<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/NCT03807206</url>
  </required_header>
  <id_info>
    <org_study_id>ROUTINE-F</org_study_id>
    <nct_id>NCT03807206</nct_id>
  </id_info>
  <brief_title>Resuscitation Outcomes in the Netherlands Flashmob Questionnaire</brief_title>
  <acronym>ROUTINE-F</acronym>
  <official_title>Resucitation Outcomes in the Netherlands: Flash Mob Research on the Subject of Patient Experiences Regarding Do Not Resuscitate Orders.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Erasmus Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Society of Anaesthesiology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Erasmus Medical Center</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 aim of this study is to gain insight in patients' experiences regarding do not&#xD;
      resuscitate conversations and decisions. A multicentre flash mob investigation will be&#xD;
      conducted in which data will be obtained over the course of two weeks using electronic&#xD;
      questionnaires that patients will fill out. General demographic data and a brief quality of&#xD;
      life assessment (EQ-5D) will be collected. Whether a DNR converstation has taken place will&#xD;
      be noted, along with patients' experiences with this conversation. Lastly the patient will be&#xD;
      asked about his/her expectations of survival after cardiopulmonary resuscitation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: In-hospital cardiac arrest, associated with a survival to discharge of 15.0%,&#xD;
      results in a good neurologic discharge in 9.1% - 30.0% of patients. Therefore it is&#xD;
      recommended to engage in advanced care planning with patients, to discuss do-not-resuscitate&#xD;
      (DNR) directives. In current knowledge, there are no published data about the prevalence of&#xD;
      these DNR orders and associated factors in hospitalized patients in the Netherlands. Also,&#xD;
      the conversation about DNR are sometimes perceived as awkward or untimely by patients.&#xD;
&#xD;
      Objective: The primary goal is to estimate prevalence DNR order in Dutch hospitals. A&#xD;
      secondary goal is to assess what geographical, patient and disease factors are associated&#xD;
      with DNR status. Furthermore patient experience in the conversation leading to DNR-orders is&#xD;
      of interest.&#xD;
&#xD;
      Study design: A cross-sectional point prevalence study, in 10 participating hospitals of the&#xD;
      ROUTiNE project.&#xD;
&#xD;
      Study population: Patients who plan to be admitted for more than 24 hours to the&#xD;
      participating hospitals, aged 18 or older, who are responsive and conscious.&#xD;
&#xD;
      Main study parameters/endpoints: The prevalence of DNR orders, expressed as number per 1000&#xD;
      beds.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: There is no risk. Only one ten-minute interview per participant. Therefore the&#xD;
      benefit of this study (as described in the objectives) outweigh the potential risks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">February 7, 2019</completion_date>
  <primary_completion_date type="Actual">February 7, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of DNR-orders</measure>
    <time_frame>1 day</time_frame>
    <description>Percentage of DNR-orders in the total cohort as noted in the electronic patient file</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DNR-order discussion prevalence</measure>
    <time_frame>1 day</time_frame>
    <description>Number of patients who have had a DNR discussion with their physician</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DNR-order discussion experience</measure>
    <time_frame>1 day</time_frame>
    <description>Patient experience with the DNR-order discussion; was it timely, was the explanation clear?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DNR-order discrepancy</measure>
    <time_frame>1 day</time_frame>
    <description>DNR-order reported by the patient, compared to DNR-order from the electronic patient file</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>1 day</time_frame>
    <description>EQ-5D (Euroqol): EQ-5D-5L is a standardized, participant-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the visual analogue scale (VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to choose one of 5 levels that best describes their health on that day: &quot;no problem&quot; (1), &quot;slight&quot; (2), &quot;moderate&quot; (3), &quot;severe&quot; (4), or &quot;unable/extreme&quot; (5). The VAS is the participant's rating of their health on a scale of 0 &quot;worst health you can imagine&quot; to 100 &quot;best health you can imagine&quot;.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>General demographic data</measure>
    <time_frame>1 day</time_frame>
    <description>Demographic profile of inpatients in the Netherlands: age, sex, religion, education, no. of diseases, no. of medications</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1136</enrollment>
  <condition>Cardiopulmonary Arrest</condition>
  <condition>DNR-orders</condition>
  <arm_group>
    <arm_group_label>Flashmob 2019</arm_group_label>
    <description>Patients from the following hospitals will receive a questionnaire/structured intereview: Erasmus MC, Franciscus Gasthuis &amp; Vlietland, Ikazia, Haaglanden Medisch Centrum, Albert Schweitzer ziekenhuis, Jeroen Bosch ziekenhuis, Rijnstate ziekenhuis, Amphia ziekenhuis, Tergooi klinieken, Medisch Spectrum Twente, Reinier de Graaf gasthuis. Pending: Maasstad ziekenhuis</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Patient questionnaire</description>
    <arm_group_label>Flashmob 2019</arm_group_label>
    <other_name>structured interview</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The base population consists of all adult patients admitted to all the participating&#xD;
        hospitals. These consist of one academic centre and 10 general hospitals. The sampling is&#xD;
        based on non-probability as it does not represent the entire population (i.e. inhabitants&#xD;
        of the Netherlands), however it is based on probability sampling when the population is&#xD;
        solely patients admitted to hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients admitted to the participating hospitals with a planned admission &gt;24&#xD;
             hours at the moment this study takes place.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Refusal to participate&#xD;
&#xD;
               -  &lt;18 years of age&#xD;
&#xD;
               -  Admitted in outpatient clinic and day treatment centres (e.g. haemodialysis)&#xD;
&#xD;
               -  Admitted &lt;24 hours, as defined by not sleeping overnight in hospital&#xD;
&#xD;
               -  No reliable proxy in the following situations:&#xD;
&#xD;
                    -  Unable to answer questions (e.g. unconscious, cognitively impaired,&#xD;
                       delirious)&#xD;
&#xD;
                    -  Language barrier (with no interpreter or family member)&#xD;
&#xD;
               -  The following hospital departments are excluded:&#xD;
&#xD;
                    -  Intensive care unit&#xD;
&#xD;
                    -  Coronary/acute cardiac care unit&#xD;
&#xD;
                    -  Obstetrics&#xD;
&#xD;
                    -  Paediatrics&#xD;
&#xD;
                    -  Stroke unit&#xD;
&#xD;
                    -  Dialysis (outpatient dialysis)&#xD;
&#xD;
                    -  Day-care wards/short-stay (i.e. &lt;1 day)&#xD;
&#xD;
                    -  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_official>
    <last_name>Robert Jan Stolker, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Monique van Dijk, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Erasmus Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rijnstate</name>
      <address>
        <city>Arnhem</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amphia</name>
      <address>
        <city>Breda</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reinier de Graaf gasthuis</name>
      <address>
        <city>Delft</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jeroen Bosch ziekenhuis</name>
      <address>
        <city>Den Bosch</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haaglanden Medisch Centrum</name>
      <address>
        <city>Den Haag</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Schweitzer ziekenhuis</name>
      <address>
        <city>Dordrecht</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente</name>
      <address>
        <city>Enschede</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tergooi ziekenhuizen</name>
      <address>
        <city>Hilversum</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <zip>3015CE</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscus Gasthuis &amp; Vlietland</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ikazia</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maasstad</name>
      <address>
        <city>Rotterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>July 14, 2019</last_update_submitted>
  <last_update_submitted_qc>July 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Erasmus Medical Center</investigator_affiliation>
    <investigator_full_name>Marc Schluep</investigator_full_name>
    <investigator_title>principal investigator/medical doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Because of the personal nature of data (reg. age, sex, religion, eductional level) we will not make it available.</ipd_description>
  </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/NCT03807206
org study id: ROUTINE-F
nct id: NCT03807206
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to gain insight in patients' experiences regarding do not
      resuscitate conversations and decisions. A multicentre flash mob investigation will be
      conducted in which data will be obtained over the course of two weeks using electronic
      questionnaires that patients will fill out. General demographic data and a brief quality of
      life assessment (EQ-5D) will be collected. Whether a DNR converstation has taken place will
      be noted, along with patients' experiences with this conversation. Lastly the patient will be
      asked about his/her expectations of survival after cardiopulmonary resuscitation.
Rationale: In-hospital cardiac arrest, associated with a survival to discharge of 15.0%,
      results in a good neurologic discharge in 9.1% - 30.0% of patients. Therefore it is
      recommended to engage in advanced care planning with patients, to discuss do-not-resuscitate
      (DNR) directives. In current knowledge, there are no published data about the prevalence of
      these DNR orders and associated factors in hospitalized patients in the Netherlands. Also,
      the conversation about DNR are sometimes perceived as awkward or untimely by patients.

      Objective: The primary goal is to estimate prevalence DNR order in Dutch hospitals. A
      secondary goal is to assess what geographical, patient and disease factors are associated
      with DNR status. Furthermore patient experience in the conversation leading to DNR-orders is
      of interest.

      Study design: A cross-sectional point prevalence study, in 10 participating hospitals of the
      ROUTiNE project.

      Study population: Patients who plan to be admitted for more than 24 hours to the
      participating hospitals, aged 18 or older, who are responsive and conscious.

      Main study parameters/endpoints: The prevalence of DNR orders, expressed as number per 1000
      beds.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: There is no risk. Only one ten-minute interview per participant. Therefore the
      benefit of this study (as described in the objectives) outweigh the potential risks.
observational model: Cohort
time perspective: Cross-Sectional
measure: Prevalence of DNR-orders
time frame: 1 day
description: Percentage of DNR-orders in the total cohort as noted in the electronic patient file
measure: DNR-order discussion prevalence
time frame: 1 day
description: Number of patients who have had a DNR discussion with their physician
measure: DNR-order discussion experience
time frame: 1 day
description: Patient experience with the DNR-order discussion; was it timely, was the explanation clear?
measure: DNR-order discrepancy
time frame: 1 day
description: DNR-order reported by the patient, compared to DNR-order from the electronic patient file
measure: Quality of life
time frame: 1 day
description: EQ-5D (Euroqol): EQ-5D-5L is a standardized, participant-rated instrument for use as a measure of health outcomes. The EQ 5D-5L includes 2 components: the EQ-5D-5L descriptive system and the visual analogue scale (VAS). The EQ-5D-5L descriptive system provides a profile of the participant's health state in 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, the participant is instructed to choose one of 5 levels that best describes their health on that day: "no problem" (1), "slight" (2), "moderate" (3), "severe" (4), or "unable/extreme" (5). The VAS is the participant's rating of their health on a scale of 0 "worst health you can imagine" to 100 "best health you can imagine".
measure: General demographic data
time frame: 1 day
description: Demographic profile of inpatients in the Netherlands: age, sex, religion, education, no. of diseases, no. of medications
arm group label: Flashmob 2019
description: Patients from the following hospitals will receive a questionnaire/structured intereview: Erasmus MC, Franciscus Gasthuis & Vlietland, Ikazia, Haaglanden Medisch Centrum, Albert Schweitzer ziekenhuis, Jeroen Bosch ziekenhuis, Rijnstate ziekenhuis, Amphia ziekenhuis, Tergooi klinieken, Medisch Spectrum Twente, Reinier de Graaf gasthuis. Pending: Maasstad ziekenhuis
intervention type: Behavioral
intervention name: Questionnaire
description: Patient questionnaire
arm group label: Flashmob 2019
other name: structured interview
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Jan Stolker, MD PhD
role: Principal Investigator
affiliation: Erasmus Medical Center
last name: Monique van Dijk, MD PhD
role: Principal Investigator
affiliation: Erasmus Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Erasmus Medical Center
investigator full name: Marc Schluep
investigator title: principal investigator/medical doctor
mesh term: Heart Arrest
sharing ipd: No
ipd description: Because of the personal nature of data (reg. age, sex, religion, eductional level) we will not make it available.