (intervention/post-implementation group). Nurses, social workers, case managers, nurse practitioners, and physicians will be eligible to participate in a survey about protocol acceptability and satisfaction if they worked on the unit after protocol implementation.
A study team member will approach caregivers and ask if they would be potentially interested in filling out a survey about their experiences with being screened for social needs during their hospitalization and being contacted in 90 days for a follow-up survey. If interested, a study team member will screen the caregiver for eligibility and then obtain caregiver informed consent before administering the baseline survey. The consent will include a HIPAA authorization form to enable access to EHR records for the purposes of extracting utilization data (e.g., missed follow-up appointments). A follow-up survey will be administered via phone 3 months later. For care team members, an email will be sent to unit staff requesting participation in a voluntary survey regarding the social needs protocol with a link to the consent and survey included.
The investigators' goal is to recruit 25 caregivers in both the pre- and post-period, for a total of 50 caregivers. For the care team member survey, the hope is to gain as many members' input as possible. Based on the employee engagement response at the study site, the investigators believe that emailing roughly 93 care team members will respond.
The investigators will develop a social needs screening and intervention protocol for the ward based on: 1) input from unit leaders and stakeholders; 2) interviews from caregivers and care team members conducted previously. The goal is to develop and implement the protocol with a multidisciplinary group of unit stakeholders in 6 months.
Children hospitalized within the 4 months prior to intervention implementation will serve as the control group. Children hospitalized after a two-month "wash-in" period after protocol implementation will represent the intervention group. Post-intervention data will be collected for 4 months after implementation. The pilot will consist of roughly 50 caregivers of children and 93 care team members of the inpatient ward. This will allow us to estimate effect sizes for a future multi-site randomized clinical trial. Although The investigators may detect some intervention effects, the goal of the pilot is to assess feasibility and acceptability.
- Conditions
- Social Needs Screening, Caregiver-care Team Relationships, Social Needs Status, Child Health Status, Caregiver Health Status, Utilization, Health Care
- Being tested
- Social needs screening protocol
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social needs screening protocolOther
Pediatric hospital ward stakeholders will develop and implement a social needs screening protocol designed to screen families of hospitalized children for social risk factors and then provide resources to address their social needs. The intervention will consist of the protocol that is developed and implemented.
| Study group | Role | What they receive |
|---|---|---|
| Control (pre-implementation) arm | No intervention | Caregivers recruited from the pediatric hospital ward before the social needs screening and intervention protocol is implemented will compose the "control" group or pre-implementation group. |
| Intervention (post-implementation) arm | Experimental | Caregivers recruited from the pediatric hospital ward after the social needs screening and intervention protocol is implemented will compose the "intervention" group or post-implementation group. Receives: Other: Social needs screening protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of protocol implementation
Feasibility of developing and implementing a social needs screening and intervention - measured dichotomously (yes/no) whether the protocol was developed and implemented within 6 months
Measured: 6 months after first meeting of protocol committee
Acceptability of social needs screening
Caregiver acceptability will be assessed using baseline surveys administered during inpatient recruitment in the pre-/ and post-protocol implementation periods. Care team member acceptability will be assessed using surveys administered after protocol implementation - Likert scale derived from De Marchis et al.'s 2019 paper: Do you think it is appropriate to be asked questions about your social and economic needs during your child's hospitalization? a) Very appropriate b) Somewhat appropriate c) Neither appropriate nor inappropriate d) Somewhat inappropriate e) Very inappropriate
Measured: Up to 6 months post baseline data collection
Secondary outcomes (9)
Recruitment rate
Proportion of caregivers recruited out of 50
Measured: Up to 12 months after first meeting of protocol committee
Retention retention rate
Proportion of caregivers recruited that answer a post-hospitalization survey
Measured: Up to 15 months after first meeting of protocol committee
Social needs screening rate
Proportion of families screened for social needs in the hospital
Measured: Up to 12 months after first meeting of protocol committee
Caregiver-care team relationships
Assessments of the experience of caregivers with healthcare staff - Likert scale derived from De Marchis et al. 2019's paper: : How much do you trust your health care provider(s) at this hospital? 1 (not at all) through 10 (completely)
Measured: Up to 15 months after first meeting of protocol committee
Family social needs
Depending on what social needs the inpatient unit decides to screen for (e.g., food insecurity, transportation needs), the investigators will measure the rates of those needs at the time of recruitment and then again 3 months post-discharge - dichotomous (i.e., presence or absence of food insecurity; presence or absence of transportation needs)
Measured: Up to 15 months after first meeting of protocol committee
Child health status
Caregiver-endorsed measures of child health - Likert scale as derived from Gottlieb et al.'s 2020 paper: In general, would you say your child's health is: Excellent, very good, good, fair, poor
Measured: Up to 15 months after first meeting of protocol committee
Rehospitalization rate
Proportion of children being readmitted within 3 months after discharge as reported by the caregiver
Measured: Up to 15 months after first meeting of protocol committee
Post-hospitalization emergency department visit rate
Proportion of children being having an emergency department visit within 3 months after discharge as reported by the caregiver
Measured: Up to 15 months after first meeting of protocol committee
Missed follow-up visit rate
Proportion of children missing a follow-up visit within 3 months after discharge as reported by the caregiver
Measured: Up to 15 months after first meeting of protocol committee
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start8 Nov 2023
- Primary completion1 Aug 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Social Needs ScreeningStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The investigators will utilize a before-and-after trial design, whereby the "control group" consists of caregivers studied before a social needs screening protocol is implemented on a pediatric hospital ward, and the "intervention group" consists of caregivers studied after a social needs screening protocol is implemented on a pediatric hospital ward.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Matthew S Pantell, MD, MS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05968716
- Sponsor's protocol ID
- 1K08HS028473-01A1
- Other IDs
- 1K08HS028473-01A1
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As this is a pilot trial to examine the feasibility and acceptability of conducting a larger trial: 1) the study sample will be small and the investigators do not want to increase the risk of participant identification; 2) the pilot will not be powered enough to answer research questions related to outcomes for which other researchers might want to examine the data.
Publications
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.
PubMed 32154888De Marchis EH, Hessler D, Fichtenberg C, Adler N, Byhoff E, Cohen AJ, Doran KM, Ettinger de Cuba S, Fleegler EW, Lewis CC, Lindau ST, Tung EL, Huebschmann AG, Prather AA, Raven M, Gavin N, Jepson S, Johnson W, Ochoa E Jr, Olson AL, Sandel M, Sheward RS, Gottlieb LM. Part I: A Quantitative Study of Social Risk Screening Acceptability in Patients and Caregivers. Am J Prev Med. 2019 Dec;57(6 Suppl 1):S25-S37. doi: 10.1016/j.amepre.2019.07.010.
PubMed 31753277Gottlieb LM, Hessler D, Long D, Laves E, Burns AR, Amaya A, Sweeney P, Schudel C, Adler NE. Effects of Social Needs Screening and In-Person Service Navigation on Child Health: A Randomized Clinical Trial. JAMA Pediatr. 2016 Nov 7;170(11):e162521. doi: 10.1001/jamapediatrics.2016.2521. Epub 2016 Nov 7.
PubMed 27599265University of California, San Francisco Learning & Organization Development Employee Engagement. "Gallup Engagement Survey." Last accessed online on 10/8/2020: https://devlearning.ucsf.edu/gallup
Gold R, Bunce A, Cottrell E, Marino M, Middendorf M, Cowburn S, Wright D, Mossman N, Dambrun K, Powell BJ, Gruss I, Gottlieb L, Dearing M, Scott J, Yosuf N, Krancari M. Study protocol: a pragmatic, stepped-wedge trial of tailored support for implementing social determinants of health documentation/action in community health centers, with realist evaluation. Implement Sci. 2019 Jan 28;14(1):9. doi: 10.1186/s13012-019-0855-9.
PubMed 30691480Schickedanz A, Hamity C, Rogers A, Sharp AL, Jackson A. Clinician Experiences and Attitudes Regarding Screening for Social Determinants of Health in a Large Integrated Health System. Med Care. 2019 Jun;57 Suppl 6 Suppl 2(Suppl 6 2):S197-S201. doi: 10.1097/MLR.0000000000001051.
PubMed 31095061Pantell MS, Kaiser SV, Torres JM, Gottlieb LM, Adler NE. Associations Between Social Factor Documentation and Hospital Length of Stay and Readmission Among Children. Hosp Pediatr. 2020 Jan;10(1):12-19. doi: 10.1542/hpeds.2019-0123.
PubMed 31888952Glick AF, Tomopoulos S, Fierman AH, Trasande L. Disparities in Mortality and Morbidity in Pediatric Asthma Hospitalizations, 2007 to 2011. Acad Pediatr. 2016 Jul;16(5):430-437. doi: 10.1016/j.acap.2015.12.014. Epub 2016 Jan 6.
PubMed 26768727Kaiser SV, Bakel LA, Okumura MJ, Auerbach AD, Rosenthal J, Cabana MD. Risk Factors for Prolonged Length of Stay or Complications During Pediatric Respiratory Hospitalizations. Hosp Pediatr. 2015 Sep;5(9):461-73. doi: 10.1542/hpeds.2014-0246.
PubMed 26330245Boyle CA, Decoufle P, Yeargin-Allsopp M. Prevalence and health impact of developmental disabilities in US children. Pediatrics. 1994 Mar;93(3):399-403.
PubMed 7509480Dell SD, Parkin PC, Macarthur C. Childhood asthma admissions: determinants of short stay. Pediatr Allergy Immunol. 2001 Dec;12(6):327-30. doi: 10.1034/j.1399-3038.2001.0s079.x.
PubMed 11846870Carroll CL, Uygungil B, Zucker AR, Schramm CM. Identifying an at-risk population of children with recurrent near-fatal asthma exacerbations. J Asthma. 2010 May;47(4):460-4. doi: 10.3109/02770903.2010.481344.
PubMed 20528602Macy ML, Stanley RM, Sasson C, Gebremariam A, Davis MM. High turnover stays for pediatric asthma in the United States: analysis of the 2006 Kids' Inpatient Database. Med Care. 2010 Sep;48(9):827-33. doi: 10.1097/MLR.0b013e3181f2595e.
PubMed 20706158Lin HC, Kao S, Wen HC, Wu CS, Chung CL. Length of stay and costs for asthma patients by hospital characteristics--a five-year population-based analysis. J Asthma. 2005 Sep;42(7):537-42. doi: 10.1080/02770900500214783.
PubMed 16169785Srivastava R, Homer CJ. Length of stay for common pediatric conditions: teaching versus nonteaching hospitals. Pediatrics. 2003 Aug;112(2):278-81. doi: 10.1542/peds.112.2.278.
PubMed 12897273
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Unmet Social Needs Among Hospitalized Children
- ClinicalTrials.gov ID
- NCT05968716
- Acronym / sponsor ID
- 1K08HS028473-01A1
- Conditions
- Social Needs Screening, Caregiver-care Team Relationships, Social Needs Status, Child Health Status, Caregiver Health Status, Utilization, Health Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- 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 purpose of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol. The investigators will work with pediatric word healthcare team members to develop a social needs screening and intervention protocol. They will then compare preliminary health and social outcome measures between children hospitalized during the pre-intervention period (control group) vs. the post-intervention period (intervention group).
Detailed description
Millions of children in the US live in families with unmet social needs, and numbers increased during the COVID-19 pandemic. Children with unmet social needs are at increased risk of experiencing worse health and health care outcomes, and addressing unmet social needs can improve health and reduce health care utilization. Consequently, many professional organizations now endorse screening for and addressing social needs in clinical settings. However, despite social needs screening recommendations, there are no established best practices for clinical settings, and there has not been much focus on the pediatric inpatient setting. In order to understand whether identifying and addressing social needs in the pediatric inpatient setting positively impacts social and health outcomes, interventions must be developed and assessed that seek to accomplish this. Before launching large trials to assess such interventions, the feasibility and acceptability of implementing social needs interventions in the pediatric inpatient setting must determined. The objective of this pilot study is to determine the feasibility and acceptability of implementing a social needs screening and intervention protocol in the pediatric inpatient setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and acceptable to implement a social needs screening and intervention protocol in this setting.
The investigators will utilize a before-and-after trial design to assess feasibility, acceptability, process, and preliminary outcome measures of implementing a social needs screening and intervention protocol in a tertiary children's hospital. Caregivers of hospitalized pediatric patients will be eligible to participate in surveys about screening acceptability and social and health outcomes if they are over 18 and their child is hospitalized on the transitional care general pediatrics unit within the 4 months prior to implementation of the protocol (control/pre-implementation group) or 4 months after the wash-in period (intervention/post-implementation group). Nurses, social workers, case managers, nurse practitioners, and physicians will be eligible to participate in a survey about protocol acceptability and satisfaction if they worked on the unit after protocol implementation.
A study team member will approach caregivers and ask if they would be potentially interested in filling out a survey about their experiences with being screened for social needs during their hospitalization and being contacted in 90 days for a follow-up survey. If interested, a study team member will screen the caregiver for eligibility and then obtain caregiver informed consent before administering the baseline survey. The consent will include a HIPAA authorization form to enable access to EHR records for the purposes of extracting utilization data (e.g., missed follow-up appointments). A follow-up survey will be administered via phone 3 months later. For care team members, an email will be sent to unit staff requesting participation in a voluntary survey regarding the social needs protocol with a link to the consent and survey included.
The investigators' goal is to recruit 25 caregivers in both the pre- and post-period, for a total of 50 caregivers. For the care team member survey, the hope is to gain as many members' input as possible. Based on the employee engagement response at the study site, the investigators believe that emailing roughly 93 care team members will respond.
The investigators will develop a social needs screening and intervention protocol for the ward based on: 1) input from unit leaders and stakeholders; 2) interviews from caregivers and care team members conducted previously. The goal is to develop and implement the protocol with a multidisciplinary group of unit stakeholders in 6 months.
Children hospitalized within the 4 months prior to intervention implementation will serve as the control group. Children hospitalized after a two-month "wash-in" period after protocol implementation will represent the intervention group. Post-intervention data will be collected for 4 months after implementation. The pilot will consist of roughly 50 caregivers of children and 93 care team members of the inpatient ward. This will allow us to estimate effect sizes for a future multi-site randomized clinical trial. Although The investigators may detect some intervention effects, the goal of the pilot is to assess feasibility and acceptability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will utilize a before-and-after trial design, whereby the "control group" consists of caregivers studied before a social needs screening protocol is implemented on a pediatric hospital ward, and the "intervention group" consists of caregivers studied after a social needs screening protocol is implemented on a pediatric hospital ward.
| Arm | Type | Receives |
|---|---|---|
| Control (pre-implementation) arm | No intervention | –Caregivers recruited from the pediatric hospital ward before the social needs screening and intervention protocol is implemented will compose the "control" group or pre-implementation group. |
| Intervention (post-implementation) arm | Experimental | Other: Social needs screening protocolCaregivers recruited from the pediatric hospital ward after the social needs screening and intervention protocol is implemented will compose the "intervention" group or post-implementation group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Caregiver's child is hospitalized in the Transitional Care Unit (TCU) of Benioff Children's Hospital - San Francisco
- English or Spanish Speaking
- Parent/caregiver accompanying a patient hospitalized 0-17 years old
- Consenting adult over or equal to 18 years old
- Initially admitted to the TCU
Key exclusion criteria (5 listed)
- Non-English or non-Spanish speaking caregiver
- Caregiver under age 18
- Family participated in study previously
- Caregiver's child was initially admitted to a unit besides the TCU
- Caregiver's child is NOT part of a service for which pediatric residents or advance practice providers provide care
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 |
|---|---|---|
| Social needs screening protocolPediatric hospital ward stakeholders will develop and implement a social needs screening protocol designed to screen families of hospitalized children for social risk factors and then provide resources to address their social needs. The intervention will consist of the protocol that is developed and implemented. | Other | Intervention (post-implementation) arm |
Primary outcome
Feasibility of protocol implementation
Time frame: 6 months after first meeting of protocol committee
Feasibility of developing and implementing a social needs screening and intervention - measured dichotomously (yes/no) whether the protocol was developed and implemented within 6 months
Acceptability of social needs screening
Time frame: Up to 6 months post baseline data collection
Caregiver acceptability will be assessed using baseline surveys administered during inpatient recruitment in the pre-/ and post-protocol implementation periods. Care team member acceptability will be assessed using surveys administered after protocol implementation - Likert scale derived from De Marchis et al.'s 2019 paper: Do you think it is appropriate to be asked questions about your social and economic needs during your child's hospitalization? a) Very appropriate b) Somewhat appropriate c) Neither appropriate nor inappropriate d) Somewhat inappropriate e) Very inappropriate
9 secondary outcomes
Recruitment rate
Time frame: Up to 12 months after first meeting of protocol committee
Retention retention rate
Time frame: Up to 15 months after first meeting of protocol committee
Social needs screening rate
Time frame: Up to 12 months after first meeting of protocol committee
Caregiver-care team relationships
Time frame: Up to 15 months after first meeting of protocol committee
Family social needs
Time frame: Up to 15 months after first meeting of protocol committee
Child health status
Time frame: Up to 15 months after first meeting of protocol committee
Rehospitalization rate
Time frame: Up to 15 months after first meeting of protocol committee
Post-hospitalization emergency department visit rate
Time frame: Up to 15 months after first meeting of protocol committee
Missed follow-up visit rate
Time frame: Up to 15 months after first meeting of protocol committee
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Background: PubMed 32154888Gottlieb 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.
- Background: PubMed 31753277De Marchis EH, Hessler D, Fichtenberg C, Adler N, Byhoff E, Cohen AJ, Doran KM, Ettinger de Cuba S, Fleegler EW, Lewis CC, Lindau ST, Tung EL, Huebschmann AG, Prather AA, Raven M, Gavin N, Jepson S, Johnson W, Ochoa E Jr, Olson AL, Sandel M, Sheward RS, Gottlieb LM. Part I: A Quantitative Study of Social Risk Screening Acceptability in Patients and Caregivers. Am J Prev Med. 2019 Dec;57(6 Suppl 1):S25-S37. doi: 10.1016/j.amepre.2019.07.010.
- Background: PubMed 27599265Gottlieb LM, Hessler D, Long D, Laves E, Burns AR, Amaya A, Sweeney P, Schudel C, Adler NE. Effects of Social Needs Screening and In-Person Service Navigation on Child Health: A Randomized Clinical Trial. JAMA Pediatr. 2016 Nov 7;170(11):e162521. doi: 10.1001/jamapediatrics.2016.2521. Epub 2016 Nov 7.
- BackgroundUniversity of California, San Francisco Learning & Organization Development Employee Engagement. "Gallup Engagement Survey." Last accessed online on 10/8/2020: https://devlearning.ucsf.edu/gallup
- Background: PubMed 30691480Gold R, Bunce A, Cottrell E, Marino M, Middendorf M, Cowburn S, Wright D, Mossman N, Dambrun K, Powell BJ, Gruss I, Gottlieb L, Dearing M, Scott J, Yosuf N, Krancari M. Study protocol: a pragmatic, stepped-wedge trial of tailored support for implementing social determinants of health documentation/action in community health centers, with realist evaluation. Implement Sci. 2019 Jan 28;14(1):9. doi: 10.1186/s13012-019-0855-9.
- Background: PubMed 31095061Schickedanz A, Hamity C, Rogers A, Sharp AL, Jackson A. Clinician Experiences and Attitudes Regarding Screening for Social Determinants of Health in a Large Integrated Health System. Med Care. 2019 Jun;57 Suppl 6 Suppl 2(Suppl 6 2):S197-S201. doi: 10.1097/MLR.0000000000001051.
- Background: PubMed 31888952Pantell MS, Kaiser SV, Torres JM, Gottlieb LM, Adler NE. Associations Between Social Factor Documentation and Hospital Length of Stay and Readmission Among Children. Hosp Pediatr. 2020 Jan;10(1):12-19. doi: 10.1542/hpeds.2019-0123.
- Background: PubMed 26768727Glick AF, Tomopoulos S, Fierman AH, Trasande L. Disparities in Mortality and Morbidity in Pediatric Asthma Hospitalizations, 2007 to 2011. Acad Pediatr. 2016 Jul;16(5):430-437. doi: 10.1016/j.acap.2015.12.014. Epub 2016 Jan 6.
- Background: PubMed 26330245Kaiser SV, Bakel LA, Okumura MJ, Auerbach AD, Rosenthal J, Cabana MD. Risk Factors for Prolonged Length of Stay or Complications During Pediatric Respiratory Hospitalizations. Hosp Pediatr. 2015 Sep;5(9):461-73. doi: 10.1542/hpeds.2014-0246.
- Background: PubMed 7509480Boyle CA, Decoufle P, Yeargin-Allsopp M. Prevalence and health impact of developmental disabilities in US children. Pediatrics. 1994 Mar;93(3):399-403.
- Background: PubMed 11846870Dell SD, Parkin PC, Macarthur C. Childhood asthma admissions: determinants of short stay. Pediatr Allergy Immunol. 2001 Dec;12(6):327-30. doi: 10.1034/j.1399-3038.2001.0s079.x.
- Background: PubMed 20528602Carroll CL, Uygungil B, Zucker AR, Schramm CM. Identifying an at-risk population of children with recurrent near-fatal asthma exacerbations. J Asthma. 2010 May;47(4):460-4. doi: 10.3109/02770903.2010.481344.
- Individual participant dataSharing planned: No. As this is a pilot trial to examine the feasibility and acceptability of conducting a larger trial: 1) the study sample will be small and the investigators do not want to increase the risk of participant identification; 2) the pilot will not be powered enough to answer research questions related to outcomes for which other researchers might want to examine the data.
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Dietary Intervention, Produce Prescription
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.
Matthew S Pantell, MD, MS 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 Social needs screening protocol in people with Social Needs Screening and Caregiver-care Team Relationships, 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 6 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of protocol implementation (time frame: 6 months after first meeting of protocol committee). 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 NCT05968716, which also lists 17 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 13 Apr 2026.