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

NCT06733974 | Recruiting

• 2 other identifiers: APHP230838IDRCB no. 2023-A02158-37
• Study Type: interventional
• Target: 924
• Locations: 1 country
• Sites: 1

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.

Conditions

Grief Disorder, Prolonged

Keywords

Post-traumatic stress disorder (PTSD); prolonged grief disorder (PGD)

Outcome Measures

Primary Outcomes (1)

• Prolonged Grief 13-item revised scale (PG-R-13)

  The PG-R-13 measures the new DSM-V criteria for prolonged grief: yearning, preoccupation, identity disruption, disbelief, avoidance, intense emotional pain, difficulty with reintegration, emotional numbness, feeling that life is meaningless and intense loneliness. The score ranges from 10-50 and a score of 30 or more defined the prolonged grief disorder.

  6 months after inclusion.

Secondary Outcomes (2)

• Signs of PTSD assessed by the PCL-5 scale.

  3 months

• signs of anxiety and depression HADS scale

  3 months

Other Outcomes (4)

• signs of PTSD

  6 months

• signs of anxiety

  6 months

• signs of depression

  6 months

Study Arms (2)

Usual care

NO INTERVENTION

Multi-faceted Intervention

EXPERIMENTAL

Other: Multi-faceted Intervention

Interventions

Multi-faceted Intervention OTHER

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.

Multi-faceted Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Emergency Department Hospital Pitié-Salpêtrière

Paris, Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Prolonged Grief Disorder; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic

Study Officials

• Yonathan FREUND, PU-PH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonathan FREUND, PU-PH

CONTACT

+33663549017; yonathan.freund@aphp.fr

Mélanie ROUSSEL, MD-PhD

CONTACT

melanie.roussel@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 13, 2024
• Study Start: June 4, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Locations

FR (1)