Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06071078

Impact of a Protocol for Announcing the Limitation and Discontinuation of Therapies in the Emergency Departments on the Stress of Families

Led by Hospices Civils de Lyon · Updated on 2025-08-28

538

Participants Needed

9

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Death in emergency departments is a frequent and challenging event, with about 0.3 to 0.5% of emergency admissions resulting in death, often requiring decisions to withhold or withdraw life-sustaining treatments. This trial evaluates the impact of a new protocol involving human simulation and participation of partner families to improve how emergency staff announce these decisions, aiming to reduce stress and post-traumatic symptoms in families. The study also examines how such training affects caregivers' communication skills and confidence during these difficult announcements. The study compares a model announcement protocol using human simulation and involvement of partner families in both a simulation center and real emergency settings against usual practices. Emergency services are grouped into clusters undergoing sequential training following a stepped wedge design. Professionals in the intervention group receive training in the DISCUSS announcement protocol, aiming to improve communication and reduce family distress when decisions about limiting or stopping treatments are made. Participants include relatives present at the emergency department when the treatment limitation decision is announced, as well as caregivers working in participating wards. Assessments include measuring post-traumatic stress symptoms in families at 7, 30, and 90 days after the announcement using validated scales. Caregivers’ communication assertiveness, self-confidence, stress levels, and satisfaction with the training are evaluated at several points up to 20 months. The study runs from January 2024 to January 2026 and includes a single-blind randomized design.

CONDITIONS

Brief Title

Impact of a Protocol for Announcing Decision of Withholding and Withdrawing Life-sustaining Treatments on the Stress of the Relatives in the Emergency Departments

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Trusted persons, families, or close relatives present in the emergency department at the first announcement of a decision to limit or stop therapies by a participating physician
  • Age 18 years or older
  • Provided informed consent and signed voice rights for semi-directed interviews
  • Caregivers working in participating wards who provide informed consent and signed voice rights
  • Partner families who are trusted persons, families, or relatives present at the emergency department during the first announcement with signed consent for voice recording
Not Eligible

You will not qualify if you...

  • Relatives who received the announcement entirely by telephone
  • Relatives unable to understand or write in French
  • Pregnant women, women in labor, or nursing mothers
  • Persons deprived of liberty by judicial or administrative decision
  • Persons under psychiatric care
  • Persons admitted to health or social institutions for reasons other than research
  • Adults under legal protection measures such as guardians or curators
  • Persons not affiliated with a social security system or similar
  • Caregivers not affiliated with a social security system or similar

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)

Outpatient Treatment

Duration - Single event at the emergency department

Participants experience the announcement of withholding and withdrawing life-sustaining treatments according to either usual practice or the DISCUSS announcement protocol delivered by trained professionals.

1 visit (in-person)

Follow-up

Duration - Up to 90 days after the announcement

Participants' families and caregivers are assessed for stress, anxiety, depression, and experiences following the announcement of treatment limitation or cessation. Caregivers also evaluate communication, assertiveness, confidence, and stress levels related to the protocol training.

3 visits (Day 7, Day 30, and Day 90 after the announcement)

Trial Site Locations

Total: 9 locations

1

CHU Angers

Angers, France, 49000

Actively Recruiting

2

CH de Bourg-en-Bresse

Bourg-en-Bresse, France, 01000

Actively Recruiting

3

CHU de Clermont-Ferrand

Clermont-Ferrand, France, 63000

Actively Recruiting

4

CHU de Grenoble

Grenoble, France, 38000

Actively Recruiting

5

Groupement hospitalier centre, Hospices Civils de Lyon

Lyon, France, 69003

Actively Recruiting

6

Groupement hospitalier nord, Hospices Civils de Lyon

Lyon, France, 69004

Actively Recruiting

7

Groupement hospitalier sud, Hospices Civils de Lyon

Lyon, France, 69310

Actively Recruiting

8

CHU de Toulouse

Toulouse, France, 31000

Actively Recruiting

9

CH de Villefranche

Villefranche-sur-Saône, France, 69400

Actively Recruiting

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Research Team

M

Marion MD DOUPLAT

A

Anne TERMOZ

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Evaluating the impact of a standardised intervention for announcing decisions of withholding and withdrawing life-sustaining treatments on the stress of relatives in emergency departments (DISCUSS): protocol for a stepped-wedge randomised controlled trial.

Anne Termoz, Fabien Subtil, Pauline Drouin...

https://pubmed.ncbi.nlm.nih.gov/39237283