Using a structured DISCUSS protocol to announce withholding or stopping life support to relatives in emergency departments
Impact of a Protocol for Announcing the Limitation and Discontinuation of Therapies in the Emergency Departments on the Stress of Families
NA · Hospices Civils de Lyon · NCT06071078
This project will test whether training emergency staff to use the DISCUSS announcement protocol reduces stress and later PTSD‑related symptoms in relatives told that life‑support will be limited or stopped.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 538 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 9 sites (Angers and 8 other locations) |
| Trial ID | NCT06071078 on ClinicalTrials.gov |
What this trial studies
The intervention trains emergency department clinicians to use the DISCUSS protocol when announcing decisions to withhold or withdraw life‑sustaining treatments. Relatives who receive the first announcement in participating EDs are enrolled and complete questionnaires on anxiety, depression, and post‑traumatic stress symptoms, and some take part in semi‑structured interviews. Caregivers on participating wards also receive the training and provide feedback. Outcomes are compared across multiple French hospital sites to measure changes in relatives' stress and experience of the announcement process.
Who should consider this trial
Good fit: Ideal participants are adult trusted persons, family members, or close relatives who are present in the ED and receive the first announcement that life‑sustaining treatments will be limited or stopped by a participating physician.
Not a fit: People who are not present for the initial announcement, who are under 18, who decline consent, or whose care occurs outside the participating hospitals are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the protocol could reduce acute stress and lower the risk of later PTSD in families while improving how end‑of‑life decisions are communicated in emergency settings.
How similar studies have performed: Communication‑training interventions in ICU and palliative settings have shown some positive effects on family satisfaction and distress, but there is limited high‑quality evidence specifically for the emergency department context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: For relatives, will be included in the study: * Trusted persons, families or relatives present in the emergency departments and to whom the 1st announcement of a decision to limit or stop therapies is made by a physician participating in the study. Several persons can be included for the same patient (maximum 3) in the following order: trusted person \> family \> close relative. * Age of trusted person, family or close friends over 18 years old. * Informed consent given and voice rights signed for families accepting the semi-directed interview. For caregivers, also included in the study will be: * Caregivers on participating wards. * Informed consent given and voice rights signed for families accepting the semi-directed interview. For partner families, will be included in the study: * Trusted persons, families or relatives present in the emergency department and to whom the 1st announcement of a decision to limit or stop therapy by a physician in a participating emergency department is made. * Age of trusted person, family or close friends over 18 years old. * Signed consent for the right to voice recording. Exclusion Criteria: For relatives: * Trusted person, family or close friend whose announcement would have been made entirely by telephone. * Trusted person, family or close friend unable to understand or write in French. * Pregnant women, women in labor or nursing mothers. * Persons deprived of liberty by a judicial or administrative decision. * Persons under psychiatric care. * Persons admitted to a health or social institution for purposes other than research. * Persons of full age who are subjects to a legal protection measure (guardians, curators). * Persons not affiliated to a social security system or beneficiaries of a similar system. For caregivers: \- Persons not affiliated to a social security system or beneficiaries of a similar system.
Where this trial is running
Angers and 8 other locations
- CHU Angers — Angers, France (RECRUITING)
- CH de Bourg-en-Bresse — Bourg-en-Bresse, France (RECRUITING)
- CHU de Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- CHU de Grenoble — Grenoble, France (RECRUITING)
- Groupement hospitalier centre, Hospices Civils de Lyon — Lyon, France (RECRUITING)
- Groupement hospitalier nord, Hospices Civils de Lyon — Lyon, France (RECRUITING)
- Groupement hospitalier sud, Hospices Civils de Lyon — Lyon, France (RECRUITING)
- CHU de Toulouse — Toulouse, France (RECRUITING)
- CH de Villefranche — Villefranche-sur-Saône, France (RECRUITING)
Study contacts
- Study coordinator: Marion MD DOUPLAT
- Email: marion.douplat@chu-lyon.fr
- Phone: 04 78 86 28 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End of Life, Limitation and cessation of treatment, Stress, End of life