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Recruiting NCT06733974

NCT06733974 A Multifaceted Intervention Strategy for Relatives of End-of-life Patients in the Emergency Department

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Clinical Trial Summary
NCT ID NCT06733974
Status Recruiting
Phase
Sponsor Assistance Publique - Hôpitaux de Paris
Condition Grief Disorder, Prolonged
Study Type INTERVENTIONAL
Enrollment 924 participants
Start Date 2025-06-04
Primary Completion 2027-06

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Multi-faceted Intervention

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 924 participants in total. It began in 2025-06-04 with a primary completion date of 2027-06.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

In France, a study has reported that about 0.2% of patients visiting the ED died in the ED. A large survey of 145 EDs in 3 French speaking countries has reported that a median of 2 patients dies each week in each ED and its observation unit. After the death of a loved one, prolonged grief disorder (PGD) is a bereavement-specific syndrome that is defined as intense, prolonged yearning and preoccupation with thoughts of the deceased. PGD prevalence after the loss of a relative was 10% (95%CI 7-14) in the general population.Post-traumatic stress disorder (PTSD) is a mental health condition that is triggered by experiencing a terrifying event. Symptoms may include flashbacks, nightmares, and severe anxiety. The reported lifetime PTSD prevalence is 7% among adults in the general population. Admission and death in the hospital can be a traumatic and stressful experience for relatives, and is associated with an up to 50% risk of PGD and PTSD at 6 months. In the setting of ICU, several studies have reported that implementation of simple human interventions (information supports including written information on end-of-life care and pro-active communication strategy with systematic interviews with relatives), was associated with a lower risk of PTSD at 3 months (45% vs. 69%) and PGD at 6 months (21% vs 57%). Furthermore, it has been reported that offering the possibility of relatives to be present during nursing and medical care may be beneficial. In the out of hospital setting, offering the possibility for relative to be present during resuscitation was also associated with a reduction of PTSD at 3 months (15% vs 26%), which was confirmed at 1 year. The ED setting differs from the one of ICU mainly because exposition time to the dying process is shorter and healthcare workers are less used to manage end of life. Whether these strategies are beneficial for patients dying in the ED, where dying patients are older with more end- stage chronic diseases and shorter length of stay, remains unknown. The hypothesize of the study is that a multifaceted intervention, including pro-active communication strategy, visual supports, and offering the possibility to be present during nursing and medical care would decrease the risk of PGD in relatives of patients dying in the ED.

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 of a patient under 18 years of age * 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

Contact & Investigator

Central Contact

Yonathan FREUND, PU-PH

✉ yonathan.freund@aphp.fr

📞 +33663549017

Principal Investigator

Yonathan FREUND, PU-PH

PRINCIPAL INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Frequently Asked Questions

Who can join the NCT06733974 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying Grief Disorder, Prolonged. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06733974 currently recruiting?

Yes, NCT06733974 is actively recruiting participants. Contact the research team at yonathan.freund@aphp.fr for enrollment information.

Where is the NCT06733974 trial being conducted?

This trial is being conducted at Paris, France.

Who is sponsoring the NCT06733974 clinical trial?

NCT06733974 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Yonathan FREUND, PU-PH at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 924 participants.

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