Experience of Relatives and Intensive Care Units Caregivers of Controlled Donation After Circulatory Death (CARE-M3)

  • STATUS
    Recruiting
  • End date
    Oct 27, 2024
  • participants needed
    357
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 19 April 2022

Summary

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.

Description

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.

At the time of the discussion about OD with the relatives :

  • The screening for inclusion will be done.
  • If 1 relative volunteers to participate in the study (non-opposition noted by the investigator), the situation is included in CARE-M3 "relative" section.
  • If no relatives volunteer to participate in the study, the situation can be included in CARE M3 for the caregiver section after the patient's death.

After the patient death, wether or not OD occurs:

  • 3 caregivers (1 physician and 2 paramedics) can be included. These are the caregivers who are present at the time the WLST is initiated.
  • If at least two caregivers volunteer to participate in the study, the situation is included in CARE-M3 caregiver section.

Objectives concerning the relatives

  • Primary objective: to study their risk of developing symptoms of post-traumatic stress disorder in the months following the patient's death.
  • Secondary objectives: assessment of symptoms of anxiety, depression, complicated grief, assessment of understanding of the decision process to withdraw LST and the cDCD procedure.

Objectives concerning the ICU caregivers

  • Primary objective: to study their risk developing anxiety relating to the event.
  • Secondary objectives: evaluation of the impact of the cDCD procedure on the WLST decision-making process, end-of-life practices, support at the end-of-life (EOL) and quality of the EOL.

Details
Condition Death, Assisted, Tissue and Organ Procurement, Life Support Care
Treatment Relative section, Caregiver section
Clinical Study IdentifierNCT05041023
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Relative and/or caregiver who has given non-objection to the use of the data
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

Exclusion Criteria

None
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