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

NCT ID: NCT06071078

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2026-01-19

Brief Summary

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

End of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

DISCUSS announcement protocol

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

Group Type: EXPERIMENTAL

Training of professionals according to the DISCUSS announcement protocol

Intervention Type: BEHAVIORAL

The emergency services will be divided into 4 clusters (2 or 3 services per cluster). Each cluster will belong successively to the control arm and then to the intervention arm according to a 5 successive steps of 4 months duration (stepped wedge method). The deployment of the training will therefore not be done simultaneously in the different services.

Individuals in this group will have received a decision of withholding and withdrawing life-sustaining treatments according to the DISCUSS announcement protocol, by a professional trained in this procedure.

Control

Individuals will receive the usual practices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Training of professionals according to the DISCUSS announcement protocol

The emergency services will be divided into 4 clusters (2 or 3 services per cluster). Each cluster will belong successively to the control arm and then to the intervention arm according to a 5 successive steps of 4 months duration (stepped wedge method). The deployment of the training will therefore not be done simultaneously in the different services.

Individuals in this group will have received a decision of withholding and withdrawing life-sustaining treatments according to the DISCUSS announcement protocol, by a professional trained in this procedure.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

For relatives, will be included in the study:

• Trusted persons, families or relatives present in the emergency departments and to whom the 1st announcement of a decision to limit or stop therapies is made by a physician participating in the study. Several persons can be included for the same patient (maximum 3) in the following order: trusted person > family > close relative.
• Age of trusted person, family or close friends over 18 years old.
• Informed consent given and voice rights signed for families accepting the semi-directed interview.

For caregivers, also included in the study will be:

• Caregivers on participating wards.
• Informed consent given and voice rights signed for families accepting the semi-directed interview.

For partner families, will be included in the study:

• Trusted persons, families or relatives present in the emergency department and to whom the 1st announcement of a decision to limit or stop therapy by a physician in a participating emergency department is made.
• Age of trusted person, family or close friends over 18 years old.
• Signed consent for the right to voice recording.

Exclusion Criteria

For relatives:

• Trusted person, family or close friend whose announcement would have been made entirely by telephone.
• Trusted person, family or close friend unable to understand or write in French.
• Pregnant women, women in labor or nursing mothers.
• Persons deprived of liberty by a judicial or administrative decision.
• Persons under psychiatric care.
• Persons admitted to a health or social institution for purposes other than research.
• Persons of full age who are subjects to a legal protection measure (guardians, curators).
• Persons not affiliated to a social security system or beneficiaries of a similar system.

For caregivers:

• Persons not affiliated to a social security system or beneficiaries of a similar system.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Angers

Angers, , France

Site Status: RECRUITING

CH de Bourg-en-Bresse

Bourg-en-Bresse, , France

Site Status: RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

CHU de Grenoble

Grenoble, , France

Site Status: RECRUITING

Groupement hospitalier centre, Hospices Civils de Lyon

Lyon, , France

Site Status: RECRUITING

Groupement hospitalier nord, Hospices Civils de Lyon

Lyon, , France

Site Status: RECRUITING

Groupement hospitalier sud, Hospices Civils de Lyon

Lyon, , France

Site Status: RECRUITING

CHU de Toulouse

Toulouse, , France

Site Status: RECRUITING

CH de Villefranche

Villefranche-sur-Saône, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Marion MD DOUPLAT

Role: CONTACT

marion.douplat@chu-lyon.fr

04 78 86 28 54 ext. +33

Anne TERMOZ

Role: CONTACT

anne.termoz@chu-lyon.fr

04 27 85 63 00 ext. +33

Facility Contacts

Perrine MD LEDUC

Role: primary

Sébastien MD ROUX

Role: primary

Fares PR MOUSTAFA

Role: primary

Damien MD VIGLINO

Role: primary

Charlotte MD DUPUY

Role: primary

Bénédicte MD CLEMENT

Role: primary

Véronique MD POTINET

Role: primary

Xavier MD DUBUCS

Role: primary

Frédéric MD VERBOIS

Role: primary

References

Termoz A, Subtil F, Drouin P, Marchal M, Verroul M, Langlois C, Bravant E, Jacquin L, Clement B, Viglino D, Roux-Boniface D, Verbois F, Demarquet M, Dubucs X, Douillet D, Tazarourte K, Schott-Pethelaz AM, Haesebaert J, Douplat M. Evaluating the impact of a standardised intervention for announcing decisions of withholding and withdrawing life-sustaining treatments on the stress of relatives in emergency departments (DISCUSS): protocol for a stepped-wedge randomised controlled trial. BMJ Open. 2024 Sep 5;14(9):e087444. doi: 10.1136/bmjopen-2024-087444.

Reference Type: DERIVED

PMID: 39237283 (View on PubMed)

Other Identifiers

69HCL20_0070

Identifier Type: -

Identifier Source: org_study_id