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

Overview

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.

Interventions

• Behavioral Training of professionals according to the DISCUSS announcement protocol
  The emergency services will be divided into 4 clusters (2 or 3 services per cluster). Each cluster will belong successively to the control arm and then to the intervention arm according to a 5 successive steps of 4 months duration (stepped wedge method). The deployment of the training will therefore not be done simultaneously in the different services. Individuals in this group will have received a decision of withholding and withdrawing life-sustaining treatments according to the DISCUSS annou

Primary outcome measures

• Assessment of post-traumatic stress symptoms [Time frame: Day 90 after the announcement in the emergency department]

Secondary outcome measures (12)

• 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Sequential

Masking

Single blind

Primary purpose

Supportive care

Study locations

France · 9 centers

• CHU Angers — Angers
• CH de Bourg-en-Bresse — Bourg-en-Bresse
• CHU de Clermont-Ferrand — Clermont-Ferrand
• CHU de Grenoble — Grenoble
• Groupement hospitalier centre, Hospices Civils de Lyon — Lyon
• Groupement hospitalier nord, Hospices Civils de Lyon — Lyon
• Groupement hospitalier sud, Hospices Civils de Lyon — Lyon
• CHU de Toulouse — Toulouse
• … and 1 more center

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 emer PMID 39237283

Identifiers

NCT: NCT06071078 · 69HCL20_0070

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗