Clinical trial NCT02854267: Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin
Official title: Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Organ Donation
Keywords: organ procurement
brain death
organ donation
next of kins
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 322
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Interviews with next of kins as a part of organ donation

Brief summary: A dedicated guide for physicians and organ procurement nurses meeting with the next of kin could be associated with a reduction in organ donation refusal rate, and in anxiety of professionals involved in such meetings

Detailed description: The main obstacle for organ procurement in brain dead patients in France is organ donation refusal by the next of kin. When refusal is reflecting the patient's position, ending the organ donation procedure respects the bioethic French laws. Nevertheless, the actual position of the deceased patient often remains unknown. In these cases, organ donation refusal does not necessarily respect the deceased wishes. Many factors have been associated to next of kin organ donation refusal in such situations. Among those factors, some concerning the meeting with the next of kin have been isolated. French data on this subject are lacking.

A dedicated guide for the conduct of meetings with the next of kin has been elaborated by a working group of our network. Its diffusion will take place last quarter of 2016. The purpose of our study is to evaluate its usefulness through an observational multicenter before-after study, concerning every situation of brain dead patient where the next of kin are met by the medical staff. The refusal rate will be assessed over the first period (before the diffusion of the guide), from july 2012 to june 2014, and compared to that assessed over the second period (after the diffusion of the guide) from january 2017 to december 2018, using the national database of Biomedicine Agency. A comparison of this change in refusal rate will be made between centers of our network and the remaining centers in France nationwide. Anxiety of professionals will be assessed prospectively after each meeting conducted in one of our network centers, over 2 periods, before (from July to October 2016) and after (starting in january 2017) the diffusion of the dedicated guide for the conduct of the meeting with the next of kin. Compliance to the guide by the physicians and organ procurement nurses will be assessed after its diffusion in the centers of our network.

Eligibility criteria: Inclusion Criteria:

* situation of confirmed brain dead patient, or dead patient with pending confirmation of brain death

Exclusion Criteria:

* situations where the next of kins are met before brain death

Primary outcomes:
measure: Refusal to organ procurement as expressed by next of kins
timeFrame: 2 years
Secondary outcomes:
measure: Anxiety level of caregivers after meeting with the next of kins
timeFrame: 2 years
measure: Compliance to the guide
timeFrame: 2 years
Other outcomes:
Locations:
city: Clichy
country: France
facility: Hopital Beaujon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Stanislas Kandelman, MD
role: PRINCIPAL_INVESTIGATOR
References: