NCT04442438|Completed

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

Radboud University Medical Center ClinicalTrials.gov

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1 other identifier

CH2018-01

Study Type

interventional

Target

435

Locations

1 country

Sites

Timeline

RegisteredJun 2020

StartedOct 2019

CompletionNov 2022

Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

435

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.1 years study duration

Study Start

First participant enrolled

October 1, 2019

Completed

9 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2020

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed

1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed

Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

1.9 years

First QC Date

June 17, 2020

Last Update Submit

November 2, 2022

Conditions

Burnout, Professional Caregiver Exhaustion

Keywords

Moral case deliberationMoral distressCohort studyIntensive care unitsQuality of careMoral developmentOrganizational culture

Outcome Measures

Primary Outcomes (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.
six months

Secondary Outcomes (1)

Moral distress - measured by the 21-item moral distress scale (revised version) survey instrument
six months

Other Outcomes (1)

Team cohesion - measured by the Team Climate Inventory survey instrument
six months

Study Arms (6)

Intensive care unit 1

EXPERIMENTAL

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.