xml: <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/NCT05998330</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001894</org_study_id>
      <secondary_id>80736</secondary_id>
      <secondary_id>242379</secondary_id>
      <secondary_id>243432</secondary_id>
      <secondary_id>236965</secondary_id>
      <nct_id>NCT05998330</nct_id>
    </id_info>
    <brief_title>LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease</brief_title>
    <acronym>LiverPAL</acronym>
    <official_title>LiverPAL: A Randomized Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts General Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate whether early integration of palliative care&#xD;
        in the care of hospitalized patients with advanced liver disease (AdvLD) can improve&#xD;
        patients' quality of life, physical symptoms, mood, and serious illness communication.&#xD;
        Palliative care is a medical specialty focused on lessening (or &quot;palliating&quot;) symptoms and&#xD;
        assisting in coping with serious illness.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main purpose of this study is to compare two types of care - usual hepatology care and&#xD;
        usual hepatology care with early involvement of palliative care clinicians to see which is&#xD;
        better for improving the experience of hospitalized patients with advanced liver disease&#xD;
        (AdvLD).&#xD;
  &#xD;
        The investigators aim to find out whether introducing hospitalized patients with AdvLD to the&#xD;
        palliative care team that specializes in symptom management can improve the quality of life&#xD;
        and physical and psychological symptoms that patients and families experience during their&#xD;
        hospitalizations as well as enhance the quality of patients' end of life care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2027</completion_date>
    <primary_completion_date type="Anticipated">July 2027</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>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks</measure>
      <time_frame>Up to 4 weeks</time_frame>
      <description>Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient FACIT-Pal Score longitudinally between study arms</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Depression Scores (Patient Health Questionnaire-9, PHQ-9)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare patient depression scores (PHQ-9) between study arms. Score range 0-27 with higher scores indicating higher depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Quality of Life (PROMIS-29+2)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare patient quality of life (PROMIS-29+2) scores between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient End-of-Life (EOL) Care Communication with Caregivers</measure>
      <time_frame>Final assessment prior to patient death or at 6 months</time_frame>
      <description>&quot;Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient End-of-Life (EOL) Care Communication with Clinicians</measure>
      <time_frame>Final assessment prior to patient death or at 6 months</time_frame>
      <description>&quot;Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?&quot;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Documentation of Patient End-of-Life (EOL) Care Preferences</measure>
      <time_frame>After patient death, up to 60 months</time_frame>
      <description>Compare documentation of EOL care preferences in the electronic health record between study arms since baseline.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient End-of-Life (EOL) Care</measure>
      <time_frame>Within 30 days of patient death</time_frame>
      <description>Compare rate of receipt of intensive EOL care (renal replacement therapy, mechanical ventilation, and/or cardiopulmonary resuscitation or death in the intensive care unit) between study arms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Quality of Life (PROMIS-29+2)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare caregiver quality of life (PROMIS-29+2) between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare caregiver depression symptoms (HADS-D) between study arms. Score range 0-21 with higher scores indicating higher depression symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare caregiver anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Depression Scores (Patient Health Questionnaire-9, PHQ-9)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare caregiver depression scores (PHQ-9) between study arms. Score range 0-27 with higher scores indicating higher depression.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Burden (Zarit Burden Index 12, ZBI-12)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare caregiver burden scores (ZBI-12) between study arms. Score range 0-48 with higher scores indicating higher caregiver burden.</description>
    </other_outcome>
    <other_outcome>
      <measure>Receipt of goal-concordant end-of-life care - patient wishes followed</measure>
      <time_frame>Within 30 days of patient death</time_frame>
      <description>Bereaved caregivers will be asked &quot;In [participant's] opinion, to what extent were [the patient's] wishes followed in the medical care received in the last month of life?&quot; Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that &quot;followed patients' wishes a great deal.&quot;</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of Life Near Death (QOD)</measure>
      <time_frame>After patient death, up to 60 months</time_frame>
      <description>Bereaved caregivers will be asked &quot;Just prior to the death of [the patient] (eg, his/her last week; when last seen), how would [participant] rate [the patient's] level of…&quot; (1) &quot;psychological distress?&quot; (0 = none; 10 = extremely upset); (2) &quot;physical distress?&quot; (0 = none; 10 = extremely distressed); and (3) &quot;overall quality of life in the last week of life/death?&quot; (0 = worst possible; 10 = best possible). Ratings for these three items will be averaged (with reverse coding for the psychological and physical distress items). Scores range 0-10 with higher composite scores representing better QOD.</description>
    </other_outcome>
    <other_outcome>
      <measure>Prolonged Grief Disorder (PG-13-R)</measure>
      <time_frame>At least 12 months after patient death, up to 60 months</time_frame>
      <description>Compare rates of prolonged grief disorder (PG-13-R) among bereaved caregivers between study arms. Score range 10-50 for symptom items with higher scores indicating worsening symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Healthcare Utilization at End-of-Life - Hospice</measure>
      <time_frame>After patient death, up to 60 months</time_frame>
      <description>Compare rates of hospice utilization (yes/no) between study arms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Healthcare Utilization at End-of-Life - Hospice length of stay</measure>
      <time_frame>After patient death, up to 60 months</time_frame>
      <description>Compare number of days in hospice for patients admitted to hospice between study arms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Healthcare Utilization - Days alive and out of the hospital</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare days alive and out of the hospital at 6 months (180 days) after randomization</description>
    </other_outcome>
    <other_outcome>
      <measure>Healthcare Utilization - liver transplantation</measure>
      <time_frame>Up to 60 months</time_frame>
      <description>Compare rates of liver transplantation (yes/no) between study arms</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient Coping (Brief COPE)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare patient coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Coping (Brief COPE)</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>Compare caregiver coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient Feeling Heard and Understood Scale</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>We will use the validated 4-item scale &quot;Feeling Heard and Understood&quot; as a self-reported measure capturing seriously ill patients' global assessment of their health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.</description>
    </other_outcome>
    <other_outcome>
      <measure>Caregiver Feeling Heard and Understood Scale</measure>
      <time_frame>Up to 6 months</time_frame>
      <description>We will use the validated 4-item scale &quot;Feeling Heard and Understood&quot; as a self-reported measure capturing seriously ill patients' caregivers' global assessment of their loved one's health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Liver Disease Chronic</condition>
    <condition>End Stage Liver DIsease</condition>
    <condition>Cirrhosis</condition>
    <condition>Cirrhosis, Liver</condition>
    <condition>Advanced Cirrhosis</condition>
    <arm_group>
      <arm_group_label>Usual Hepatology Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Usual hepatology care</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Hepatology Care with Early Palliative Care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Usual hepatology care with early palliative care</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>LiverPAL</intervention_name>
      <description>The intervention include integrating early palliative care with usual hepatology care to evaluate and treat patients' symptoms, enhance their illness and prognostic understanding, support their coping, and coordinate their serious illness, transitional, and end-of-life care.</description>
      <arm_group_label>Usual Hepatology Care with Early Palliative Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Patient Inclusion Criteria:&#xD;
  &#xD;
            1. Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis&#xD;
               with one of the following (new or ongoing) within the prior six months from date of&#xD;
               consent:&#xD;
  &#xD;
                 -  Ascites (requiring diuretics or serial large volume paracenteses)&#xD;
  &#xD;
                 -  Spontaneous bacterial peritonitis&#xD;
  &#xD;
                 -  Hepatic hydrothorax (requiring diuretics)&#xD;
  &#xD;
                 -  Variceal bleed (with one or more occurrences)&#xD;
  &#xD;
                 -  Overt hepatic encephalopathy (requiring medications)&#xD;
  &#xD;
            2. Ability to comprehend English&#xD;
  &#xD;
          Patient Exclusion Criteria:&#xD;
  &#xD;
            1. Prior history of liver transplantation&#xD;
  &#xD;
            2. Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder&#xD;
               or other comorbid condition which the primary medical, hepatology, and/or transplant&#xD;
               surgery teams believes prohibits the ability to provide informed consent&#xD;
  &#xD;
            3. Current or recent (within 5 years of receiving curative cancer treatment) history of&#xD;
               extrahepatic malignancy (excluding non-melanoma skin cancer)&#xD;
  &#xD;
            4. Presence of hepatocellular carcinoma beyond Milan criteria&#xD;
  &#xD;
            5. Are already receiving hospice care&#xD;
  &#xD;
            6. Receive a score of &lt;10 on the Simplified Animal Naming Test&#xD;
  &#xD;
          Caregiver Inclusion Criteria&#xD;
  &#xD;
            1. Adult caregiver (≥ 18 years of age)&#xD;
  &#xD;
            2. A relative or friend identified by the patient upon whom the patient relies for help&#xD;
               and who likely is to be present in-person during hospitalizations or clinic&#xD;
               appointments, or willing to participate by phone&#xD;
  &#xD;
            3. Ability to comprehend English and can complete questionnaires&#xD;
  &#xD;
          Caregiver Exclusion Criteria&#xD;
  &#xD;
          1. Inability to comprehend English&#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>Nneka Ufere, MD MSCE</last_name>
      <role>Principal Investigator</role>
      <affiliation>Massachusetts General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lucinda Li, BS</last_name>
      <phone>617-726-3670</phone>
      <email>luli1@mgh.harvard.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ennie Zhu, AB</last_name>
      <phone>617-724-1316</phone>
      <email>ezhu3@mgh.harvard.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lucinda Li, BS</last_name>
        <phone>617-726-3670</phone>
        <email>luli@mgh.harvard.edu</email>
      </contact>
      <contact_backup>
        <last_name>Enya Zhu, BA</last_name>
        <phone>617-724-1316</phone>
        <email>ezhu3@mgh.harvard.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Nneka Ufere, MD MSCE</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
      <investigator_full_name>Nneka nnaoke Ufere</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <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>End Stage Liver Disease</mesh_term>
      <mesh_term>Fibrosis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05998330
  org study id: 2023P001894
  secondary id: 80736
  secondary id: 242379
  secondary id: 243432
  secondary id: 236965
  nct id: NCT05998330
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate whether early integration of palliative care
        in the care of hospitalized patients with advanced liver disease (AdvLD) can improve
        patients' quality of life, physical symptoms, mood, and serious illness communication.
        Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and
        assisting in coping with serious illness.
  The main purpose of this study is to compare two types of care - usual hepatology care and
        usual hepatology care with early involvement of palliative care clinicians to see which is
        better for improving the experience of hospitalized patients with advanced liver disease
        (AdvLD).
  
        The investigators aim to find out whether introducing hospitalized patients with AdvLD to the
        palliative care team that specializes in symptom management can improve the quality of life
        and physical and psychological symptoms that patients and families experience during their
        hospitalizations as well as enhance the quality of patients' end of life care.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
  time frame: Up to 4 weeks
  description: Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life.
  measure: Patient FACIT-Pal Score longitudinally between study arms
  time frame: Up to 6 months
  description: Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life.
  measure: Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)
  time frame: Up to 6 months
  description: Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden.
  measure: Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
  time frame: Up to 6 months
  description: Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms.
  measure: Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)
  time frame: Up to 6 months
  description: Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.
  measure: Patient Depression Scores (Patient Health Questionnaire-9, PHQ-9)
  time frame: Up to 6 months
  description: Compare patient depression scores (PHQ-9) between study arms. Score range 0-27 with higher scores indicating higher depression.
  measure: Patient Quality of Life (PROMIS-29+2)
  time frame: Up to 6 months
  description: Compare patient quality of life (PROMIS-29+2) scores between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores.
  measure: Patient End-of-Life (EOL) Care Communication with Caregivers
  time frame: Final assessment prior to patient death or at 6 months
  description: "Has [participant] talked with [participant's] family or friends about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"
  measure: Patient End-of-Life (EOL) Care Communication with Clinicians
  time frame: Final assessment prior to patient death or at 6 months
  description: "Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?"
  measure: Documentation of Patient End-of-Life (EOL) Care Preferences
  time frame: After patient death, up to 60 months
  description: Compare documentation of EOL care preferences in the electronic health record between study arms since baseline.
  measure: Patient End-of-Life (EOL) Care
  time frame: Within 30 days of patient death
  description: Compare rate of receipt of intensive EOL care (renal replacement therapy, mechanical ventilation, and/or cardiopulmonary resuscitation or death in the intensive care unit) between study arms.
  measure: Caregiver Quality of Life (PROMIS-29+2)
  time frame: Up to 6 months
  description: Compare caregiver quality of life (PROMIS-29+2) between study arms. Scores range 4-20 for raw items and 2-10 for cognitive function, with a higher score represents more of the concept being measured. Raw scores are translated into standardized T-scores.
  measure: Caregiver Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
  time frame: Up to 6 months
  description: Compare caregiver depression symptoms (HADS-D) between study arms. Score range 0-21 with higher scores indicating higher depression symptoms.
  measure: Caregiver Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A) between study arms.
  time frame: Up to 6 months
  description: Compare caregiver anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms.
  measure: Caregiver Depression Scores (Patient Health Questionnaire-9, PHQ-9)
  time frame: Up to 6 months
  description: Compare caregiver depression scores (PHQ-9) between study arms. Score range 0-27 with higher scores indicating higher depression.
  measure: Caregiver Burden (Zarit Burden Index 12, ZBI-12)
  time frame: Up to 6 months
  description: Compare caregiver burden scores (ZBI-12) between study arms. Score range 0-48 with higher scores indicating higher caregiver burden.
  measure: Receipt of goal-concordant end-of-life care - patient wishes followed
  time frame: Within 30 days of patient death
  description: Bereaved caregivers will be asked "In [participant's] opinion, to what extent were [the patient's] wishes followed in the medical care received in the last month of life?" Receipt of goal-concordant end-of-life care - patient wishes followed will be defined as care that "followed patients' wishes a great deal."
  measure: Quality of Life Near Death (QOD)
  time frame: After patient death, up to 60 months
  description: Bereaved caregivers will be asked "Just prior to the death of [the patient] (eg, his/her last week; when last seen), how would [participant] rate [the patient's] level of…" (1) "psychological distress?" (0 = none; 10 = extremely upset); (2) "physical distress?" (0 = none; 10 = extremely distressed); and (3) "overall quality of life in the last week of life/death?" (0 = worst possible; 10 = best possible). Ratings for these three items will be averaged (with reverse coding for the psychological and physical distress items). Scores range 0-10 with higher composite scores representing better QOD.
  measure: Prolonged Grief Disorder (PG-13-R)
  time frame: At least 12 months after patient death, up to 60 months
  description: Compare rates of prolonged grief disorder (PG-13-R) among bereaved caregivers between study arms. Score range 10-50 for symptom items with higher scores indicating worsening symptoms.
  measure: Healthcare Utilization at End-of-Life - Hospice
  time frame: After patient death, up to 60 months
  description: Compare rates of hospice utilization (yes/no) between study arms.
  measure: Healthcare Utilization at End-of-Life - Hospice length of stay
  time frame: After patient death, up to 60 months
  description: Compare number of days in hospice for patients admitted to hospice between study arms.
  measure: Healthcare Utilization - Days alive and out of the hospital
  time frame: Up to 6 months
  description: Compare days alive and out of the hospital at 6 months (180 days) after randomization
  measure: Healthcare Utilization - liver transplantation
  time frame: Up to 60 months
  description: Compare rates of liver transplantation (yes/no) between study arms
  measure: Patient Coping (Brief COPE)
  time frame: Up to 6 months
  description: Compare patient coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.
  measure: Caregiver Coping (Brief COPE)
  time frame: Up to 6 months
  description: Compare caregiver coping using the Brief Cope questionnaire between study arms. We will administer 14 items of the Brief COPE comprising seven subscales (active coping, use of emotional support, positive reframing, acceptance, behavioral disengagement, denial, and self-blame). Higher scores on each subscale indicate more use of that particular coping strategy.
  measure: Patient Feeling Heard and Understood Scale
  time frame: Up to 6 months
  description: We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' global assessment of their health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.
  measure: Caregiver Feeling Heard and Understood Scale
  time frame: Up to 6 months
  description: We will use the validated 4-item scale "Feeling Heard and Understood" as a self-reported measure capturing seriously ill patients' caregivers' global assessment of their loved one's health care quality in the hospital environment. Response options range from 0 (not at all true) to 4 (completely true) for a score range of 0-16.
  arm group label: Usual Hepatology Care
  arm group type: No Intervention
  description: Usual hepatology care
  arm group label: Usual Hepatology Care with Early Palliative Care
  arm group type: Experimental
  description: Usual hepatology care with early palliative care
  intervention type: Behavioral
  intervention name: LiverPAL
  description: The intervention include integrating early palliative care with usual hepatology care to evaluate and treat patients' symptoms, enhance their illness and prognostic understanding, support their coping, and coordinate their serious illness, transitional, and end-of-life care.
  arm group label: Usual Hepatology Care with Early Palliative Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nneka Ufere, MD MSCE
  role: Principal Investigator
  affiliation: Massachusetts General Hospital
  last name: Lucinda Li, BS
  phone: 617-726-3670
  email: luli1@mgh.harvard.edu
  last name: Ennie Zhu, AB
  phone: 617-724-1316
  email: ezhu3@mgh.harvard.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Massachusetts General Hospital
  investigator full name: Nneka nnaoke Ufere
  investigator title: Assistant Professor
  mesh term: Liver Cirrhosis
  mesh term: Liver Diseases
  mesh term: End Stage Liver Disease
  mesh term: Fibrosis