<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/NCT03793803</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 15-2215</org_study_id>
    <nct_id>NCT03793803</nct_id>
  </id_info>
  <brief_title>Trial of Mount Sinai Palliative Care at Home</brief_title>
  <official_title>Clinical Trial of Home Palliative Care for Seriously Ill Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</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 proposed project is a randomized controlled trial of a new home-based palliative care&#xD;
      program for adults with serious illness and their caregivers within the Mount Sinai Health&#xD;
      System. Potential subjects will be identified from Mount Sinai records or referred by a Mount&#xD;
      Sinai healthcare provider. Patients will only be approached after authorization by their&#xD;
      Mount Sinai physician. Participants who consent to enrollment will be randomized to receive&#xD;
      the intervention (home-based palliative care program) or usual care (with their nominated&#xD;
      Mount Sinai physician). Patients will be enrolled in the study for a minimum of 6 months.&#xD;
&#xD;
      After 6 months, patients can remain in the program if there is ongoing clinical need; data&#xD;
      collection beyond 6 months will be done on all patients through chart abstraction/&#xD;
      administrative claims only.&#xD;
&#xD;
      Effectiveness of the intervention will be determined through assessment of patient and&#xD;
      caregiver reported outcomes and abstraction of data from medical records and administrative&#xD;
      claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of&#xD;
      life, satisfaction with care, documentation of advanced directives, receipt of care&#xD;
      consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression&#xD;
      (iii) Healthcare utilization and costs of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this randomized controlled trial is to study the impact of a new home based&#xD;
      palliative care program on patients' symptoms, quality of life, satisfaction with care,&#xD;
      completion of advance care planning documentation and receipt of care consistent with&#xD;
      preferences. In addition, the study will examine the impact of this model of care on patient&#xD;
      healthcare utilization, including hospitalization, emergency department utilization, and&#xD;
      hospice use prior to death. The trial will also include patients' caregivers, in order to&#xD;
      examine the impact of the intervention on caregiver burden and prevalence of depression.&#xD;
&#xD;
      Patients randomized to the intervention will be scheduled for an intake visit. This visit&#xD;
      will be undertaken by the team's registered nurse and/or social worker, together with a&#xD;
      community health worker, and other team members (advanced practice nurse, MD), depending on&#xD;
      patients' needs. Following this visit, and in conjunction with the nurse practitioner and/or&#xD;
      MD, a care plan will be developed to address areas of clinical need highlighted during the&#xD;
      intake visit.&#xD;
&#xD;
      Patients in the intervention arm will receive ongoing monitoring and input (telephone-based&#xD;
      and in-person) from members of the clinical team, dependent on their identified needs.&#xD;
      Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of&#xD;
      clinical need. Patients and caregivers will be provided with access to a 24 hour telephone&#xD;
      line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours.&#xD;
      These physicians will be able to provide advice to patients and caregivers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">November 1, 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients and caregivers are randomized to receive care from the home-based palliative care team or will receive usual care from their primary physician</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single Blind Control - Outcomes assessor is blind to randomization arms</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Integrated Palliative Outcomes Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Patient symptoms determined by the Integrated Palliative Outcomes Scale, a validated structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. The Integrated Palliative Outcomes Scale is scored on a likert scale from 0-4, with higher score indicating worse symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>McGill quality of life-revised</measure>
    <time_frame>6 months</time_frame>
    <description>McGill quality of life-revised is a 14 item instrument administered to patient-subjects via telephone interview or in person by the trained research coordinator. Each item score on likert scale from 0-10, full scale from 0-140 with higher score indicating better quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Satisfaction with End-of-Life Care (FAMCARE-10)</measure>
    <time_frame>6 months</time_frame>
    <description>FAMCARE-10 to assess patient satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Completion of Advance Directives</measure>
    <time_frame>6 months</time_frame>
    <description>Study team will examine the patient's chart for completion of advanced directives.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Preference Consistent Care</measure>
    <time_frame>6 months</time_frame>
    <description>Study team will examine if the care patients receive is concordant with the care they wanted to receive. simple chart review of whether care received matches stated preferences (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Zarit Burden Inventory</measure>
    <time_frame>6 months</time_frame>
    <description>Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point score range from 0 (never) to 4 (always). Full scale from 0 to 88, with higher score indicating more burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAMCARE-10</measure>
    <time_frame>6 months</time_frame>
    <description>FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Patient Health Questionnaire (PHQ-9)</measure>
    <time_frame>6 months</time_frame>
    <description>PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as &quot;0&quot; (not at all) to &quot;3&quot; (nearly every day). Full scale from 0-27, with higher score indicating worse depression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of inpatient admissions</measure>
    <time_frame>6 months</time_frame>
    <description>Number of inpatient admissions to measure healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency department visits</measure>
    <time_frame>6 months</time_frame>
    <description>Number of emergency department visits to measure healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of outpatient appointments</measure>
    <time_frame>6 months</time_frame>
    <description>Number of outpatient appointments to measure healthcare utilization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">193</enrollment>
  <condition>Organ Failure</condition>
  <arm_group>
    <arm_group_label>Home Palliative Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized to Intervention Arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Arm</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care - Patients will be cared for by the physician who treats their primary illness(es).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Home Palliative Care</intervention_name>
    <description>Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.</description>
    <arm_group_label>Home Palliative Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of a &quot;serious medical illness&quot; - according to pre-specified diagnostic&#xD;
             code-based criteria&#xD;
&#xD;
          -  Subject has a Mount Sinai physician who authorizes their participation in the study&#xD;
             and receipt of the program&#xD;
&#xD;
          -  Subject is resident in Manhattan outside of a long term care facility and is not&#xD;
             receiving hospice 5.&#xD;
&#xD;
          -  Subject has evidence of capacity to benefit from enrollment in palliative care program&#xD;
&#xD;
          -  Subject is conversant in English or Spanish&#xD;
&#xD;
          -  Subject has capacity to consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has no usual physician within Mount Sinai&#xD;
&#xD;
          -  Subject's usual physician doesn't provide authorization to patient participation&#xD;
&#xD;
          -  Subject resident outside of Manhattan or in long term care facility or receiving&#xD;
             hospice&#xD;
&#xD;
          -  Subject is not conversant in English or Spanish&#xD;
&#xD;
          -  Subject cannot provide informed consent to participation&#xD;
&#xD;
          -  Dementia (where the subject does not have the capacity to consent)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathan Goldstein, MD</last_name>
    <role>Study Director</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Beth Israel</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai West</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai St Luke's</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10025</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>April 28, 2022</last_update_submitted>
  <last_update_submitted_qc>April 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 29, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>Nathan Goldstein</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Palliative Care</keyword>
  <keyword>Home-Based Care</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03793803
org study id: GCO 15-2215
nct id: NCT03793803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed project is a randomized controlled trial of a new home-based palliative care
      program for adults with serious illness and their caregivers within the Mount Sinai Health
      System. Potential subjects will be identified from Mount Sinai records or referred by a Mount
      Sinai healthcare provider. Patients will only be approached after authorization by their
      Mount Sinai physician. Participants who consent to enrollment will be randomized to receive
      the intervention (home-based palliative care program) or usual care (with their nominated
      Mount Sinai physician). Patients will be enrolled in the study for a minimum of 6 months.

      After 6 months, patients can remain in the program if there is ongoing clinical need; data
      collection beyond 6 months will be done on all patients through chart abstraction/
      administrative claims only.

      Effectiveness of the intervention will be determined through assessment of patient and
      caregiver reported outcomes and abstraction of data from medical records and administrative
      claims. Impact on the following parameters will be measured: (i) Patient symptoms, quality of
      life, satisfaction with care, documentation of advanced directives, receipt of care
      consistent with preferences (ii) Caregiver burden, satisfaction with care, and depression
      (iii) Healthcare utilization and costs of care.
The objective of this randomized controlled trial is to study the impact of a new home based
      palliative care program on patients' symptoms, quality of life, satisfaction with care,
      completion of advance care planning documentation and receipt of care consistent with
      preferences. In addition, the study will examine the impact of this model of care on patient
      healthcare utilization, including hospitalization, emergency department utilization, and
      hospice use prior to death. The trial will also include patients' caregivers, in order to
      examine the impact of the intervention on caregiver burden and prevalence of depression.

      Patients randomized to the intervention will be scheduled for an intake visit. This visit
      will be undertaken by the team's registered nurse and/or social worker, together with a
      community health worker, and other team members (advanced practice nurse, MD), depending on
      patients' needs. Following this visit, and in conjunction with the nurse practitioner and/or
      MD, a care plan will be developed to address areas of clinical need highlighted during the
      intake visit.

      Patients in the intervention arm will receive ongoing monitoring and input (telephone-based
      and in-person) from members of the clinical team, dependent on their identified needs.
      Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the level of
      clinical need. Patients and caregivers will be provided with access to a 24 hour telephone
      line, staffed by a Mount Sinai based physician, which acts as an advice line out of hours.
      These physicians will be able to provide advice to patients and caregivers.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients and caregivers are randomized to receive care from the home-based palliative care team or will receive usual care from their primary physician
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Single Blind Control - Outcomes assessor is blind to randomization arms
measure: Integrated Palliative Outcomes Scale
time frame: 6 months
description: Patient symptoms determined by the Integrated Palliative Outcomes Scale, a validated structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. The Integrated Palliative Outcomes Scale is scored on a likert scale from 0-4, with higher score indicating worse symptoms.
measure: McGill quality of life-revised
time frame: 6 months
description: McGill quality of life-revised is a 14 item instrument administered to patient-subjects via telephone interview or in person by the trained research coordinator. Each item score on likert scale from 0-10, full scale from 0-140 with higher score indicating better quality of life.
measure: Family Satisfaction with End-of-Life Care (FAMCARE-10)
time frame: 6 months
description: FAMCARE-10 to assess patient satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction
measure: Number of Completion of Advance Directives
time frame: 6 months
description: Study team will examine the patient's chart for completion of advanced directives.
measure: Number of Preference Consistent Care
time frame: 6 months
description: Study team will examine if the care patients receive is concordant with the care they wanted to receive. simple chart review of whether care received matches stated preferences (yes/no).
measure: Zarit Burden Inventory
time frame: 6 months
description: Zarit Burden Inventory to determine caregiver burden by using a validated structured 22-item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. Each item is on a 5-point score range from 0 (never) to 4 (always). Full scale from 0 to 88, with higher score indicating more burden.
measure: FAMCARE-10
time frame: 6 months
description: FAMCARE-10 to assess caregiver satisfaction by using a validated 10-item structured questionnaire administered to patient-subjects via telephone interview or in person by the trained research coordinator. FamCare each item score on likert scale 0-3, total scale from 0-30, with higher score indicating higher satisfaction.
measure: The Patient Health Questionnaire (PHQ-9)
time frame: 6 months
description: PHQ-9 to assess Caregiver Depression by using a validated structured 9 item questionnaire administered to caregiver-subjects via telephone interview or in person by the trained research coordinator. The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Full scale from 0-27, with higher score indicating worse depression.
measure: Number of inpatient admissions
time frame: 6 months
description: Number of inpatient admissions to measure healthcare utilization
measure: Number of emergency department visits
time frame: 6 months
description: Number of emergency department visits to measure healthcare utilization
measure: Number of outpatient appointments
time frame: 6 months
description: Number of outpatient appointments to measure healthcare utilization
arm group label: Home Palliative Care
arm group type: Experimental
description: Randomized to Intervention Arm
arm group label: Control Arm
arm group type: No Intervention
description: Usual Care - Patients will be cared for by the physician who treats their primary illness(es).
intervention type: Behavioral
intervention name: Home Palliative Care
description: Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
arm group label: Home Palliative Care
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Goldstein, MD
role: Study Director
affiliation: Icahn School of Medicine at Mount Sinai
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: Nathan Goldstein
investigator title: Professor
sharing ipd: No