<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/NCT03798327</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-02787</org_study_id>
    <secondary_id>R56AG067045-01</secondary_id>
    <nct_id>NCT03798327</nct_id>
  </id_info>
  <brief_title>Palliative Care at Home for Dementia</brief_title>
  <official_title>Video-Assisted Palliative Care Intervention for Patients With Advanced Dementia at Home</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </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 advanced dementia 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 6 months.&#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. Visits will combine a combination of video-teleconferencing technology and&#xD;
      in person visits. 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;
      video-based, and in-person) from members of the clinical team, dependent on their identified&#xD;
      needs. Patients' cases will be discussed at the weekly IDT meeting, as appropriate to the&#xD;
      level of clinical need. Patients and caregivers will be provided with access to a 24 hour&#xD;
      telephone line, staffed by a Mount Sinai based physician, which acts as an advice line out of&#xD;
      hours. 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">November 1, 2018</start_date>
  <completion_date type="Actual">April 29, 2022</completion_date>
  <primary_completion_date type="Actual">April 29, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Single blind control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom Management at the End of Life for Dementia scale</measure>
    <time_frame>6 months</time_frame>
    <description>This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator&#xD;
Scale: Symptom Management at the End of Life for Dementia - Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Quality of Life - Alzheimer's Disease scale</measure>
    <time_frame>6 months</time_frame>
    <description>This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator.&#xD;
Scale: Quality of Life - Alzheimer's Disease; Likert scale, 13 items, each 1-4, (52 total possible score) lower is worse quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Complete of Advance Directives</measure>
    <time_frame>6 months</time_frame>
    <description>The Study Team will examine the patient's chart for completion of advanced directives&#xD;
Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preference Consistent Care</measure>
    <time_frame>6 months</time_frame>
    <description>The Study Team will examine if the care patients receive is concordant with the care they wanted to receive.&#xD;
Scale: Simple chart review of whether care received matches stated preferences (yes/no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Zaria 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 scale range from 0 (never) to 4 (always)&#xD;
Scale: Zarit Burden Inventory - Likert scale 0-4,total score = 0-88, higher score is more burden</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver 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.&#xD;
Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver 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).&#xD;
Scale: Patient Health Questionnaire - 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions</measure>
    <time_frame>6 months</time_frame>
    <description>healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of emergency department visits</measure>
    <time_frame>6 months</time_frame>
    <description>healthcare utilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of outpatient appointments</measure>
    <time_frame>6 months</time_frame>
    <description>healthcare utilization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Dementia</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 dementia and other illnesses.</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 advanced dementia&#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 or has a caregiver who can provide consent for the&#xD;
             patient&#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 consent or has no caregiver who can provide consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 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>July 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>July 28, 2022</last_update_submitted>
  <last_update_submitted_qc>July 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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, Geriatrics and Palliative Medicine</investigator_title>
  </responsible_party>
  <keyword>Palliative Care</keyword>
  <keyword>Home-Based Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <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/NCT03798327
org study id: GCO 17-02787
secondary id: R56AG067045-01
nct id: NCT03798327
lead sponsor: 
collaborator: 
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 advanced dementia 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 6 months.

      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. Visits will combine a combination of video-teleconferencing technology and
      in person visits. 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,
      video-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
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
masking description: Single blind control
measure: Symptom Management at the End of Life for Dementia scale
time frame: 6 months
description: This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator
Scale: Symptom Management at the End of Life for Dementia - Likert scale, 9 items, each 0-5, (45 total possible score) higher is worse symptoms
measure: Patient Quality of Life - Alzheimer's Disease scale
time frame: 6 months
description: This will be determined using a validated structured questionnaire administered to patient-subjects or caregiver via telephone interview or in person by the trained research coordinator.
Scale: Quality of Life - Alzheimer's Disease; Likert scale, 13 items, each 1-4, (52 total possible score) lower is worse quality of life
measure: Number of Complete of Advance Directives
time frame: 6 months
description: The Study Team will examine the patient's chart for completion of advanced directives
Scale: Study Team will examine the patient's chart for completion of advanced directives (yes/no).
measure: Preference Consistent Care
time frame: 6 months
description: The Study Team will examine if the care patients receive is concordant with the care they wanted to receive.
Scale: Simple chart review of whether care received matches stated preferences (yes/no)
measure: Caregiver Zaria 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 scale range from 0 (never) to 4 (always)
Scale: Zarit Burden Inventory - Likert scale 0-4,total score = 0-88, higher score is more burden
measure: Caregiver 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.
Scale: FamCare; Likert scale, 0-3, higher is higher satisfaction
measure: Caregiver 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).
Scale: Patient Health Questionnaire - 9; Likert scale, 0-3, total possible = 0-27; higher is worse depression [Time Frame: 6 months]
measure: Number of hospital admissions
time frame: 6 months
description: healthcare utilization
measure: Number of emergency department visits
time frame: 6 months
description: healthcare utilization
measure: Number of outpatient appointments
time frame: 6 months
description: 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 dementia and other illnesses.
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: 65 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, Geriatrics and Palliative Medicine
mesh term: Dementia
sharing ipd: No