<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/NCT03022630</url>
  </required_header>
  <id_info>
    <org_study_id>160746</org_study_id>
    <nct_id>NCT03022630</nct_id>
  </id_info>
  <brief_title>Palliative Care for Non-Malignant Diseases (COMPASS Trial)</brief_title>
  <acronym>COMPASS</acronym>
  <official_title>The Creation of Models for Palliative Assessments to Support Severe Illness (COMPASS) Investigation: Testing Early and Ongoing Implementation of Palliative Care for Incurable Non-malignant Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate, through a randomized controlled trial, the impact&#xD;
      of integrated comprehensive palliative care services on time to first hospital readmission&#xD;
      and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The&#xD;
      intervention includes comprehensive, standardized palliative care services for adult&#xD;
      hepatology cirrhosis patients for which prognosis is poor.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Palliative care is specialized medical care focused on providing patients with relief from&#xD;
      the symptoms, pain, and stress of serious or life-limiting illness, regardless of diagnosis,&#xD;
      by anticipating, preventing, and treating suffering. Palliative care aims to provide patients&#xD;
      and their families with services to help patients make the best possible medical decisions in&#xD;
      the face of serious illness. Unfortunately it is often thought to be synonymous with hospice&#xD;
      care and therefore underutilized as a part of standard care. Patients with chronic liver&#xD;
      disease or cirrhosis may be a particularly underserved population for palliative care, as&#xD;
      palliative care may be disregarded until hope of liver transplantation is lost.&#xD;
&#xD;
      Study Description:&#xD;
&#xD;
        -  Adult patients admitted to Vanderbilt University Medical Center with cirrhotic advanced&#xD;
           liver disease and poor prognosis will be randomized to receive either usual hepatic care&#xD;
           or usual hepatic care with comprehensive palliative care services.&#xD;
&#xD;
        -  Participants randomized to the intervention arm will receive patient-friendly&#xD;
           informational materials, a comprehensive initial palliative care consultation, and&#xD;
           follow-up consultations while inpatient. After discharge from hospital, follow-up&#xD;
           consults will occur via telephone contact. Telephone contacts will occur on a flexible&#xD;
           schedule based on needs and wishes of the participant at a minimum frequency of one&#xD;
           contact per month.&#xD;
&#xD;
        -  Participants will receive the palliative care intervention for at least 1 year after&#xD;
           randomization to the intervention arm or until death.&#xD;
&#xD;
        -  Participants randomized to the usual care arm will not be scheduled to meet with the&#xD;
           palliative care service unless a meeting is requested by the patient, the family, or&#xD;
           treating physician. These consultations include the same palliative care services as the&#xD;
           intervention arm, excluding the telephone follow-up consultations.&#xD;
&#xD;
        -  All participants will complete quality of life, mood, and satisfaction with care&#xD;
           assessments at specified time points for 1 year after randomization or until death.&#xD;
           Optional caregiver participation includes completion of satisfaction with care&#xD;
           assessments.&#xD;
&#xD;
      Specific aims include:&#xD;
&#xD;
        1. Assess the impact of systematic, comprehensive palliative care services compared to&#xD;
           usual hepatic care on time to first hospital readmission within 1-year post&#xD;
           randomization.&#xD;
&#xD;
        2. Assess the impact of systematic, comprehensive palliative care services compared to&#xD;
           usual hepatic care on other hospital utilization, including days alive out of hospital&#xD;
           within 6- months post randomization, total days in hospital (and ICU) within 1-year post&#xD;
           randomization, number and cost of hospital admissions within 1-year post randomization,&#xD;
           median length of stay per admission, transfers and time to hospice placement, and&#xD;
           survival within 1-year post randomization.&#xD;
&#xD;
        3. Assess the impact of systematic, comprehensive palliative care services compared to&#xD;
           usual hepatic care on qualify of life.&#xD;
&#xD;
        4. Assess the impact of systematic, comprehensive palliative care services compared to&#xD;
           usual hepatic care on patient/caregiver satisfaction.&#xD;
&#xD;
        5. Evaluate the fidelity of the palliative care intervention and assess the&#xD;
           generalizability of implementing a large-scale Palliative Care program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    slow enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Actual">June 21, 2018</completion_date>
  <primary_completion_date type="Actual">June 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to First Hospital Readmission Within 6 Months Post-randomization</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Assess the impact of palliative care services on time to first hospital readmission.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Days Alive Out of Hospital</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Days alive out of hospital from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Days in Hospital</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total Days in ICU</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Total days in ICU from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Hospital Readmissions</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Number of hospital readmissions from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Length of Hospital Stay Per Admission</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospice Referral</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Number of transfers to hospice within 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Hospice Placement</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Chronic Liver Disease Questionnaire (CLDQ)</measure>
    <time_frame>Change from baseline over 6 months post-randomization</time_frame>
    <description>Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is &quot;present always&quot; while a score of 7 means the symptom is &quot;never present&quot;. Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in EQ-5D-5L</measure>
    <time_frame>Change from baseline over 6 months post-randomization</time_frame>
    <description>Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Emotional Distress - Anxiety - Short Form 4a</measure>
    <time_frame>Change from baseline over 6 months post-randomization</time_frame>
    <description>Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in PROMIS Emotional Distress - Depression - Short Form 4a</measure>
    <time_frame>Change from baseline over 6 months post-randomization</time_frame>
    <description>Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)</measure>
    <time_frame>Change from baseline over 6 months post-randomization</time_frame>
    <description>Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Kingston Caregiver Stress Scale</measure>
    <time_frame>Change from baseline over 6 months post-randomization</time_frame>
    <description>The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)</measure>
    <time_frame>Change from baseline over 6 months post-randomization</time_frame>
    <description>Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Liver Transplant Status</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Number of deferred, listed, and declined listing for liver transplant compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Model for End-Stage Liver Disease (MELD) Score</measure>
    <time_frame>Baseline</time_frame>
    <description>Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completed Liver Transplants</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical Symptoms</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Advance Directives</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Percentage of patients with documented advance care directives compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>6 months post-randomization</time_frame>
    <description>Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Provider Satisfaction</measure>
    <time_frame>Change from Baseline to study closeout.</time_frame>
    <description>The &quot;ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor&quot; instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35.&#xD;
Time frame was changed due to early termination. Data was not collected.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Liver Cirrhosis</condition>
  <condition>NASH (Non-Alcoholic Steatohepatitis)</condition>
  <arm_group>
    <arm_group_label>Comprehensive Palliative Care services</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Comprehensive Palliative Care services in addition to usual hepatic care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual hepatic care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual hepatic care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comprehensive Palliative Care services</intervention_name>
    <description>Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
    <arm_group_label>Comprehensive Palliative Care services</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual hepatic care</intervention_name>
    <description>Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
    <arm_group_label>Usual hepatic care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatient at Vanderbilt University Medical Center with advanced cirrhotic liver&#xD;
             disease, whose treating hepatologist indicates a 'No' response to the question, &quot;Would&#xD;
             you be surprised if this patient died within 1 year?&quot;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Receipt of liver transplant at the time of potential enrollment&#xD;
&#xD;
          -  Inability to give written informed consent (patient or surrogate decision-maker)&#xD;
&#xD;
          -  Inability to respond to questions in English&#xD;
&#xD;
          -  Treating hepatologist denies permission to enroll&#xD;
&#xD;
          -  Receiving hepatology care at non-Vanderbilt sites (to ensure appropriate follow-up)&#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>Gordon Bernard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>June 3, 2016</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>August 6, 2019</results_first_submitted>
  <results_first_submitted_qc>November 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">November 22, 2019</results_first_posted>
  <last_update_submitted>November 20, 2019</last_update_submitted>
  <last_update_submitted_qc>November 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Gordon Bernard</investigator_full_name>
    <investigator_title>Study Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>palliative care</keyword>
  <keyword>cirrhosis</keyword>
  <keyword>liver disease</keyword>
  <keyword>hepatology</keyword>
  <keyword>end of life care</keyword>
  <keyword>supportive care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Cirrhosis</mesh_term>
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>April 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/30/NCT03022630/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Comprehensive Palliative Care Services</title>
          <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
        </group>
        <group group_id="P2">
          <title>Usual Hepatic Care</title>
          <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="32"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Comprehensive Palliative Care Services</title>
          <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
        </group>
        <group group_id="B2">
          <title>Usual Hepatic Care</title>
          <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="31"/>
            <count group_id="B2" value="32"/>
            <count group_id="B3" value="63"/>
          </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="55.1" spread="12.3"/>
                    <measurement group_id="B2" value="56.8" spread="9.4"/>
                    <measurement group_id="B3" value="56" spread="10.9"/>
                  </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="17"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_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_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_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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="57"/>
                  </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_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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to First Hospital Readmission Within 6 Months Post-randomization</title>
        <description>Assess the impact of palliative care services on time to first hospital readmission.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to First Hospital Readmission Within 6 Months Post-randomization</title>
          <description>Assess the impact of palliative care services on time to first hospital readmission.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="117" lower_limit="44" upper_limit="NA">NA is due to censoring for death and withdrawals.</measurement>
                    <measurement group_id="O2" value="68" lower_limit="22" upper_limit="NA">NA is due to censoring for death and withdrawals.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Days Alive Out of Hospital</title>
        <description>Days alive out of hospital from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Days Alive Out of Hospital</title>
          <description>Days alive out of hospital from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="174" lower_limit="59.5" upper_limit="183"/>
                    <measurement group_id="O2" value="178" lower_limit="86.5" upper_limit="182.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Days in Hospital</title>
        <description>Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Days in Hospital</title>
          <description>Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="10.5"/>
                    <measurement group_id="O2" value="3" lower_limit="0" upper_limit="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Days in ICU</title>
        <description>Total days in ICU from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Total Days in ICU</title>
          <description>Total days in ICU from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 ICU days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 ICU days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 ICU days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>6 ICU days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>7 ICU days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>9 ICU days</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Hospital Readmissions</title>
        <description>Number of hospital readmissions from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Hospital Readmissions</title>
          <description>Number of hospital readmissions from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>0 readmissions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>1 readmission</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 readmissions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 readmissions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 readmissions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>5 readmissions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Length of Hospital Stay Per Admission</title>
        <description>Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>The sample size indicates number of hospital readmissions per study arm.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Median Length of Hospital Stay Per Admission</title>
          <description>Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>The sample size indicates number of hospital readmissions per study arm.</population>
          <units>days per admission</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="O2" value="2.5" lower_limit="2" upper_limit="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospice Referral</title>
        <description>Number of transfers to hospice within 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospice Referral</title>
          <description>Number of transfers to hospice within 6 months post randomization compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 patients withdrew from the usual hepatic care group and thus only 27 were included in this analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Hospice Placement</title>
        <description>Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Hospice Placement</title>
          <description>Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.</description>
          <population>There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>4.36 days</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2.78 days</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>143.84 days</title>
                  <measurement_list>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Chronic Liver Disease Questionnaire (CLDQ)</title>
        <description>Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is &quot;present always&quot; while a score of 7 means the symptom is &quot;never present&quot;. Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>Change from baseline over 6 months post-randomization</time_frame>
        <population>Only 5 participants in each group returned both the baseline and 6-month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Chronic Liver Disease Questionnaire (CLDQ)</title>
          <description>Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is &quot;present always&quot; while a score of 7 means the symptom is &quot;never present&quot;. Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>Only 5 participants in each group returned both the baseline and 6-month surveys.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.52" lower_limit="0.34" upper_limit="1.41"/>
                    <measurement group_id="O2" value="0.34" lower_limit="-0.1" upper_limit="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in EQ-5D-5L</title>
        <description>Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>Change from baseline over 6 months post-randomization</time_frame>
        <population>Only 5 participants from each group returned both baseline and 6-month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in EQ-5D-5L</title>
          <description>Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>Only 5 participants from each group returned both baseline and 6-month surveys.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="-5" upper_limit="31"/>
                    <measurement group_id="O2" value="-1" lower_limit="-7" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PROMIS Emotional Distress - Anxiety - Short Form 4a</title>
        <description>Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>Change from baseline over 6 months post-randomization</time_frame>
        <population>Only 5 participants from each group returned both baseline and 6-month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PROMIS Emotional Distress - Anxiety - Short Form 4a</title>
          <description>Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>Only 5 participants from each group returned both baseline and 6-month surveys.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-1" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in PROMIS Emotional Distress - Depression - Short Form 4a</title>
        <description>Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>Change from baseline over 6 months post-randomization</time_frame>
        <population>Only 4 participants from the comprehensive palliative care services each group and 5 participants from the usual hepatic care group returned both baseline and 6-month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in PROMIS Emotional Distress - Depression - Short Form 4a</title>
          <description>Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>Only 4 participants from the comprehensive palliative care services each group and 5 participants from the usual hepatic care group returned both baseline and 6-month surveys.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4" lower_limit="-7.95" upper_limit="-2.17"/>
                    <measurement group_id="O2" value="-3.2" lower_limit="-3.5" upper_limit="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)</title>
        <description>Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>Change from baseline over 6 months post-randomization</time_frame>
        <population>Only 5 participants from the comprehensive palliative care services each group and 4 participants from the usual hepatic care group returned both baseline and 6-month surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)</title>
          <description>Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>Only 5 participants from the comprehensive palliative care services each group and 4 participants from the usual hepatic care group returned both baseline and 6-month surveys.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="3.25"/>
                    <measurement group_id="O2" value="0.8" lower_limit="-0.91" upper_limit="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Kingston Caregiver Stress Scale</title>
        <description>The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>Change from baseline over 6 months post-randomization</time_frame>
        <population>The intended population included caregivers. There is no statistics to report. The two scores from participants in the intervention group are indicated below.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services - Caregivers</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care - Caregivers</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Kingston Caregiver Stress Scale</title>
          <description>The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>The intended population included caregivers. There is no statistics to report. The two scores from participants in the intervention group are indicated below.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Change in Kingston Caregiver Stress Scale Score:15</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Change in Kingston Caregiver Stress Scale Score:7</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)</title>
        <description>Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>Change from baseline over 6 months post-randomization</time_frame>
        <population>The intended population includes the caregivers. Only one caregiver in each group returned both surveys.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Service - Caregivers</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care - Caregivers</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)</title>
          <description>Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>The intended population includes the caregivers. Only one caregiver in each group returned both surveys.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="-2.83" lower_limit="-2.83" upper_limit="-2.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Liver Transplant Status</title>
        <description>Number of deferred, listed, and declined listing for liver transplant compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>Liver transplant status data was not obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Liver Transplant Status</title>
          <description>Number of deferred, listed, and declined listing for liver transplant compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained.</description>
          <population>Liver transplant status data was not obtained.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Model for End-Stage Liver Disease (MELD) Score</title>
        <description>Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant.</description>
        <time_frame>Baseline</time_frame>
        <population>Baseline MELD scores were only available for 26 intervention group participants and 27 control group participants.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Model for End-Stage Liver Disease (MELD) Score</title>
          <description>Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant.</description>
          <population>Baseline MELD scores were only available for 26 intervention group participants and 27 control group participants.</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="20" upper_limit="26"/>
                    <measurement group_id="O2" value="24" lower_limit="17.5" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Completed Liver Transplants</title>
        <description>Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 participants withdrew from the usual hepatic care group.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Completed Liver Transplants</title>
          <description>Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 participants withdrew from the usual hepatic care group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Physical Symptoms</title>
        <description>Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>Physical symptom data was not obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Physical Symptoms</title>
          <description>Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained.</description>
          <population>Physical symptom data was not obtained.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Advance Directives</title>
        <description>Percentage of patients with documented advance care directives compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 participants withdrew from the usual hepatic care group.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Advance Directives</title>
          <description>Percentage of patients with documented advance care directives compared across arms.&#xD;
Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 participants withdrew from the usual hepatic care group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Survival</title>
        <description>Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination.</description>
        <time_frame>6 months post-randomization</time_frame>
        <population>5 participants withdrew from the usual hepatic care group.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Survival</title>
          <description>Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination.</description>
          <population>5 participants withdrew from the usual hepatic care group.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Provider Satisfaction</title>
        <description>The &quot;ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor&quot; instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35.&#xD;
Time frame was changed due to early termination. Data was not collected.</description>
        <time_frame>Change from Baseline to study closeout.</time_frame>
        <population>The provider population was not analyzed because data was not collected.</population>
        <group_list>
          <group group_id="O1">
            <title>Comprehensive Palliative Care Services - Providers</title>
            <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
          </group>
          <group group_id="O2">
            <title>Usual Hepatic Care - Providers</title>
            <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
          </group>
        </group_list>
        <measure>
          <title>Provider Satisfaction</title>
          <description>The &quot;ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor&quot; instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35.&#xD;
Time frame was changed due to early termination. Data was not collected.</description>
          <population>The provider population was not analyzed because data was not collected.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>baseline to 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Comprehensive Palliative Care Services</title>
          <description>Comprehensive Palliative Care services in addition to usual hepatic care&#xD;
Comprehensive Palliative Care services: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.</description>
        </group>
        <group group_id="E2">
          <title>Usual Hepatic Care</title>
          <description>Usual hepatic care&#xD;
Usual hepatic care: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="32"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
              </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>Dr. Cheryl Gatto</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>6153432252</phone>
      <email>cheryl.l.gatto.1@vumc.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03022630
org study id: 160746
nct id: NCT03022630
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate, through a randomized controlled trial, the impact
      of integrated comprehensive palliative care services on time to first hospital readmission
      and other hospital utilization outcomes, quality of life, and patient/caregiver outcomes. The
      intervention includes comprehensive, standardized palliative care services for adult
      hepatology cirrhosis patients for which prognosis is poor.
Palliative care is specialized medical care focused on providing patients with relief from
      the symptoms, pain, and stress of serious or life-limiting illness, regardless of diagnosis,
      by anticipating, preventing, and treating suffering. Palliative care aims to provide patients
      and their families with services to help patients make the best possible medical decisions in
      the face of serious illness. Unfortunately it is often thought to be synonymous with hospice
      care and therefore underutilized as a part of standard care. Patients with chronic liver
      disease or cirrhosis may be a particularly underserved population for palliative care, as
      palliative care may be disregarded until hope of liver transplantation is lost.

      Study Description:

        -  Adult patients admitted to Vanderbilt University Medical Center with cirrhotic advanced
           liver disease and poor prognosis will be randomized to receive either usual hepatic care
           or usual hepatic care with comprehensive palliative care services.

        -  Participants randomized to the intervention arm will receive patient-friendly
           informational materials, a comprehensive initial palliative care consultation, and
           follow-up consultations while inpatient. After discharge from hospital, follow-up
           consults will occur via telephone contact. Telephone contacts will occur on a flexible
           schedule based on needs and wishes of the participant at a minimum frequency of one
           contact per month.

        -  Participants will receive the palliative care intervention for at least 1 year after
           randomization to the intervention arm or until death.

        -  Participants randomized to the usual care arm will not be scheduled to meet with the
           palliative care service unless a meeting is requested by the patient, the family, or
           treating physician. These consultations include the same palliative care services as the
           intervention arm, excluding the telephone follow-up consultations.

        -  All participants will complete quality of life, mood, and satisfaction with care
           assessments at specified time points for 1 year after randomization or until death.
           Optional caregiver participation includes completion of satisfaction with care
           assessments.

      Specific aims include:

        1. Assess the impact of systematic, comprehensive palliative care services compared to
           usual hepatic care on time to first hospital readmission within 1-year post
           randomization.

        2. Assess the impact of systematic, comprehensive palliative care services compared to
           usual hepatic care on other hospital utilization, including days alive out of hospital
           within 6- months post randomization, total days in hospital (and ICU) within 1-year post
           randomization, number and cost of hospital admissions within 1-year post randomization,
           median length of stay per admission, transfers and time to hospice placement, and
           survival within 1-year post randomization.

        3. Assess the impact of systematic, comprehensive palliative care services compared to
           usual hepatic care on qualify of life.

        4. Assess the impact of systematic, comprehensive palliative care services compared to
           usual hepatic care on patient/caregiver satisfaction.

        5. Evaluate the fidelity of the palliative care intervention and assess the
           generalizability of implementing a large-scale Palliative Care program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Time to First Hospital Readmission Within 6 Months Post-randomization
time frame: 6 months post-randomization
description: Assess the impact of palliative care services on time to first hospital readmission.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Days Alive Out of Hospital
time frame: 6 months post-randomization
description: Days alive out of hospital from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Total Days in Hospital
time frame: 6 months post-randomization
description: Total days in hospital from randomization to 6 months post randomization compared across arms Time frame was changed from 1 year to 6 months due to early termination.
measure: Total Days in ICU
time frame: 6 months post-randomization
description: Total days in ICU from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Number of Hospital Readmissions
time frame: 6 months post-randomization
description: Number of hospital readmissions from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Median Length of Hospital Stay Per Admission
time frame: 6 months post-randomization
description: Median length of hospital stay per admission from randomization to 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Hospice Referral
time frame: 6 months post-randomization
description: Number of transfers to hospice within 6 months post randomization compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Time to Hospice Placement
time frame: 6 months post-randomization
description: Number of days from hospice referral to time to hospice placement. Time frame was changed from 1 year to 6 months due to early termination. There are only 3 patients with a hospice admission date that is after baseline discharge, all of whom are from the control group. The remaining patients with hospice referral but are missing a hospice admission date due to death before hospice admission. Therefore, it is not feasible to calculate any statistics.
measure: Change in Chronic Liver Disease Questionnaire (CLDQ)
time frame: Change from baseline over 6 months post-randomization
description: Change in liver disease-related quality of life: The CLDQ is a 29-item questionnaire measuring 6 domains. Item scores range from 1 to 7 with higher scores indicating better quality of life. The total score can range from 29 to 203 with a score of 1 meaning the symptom being assessed is "present always" while a score of 7 means the symptom is "never present". Therefore, a higher score corresponds to a better quality of life while a lower score corresponds to a worse quality of life. The questions in each domain have a range of factor loads indicative of their impact, and a clinically important difference is defined as a score change of 0.5.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Change in EQ-5D-5L
time frame: Change from baseline over 6 months post-randomization
description: Change in generic health status: The EQ-5D-5L is a 5-item questionnaire with responses ranging from absence of symptom to extreme experience of the symptom. This scale is numbered from 0 to 100. 100 means the best health you can imagine and 0 means the worst health you can imagine.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Change in PROMIS Emotional Distress - Anxiety - Short Form 4a
time frame: Change from baseline over 6 months post-randomization
description: Change in mood (anxiety): The PROMIS Emotional Distress - Anxiety - Short Form 4a contains 4 items that measure anxiety on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score can range from 4 to 20 which converts to a t-score range of 40.3 to 81.6.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Change in PROMIS Emotional Distress - Depression - Short Form 4a
time frame: Change from baseline over 6 months post-randomization
description: Change in mood (depression): The PROMIS Emotional Distress - Depression - Short Form 4a contains 4 items that measure depression on a 5-point Likert scale with higher scores indicating increased symptomatology. The raw score ranges from 4 to 20 which converts to a t-score range of 41.0 to 79.4.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient)
time frame: Change from baseline over 6 months post-randomization
description: Change in patient satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better satisfaction with care. The score can range from 0 to 110.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Change in Kingston Caregiver Stress Scale
time frame: Change from baseline over 6 months post-randomization
description: The Kingston Caregiver Stress Scale will be used to measure caregiver stress. The KCSS is designed to measure stress experienced by lay caregivers, not institutional staff, and was designed to monitor change in an individuals stress over time. Ten items are grouped into three categories: care giving, family, and financial issues. Scores can range from 10 to 50. Lower scores indicate less stress and higher scores indicate high stress.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Change in Satisfaction With Care (Quality of End-of-Life Care: Questionnaire for Patient Adapted for Caregiver)
time frame: Change from baseline over 6 months post-randomization
description: Change in caregiver satisfaction with care: The Quality of End-of-Life Care: Questionnaire for Patient item wording was modified to apply to caregivers. The questionnaire is an 11-item questionnaire, with items scored on a 10-point Likert type scale with higher scores indicating better quality of care. The score can range from 0 to 110.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Liver Transplant Status
time frame: 6 months post-randomization
description: Number of deferred, listed, and declined listing for liver transplant compared across arms.
Time frame was changed from 1 year to 6 months due to early termination. Liver transplant status data was not obtained.
measure: Model for End-Stage Liver Disease (MELD) Score
time frame: Baseline
description: Baseline MELD score compared across arms. MELD score ranks the participants degree of sickness and indicates how much the participant needs a liver transplant. The score ranges from 6-40. The higher the number the more urgent the need for a transplant.
measure: Completed Liver Transplants
time frame: 6 months post-randomization
description: Number of patients with completed liver transplants compared across arms. Time frame was changed from 1 year to 6 months due to early termination.
measure: Physical Symptoms
time frame: 6 months post-randomization
description: Number of documented physical symptoms (ascites, variceal bleeding, encephalopathy, etc.) compared across arms.
Time frame was changed from 1 year to 6 months due to early termination. Physical symptom data was not obtained.
measure: Presence of Advance Directives
time frame: 6 months post-randomization
description: Percentage of patients with documented advance care directives compared across arms.
Time frame was changed from 1 year to 6 months due to early termination.
measure: Survival
time frame: 6 months post-randomization
description: Survival rate compared across arms. Time frame was changed from 1 year to 6 months due to early termination.
measure: Provider Satisfaction
time frame: Change from Baseline to study closeout.
description: The "ICU Provider Satisfaction Survey with the Palliative Care Program:Veterans Affairs of Ann Arbor" instrument is available online and has been modified for the current study by removing the 'ICU' reference and revising 'pain' to symptoms more relevant to the current population. The survey includes 7-item questionnaire, with items scored on a 5-point Likert type scale with higher scores indicating better provider satisfaction. The score can range from 0 to 35.
Time frame was changed due to early termination. Data was not collected.
arm group label: Comprehensive Palliative Care services
arm group type: Other
description: Comprehensive Palliative Care services in addition to usual hepatic care
arm group label: Usual hepatic care
arm group type: Other
description: Usual hepatic care
intervention type: Other
intervention name: Comprehensive Palliative Care services
description: Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.
arm group label: Comprehensive Palliative Care services
intervention type: Other
intervention name: Usual hepatic care
description: Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
arm group label: Usual hepatic care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gordon Bernard, MD
role: Principal Investigator
affiliation: Vanderbilt University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Gordon Bernard
investigator title: Study Principal Investigator
mesh term: Liver Cirrhosis
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
mesh term: Fibrosis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 