<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/NCT04442438</url>
  </required_header>
  <id_info>
    <org_study_id>CH2018-01</org_study_id>
    <nct_id>NCT04442438</nct_id>
  </id_info>
  <brief_title>Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU</brief_title>
  <acronym>MCDIC</acronym>
  <official_title>Moral Case Deliberation on the Intensive Care: Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZonMw: The Netherlands Organisation for Health Research and Development</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Radboud University 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>
      Burnout syndrome (BOS) has a high prevalence in critical care nurses and physicians. Both&#xD;
      personal characteristics and work-related factors have been associated with BOS. Despite this&#xD;
      high prevalence of burnout and its potential for serious consequences, few studies have&#xD;
      tested interventions to address the problem. Whereas person-directed interventions may be&#xD;
      effective for periods less than 6 months, changes in the organization tend to have a longer&#xD;
      lasting effect. Lack of participation in morally complex decision-making is assumed to be an&#xD;
      important risk factor for the development of burnout symptoms. Implementation of structured,&#xD;
      multi-professional medical ethical decision-making - so called moral case deliberation (MCD)&#xD;
      - is proven feasible in an ICU setting. Health care workers involved in patient care&#xD;
      perceived that active participation in ethical decision making resulted in better awareness&#xD;
      of the background of the individual decisions and improved understanding of the ethical&#xD;
      dilemma. The effects of this intervention on health-care workers well-being was not&#xD;
      investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have shown that healthcare professionals working at the ICU are exposed to greater&#xD;
      risk of developing burnout than colleagues working in other fields of medicine (Moss, Good,&#xD;
      Gozal, Kleinpell, &amp; Sessler, 2016). It is widely suggested that moral distress, resulting&#xD;
      from morally problematic situations particular for the ICU, is an important risk factor for&#xD;
      burnout (Fumis, Junqueira Amarante, de Fatima Nascimento, &amp; Vieira Junior, 2017). One&#xD;
      suggested way to help caregivers mitigate moral distress is moral case deliberation. Moral&#xD;
      case deliberation is a structured dialogue between healthcare providers about ethically&#xD;
      problematic situations in their daily practice. It has been widely held that frequent moral&#xD;
      case deliberation may help healthcare providers to better appreciate moral problems, to learn&#xD;
      about their own and others' moral viewpoints, to foster a sense cohesion within their team&#xD;
      and to mitigate moral distress (Haan, van Gurp, Naber, &amp; Groenewoud, 2018). Moral case&#xD;
      deliberation may particularly help professionals if it is based on professionals' own&#xD;
      objectives in and experiences and expectations of moral case deliberation. It is therefore&#xD;
      needed to firmly root moral case deliberation in the ICU practice together with/with the help&#xD;
      of ICU-professionals (Weidema, van Dartel, &amp; Molewijk, 2016). Healthcare professionals&#xD;
      themselves are best able to evaluate, learn from and adjust the practice of moral case&#xD;
      deliberation on the ICU.&#xD;
&#xD;
      This research sets out to assess the claim that moral case deliberation can help mitigate&#xD;
      moral distress among healthcare providers and as such reduce the risk of burnout. It does so&#xD;
      by employing Mixed Methods Action Research (MMAR), through which the research will be&#xD;
      conducted through and with ICU-professionals, creating co-ownership of moral case&#xD;
      deliberation among participants. The study hopes to achieve that, instead of developing&#xD;
      burnout as a consequence of moral distress, moral case deliberation will help IC&#xD;
      professionals learn from morally distressing situations, potentially leading to cultural an&#xD;
      organizational improvement and improvement of quality of care.&#xD;
&#xD;
      Research questions to be answered:&#xD;
&#xD;
        1. How does moral distress, as a supposed risk factor for burnout of IC-professionals,&#xD;
           relate to other risk factors of burnout, personality, negative work-home interactions&#xD;
           and the ICU context?&#xD;
&#xD;
        2. How do IC-professionals experience preparation, participation and the impact on daily&#xD;
           practice of particular moral case deliberations?&#xD;
&#xD;
        3. Does moral case deliberation lead to a reduction of moral distress, burnout and team&#xD;
           cohesion?&#xD;
&#xD;
        4. How can IC-professionals establish cumulative learning from moral case deliberation&#xD;
           throughout their department?&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Quantitative methods Quantitative methods will be used to assess questions 1 and 3. Survey&#xD;
      data will be gathered in a stepped wedge trial. Surveys will be sent to around 450&#xD;
      ICU-professionals which are nested in six ICUs, nested in two hospitals. The data thus has a&#xD;
      multilevel structure (individuals in units in hospitals). The study aims for a response rate&#xD;
      of 50% or higher, including more than 230 participants. This is expectation is formulated on&#xD;
      the basis of the departments' experience of response rates in previous studies done in this&#xD;
      population. During the trial, the different ICUs will receive the intervention in a stepwise&#xD;
      manner. Within a stepped wedge design, what is randomized is the time point at which a unit&#xD;
      receives the intervention. One unit starts in January 2020 and will receive the intervention&#xD;
      for the full two years. Two units will start participating as of July 2020 and will then&#xD;
      participate until December 2021. In January 2021, two other units will start participating.&#xD;
      The last unit will receive the intervention as of July 2021 and participate for the remaining&#xD;
      six months.&#xD;
&#xD;
      Survey data will be gathered at five measurement points, after every 6 months, the first&#xD;
      being a baseline measurement. The baseline measurement will take place before January 2020,&#xD;
      the second measurement will take place before July 2020, the third measurement will take in&#xD;
      the months preceding January 2021, the fourth measurement will take place in the months&#xD;
      preceding July 2021 and the last measurement will take place in December 2021. The survey&#xD;
      consists of validated measurements for burnout syndrome (UBOS-C), moral distress (MDS-R),&#xD;
      work-home interaction (SWING), personality (BFI), departmental culture (Culture of Care&#xD;
      Barometer) and team cohesion (a set of six questions taken from the Safety Attitudes&#xD;
      Questionnaire).&#xD;
&#xD;
      The baseline data will inspire answering research question 1. Hierarchical linear regression&#xD;
      analysis will be used to assess the association between several concepts (e.g. moral&#xD;
      distress, work-home interaction, personality). With hierarchical regression analysis, the&#xD;
      explaining variance of moral distress on burn-out, controlled for burnout risk factors such&#xD;
      as work-home interaction and personality, will be analysed. Hierarchical linear regression is&#xD;
      a framework for model comparison: several regression models are built by adding variables to&#xD;
      previous model at each new step and thus, later models always include the previous smaller&#xD;
      models. The question is whether the newly added variable shows a significant improvement in&#xD;
      the proportion of explained variance of burnout (the R2).&#xD;
&#xD;
      The survey data gathered at all five measurement points is suited for analysis which allows&#xD;
      for assessment of question 3. The data gathered in the stepped wedge design, in which&#xD;
      clusters (units) are randomized, is well suited for interrupted time series analysis.&#xD;
      Interrupted time series analysis is used to evaluate the effect of an intervention in&#xD;
      longitudinal data. The key assumption of interrupted time series analysis of this data is&#xD;
      that moral case deliberation, as an intervention, changes the pre-intervention trend of&#xD;
      burnout prevalence among ICU-professionals; in other words, it assumes that the&#xD;
      pre-intervention trend would continue unchanged into the post-intervention period if there&#xD;
      had not been an intervention. Training, as well as the advice of an expert statistician&#xD;
      (Steven Teerenstra), will be sought to gain better insight in conducting interrupted time&#xD;
      series analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Single Group Assignment</intervention_model>
    <intervention_model_description>Longitudinal Stepped Wedge cluster randomized Trial with an open cohort</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument</measure>
    <time_frame>six months</time_frame>
    <description>An excessive reaction to stress caused by one's environment that may be Burnout is characterized by feelings of emotional and physical exhaustion, coupled with a sense of frustration and failure. This is measured through the Utrecht Burnout Scale (UBOS-C) survey instrument, a Dutch version of the Maslach Burnout Inventory (MBI), containing 20 items. The MBI measures three dimensions of burnout: emotional exhaustion, depersonalisation and personal accomplishment on 0 to 6 scales. Higher scores on emotional exhaustion and depersonalisation mean a worse outcome, while a higher score on personal accomplishment means a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Moral distress - measured by the 21-item moral distress scale (revised version) survey instrument</measure>
    <time_frame>six months</time_frame>
    <description>Moral distress is the emotional state that arises from a situation when an ICU professional feels that the ethically correct action to take is different from what he or she is tasked with doing. When policies or procedures prevent a professional from doing what he or she thinks is right, that presents a moral dilemma. Moral distress will be measured by the moral distress scale, a survey instrument containing 21 items. Participants are asked to rate all these situations in terms of frequency and intensity on scales ranging from 0 to 4. A total moral distress scale is calculated by multiplying frequency and intensity and adding all items together, which makes up a score between 0 and 336. A higher value means a worse outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Team cohesion - measured by the Team Climate Inventory survey instrument</measure>
    <time_frame>six months</time_frame>
    <description>Degree to which participants feel that they are part of a team. It is measured throuhg the Team Climate Inventory survey instrument, a survey instrument containing 6 items.</description>
  </other_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">435</enrollment>
  <condition>Burnout, Professional</condition>
  <condition>Caregiver Exhaustion</condition>
  <arm_group>
    <arm_group_label>Intensive care unit 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives of intervention consisting of monthly moral case deliberation (ethical decision-making) meetings, planned and set up by ICU professionals which have received the task of being more attentive to ethical situations during work.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive care unit 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First non-intervention, then flips to experimental arm type after six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive care unit 3</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First non-intervention, then flips to experimental arm type after six months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive care unit 4</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First non-intervention, then flips to experimental arm type after twelve months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive care unit 5</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First non-intervention, then flips to experimental arm type after twelve months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intensive care unit 6</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>First non-intervention, then flips to experimental arm type after Eighteen months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Monthly moral case deliberation</intervention_name>
    <description>Once per month, ICU professionals will take part in moral case deliberation. As part of the intervention, two or three ICU professionals (physicians and nurses) are tasked with selecting a case for moral discussion. Moral case deliberation is attended by around thirty individuals per month per unit. A feedback system will be developed used to spread the knowledge/insights from the case deliberation to all professionals in the unit.</description>
    <arm_group_label>Intensive care unit 1</arm_group_label>
    <arm_group_label>Intensive care unit 2</arm_group_label>
    <arm_group_label>Intensive care unit 3</arm_group_label>
    <arm_group_label>Intensive care unit 4</arm_group_label>
    <arm_group_label>Intensive care unit 5</arm_group_label>
    <arm_group_label>Intensive care unit 6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ICU professionals age 16 years or older working in intensive care departments in the&#xD;
             Radboud University Medical Centre or the Canisius Wilhelmina Hospital&#xD;
&#xD;
          -  gave written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jelle Van Gurp, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IQ healthcare, Radboud University medical center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hans Van der Hoeven, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intensive care, Radboud Univesity medical center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Radboud university medical centre</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canisius Wilhelmina Ziekenhuis</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6532 SZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 17, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Radboud University Medical Center</investigator_affiliation>
    <investigator_full_name>Marieke Zegers</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Moral case deliberation</keyword>
  <keyword>Moral distress</keyword>
  <keyword>Cohort study</keyword>
  <keyword>Intensive care units</keyword>
  <keyword>Quality of care</keyword>
  <keyword>Moral development</keyword>
  <keyword>Organizational culture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Professional</mesh_term>
    <mesh_term>Burnout, Psychological</mesh_term>
    <mesh_term>Caregiver Burden</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/NCT04442438
org study id: CH2018-01
nct id: NCT04442438
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Burnout syndrome (BOS) has a high prevalence in critical care nurses and physicians. Both
      personal characteristics and work-related factors have been associated with BOS. Despite this
      high prevalence of burnout and its potential for serious consequences, few studies have
      tested interventions to address the problem. Whereas person-directed interventions may be
      effective for periods less than 6 months, changes in the organization tend to have a longer
      lasting effect. Lack of participation in morally complex decision-making is assumed to be an
      important risk factor for the development of burnout symptoms. Implementation of structured,
      multi-professional medical ethical decision-making - so called moral case deliberation (MCD)
      - is proven feasible in an ICU setting. Health care workers involved in patient care
      perceived that active participation in ethical decision making resulted in better awareness
      of the background of the individual decisions and improved understanding of the ethical
      dilemma. The effects of this intervention on health-care workers well-being was not
      investigated.
Studies have shown that healthcare professionals working at the ICU are exposed to greater
      risk of developing burnout than colleagues working in other fields of medicine (Moss, Good,
      Gozal, Kleinpell, & Sessler, 2016). It is widely suggested that moral distress, resulting
      from morally problematic situations particular for the ICU, is an important risk factor for
      burnout (Fumis, Junqueira Amarante, de Fatima Nascimento, & Vieira Junior, 2017). One
      suggested way to help caregivers mitigate moral distress is moral case deliberation. Moral
      case deliberation is a structured dialogue between healthcare providers about ethically
      problematic situations in their daily practice. It has been widely held that frequent moral
      case deliberation may help healthcare providers to better appreciate moral problems, to learn
      about their own and others' moral viewpoints, to foster a sense cohesion within their team
      and to mitigate moral distress (Haan, van Gurp, Naber, & Groenewoud, 2018). Moral case
      deliberation may particularly help professionals if it is based on professionals' own
      objectives in and experiences and expectations of moral case deliberation. It is therefore
      needed to firmly root moral case deliberation in the ICU practice together with/with the help
      of ICU-professionals (Weidema, van Dartel, & Molewijk, 2016). Healthcare professionals
      themselves are best able to evaluate, learn from and adjust the practice of moral case
      deliberation on the ICU.

      This research sets out to assess the claim that moral case deliberation can help mitigate
      moral distress among healthcare providers and as such reduce the risk of burnout. It does so
      by employing Mixed Methods Action Research (MMAR), through which the research will be
      conducted through and with ICU-professionals, creating co-ownership of moral case
      deliberation among participants. The study hopes to achieve that, instead of developing
      burnout as a consequence of moral distress, moral case deliberation will help IC
      professionals learn from morally distressing situations, potentially leading to cultural an
      organizational improvement and improvement of quality of care.

      Research questions to be answered:

        1. How does moral distress, as a supposed risk factor for burnout of IC-professionals,
           relate to other risk factors of burnout, personality, negative work-home interactions
           and the ICU context?

        2. How do IC-professionals experience preparation, participation and the impact on daily
           practice of particular moral case deliberations?

        3. Does moral case deliberation lead to a reduction of moral distress, burnout and team
           cohesion?

        4. How can IC-professionals establish cumulative learning from moral case deliberation
           throughout their department?

      Methods:

      Quantitative methods Quantitative methods will be used to assess questions 1 and 3. Survey
      data will be gathered in a stepped wedge trial. Surveys will be sent to around 450
      ICU-professionals which are nested in six ICUs, nested in two hospitals. The data thus has a
      multilevel structure (individuals in units in hospitals). The study aims for a response rate
      of 50% or higher, including more than 230 participants. This is expectation is formulated on
      the basis of the departments' experience of response rates in previous studies done in this
      population. During the trial, the different ICUs will receive the intervention in a stepwise
      manner. Within a stepped wedge design, what is randomized is the time point at which a unit
      receives the intervention. One unit starts in January 2020 and will receive the intervention
      for the full two years. Two units will start participating as of July 2020 and will then
      participate until December 2021. In January 2021, two other units will start participating.
      The last unit will receive the intervention as of July 2021 and participate for the remaining
      six months.

      Survey data will be gathered at five measurement points, after every 6 months, the first
      being a baseline measurement. The baseline measurement will take place before January 2020,
      the second measurement will take place before July 2020, the third measurement will take in
      the months preceding January 2021, the fourth measurement will take place in the months
      preceding July 2021 and the last measurement will take place in December 2021. The survey
      consists of validated measurements for burnout syndrome (UBOS-C), moral distress (MDS-R),
      work-home interaction (SWING), personality (BFI), departmental culture (Culture of Care
      Barometer) and team cohesion (a set of six questions taken from the Safety Attitudes
      Questionnaire).

      The baseline data will inspire answering research question 1. Hierarchical linear regression
      analysis will be used to assess the association between several concepts (e.g. moral
      distress, work-home interaction, personality). With hierarchical regression analysis, the
      explaining variance of moral distress on burn-out, controlled for burnout risk factors such
      as work-home interaction and personality, will be analysed. Hierarchical linear regression is
      a framework for model comparison: several regression models are built by adding variables to
      previous model at each new step and thus, later models always include the previous smaller
      models. The question is whether the newly added variable shows a significant improvement in
      the proportion of explained variance of burnout (the R2).

      The survey data gathered at all five measurement points is suited for analysis which allows
      for assessment of question 3. The data gathered in the stepped wedge design, in which
      clusters (units) are randomized, is well suited for interrupted time series analysis.
      Interrupted time series analysis is used to evaluate the effect of an intervention in
      longitudinal data. The key assumption of interrupted time series analysis of this data is
      that moral case deliberation, as an intervention, changes the pre-intervention trend of
      burnout prevalence among ICU-professionals; in other words, it assumes that the
      pre-intervention trend would continue unchanged into the post-intervention period if there
      had not been an intervention. Training, as well as the advice of an expert statistician
      (Steven Teerenstra), will be sought to gain better insight in conducting interrupted time
      series analysis.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: Longitudinal Stepped Wedge cluster randomized Trial with an open cohort
primary purpose: Prevention
masking: None (Open Label)
measure: Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument
time frame: six months
description: An excessive reaction to stress caused by one's environment that may be Burnout is characterized by feelings of emotional and physical exhaustion, coupled with a sense of frustration and failure. This is measured through the Utrecht Burnout Scale (UBOS-C) survey instrument, a Dutch version of the Maslach Burnout Inventory (MBI), containing 20 items. The MBI measures three dimensions of burnout: emotional exhaustion, depersonalisation and personal accomplishment on 0 to 6 scales. Higher scores on emotional exhaustion and depersonalisation mean a worse outcome, while a higher score on personal accomplishment means a better outcome.
measure: Moral distress - measured by the 21-item moral distress scale (revised version) survey instrument
time frame: six months
description: Moral distress is the emotional state that arises from a situation when an ICU professional feels that the ethically correct action to take is different from what he or she is tasked with doing. When policies or procedures prevent a professional from doing what he or she thinks is right, that presents a moral dilemma. Moral distress will be measured by the moral distress scale, a survey instrument containing 21 items. Participants are asked to rate all these situations in terms of frequency and intensity on scales ranging from 0 to 4. A total moral distress scale is calculated by multiplying frequency and intensity and adding all items together, which makes up a score between 0 and 336. A higher value means a worse outcome.
measure: Team cohesion - measured by the Team Climate Inventory survey instrument
time frame: six months
description: Degree to which participants feel that they are part of a team. It is measured throuhg the Team Climate Inventory survey instrument, a survey instrument containing 6 items.
arm group label: Intensive care unit 1
arm group type: Experimental
description: Receives of intervention consisting of monthly moral case deliberation (ethical decision-making) meetings, planned and set up by ICU professionals which have received the task of being more attentive to ethical situations during work.
arm group label: Intensive care unit 2
arm group type: Other
description: First non-intervention, then flips to experimental arm type after six months.
arm group label: Intensive care unit 3
arm group type: Other
description: First non-intervention, then flips to experimental arm type after six months.
arm group label: Intensive care unit 4
arm group type: Other
description: First non-intervention, then flips to experimental arm type after twelve months.
arm group label: Intensive care unit 5
arm group type: Other
description: First non-intervention, then flips to experimental arm type after twelve months.
arm group label: Intensive care unit 6
arm group type: Other
description: First non-intervention, then flips to experimental arm type after Eighteen months.
intervention type: Other
intervention name: Monthly moral case deliberation
description: Once per month, ICU professionals will take part in moral case deliberation. As part of the intervention, two or three ICU professionals (physicians and nurses) are tasked with selecting a case for moral discussion. Moral case deliberation is attended by around thirty individuals per month per unit. A feedback system will be developed used to spread the knowledge/insights from the case deliberation to all professionals in the unit.
arm group label: Intensive care unit 1
arm group label: Intensive care unit 2
arm group label: Intensive care unit 3
arm group label: Intensive care unit 4
arm group label: Intensive care unit 5
arm group label: Intensive care unit 6
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jelle Van Gurp, PhD
role: Principal Investigator
affiliation: IQ healthcare, Radboud University medical center
last name: Hans Van der Hoeven, MD, PhD
role: Principal Investigator
affiliation: Intensive care, Radboud Univesity medical center
facility: 
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Radboud University Medical Center
investigator full name: Marieke Zegers
investigator title: Principal Investigator
mesh term: Burnout, Professional
mesh term: Burnout, Psychological
mesh term: Caregiver Burden
sharing ipd: No