<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/NCT03287323</url>
  </required_header>
  <id_info>
    <org_study_id>837.108.17 (10942)</org_study_id>
    <nct_id>NCT03287323</nct_id>
  </id_info>
  <brief_title>Proactive Palliative Care Intervention in a Surgical ICU: Influence on Family Satisfaction and Patient Distress</brief_title>
  <acronym>PALL-ICU</acronym>
  <official_title>The Influence of a Proactive Palliative Care Intervention on Family Satisfaction and Biopsychosocial Problem-related Distress of Patients in a Surgical Intensive Care Unit: A Prospective Single-center Interventional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</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>
      Patients will be identified according to pre-defined trigger criteria for a palliative&#xD;
      intervention. One hundred patients of a control group will receive standard intensive care&#xD;
      treatment (Usual Care Group). Patients' biopsychosocial problem-related distress will be&#xD;
      evaluated and family satisfaction with intensive care will be measured with standardized&#xD;
      questionnaires. In the subsequent intervention part of the study one hundred patients will&#xD;
      additionally be offered a palliative care treatment (Proactive Care Group) and patients'&#xD;
      biopsychosocial problem-related distress as well as family satisfaction will also be&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project consists of different consecutive parts:&#xD;
&#xD;
        1. Trigger criteria: Trigger criteria for patients with unmet palliative care needs in an&#xD;
           intensive care unit have been specified prior to start of the clinical study by survey&#xD;
           of staff of the surgical intensive care unit (intensivists and nursing staff): Trigger&#xD;
           criteria include a) advanced cancer, b) multi-organ failure, c) severe cognitive&#xD;
           impairment or dementia&#xD;
&#xD;
        2. Clinical study: Proactive palliative care intervention vs. standard care for intensive&#xD;
           care patients. Initially patients fulfilling the defined trigger criteria will be&#xD;
           enrolled in the standard care group (Group 1). In the intervention part of the study,&#xD;
           enrolled patients will be offered a set of different palliative care interventions in&#xD;
           addition to standard intensive care (Group 2). In both groups, family satisfaction will&#xD;
           be evaluated with the FS-ICU-24 (Family Satisfaction Intensive Care) questionnaire after&#xD;
           discharge of the patients from the ICU. 8 weeks (60 days +/- 7 days) after inclusion in&#xD;
           the study, patients' biopsychosocial distress will be assessed with standardized patient&#xD;
           questionnaires (NCCN Distress thermometer, PHQ-2 Patient Health Questionnaire). One year&#xD;
           after inclusion in the study, patients' functional status will be evaluated in a&#xD;
           telephone interview using the Barthel Index. Planned duration of clinical part of the&#xD;
           study: 3 years, thereof&#xD;
&#xD;
             1. Patient-related:&#xD;
&#xD;
                Duration of palliative care intervention: approx. 60 mins for each patient contact.&#xD;
                The number of interventions depends on the duration of ICU stay per patient.&#xD;
                Follow-up per patient until 1 year after enrolment.&#xD;
&#xD;
             2. Study-related:&#xD;
&#xD;
           The clinical study starts with the enrollment of the first ICU patient. Data will be&#xD;
           collected between the admission of the patient in the ICU until discharge from ICU and&#xD;
           hospital discharge, respectively. Follow-up visits will be performed 8 weeks and 1 year&#xD;
           after enrolment. Patients will be recruited over an estimated period of approx. 3 years,&#xD;
           assuming that 1-2 patients per week can be included. Follow-up data will be collected up&#xD;
           to 1 year after last patient in.&#xD;
&#xD;
        3. Termination of study including data analysis and evaluation, and publication of the&#xD;
           study results: approx. 1 year&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">April 2020</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>Sequential Assignment</intervention_model>
    <intervention_model_description>Prospective before-and after interventional study including 100 patients who receive usual intensive care followed by an interventional part with 100 patients who receive additional palliative care consultations</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).</measure>
    <time_frame>after discharge from ICU, up to 1 year after enrolment</time_frame>
    <description>To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs on family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients' biopsychosocial problem-related distress after intensive care treatment measured with the NCCN distress thermometer</measure>
    <time_frame>60 days +/- 7 days after enrolment</time_frame>
    <description>To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on patients' self-reported distress, measured with the NCCN distress thermometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care length of stay</measure>
    <time_frame>up to 1 year after enrolment</time_frame>
    <description>To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on ICU length of stay, measured as days in ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospitalization</measure>
    <time_frame>up to 1 year after enrolment</time_frame>
    <description>To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on hospital length of stay, measured as days in hospital.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year Patient survival</measure>
    <time_frame>up to 1 year after enrolment</time_frame>
    <description>To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on overall survival of patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ replacement therapy</measure>
    <time_frame>up to 1 year after enrolment</time_frame>
    <description>To evaluate organ dysfunction and duration of replacement therapy, measured as days of mechanical ventilation and/or days of ECMO and/or days of hemofiltration, if applicable</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional assessment after 1 year</measure>
    <time_frame>up to 1 year after enrolment</time_frame>
    <description>To evaluate functionality with regard to activities of daily living (Barthel Index)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>Usual Care Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>One hundred patients of a control group will receive standard intensive care treatment (Usual Care Group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proactive Palliative Care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>One hundred patients will additionally be offered a palliative care Intervention (Proactive Palliative Care Group).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Proactive Palliative Care</intervention_name>
    <description>In the intervention part of the study, enrolled patients will be offered a set of different palliative care interventions, including symptom management, advance care planning, palliative physiotherapy, social and spiritual support, communication with patients and caregivers, in addition to standard intensive care.</description>
    <arm_group_label>Proactive Palliative Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  need for intensive care for more than 3 days and at least one of the following trigger&#xD;
             criteria:&#xD;
&#xD;
               1. known advanced cancer&#xD;
&#xD;
               2. severe cognitive impairment or dementia&#xD;
&#xD;
               3. multi-organ failure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who already receive palliative care&#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_contact>
    <last_name>Rita Laufenberg-Feldmann, M.D.</last_name>
    <phone>+49 (0) 6131 17</phone>
    <phone_ext>6751</phone_ext>
    <email>rita.Laufenberg@unimedizin-mainz.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marion Ferner, M.D.</last_name>
    <phone>+49 (0) 6131 17</phone>
    <phone_ext>6751</phone_ext>
    <email>Marion.Ferner@unimedizin-mainz.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Anaesthesiology, University Medical Center of Johannes Gutenberg-University Mainz, Germany</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rita Laufenberg-Feldmann, M.D.</last_name>
      <phone>+49 (0) 6131 17</phone>
      <phone_ext>6751</phone_ext>
      <email>Rita.Laufenberg@unimedizin-mainz.de</email>
    </contact>
    <contact_backup>
      <last_name>Marion Ferner, M.D.</last_name>
      <phone>+49 (0) 6131 17</phone>
      <phone_ext>6751</phone_ext>
      <email>Marion.Ferner@unimedizin-mainz.de</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Hua M, Wunsch H. Integrating palliative care in the ICU. Curr Opin Crit Care. 2014 Dec;20(6):673-80. doi: 10.1097/MCC.0000000000000149.</citation>
    <PMID>25233330</PMID>
  </results_reference>
  <results_reference>
    <citation>Heyland DK, Tranmer JE; Kingston General Hospital ICU Research Working Group. Measuring family satisfaction with care in the intensive care unit: the development of a questionnaire and preliminary results. J Crit Care. 2001 Dec;16(4):142-9. doi: 10.1053/jcrc.2001.30163.</citation>
    <PMID>11815899</PMID>
  </results_reference>
  <results_reference>
    <citation>Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. doi: 10.1097/01.CCM.0000251122.15053.50.</citation>
    <PMID>17133189</PMID>
  </results_reference>
  <results_reference>
    <citation>Selecky PA, Eliasson CA, Hall RI, Schneider RF, Varkey B, McCaffree DR; American College of Chest Physicians. Palliative and end-of-life care for patients with cardiopulmonary diseases: American College of Chest Physicians position statement. Chest. 2005 Nov;128(5):3599-610. doi: 10.1378/chest.128.5.3599.</citation>
    <PMID>16304319</PMID>
  </results_reference>
  <results_reference>
    <citation>Mosenthal AC, Weissman DE, Curtis JR, Hays RM, Lustbader DR, Mulkerin C, Puntillo KA, Ray DE, Bassett R, Boss RD, Brasel KJ, Campbell M, Nelson JE. Integrating palliative care in the surgical and trauma intensive care unit: a report from the Improving Palliative Care in the Intensive Care Unit (IPAL-ICU) Project Advisory Board and the Center to Advance Palliative Care. Crit Care Med. 2012 Apr;40(4):1199-206. doi: 10.1097/CCM.0b013e31823bc8e7.</citation>
    <PMID>22080644</PMID>
  </results_reference>
  <results_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>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Rita Laufenberg-Feldmann, M.D.</investigator_full_name>
    <investigator_title>Anaesthesiologist, Head of Clinical Trial Unit</investigator_title>
  </responsible_party>
  <keyword>palliative care</keyword>
  <keyword>surgical intensive care</keyword>
  <keyword>family satisfaction</keyword>
  <keyword>ICU decision-making</keyword>
  <keyword>end-of-life 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/NCT03287323
org study id: 837.108.17 (10942)
nct id: NCT03287323
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients will be identified according to pre-defined trigger criteria for a palliative
      intervention. One hundred patients of a control group will receive standard intensive care
      treatment (Usual Care Group). Patients' biopsychosocial problem-related distress will be
      evaluated and family satisfaction with intensive care will be measured with standardized
      questionnaires. In the subsequent intervention part of the study one hundred patients will
      additionally be offered a palliative care treatment (Proactive Care Group) and patients'
      biopsychosocial problem-related distress as well as family satisfaction will also be
      evaluated.
The project consists of different consecutive parts:

        1. Trigger criteria: Trigger criteria for patients with unmet palliative care needs in an
           intensive care unit have been specified prior to start of the clinical study by survey
           of staff of the surgical intensive care unit (intensivists and nursing staff): Trigger
           criteria include a) advanced cancer, b) multi-organ failure, c) severe cognitive
           impairment or dementia

        2. Clinical study: Proactive palliative care intervention vs. standard care for intensive
           care patients. Initially patients fulfilling the defined trigger criteria will be
           enrolled in the standard care group (Group 1). In the intervention part of the study,
           enrolled patients will be offered a set of different palliative care interventions in
           addition to standard intensive care (Group 2). In both groups, family satisfaction will
           be evaluated with the FS-ICU-24 (Family Satisfaction Intensive Care) questionnaire after
           discharge of the patients from the ICU. 8 weeks (60 days +/- 7 days) after inclusion in
           the study, patients' biopsychosocial distress will be assessed with standardized patient
           questionnaires (NCCN Distress thermometer, PHQ-2 Patient Health Questionnaire). One year
           after inclusion in the study, patients' functional status will be evaluated in a
           telephone interview using the Barthel Index. Planned duration of clinical part of the
           study: 3 years, thereof

             1. Patient-related:

                Duration of palliative care intervention: approx. 60 mins for each patient contact.
                The number of interventions depends on the duration of ICU stay per patient.
                Follow-up per patient until 1 year after enrolment.

             2. Study-related:

           The clinical study starts with the enrollment of the first ICU patient. Data will be
           collected between the admission of the patient in the ICU until discharge from ICU and
           hospital discharge, respectively. Follow-up visits will be performed 8 weeks and 1 year
           after enrolment. Patients will be recruited over an estimated period of approx. 3 years,
           assuming that 1-2 patients per week can be included. Follow-up data will be collected up
           to 1 year after last patient in.

        3. Termination of study including data analysis and evaluation, and publication of the
           study results: approx. 1 year
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Prospective before-and after interventional study including 100 patients who receive usual intensive care followed by an interventional part with 100 patients who receive additional palliative care consultations
primary purpose: Supportive Care
masking: None (Open Label)
measure: family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).
time frame: after discharge from ICU, up to 1 year after enrolment
description: To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs on family satisfaction in a surgical intensive care unit using a standardized questionnaire (FS-ICU).
measure: Patients' biopsychosocial problem-related distress after intensive care treatment measured with the NCCN distress thermometer
time frame: 60 days +/- 7 days after enrolment
description: To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on patients' self-reported distress, measured with the NCCN distress thermometer
measure: Intensive care length of stay
time frame: up to 1 year after enrolment
description: To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on ICU length of stay, measured as days in ICU.
measure: Duration of hospitalization
time frame: up to 1 year after enrolment
description: To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on hospital length of stay, measured as days in hospital.
measure: 1-year Patient survival
time frame: up to 1 year after enrolment
description: To evaluate the effects of a proactive palliative care intervention for selected patients with unmet palliative needs in a surgical intensive care unit on overall survival of patients.
measure: Organ replacement therapy
time frame: up to 1 year after enrolment
description: To evaluate organ dysfunction and duration of replacement therapy, measured as days of mechanical ventilation and/or days of ECMO and/or days of hemofiltration, if applicable
measure: Functional assessment after 1 year
time frame: up to 1 year after enrolment
description: To evaluate functionality with regard to activities of daily living (Barthel Index)
arm group label: Usual Care Group
arm group type: No Intervention
description: One hundred patients of a control group will receive standard intensive care treatment (Usual Care Group).
arm group label: Proactive Palliative Care
arm group type: Other
description: One hundred patients will additionally be offered a palliative care Intervention (Proactive Palliative Care Group).
intervention type: Other
intervention name: Proactive Palliative Care
description: In the intervention part of the study, enrolled patients will be offered a set of different palliative care interventions, including symptom management, advance care planning, palliative physiotherapy, social and spiritual support, communication with patients and caregivers, in addition to standard intensive care.
arm group label: Proactive Palliative Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rita Laufenberg-Feldmann, M.D.
phone: +49 (0) 6131 17
phone ext: 6751
email: rita.Laufenberg@unimedizin-mainz.de
last name: Marion Ferner, M.D.
phone: +49 (0) 6131 17
phone ext: 6751
email: Marion.Ferner@unimedizin-mainz.de
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
citation: Hua M, Wunsch H. Integrating palliative care in the ICU. Curr Opin Crit Care. 2014 Dec;20(6):673-80. doi: 10.1097/MCC.0000000000000149.
PMID: 25233330
citation: Heyland DK, Tranmer JE; Kingston General Hospital ICU Research Working Group. Measuring family satisfaction with care in the intensive care unit: the development of a questionnaire and preliminary results. J Crit Care. 2001 Dec;16(4):142-9. doi: 10.1053/jcrc.2001.30163.
PMID: 11815899
citation: Wall RJ, Engelberg RA, Downey L, Heyland DK, Curtis JR. Refinement, scoring, and validation of the Family Satisfaction in the Intensive Care Unit (FS-ICU) survey. Crit Care Med. 2007 Jan;35(1):271-9. doi: 10.1097/01.CCM.0000251122.15053.50.
PMID: 17133189
citation: Selecky PA, Eliasson CA, Hall RI, Schneider RF, Varkey B, McCaffree DR; American College of Chest Physicians. Palliative and end-of-life care for patients with cardiopulmonary diseases: American College of Chest Physicians position statement. Chest. 2005 Nov;128(5):3599-610. doi: 10.1378/chest.128.5.3599.
PMID: 16304319
citation: Mosenthal AC, Weissman DE, Curtis JR, Hays RM, Lustbader DR, Mulkerin C, Puntillo KA, Ray DE, Bassett R, Boss RD, Brasel KJ, Campbell M, Nelson JE. Integrating palliative care in the surgical and trauma intensive care unit: a report from the Improving Palliative Care in the Intensive Care Unit (IPAL-ICU) Project Advisory Board and the Center to Advance Palliative Care. Crit Care Med. 2012 Apr;40(4):1199-206. doi: 10.1097/CCM.0b013e31823bc8e7.
PMID: 22080644
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: Johannes Gutenberg University Mainz
investigator full name: Rita Laufenberg-Feldmann, M.D.
investigator title: Anaesthesiologist, Head of Clinical Trial Unit
sharing ipd: No