A multifaceted intervention strategy for relatives of patients dying in the emergency department to reduce prolonged grief: study protocol for a cluster randomized controlled trial (MYRIADE)

In France, about 0.2% of emergency department (ED) visits result in the patient's death, corresponding to a median of two deaths per week per ED. Bereaved relatives are at increased risk of prolonged grief disorder (PGD) and post-traumatic stress disorder (PTSD). In the intensive care unit (ICU), interventions combining proactive communication strategies, informational support, and family involvement in patient care have been shown to improve psychological outcomes. However, the ED setting differs, with much shorter exposure to the dying process and healthcare professionals generally less accustomed to providing end-of-life care. No randomized trial has yet tested a comprehensive multifaceted intervention for relatives of patients dying in the ED. MYRIADE is a prospective, multicentre, parallel cluster randomized controlled trial in 31 French EDs. Centres are randomized 1:1, stratified by academic status and size (small versus large, based on the ED's inclusion potential), to a multifaceted intervention or to usual care. The intervention comprises three steps: at ED arrival, proactive communication with relatives and an information booklet with short videos; during the patient's course, the opportunity for relatives to take part in nursing care; and after the death, a dedicated discussion with the team and bereavement materials. Participants are adult relatives of patients dying either in the ED or in its observation unit (anticipated life expectancy < 72 h with a treatment-limitation decision). The primary outcome is PGD, measured with the Prolonged Grief 13-item revised scale (PG-13-R) 6 months after the death; secondary outcomes are PTSD (PCL-5) and anxiety and depression (HADS) at 3 months. A total of 924 relatives (462 per group) provides 80% power to detect a reduction in PGD from 25% to 15%, accounting for the cluster design. Analyses will follow the intention-to-treat principle using generalized linear mixed models with centre included as a random effect. MYRIADE is the first randomized trial to assess a multifaceted intervention for relatives of patients dying in the ED. If effective, this low-resource strategy, which requires no additional staff, could be widely implemented to reduce the psychological burden of bereavement. ClinicalTrials.gov [NCT 06733974 https://clinicaltrials.gov/study/NCT06733974], registered [13-12-2024]. Funded by the French Ministry of Health (PHRC-N 2023).