<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/NCT04491448</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY20010212</org_study_id>
    <nct_id>NCT04491448</nct_id>
  </id_info>
  <brief_title>Acceptability of Social Risk Screening</brief_title>
  <official_title>Acceptability of Social Risk Screening in Adult Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</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>
      Social risk screening asks patients to provide information on health-related social needs&#xD;
      that are non-medical but affect health. These include housing stability, food security,&#xD;
      reliable medical transportation, consistent utilities service (heat, light, water), and&#xD;
      interpersonal safety. This research will determine the acceptability of such screening in&#xD;
      adult patients who attend a primary care clinic in-person or via a telemedicine visit, the&#xD;
      level of social need in patients, and how to flag such information for care, planning, and&#xD;
      follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate the acceptability of social risk screening among adult patients seen&#xD;
      in the General Internal Medicine Offices (GIMO) at Montefiore Hospital. The research will&#xD;
      enroll patients using the resident clinic, which provides medical care to lower-income&#xD;
      patients as well as other patients. The study will be limited to new patients or patients&#xD;
      receiving routine follow-up care.&#xD;
&#xD;
      Acceptability will be assessed by (i) the proportion of patients completing the screen among&#xD;
      those approached; (ii) the proportion of screening questions completed; and (iii) the&#xD;
      proportion of patients willing to complete the screening over the phone (a) by interviewer or&#xD;
      (b) on via website using Qualtrics.&#xD;
&#xD;
      The representativeness of the sample will be assessed by comparing the participant sample to&#xD;
      aggregate clinic demographic characteristics and deidentified Epic EHR indicators using an&#xD;
      honest broker.&#xD;
&#xD;
      The survey instrument is the CMS Accountable Care Communities instrument. It includes patient&#xD;
      indicators (demography) and appraisals of care (e.g., trust) that will allow assessment of&#xD;
      correlates of social need and acceptability of screening in the clinical setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 12, 2020</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of social needs screening in medical encounter</measure>
    <time_frame>One-time interview, 20-25 minutes</time_frame>
    <description>Proportion reporting social needs relevant to medical care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effects of reported social needs on medical utilization and patient behavior</measure>
    <time_frame>One-time interview, 20-25 minutes</time_frame>
    <description>Reports of missed appointments and need for social work referrals</description>
  </secondary_outcome>
  <enrollment type="Actual">218</enrollment>
  <condition>Primary Health Care</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social needs screening</intervention_name>
    <description>Interview and referral for non-medical health-related social needs</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for a routine physicals or new patient visits&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18+&#xD;
&#xD;
          2. New patient or routine physical exam, GIMO clinic, Montefiore Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to provide verbal informed consent&#xD;
&#xD;
          2. Unable to complete questionnaire&#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>Steven M Albert, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15261</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Steven M. Albert</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified data will be made available to other researchers and students who approach the investigators and prepare detailed analytic plans. The Office of Sponsored Programs will review requests to share de-identified research data/materials to determine whether an agreement needs to be executed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>6 Months after study completion</ipd_time_frame>
    <ipd_access_criteria>Contact PI</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04491448
org study id: STUDY20010212
nct id: NCT04491448
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Social risk screening asks patients to provide information on health-related social needs
      that are non-medical but affect health. These include housing stability, food security,
      reliable medical transportation, consistent utilities service (heat, light, water), and
      interpersonal safety. This research will determine the acceptability of such screening in
      adult patients who attend a primary care clinic in-person or via a telemedicine visit, the
      level of social need in patients, and how to flag such information for care, planning, and
      follow up.
This study will evaluate the acceptability of social risk screening among adult patients seen
      in the General Internal Medicine Offices (GIMO) at Montefiore Hospital. The research will
      enroll patients using the resident clinic, which provides medical care to lower-income
      patients as well as other patients. The study will be limited to new patients or patients
      receiving routine follow-up care.

      Acceptability will be assessed by (i) the proportion of patients completing the screen among
      those approached; (ii) the proportion of screening questions completed; and (iii) the
      proportion of patients willing to complete the screening over the phone (a) by interviewer or
      (b) on via website using Qualtrics.

      The representativeness of the sample will be assessed by comparing the participant sample to
      aggregate clinic demographic characteristics and deidentified Epic EHR indicators using an
      honest broker.

      The survey instrument is the CMS Accountable Care Communities instrument. It includes patient
      indicators (demography) and appraisals of care (e.g., trust) that will allow assessment of
      correlates of social need and acceptability of screening in the clinical setting.
observational model: Cohort
time perspective: Cross-Sectional
measure: Acceptability of social needs screening in medical encounter
time frame: One-time interview, 20-25 minutes
description: Proportion reporting social needs relevant to medical care
measure: Effects of reported social needs on medical utilization and patient behavior
time frame: One-time interview, 20-25 minutes
description: Reports of missed appointments and need for social work referrals
intervention type: Behavioral
intervention name: Social needs screening
description: Interview and referral for non-medical health-related social needs
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Steven M Albert, PhD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Steven M. Albert
investigator title: Professor
sharing ipd: Yes
ipd description: Deidentified data will be made available to other researchers and students who approach the investigators and prepare detailed analytic plans. The Office of Sponsored Programs will review requests to share de-identified research data/materials to determine whether an agreement needs to be executed.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: 6 Months after study completion
ipd access criteria: Contact PI