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Burnout, ProfessionalMCDICNCT04442438

Effect of Implementation of a Moral Case Delibration Meetings on the Prevalence of Burn-out Syndrome in the ICU

A study testing Monthly moral case deliberation in people with Burnout, Professional and Caregiver Exhaustion, run by Radboud University Medical Center at 2 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
Burnout, Professional, Caregiver Exhaustion
What is being tested?
Monthly moral case deliberation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
435 participants
Where
2 sitesNetherlands
Study dates
1 Oct 2019to 1 Nov 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • -

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites
  • Radboud university medical centre

    Nijmegen, Gelderland, 6525 GA

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ

Other trials in Netherlands

About this study

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

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.

Read the 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:

  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.

Being tested
Monthly moral case deliberation
Keywords
Moral case deliberation, Moral distress, Cohort study, Intensive care units, Quality of care, Moral development, Organizational culture
Medical subject headings
Burnout, Professional, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Monthly moral case deliberationOther

    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.

Study groups in NCT04442438
Study groupRoleWhat they receive
Intensive care unit 1ExperimentalReceives 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.
Receives: Other: Monthly moral case deliberation
Intensive care unit 2OtherFirst non-intervention, then flips to experimental arm type after six months.
Receives: Other: Monthly moral case deliberation
Intensive care unit 3OtherFirst non-intervention, then flips to experimental arm type after six months.
Receives: Other: Monthly moral case deliberation
Intensive care unit 4OtherFirst non-intervention, then flips to experimental arm type after twelve months.
Receives: Other: Monthly moral case deliberation
Intensive care unit 5OtherFirst non-intervention, then flips to experimental arm type after twelve months.
Receives: Other: Monthly moral case deliberation
Intensive care unit 6OtherFirst non-intervention, then flips to experimental arm type after Eighteen months.
Receives: Other: Monthly moral case deliberation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument

    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.

    Measured: six months

Secondary outcomes (1)
  1. Moral distress - measured by the 21-item moral distress scale (revised version) survey instrument

    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.

    Measured: six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2020
  2. Study start1 Oct 2019
  3. Primary completion1 Sep 2021
  4. Study completion1 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Single group
Model description
Longitudinal Stepped Wedge cluster randomized Trial with an open cohort
Masking
None (open label)
Enrolment
435 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04442438
Sponsor's protocol ID
CH2018-01
Acronym
MCDIC
Status last verified
Nov 2022
First submitted
17 Jun 2020
Last updated
4 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kok N, Zegers M, Teerenstra S, Fuchs M, van der Hoeven JG, van Gurp JLP, Hoedemaekers CWE. Effect of Structural Moral Case Deliberation on Burnout Symptoms, Moral Distress, and Team Climate in ICU Professionals: A Parallel Cluster Randomized Trial. Crit Care Med. 2023 Oct 1;51(10):1294-1305. doi: 10.1097/CCM.0000000000005940. Epub 2023 Jun 5.

    PubMed 37272981

Questions about this trial

What is this clinical trial studying?

A study testing Monthly moral case deliberation in people with Burnout, Professional and Caregiver Exhaustion, run by Radboud University Medical Center at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burnout - measured by the Utrecht Burnout Scale (UBOS-C) survey instrument (time frame: six months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04442438, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.

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