End of LifeDISCUSSNCT06071078
Impact of a Protocol for Announcing Decision of Withholding and Withdrawing Life-sustaining Treatments on the Stress of the Relatives in the Emergency Departments
A study testing Training of professionals according to the DISCUSS announcement protocol in people with End of Life, run by Hospices Civils de Lyon at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End of Life
- What is being tested?
- Training of professionals according to the DISCUSS announcement protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 538 participants
- Where
- 9 sitesFrance
- Study dates
- 19 Jan 2024to 19 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
CHU Angers
Angers, 49000
Perrine MD LEDUC
- Recruiting
CH de Bourg-en-Bresse
Bourg-en-Bresse, 01000
Sébastien MD ROUX
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Fares PR MOUSTAFA
- Recruiting
CHU de Grenoble
Grenoble, 38000
Damien MD VIGLINO
- Recruiting
Groupement hospitalier centre, Hospices Civils de Lyon
Lyon, 69003
Charlotte MD DUPUY
- Recruiting
Groupement hospitalier nord, Hospices Civils de Lyon
Lyon, 69004
Bénédicte MD CLEMENT
- Recruiting
Groupement hospitalier sud, Hospices Civils de Lyon
Lyon, 69310
Véronique MD POTINET
- Recruiting
CHU de Toulouse
Toulouse, 31000
Xavier MD DUBUCS
- Recruiting
CH de Villefranche
Villefranche-sur-Saône, 69400
Frédéric MD VERBOIS
About this study
Official title: Impact of a Protocol for Announcing the Limitation and Discontinuation of Therapies in the Emergency Departments on the Stress of Families
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.
Read more
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
- Being tested
- Training of professionals according to the DISCUSS announcement protocol
- Keywords
- Limitation and cessation of treatment, Stress, End of life
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training of professionals according to the DISCUSS announcement protocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DISCUSS announcement protocol | Experimental | 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 Receives: Behavioral: Training of professionals according to the DISCUSS announcement protocol |
| Control | No intervention | Individuals will receive the usual practices. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day 90 after the announcement in the emergency department
Secondary outcomes (27)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 90 after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start19 Jan 2024
- Primary completion19 Jan 2026 (estimated)
- Study completion19 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End of LifeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 538 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071078
- Sponsor's protocol ID
- 69HCL20_0070
- Acronym
- DISCUSS
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2023
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 39237283
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Protocol for Announcing the Limitation and Discontinuation of Therapies in the Emergency Departments on the Stress of Families
- ClinicalTrials.gov ID
- NCT06071078
- Acronym / sponsor ID
- DISCUSS / 69HCL20_0070
- Conditions
- End of Life
- Keywords
- Limitation and cessation of treatment, Stress, End of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 538 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 19 Jan 2026 (estimated)
- Study completion
- 19 Jan 2026 (estimated)
- First posted
- 6 Oct 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Stepped-wedge trial
| Arm | Type | Receives |
|---|---|---|
| DISCUSS announcement protocol | Experimental | Behavioral: Training of professionals according to the DISCUSS announcement protocolModel 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 |
| Control | No intervention | –Individuals will receive the usual practices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Caregivers on participating wards.
- Informed consent given and voice rights signed for families accepting the semi-directed interview.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training of professionals according to the DISCUSS announcement protocolThe 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. | Behavioural | DISCUSS announcement protocol |
Primary outcome
Assessment of post-traumatic stress symptoms
Time frame: Day 90 after the announcement in the emergency department
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).
27 secondary outcomes
Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms
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
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
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
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
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
Time frame: Day 90 after the announcement in the emergency department
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences
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
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
Time frame: Day 90 after the announcement in the emergency department
Caregivers - Satisfaction with protocol 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
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
Time frame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
Caregivers - Evaluate 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
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
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
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
Time frame: Day 90 after the announcement in the emergency department
Caregivers - Evaluating behavior change
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
Time frame: Day 90 after training
Emergency departments - Implementation of the protocol in practice
Time frame: Day 90 after training
Emergency departments - Mechanisms of effect of the intervention - Participation and satisfaction of professionals with the training
Time frame: Day 90 after training
Emergency departments - Mechanisms of effect of the intervention - Reactions of families during the LAT
Time frame: Day 90 after training
Emergency departments - Mechanisms of effect of the intervention - Unexpected effects of the use of the announcement protocol
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Departmental organizational factors
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Leadership-facilitator in the team
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Number of emergency department visits with flow analysis
Time frame: Day 90 after training
Emergency departments - Favourable or limiting contextual factors - Characteristics of the patients cared for
Time frame: Day 90 after training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Derived from this study: PubMed 39237283Termoz 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.
- Individual participant dataSharing planned: 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.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training of professionals according to the DISCUSS announcement protocol in people with End of Life, run by Hospices Civils de Lyon at 9 sites 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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion MD DOUPLAT (04 78 86 28 54 ext. +33, marion.douplat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of post-traumatic stress symptoms (time frame: Day 90 after the announcement in the emergency department). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071078, which also lists 1 linked publication.
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 28 Aug 2025.