Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06733974

A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-06

924

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

In France, a study has reported that about 0.2% of patients visiting the ED died in the ED. A large survey of 145 EDs in 3 French speaking countries has reported that a median of 2 patients dies each week in each ED and its observation unit. After the death of a loved one, prolonged grief disorder (PGD) is a bereavement-specific syndrome that is defined as intense, prolonged yearning and preoccupation with thoughts of the deceased. PGD prevalence after the loss of a relative was 10% (95%CI 7-14) in the general population.Post-traumatic stress disorder (PTSD) is a mental health condition that is triggered by experiencing a terrifying event. Symptoms may include flashbacks, nightmares, and severe anxiety. The reported lifetime PTSD prevalence is 7% among adults in the general population. Admission and death in the hospital can be a traumatic and stressful experience for relatives, and is associated with an up to 50% risk of PGD and PTSD at 6 months. In the setting of ICU, several studies have reported that implementation of simple human interventions (information supports including written information on end-of-life care and pro-active communication strategy with systematic interviews with relatives), was associated with a lower risk of PTSD at 3 months (45% vs. 69%) and PGD at 6 months (21% vs 57%). Furthermore, it has been reported that offering the possibility of relatives to be present during nursing and medical care may be beneficial. In the out of hospital setting, offering the possibility for relative to be present during resuscitation was also associated with a reduction of PTSD at 3 months (15% vs 26%), which was confirmed at 1 year. The ED setting differs from the one of ICU mainly because exposition time to the dying process is shorter and healthcare workers are less used to manage end of life. Whether these strategies are beneficial for patients dying in the ED, where dying patients are older with more end- stage chronic diseases and shorter length of stay, remains unknown. The hypothesize of the study is that a multifaceted intervention, including pro-active communication strategy, visual supports, and offering the possibility to be present during nursing and medical care would decrease the risk of PGD in relatives of patients dying in the ED.

CONDITIONS

Official Title

A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Relative of a patient dying in the ED with an expected life expectancy under 72 hours and a do not resuscitate order or treatment withholding
  • Priority given to the patient's trusted person, the relative most involved in care, partner, parent, child, or another family member
  • Age 18 years or older
  • Willing to participate in phone follow-up interviews at 3 and 6 months
  • Provides informed oral consent
  • Has health insurance (except AME)
Not Eligible

You will not qualify if you...

  • Does not understand, read, or speak French
  • Relative of organ donor patients receiving specific transplant team support
  • Unable to complete follow-up
  • Participating in another intervention trial
  • Under legal protection such as tutorship or curatorship
  • Deprived of liberty by judicial or administrative decision
  • Physically unable to give oral consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Emergency Department Hospital Pitié-Salpêtrière

Paris, Paris, France, 75013

Actively Recruiting

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Research Team

Y

Yonathan FREUND, PU-PH

CONTACT

M

Mélanie ROUSSEL, MD-PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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