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

Primary Purpose

End of Life

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Training of professionals according to the DISCUSS announcement protocol
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for End of Life focused on measuring Limitation and cessation of treatment, Stress, End of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CHU Angers
  • CH de Bourg-en-Bresse
  • CHU de Clermont-Ferrand
  • CHU de Grenoble
  • Groupement hospitalier centre, Hospices Civils de Lyon
  • Groupement hospitalier nord, Hospices Civils de Lyon
  • Groupement hospitalier sud, Hospices Civils de Lyon
  • CHU de Toulouse
  • CH de Villefranche

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DISCUSS announcement protocol

Control

Arm Description

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

Individuals will receive the usual practices.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Caregivers - Evaluating behavior change
The theory of behavioural change will be evaluated by a questionnaire completed 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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 8, 2023
Last Updated
October 2, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT06071078
Brief 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
Acronym
DISCUSS
Official Title
Impact of a Protocol for Announcing the Limitation and Discontinuation of Therapies in the Emergency Departments on the Stress of Families
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End of Life
Keywords
Limitation and cessation of treatment, Stress, End of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Stepped-wedge trial
Masking
Outcomes Assessor
Masking Description
The evaluation will be carried out centrally for all the subjects included, 90 days after the announcement to the emergency room, by a psychologist, trained in the data collection interview, on the telephone, without the knowledge of the group (training provided or not to caregivers).
Allocation
Randomized
Enrollment
532 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DISCUSS announcement protocol
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
Individuals will receive the usual practices.
Intervention Type
Behavioral
Intervention Name(s)
Training of professionals according to the DISCUSS announcement protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of post-traumatic stress symptoms
Description
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
Secondary Outcome Measure Information:
Title
Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms
Description
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
Title
Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms
Description
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
Title
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Diagnosis of post-traumatic stress
Description
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
Title
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
Description
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
Title
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
Description
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
Title
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
Description
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
Title
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences
Description
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
Title
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences in the training group
Description
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
Title
Families - Effect of the protocol for announcing therapeutic limitations or cessation - Impact on the socio-professional life of families
Description
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
Title
Caregivers - Satisfaction with protocol training
Description
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
Title
Caregivers - Impact of partner families' involvement in training on professionals
Description
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
Title
Caregivers - Evaluating assertiveness at the communication level prior to protocol training
Description
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
Title
Caregivers - Evaluate assertiveness in communication
Description
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
Title
Caregivers - Evaluation of self-confidence in complex relational situations addressed during simulation prior to protocol training
Description
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
Title
Caregivers - Evaluation of self-confidence in complex relational situations addressed during simulation 90 days after training
Description
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
Title
Caregivers - Evaluate real-life stress levels in caregivers' professional environment for decision of withholding and withdrawing life-sustaining treatments prior to protocol training
Description
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
Title
Caregivers - Evaluate real-life stress levels in caregivers' professional environment for decision of withholding and withdrawing life-sustaining treatments announcement
Description
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
Title
Caregivers - Evaluating behavior change
Description
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
Title
Caregivers - Evaluating caregivers' experience of decision of withholding and withdrawing life-sustaining treatments after training
Description
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
Title
Emergency departments - Implementation of the protocol in practice
Description
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
Title
Emergency departments - Mechanisms of effect of the intervention - Participation and satisfaction of professionals with the training
Description
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time Frame
Day 90 after training
Title
Emergency departments - Mechanisms of effect of the intervention - Reactions of families during the LAT
Description
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time Frame
Day 90 after training
Title
Emergency departments - Mechanisms of effect of the intervention - Unexpected effects of the use of the announcement protocol
Description
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time Frame
Day 90 after training
Title
Emergency departments - Favourable or limiting contextual factors - Departmental organizational factors
Description
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time Frame
Day 90 after training
Title
Emergency departments - Favourable or limiting contextual factors - Leadership-facilitator in the team
Description
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time Frame
Day 90 after training
Title
Emergency departments - Favourable or limiting contextual factors - Number of emergency department visits with flow analysis
Description
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time Frame
Day 90 after training
Title
Emergency departments - Favourable or limiting contextual factors - Characteristics of the patients cared for
Description
It will be evaluated by questionnaires and ad hoc indicators and during semi-structured interviews.
Time Frame
Day 90 after training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion MD DOUPLAT
Phone
04 78 86 28 54
Ext
+33
Email
marion.douplat@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne TERMOZ
Phone
04 27 85 63 00
Ext
+33
Email
anne.termoz@chu-lyon.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrine MD LEDUC
Facility Name
CH de Bourg-en-Bresse
City
Bourg-en-Bresse
ZIP/Postal Code
01000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien MD ROUX
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannot PR SCHMIDT
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien MD VIGLINO
Facility Name
Groupement hospitalier centre, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent MD JACQUIN
Facility Name
Groupement hospitalier nord, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bénédicte MD CLEMENT
Facility Name
Groupement hospitalier sud, Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69310
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique MD POTINET
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier MD DUBUCS
Facility Name
CH de Villefranche
City
Villefranche-sur-Saône
ZIP/Postal Code
69400
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric MD VERBOIS

12. IPD Sharing Statement

Learn more about this trial

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

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