The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs.
| Title: | The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and families in French ICUs. |
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| Authors: | Garrouste-Orgeas M; Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM and Paris Diderot University, Department of Biostatistics - HUPNVS - AP-HP, UFR de Médecine - Bichat University Hospital, Paris, France. maite.garrouste@ihfb.org.; Department of Biostatistics, Outcomerea, Paris, France. maite.garrouste@ihfb.org.; Medical unit, French British Hospital Institute, Levallois-Perret, France. maite.garrouste@ihfb.org.; Flahault C; Psychology laboratory and work process, Paris Descartes University, Paris, France.; Fasse L; Laboratoire Psy-DREPI EA-7458, Bourgogne Franche Comté University, Dijon, France.; Ruckly S; Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM and Paris Diderot University, Department of Biostatistics - HUPNVS - AP-HP, UFR de Médecine - Bichat University Hospital, Paris, France.; Department of Biostatistics, Outcomerea, Paris, France.; Amdjar-Badidi N; Medical-Surgical ICU, General Hospital René Dubos, Pontoise, France.; Argaud L; Medical ICU, Edouard Herriot University Hospital, Lyon, France.; Badie J; Medical-Surgical ICU, General Hospital Belfort-Montbeliard, Belfort, France.; Bazire A; Medical ICU, La Cavale Blanche University Hospital, Brest, France.; Bige N; Medical ICU, Saint Antoine University Hospital, Paris, France.; Boulet E; Medical ICU, Beaumont General Hospital, Beaumont, France.; Bouadma L; Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM and Paris Diderot University, Department of Biostatistics - HUPNVS - AP-HP, UFR de Médecine - Bichat University Hospital, Paris, France.; Medical ICU, Bichat University Hospital, Paris, France.; Bretonnière C; Medical ICU, Nantes University Hospital, Nantes, France.; EA3826, Laboratory of clinical and experimental therapeutics of infections, University of Nantes, Nantes, France.; Floccard B; Medical ICU, Hospices Civils de Lyon, Edouard Herriot University Hospital, Lyon, France.; Gaffinel A; Medical-Surgical ICU, Gustave Roussy Cancer Campus, Villejuif, France.; de Forceville X; Medical-Surgical ICU, Est Francilien Hospital network, Meaux, France.; Grand H; Medical-Surgical ICU, Hospital Robert Boulin, Libourne, France.; Halidfar R; Medical ICU, Albert Michallon University Hospital, Grenoble, France.; Hamzaoui O; Medical ICU, University Hospital Paris-Sud, Beclère University Hospital, Clamart, France.; Jourdain M; Lille University, Inserm U1190, Lille, France.; Group of medical ICUs, Lille University Hospital, Lille, France.; Jost PH; Surgical ICU, Henri Mondor University Hospital, Créteil, France.; Kipnis E; Surgical ICU, Lille University Hospital, Lille, France.; Large A; Medical ICU, François Mitterrand University Hospital, Dijon, France.; Lautrette A; Medical ICU, Gabriel-Montpied University Hospital, Clermont Ferrand, France.; LMGE UMR CNRS 6023, University of Clermont-Ferrand, Clermont Ferrand, France.; Lesieur O; Medical-Surgical ICU, General Hospital, La Rochelle, France.; EA 4569, University Paris Descartes, Paris, France.; Maxime V; Medical ICU, Raymond Poincaré University Hospital, Garches, France.; Mercier E; CRICS group, Medical-Surgical ICU, Tours University Hospital, Tours, France.; Mira JP; Medical ICU, Cochin University Hospital, Paris, France.; Monseau Y; Medical-Surgical ICU, General Hospital, Périgueux, France.; Parmentier-Decrucq E; Group of medical ICUs, Lille University Hospital, Lille, France.; Rigaud JP; Department of Intensive Care, Dieppe General Hôpital, Dieppe, France.; Rouget A; Medical-Surgical ICU, Rangueil University Hospital, Toulouse, France.; Santoli F; Medical ICU, General Hospital Robert Ballanger, Aulnay-Sous-Bois, France.; Simon G; Medical-Surgical ICU, General Hospital, Troyes, France.; Tamion F; Medical ICU, University medical center, Rouen, France.; INSERM U-1096, University of Rouen, Rouen, France.; Thieulot-Rolin N; Medical-Surgical ICU, General Hôpital, Melun, France.; Thirion M; Medical-Surgical ICU, General Hospital Victor Dupouy, Argenteuil, France.; Valade S; Medical ICU, Saint Louis University Hospital, Paris, France.; Vinatier I; Medical ICU, Les Oudaries Hospital, La Roche-sur-Yon, France.; Vioulac C; Psychology laboratory and work process, Paris Descartes University, Paris, France.; Bailly S; Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM and Paris Diderot University, Department of Biostatistics - HUPNVS - AP-HP, UFR de Médecine - Bichat University Hospital, Paris, France.; Timsit JF; Infection, Antimicrobials, Modelling, Evolution (IAME), UMR 1137, INSERM and 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: | Trials [Trials] 2017 Nov 15; Vol. 18 (1), pp. 542. Date of Electronic Publication: 2017 Nov 15. |
| Publication Type: | Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| MeSH Terms: | Critical Care* ; Family Relations* ; Intensive Care Units* ; Medical Records* ; Quality of Life*; Anxiety/*psychology ; Depression/*psychology ; Patients/*psychology ; Stress Disorders, Post-Traumatic/*psychology; Anxiety/diagnosis ; Depression/diagnosis ; Stress Disorders, Post-Traumatic/diagnosis ; Cost of Illness ; France ; Health Status ; Humans ; Memory ; Mental Health ; Narration ; Prospective Studies ; Research Design ; Surveys and Questionnaires ; Syndrome ; Time Factors |
| Abstract: | Background: Post-intensive care syndrome includes the multiple consequences of an intensive care unit (ICU) stay for patients and families. It has become a new challenge for intensivists. Prevention programs have been disappointing, except for ICU diaries, which report the patient's story in the ICU. However, the effectiveness of ICU diaries for patients and families is still controversial, as the interpretation of the results of previous studies was open to criticism hampering an expanded use of the diary. The primary objective of the study is to evaluate the post-traumatic stress syndrome in patients. The secondary objectives are to evaluate the post-traumatic stress syndrome in families, anxiety and depression symptoms in patients and families, and the recollected memories of patients. Endpoints will be evaluated 3 months after ICU discharge or death.; Methods: A prospective, multicenter, randomized, assessor-blind comparative study of the effect of an ICU diary on patients and families. We will compare two groups: one group with an ICU diary written by staff and family and given to the patient at ICU discharge or to the family in case of death, and a control group without any ICU diary. Each of the 35 participating centers will include 20 patients having at least one family member who will likely visit the patient during their ICU stay. Patients must be ventilated within 48 h after ICU admission and not have any previous chronic neurologic or acute condition responsible for cognitive impairments that would hamper their participation in a phone interview. Three months after ICU discharge or death of the patient, a psychologist will contact the patient and family by phone. Post-traumatic stress syndrome will be evaluated using the Impact of Events Scale-Revised questionnaire, anxiety and depression symptoms using the Hospital Anxiety and Depression Scale questionnaire, both in patients and families, and memory recollection using the ICU Memory Tool Questionnaire in patients. The content of a randomized sample of diaries of each center will be analyzed using a grid. An interview of the patients in the intervention arm will be conducted 6 months after ICU discharge to analyze in depth how they use the diary.; Discussion: This study will provide new insights on the impact of ICU diaries on post-traumatic stress disorders in patients and families after an ICU stay.; Trial Registration: ClinicalTrial.gov, ID: NCT02519725 . Registered on 13 July 2015. |
| References: | Crit Care Med. 2011 Feb;39(2):371-9. (PMID: 20959786); Chest. 2008 Feb;133(2):339-41. (PMID: 18252911); Am J Respir Crit Care Med. 2016 Oct 1;194(7):831-844. (PMID: 26974173); Crit Care Med. 2012 Apr;40(4):1088-97. (PMID: 22080631); Memory. 2000 Mar;8(2):79-94. (PMID: 10829125); Intensive Crit Care Nurs. 2009 Oct;25(5):268-77. (PMID: 19632844); J Crit Care. 2015 Feb;30(1):130-7. (PMID: 25449881); Crit Care Med. 2001 Mar;29(3):573-80. (PMID: 11373423); BMJ Open. 2015 Nov 27;5(11):e006852. (PMID: 26614615); Ann Surg. 1985 Dec;202(6):685-93. (PMID: 4073980); Nurs Crit Care. 2010 Jan-Feb;15(1):26-33. (PMID: 20070812); Nurs Crit Care. 2010 Jul-Aug;15(4):176-84. (PMID: 20626794); Crit Care Med. 2016 Jun;44(6):1116-28. (PMID: 26937860); Crit Care Med. 2012 Feb;40(2):502-9. (PMID: 21946660); Acta Psychiatr Scand. 1983 Jun;67(6):361-70. (PMID: 6880820); Crit Care Med. 2014 May;42(5):1263-71. (PMID: 24413580); Crit Care Med. 2012 Jul;40(7):2033-40. (PMID: 22584757); Crit Care Med. 2001 Mar;29(3):519-25. (PMID: 11373414); Crit Care Med. 2005 Mar;33(3):574-9. (PMID: 15753749); Crit Care Med. 2014 Dec;42(12):2518-26. (PMID: 25083984); N Engl J Med. 2002 Apr 4;346(14):1061-6. (PMID: 11932474); N Engl J Med. 2016 May 12;374(19):1831-41. (PMID: 27168433); Intensive Care Med. 2009 May;35(5):796-809. (PMID: 19165464); Adv Intern Med. 1974;19:135-58. (PMID: 4592709); J Intensive Care Med. 2006 May-Jun;21(3):173-82. (PMID: 16672639); Am J Crit Care. 2012 May;21(3):172-6. (PMID: 22549573); Qual Health Res. 2007 Sep;17(7):893-901. (PMID: 17724101); Crit Care Med. 2009 Jan;37(1):184-91. (PMID: 19050634); JAMA. 1993 Dec 22-29;270(24):2957-63. (PMID: 8254858); Crit Care. 2016 Jan 21;20:16. (PMID: 26792081); Crit Care. 2010;14(5):R168. (PMID: 20843344); Crit Care. 2011;15(1):R41. (PMID: 21272307); Addict Behav. 2008 Aug;33(8):1039-47. (PMID: 18501524); Crit Care. 2013 Dec 18;17(6):253. (PMID: 24351578); J Psychosom Res. 2002 Feb;52(2):69-77. (PMID: 11832252); BMJ. 2009 Oct 16;339:b3723. (PMID: 19837741); Intensive Care Med. 2001 Feb;27(2):344-6. (PMID: 11396277); Acta Anaesthesiol Scand. 2010 Jul;54(6):736-43. (PMID: 20236095); Intensive Care Med. 2013 Sep;39(9):1565-73. (PMID: 23765236); Am J Respir Crit Care Med. 2010 May 15;181(10):1121-7. (PMID: 20224063); Crit Care Med. 2011 Jan;39(1):112-8. (PMID: 21037472); JAMA. 2010 Oct 27;304(16):1833-4. (PMID: 20978262); Crit Care Med. 2003 Oct;31(10):2456-61. (PMID: 14530751); Gen Hosp Psychiatry. 2008 Sep-Oct;30(5):421-34. (PMID: 18774425); Crit Care Med. 2011 Aug;39(8):1922-8. (PMID: 21572330); Crit Care Med. 2016 Feb;44(2):381-5. (PMID: 26771784); J Intensive Care Soc. 2015 Aug;16(3):226-233. (PMID: 28979415); Nurs Crit Care. 2009 Mar-Apr;14(2):61-7. (PMID: 19243522); Crit Care. 2013 Jan 21;17(1):R13. (PMID: 23336394); Intensive Care Med. 2004 Mar;30(3):456-60. (PMID: 14767589); Am J Crit Care. 2012 Nov;21(6):386-93; quiz 394. (PMID: 23117902) |
| Grant Information: | 2014 ENG 50328 Fondation de France |
| Contributed Indexing: | Keywords: Anxiety; Depression; Family; ICU diary; Intensive care unit; Stress disorders; post-traumatic |
| Molecular Sequence: | ClinicalTrials.gov NCT02519725 |
| Entry Date(s): | Date Created: 20171117 Date Completed: 20180709 Latest Revision: 20260127 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC5688734 |
| DOI: | 10.1186/s13063-017-2283-y |
| PMID: | 29141694 |
| Database: | MEDLINE |
Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial