- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05722431
Ethical Deliberation in the Intensive Care Unit, Impact of Formalized Multidisciplinary Team Meetings, a Pilot Study
Délibération éthique en réanimation, Impact de la Mise en Place de réunions éthiques formalisées, Une étude Pilote
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Romain Miguel Montanes, MD
- Phone Number: 0247474747
- Email: r.miguelmontanes@chu-tours.fr
Study Contact Backup
- Name: Wiebe de JONG, MSc
- Phone Number: +33(0)247474680
- Email: w.dejong@chu-tours.fr
Study Locations
-
-
-
Tours, France, 37000
- Recruiting
- Trauma and surgical intensive care unit, Tours University Hospital
-
Contact:
- Romain Miguel Montanes
- Phone Number: 0247474747
- Email: r.miguelmontanes@chu-tours.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- All patients admitted in the ICU
Exclusion Criteria:
- Age below 18
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)".
|
june 2023, january 2024
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in nurses psychological well being at work
Time Frame: 2 evaluations: may 2023, january 2024
|
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).
|
2 evaluations: may 2023, january 2024
|
Change in nurses frustration of job's related psychological needs
Time Frame: 2 evaluations: may 2023, january 2024
|
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)
|
2 evaluations: may 2023, january 2024
|
Change in nurses desire to leave
Time Frame: 2 evaluations: may 2023, january 2024
|
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) |
2 evaluations: may 2023, january 2024
|
Non beneficial care
Time Frame: January 2024
|
Duration of mechanical ventilation in patients who ultimately die (number of days)
|
January 2024
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ROMAIN MIGUEL MONTANES, MD, University Hospital of Tours
- Principal Investigator: Servane Barrault, PhD, University of Tours
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Other Study ID Numbers
- DER
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.
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