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

NCT05041023 | Completed

• 1 other identifier: APHP200936
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

End-of-life; Withdrawal of life-sustaining treatments; Controlled donation after circulatory death

Outcome Measures

Primary Outcomes (2)

• Hetero-evaluation of the relative using the IES-R scale

  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.

  3 months after patient's death

• Self-report of the caregiver using the STAI inventory

  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.

  within 72 hours following the patient's death

Secondary Outcomes (9)

• Hetero-evaluation of the relative using the HADS anxiety-depression scales

  3 months after patient's death

• Hetero-evaluation of the relative using the CAESAR end-of-life quality scale

  3 months after patient's death

• Hetero-evaluation of the relative using the questionnaire survey

  3 months after patient's death

• 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

Study Arms (2)

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.

Other: Relative section

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).

Other: Caregiver section

Interventions

Relative section 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.

Relative volunteers

Caregiver section 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.

Caregivers

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Agence de La Biomédecine: collaborator
• Fondation de France: collaborator

Study Sites (1)

APHP - Lariboisière hospital - réanimation chirurgicale

Paris, 75010, France

Location

Related Publications (2)

• Le Dorze M, Renet A, Barthelemy R, Souppart V, Kentish-Barnes N; CARE-M3 Research Group. Relatives' experiences of end-of-life care and organ donation after controlled circulatory death: a national prospective multicenter study. Crit Care. 2025 Dec 21. doi: 10.1186/s13054-025-05807-8. Online ahead of print.

  PMID: 41423695 DERIVED

• 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.

  PMID: 39385217 DERIVED

MeSH Terms

Conditions

Suicide, Assisted; Death

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthieu LE DORZE, Md

  Department of anaesthesiology and critical care medicine. Lariboisiere Hospital.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 10, 2021
• Study Start: October 27, 2021
• Primary Completion: May 20, 2024
• Study Completion: September 13, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)