Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06071078

Impact of a Protocol for Announcing Decision of Withholding and Withdrawing Life-sustaining Treatments on the Stress of the Relatives in the Emergency Departments

Led by Hospices Civils de Lyon · Updated on 2025-08-28

538

Participants Needed

9

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Death is a daily reality in the emergency department. Deaths represent 0.3 to 0.5% of emergency admissions, i.e. approximately 26,000 per year for the whole of France. For 80% of these deceased patients, a decision of withholding and withdrawing life-sustaining treatments was made in the emergency departments. The announcement of death and decision of withholding and withdrawing life-sustaining treatments in this context is complex because of the lack of time and the inappropriate places for the announcement. In addition, the short delay in the occurrence of these events may increase the stress and anxiety of families who are unprepared for the announcement. However, there is little data in the literature on the impact on families in terms of their experience of announcements in the emergency context. It has been established that symptoms of anxiety and depression are correlated with the onset of posttraumatic stress disorder and that the latter is more important in the families of deceased patients and after a decision to undergo decision of withholding and withdrawing life-sustaining treatments in the intensive care unit. In order to identify it, several tools have been developed, including the Impact Event Scale (IES), which has been widely used to detect symptoms related to PTSD. It has also been shown that training nursing staff in communication skills or the use of written support in dealing with the families of patients who have died in intensive care reduces the appearance of post-traumatic stress symptoms. Human simulation is a pedagogical technique for learning interpersonal skills through role playing. It is used, among other things, in announcement situations in medicine. Nevertheless, its impact in emergency medicine has not been evaluated. Moreover, it has been shown that the involvement of the patient-partner in the care process must be improved and encouraged and that its impact has yet to be evaluated. Therefore, the objective is to evaluate the impact of a model protocol for announcing decision of withholding and withdrawing life-sustaining treatments, with human simulation and the intervention of partner families in a simulation center and in situ, on the reduction of family stress following the announcement of a decision of withholding and withdrawing life-sustaining treatments in the emergency departments. Hypothesis is that training all emergency department caregivers in the use of a model announcement protocol with the support of human simulation, combining training of pairs in a simulation center and in situ training, and the participation of partner families, would allow for a better understanding of announce of withholding and withdrawing life-sustaining treatments decision in the emergency department and reduce their impact on families in terms of the occurrence of acute stress and post-traumatic stress symptoms.

CONDITIONS

Official Title

Impact of a Protocol for Announcing Decision of Withholding and Withdrawing Life-sustaining Treatments on the Stress of the Relatives in the Emergency Departments

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Trusted persons, families, or relatives present in the emergency department who receive the first announcement of a decision to limit or stop therapies by a participating physician
  • Age over 18 years for trusted persons, families, or close friends
  • Informed consent given and voice recording rights signed for families accepting the semi-directed interview
  • Caregivers working on participating wards
  • Signed consent for voice recording for partner families involved in the training protocol
Not Eligible

You will not qualify if you...

  • Trusted persons, families, or close friends who received the announcement entirely by telephone
  • Unable to understand or write in French
  • Pregnant women, women in labor, or nursing mothers
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under psychiatric care
  • Persons admitted to a health or social institution for non-research purposes
  • Adults under legal protection measures (guardianship, curatorship)
  • Persons not affiliated with a social security system or similar
  • Caregivers not affiliated with a social security system or similar

AI-Screening

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Trial Site Locations

Total: 9 locations

1

CHU Angers

Angers, France, 49000

Actively Recruiting

2

CH de Bourg-en-Bresse

Bourg-en-Bresse, France, 01000

Actively Recruiting

3

CHU de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

4

CHU de Grenoble

Grenoble, France, 38000

Actively Recruiting

5

Groupement hospitalier centre, Hospices Civils de Lyon

Lyon, France, 69003

Actively Recruiting

6

Groupement hospitalier nord, Hospices Civils de Lyon

Lyon, France, 69004

Actively Recruiting

7

Groupement hospitalier sud, Hospices Civils de Lyon

Lyon, France, 69310

Actively Recruiting

8

CHU de Toulouse

Toulouse, France, 31000

Actively Recruiting

9

CH de Villefranche

Villefranche-sur-Saône, France, 69400

Actively Recruiting

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Research Team

M

Marion MD DOUPLAT

CONTACT

A

Anne TERMOZ

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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