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Randomized Controlled Trial Multicenter Study
A three-step support strategy for relatives of patients dying in the intensive care unit: a cluster randomised trial.
- Nancy Kentish-Barnes, Sylvie Chevret, Sandrine Valade, Samir Jaber, Lionel Kerhuel, Olivier Guisset, Maëlle Martin, Amélie Mazaud, Laurent Papazian, Laurent Argaud, Alexandre Demoule, David Schnell, Eddy Lebas, Frédéric Ethuin, Emmanuelle Hammad, Sybille Merceron, Juliette Audibert, Clarisse Blayau, Pierre-Yves Delannoy, Alexandre Lautrette, Olivier Lesieur, Anne Renault, Danielle Reuter, Nicolas Terzi, Bénédicte Philippon-Jouve, Maud Fiancette, Michel Ramakers, Jean-Philippe Rigaud, Virginie Souppart, Karim Asehnoune, Benoît Champigneulle, Dany Goldgran-Toledano, Jean-Louis Dubost, Pierre-Edouard Bollaert, Renaud Chouquer, Frédéric Pochard, Alain Cariou, and Elie Azoulay.
- AP-HP Nord, Saint Louis Hospital, Medical Intensive Care, Famiréa Research Group, Paris, France. Electronic address: nancy.kentish@aphp.fr.
- Lancet. 2022 Feb 12; 399 (10325): 656-664.
BackgroundIn 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 ClinicalTrials.gov, NCT02955992.FindingsBetween 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.Copyright © 2022 Elsevier Ltd. All rights reserved.
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