跳至主要内容
临床试验/NCT02854267
NCT02854267已完成不适用

Organ Procurement : Usefulness of a Guide for Meeting With the Next of Kin

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
322
试验地点
1
主要终点
Refusal to organ procurement as expressed by next of kins

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Refusal to organ procurement as expressed by next of kins

时间窗: 2 years

Assessed in the national biomedicine agency database retrospectively over a 2-years period before diffusion of a dedicated guide for meeting, and prospectively over a 2 years period after the diffusion of a dedicated guide for meeting

次要结局

  • Anxiety level of caregivers after meeting with the next of kins(2 years)
  • Compliance to the guide(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验