<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/NCT02232126</url>
  </required_header>
  <id_info>
    <org_study_id>UP-10-00372</org_study_id>
    <secondary_id>5R21AG034557-02</secondary_id>
    <nct_id>NCT02232126</nct_id>
  </id_info>
  <brief_title>Social Work Intervention Focused on Transitions</brief_title>
  <acronym>SWIFT</acronym>
  <official_title>Social Work Intervention Focused on Transitions Among At-Risk Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Huntington Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In response to Program Announcement (PA)-09-164, &quot;NIH Exploratory/Developmental Research&#xD;
      Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work&#xD;
      Intervention Focused on Transitions among at-risk older adults following hospital discharge&#xD;
      to home. This study is drawn from several observations. First, transitions between care&#xD;
      settings create elevated risk for poor outcomes and for readmission among older adults&#xD;
      leaving the hospital for home largely due to fragmented care and poor communication. Next,&#xD;
      while few studies exist that test methods to improve transitions, those available are largely&#xD;
      medically focused, using a nurse or advanced practice nurse in their approach. Although&#xD;
      evidence exists to support the effectiveness of these models, few have been replicated and&#xD;
      none have been integrated into standard health care practice. This may be attributed to&#xD;
      several factors including the availability of the needed staff, the lack of existing&#xD;
      structures to support these roles, and the costs of implementing these interventions.&#xD;
      Finally, a social work driven intervention may provide a replicable mechanism for bridging&#xD;
      medical care, addressing psychosocial needs as well as medical needs, and improving linkages&#xD;
      with community services while reducing care duplication. This study aimed to test a&#xD;
      structured social work transition intervention model to reduce rates of hospital readmission&#xD;
      and medical service use while improving patient satisfaction with the care transition&#xD;
      process. A randomized pilot study was used to test a social work transitions model designed&#xD;
      to improve care provided to frail older adults being discharged from the hospital to return&#xD;
      to the community. Eligible patients consenting to participate (n=181) were randomly assigned&#xD;
      to either the social work transitions model intervention or usual care. This project was&#xD;
      conducted at Huntington Hospital, a 525-bed, nonprofit, community hospital located in&#xD;
      Pasadena, California. In an average year, Huntington Hospital has approximately 10,000 older&#xD;
      adults discharged from their facility, 44% of who are 80 years old or older. Those randomized&#xD;
      to the intervention arm received up to six sessions from the social worker, at least one&#xD;
      provided in the home. The social work intervention was designed to overcome common problems&#xD;
      following hospital discharge including medication review, discussion and planning around&#xD;
      discharge instruction, assistance in scheduling follow up appointments, assessments of&#xD;
      psychosocial and other support service needs and provision of linkages to address those&#xD;
      needs. Outcomes were measured three and six months following arrival at home, with an interim&#xD;
      measure of satisfaction at 10 days following arrival at home, with measures including patient&#xD;
      level of depression, pain, physical functioning, self-efficacy with disease management, and&#xD;
      medical service use.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>30-day Hospital Readmission</measure>
    <time_frame>30-days post hospitalization</time_frame>
    <description>The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-day Readmission Among Intervention Participants</measure>
    <time_frame>30-days</time_frame>
    <description>The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">181</enrollment>
  <condition>Study Focus: 30-day Rehospitalizations Among At-risk Older Adults Randomized to a Social Work-driven Care Transitions Intervention</condition>
  <condition>Heart Disease</condition>
  <condition>Diabetes</condition>
  <condition>Hypertension</condition>
  <condition>Cancer</condition>
  <condition>Depression</condition>
  <condition>Asthma</condition>
  <condition>Chronic Heart Failure</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <condition>Stroke</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>SWIFT home intervention</intervention_name>
    <description>1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 or more&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Community dwelling (own home, vs. assisted living facility/skilled care)&#xD;
&#xD;
          -  Living within specified service net&#xD;
&#xD;
          -  Cognitively intact (as measured by a score of 5 or more on the SPMSQ)&#xD;
&#xD;
          -  Meeting at lease one or more of the following:&#xD;
&#xD;
          -  Age 75 or more&#xD;
&#xD;
          -  Taking 5 or more prescription medications&#xD;
&#xD;
          -  Had at least one inpatient admission or emergency department visit in previous 6&#xD;
             months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age 64 or younger&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Diagnosed with end-stage renal disease&#xD;
&#xD;
          -  Hospice recipient&#xD;
&#xD;
          -  Diagnosis of Alzheimer's disease or severe dementia&#xD;
&#xD;
          -  Residing in assisted living or skilled care facility&#xD;
&#xD;
          -  Homeless&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntington Hospital</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <results_first_submitted>December 4, 2014</results_first_submitted>
  <results_first_submitted_qc>December 19, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2017</results_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Susan Enguidanos</investigator_full_name>
    <investigator_title>Associate Professor of Gerontology</investigator_title>
  </responsible_party>
  <keyword>Hospital readmissions</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Older adults</keyword>
  <keyword>Care transitions</keyword>
  <keyword>Social work</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Heart Diseases</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Usual Care</title>
        </group>
        <group group_id="P2">
          <title>Intervention</title>
          <description>SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Usual Care</title>
          <description>Usual care consisted of the usual course of care provided to older adults transitioning home from a hospital stay at Huntington Memorial Hospital</description>
        </group>
        <group group_id="B2">
          <title>Intervention</title>
          <description>SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts</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="91"/>
            <count group_id="B2" value="90"/>
            <count group_id="B3" value="181"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="79.2" spread="8.8"/>
                    <measurement group_id="B2" value="78.4" spread="7.8"/>
                    <measurement group_id="B3" value="78.8" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <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>
              <title>Asian/Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Declined to provide response</title>
              <category_list>
                <category>
                  <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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="181"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital status</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="45"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Single</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Divorced</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Widowed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Declined to provide response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current living situation</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Own house/apartment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="78"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Living in family member's home</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Declined to provide response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Who do you live with?</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Alone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spouse/partner</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Child</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paid caregiver</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Declined to provide response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Who is your primary caregiver?</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>No one/self</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="33"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spouse</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Significant other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Child</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Paid caregiver</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Declined to provide response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current annual income</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Under $10,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$10,000-$19,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$20,000-$29,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$30,000-$39,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$40,000-$49,000</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>$50,000 or more</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Refused to respond</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest grade completed in school</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>8th grade or less</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>9th-11th grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High school graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some college</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>College graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Graduate degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Doctoral degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Declined to provide response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Chronic condition inventory</title>
          <description>Measure NOT mutually exclusive. Inventory of conditions</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Cancer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dementia/Alzheimer's disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Depression</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stroke</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patient Health Questionnaire 9-item (PHQ-9)</title>
          <description>The Patient Health Questionnaire, 9-item uses nine questions to asses for depression and has been widely and successfully used in health care research since the early 1990's, particularly in investigations among older adults aged 65 years or more.&#xD;
A total score is reported at the end of the questionnaire and scores can range from 0-27 with a higher value indicating more severe or worse depression. Total scores correspond to the following: 0 no depression, 1-4 minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderate severe depression, and 20-27 severe depression.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.33" spread="3.9"/>
                    <measurement group_id="B2" value="6.15" spread="5.1"/>
                    <measurement group_id="B3" value="5.24" spread="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pain (Number Rating Scale)</title>
          <description>The Number Rating Scale is a self-reported measure for pain level that is widely used in US hospitals. Patients are asked to rate their level of pain felt over the last 24-hours on a scale ranging from 0-10, where zero indicates no pain, and 10 is the worst pain imaginable.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.54" spread="3.4"/>
                    <measurement group_id="B2" value="9.18" spread="1.1"/>
                    <measurement group_id="B3" value="6.36" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Physical Functioning Index (abbreviated Short Form-12)</title>
          <description>The Short-Form, 12-item is a survey tool to measure physical health and functional level and an abbreviated version of this tool was used in the present study which constituted eight of the 12-items that focused on physical functioning. Response options ranged from 'not limited at all,' to 'limited a lot' and after assigning numerical values to response options, total scores ranged from 0-16 with a higher score corresponding to greater physical limitations.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.67" spread="5.12"/>
                    <measurement group_id="B2" value="7.18" spread="5.08"/>
                    <measurement group_id="B3" value="7.43" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cognition (SPMSQ score)</title>
          <description>The Short Portable Mental Health Questionnaire (SPMSQ) is widely used tool to screen for cognitive impairment. This questionnaire consists of 10 questions and a total score is derived at the end. Scores can range from 0-10 where a low score indicates high cognitive impairment and a high score indicates higher cognitive functioning. The scale has an established cut-off score of 5 where those scoring 5 or higher are cognitively intact to participate in research, understand the study and associated activities, and provide consent. Those scoring below 5 are deemed ineligible.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.08" spread="1.2"/>
                    <measurement group_id="B2" value="9.18" spread="1.1"/>
                    <measurement group_id="B3" value="9.13" spread="1.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of health conditions</title>
          <units>health conditions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.35" spread="4.1"/>
                    <measurement group_id="B2" value="5.88" spread="2.9"/>
                    <measurement group_id="B3" value="6.17" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of daily medications</title>
          <units>medications</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.61" spread="3.8"/>
                    <measurement group_id="B2" value="8.00" spread="3.8"/>
                    <measurement group_id="B3" value="7.81" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Discharged home under self-care</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="128"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Had inpatient stay or emergency department visit in previous 6 months</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Has Advance Directive</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>30-day Hospital Readmission</title>
        <description>The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.</description>
        <time_frame>30-days post hospitalization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Usual Care</title>
            <description>Usual Care in the present study constitutes usual care that is delivered to older adults transitioning from the hospital to home from Huntington Memorial Hospital.</description>
          </group>
          <group group_id="O2">
            <title>Intervention</title>
            <description>SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts</description>
          </group>
        </group_list>
        <measure>
          <title>30-day Hospital Readmission</title>
          <description>The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.</description>
          <units>30-day hospital readmissions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>30-day Readmission Among Intervention Participants</title>
        <description>The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.</description>
        <time_frame>30-days</time_frame>
        <population>Analysis among Intervention group ONLY for this outcome</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group: Received Intervention</title>
            <description>Patients randomized to the intervention group and received the intervention. SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts</description>
          </group>
          <group group_id="O2">
            <title>Intervention Group: Opt-outs</title>
            <description>Patients randomized to the intervention group that refused the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>30-day Readmission Among Intervention Participants</title>
          <description>The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.</description>
          <population>Analysis among Intervention group ONLY for this outcome</population>
          <units>30-day hospital readmissions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Usual Care</title>
          <description>Usual care for the present study constituted the usual course of care provided to older adults transitioning from hospital to home from Huntington Memorial Hospital.</description>
        </group>
        <group group_id="E2">
          <title>Intervention</title>
          <description>SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </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="91"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="90"/>
              </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>Dr. Susan Enguidanos</name_or_title>
      <organization>University of Southern California</organization>
      <phone>213-740-9822</phone>
      <email>enguidan@usc.edu</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/NCT02232126
org study id: UP-10-00372
secondary id: 5R21AG034557-02
nct id: NCT02232126
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
In response to Program Announcement (PA)-09-164, "NIH Exploratory/Developmental Research
      Grant Program (R21) a randomized pilot study testing the efficacy of SWIFT: Social Work
      Intervention Focused on Transitions among at-risk older adults following hospital discharge
      to home. This study is drawn from several observations. First, transitions between care
      settings create elevated risk for poor outcomes and for readmission among older adults
      leaving the hospital for home largely due to fragmented care and poor communication. Next,
      while few studies exist that test methods to improve transitions, those available are largely
      medically focused, using a nurse or advanced practice nurse in their approach. Although
      evidence exists to support the effectiveness of these models, few have been replicated and
      none have been integrated into standard health care practice. This may be attributed to
      several factors including the availability of the needed staff, the lack of existing
      structures to support these roles, and the costs of implementing these interventions.
      Finally, a social work driven intervention may provide a replicable mechanism for bridging
      medical care, addressing psychosocial needs as well as medical needs, and improving linkages
      with community services while reducing care duplication. This study aimed to test a
      structured social work transition intervention model to reduce rates of hospital readmission
      and medical service use while improving patient satisfaction with the care transition
      process. A randomized pilot study was used to test a social work transitions model designed
      to improve care provided to frail older adults being discharged from the hospital to return
      to the community. Eligible patients consenting to participate (n=181) were randomly assigned
      to either the social work transitions model intervention or usual care. This project was
      conducted at Huntington Hospital, a 525-bed, nonprofit, community hospital located in
      Pasadena, California. In an average year, Huntington Hospital has approximately 10,000 older
      adults discharged from their facility, 44% of who are 80 years old or older. Those randomized
      to the intervention arm received up to six sessions from the social worker, at least one
      provided in the home. The social work intervention was designed to overcome common problems
      following hospital discharge including medication review, discussion and planning around
      discharge instruction, assistance in scheduling follow up appointments, assessments of
      psychosocial and other support service needs and provision of linkages to address those
      needs. Outcomes were measured three and six months following arrival at home, with an interim
      measure of satisfaction at 10 days following arrival at home, with measures including patient
      level of depression, pain, physical functioning, self-efficacy with disease management, and
      medical service use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: 30-day Hospital Readmission
time frame: 30-days post hospitalization
description: The outcome measure is the number of readmissions experienced by participants in the Usual Care and Intervention groups within 30-days of their index discharge.
measure: 30-day Readmission Among Intervention Participants
time frame: 30-days
description: The outcome measure is the rate of 30-day readmissions among Intervention group participants that declined to receive the in-home social work intervention versus those Intervention group participants that received the in-home social work intervention.
arm group label: Usual Care
arm group type: No Intervention
arm group label: Intervention
arm group type: Experimental
intervention type: Other
intervention name: SWIFT home intervention
description: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
arm group label: Intervention
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Susan Enguidanos
investigator title: Associate Professor of Gerontology
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Heart Diseases
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 