<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/NCT04487054</url>
  </required_header>
  <id_info>
    <org_study_id>1711863473</org_study_id>
    <nct_id>NCT04487054</nct_id>
  </id_info>
  <brief_title>Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit-A Pilot Study</brief_title>
  <official_title>Outcomes of Early Palliative Care Intervention for High-Risk Patients in the Intensive Care Unit- A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>West Virginia University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West Virginia University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators propose to conduct a feasibility study of identifying high-risk ICU&#xD;
      patients using previously validated integrated prediction model and employing early&#xD;
      palliative care intervention. The study will consist of two four-month time periods: usual&#xD;
      care in time period one and usual care plus targeted pro-active palliative care intervention&#xD;
      within 48 hours of ICU admission in time period two.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Pre and post phase study evaluating the utility of pro-active palliative care in high risk ICU patients identified using integrated prediction model</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length Of Stay (LOS) in the medical ICU</measure>
    <time_frame>From enrollment to Discharge from the ICU, an average of 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Length Of Stay in hospital</measure>
    <time_frame>From enrollment to Discharge from the hospital, an average of 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical ICU re-admission during the hospital stay</measure>
    <time_frame>From enrollment to discharge from the hospital, up to 16 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission</measure>
    <time_frame>From enrollment to discharge from the hospital, an average of 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Family satisfaction with care in ICU (modified from the FS-ICU 24 and Bereaved Family Survey (BFS) global performance measure #18)</measure>
    <time_frame>From enrollment to six weeks post ICU discharge</time_frame>
    <description>Six-weeks post discharge, a telephone survey will be conducted with health care surrogate or medical power attorney to determine their satisfaction with the care received in ICU. The results will be compared between participants that received early palliative care intervention and those that did not.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Advance directive completion [a written statement of a person's wishes regarding medical treatment]</measure>
    <time_frame>From enrollment to hospital discharge, an average of 24 weeks</time_frame>
    <description>Difference in completion rate of the advance directive between the baseline period and following the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician Orders for Scope of Treatment (POST) form completion</measure>
    <time_frame>From enrollment to hospital discharge, an average of 24 weeks</time_frame>
    <description>Difference in completion rate of the Physician Orders for scope of Treatment (POST) form between the baseline period and following the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Discharge outcomes</measure>
    <time_frame>From enrollment to six weeks post ICU discharge</time_frame>
    <description>Difference in discharge outcome (location) between the baseline period and following the intervention</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Site of death (ICU, hospital, home, hospice nursing home)</measure>
    <time_frame>From enrollment to six weeks post ICU discharge</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>End-of-life Care</condition>
  <condition>Palliative Care</condition>
  <condition>Intensive Care Unit</condition>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the ICU with a poor prognosis will receive usual care in time period one.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care plus palliative care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the ICU with a poor prognosis will receive usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pro-active palliative care</intervention_name>
    <description>Patient with high risk of mortality in ICU will be identified using our previously validated prognostic model. Intervention phase will employ pro-active palliative care on eligible patients after they survive 48 hours in ICU.</description>
    <arm_group_label>Usual care plus palliative care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients greater than 18 years of age admitted to the medical ICU at West Virginia&#xD;
             University Hospital.&#xD;
&#xD;
          -  Patients with a predicted six-month mortality greater than 40% on the integrated&#xD;
             prognostic model.&#xD;
&#xD;
          -  Patients who live longer than 48 hours after medical ICU admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who did not meet inclusion criteria will be excluded.&#xD;
&#xD;
          -  Pregnant female/incarcerated patients will be excluded.&#xD;
&#xD;
          -  Since this is a study in an adult patient population, children will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>West Virginia University Hospital</name>
      <address>
        <city>Morgantown</city>
        <state>West Virginia</state>
        <zip>26506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>West Virginia University</investigator_affiliation>
    <investigator_full_name>Rahul Sangani</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Pro-active palliative care</keyword>
  <keyword>Intensive care unit</keyword>
  <keyword>Surprise question</keyword>
  <keyword>End-of-life care</keyword>
  <keyword>family satisfaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <!-- 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/NCT04487054
org study id: 1711863473
nct id: NCT04487054
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators propose to conduct a feasibility study of identifying high-risk ICU
      patients using previously validated integrated prediction model and employing early
      palliative care intervention. The study will consist of two four-month time periods: usual
      care in time period one and usual care plus targeted pro-active palliative care intervention
      within 48 hours of ICU admission in time period two.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Pre and post phase study evaluating the utility of pro-active palliative care in high risk ICU patients identified using integrated prediction model
primary purpose: Supportive Care
masking: None (Open Label)
measure: Length Of Stay (LOS) in the medical ICU
time frame: From enrollment to Discharge from the ICU, an average of 24 weeks
measure: Length Of Stay in hospital
time frame: From enrollment to Discharge from the hospital, an average of 24 weeks
measure: Medical ICU re-admission during the hospital stay
time frame: From enrollment to discharge from the hospital, up to 16 weeks
measure: Treatment limitation orders (do-not-resuscitate, do-not-intubate, no vasopressors, etc) within 48 hours of admission
time frame: From enrollment to discharge from the hospital, an average of 24 weeks
measure: Family satisfaction with care in ICU (modified from the FS-ICU 24 and Bereaved Family Survey (BFS) global performance measure #18)
time frame: From enrollment to six weeks post ICU discharge
description: Six-weeks post discharge, a telephone survey will be conducted with health care surrogate or medical power attorney to determine their satisfaction with the care received in ICU. The results will be compared between participants that received early palliative care intervention and those that did not.
measure: Advance directive completion [a written statement of a person's wishes regarding medical treatment]
time frame: From enrollment to hospital discharge, an average of 24 weeks
description: Difference in completion rate of the advance directive between the baseline period and following the intervention
measure: Physician Orders for Scope of Treatment (POST) form completion
time frame: From enrollment to hospital discharge, an average of 24 weeks
description: Difference in completion rate of the Physician Orders for scope of Treatment (POST) form between the baseline period and following the intervention
measure: Discharge outcomes
time frame: From enrollment to six weeks post ICU discharge
description: Difference in discharge outcome (location) between the baseline period and following the intervention
measure: Site of death (ICU, hospital, home, hospice nursing home)
time frame: From enrollment to six weeks post ICU discharge
arm group label: Usual care
arm group type: No Intervention
description: Subjects in the ICU with a poor prognosis will receive usual care in time period one.
arm group label: Usual care plus palliative care
arm group type: Experimental
description: Subjects in the ICU with a poor prognosis will receive usual care plus targeted pro-active palliative care intervention within 48 hours of ICU admission in time period two.
intervention type: Other
intervention name: Pro-active palliative care
description: Patient with high risk of mortality in ICU will be identified using our previously validated prognostic model. Intervention phase will employ pro-active palliative care on eligible patients after they survive 48 hours in ICU.
arm group label: Usual care plus palliative care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: West Virginia University
investigator full name: Rahul Sangani
investigator title: Principal Investigator
mesh term: Death