Nancy Kentish-Barnes1, Sylvie Chevret2, Benoît Champigneulle3, Marina Thirion4, Virginie Souppart1, Marion Gilbert5, Olivier Lesieur6, Anne Renault7, Maïté Garrouste-Orgeas8, Laurent Argaud9, Marion Venot10, Alexandre Demoule11, Olivier Guisset12, Isabelle Vinatier13, Gilles Troché14, Julien Massot15, Samir Jaber16, Caroline Bornstain17, Véronique Gaday18, René Robert19, Jean-Philippe Rigaud20, Raphaël Cinotti21, Mélanie Adda22, François Thomas23, Laure Calvet24, Marion Galon1, Zoé Cohen-Solal1, Alain Cariou25, Elie Azoulay26,27. 1. Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Famiréa Research Group, Paris, France. 2. ECSTRA Team, Biostatistics and Clinical Epidemiology, UMR 1153, INSERM, Paris Diderot Sorbonne University and Service de Biostatistique et Information Médicale AP-HP, Hôpital Saint-Louis, Paris, France. 3. Assistance Publique, Hôpitaux de Paris, Cochin University Hospital, Paris, France. 4. Victor Dupouy Hospital, Argenteuil, France. 5. Sud Francilien Hospital, Corbeil-Essonnes, France. 6. La Rochelle Hospital, La Rochelle, France. 7. Cavale Blanche University Hospital, Brest, France. 8. Saint Joseph Hospital, Paris, France. 9. Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon Est University, Lyon, France. 10. Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Paris, France. 11. Assistance Publique, Hôpitaux de Paris, La Pitié-Salpêtrière University Hospital, Paris, France. 12. Saint André University Hospital, Bordeaux, France. 13. Les Oudairies Hospital, La Roche sur Yon, France. 14. Versailles Hospital, Versailles, France. 15. Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France. 16. Saint Eloi University Hospital, and Inserm U-1046, Montpellier, France. 17. Le Raincy-Montfermeil Hospital, Montfermeil, France. 18. René-Dubos Hospital, Pontoise, France. 19. Poitiers University Hospital and Poitiers University and Inserm CIC 1402, Poitiers, France. 20. Dieppe Hospital, Dieppe, France. 21. Hôtel Dieu University Hospital, Nantes, France. 22. Assistance Publique, Hôpitaux de Marseille, Hôpital Nord University Hospital, Marseille, France. 23. Sud Amiens University Hospital, Amiens, France. 24. Gabriel Montpied University Hospital, Clermont-Ferrand, France. 25. Assistance Publique, Hôpitaux de Paris, Cochin University Hospital, Paris Descartes University, Paris, France. 26. Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Famiréa Research Group, Paris, France. elie.azoulay@aphp.fr. 27. Medical Intensive Care Unit, Hôpital Saint-Louis, ECSTRA Team, and Clinical Epidemiology, UMR 1153 (Center of Epidemiology and Biostatistics Sorbonne Paris Cité, CRESS), INSERM, Paris Diderot Sorbonne University , 1 rue Claude Vellefaux, 75010, Paris, France. elie.azoulay@aphp.fr.
Abstract
PURPOSE:Family members of patients who die in the intensive care unit (ICU) may experience symptoms of stress, anxiety, depression, posttraumatic stress disorder (PTSD), and/or prolonged grief. We evaluated whether grief symptoms were alleviated if the physician and the nurse in charge at the time of death sent the closest relative a handwritten condolence letter. METHODS: Multicenter randomized trial conducted among 242 relatives of patients who died at 22 ICUs in France between December 2014 and October 2015. Relatives were randomly assigned to receiving (n = 123) or not receiving (n = 119) a condolence letter. The primary endpoint was the Hospital Anxiety and Depression Score (HADS) at 1 month. Secondary endpoints included HADS, complicated grief (ICG), and PTSD-related symptoms (IES-R) at 6 months. Observers were blinded to group allocation. RESULTS: At 1 month, 208 (85.9%) relatives completed the HADS; median score was 16 [IQR, 10-22] with and 14 [8-21.5] without the letter (P = 0.36). Although scores were higher in the intervention group, there were no significant differences regarding the HADS-depression subscale (8 [4-12] vs. 6 [2-12], mean difference 1.1 [-0.5 to 2.6]; P = 0.09) and prevalence of depression symptoms (56.0 vs. 42.4%, RR 0.76 [0.57-1.00]; P = 0.05). At 6 months, 190 (78.5%) relatives were interviewed. The intervention significantly increased the HADS (13 [7-19] vs. 10 [4-17.5], P = 0.04), HADS-depression subscale (6 [2-10] vs. 3 [1-9], P = 0.02), prevalence of depression symptoms (36.6 vs. 24.7%, P = 0.05) and PTSD-related symptoms (52.4 vs. 37.1%, P = 0.03). CONCLUSIONS: In relatives of patients who died in the ICU, a condolence letter failed to alleviate grief symptoms and may have worsened depression and PTSD-related symptoms. Trial registration Clinicaltrials.gov Identifier: NCT02325297.
RCT Entities:
PURPOSE: Family members of patients who die in the intensive care unit (ICU) may experience symptoms of stress, anxiety, depression, posttraumatic stress disorder (PTSD), and/or prolonged grief. We evaluated whether grief symptoms were alleviated if the physician and the nurse in charge at the time of death sent the closest relative a handwritten condolence letter. METHODS: Multicenter randomized trial conducted among 242 relatives of patients who died at 22 ICUs in France between December 2014 and October 2015. Relatives were randomly assigned to receiving (n = 123) or not receiving (n = 119) a condolence letter. The primary endpoint was the Hospital Anxiety and Depression Score (HADS) at 1 month. Secondary endpoints included HADS, complicated grief (ICG), and PTSD-related symptoms (IES-R) at 6 months. Observers were blinded to group allocation. RESULTS: At 1 month, 208 (85.9%) relatives completed the HADS; median score was 16 [IQR, 10-22] with and 14 [8-21.5] without the letter (P = 0.36). Although scores were higher in the intervention group, there were no significant differences regarding the HADS-depression subscale (8 [4-12] vs. 6 [2-12], mean difference 1.1 [-0.5 to 2.6]; P = 0.09) and prevalence of depression symptoms (56.0 vs. 42.4%, RR 0.76 [0.57-1.00]; P = 0.05). At 6 months, 190 (78.5%) relatives were interviewed. The intervention significantly increased the HADS (13 [7-19] vs. 10 [4-17.5], P = 0.04), HADS-depression subscale (6 [2-10] vs. 3 [1-9], P = 0.02), prevalence of depression symptoms (36.6 vs. 24.7%, P = 0.05) and PTSD-related symptoms (52.4 vs. 37.1%, P = 0.03). CONCLUSIONS: In relatives of patients who died in the ICU, a condolence letter failed to alleviate grief symptoms and may have worsened depression and PTSD-related symptoms. Trial registration Clinicaltrials.gov Identifier: NCT02325297.
Entities:
Keywords:
Bereaved relatives; Grief symptoms; Letter of condolence
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