Clinical trial NCT06071078: Impact of a Protocol for Announcing Decision of Withholding and Withdrawing Life-sustaining Treatments on the Stress of the Relatives in the Emergency Departments
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: End of Life
Keywords: Limitation and cessation of treatment
Stress
End of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 532
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped-wedge trial
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Assessment of post-traumatic stress symptoms
timeFrame: Day 90 after the announcement in the emergency department
Secondary outcomes:
measure: Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms
timeFrame: Day 7 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms
timeFrame: Day 30 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing therapeutic limitations or cessation - Diagnosis of post-traumatic stress
timeFrame: Day 90 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
timeFrame: Day 7 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
timeFrame: Day 30 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms
timeFrame: Day 90 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences
timeFrame: Day 7 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences in the training group
timeFrame: Day 90 after the announcement in the emergency department
measure: Families - Effect of the protocol for announcing therapeutic limitations or cessation - Impact on the socio-professional life of families
timeFrame: Day 90 after the announcement in the emergency department
measure: Caregivers - Satisfaction with protocol training
timeFrame: Month 4, Month 8, Month 12, Month 16, Month 20 after training
measure: Caregivers - Impact of partner families' involvement in training on professionals
timeFrame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
measure: Caregivers - Evaluating assertiveness at the communication level prior to protocol training
timeFrame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
measure: Caregivers - Evaluate assertiveness in communication
timeFrame: Day 90 after the announcement in the emergency department
measure: Caregivers - Evaluation of self-confidence in complex relational situations addressed during simulation prior to protocol training
timeFrame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
measure: Caregivers - Evaluation of self-confidence in complex relational situations addressed during simulation 90 days after training
timeFrame: Day 90 after the announcement in the emergency department
measure: Caregivers - Evaluate real-life stress levels in caregivers' professional environment for decision of withholding and withdrawing life-sustaining treatments prior to protocol training
timeFrame: Month 4, Month 8, Month 12, Month 16, Month 20 before training
measure: Caregivers - Evaluate real-life stress levels in caregivers' professional environment for decision of withholding and withdrawing life-sustaining treatments announcement
timeFrame: Day 90 after the announcement in the emergency department
measure: Caregivers - Evaluating behavior change
timeFrame: Month 4, Month 8, Month 12, Month 16, Month 20 after training
measure: Caregivers - Evaluating caregivers' experience of decision of withholding and withdrawing life-sustaining treatments after training
timeFrame: Day 90 after training
measure: Emergency departments - Implementation of the protocol in practice
timeFrame: Day 90 after training
measure: Emergency departments - Mechanisms of effect of the intervention - Participation and satisfaction of professionals with the training
timeFrame: Day 90 after training
measure: Emergency departments - Mechanisms of effect of the intervention - Reactions of families during the LAT
timeFrame: Day 90 after training
measure: Emergency departments - Mechanisms of effect of the intervention - Unexpected effects of the use of the announcement protocol
timeFrame: Day 90 after training
measure: Emergency departments - Favourable or limiting contextual factors - Departmental organizational factors
timeFrame: Day 90 after training
measure: Emergency departments - Favourable or limiting contextual factors - Leadership-facilitator in the team
timeFrame: Day 90 after training
measure: Emergency departments - Favourable or limiting contextual factors - Number of emergency department visits with flow analysis
timeFrame: Day 90 after training
measure: Emergency departments - Favourable or limiting contextual factors - Characteristics of the patients cared for
timeFrame: Day 90 after training
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Bourg-en-Bresse
country: France
facility: CH de Bourg-en-Bresse
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lyon
country: France
facility: Groupement hospitalier centre, Hospices Civils de Lyon
city: Lyon
country: France
facility: Groupement hospitalier nord, Hospices Civils de Lyon
city: Lyon
country: France
facility: Groupement hospitalier sud, Hospices Civils de Lyon
city: Toulouse
country: France
facility: CHU de Toulouse
city: Villefranche-sur-Saône
country: France
facility: CH de Villefranche
Study officials:
References: