title: Effect of a condolence letter on grief symptoms among relatives of patients who died in the ICU: a randomized clinical trial.
abstract: OBJECTIVE
  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.
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Famiréa Research Group, Paris, France.
authors.forename: Nancy
authors.initials: N
authors.lastname: Kentish-Barnes
authors.affiliation: 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.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Cochin University Hospital, Paris, France.
authors.forename: Benoît
authors.initials: B
authors.lastname: Champigneulle
authors.affiliation: Victor Dupouy Hospital, Argenteuil, France.
authors.forename: Marina
authors.initials: M
authors.lastname: Thirion
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Famiréa Research Group, Paris, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Souppart
authors.affiliation: Sud Francilien Hospital, Corbeil-Essonnes, France.
authors.forename: Marion
authors.initials: M
authors.lastname: Gilbert
authors.affiliation: La Rochelle Hospital, La Rochelle, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Lesieur
authors.affiliation: Cavale Blanche University Hospital, Brest, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Renault
authors.affiliation: Saint Joseph Hospital, Paris, France.
authors.forename: Maïté
authors.initials: M
authors.lastname: Garrouste-Orgeas
authors.affiliation: Hospices Civils de Lyon, Edouard Herriot Hospital, Lyon Est University, Lyon, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Argaud
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Paris, France.
authors.forename: Marion
authors.initials: M
authors.lastname: Venot
authors.affiliation: Assistance Publique, Hôpitaux de Paris, La Pitié-Salpêtrière University Hospital, Paris, France.
authors.forename: Alexandre
authors.initials: A
authors.lastname: Demoule
authors.affiliation: Saint André University Hospital, Bordeaux, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Guisset
authors.affiliation: Les Oudairies Hospital, La Roche sur Yon, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Vinatier
authors.affiliation: Versailles Hospital, Versailles, France.
authors.forename: Gilles
authors.initials: G
authors.lastname: Troché
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Massot
authors.affiliation: Saint Eloi University Hospital, and Inserm U-1046, Montpellier, France.
authors.forename: Samir
authors.initials: S
authors.lastname: Jaber
authors.affiliation: Le Raincy-Montfermeil Hospital, Montfermeil, France.
authors.forename: Caroline
authors.initials: C
authors.lastname: Bornstain
authors.affiliation: René-Dubos Hospital, Pontoise, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Gaday
authors.affiliation: Poitiers University Hospital and Poitiers University and Inserm CIC 1402, Poitiers, France.
authors.forename: René
authors.initials: R
authors.lastname: Robert
authors.affiliation: Dieppe Hospital, Dieppe, France.
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Rigaud
authors.affiliation: Hôtel Dieu University Hospital, Nantes, France.
authors.forename: Raphaël
authors.initials: R
authors.lastname: Cinotti
authors.affiliation: Assistance Publique, Hôpitaux de Marseille, Hôpital Nord University Hospital, Marseille, France.
authors.forename: Mélanie
authors.initials: M
authors.lastname: Adda
authors.affiliation: Sud Amiens University Hospital, Amiens, France.
authors.forename: François
authors.initials: F
authors.lastname: Thomas
authors.affiliation: Gabriel Montpied University Hospital, Clermont-Ferrand, France.
authors.forename: Laure
authors.initials: L
authors.lastname: Calvet
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Famiréa Research Group, Paris, France.
authors.forename: Marion
authors.initials: M
authors.lastname: Galon
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Famiréa Research Group, Paris, France.
authors.forename: Zoé
authors.initials: Z
authors.lastname: Cohen-Solal
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Cochin University Hospital, Paris Descartes University, Paris, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Cariou
authors.affiliation: Assistance Publique, Hôpitaux de Paris, Saint-Louis University Hospital, Famiréa Research Group, Paris, France. elie.azoulay@aphp.fr.|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.
authors.forename: Elie
authors.initials: E
authors.lastname: Azoulay
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D001007:Anxiety / Q000517:prevention & control / Q000523:psychology*; D001293:Attitude to Death; D001601:Bereavement; D015709:Correspondence as Topic; D003863:Depression / Q000517:prevention & control / Q000523:psychology*; D004645:Empathy; D005190:Family / Q000523:psychology*; D005260:Female; D005602:France; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016017:Odds Ratio; D011368:Professional-Family Relations; D012737:Sex Factors; D013313:Stress Disorders, Post-Traumatic / Q000517:prevention & control / Q000523:psychology*; D011795:Surveys and Questionnaires; D013997:Time Factors
keywords: Bereaved relatives; Grief symptoms; Letter of condolence