xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05968716</url>
    </required_header>
    <id_info>
      <org_study_id>1K08HS028473-01A1</org_study_id>
      <secondary_id>1K08HS028473-01A1</secondary_id>
      <nct_id>NCT05968716</nct_id>
    </id_info>
    <brief_title>Addressing Unmet Social Needs Among Hospitalized Children</brief_title>
    <official_title>Addressing Unmet Social Needs Among Hospitalized Children</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of California, San Francisco</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Agency for Healthcare Research and Quality (AHRQ)</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
    </sponsors>
    <source>University of California, San Francisco</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this pilot study is to determine the feasibility and acceptability of&#xD;
        implementing a social needs screening and intervention protocol in the pediatric inpatient&#xD;
        setting by conducting a pilot trial on a pediatric ward. The investigators' hypothesis is&#xD;
        that it will be feasible and acceptable to implement a social needs screening and&#xD;
        intervention protocol. The investigators will work with pediatric word healthcare team&#xD;
        members to develop a social needs screening and intervention protocol. They will then compare&#xD;
        preliminary health and social outcome measures between children hospitalized during the&#xD;
        pre-intervention period (control group) vs. the post-intervention period (intervention&#xD;
        group).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Millions of children in the US live in families with unmet social needs, and numbers&#xD;
        increased during the COVID-19 pandemic. Children with unmet social needs are at increased&#xD;
        risk of experiencing worse health and health care outcomes, and addressing unmet social needs&#xD;
        can improve health and reduce health care utilization. Consequently, many professional&#xD;
        organizations now endorse screening for and addressing social needs in clinical settings.&#xD;
        However, despite social needs screening recommendations, there are no established best&#xD;
        practices for clinical settings, and there has not been much focus on the pediatric inpatient&#xD;
        setting. In order to understand whether identifying and addressing social needs in the&#xD;
        pediatric inpatient setting positively impacts social and health outcomes, interventions must&#xD;
        be developed and assessed that seek to accomplish this. Before launching large trials to&#xD;
        assess such interventions, the feasibility and acceptability of implementing social needs&#xD;
        interventions in the pediatric inpatient setting must determined. The objective of this pilot&#xD;
        study is to determine the feasibility and acceptability of implementing a social needs&#xD;
        screening and intervention protocol in the pediatric inpatient setting by conducting a pilot&#xD;
        trial on a pediatric ward. The investigators' hypothesis is that it will be feasible and&#xD;
        acceptable to implement a social needs screening and intervention protocol in this setting.&#xD;
  &#xD;
        The investigators will utilize a before-and-after trial design to assess feasibility,&#xD;
        acceptability, process, and preliminary outcome measures of implementing a social needs&#xD;
        screening and intervention protocol in a tertiary children's hospital. Caregivers of&#xD;
        hospitalized pediatric patients will be eligible to participate in surveys about screening&#xD;
        acceptability and social and health outcomes if they are over 18 and their child is&#xD;
        hospitalized on the transitional care general pediatrics unit within the 4 months prior to&#xD;
        implementation of the protocol (control/pre-implementation group) or 4 months after the&#xD;
        wash-in period (intervention/post-implementation group). Nurses, social workers, case&#xD;
        managers, nurse practitioners, and physicians will be eligible to participate in a survey&#xD;
        about protocol acceptability and satisfaction if they worked on the unit after protocol&#xD;
        implementation.&#xD;
  &#xD;
        A study team member will approach caregivers and ask if they would be potentially interested&#xD;
        in filling out a survey about their experiences with being screened for social needs during&#xD;
        their hospitalization and being contacted in 90 days for a follow-up survey. If interested, a&#xD;
        study team member will screen the caregiver for eligibility and then obtain caregiver&#xD;
        informed consent before administering the baseline survey. The consent will include a HIPAA&#xD;
        authorization form to enable access to EHR records for the purposes of extracting utilization&#xD;
        data (e.g., missed follow-up appointments). A follow-up survey will be administered via phone&#xD;
        3 months later. For care team members, an email will be sent to unit staff requesting&#xD;
        participation in a voluntary survey regarding the social needs protocol with a link to the&#xD;
        consent and survey included.&#xD;
  &#xD;
        The investigators' goal is to recruit 25 caregivers in both the pre- and post-period, for a&#xD;
        total of 50 caregivers. For the care team member survey, the hope is to gain as many members'&#xD;
        input as possible. Based on the employee engagement response at the study site, the&#xD;
        investigators believe that emailing roughly 93 care team members will respond.&#xD;
  &#xD;
        The investigators will develop a social needs screening and intervention protocol for the&#xD;
        ward based on: 1) input from unit leaders and stakeholders; 2) interviews from caregivers and&#xD;
        care team members conducted previously. The goal is to develop and implement the protocol&#xD;
        with a multidisciplinary group of unit stakeholders in 6 months.&#xD;
  &#xD;
        Children hospitalized within the 4 months prior to intervention implementation will serve as&#xD;
        the control group. Children hospitalized after a two-month &quot;wash-in&quot; period after protocol&#xD;
        implementation will represent the intervention group. Post-intervention data will be&#xD;
        collected for 4 months after implementation. The pilot will consist of roughly 50 caregivers&#xD;
        of children and 93 care team members of the inpatient ward. This will allow us to estimate&#xD;
        effect sizes for a future multi-site randomized clinical trial. Although The investigators&#xD;
        may detect some intervention effects, the goal of the pilot is to assess feasibility and&#xD;
        acceptability.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>The investigators will utilize a before-and-after trial design, whereby the &quot;control group&quot; consists of caregivers studied before a social needs screening protocol is implemented on a pediatric hospital ward, and the &quot;intervention group&quot; consists of caregivers studied after a social needs screening protocol is implemented on a pediatric hospital ward.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of protocol implementation</measure>
      <time_frame>6 months after first meeting of protocol committee</time_frame>
      <description>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</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability of social needs screening</measure>
      <time_frame>Up to 6 months post baseline data collection</time_frame>
      <description>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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recruitment rate</measure>
      <time_frame>Up to 12 months after first meeting of protocol committee</time_frame>
      <description>Proportion of caregivers recruited out of 50</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Retention retention rate</measure>
      <time_frame>Up to 15 months after first meeting of protocol committee</time_frame>
      <description>Proportion of caregivers recruited that answer a post-hospitalization survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Social needs screening rate</measure>
      <time_frame>Up to 12 months after first meeting of protocol committee</time_frame>
      <description>Proportion of families screened for social needs in the hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver-care team relationships</measure>
      <time_frame>Up to 15 months after first meeting of protocol committee</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Family social needs</measure>
      <time_frame>Up to 15 months after first meeting of protocol committee</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Child health status</measure>
      <time_frame>Up to 15 months after first meeting of protocol committee</time_frame>
      <description>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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rehospitalization rate</measure>
      <time_frame>Up to 15 months after first meeting of protocol committee</time_frame>
      <description>Proportion of children being readmitted within 3 months after discharge as reported by the caregiver</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-hospitalization emergency department visit rate</measure>
      <time_frame>Up to 15 months after first meeting of protocol committee</time_frame>
      <description>Proportion of children being having an emergency department visit within 3 months after discharge as reported by the caregiver</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Missed follow-up visit rate</measure>
      <time_frame>Up to 15 months after first meeting of protocol committee</time_frame>
      <description>Proportion of children missing a follow-up visit within 3 months after discharge as reported by the caregiver</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Social Needs Screening</condition>
    <condition>Caregiver-care Team Relationships</condition>
    <condition>Social Needs Status</condition>
    <condition>Child Health Status</condition>
    <condition>Caregiver Health Status</condition>
    <condition>Utilization, Health Care</condition>
    <arm_group>
      <arm_group_label>Control (pre-implementation) arm</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Caregivers recruited from the pediatric hospital ward before the social needs screening and intervention protocol is implemented will compose the &quot;control&quot; group or pre-implementation group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Intervention (post-implementation) arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Caregivers recruited from the pediatric hospital ward after the social needs screening and intervention protocol is implemented will compose the &quot;intervention&quot; group or post-implementation group.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Social needs screening protocol</intervention_name>
      <description>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.</description>
      <arm_group_label>Intervention (post-implementation) arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Caregiver's child is hospitalized in the Transitional Care Unit (TCU) of Benioff&#xD;
               Children's Hospital - San Francisco&#xD;
  &#xD;
            -  English or Spanish Speaking&#xD;
  &#xD;
            -  Parent/caregiver accompanying a patient hospitalized 0-17 years old&#xD;
  &#xD;
            -  Consenting adult over or equal to 18 years old&#xD;
  &#xD;
            -  Initially admitted to the TCU&#xD;
  &#xD;
            -  Caregiver's child is part of a service for which pediatric residents or advance&#xD;
               practice providers provide care&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-English or non-Spanish speaking caregiver&#xD;
  &#xD;
            -  Caregiver under age 18&#xD;
  &#xD;
            -  Family participated in study previously&#xD;
  &#xD;
            -  Caregiver's child was initially admitted to a unit besides the TCU&#xD;
  &#xD;
            -  Caregiver's child is NOT part of a service for which pediatric residents or advance&#xD;
               practice providers provide care&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matthew S Pantell, MD, MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of California, San Francisco</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Matthew S Pantell, MD, MS</last_name>
      <phone>4154765001</phone>
      <email>Matt.Pantell@ucsf.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Benioff Children's Hospital - San Francisco</name>
        <address>
          <city>San Francisco</city>
          <state>California</state>
          <zip>94158</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Matthew Pantell, MD, MS</last_name>
        <phone>808-348-3487</phone>
        <email>Matt.Pantell@ucsf.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>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.</citation>
      <PMID>32154888</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31753277</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>27599265</PMID>
    </reference>
    <reference>
      <citation>University of California, San Francisco Learning &amp; Organization Development Employee Engagement. &quot;Gallup Engagement Survey.&quot; Last accessed online on 10/8/2020: https://devlearning.ucsf.edu/gallup</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30691480</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31095061</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31888952</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26768727</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>26330245</PMID>
    </reference>
    <reference>
      <citation>Boyle CA, Decoufle P, Yeargin-Allsopp M. Prevalence and health impact of developmental disabilities in US children. Pediatrics. 1994 Mar;93(3):399-403.</citation>
      <PMID>7509480</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>11846870</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>20528602</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>20706158</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>16169785</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>12897273</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31069864</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29795202</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>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.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05968716
  org study id: 1K08HS028473-01A1
  secondary id: 1K08HS028473-01A1
  nct id: NCT05968716
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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).
  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.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  intervention 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.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Feasibility of protocol implementation
  time frame: 6 months after first meeting of protocol committee
  description: 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
  measure: Acceptability of social needs screening
  time frame: Up to 6 months post baseline data collection
  description: 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
  measure: Recruitment rate
  time frame: Up to 12 months after first meeting of protocol committee
  description: Proportion of caregivers recruited out of 50
  measure: Retention retention rate
  time frame: Up to 15 months after first meeting of protocol committee
  description: Proportion of caregivers recruited that answer a post-hospitalization survey
  measure: Social needs screening rate
  time frame: Up to 12 months after first meeting of protocol committee
  description: Proportion of families screened for social needs in the hospital
  measure: Caregiver-care team relationships
  time frame: Up to 15 months after first meeting of protocol committee
  description: 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)
  measure: Family social needs
  time frame: Up to 15 months after first meeting of protocol committee
  description: 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)
  measure: Child health status
  time frame: Up to 15 months after first meeting of protocol committee
  description: 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
  measure: Rehospitalization rate
  time frame: Up to 15 months after first meeting of protocol committee
  description: Proportion of children being readmitted within 3 months after discharge as reported by the caregiver
  measure: Post-hospitalization emergency department visit rate
  time frame: Up to 15 months after first meeting of protocol committee
  description: Proportion of children being having an emergency department visit within 3 months after discharge as reported by the caregiver
  measure: Missed follow-up visit rate
  time frame: Up to 15 months after first meeting of protocol committee
  description: Proportion of children missing a follow-up visit within 3 months after discharge as reported by the caregiver
  arm group label: Control (pre-implementation) arm
  arm group type: No Intervention
  description: 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.
  arm group label: Intervention (post-implementation) arm
  arm group type: Experimental
  description: 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.
  intervention type: Other
  intervention name: Social needs screening protocol
  description: 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.
  arm group label: Intervention (post-implementation) arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthew S Pantell, MD, MS
  role: Principal Investigator
  affiliation: University of California, San Francisco
  last name: Matthew S Pantell, MD, MS
  phone: 4154765001
  email: Matt.Pantell@ucsf.edu
  facility: 
  contact: 
  country: United States
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  citation: 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
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: 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.