Status:

RECRUITING

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

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

End of Life

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Death is a daily reality in the emergency department. Deaths represent 0.3 to 0.5% of emergency admissions, i.e. approximately 26,000 per year for the whole of France. For 80% of these deceased patien...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

January 19 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 19 2026

Estimated Enrollment :

538 Patients enrolled

Trial Details

Trial ID

NCT06071078

Start Date

January 19 2024

End Date

January 19 2026

Last Update

August 28 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

CHU Angers

Angers, France, 49000

2

CH de Bourg-en-Bresse

Bourg-en-Bresse, France, 01000

3

CHU de Clermont-Ferrand

Clermont-Ferrand, France, 63000

4

CHU de Grenoble

Grenoble, France, 38000