<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/NCT03286127</url>
  </required_header>
  <id_info>
    <org_study_id>UKM_POEM I</org_study_id>
    <nct_id>NCT03286127</nct_id>
  </id_info>
  <brief_title>Palliative Outcome Evaluation Muenster I</brief_title>
  <acronym>POEM I</acronym>
  <official_title>Assessment of Palliative Care in Inpatient and Outpatient Settings Using the Integrated Palliative Care Outcome Scale: a Multi-centric Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. Franziskus Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Raphaelsklinik Münster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Josephs Hospital Warendorf</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Palliativnetz Muenster gGmbH</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Muenster</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>
      For patients with an advanced disease and their families an excellent and compassionate care&#xD;
      is essential. However, in hospitals optimal end-of-life care is not yet fully realized and&#xD;
      patient's needs are often not met. Palliative care is able to increase patients' quality of&#xD;
      life and to carefully meet their and their families' needs.&#xD;
&#xD;
      To improve the awareness of unmet needs patient-reported outcome measurement has been the&#xD;
      pivot of latest palliative care research. Besides the improvement of care outcome measurement&#xD;
      allows the evaluation of the quality of palliative care and comparisons on a national and&#xD;
      international level.&#xD;
&#xD;
      The aim of the present study is to evaluate the quality of palliative care in different&#xD;
      settings (palliative care unit, inpatient and outpatient consultation teams) using the&#xD;
      Integrated Palliative Care Outcome Scale (IPOS). The IPOS has been lately developed as&#xD;
      improved follow-up version of the Palliative Care Outcome Scale (POS) integrating most&#xD;
      important questions and simultaneously being brief and comprehensive. The study is planned as&#xD;
      a multi-centric observational study. Primary endpoint is the reduction of symptom burden of&#xD;
      patients.&#xD;
&#xD;
      The clinical study hypothesis bases on the assumption that palliative care can change the&#xD;
      symptom burden, measured by a change in the IPOS overall profile score, and that there might&#xD;
      be a difference in the size of the effect depending on the caring setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the enrolment and consent of participation the patient receive a questionnaire&#xD;
      consisting of three independent assessments: To assess the symptom burden and specific&#xD;
      palliative care needs the Integrated Palliative Outcome Scale (IPOS) is used. To measure the&#xD;
      generic health-related quality of life the patient has to answer the EuroQoL Group&#xD;
      5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). To get an opinion of the general&#xD;
      condition the patient is to complete the NCCN Distress Thermometer which includes a visual&#xD;
      analogue scale (with values from 0 to 10).&#xD;
&#xD;
      Meanwhile, a professional palliative caregiver completes a questionnaire about the main&#xD;
      demographic aspects of the patients and assess the palliative care needs and the symptom&#xD;
      burden using the IPOS.&#xD;
&#xD;
      After one week both, patient and professional palliative caregiver, will receive the same&#xD;
      questionnaires again to assess the change from baseline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>symptom burden (IPOS)</measure>
    <time_frame>From Baseline to End of Follow-Up (0, 1 week)</time_frame>
    <description>Change from baseline in palliative care needs and specific symptoms (at day 7) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Generic health-related quality of life (EQ-5D-5L)</measure>
    <time_frame>From Baseline to End of Follow-Up (0, 1 week)</time_frame>
    <description>Change from baseline in patients' generic health-related quality of life measured with the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale of the EQ-5D-5L questionnaire ranges from 0 to 100 (with 0 representing the worst health the patient can imagine and 100 representing the best health the patient can imagine).</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">347</enrollment>
  <condition>Cancer</condition>
  <condition>Chronic Heart Failure</condition>
  <condition>COPD Exacerbation</condition>
  <condition>Palliative Care</condition>
  <arm_group>
    <arm_group_label>PCU (unit)</arm_group_label>
    <description>Those patients who received specialised palliative care on a palliative care unit.(palliative care unit)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPCC (hospital)</arm_group_label>
    <description>Those patients admitted to a regular hospital ward who received specialised palliative care from an inpatient palliative care consultation team.&#xD;
(inpatient palliative care consultation team)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OPCC (outpatient)</arm_group_label>
    <description>Those patients who received specialised palliative care at home from an outpatient palliative care consultation team. (outpatient palliative care consultation team)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>specialized palliative care</intervention_name>
    <description>specialized palliative care provided in different settings</description>
    <arm_group_label>IPCC (hospital)</arm_group_label>
    <arm_group_label>OPCC (outpatient)</arm_group_label>
    <arm_group_label>PCU (unit)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of patients with an advanced life-limiting and&#xD;
        progressive disease needing palliative care. The three groups are formed depending of the&#xD;
        setting in which palliative care will be provided.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Indication for palliative care due to any advanced life-limiting and progressive&#xD;
             disease&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years&#xD;
&#xD;
          -  pregnant or breastfeeding women&#xD;
&#xD;
          -  Inability to understand information for participation&#xD;
&#xD;
          -  Refusal of participation&#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>Philipp Lenz, PD Dr. med.</last_name>
    <phone>+49 (0)251 8353052</phone>
    <email>philipp.lenz@ukmuenster.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hospital St. Raphael Muenster</name>
      <address>
        <city>Muenster</city>
        <state>North Rhine-Westphalia</state>
        <zip>48143</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marc Theisen, Dr. med.</last_name>
      <phone>+49 (0)251 5007 4118</phone>
      <email>m.theisen@alexianer.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital St. Franziskus Muenster</name>
      <address>
        <city>Muenster</city>
        <state>North Rhine-Westphalia</state>
        <zip>48145</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne Bremer, Dr. med.</last_name>
      <phone>+49 (0)251 935 5564</phone>
      <email>onkologie@sfh-muenster.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospital Muenster</name>
      <address>
        <city>Muenster</city>
        <state>North Rhine-Westphalia</state>
        <zip>48149</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philipp Lenz, PD Dr. med.</last_name>
      <phone>+49 (0)251 8353052</phone>
      <email>philipp.lenz@ukmuenster.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Palliativnetz Muenster</name>
      <address>
        <city>Muenster</city>
        <state>North Rhine-Westphalia</state>
        <zip>48161</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ulrike Hofmeister, Dr. med.</last_name>
      <phone>+49 (0)251 1625662</phone>
      <email>info@palliativnetz-muenster.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital St. Josef Warendorf</name>
      <address>
        <city>Warendorf</city>
        <state>North Rhine-Westphalia</state>
        <zip>48231</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Dirk Domagk, Prof. Dr. med.</last_name>
      <phone>+49 (0)2581 20 1752</phone>
      <email>palliativstation@jhwaf.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</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/NCT03286127
org study id: UKM_POEM I
nct id: NCT03286127
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For patients with an advanced disease and their families an excellent and compassionate care
      is essential. However, in hospitals optimal end-of-life care is not yet fully realized and
      patient's needs are often not met. Palliative care is able to increase patients' quality of
      life and to carefully meet their and their families' needs.

      To improve the awareness of unmet needs patient-reported outcome measurement has been the
      pivot of latest palliative care research. Besides the improvement of care outcome measurement
      allows the evaluation of the quality of palliative care and comparisons on a national and
      international level.

      The aim of the present study is to evaluate the quality of palliative care in different
      settings (palliative care unit, inpatient and outpatient consultation teams) using the
      Integrated Palliative Care Outcome Scale (IPOS). The IPOS has been lately developed as
      improved follow-up version of the Palliative Care Outcome Scale (POS) integrating most
      important questions and simultaneously being brief and comprehensive. The study is planned as
      a multi-centric observational study. Primary endpoint is the reduction of symptom burden of
      patients.

      The clinical study hypothesis bases on the assumption that palliative care can change the
      symptom burden, measured by a change in the IPOS overall profile score, and that there might
      be a difference in the size of the effect depending on the caring setting.
After the enrolment and consent of participation the patient receive a questionnaire
      consisting of three independent assessments: To assess the symptom burden and specific
      palliative care needs the Integrated Palliative Outcome Scale (IPOS) is used. To measure the
      generic health-related quality of life the patient has to answer the EuroQoL Group
      5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). To get an opinion of the general
      condition the patient is to complete the NCCN Distress Thermometer which includes a visual
      analogue scale (with values from 0 to 10).

      Meanwhile, a professional palliative caregiver completes a questionnaire about the main
      demographic aspects of the patients and assess the palliative care needs and the symptom
      burden using the IPOS.

      After one week both, patient and professional palliative caregiver, will receive the same
      questionnaires again to assess the change from baseline.
observational model: Case-Only
time perspective: Prospective
measure: symptom burden (IPOS)
time frame: From Baseline to End of Follow-Up (0, 1 week)
description: Change from baseline in palliative care needs and specific symptoms (at day 7) assessed with the Integrated Palliative Care Outcome Scale (IPOS). The IPOS includes 10 symptoms and 7 questions on patients and carers emotional situation, spiritual concerns, and provision of information and support. The overall profile score is the sum of the scores from each of the 17 questions.
measure: Generic health-related quality of life (EQ-5D-5L)
time frame: From Baseline to End of Follow-Up (0, 1 week)
description: Change from baseline in patients' generic health-related quality of life measured with the EuroQoL Group 5-Dimension 5-Level Self Report Questionnaire (EQ-5D-5L). The EQ-5D-5L essentially consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale of the EQ-5D-5L questionnaire ranges from 0 to 100 (with 0 representing the worst health the patient can imagine and 100 representing the best health the patient can imagine).
arm group label: PCU (unit)
description: Those patients who received specialised palliative care on a palliative care unit.(palliative care unit)
arm group label: IPCC (hospital)
description: Those patients admitted to a regular hospital ward who received specialised palliative care from an inpatient palliative care consultation team.
(inpatient palliative care consultation team)
arm group label: OPCC (outpatient)
description: Those patients who received specialised palliative care at home from an outpatient palliative care consultation team. (outpatient palliative care consultation team)
intervention type: Other
intervention name: specialized palliative care
description: specialized palliative care provided in different settings
arm group label: IPCC (hospital)
arm group label: OPCC (outpatient)
arm group label: PCU (unit)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philipp Lenz, PD Dr. med.
phone: +49 (0)251 8353052
email: philipp.lenz@ukmuenster.de
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Germany
responsible party type: Sponsor
mesh term: Heart Failure
sharing ipd: No