Maité Garrouste-Orgeas1,2,3, Cécile Flahault4, Isabelle Vinatier5, Jean-Philippe Rigaud6, Nathalie Thieulot-Rolin7, Emmanuelle Mercier8, Antoine Rouget9, Hubert Grand10, Olivier Lesieur11, Fabienne Tamion12,13, Rebecca Hamidfar14, Anne Renault15, Erika Parmentier-Decrucq16, Yannick Monseau17, Laurent Argaud18, Cédric Bretonnière19,20, Alexandre Lautrette21,22, Julio Badié23, Eric Boulet24, Bernard Floccard25, Xavier Forceville26, Eric Kipnis27, Lilia Soufir28, Sandrine Valade29, Naike Bige30, Alain Gaffinel31, Olfa Hamzaoui32, Georges Simon33, Marina Thirion34, Lila Bouadma1,35, Audrey Large36, Jean-Paul Mira37, Nora Amdjar-Badidi38, Mercé Jourdain16,39, Paul-Henri Jost40, Virginie Maxime41, François Santoli42, Stéphane Ruckly2, Christel Vioulac4, Marie Annick Leborgne4, Lucie Bellalou4, Léonor Fasse4, Benoit Misset12, Sébastien Bailly1,43, Jean-François Timsit1,2,35. 1. Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM, Paris Diderot University, Department of Biostatistics - HUPNVS. - AP-HP, UFR de Médecine - Bichat University Hospital, Paris, France. 2. Department of Biostatistics, Outcomerea, Paris, France. 3. Medical unit, French British Hospital, Levallois-Perret, France. 4. LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France. 5. Medical ICU, Les Oudaries Hospital, La Roche-sur-Yon, Vendée, France. 6. Department of Intensive Care, Dieppe General Hospital, Dieppe, France. 7. Medical-Surgical ICU, General Hospital, Melun, France. 8. CRICS-TRIGGERSEP group, Medical-Surgical ICU, Tours University Hospital, Tours, France. 9. Medical-Surgical ICU, Rangueil University Hospital, Toulouse, France. 10. Medical-Surgical ICU, Hospital Robert Boulin, Libourne, France. 11. Medical-Surgical ICU, General Hospital, La Rochelle, France. 12. Medical ICU, University Medical Center, Rouen, France. 13. INSERM U-1096, University of Rouen, Rouen, France. 14. Medical ICU, Albert Michallon University Hospital, Grenoble, France. 15. Medical ICU, La Cavale Blanche University Hospital, Brest, France. 16. Group of medical ICUs, Lille University Hospital, Lille, France. 17. Medical-Surgical ICU, General Hospital, Périgueux, France. 18. Medical ICU, Edouard Herriot University Hospital, Lyon, France. 19. Medical ICU, Nantes University Hospital, Nantes, France. 20. EA3826, Laboratory of Clinical and Experimental Therapeutics of Infections, University of Nantes, Nantes, France. 21. Medical ICU, Gabriel-Montpied University Hospital, Clermont Ferrand, France. 22. LMGE UMR CNRS 6023, University of Clermont-Ferrand, Clermont Ferrand, France. 23. Medical-Surgical ICU, General Hospital Belfort-Montbéliard, Belfort, France. 24. Medical ICU, Beaumont General Hospital, Beaumont, France. 25. Medical ICU, Hospices Civils de Lyon, Edouard Herriot University Hospital, Lyon, France. 26. Medical-Surgical ICU, Great Hospital of East Francilien, Meaux, France. 27. Surgical ICU, Lille University Hospital, Lille, France. 28. Medical-Surgical ICU, Saint Joseph Hospital Network, Paris, France. 29. Medical ICU, Saint Louis University Hospital, Paris, France. 30. Medical ICU, Saint Antoine University Hospital, Paris, France. 31. Medical-Surgical ICU, Gustave Roussy Cancer Campus, Villejuif, France. 32. Medical Surgical ICU, University Hospital Paris -Sud, Beclère University Hospital, Clamart, France. 33. Medical-Surgical ICU, General Hospital, Troyes, France. 34. Medical-Surgical ICU, General Hospital Victor Dupouy, Argenteuil, France. 35. Medical ICU, Bichat University Hospital, Paris, France. 36. Medical ICU, François Mitterrand University Hospital, Dijon, France. 37. Medical ICU, Cochin University Hospital, Paris Centre Hospital Group, AP-HP, Paris, France. 38. Medical-Surgical ICU, General Hospital René Dubos, Pontoise, France. 39. Lille University, Inserm U1190, Lille, France. 40. Surgical ICU, Henri Mondor University Hospital, Créteil, France. 41. Medical ICU, Raymond Poincaré University Hospital, Garches, France. 42. Medical ICU, General Hospital Robert Ballanger, Aulnay-Sous-Bois, France. 43. Grenoble Alpes University, INSERM, University hospital Grenoble Alpes, HP2, Grenoble, France.
Abstract
Importance: Keeping a diary for patients while they are in the intensive care unit (ICU) might reduce their posttraumatic stress disorder (PTSD) symptoms. Objectives: To assess the effect of an ICU diary on the psychological consequences of an ICU hospitalization. Design, Setting, and Participants: Assessor-blinded, multicenter, randomized clinical trial in 35 French ICUs from October 2015 to January 2017, with follow-up until July 2017. Among 2631 approached patients, 709 adult patients (with 1 family member each) who receivedmechanical ventilationwithin 48 hours after ICU admission for at least 2 days were eligible, 657 were randomized, and 339 were assessed 3 months after ICU discharge. Interventions: Patients in the intervention group (n = 355) had an ICU diary filled in by clinicians and family members. Patients in the control group (n = 354) had usual ICU care without an ICU diary. Main Outcomes and Measures: The primary outcome was significant PTSD symptoms, defined as an Impact Event Scale-Revised (IES-R) score greater than 22 (range, 0-88; a higher score indicates more severe symptoms), measured in patients 3 months after ICU discharge. Secondary outcomes, also measured at 3 months and compared between groups, included significant PTSD symptoms in family members; significant anxiety and depression symptoms in patients and family members, based on a Hospital Anxiety and Depression Scale score greater than 8 for each subscale (range, 0-42; higher scores indicate more severe symptoms; minimal clinically important difference, 2.5); and patient memories of the ICU stay, reported with the ICU memory tool. Results: Among 657 patients who were randomized (median [interquartile range] age, 62 [51-70] years; 126 women [37.2%]), 339 (51.6%) completed the trial. At 3 months, significant PTSD symptoms were reported by 49 of 164 patients (29.9%) in the intervention group vs 60 of 175 (34.3%) in the control group (risk difference, -4% [95% CI, -15% to 6%]; P = .39). The median (interquartile range) IES-R score was 12 (5-25) in the intervention group vs 13 (6-27) in the control group (difference, -1.47 [95% CI, -1.93 to 4.87]; P = .38). There were no significant differences in any of the 6 prespecified comparative secondary outcomes. Conclusions and Relevance: Among patients who received mechanical ventilation in the ICU, the use of an ICU diary filled in by clinicians and family members did not significantly reduce the number of patients who reported significant PTSD symptoms at 3 months. These findings do not support the use of ICU diaries for preventing PTSD symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT02519725.
RCT Entities:
Importance: Keeping a diary for patients while they are in the intensive care unit (ICU) might reduce their posttraumatic stress disorder (PTSD) symptoms. Objectives: To assess the effect of an ICU diary on the psychological consequences of an ICU hospitalization. Design, Setting, and Participants: Assessor-blinded, multicenter, randomized clinical trial in 35 French ICUs from October 2015 to January 2017, with follow-up until July 2017. Among 2631 approached patients, 709 adult patients (with 1 family member each) who received mechanical ventilation within 48 hours after ICU admission for at least 2 days were eligible, 657 were randomized, and 339 were assessed 3 months after ICU discharge. Interventions: Patients in the intervention group (n = 355) had an ICU diary filled in by clinicians and family members. Patients in the control group (n = 354) had usual ICU care without an ICU diary. Main Outcomes and Measures: The primary outcome was significant PTSD symptoms, defined as an Impact Event Scale-Revised (IES-R) score greater than 22 (range, 0-88; a higher score indicates more severe symptoms), measured in patients 3 months after ICU discharge. Secondary outcomes, also measured at 3 months and compared between groups, included significant PTSD symptoms in family members; significant anxiety and depression symptoms in patients and family members, based on a Hospital Anxiety and Depression Scale score greater than 8 for each subscale (range, 0-42; higher scores indicate more severe symptoms; minimal clinically important difference, 2.5); and patient memories of the ICU stay, reported with the ICU memory tool. Results: Among 657 patients who were randomized (median [interquartile range] age, 62 [51-70] years; 126 women [37.2%]), 339 (51.6%) completed the trial. At 3 months, significant PTSD symptoms were reported by 49 of 164 patients (29.9%) in the intervention group vs 60 of 175 (34.3%) in the control group (risk difference, -4% [95% CI, -15% to 6%]; P = .39). The median (interquartile range) IES-R score was 12 (5-25) in the intervention group vs 13 (6-27) in the control group (difference, -1.47 [95% CI, -1.93 to 4.87]; P = .38). There were no significant differences in any of the 6 prespecified comparative secondary outcomes. Conclusions and Relevance: Among patients who received mechanical ventilation in the ICU, the use of an ICU diary filled in by clinicians and family members did not significantly reduce the number of patients who reported significant PTSD symptoms at 3 months. These findings do not support the use of ICU diaries for preventing PTSD symptoms. Trial Registration: ClinicalTrials.gov Identifier: NCT02519725.
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