Experience of Relatives and Caregivers of Death in ICU After the Withdrawal of Life-sustaining Therapies, Associated With an Organ Procurement Procedure (Controlled Donation After Circulatory Death).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- Hetero-evaluation of the relative using the IES-R scale
研究概览
简要总结
Controlled donation after circulatory death (cDCD) refers to organ donation (OD) from patients whose death is defined using circulatory criteria and from whom circulatory death occurs after a planned withdrawal of life-sustaining therapies (WLST) in intensive care units (ICUs). During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated.
Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD. Better understanding their perceptions and experiences will enable to develop interventions to support and guide them throughout this practice.
详细描述
While withdrawal of life-sustaining therapies (WLST) decision occur significantly more frequently in intensive care units (ICUs), controlled donation after circulatory death (cDCD) evolves end-of-life care and produces a new end-of-life (EOL) model: EOL care now includes the opportunity to donate organs and tissues after death. During cDCD, the patient is still alive while OD process is being discussed and organized. Caregivers can be particularly uncomfortable in this scenario where EOL care and OD in effect overlap. Thus, the implementation of a cDCD program in France, as elsewhere, raised the issue of the potential impact of OD on WLST decision-making processes and EOL practices (particularly sedation). As other countries, the national protocol is nonetheless clear that the decision for WLST must be made in the bests interest of the patient and independent of any consideration of OD, and the donation pathway must not change EOL care. The challenge is not only to identify patients suitable as potential donors but also to provide support to grieving families and to make HCPs comfortable with OD in this particular context. In the specific context of cDCD, developing knowledge on the perceptions and experiences of relatives and ICU caregivers regarding OD is crucial but remains poorly investigated.
Investigators propose to conduct a prospective multicentric observational research to better understand relatives' and ICU caregivers' experience of cDCD.
A relative and/or at least two caregivers (1 physician and 1 or 2 paramedics) are included for any situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been discussed with the relatives, whether or not the organ procurement finally occurred.
Two situations are distinguished:
- WLST without OD possibility: the WLST is initiated while OD is no longer considered for one of the following reasons: medical unsuitability, expressed intend not to be a donor or family refusal, legal issues, logistical problems, hemodynamic instability.
- WLST with OD possibility: the WLST is initiated while OD is still considered, whether or not OD finally occurs for one of the following reasons: circulatory death declared > 180 minutes, excessive warm ischemia time due to normothermic regional perfusion dysfunction or hypoperfusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any situation of anticipated death of a patient in Intensive Care Unit ICU due to circulatory arrest:
- •For which a decision to withdraw Life-Sustaining Therapies LST was taken under the Claeys-Leonetti law, notified to relatives and accepted by relatives
- •With a first evaluation by the hospital coordination of organ and tissue removal identifying the patient at the end of life as a potential donor: patient identified under the age of 70, with no absolute contraindication to organ removal in the context of an M3 procedure
- •For which Organ Donation OD has been discussed with the relatives, whether the OD finally occurred.
- •Relative and/or caregiver who has given non-objection to the use of the data.
排除标准
- 未提供
结局指标
主要结局
Hetero-evaluation of the relative using the IES-R scale
时间窗: 3 months after patient's death
Hetero-evaluation of the relative with the IES-R score (Impact of. Event Scale - Revised score). Assessment is performed by telephone interview with an experienced psychologist. This scale measures the risk for the relative of exhibiting symptoms of post-traumatic stress disorder.
Self-report of the caregiver using the STAI inventory
时间窗: within 72 hours following the patient's death
The caregiver self-assess by responding confidentially to a questionnaire: the STAI inventory (State-Trait Anxiety Inventory). This questionnaire measures their risk of developing anxiety relating to the event.
次要结局
- Hetero-evaluation of the relative using the HADS anxiety-depression scales(6 months after patient's death)
- Hetero-evaluation of the relative using the IES-R scale(6 months after patient's death)
- Hetero-evaluation of the relative using the PG-13 scale(6 months after patient's death)
- Hetero-evaluation of the relative using the questionnaire survey(3 months after patient's death)
- Semi-structured interview with relative(from 6 to 12 months after patient's death)
- Self-evaluation of the caregiver by questionnaire survey(within 72 hours following the patient's death)
- Hetero-evaluation of the relative using the CAESAR end-of-life quality scale(3 months after patient's death)
- Semi-structured interview with caregiver(from 6 to 12 months after patient's death)
