Support program for relatives of patients expected to die in the emergency department

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

This trial will try a multifaceted support program to reduce prolonged grief and PTSD in adults who are relatives of patients expected to die in the emergency department.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 924 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris, Paris)
• Trial ID: NCT06733974 on ClinicalTrials.gov

What this trial studies

This interventional trial delivers a multifaceted support strategy to adult relatives of patients with an anticipated life expectancy under 72 hours in the ED at Pitié-Salpêtrière. The program combines targeted communication, emotional support, and structured follow-up contacts delivered during and after the ED stay. Participants give oral consent and are followed by phone interviews at 3 and 6 months to measure prolonged grief disorder and PTSD symptoms compared with usual care. Priority for enrollment is given to the patient's trusted person or the relative most involved in care, and non-French speakers or those who cannot be followed are excluded.

Who should consider this trial

Good fit: Adults (≥18) who are the patient's trusted relative or primary caregiver present when a patient is expected to die within 72 hours in the ED, who speak French and can complete phone follow-up, are ideal candidates.

Not a fit: Relatives who do not understand French, organ-donor relatives, those under legal protection or deprived of liberty, or those unable to complete follow-up are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the program could reduce the incidence or severity of prolonged grief disorder and PTSD among bereaved relatives after an in-ED death.

How similar studies have performed: Some ICU-based family support interventions have shown reductions in family distress, but multifaceted interventions specifically in ED settings are less well studied.

Eligibility criteria

Inclusion Criteria:

\- Relative of a patient, that is dying in the ED, defined by an anticipated life expectancy of less than 72H with previous do not resuscitate order or treatment withholding.

If several relative are present, participation to the trial will be offered in priority to the patient's trustworthy person, the relative most involved in the patient's care, the partner, a parent or child, another family member.

* Age \>= 18 years
* Agrees to be followed-up by phone interview at 3 and 6 months
* Informed oral consent
* Relative with health insurance (except AME).

Exclusion Criteria:

* Relative who do not understand, read, or speak French
* Relatives of organ donor patients (these relatives benefit from specific support and communication by the transplant coordination teams)
* Inability to follow up
* Participation in another intervention trial
* Relative under legal protection (tutorship or curatorship)
* Relative deprived of their liberty by a judicial or administrative decision
* Relative physically unable to give his/her oral consent

Where this trial is running

Paris, Paris

• Emergency Department Hospital Pitié-Salpêtrière — Paris, Paris, France (RECRUITING)

Study contacts

• Principal investigator: Yonathan FREUND, PU-PH — Assistance Publique - Hôpitaux de Paris
• Study coordinator: Yonathan FREUND, PU-PH

Conditions: Grief Disorder, Prolonged, Post-traumatic stress disorder, prolonged grief disorder