Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06733974

A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department: a Cluster Randomized Trial

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

924

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating whether a multifaceted support program can reduce prolonged grief disorder (PGD) in relatives of patients who die in the emergency department (ED). The study is motivated by evidence that about 0.2% of patients visiting French EDs die there, and that relatives of dying patients often experience intense grief and post-traumatic stress disorder (PTSD). While similar interventions have shown benefits in intensive care units (ICUs), it is unclear if they work in the ED setting where exposure times are shorter and staff are less accustomed to end-of-life care. The study compares usual care to a multifaceted intervention that includes proactive communication, written information about palliative care, and the opportunity for relatives to be present during nursing and medical care. Relatives in the intervention group will have a meeting with healthcare staff, receive brochures, and may have a dedicated interview and psychological follow-up after the patient's death. The study is randomized and open-label, with two groups: usual care and the multifaceted intervention. Participants are relatives of patients expected to die within 72 hours in the ED and must be at least 18 years old, able to understand French, and agree to follow-up phone interviews at 3 and 6 months. Researchers will assess prolonged grief using the PG-R-13 scale at 6 months, and secondary outcomes include PTSD symptoms and anxiety or depression measured at 3 months. The study will monitor participants' psychological status over time, aiming to understand if the intervention lowers grief and stress symptoms after loss.

CONDITIONS

Brief 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 emergency department with an anticipated life expectancy of less than 72 hours and prior do not resuscitate order or treatment withholding
  • Priority given to the patient's trustworthy person or closest involved relative
  • Age 18 years or older
  • Agrees to follow-up phone interviews at 3 and 6 months
  • Provides informed oral consent
  • Has health insurance (except AME)
Not Eligible

You will not qualify if you...

  • Relative who does not understand, read, or speak French
  • Relative of an organ donor patient
  • Unable to participate in follow-up
  • Currently enrolled in another intervention trial
  • Under legal protection (tutorship or curatorship)
  • Deprived of liberty by judicial or administrative decision
  • Physically unable to give oral consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Multi-faceted Intervention

Duration - Up to the patient's death and shortly after

Participants receive a first meeting with the healthcare team including written information about palliative care for dying patients, information on the possibility to participate in care, pro-active communication, and a dedicated interview and brochure after the patient's death with the possibility of psychological follow-up.

1 initial meeting and 1 follow-up interview after patient's death

Follow-up

Duration - Up to 6 months after inclusion

Participants are followed up with phone interviews to assess prolonged grief and signs of PTSD, anxiety, and depression.

2 phone interviews at 3 and 6 months

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

M

Mélanie ROUSSEL, MD-PhD

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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