<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/NCT03834441</url>
  </required_header>
  <id_info>
    <org_study_id>2019P000128</org_study_id>
    <nct_id>NCT03834441</nct_id>
  </id_info>
  <brief_title>Optimized Health-Related Social Needs Screening and Community Linkages</brief_title>
  <official_title>Optimized Health-Related Social Needs Screening and Community Linkages</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</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 objective of this study is to to understand the most effective method for health-related&#xD;
      social need (HRSN) screening in the challenging environment of an emergency department by&#xD;
      randomizing patients to oral or written HRSN screening in the ED.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bilingual research assistants (RA) will screen patients for eligibility based on the&#xD;
      predetermined criteria and approach eligible patients with a brief description of the study&#xD;
      and opportunity for participation. Interested participants will complete a verbal consent&#xD;
      process to reduce the barriers to participation, a brief demographic questionnaire, and an&#xD;
      assessment of health literacy (Newest Vital Sign) followed by the Partners Healthcare HRSN&#xD;
      screener randomized to an oral v. iPad screening strategy.&#xD;
&#xD;
      After completion of the screening tool, participants will complete a secondary questionnaire&#xD;
      asking about satisfaction with the process, the presence of additional HRSN not recorded by&#xD;
      the Partners HealthCare screener, and their perspectives on screening. At the conclusion, all&#xD;
      participants will be provided with standardized, bilingual list of community resources to&#xD;
      address each of the screening domains.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 7, 2019</start_date>
  <completion_date type="Actual">February 20, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported Satisfaction With the Screening Process</measure>
    <time_frame>Immediately after completing survey</time_frame>
    <description>Satisfaction with screening as measured by:&#xD;
Please tell us how satisfied you were with the questionnaire you just took:&#xD;
Extremely Quite a bit Somewhat A little bit Not at all</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Health Related Social Needs Reported</measure>
    <time_frame>Immediately after completing survey</time_frame>
    <description>We will record the number of health related social needs reported</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Emergencies</condition>
  <arm_group>
    <arm_group_label>Oral screening</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Written screening</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oral HRSN screening</intervention_name>
    <description>Verbal screening delivered by an RA</description>
    <arm_group_label>Oral screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Written HRSN screening</intervention_name>
    <description>Patient completes written screen on iPad.</description>
    <arm_group_label>Written screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age ≥ 18 years patients and either a parent/guardian of a pediatric/cognitively&#xD;
             disabled patient in the MGH ED,&#xD;
&#xD;
          2. triaged to the Acute, CDU, Fast Track, Urgent, and Pediatrics areas,&#xD;
&#xD;
          3. English- or Spanish-speaking, and&#xD;
&#xD;
          4. capable of informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. patients unwilling to have the interview audio-recorded,&#xD;
&#xD;
          2. medically unstable patients, and&#xD;
&#xD;
          3. Section 12, lack of capacity medical hold, sexual assault, child abuse, and&#xD;
             emotionally distressed patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Margaret Samuels-Kalow</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <results_first_submitted>January 27, 2022</results_first_submitted>
  <results_first_submitted_qc>January 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">February 9, 2023</results_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Margaret Samuels-Kalow</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>social needs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share IPD.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03834441/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Oral Screening</title>
          <description>Oral HRSN screening: Verbal screening delivered by an RA</description>
        </group>
        <group group_id="P2">
          <title>Written Screening</title>
          <description>Written HRSN screening: Patient completes written screen on iPad.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Allocation</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
                <participants group_id="P2" count="121"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Analysis</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="116"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="109"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Oral Screening</title>
          <description>Oral HRSN screening: Verbal screening delivered by an RA</description>
        </group>
        <group group_id="B2">
          <title>Written Screening</title>
          <description>Written HRSN screening: Patient completes written screen on iPad.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="115"/>
            <count group_id="B2" value="121"/>
            <count group_id="B3" value="236"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41" spread="15"/>
                    <measurement group_id="B2" value="39" spread="15"/>
                    <measurement group_id="B3" value="40" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="64"/>
                    <measurement group_id="B3" value="136"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White NH</title>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black NH</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other NH</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing/declined</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Health literacy</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Adequate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Limited</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-reported Satisfaction With the Screening Process</title>
        <description>Satisfaction with screening as measured by:&#xD;
Please tell us how satisfied you were with the questionnaire you just took:&#xD;
Extremely Quite a bit Somewhat A little bit Not at all</description>
        <time_frame>Immediately after completing survey</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Oral Screening</title>
            <description>Oral HRSN screening: Verbal screening delivered by an RA</description>
          </group>
          <group group_id="O2">
            <title>Written Screening</title>
            <description>Written HRSN screening: Patient completes written screen on iPad.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Satisfaction With the Screening Process</title>
          <description>Satisfaction with screening as measured by:&#xD;
Please tell us how satisfied you were with the questionnaire you just took:&#xD;
Extremely Quite a bit Somewhat A little bit Not at all</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Extremely/quite a bit</title>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="97"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Somewhat/a little/ not at all</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Health Related Social Needs Reported</title>
        <description>We will record the number of health related social needs reported</description>
        <time_frame>Immediately after completing survey</time_frame>
        <population>Would you like any information about any of the HRSN topics?</population>
        <group_list>
          <group group_id="O1">
            <title>Oral Screening</title>
            <description>Oral HRSN screening: Verbal screening delivered by an RA</description>
          </group>
          <group group_id="O2">
            <title>Written Screening</title>
            <description>Written HRSN screening: Patient completes written screen on iPad.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Health Related Social Needs Reported</title>
          <description>We will record the number of health related social needs reported</description>
          <population>Would you like any information about any of the HRSN topics?</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="115"/>
                <count group_id="O2" value="121"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="93"/>
                  </measurement_list>
                </category>
                <category>
                  <title>At least one</title>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Through study completion (no more than 1 day).</time_frame>
      <desc>Participants were enrolled in the study and completed the outcome measurement on the same day. There was no further contact with participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>Oral Screening</title>
          <description>Oral HRSN screening: Verbal screening delivered by an RA</description>
        </group>
        <group group_id="E2">
          <title>Written Screening</title>
          <description>Written HRSN screening: Patient completes written screen on iPad.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="115"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="121"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Margaret Samuels-Kalow</name_or_title>
      <organization>MGH</organization>
      <phone>617-726-8340</phone>
      <email>msamuels-kalow@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03834441
org study id: 2019P000128
nct id: NCT03834441
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to to understand the most effective method for health-related
      social need (HRSN) screening in the challenging environment of an emergency department by
      randomizing patients to oral or written HRSN screening in the ED.
Bilingual research assistants (RA) will screen patients for eligibility based on the
      predetermined criteria and approach eligible patients with a brief description of the study
      and opportunity for participation. Interested participants will complete a verbal consent
      process to reduce the barriers to participation, a brief demographic questionnaire, and an
      assessment of health literacy (Newest Vital Sign) followed by the Partners Healthcare HRSN
      screener randomized to an oral v. iPad screening strategy.

      After completion of the screening tool, participants will complete a secondary questionnaire
      asking about satisfaction with the process, the presence of additional HRSN not recorded by
      the Partners HealthCare screener, and their perspectives on screening. At the conclusion, all
      participants will be provided with standardized, bilingual list of community resources to
      address each of the screening domains.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Self-reported Satisfaction With the Screening Process
time frame: Immediately after completing survey
description: Satisfaction with screening as measured by:
Please tell us how satisfied you were with the questionnaire you just took:
Extremely Quite a bit Somewhat A little bit Not at all
measure: Number of Health Related Social Needs Reported
time frame: Immediately after completing survey
description: We will record the number of health related social needs reported
arm group label: Oral screening
arm group type: Other
arm group label: Written screening
arm group type: Other
intervention type: Other
intervention name: Oral HRSN screening
description: Verbal screening delivered by an RA
arm group label: Oral screening
intervention type: Other
intervention name: Written HRSN screening
description: Patient completes written screen on iPad.
arm group label: Written screening
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Margaret Samuels-Kalow
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Margaret Samuels-Kalow
investigator title: Assistant Professor
mesh term: Emergencies
sharing ipd: No
ipd description: There is no plan to share IPD.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 