Evaluating a Protocol Using Human Simulation to Improve Announcements About Limiting or Stopping Life-Sustaining Treatments in Emergency Departments and Reduce Family Stress
Led by Hospices Civils de Lyon · Updated on 2025-08-28
538
Participants Needed
9
Research Sites
N/A
Total Duration
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
Research Team
M
Marion MD DOUPLAT
A
Anne TERMOZ
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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
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
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)
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.