An interventional study of Training of professionals according to the DISCUSS announcement protocol in End of Life, sponsored by Hospices Civils de Lyon. Recruiting at 9 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Supportive care
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.
456 studies on the registry are indexed under Death; 86 are open to participants now.
This study's planned enrollment of 538 is above the median of 163 across 210 interventional studies indexed under Death.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For relatives, will be included in the study:
For caregivers, also included in the study will be:
For partner families, will be included in the study:
Exclusion Criteria:
For relatives:
For caregivers:
- Persons not affiliated to a social security system or beneficiaries of a similar system.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Behavioral: Training of professionals according to the DISCUSS announcement protocol
Individuals will receive the usual practices.
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.
Assessment of post-traumatic stress symptoms
Post-traumatic stress symptoms will be assessed using IES (Impact of Even Scale) at 90 days. The IES score is composed of 15 questions. The maximum score is 75, the minimum score is 0. A high score reflects an improvement/worsening of the condition of the subject participating in the study. This evaluation will be conducted by a psychologist, trained in the data collection interview, on the telephone, unbeknownst to the group (training given or not to the caregiver).
Time frame: Day 90 after the announcement in the emergency department
Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms
Post-traumatic symptoms will be assessed using the Impact of Event Scale (IES) at 7 days. The IES score is composed of 15 questions. The maximum score is 75, the minimum score is 0. A high score reflects a worsening of the condition of the subject participating in the study.
Time frame: Day 7 after the announcement in the emergency department
Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms
Post-traumatic symptoms will be assessed using the Impact of Event Scale (IES) at 30 days. The IES score is composed of 15 questions. The maximum score is 75, the minimum score is 0. A high score reflects a worsening of the condition of the subject participating in the study.
Time frame: Day 30 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Diagnosis of post-traumatic stress
The diagnosis of post-traumatic stress at 90 days will be established by the PCL-5 (Post Traumatic Stress Disorder Checklist for DSM-5, "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition"). The PCL-5 scale is composed of 20 items. The maximum score is 80, the minimum score is 0. A high score reflects a worsening of the condition of the subject participating in the study.
Time frame: Day 90 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
Anxiety and depression symptoms will be assessed using the HADS (Hospital Anxiety and Depression Scale) score at 7 days. The HADS score is composed of 14 items. The maximum score for the anxiety part is 21 and for the depression part is 21, the minimum score is 0. A high score reflects a worsening of the condition of the subject participating in the study.
Time frame: Day 7 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
Anxiety and depression symptoms will be assessed using the HADS (Hospital Anxiety and Depression Scale) score at 30 days. The HADS score is composed of 14 items. The maximum score for the anxiety part is 21 and for the depression part is 21, the minimum score is 0. A high score reflects a worsening of the condition of the subject participating in the study.
Time frame: Day 30 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
Anxiety and depression symptoms will be assessed using the HADS (Hospital Anxiety and Depression Scale) score at 90 days. The HADS score is composed of 14 items. The maximum score for the anxiety part is 21 and for the depression part is 21, the minimum score is 0. A high score reflects a worsening of the condition of the subject participating in the study.
Time frame: Day 90 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences
The experience of the relatives will be evaluated through questions collected 7 days after the announcement by a psychologist (questions on experience and feelings).
Time frame: Day 7 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences in the training group
The experiences of the families will be evaluated on a sample of the families in this "training" group. To do so, a psychologist with these families will conduct semi-directive interviews.
Time frame: Day 90 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Impact on the socio-professional life of families
The impact of the announcement on the socio-professional life of families will be assessed by the presence of at least one work stoppage related to a visit to the emergency department within 90 days of the announcement, followed by the number of days of work stoppage. These data will be collected during the 90-day telephone interview with the psychologist.
Time frame: Day 90 after the announcement in the emergency department
Caregivers - Satisfaction with protocol training
Caregivers' satisfaction will be assessed using a self-questionnaire based on the model recommended by the French National Authority for Health (Haute Autorité de Santé) and used in the SAMSEI program ("Stratégies d'Apprentissage des Métiers de Santé en Environnement Immersif", or "Learning Strategies for Healthcare Professions in an Immersive Environment" in English) and the Lyon Sud Health Simulation Center. The questionnaire will be completed by participants at the end of protocol training. The questionnaire will assess interest, practical usefulness, density of information, compliance with objectives, material conditions of training, participant activity and motivation to continue training.
Time frame: Month 4, Month 8, Month 12, Month 16, Month 20 after training
Caregivers - Impact of partner families' involvement in training on professionals
Caregivers' views on the involvement of partner families will be assessed by means of a self-administered questionnaire and during semi-structured interviews. The questionnaire will be completed by the participants before and after the training and intervention of the partner families.
Time frame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
Caregivers - Evaluating assertiveness at the communication level prior to protocol training
Caregivers' assertiveness in communication will be assessed at the beginning of the study using the Cungi and Rey scale. The Cungi and Rey scale is composed of 10 items. The maximum score is 80, the minimum score is 10. A high score reflects a good level of assertiveness in communication.
Time frame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
Caregivers - Evaluate assertiveness in communication
Caregivers' assertiveness in communication will be assessed at the beginning of the study using the Cungi and Rey scale. The Cungi and Rey scale is composed of 10 items. The maximum score is 80, the minimum score is 10. A high score reflects a good level of assertiveness in communication.
Time frame: Day 90 after the announcement in the emergency department
Caregivers - Evaluation of self-confidence in complex relational situations addressed during simulation prior to protocol training
Caregivers' self-confidence in the complex relational situations addressed during the simulation will be assessed by a self-questionnaire using a Likert-type scale at the start of the study.
Time frame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
Caregivers - Evaluation of self-confidence in complex relational situations addressed during simulation 90 days after training
Caregivers' self-confidence in the complex relational situations addressed during the simulation will be assessed by a self-questionnaire using a Likert-type scale at 90 days after the human simulation training.
Time frame: Day 90 after the announcement in the emergency department
Caregivers - Evaluate real-life stress levels in caregivers' professional environment for decision of withholding and withdrawing life-sustaining treatments prior to protocol training
Caregivers' stress in their professional environment will be assessed using the Karasek scale, which evaluates mental stress at work at the start of the study. The Karasek scale is composed of 29 items. The maximum score is 116, the minimum score is 29.
Time frame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
Caregivers - Evaluate real-life stress levels in caregivers' professional environment for decision of withholding and withdrawing life-sustaining treatments announcement
Caregivers' stress in their professional environment will be assessed using the Karasek scale, which evaluates mental stress at work at 90 days after human simulation training. The Karasek scale is composed of 29 items. The maximum score is 116, the minimum score is 29.
Time frame: Day 90 after the announcement in the emergency department
Caregivers - Evaluating behavior change
The theory of behavioural change will be evaluated by a questionnaire completed after training.
Time frame: Month 4, Month 8, Month 12, Month 16, Month 20 after training
Caregivers - Evaluating caregivers' experience of decision of withholding and withdrawing life-sustaining treatments after training
The qualitative evaluation of caregivers' experience of the announcement will be carried out in the form of semi-structured interviews 90 days after the training.
Time frame: Day 90 after training
Emergency departments - Implementation of the protocol in practice
The implementation of the protocol will be assessed by the adoption of the announcement protocol by professionals, the deployment of the various components of the intervention protocol (dedicated place, presence of pairs, duration of the announcement, etc.), the adaptations made for announcements of death and decision of withholding and withdrawing life-sustaining treatments. It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Emergency departments - Mechanisms of effect of the intervention - Participation and satisfaction of professionals with the training
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Emergency departments - Mechanisms of effect of the intervention - Reactions of families during the LAT
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Emergency departments - Mechanisms of effect of the intervention - Unexpected effects of the use of the announcement protocol
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Departmental organizational factors
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Leadership-facilitator in the team
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Number of emergency department visits with flow analysis
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Characteristics of the patients cared for
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time frame: Day 90 after training
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices) may be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose on request after authorization by the sponsor, the legal department of the Hospices Civils de Lyon and the signature of contract between identified parts.
Supporting information: Study protocol
Time frame: beginning 3 months and ending 5 years following publication
Access criteria: anne.termoz@chu-lyon.fr
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