Experience of Relatives and Intensive Care Units Caregivers of Controlled Donation After Circulatory Death

NCT ID: NCT05041023

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 367 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-27
• Study Completion Date: 2024-09-13

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.

Conditions

Death, Assisted; Tissue and Organ Procurement; Life Support Care

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Relative volunteers

For each situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been discussed with the relatives, a relative can be included after information and acceptance of the study. One relative per situation can be included : the most involved personn in the relationship with the resuscitation team.

Relative section

Intervention Type: OTHER

Relatives are assessed by phone calling with an experienced psychologist at 3 and 6 months after patient's death. Relatives answer to self-questionnaire and 3 scales.

Furthermore, 20 of them are offered to participate in a semi-structured interview with an experienced psychologist, within 6 months to 1 year following the patient's death.

Caregivers

For each situation of death of a patient in ICU following a decision to withdraw LST and for which OD has been considered, 2 to 3 caregivers who are present at the time the WLST is initiated can be included (1 physician and 1 or 2 paramedics).

Caregiver section

Intervention Type: OTHER

Caregivers are self-evaluated within 72 hours after death by questionnaire survey, whose results will remain confidential to the center that included the situation.

Furthermore, 20 of them (10 medical staff and 10 paramedical staff and / or until saturation) are offered to participate in a semi-structured interview with an experienced psychologist.

Interventions

Relative section

Relatives are assessed by phone calling with an experienced psychologist at 3 and 6 months after patient's death. Relatives answer to self-questionnaire and 3 scales.

Furthermore, 20 of them are offered to participate in a semi-structured interview with an experienced psychologist, within 6 months to 1 year following the patient's death.

Intervention Type: OTHER

Caregiver section

Caregivers are self-evaluated within 72 hours after death by questionnaire survey, whose results will remain confidential to the center that included the situation.

Furthermore, 20 of them (10 medical staff and 10 paramedical staff and / or until saturation) are offered to participate in a semi-structured interview with an experienced psychologist.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agence de La Biomédecine

OTHER_GOV

Sponsor Role: collaborator

Fondation de France

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu LE DORZE, Md

Role: STUDY_DIRECTOR

Department of anaesthesiology and critical care medicine. Lariboisiere Hospital.

Locations

APHP - Lariboisière hospital - réanimation chirurgicale

Paris, , France

Countries

France

References

Le Dorze M, Barthelemy R, Lesieur O, Audibert G, Azais MA, Carpentier D, Cerf C, Cheisson G, Chouquer R, Degos V, Fresco M, Lambiotte F, Mercier E, Morel J, Muller L, Parmentier-Decrucq E, Prin S, Rouhani A, Roussin F, Venhard JC, Willig M, Vernay C, Chousterman B, Kentish-Barnes N; CARE-M3 Research Group. Tensions between end-of-life care and organ donation in controlled donation after circulatory death: ICU healthcare professionals experiences. BMC Med Ethics. 2024 Oct 9;25(1):110. doi: 10.1186/s12910-024-01093-1.

Reference Type: DERIVED

PMID: 39385217 (View on PubMed)

Other Identifiers

APHP200936

Identifier Type: -

Identifier Source: org_study_id