Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial.
| Title: | Effect of an ICU Diary on Posttraumatic Stress Disorder Symptoms Among Patients Receiving Mechanical Ventilation: A Randomized Clinical Trial. |
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| Authors: | Garrouste-Orgeas M; 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.; Department of Biostatistics, Outcomerea, Paris, France.; Medical unit, French British Hospital, Levallois-Perret, France.; Flahault C; LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France.; Vinatier I; Medical ICU, Les Oudaries Hospital, La Roche-sur-Yon, Vendée, France.; Rigaud JP; Department of Intensive Care, Dieppe General Hospital, Dieppe, France.; Thieulot-Rolin N; Medical-Surgical ICU, General Hospital, Melun, France.; Mercier E; CRICS-TRIGGERSEP group, Medical-Surgical ICU, Tours University Hospital, Tours, France.; Rouget A; Medical-Surgical ICU, Rangueil University Hospital, Toulouse, France.; Grand H; Medical-Surgical ICU, Hospital Robert Boulin, Libourne, France.; Lesieur O; Medical-Surgical ICU, General Hospital, La Rochelle, France.; Tamion F; Medical ICU, University Medical Center, Rouen, France.; INSERM U-1096, University of Rouen, Rouen, France.; Hamidfar R; Medical ICU, Albert Michallon University Hospital, Grenoble, France.; Renault A; Medical ICU, La Cavale Blanche University Hospital, Brest, France.; Parmentier-Decrucq E; Group of medical ICUs, Lille University Hospital, Lille, France.; Monseau Y; Medical-Surgical ICU, General Hospital, Périgueux, France.; Argaud L; Medical ICU, Edouard Herriot University Hospital, Lyon, France.; Bretonnière C; Medical ICU, Nantes University Hospital, Nantes, France.; EA3826, Laboratory of Clinical and Experimental Therapeutics of Infections, University of Nantes, Nantes, France.; Lautrette A; Medical ICU, Gabriel-Montpied University Hospital, Clermont Ferrand, France.; LMGE UMR CNRS 6023, University of Clermont-Ferrand, Clermont Ferrand, France.; Badié J; Medical-Surgical ICU, General Hospital Belfort-Montbéliard, Belfort, France.; Boulet E; Medical ICU, Beaumont General Hospital, Beaumont, France.; Floccard B; Medical ICU, Hospices Civils de Lyon, Edouard Herriot University Hospital, Lyon, France.; Forceville X; Medical-Surgical ICU, Great Hospital of East Francilien, Meaux, France.; Kipnis E; Surgical ICU, Lille University Hospital, Lille, France.; Soufir L; Medical-Surgical ICU, Saint Joseph Hospital Network, Paris, France.; Valade S; Medical ICU, Saint Louis University Hospital, Paris, France.; Bige N; Medical ICU, Saint Antoine University Hospital, Paris, France.; Gaffinel A; Medical-Surgical ICU, Gustave Roussy Cancer Campus, Villejuif, France.; Hamzaoui O; Medical Surgical ICU, University Hospital Paris -Sud, Beclère University Hospital, Clamart, France.; Simon G; Medical-Surgical ICU, General Hospital, Troyes, France.; Thirion M; Medical-Surgical ICU, General Hospital Victor Dupouy, Argenteuil, France.; Bouadma L; 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.; Medical ICU, Bichat University Hospital, Paris, France.; Large A; Medical ICU, François Mitterrand University Hospital, Dijon, France.; Mira JP; Medical ICU, Cochin University Hospital, Paris Centre Hospital Group, AP-HP, Paris, France.; Amdjar-Badidi N; Medical-Surgical ICU, General Hospital René Dubos, Pontoise, France.; Jourdain M; Group of medical ICUs, Lille University Hospital, Lille, France.; Lille University, Inserm U1190, Lille, France.; Jost PH; Surgical ICU, Henri Mondor University Hospital, Créteil, France.; Maxime V; Medical ICU, Raymond Poincaré University Hospital, Garches, France.; Santoli F; Medical ICU, General Hospital Robert Ballanger, Aulnay-Sous-Bois, France.; Ruckly S; Department of Biostatistics, Outcomerea, Paris, France.; Vioulac C; LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France.; Leborgne MA; LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France.; Bellalou L; LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France.; Fasse L; LPPS-EA4057, Laboratory of Psychopathology and Health Process, Paris Descartes University, Paris, France.; Misset B; Medical ICU, University Medical Center, Rouen, France.; Bailly S; 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.; Grenoble Alpes University, INSERM, University hospital Grenoble Alpes, HP2, Grenoble, France.; Timsit JF; 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.; Department of Biostatistics, Outcomerea, Paris, France.; Medical ICU, Bichat University Hospital, Paris, France. |
| Source: | JAMA [JAMA] 2019 Jul 16; Vol. 322 (3), pp. 229-239. |
| Publication Type: | Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
| Language: | English |
| Journal Info: | Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA |
| Imprint Name(s): | Original Publication: Chicago : American Medical Association, 1960- |
| MeSH Terms: | Intensive Care Units*; Critical Care/*psychology ; Respiration, Artificial/*psychology ; Stress Disorders, Post-Traumatic/*prevention & control; Family/psychology ; Health Personnel/psychology ; Aged ; Female ; Hospitalization ; Humans ; Male ; Middle Aged ; Records |
| 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 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. |
| Comments: | Comment in: JAMA. 2019 Jul 16;322(3):213-215. doi: 10.1001/jama.2019.9059.. (PMID: 31310279); Comment in: JAMA. 2019 Nov 26;322(20):2025. doi: 10.1001/jama.2019.16114.. (PMID: 31769819) |
| References: | Crit Care Med. 2000 Aug;28(8):3044-9. (PMID: 10966293); Crit Care Med. 2001 Mar;29(3):573-80. (PMID: 11373423); Crit Care Med. 2001 Jul;29(7):1370-9. (PMID: 11445689); Crit Care Med. 2003 Oct;31(10):2456-61. (PMID: 14530751); Intensive Care Med. 2004 Mar;30(3):456-60. (PMID: 14767589); Nurs Crit Care. 2005 Jan-Feb;10(1):31-4. (PMID: 15739637); Addict Behav. 2008 Aug;33(8):1039-47. (PMID: 18501524); Crit Care Med. 2009 Jan;37(1):184-91. (PMID: 19050634); Nurs Crit Care. 2009 Mar-Apr;14(2):61-7. (PMID: 19243522); Chest. 2009 Mar;135(3):678-687. (PMID: 19265087); JAMA. 2009 Mar 25;301(12):1231-41. (PMID: 19318651); Intensive Crit Care Nurs. 2010 Oct;26(5):278-87. (PMID: 20692158); Crit Care. 2010;14(5):R168. (PMID: 20843344); Crit Care Med. 2011 Jan;39(1):112-8. (PMID: 21037472); Crit Care. 2011;15(1):R41. (PMID: 21272307); Crit Care Med. 2012 Feb;40(2):502-9. (PMID: 21946660); Crit Care Med. 2012 Apr;40(4):1088-97. (PMID: 22080631); Crit Care Med. 2012 Jul;40(7):2033-40. (PMID: 22584757); Am J Crit Care. 2012 Nov;21(6):386-93; quiz 394. (PMID: 23117902); Aust Crit Care. 2014 Feb;27(1):28-35. (PMID: 23938098); N Engl J Med. 2013 Oct 3;369(14):1306-16. (PMID: 24088092); Crit Care. 2013 Dec 18;17(6):253. (PMID: 24351578); PLoS One. 2014 Oct 16;9(10):e110146. (PMID: 25329581); Eur Respir J. 2015 May;45(5):1341-52. (PMID: 25614168); Crit Care Med. 2015 May;43(5):1121-9. (PMID: 25654178); Am J Respir Crit Care Med. 2016 Jan 15;193(2):154-62. (PMID: 26378963); Gen Hosp Psychiatry. 2016 Sep-Oct;42:32-5. (PMID: 27638969); Intensive Care Med. 2017 Apr;43(4):473-484. (PMID: 28197680); Am J Respir Crit Care Med. 2018 Jan 1;197(1):66-78. (PMID: 28872898); Trials. 2017 Nov 15;18(1):542. (PMID: 29141694); N Engl J Med. 2018 Jun 21;378(25):2365-2375. (PMID: 29791247); Crit Care Med. 2018 Aug;46(8):1328-1333. (PMID: 29794546); Med Klin Intensivmed Notfmed. 2019 Feb;114(1):68-76. (PMID: 29995235); Crit Care Med. 2018 Dec;46(12):1914-1922. (PMID: 30119073); Acta Psychiatr Scand. 1983 Jun;67(6):361-70. (PMID: 6880820) |
| Molecular Sequence: | ClinicalTrials.gov NCT02519725 |
| Entry Date(s): | Date Created: 20190717 Date Completed: 20190731 Latest Revision: 20200225 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC6635906 |
| DOI: | 10.1001/jama.2019.9058 |
| PMID: | 31310299 |
| Database: | MEDLINE |
Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't