<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/NCT03810534</url>
  </required_header>
  <id_info>
    <org_study_id>18-1513</org_study_id>
    <secondary_id>R01NR017636</secondary_id>
    <nct_id>NCT03810534</nct_id>
  </id_info>
  <brief_title>Connect-Home Clinical Trial</brief_title>
  <official_title>Connect-Home: Testing the Efficacy of Transitional Care of Patients and Caregivers During Transitions From Skilled Nursing Facilities to Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Nursing Research (NINR)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study will test whether transitional care targeting care needs of seriously ill, skilled&#xD;
      nursing facility (SNF) patients and their caregivers will help to improve SNF patient&#xD;
      outcomes (preparedness for discharge, quality of life, function and acute care use) and&#xD;
      caregiver outcomes (preparedness for the caregiving role. caregiver burden and caregiver&#xD;
      distress).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prior research has not established an evidence-based model of transitional care for seriously&#xD;
      ill SNF patients (and their caregivers) who transfer from SNF to home-based care.&#xD;
      Connect-Home, the intervention to be tested in this study, will use existing nursing home&#xD;
      staff and community-based nurses to deliver transitional care in SNFs and the patient's home.&#xD;
&#xD;
      The feasibility, acceptability, and estimated efficacy of Connect-Home was demonstrated in a&#xD;
      pilot test of pre-discharge elements of Connect-Home (N=133 patients and their caregivers).&#xD;
      Compared to controls, intervention participants were significantly more prepared for&#xD;
      discharge (higher scores on Care Transitions Measure-15) and they more frequently received&#xD;
      individualized plans for continuing care at home. Virtually all SNF staff participants (97%)&#xD;
      recommended the intervention for future use, demonstrating its acceptability. The objective&#xD;
      of this study is to test the efficacy of Connect-Home for seriously ill patients discharged&#xD;
      to home and their caregivers.&#xD;
&#xD;
      In this trial, intervention participants will receive the Connect-Home intervention; the&#xD;
      intervention has two steps. While the patient is in the SNF, nurses, social workers and&#xD;
      rehabilitation therapists will create an individualized Transition Plan of Care and prepare&#xD;
      the patient and caregiver to manage the patient's serious illness at home. Within 24 hours of&#xD;
      the time that the SNF patient discharges to home, a Connect-Home Activation Nurse (Activation&#xD;
      RN) will visit the patient at home; the Activation RN will help the patient and family&#xD;
      caregiver implement the written Transition Plan of Care. The Connect-Home intervention will&#xD;
      focus on six key care needs: (1) home safety and level of assistance; (2) advance care&#xD;
      planning; (3) symptom management; (4) medication reconciliation; (5) function and activity;&#xD;
      and (6) coordination of follow-up medical care. In this trial, the control participants will&#xD;
      receive usual discharge planning in the SNF only. Usual discharge planning for SNF patients&#xD;
      includes assignment to an interdisciplinary team that develops discharge instructions for the&#xD;
      patient to follow at home with oversight by a physician. Usual care does not include a&#xD;
      structured home visit after the patient discharges to home.&#xD;
&#xD;
      Patient and caregiver outcomes will assessed in 7, 30, and 60 days after the patient&#xD;
      discharged from the SNF to home. Outcomes assessors will be blinded to study group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">September 12, 2021</completion_date>
  <primary_completion_date type="Actual">July 24, 2021</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>Crossover Assignment</intervention_model>
    <intervention_model_description>The Connect-Home study employs a stepped wedge cluster-randomized trial design, which is a crossover design at the cluster level where clusters of individuals (i.e., residents in a nursing home) crossover from control to intervention condition at randomly assigned timepoints or steps.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>7 Days After SNF Discharge</time_frame>
    <description>The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge</measure>
    <time_frame>7 Days After Patient SNF Discharge</time_frame>
    <description>The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>30 Days After SNF Discharge</time_frame>
    <description>The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>60 Days After SNF Discharge</time_frame>
    <description>The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Space Assessment 30 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>30 Days After SNF Discharge</time_frame>
    <description>Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the &quot;Life-space level&quot; (range 1-5) and the &quot;independence&quot; score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Life Space Assessment 60 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>60 Days After SNF Discharge</time_frame>
    <description>Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the &quot;Life-space level&quot; (range 1-5) and the &quot;independence&quot; score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>30 Days After Patient's SNF Discharge</time_frame>
    <description>Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that &quot;caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning.&quot; Scores range 0-48; higher scores are associated with depression and social isolation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>60 Days After Patient's SNF Discharge</time_frame>
    <description>Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that &quot;caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning.&quot; Scores range 0-48; higher scores are associated with depression and social isolation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer 30 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>30 Days After Patient's SNF Discharge</time_frame>
    <description>Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores &gt;4 associated with poor coping and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress Thermometer 60 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>60 Days After Patient's SNF Discharge</time_frame>
    <description>Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores &gt;4 associated with poor coping and depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>30 Days After SNF Discharge</time_frame>
    <description>Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge</measure>
    <time_frame>60 Days After SNF Discharge</time_frame>
    <description>Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">654</enrollment>
  <condition>Transitional Care</condition>
  <condition>Caregivers</condition>
  <condition>Patient Discharge</condition>
  <condition>Aging</condition>
  <condition>Frailty</condition>
  <arm_group>
    <arm_group_label>Connect-Home</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Connect-Home intervention at the skilled nursing facility and at the subject's home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard discharge planning at the skilled nursing facility only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Connect-Home</intervention_name>
    <description>Connect-Home will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses, therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness and functional needs. In Step 2, the Connect-Home Activation RN will visit the patient's home within 24 hours of discharge; the nurse will activate the Transition Plan of Care at home. Both intervention steps focus on 6 key care needs to optimize patient and caregiver outcomes: 1) home safety and level of assistance; 2) advance care planning; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.</description>
    <arm_group_label>Connect-Home</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for patients:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Have a Minimum Data Set 3.0 Section GG Mobility Assessment Score of 3 or less,&#xD;
             indicating the patient requires at least 25-50% assistance for functional mobility&#xD;
&#xD;
          -  Be diagnosed with at least 1 serious medical illness (neurodegenerative dementia,&#xD;
             cancer, chronic kidney disease, cirrhosis, congestive heart failure, chronic&#xD;
             obstructive or interstitial lung disease, acute infection with sepsis, acute major&#xD;
             motor stroke, acute coronary syndrome, acute hip fracture, diabetes with end organ&#xD;
             complications, or intensive care for &gt;3 days while hospitalized)&#xD;
&#xD;
          -  Having a caregiver who can be enrolled in the study&#xD;
&#xD;
          -  For patients with cognitive impairment additional criteria include documentation in&#xD;
             the medical record of a caregiver who is the patient's legally authorized&#xD;
             representative; and consent of the caregiver to participate in the study as the&#xD;
             patient's representative.&#xD;
&#xD;
        Inclusion Criteria for Caregivers:&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Self-reports assisting the patient at home.&#xD;
&#xD;
        Exclusion Criteria for Patients:&#xD;
&#xD;
          -  Planned hospital readmission for procedures/treatments in next 90 days.&#xD;
&#xD;
        There are no exclusion criteria for Caregivers.&#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>Mark Toles, PhD, RN</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC-Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>June 1, 2022</results_first_submitted>
  <results_first_submitted_qc>July 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">August 23, 2022</results_first_posted>
  <last_update_submitted>July 29, 2022</last_update_submitted>
  <last_update_submitted_qc>July 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transitional Care</keyword>
  <keyword>Skilled Nursing Facilities</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Frailty</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>9 to 36 months following publication.</ipd_time_frame>
    <ipd_access_criteria>Investigators who propose to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and must execute a data use/sharing agreement with UNC.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 13, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03810534/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT03810534/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>SNF 1</title>
          <description>Connect-Home intervention at skilled nursing facility (SNF) 1.&#xD;
Participants at this SNF enter the Standard of Care phase for 5 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 11 months.&#xD;
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="P2">
          <title>SNF 2</title>
          <description>Connect-Home intervention at skilled nursing facility (SNF) 2.&#xD;
Participants at this SNF enter the Standard of Care phase for 6 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 10 months.&#xD;
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="P3">
          <title>SNF 3</title>
          <description>Connect-Home intervention at skilled nursing facility (SNF) 3.&#xD;
Participants at this SNF enter the Standard of Care phase for 7 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 9 months.&#xD;
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="P4">
          <title>SNF 4</title>
          <description>Connect-Home intervention at skilled nursing facility (SNF) 4.&#xD;
Participants at this SNF enter the Standard of Care phase for 8 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 8 months.&#xD;
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="P5">
          <title>SNF 5</title>
          <description>Connect-Home intervention at skilled nursing facility (SNF) 5.&#xD;
Participants at this SNF enter the Standard of Care phase for 9 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 7 months.&#xD;
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="P6">
          <title>SNF 6</title>
          <description>Connect-Home intervention at skilled nursing facility (SNF) 6.&#xD;
Participants at this SNF enter the Standard of Care phase for 10 months, the Pre-Implementation phase for 2 months and the Connect-Home phase for 6 months.&#xD;
Participants will encounter discharge planning at the skilled nursing facility and will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Standard of Care (5-10 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
                <participants group_id="P2" count="46"/>
                <participants group_id="P3" count="54"/>
                <participants group_id="P4" count="62"/>
                <participants group_id="P5" count="34"/>
                <participants group_id="P6" count="88"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patients Started</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="31"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Caregivers Started</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="23"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="31"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="44"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 7-day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="29"/>
                <participants group_id="P5" count="13"/>
                <participants group_id="P6" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 7-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="21"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="29"/>
                <participants group_id="P5" count="13"/>
                <participants group_id="P6" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 30-day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="12"/>
                <participants group_id="P6" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 30-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 60-Day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 60-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="15"/>
                <participants group_id="P4" count="20"/>
                <participants group_id="P5" count="9"/>
                <participants group_id="P6" count="31"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="32"/>
                <participants group_id="P3" count="32"/>
                <participants group_id="P4" count="40"/>
                <participants group_id="P5" count="19"/>
                <participants group_id="P6" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="22"/>
                <participants group_id="P5" count="15"/>
                <participants group_id="P6" count="25"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Pre-Implementation Phase (2 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patients Started</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Caregivers Started</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 7-Day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 7-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 30-Day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 30-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 60-Day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 60-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Connect-Home (5-10 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="82"/>
                <participants group_id="P2" count="80"/>
                <participants group_id="P3" count="66"/>
                <participants group_id="P4" count="54"/>
                <participants group_id="P5" count="10"/>
                <participants group_id="P6" count="38"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Patients Started</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Caregivers Started</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="40"/>
                <participants group_id="P3" count="33"/>
                <participants group_id="P4" count="27"/>
                <participants group_id="P5" count="5"/>
                <participants group_id="P6" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 7-Day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="27"/>
                <participants group_id="P4" count="23"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 7-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="29"/>
                <participants group_id="P4" count="24"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 30-Day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="3"/>
                <participants group_id="P6" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 30-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="34"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="25"/>
                <participants group_id="P4" count="21"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 60-Day (Patients)</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="23"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 60-Day (Caregivers)</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="27"/>
                <participants group_id="P3" count="21"/>
                <participants group_id="P4" count="19"/>
                <participants group_id="P5" count="2"/>
                <participants group_id="P6" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="62"/>
                <participants group_id="P2" count="52"/>
                <participants group_id="P3" count="44"/>
                <participants group_id="P4" count="38"/>
                <participants group_id="P5" count="4"/>
                <participants group_id="P6" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="16"/>
                <participants group_id="P5" count="6"/>
                <participants group_id="P6" count="19"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Connect-Home Patients</title>
          <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="B2">
          <title>Connect-Home Caregivers</title>
          <description>Caregivers of Connect-Home study patients.</description>
        </group>
        <group group_id="B3">
          <title>Control Patients</title>
          <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="B4">
          <title>Control Caregivers</title>
          <description>Caregivers of Control study patients.</description>
        </group>
        <group group_id="B5">
          <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="165"/>
            <count group_id="B2" value="165"/>
            <count group_id="B3" value="162"/>
            <count group_id="B4" value="162"/>
            <count group_id="B5" value="654"/>
          </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="76.5" spread="9.49"/>
                    <measurement group_id="B2" value="58.1" spread="14.02"/>
                    <measurement group_id="B3" value="76.6" spread="9.55"/>
                    <measurement group_id="B4" value="60.9" spread="13.72"/>
                    <measurement group_id="B5" value="76.5" spread="9.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</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="104"/>
                    <measurement group_id="B2" value="119"/>
                    <measurement group_id="B3" value="105"/>
                    <measurement group_id="B4" value="116"/>
                    <measurement group_id="B5" value="444"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="46"/>
                    <measurement group_id="B5" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="162"/>
                    <measurement group_id="B4" value="162"/>
                    <measurement group_id="B5" value="654"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="40"/>
                    <measurement group_id="B4" value="43"/>
                    <measurement group_id="B5" value="157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="119"/>
                    <measurement group_id="B4" value="113"/>
                    <measurement group_id="B5" value="472"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="162"/>
                    <measurement group_id="B4" value="162"/>
                    <measurement group_id="B5" value="654"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge</title>
        <description>The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.</description>
        <time_frame>7 Days After SNF Discharge</time_frame>
        <population>Data reported for participants who answered the 7-day data collection phone call.</population>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge</title>
          <description>The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.</description>
          <population>Data reported for participants who answered the 7-day data collection phone call.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="142"/>
                <count group_id="O2" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.80" spread="16.08"/>
                    <measurement group_id="O2" value="68.33" spread="17.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.62</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.64</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.24</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge</title>
        <description>The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.</description>
        <time_frame>7 Days After Patient SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge</title>
          <description>The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="140"/>
                <count group_id="O2" value="141"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.14" spread="6.74"/>
                    <measurement group_id="O2" value="19.26" spread="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.31</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-1.47</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>1.44</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge</title>
        <description>The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.</description>
        <time_frame>30 Days After SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge</title>
          <description>The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="91"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.69" spread="1.81"/>
                    <measurement group_id="O2" value="7.69" spread="1.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.93</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.03</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.33</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge</title>
        <description>The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.</description>
        <time_frame>60 Days After SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge</title>
          <description>The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="88"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.81" spread="1.58"/>
                    <measurement group_id="O2" value="7.71" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.60</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.18</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.34</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Life Space Assessment 30 Days After Skilled Nursing Facility Discharge</title>
        <description>Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the &quot;Life-space level&quot; (range 1-5) and the &quot;independence&quot; score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.</description>
        <time_frame>30 Days After SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Life Space Assessment 30 Days After Skilled Nursing Facility Discharge</title>
          <description>Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the &quot;Life-space level&quot; (range 1-5) and the &quot;independence&quot; score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="125"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.18" spread="16.67"/>
                    <measurement group_id="O2" value="22.97" spread="15.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.53</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>2.24</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.49</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Life Space Assessment 60 Days After Skilled Nursing Facility Discharge</title>
        <description>Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the &quot;Life-space level&quot; (range 1-5) and the &quot;independence&quot; score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.</description>
        <time_frame>60 Days After SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Life Space Assessment 60 Days After Skilled Nursing Facility Discharge</title>
          <description>Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the &quot;Life-space level&quot; (range 1-5) and the &quot;independence&quot; score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="108"/>
                <count group_id="O2" value="105"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.55" spread="17.41"/>
                    <measurement group_id="O2" value="28.60" spread="18.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.83</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.78</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>3.57</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge</title>
        <description>Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that &quot;caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning.&quot; Scores range 0-48; higher scores are associated with depression and social isolation.</description>
        <time_frame>30 Days After Patient's SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge</title>
          <description>Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that &quot;caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning.&quot; Scores range 0-48; higher scores are associated with depression and social isolation.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.27" spread="9.77"/>
                    <measurement group_id="O2" value="12.33" spread="10.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.75</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.67</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.05</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge</title>
        <description>Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that &quot;caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning.&quot; Scores range 0-48; higher scores are associated with depression and social isolation.</description>
        <time_frame>60 Days After Patient's SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge</title>
          <description>Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that &quot;caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning.&quot; Scores range 0-48; higher scores are associated with depression and social isolation.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="106"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.84" spread="9.40"/>
                    <measurement group_id="O2" value="11.35" spread="8.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.50</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>1.44</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.07</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer 30 Days After Skilled Nursing Facility Discharge</title>
        <description>Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores &gt;4 associated with poor coping and depression.</description>
        <time_frame>30 Days After Patient's SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer 30 Days After Skilled Nursing Facility Discharge</title>
          <description>Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores &gt;4 associated with poor coping and depression.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="118"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.19" spread="2.66"/>
                    <measurement group_id="O2" value="3.02" spread="3.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.48</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.36</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.50</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Distress Thermometer 60 Days After Skilled Nursing Facility Discharge</title>
        <description>Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores &gt;4 associated with poor coping and depression.</description>
        <time_frame>60 Days After Patient's SNF Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Distress Thermometer 60 Days After Skilled Nursing Facility Discharge</title>
          <description>Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores &gt;4 associated with poor coping and depression.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.03" spread="3.07"/>
                    <measurement group_id="O2" value="2.60" spread="2.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.22</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.65</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.52</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>The final estimated mean difference is based on a linear mixed model that adjusts for time and is not equal to the difference in the unadjusted, observed means.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge</title>
        <description>Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.</description>
        <time_frame>30 Days After SNF Discharge</time_frame>
        <population>Data are reported only for participants who had acute care use.</population>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge</title>
          <description>Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.</description>
          <population>Data are reported only for participants who had acute care use.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="135"/>
                <count group_id="O2" value="130"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".65" spread="1.82"/>
                    <measurement group_id="O2" value="1.01" spread="3.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.88</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean ratio</param_type>
            <param_value>.96</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.25</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge</title>
        <description>Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.</description>
        <time_frame>60 Days After SNF Discharge</time_frame>
        <population>Data are reported only for participants who had acute care use.</population>
        <group_list>
          <group group_id="O1">
            <title>Connect-Home</title>
            <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge</title>
          <description>Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.</description>
          <population>Data are reported only for participants who had acute care use.</population>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="136"/>
                <count group_id="O2" value="131"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".82" spread="2.00"/>
                    <measurement group_id="O2" value="1.24" spread="3.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.23</p_value>
            <method>Mixed Models Analysis</method>
            <param_type>Mean ratio</param_type>
            <param_value>.72</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>.18</dispersion_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from when participants entered the study to when they completed study procedures, an approximate total of up to 90 days.</time_frame>
      <desc>Due to the severity of illness present in the study population, unrelated adverse events were expected during this study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Connect-Home Patients</title>
          <description>Connect-Home intervention at the skilled nursing facility and at the subject's home. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="E2">
          <title>Connect-Home Caregivers</title>
          <description>Caregivers of Connect-Home study patients.</description>
        </group>
        <group group_id="E3">
          <title>Control Patients</title>
          <description>Standard discharge planning at the skilled nursing facility only. Participants will have data collected at 7, 30, and 60 days post SNF discharge.</description>
        </group>
        <group group_id="E4">
          <title>Control Caregivers</title>
          <description>Caregivers of Control study patients.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="165"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="162"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="38" subjects_at_risk="165"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" subjects_affected="34" subjects_at_risk="162"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Due to Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for Racing Heart Issues</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Low Blood Pressure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Fluid Build-Up</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Left Thoracentesis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Cardiac Stent Placement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Congestive Heart Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Chest Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Due to Colon Tear</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Abdominal Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for generalized weakness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Reason Undisclosed</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Due to Gall Bladder Issues</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Due to Fracture Subsequent to Fall</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Lower Extremity Weakness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Leg Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization due to Mini Stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Acute Metabolic Encephalopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Tremors</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization due to Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization due to Kidney Issues</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Due to Shortness of Breath</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="4" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization for Neck Laceration Caused by Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Hospitalization Due to Skin Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Due to Toe Amputation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization Due to Vasculitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="165"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </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="165"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="165"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Mark Toles, MPH</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-966-5684</phone>
      <email>mtoles@email.unc.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/NCT03810534
org study id: 18-1513
secondary id: R01NR017636
nct id: NCT03810534
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will test whether transitional care targeting care needs of seriously ill, skilled
      nursing facility (SNF) patients and their caregivers will help to improve SNF patient
      outcomes (preparedness for discharge, quality of life, function and acute care use) and
      caregiver outcomes (preparedness for the caregiving role. caregiver burden and caregiver
      distress).
Prior research has not established an evidence-based model of transitional care for seriously
      ill SNF patients (and their caregivers) who transfer from SNF to home-based care.
      Connect-Home, the intervention to be tested in this study, will use existing nursing home
      staff and community-based nurses to deliver transitional care in SNFs and the patient's home.

      The feasibility, acceptability, and estimated efficacy of Connect-Home was demonstrated in a
      pilot test of pre-discharge elements of Connect-Home (N=133 patients and their caregivers).
      Compared to controls, intervention participants were significantly more prepared for
      discharge (higher scores on Care Transitions Measure-15) and they more frequently received
      individualized plans for continuing care at home. Virtually all SNF staff participants (97%)
      recommended the intervention for future use, demonstrating its acceptability. The objective
      of this study is to test the efficacy of Connect-Home for seriously ill patients discharged
      to home and their caregivers.

      In this trial, intervention participants will receive the Connect-Home intervention; the
      intervention has two steps. While the patient is in the SNF, nurses, social workers and
      rehabilitation therapists will create an individualized Transition Plan of Care and prepare
      the patient and caregiver to manage the patient's serious illness at home. Within 24 hours of
      the time that the SNF patient discharges to home, a Connect-Home Activation Nurse (Activation
      RN) will visit the patient at home; the Activation RN will help the patient and family
      caregiver implement the written Transition Plan of Care. The Connect-Home intervention will
      focus on six key care needs: (1) home safety and level of assistance; (2) advance care
      planning; (3) symptom management; (4) medication reconciliation; (5) function and activity;
      and (6) coordination of follow-up medical care. In this trial, the control participants will
      receive usual discharge planning in the SNF only. Usual discharge planning for SNF patients
      includes assignment to an interdisciplinary team that develops discharge instructions for the
      patient to follow at home with oversight by a physician. Usual care does not include a
      structured home visit after the patient discharges to home.

      Patient and caregiver outcomes will assessed in 7, 30, and 60 days after the patient
      discharged from the SNF to home. Outcomes assessors will be blinded to study group.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: The Connect-Home study employs a stepped wedge cluster-randomized trial design, which is a crossover design at the cluster level where clusters of individuals (i.e., residents in a nursing home) crossover from control to intervention condition at randomly assigned timepoints or steps.
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Care Transitions Measure-15 Score 7 Days After Skilled Nursing Facility Discharge
time frame: 7 Days After SNF Discharge
description: The patient's preparedness for discharge will be measured by the Care Transitions Measure-15 (CTM-15), which includes 5 items on a 4-point scale. The CTM-15 measures self-reported knowledge and skills for continuing care at home. Summary score range 0-100, with higher scores associated with less acute care use after discharge.
measure: Preparedness for Caregiving Scale Score 7 Days After Patient's Skill Nursing Facility Discharge
time frame: 7 Days After Patient SNF Discharge
description: The caregiver's preparedness for caregiving will be measured by the Preparedness for Caregiving Scale (PCS), which includes 8 items on a five-point Likert scale (0-4). The PCS measures self-reported readiness for caregiving. Range = 0-32, with higher scores associated with less anxiety.
measure: McGill Quality of Life Questionnaire-Revised Score 30 Days After Skilled Nursing Facility Discharge
time frame: 30 Days After SNF Discharge
description: The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.
measure: McGill Quality of Life Questionnaire-Revised Score 60 Days After Skilled Nursing Facility Discharge
time frame: 60 Days After SNF Discharge
description: The patient's quality of life will be measured using the McGill Quality of Life Questionnaire-Revised (MQoL-R), which includes 14 items on a ten-point Likert scale. The scale is recommended for studies of palliative care and measures quality of life across disease trajectories. Range = 0-10, with higher score indicating better quality of life. There are 4 MQOL-R subscales. Each subscale score is the mean of its items that range from 0-10. The Total Score, also ranging from 0-10, is the mean of the subscale score means.
measure: Life Space Assessment 30 Days After Skilled Nursing Facility Discharge
time frame: 30 Days After SNF Discharge
description: Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.
measure: Life Space Assessment 60 Days After Skilled Nursing Facility Discharge
time frame: 60 Days After SNF Discharge
description: Patient's function will be measured using the Life Space Assessment, which includes 5 Likert scales corresponding to a hierarchy of levels of mobility (each scored from 0-4) where weights are the product of the "Life-space level" (range 1-5) and the "independence" score (range 1-2). The range is 1-120. Lower scores are associated with falls and hospitalization.
measure: Zarit Caregiver Burden Scale 30 Days After Skilled Nursing Facility Discharge
time frame: 30 Days After Patient's SNF Discharge
description: Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.
measure: Zarit Caregiver Burden Scale 60 Days After Skilled Nursing Facility Discharge
time frame: 60 Days After Patient's SNF Discharge
description: Caregiver burden will be measured using the Zarit Caregiver Burden Scale, which includes 12 items on a five-point scale, measuring caregiver perceptions that "caregiving has an adverse effect on their emotional, social, financial, physical and spiritual functioning." Scores range 0-48; higher scores are associated with depression and social isolation.
measure: Distress Thermometer 30 Days After Skilled Nursing Facility Discharge
time frame: 30 Days After Patient's SNF Discharge
description: Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression.
measure: Distress Thermometer 60 Days After Skilled Nursing Facility Discharge
time frame: 60 Days After Patient's SNF Discharge
description: Caregiver distress will be measured using the Distress Thermometer, which includes 1 item on an 11-point scale, measuring negative affect (e.g., sadness and fear) related to caregiving for a severely ill person. Score ranges 0-10, with scores >4 associated with poor coping and depression.
measure: Self-Reported Days of ED or Hospital Use 30 Days After Skilled Nursing Facility Discharge
time frame: 30 Days After SNF Discharge
description: Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the Emergency Department (ED) or hospital in 30 days after SNF discharge.
measure: Self-Reported Days of ED or Hospital Use 60 Days After Skilled Nursing Facility Discharge
time frame: 60 Days After SNF Discharge
description: Patient's days of acute care use will be measured using the self-reported number of combined number of days the patient spends in the ED or hospital in 60 days after SNF discharge.
arm group label: Connect-Home
arm group type: Experimental
description: Connect-Home intervention at the skilled nursing facility and at the subject's home.
arm group label: Control
arm group type: No Intervention
description: Standard discharge planning at the skilled nursing facility only.
intervention type: Behavioral
intervention name: Connect-Home
description: Connect-Home will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses, therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness and functional needs. In Step 2, the Connect-Home Activation RN will visit the patient's home within 24 hours of discharge; the nurse will activate the Transition Plan of Care at home. Both intervention steps focus on 6 key care needs to optimize patient and caregiver outcomes: 1) home safety and level of assistance; 2) advance care planning; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.
arm group label: Connect-Home
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Toles, PhD, RN
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd info type: Study Protocol
ipd time frame: 9 to 36 months following publication.
ipd access criteria: Investigators who propose to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and must execute a data use/sharing agreement with UNC.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 