Clinical trial NCT05041023: Experience of Relatives and Intensive Care Units Caregivers of Controlled Donation After Circulatory Death
Official title: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Death, Assisted
Tissue and Organ Procurement
Life Support Care
Keywords: End-of-life
Withdrawal of life-sustaining treatments
Controlled donation after circulatory death
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
name: Fondation de France
First posted: 2021-09-10
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The relatives of patients who have died in ICU are the first attendant of the patient at the end-of-life EOL. During this procedure, relatives are particularly solicited because they are strongly involved in the decision-making process. The most involved relative in the relationship with the resuscitation team will be asked to participate in the study.

Caregivers included in the study are caregivers from ICU who are present at the time the withdrawal of life-sustaining therapies WLST is initiated: at least 1 physician and 1 or 2 paramedics.

Brief 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.

Detailed 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.

Eligibility criteria: 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 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.

Exclusion Criteria:

* None

Primary outcomes:
measure: Hetero-evaluation of the relative using the IES-R scale
timeFrame: 3 months after patient's death
measure: Self-report of the caregiver using the STAI inventory
timeFrame: within 72 hours following the patient's death
Secondary outcomes:
measure: Hetero-evaluation of the relative using the HADS anxiety-depression scales
timeFrame: 3 months after patient's death
measure: Hetero-evaluation of the relative using the CAESAR end-of-life quality scale
timeFrame: 3 months after patient's death
measure: Hetero-evaluation of the relative using the questionnaire survey
timeFrame: 3 months after patient's death
measure: Hetero-evaluation of the relative using the HADS anxiety-depression scales
timeFrame: 6 months after patient's death
measure: Hetero-evaluation of the relative using the IES-R scale
timeFrame: 6 months after patient's death
measure: Hetero-evaluation of the relative using the PG-13 scale
timeFrame: 6 months after patient's death
measure: Semi-structured interview with relative
timeFrame: from 6 to 12 months after patient's death
measure: Self-evaluation of the caregiver by questionnaire survey
timeFrame: within 72 hours following the patient's death
measure: Semi-structured interview with caregiver
timeFrame: from 6 to 12 months after patient's death
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP - Lariboisière hospital - réanimation chirurgicale
Study officials:
affiliation: Department of anaesthesiology and critical care medicine. Lariboisiere Hospital.
name: Matthieu LE DORZE, Md
role: STUDY_DIRECTOR
References: