Addressing Unmet Social Needs Among Hospitalized Children

NCT05968716 | Active Not Recruiting

• 1 other identifier: 1K08HS028473-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Social Needs Screening; Caregiver-care Team Relationships; Social Needs Status; Child Health Status; Caregiver Health Status; Utilization, Health Care

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Up to 6 months post baseline data collection

Secondary Outcomes (9)

• Recruitment rate

  Up to 12 months after first meeting of protocol committee

• Retention retention rate

  Up to 15 months after first meeting of protocol committee

• Social needs screening rate

  Up to 12 months after first meeting of protocol committee

• Caregiver-care team relationships

  Up to 15 months after first meeting of protocol committee

• Family social needs

  Up to 15 months after first meeting of protocol committee

Study Arms (2)

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.

Other: Social needs screening protocol

Interventions

Social needs screening protocol OTHER

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.

Intervention (post-implementation) arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Benioff Children's Hospital - San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (17)

• 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 BACKGROUND

• De 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.

  PMID: 31753277 BACKGROUND

• Gottlieb 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.

  PMID: 27599265 BACKGROUND

• University 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

• 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.

  PMID: 30691480 BACKGROUND

• Schickedanz 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.

  PMID: 31095061 BACKGROUND

• Pantell 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.

  PMID: 31888952 BACKGROUND

• Glick 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.

  PMID: 26768727 BACKGROUND

• Kaiser 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.

  PMID: 26330245 BACKGROUND

• Boyle CA, Decoufle P, Yeargin-Allsopp M. Prevalence and health impact of developmental disabilities in US children. Pediatrics. 1994 Mar;93(3):399-403.

  PMID: 7509480 BACKGROUND

• Dell 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.

  PMID: 11846870 BACKGROUND

• Carroll 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.

  PMID: 20528602 BACKGROUND

• Macy 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.

  PMID: 20706158 BACKGROUND

• Lin 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.

  PMID: 16169785 BACKGROUND

• Srivastava 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.

  PMID: 12897273 BACKGROUND

• Alderwick H, Gottlieb LM. Meanings and Misunderstandings: A Social Determinants of Health Lexicon for Health Care Systems. Milbank Q. 2019 Jun;97(2):407-419. doi: 10.1111/1468-0009.12390. Epub 2019 May 8.

  PMID: 31069864 BACKGROUND

• Beck AF, Cohen AJ, Colvin JD, Fichtenberg CM, Fleegler EW, Garg A, Gottlieb LM, Pantell MS, Sandel MT, Schickedanz A, Kahn RS. Perspectives from the Society for Pediatric Research: interventions targeting social needs in pediatric clinical care. Pediatr Res. 2018 Jul;84(1):10-21. doi: 10.1038/s41390-018-0012-1. Epub 2018 May 23.

  PMID: 29795202 BACKGROUND

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Matthew S Pantell, MD, MS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 1, 2023
• Study Start: November 8, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)