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Abstract
Summary Background
In relatives of patients dying in intensive care units (ICUs), inadequate team support can increase the prevalence of prolonged grief and other psychological harm. We aimed to evaluate whether a proactive communication and support intervention would improve relatives' outcomes.
MethodsWe undertook a prospective, multicentre, cluster randomised controlled trial in 34 ICUs in France, to compare standard care with a physician-driven, nurse-aided, three-step support strategy for families throughout the dying process, following a decision to withdraw or withhold life support. Inclusion criteria were relatives of patients older than 18 years with an ICU length of stay 2 days or longer. Participating ICUs were randomly assigned (1:1 ratio) into an intervention cluster and a control cluster. The randomisation scheme was generated centrally by a statistician not otherwise involved in the study, using permutation blocks of non-released size. In the intervention group, three meetings were held with relatives: a family conference to prepare the relatives for the imminent death, an ICU-room visit to provide active support, and a meeting after the patient's death to offer condolences and closure. ICUs randomly assigned to the control group applied their best standard of care in terms of support and communication with relatives of dying patients. The primary endpoint was the proportion of relatives with prolonged grief (measured with PG-13, score ≥30) 6 months after the death. Analysis was by intention to treat, with the bereaved relatives as the unit of observation. The study is registered with
Between Feb 23, 2017, and Oct 8, 2019, we enrolled 484 relatives of ICU patients to the intervention group and 391 to the control group. 379 (78%) relatives in the intervention group and 309 (79%) in the control group completed the 6-month interview to measure the primary endpoint. The intervention significantly reduced the number of relatives with prolonged grief symptoms (66 [21%] vs 57 [15%]; p=0·035) and the median PG-13 score was significantly lower in the intervention group than in the control group (19 [IQR 14–26] vs 21 [15–29], mean difference 2·5, 95% CI 1·04–3·95).
InterpretationAmong relatives of patients dying in the ICU, a physician-driven, nurse-aided, three-step support strategy significantly reduced prolonged grief symptoms.
FundingFrench Ministry of Health
Details
1 AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France
2 Department of Biostatistics and Medical Information, UMR 1153, ECSTRRA Team, INSERM, Paris University, Saint Louis Hospital, AP-HP, Paris, France
3 AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France; AP-HP Centre, Cochin Hospital, Medical Intensive Care, Paris, France
4 Saint Eloi University Hospital, Department of Anesthesia and Critical Care Medicine, Montpellier and PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France
5 Saint André University Hospital, Medical Intensive Care, Bordeaux, France
6 Hôtel Dieu University Hospital, Medical Intensive Care, Nantes, France
7 Hospices Civils de Lyon, Edouard Herriot University Hospital, Surgical Intensive Care, Lyon, France
8 AP-HM, Hôpital Nord, Medical Intensive Care and Aix-Marseille University, Faculté des Sciences Médicales et Paramédicales, Centre d'Etudes et de Recherches sur les Services de Santé et qualité de vie EA 3279, Marseille, France
9 Hospices Civils de Lyon, Edouard Herriot Hospital, Medical Intensive Care, and Université de Lyon, Lyon, France
10 AP-HP Sorbonne Université, La Pitié-Salpêtrière University Hospital, Medical Intensive Care Unit and Sorbonne Université, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France
11 Angoulême Hospital, Medical and Surgical Intensive Care, Angoulême, France
12 Bretagne Atlantique Hospital, Medical and Surgical Intensive Care, Vannes, France
13 Côte de Nacre University Hospital, Surgical Intensive Care, Caen, France
14 AP-HM, Hospital Nord, Anaesthesia and Intensive Care, Marseille, France
15 André Mignot Hospital, Medical Intensive Care, Le Chesnay, France
16 Louis Pasteur Hospital, Medical and Surgical Intensive Care, Chartres, France
17 AP-HP Sorbonne University, Tenon Hospital, Medical Intensive Care, Paris, France
18 Chatilliez Hospital, Medical and Surgical Intensive Care, Tourcoing, France
19 Gabriel Montpied University Hospital, Medical Intensive Care, Clermont Ferrand, France
20 La Rochelle Hospital, Medical and Surgical Intensive Care, La Rochelle, France
21 Cavale Blanche University Hospital, Medical Intensive Care, Brest, France
22 Sud Francilien Hospital, Medical and Surgical Intensive Care, Evry, France
23 Grenoble Alpes University Hospital, Medical Intensive Care, Grenoble, France
24 Roanne Hospital, Medical and Surgical Intensive Care, Roanne, France
25 Les Oudairies Hospital, Medical and Surgical Intensive Care, La Roche-sur-Yon, France
26 Saint Lô Hospital, Medical and Surgical Intensive Care, Saint Lô, France
27 Dieppe Hospital, Medical and Surgical Intensive Care, Dieppe, Paris
28 Hôtel Dieu University Hospital, Department of Anesthesia and Critical Care, Nantes, France
29 AP-HP Centre, Hôpital Européen Georges Pompidou, Department of Aaesthesia and Critical Care, Paris, France
30 Montfermeil Hospital, Medical and Surgical Intensive Care, Montfermeil, France
31 René Dubos Hospital, Medical and Surgical Intensive Care, Pontoise, France
32 University Hospital Central, Medical Intensive Care, Nancy, France
33 Annecy Hospital, Medical and Surgical Intensive Care, Annecy, France
34 AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France; AP-HP Nord, Fernand Widal Hospital, DMU Neurosciences, Département de Psychiatrie et de Médecine Addictologique, Paris, France
35 AP-HP Centre, Cochin Hospital, Medical Intensive Care, Paris, France; Paris University, Paris, France
36 AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France; Department of Biostatistics and Medical Information, UMR 1153, ECSTRRA Team, INSERM, Paris University, Saint Louis Hospital, AP-HP, Paris, France