Impact of a Protocol for Announcing the Limitation and Discontinuation of Therapies in the Emergency Departments on the Stress of Families
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 538
- 试验地点
- 18
- 主要终点
- Assessment of post-traumatic stress symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Assessment of post-traumatic stress symptoms
时间窗: 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).
次要结局
- Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences in the training group(Day 90 after the announcement in the emergency department)
- Families - Effect of the protocol for announcing therapeutic limitations or cessation - Anxiety and depression symptoms(Day 90 after the announcement in the emergency department)
- Caregivers - Satisfaction with protocol training(Month 4, Month 8, Month 12, Month 16, Month 20 after training)
- Caregivers - Evaluate assertiveness in communication(Day 90 after the announcement in the emergency department)
- Families - Effect of the protocol for announcing limitations or cessation of treatment - Post-traumatic stress symptoms(Day 30 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(Day 90 after the announcement in the emergency department)
- Caregivers - Impact of partner families' involvement in training on professionals(Month 4, Month 8, Month 12, Month 16, Month 20 before training)
- Caregivers - Evaluating assertiveness at the communication level prior to protocol training(Month 4, Month 8, Month 12, Month 16, Month 20 before training)
- Emergency departments - Favourable or limiting contextual factors - Characteristics of the patients cared for(Day 90 after training)
- Families - Effect of the protocol for announcing therapeutic limitations or cessation - Families' experiences(Day 7 after the announcement in the emergency department)
- Caregivers - Evaluation of self-confidence in complex relational situations addressed during simulation prior to protocol training(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 prior to protocol training(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(Day 90 after the announcement in the emergency department)
- Families - Effect of the protocol for announcing therapeutic limitations or cessation - Diagnosis of post-traumatic stress(Day 90 after the announcement in the emergency department)
- Caregivers - Evaluating behavior change(Month 4, Month 8, Month 12, Month 16, Month 20 after training)
- Emergency departments - Mechanisms of effect of the intervention - Participation and satisfaction of professionals with the training(Day 90 after training)
- Emergency departments - Mechanisms of effect of the intervention - Reactions of families during the LAT(Day 90 after training)
- Caregivers - Evaluate real-life stress levels in caregivers' professional environment for decision of withholding and withdrawing life-sustaining treatments announcement(Day 90 after the announcement in the emergency department)
- Caregivers - Evaluating caregivers' experience of decision of withholding and withdrawing life-sustaining treatments after training(Day 90 after training)
- Emergency departments - Implementation of the protocol in practice(Day 90 after training)
- Emergency departments - Favourable or limiting contextual factors - Departmental organizational factors(Day 90 after training)
- Emergency departments - Favourable or limiting contextual factors - Leadership-facilitator in the team(Day 90 after training)
- Emergency departments - Mechanisms of effect of the intervention - Unexpected effects of the use of the announcement protocol(Day 90 after training)
- Emergency departments - Favourable or limiting contextual factors - Number of emergency department visits with flow analysis(Day 90 after training)