Ethics, NarrativeNCT05722431
Ethical Deliberation in the Intensive Care Unit, Impact of Formalized Multidisciplinary Team Meetings, a Pilot Study
An observational study of Ethics, Narrative, run by University Hospital, Tours at 1 site in France.
Trial summary
Most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (WWLST) decision. The implementation of formalized interdisciplinary team meetings for ethical deliberation in the ICU may improve nurses participation in WWLST decisions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ethics, Narrative
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2023to 31 Oct 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted in the ICU
Who may be able to join
- All patients admitted in the ICU
Who cannot join
- Age below 18
Trial locations and contacts
1 site in 1 country.
France1 site
Trauma and surgical intensive care unit, Tours University Hospital
Tours, 37000
About this study
Most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (WWLST) decision. The implementation of formalized interdisciplinary team meetings for ethical deliberation in the ICU may improve nurses participation in WWLST decisions. The investigators decided to implement such team meetings in their ICU. At this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.
Read the detailed description
Most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (WWLST) decision. Because those decisions are value-laden, guidelines as well as french regulations recommend that they should involve not only medical doctors but also nurses. Despite that, nurses' involvement remains incomplete. Poor collaboration between doctors and nurses on ethical decisions is associated with job dissatisfaction, burnout and desire to quit. The implementation of formalized interdisciplinary team meetings for ethical deliberation in the ICU may improve nurses participation in WWLST decisions.
For those reasons the investigators decided to implement such team meetings in their ICU. At this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.
- Conditions
- Ethics, Narrative
- Keywords
- End of life decisions in the ICU, Multidisciplinary team meetings, Ethical decision making climate, Nurses job satisfaction
- Medical subject headings
- Narration
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nurses perception of ethical decision making climate in the ICU
Nurses answers to the questionnaire "Ethical Decision-Making Climate Questionnaire (7 factors evaluated, for each factor score ranges from 1 to 5, higher scores indicate a better climate)".
Measured: june 2023, january 2024
Secondary outcomes (4)
Change in nurses psychological well being at work
Nurses answers to the Index of psychological well being at work (5 factors, for each factor score ranges from 1 to 5, higher scores indicate more well being).
Measured: 2 evaluations: may 2023, january 2024
Change in nurses frustration of job's related psychological needs
Nurses answers to the Job related psychological needs frustration score (3 factors, for each factor score ranges from 1 to 5, higher score indicate more frustration)
Measured: 2 evaluations: may 2023, january 2024
Change in nurses desire to leave
Nurses answers to a one question questionnaire:
"I have thoughts about leaving my current position/job" (lickert scale, score range from 1 to 5, higher score indicate a higher desire to leave)
Measured: 2 evaluations: may 2023, january 2024
Non beneficial care
Duration of mechanical ventilation in patients who ultimately die (number of days)
Measured: January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Feb 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ethics, NarrativeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ROMAIN MIGUEL MONTANES, MD, Principal investigator, University Hospital of TOURSServane Barrault, PhD, Principal investigator, University of Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722431
- Sponsor's protocol ID
- DER
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethical Deliberation in the Intensive Care Unit, Impact of Formalized Multidisciplinary Team Meetings, a Pilot Study
- ClinicalTrials.gov ID
- NCT05722431
- Acronym / sponsor ID
- DER
- Conditions
- Ethics, Narrative
- Keywords
- End of life decisions in the ICU, Multidisciplinary team meetings, Ethical decision making climate, Nurses job satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (WWLST) decision. The implementation of formalized interdisciplinary team meetings for ethical deliberation in the ICU may improve nurses participation in WWLST decisions. The investigators decided to implement such team meetings in their ICU. At this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.
Detailed description
Most patients who die in the intensive care unit do so after a withholding or withdrawing of life sustaining treatments (WWLST) decision. Because those decisions are value-laden, guidelines as well as french regulations recommend that they should involve not only medical doctors but also nurses. Despite that, nurses' involvement remains incomplete. Poor collaboration between doctors and nurses on ethical decisions is associated with job dissatisfaction, burnout and desire to quit. The implementation of formalized interdisciplinary team meetings for ethical deliberation in the ICU may improve nurses participation in WWLST decisions.
For those reasons the investigators decided to implement such team meetings in their ICU. At this occasion, the investigators will measure job satisfaction, job related frustration and ethical decision making climate climate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted in the ICU
Key inclusion criteria (1 listed)
- All patients admitted in the ICU
Key exclusion criteria (1 listed)
- Age below 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in nurses perception of ethical decision making climate in the ICU
Time frame: june 2023, january 2024
Nurses answers to the questionnaire "Ethical Decision-Making Climate Questionnaire (7 factors evaluated, for each factor score ranges from 1 to 5, higher scores indicate a better climate)".
4 secondary outcomes
Change in nurses psychological well being at work
Time frame: 2 evaluations: may 2023, january 2024
Change in nurses frustration of job's related psychological needs
Time frame: 2 evaluations: may 2023, january 2024
Change in nurses desire to leave
Time frame: 2 evaluations: may 2023, january 2024
Non beneficial care
Time frame: January 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ROMAIN MIGUEL MONTANES, MD principal investigator
University Hospital of TOURS
Servane Barrault, PhD principal investigator
University of Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ethics, Narrative, run by University Hospital, Tours at 1 site in France.
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 1 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 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Change in nurses perception of ethical decision making climate in the ICU (time frame: june 2023, january 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 May 2026.