<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/NCT03263143</url>
  </required_header>
  <id_info>
    <org_study_id>201707067</org_study_id>
    <nct_id>NCT03263143</nct_id>
    <nct_alias>NCT03210116</nct_alias>
  </id_info>
  <brief_title>Palliative Care in the ICU</brief_title>
  <official_title>Early Palliative Care in the Medical Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</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 study compares early palliative care consultation to standard of care in the medical&#xD;
      intensive care unit (ICU). The study will assess if the intervention leads to an increased&#xD;
      proportion of clearly delineated goals of care and examine if this intervention leads to&#xD;
      decreased healthcare resource utilization such as length of stay, duration of intensive&#xD;
      treatments including mechanical ventilation, and hospital re-admissions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The medical intensive care unit will be split into two groups, assigned as either early&#xD;
           palliative care consultation or standard of care. Current standard of care in the ICU is&#xD;
           that primary clinician providers determine the need and time for palliative care&#xD;
           consultation, which can occur approximately 5 - 14 days after admission.&#xD;
&#xD;
        -  A palliative care screening tool will be used to determine if a newly admitted patient&#xD;
           is eligible for palliative care consultation.&#xD;
&#xD;
        -  Up to two patients per ICU per weekday will be enrolled into the study, due to workload&#xD;
           limitations on the palliative care consult team.&#xD;
&#xD;
        -  For patients in the intervention group, a palliative care consultation will be performed&#xD;
           within 48 hours of ICU admission and patients will be followed throughout their&#xD;
           hospitalization.&#xD;
&#xD;
        -  Patients in the standard of care group will receive usual care. Palliative care may be&#xD;
           consulted at the primary team's clinical discretion.&#xD;
&#xD;
        -  The two medical ICU groups will be crossed over after three months with a washout period&#xD;
           of six weeks, for a total of approximately eight months of study&#xD;
&#xD;
        -  Electronic medical records will be reviewed after patient discharge to collect data on&#xD;
           clinical outcomes as described elsewhere&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">June 9, 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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in code status to do-not-resuscitate/do-not-intubate</measure>
    <time_frame>Through patient admission until discharge, charts reviewed an average of one month after discharge</time_frame>
    <description>As determined by code status orders in the electronic medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Cardiopulmonary Resuscitation (CPR) performed</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical Ventilation usage and duration</measure>
    <time_frame>After date of discharge, charts reviewed an average of one month after discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>After date of discharge, charts reviewed an average of one month after discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU Length of Stay</measure>
    <time_frame>After date of discharge, charts reviewed an average of one month after discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>After date of discharge, charts reviewed an average of one month after discharge</time_frame>
    <description>Excluding patients transitioned to hospice prior to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>30-day mortality</measure>
    <time_frame>One to two months after patient discharge, verified at study completion</time_frame>
    <description>Including all patients, including those on hospice</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospice transition or discharge</measure>
    <time_frame>Through patient admission until discharge, charts reviewed an average of one month after discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-discharge ER visits and/or readmissions</measure>
    <time_frame>One to two months after patient discharge, verified at study completion</time_frame>
    <description>Determined by review of the BJC healthcare system electronic medical record</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospital operating cost</measure>
    <time_frame>Through study completion, an average of 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasopressor usage and duration</measure>
    <time_frame>After date of discharge, charts reviewed an average of one month after discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic usage and duration</measure>
    <time_frame>After date of discharge, charts reviewed an average of one month after discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants treated with hemodialysis</measure>
    <time_frame>Through study completion, an average of six months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with tracheostomy performed during hospital stay</measure>
    <time_frame>Through study completion, an average of six months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">242</enrollment>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Early Palliative Care Consultation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Palliative Care</intervention_name>
    <description>Palliative Care Consultation within 24 to 48 hours after admission</description>
    <arm_group_label>Early Palliative Care Consultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Admitted to the ICU in the last 24 hours&#xD;
&#xD;
          -  Admitted from Skilled nursing facility (SNF), long term acute care (LTAC)facility,&#xD;
             long term ventilator care (vent LTC) unit, or home care with private duty nursing with&#xD;
             activity of daily living (ADL) dependencies&#xD;
&#xD;
          -  End-stage dementia, amyotrophic lateral sclerosis, Parkinson's, multiple sclerosis&#xD;
&#xD;
          -  Advanced or Metastatic Cancer&#xD;
&#xD;
          -  Cardiac or respiratory arrest with neurological compromise&#xD;
&#xD;
          -  Multi- organ system failure (more than 2 organ failures)&#xD;
&#xD;
          -  Known diagnosis of end stage organ disease including cirrhosis, end-stage renal&#xD;
             disease, congestive heart failure New York Heart Association &gt;III, chronic obstructive&#xD;
             pulmonary disease on home O2&#xD;
&#xD;
          -  Shock requiring &gt; 6 hours of vasopressors or inotropes&#xD;
&#xD;
          -  Acute Respiratory failure requiring intubation or BiPAP&#xD;
&#xD;
          -  Admitted to ICU with hospital length of stay of more than 5 days or ICU readmission&#xD;
             with the same diagnosis in 30 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All stem cell transplant patients, for solid organ transplant, if undergoing&#xD;
             evaluation for solid organ transplant or within 1 year post-transplant.&#xD;
&#xD;
          -  Patients who do not speak English if interpreter is unavailable&#xD;
&#xD;
          -  Patients without capacity to participate in palliative care discussions without a&#xD;
             surrogate available&#xD;
&#xD;
          -  Patients or patient surrogate refusal of palliative care consultation&#xD;
&#xD;
          -  Prior Palliative Care Consultation during the same hospitalization&#xD;
&#xD;
          -  For purposes of primary outcome analysis, patients determined to already be DNR/DNI at&#xD;
             time of ICU admission&#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>Barnes Jewish Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Adelson K, Paris J, Horton JR, Hernandez-Tellez L, Ricks D, Morrison RS, Smith CB. Standardized Criteria for Palliative Care Consultation on a Solid Tumor Oncology Service Reduces Downstream Health Care Use. J Oncol Pract. 2017 May;13(5):e431-e440. doi: 10.1200/JOP.2016.016808. Epub 2017 Mar 17.</citation>
    <PMID>28306372</PMID>
  </reference>
  <reference>
    <citation>Aslakson R, Cheng J, Vollenweider D, Galusca D, Smith TJ, Pronovost PJ. Evidence-based palliative care in the intensive care unit: a systematic review of interventions. J Palliat Med. 2014 Feb;17(2):219-35. doi: 10.1089/jpm.2013.0409.</citation>
    <PMID>24517300</PMID>
  </reference>
  <reference>
    <citation>Hsu-Kim C, Friedman T, Gracely E, Gasperino J. Integrating Palliative Care into Critical Care: A Quality Improvement Study. J Intensive Care Med. 2015 Sep;30(6):358-64. doi: 10.1177/0885066614523923. Epub 2014 Mar 5.</citation>
    <PMID>24603677</PMID>
  </reference>
  <reference>
    <citation>Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015 May;43(5):1102-11. doi: 10.1097/CCM.0000000000000852.</citation>
    <PMID>25574794</PMID>
  </reference>
  <reference>
    <citation>Kyeremanteng K, Gagnon LP, Thavorn K, Heyland D, D'Egidio G. The Impact of Palliative Care Consultation in the ICU on Length of Stay: A Systematic Review and Cost Evaluation. J Intensive Care Med. 2018 Jun;33(6):346-353. doi: 10.1177/0885066616664329. Epub 2016 Aug 31.</citation>
    <PMID>27582396</PMID>
  </reference>
  <reference>
    <citation>Penrod JD, Pronovost PJ, Livote EE, Puntillo KA, Walker AS, Wallenstein S, Mercado AF, Swoboda SM, Ilaoa D, Thompson DA, Nelson JE. Meeting standards of high-quality intensive care unit palliative care: clinical performance and predictors. Crit Care Med. 2012 Apr;40(4):1105-12. doi: 10.1097/CCM.0b013e3182374a50.</citation>
    <PMID>22202706</PMID>
  </reference>
  <reference>
    <citation>Mun E, Ceria-Ulep C, Umbarger L, Nakatsuka C. Trend of Decreased Length of Stay in the Intensive Care Unit (ICU) and in the Hospital with Palliative Care Integration into the ICU. Perm J. 2016 Fall;20(4):16-036. doi: 10.7812/TPP/16-036. Epub 2016 Aug 31.</citation>
    <PMID>27644048</PMID>
  </reference>
  <reference>
    <citation>Braus N, Campbell TC, Kwekkeboom KL, Ferguson S, Harvey C, Krupp AE, Lohmeier T, Repplinger MD, Westergaard RP, Jacobs EA, Roberts KF, Ehlenbach WJ. Prospective study of a proactive palliative care rounding intervention in a medical ICU. Intensive Care Med. 2016 Jan;42(1):54-62. doi: 10.1007/s00134-015-4098-1. Epub 2015 Nov 10.</citation>
    <PMID>26556622</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Washington University School of Medicine</investigator_affiliation>
    <investigator_full_name>Marin Kollef</investigator_full_name>
    <investigator_title>Professor, Division of Pulmonary and Critical Care Medicine</investigator_title>
  </responsible_party>
  <!-- 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/NCT03263143
org study id: 201707067
nct id: NCT03263143
nct alias: NCT03210116
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study compares early palliative care consultation to standard of care in the medical
      intensive care unit (ICU). The study will assess if the intervention leads to an increased
      proportion of clearly delineated goals of care and examine if this intervention leads to
      decreased healthcare resource utilization such as length of stay, duration of intensive
      treatments including mechanical ventilation, and hospital re-admissions.
-  The medical intensive care unit will be split into two groups, assigned as either early
           palliative care consultation or standard of care. Current standard of care in the ICU is
           that primary clinician providers determine the need and time for palliative care
           consultation, which can occur approximately 5 - 14 days after admission.

        -  A palliative care screening tool will be used to determine if a newly admitted patient
           is eligible for palliative care consultation.

        -  Up to two patients per ICU per weekday will be enrolled into the study, due to workload
           limitations on the palliative care consult team.

        -  For patients in the intervention group, a palliative care consultation will be performed
           within 48 hours of ICU admission and patients will be followed throughout their
           hospitalization.

        -  Patients in the standard of care group will receive usual care. Palliative care may be
           consulted at the primary team's clinical discretion.

        -  The two medical ICU groups will be crossed over after three months with a washout period
           of six weeks, for a total of approximately eight months of study

        -  Electronic medical records will be reviewed after patient discharge to collect data on
           clinical outcomes as described elsewhere
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change in code status to do-not-resuscitate/do-not-intubate
time frame: Through patient admission until discharge, charts reviewed an average of one month after discharge
description: As determined by code status orders in the electronic medical record
measure: Number of participants with Cardiopulmonary Resuscitation (CPR) performed
time frame: Through study completion, an average of 6 months
measure: Mechanical Ventilation usage and duration
time frame: After date of discharge, charts reviewed an average of one month after discharge
measure: Hospital Length of Stay
time frame: After date of discharge, charts reviewed an average of one month after discharge
measure: ICU Length of Stay
time frame: After date of discharge, charts reviewed an average of one month after discharge
measure: In-hospital mortality
time frame: After date of discharge, charts reviewed an average of one month after discharge
description: Excluding patients transitioned to hospice prior to death
measure: 30-day mortality
time frame: One to two months after patient discharge, verified at study completion
description: Including all patients, including those on hospice
measure: Hospice transition or discharge
time frame: Through patient admission until discharge, charts reviewed an average of one month after discharge
measure: Post-discharge ER visits and/or readmissions
time frame: One to two months after patient discharge, verified at study completion
description: Determined by review of the BJC healthcare system electronic medical record
measure: Total hospital operating cost
time frame: Through study completion, an average of 6 months
measure: Vasopressor usage and duration
time frame: After date of discharge, charts reviewed an average of one month after discharge
measure: Antibiotic usage and duration
time frame: After date of discharge, charts reviewed an average of one month after discharge
measure: Number of participants treated with hemodialysis
time frame: Through study completion, an average of six months
measure: Number of participants with tracheostomy performed during hospital stay
time frame: Through study completion, an average of six months
arm group label: Standard of Care
arm group type: No Intervention
arm group label: Early Palliative Care Consultation
arm group type: Other
intervention type: Other
intervention name: Palliative Care
description: Palliative Care Consultation within 24 to 48 hours after admission
arm group label: Early Palliative Care Consultation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Adelson K, Paris J, Horton JR, Hernandez-Tellez L, Ricks D, Morrison RS, Smith CB. Standardized Criteria for Palliative Care Consultation on a Solid Tumor Oncology Service Reduces Downstream Health Care Use. J Oncol Pract. 2017 May;13(5):e431-e440. doi: 10.1200/JOP.2016.016808. Epub 2017 Mar 17.
PMID: 28306372
citation: Aslakson R, Cheng J, Vollenweider D, Galusca D, Smith TJ, Pronovost PJ. Evidence-based palliative care in the intensive care unit: a systematic review of interventions. J Palliat Med. 2014 Feb;17(2):219-35. doi: 10.1089/jpm.2013.0409.
PMID: 24517300
citation: Hsu-Kim C, Friedman T, Gracely E, Gasperino J. Integrating Palliative Care into Critical Care: A Quality Improvement Study. J Intensive Care Med. 2015 Sep;30(6):358-64. doi: 10.1177/0885066614523923. Epub 2014 Mar 5.
PMID: 24603677
citation: Khandelwal N, Kross EK, Engelberg RA, Coe NB, Long AC, Curtis JR. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015 May;43(5):1102-11. doi: 10.1097/CCM.0000000000000852.
PMID: 25574794
citation: Kyeremanteng K, Gagnon LP, Thavorn K, Heyland D, D'Egidio G. The Impact of Palliative Care Consultation in the ICU on Length of Stay: A Systematic Review and Cost Evaluation. J Intensive Care Med. 2018 Jun;33(6):346-353. doi: 10.1177/0885066616664329. Epub 2016 Aug 31.
PMID: 27582396
citation: Penrod JD, Pronovost PJ, Livote EE, Puntillo KA, Walker AS, Wallenstein S, Mercado AF, Swoboda SM, Ilaoa D, Thompson DA, Nelson JE. Meeting standards of high-quality intensive care unit palliative care: clinical performance and predictors. Crit Care Med. 2012 Apr;40(4):1105-12. doi: 10.1097/CCM.0b013e3182374a50.
PMID: 22202706
citation: Mun E, Ceria-Ulep C, Umbarger L, Nakatsuka C. Trend of Decreased Length of Stay in the Intensive Care Unit (ICU) and in the Hospital with Palliative Care Integration into the ICU. Perm J. 2016 Fall;20(4):16-036. doi: 10.7812/TPP/16-036. Epub 2016 Aug 31.
PMID: 27644048
citation: Braus N, Campbell TC, Kwekkeboom KL, Ferguson S, Harvey C, Krupp AE, Lohmeier T, Repplinger MD, Westergaard RP, Jacobs EA, Roberts KF, Ehlenbach WJ. Prospective study of a proactive palliative care rounding intervention in a medical ICU. Intensive Care Med. 2016 Jan;42(1):54-62. doi: 10.1007/s00134-015-4098-1. Epub 2015 Nov 10.
PMID: 26556622
responsible party type: Principal Investigator
investigator affiliation: Washington University School of Medicine
investigator full name: Marin Kollef
investigator title: Professor, Division of Pulmonary and Critical Care Medicine