- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04442438
Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU (MCDIC)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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:
- 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?
- How do IC-professionals experience preparation, participation and the impact on daily practice of particular moral case deliberations?
- Does moral case deliberation lead to a reduction of moral distress, burnout and team cohesion?
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 GA
- Radboud University Medical Centre
-
Nijmegen, Gelderland, Netherlands, 6532 SZ
- Canisius Wilhelmina Ziekenhuis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- ICU professionals age 16 years or older working in intensive care departments in the Radboud University Medical Centre or the Canisius Wilhelmina Hospital
- gave written informed consent
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intensive care unit 1
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.
|
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.
|
Other: Intensive care unit 2
First non-intervention, then flips to experimental arm type after six months.
|
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.
|
Other: Intensive care unit 3
First non-intervention, then flips to experimental arm type after six months.
|
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.
|
Other: Intensive care unit 4
First non-intervention, then flips to experimental arm type after twelve months.
|
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.
|
Other: Intensive care unit 5
First non-intervention, then flips to experimental arm type after twelve months.
|
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.
|
Other: Intensive care unit 6
First non-intervention, then flips to experimental arm type after Eighteen months.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument
Time Frame: six months
|
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.
|
six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Moral distress - measured by the 21-item moral distress scale (revised version) survey instrument
Time Frame: six months
|
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.
|
six months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Team cohesion - measured by the Team Climate Inventory survey instrument
Time Frame: six months
|
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.
|
six months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jelle Van Gurp, PhD, IQ healthcare, Radboud University medical center
- Principal Investigator: Hans Van der Hoeven, MD, PhD, Intensive care, Radboud Univesity medical center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH2018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Burnout, Professional
-
Region SkaneLund University; Swedish Council for Working Life and Social Research; County...CompletedProfessional BurnoutSweden
-
Mayo ClinicCompletedJob Stress | Professional Burnout | Professional StressUnited States
-
Colleen J KleinRecruitingJob Stress | Professional BurnoutUnited States
-
University of MichiganRecruiting
-
University of Colorado, DenverMayo Clinic; Physicians FoundationRecruiting
-
michal rollTel Aviv University; Association for Children at RiskUnknownBurnout, Professional | Professional-Patient Relations
-
West University of TimisoaraCompletedMental Health Wellness | Professional BurnoutRomania
-
Inonu UniversityCompletedAnxiety | Mindfulness | Job Satisfaction | Midwives | Professional BurnoutTurkey
-
University Grenoble AlpsCompletedMedical Education | Anesthesia | Anxiety State | Professional Burnout | High Fidelity Simulation | Professional StressFrance
-
Mayo ClinicCompletedStress | Anxiety | Leadership | Professional Role | Goals | Well-Being | Physician's Role | Professional Burnout | Development, HumanUnited States
Clinical Trials on Monthly moral case deliberation
-
Medical College of WisconsinRecruitingDiabetes Mellitus, Type 2United States
-
London School of Hygiene and Tropical MedicineRadboud University Medical Center; Centre national de recherche et de formation... and other collaboratorsCompletedMalariaBurkina Faso
-
London School of Hygiene and Tropical MedicineRadboud University Medical Center; University of California, San Francisco; Medical... and other collaboratorsRecruiting
-
OrygenNational Institute of Mental Health (NIMH); University of California, Davis; University...UnknownPersonality Disorders | Psychotic Disorders | Clinical High RiskAustralia