RecruitingNot ApplicableNCT06733974

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

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

924 participants

Start Date

Jun 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a support program for family members and loved ones of patients who are in the emergency department (ED) in their final hours of life. The goal is to help reduce grief and emotional distress for these relatives in the months after loss. **You may be eligible if...** - You are a family member or close loved one of a patient who is dying in the emergency department and is not expected to survive more than 72 hours - You are 18 years of age or older - You are willing to participate in phone follow-up calls at 3 and 6 months - You have health insurance coverage **You may NOT be eligible if...** - You do not consent to participate - You are not covered under health insurance (including those with only emergency medical aid coverage) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMulti-faceted Intervention

The participant, i.e. relative, will receive the multifaceted intervention which include: a first meeting with the healthcare team including written information about palliative care for dying patients, information on possibility to participate in care, pro-active communication, and dedicated interview and brochure after the patient's death with possibility of psychological follow up.


Locations(1)

Emergency Department Hospital Pitié-Salpêtrière

Paris, Paris, France

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NCT06733974


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