The ICU-Diary study: prospective, multicenter comparative study of the impact of an ICU diary on the wellbeing of patients and ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-11-15

AUTHORS

Maïté Garrouste-Orgeas, Cécile Flahault, Léonor Fasse, Stéphane Ruckly, Nora Amdjar-Badidi, Laurent Argaud, Julio Badie, Amélie Bazire, Naike Bige, Eric Boulet, Lila Bouadma, Cédric Bretonnière, Bernard Floccard, Alain Gaffinel, Xavier de Forceville, Hubert Grand, Rebecca Halidfar, Olfa Hamzaoui, Mercé Jourdain, Paul-Henri Jost, Eric Kipnis, Audrey Large, Alexandre Lautrette, Olivier Lesieur, Virginie Maxime, Emmanuelle Mercier, Jean Paul Mira, Yannick Monseau, Erika Parmentier-Decrucq, Jean-Philippe Rigaud, Antoine Rouget, François Santoli, Georges Simon, Fabienne Tamion, Nathalie Thieulot-Rolin, Marina Thirion, Sandrine Valade, Isabelle Vinatier, Christel Vioulac, Sebastien Bailly, Jean-François Timsit

ABSTRACT

BackgroundPost-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.MethodsA 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.DiscussionThis 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 registrationClinicalTrial.gov, ID: NCT02519725. Registered on 13 July 2015. More... »

PAGES

542

Journal

TITLE

Trials

ISSUE

1

VOLUME

18

Author Affiliations

  • Medical unit, French British Hospital Institute, Levallois-Perret, France
  • Psychology laboratory and work process, Paris Descartes University, Paris, France
  • Laboratoire Psy-DREPI EA-7458, Bourgogne Franche Comté University, Dijon, France
  • Department of Biostatistics, Outcomerea, Paris, France
  • Medical-Surgical ICU, General Hospital René Dubos, Pontoise, France
  • Medical ICU, Edouard Herriot University Hospital, Lyon, France
  • Medical-Surgical ICU, General Hospital Belfort-Montbeliard, Belfort, France
  • Medical ICU, La Cavale Blanche University Hospital, Brest, France
  • Medical ICU, Saint Antoine University Hospital, Paris, France
  • Medical ICU, Beaumont General Hospital, Beaumont, France
  • Medical ICU, Bichat University Hospital, Paris, France
  • EA3826, Laboratory of clinical and experimental therapeutics of infections, University of Nantes, Nantes, France
  • Medical ICU, Hospices Civils de Lyon, Edouard Herriot University Hospital, Lyon, France
  • Medical-Surgical ICU, Gustave Roussy Cancer Campus, Villejuif, France
  • Medical-Surgical ICU, Est Francilien Hospital network, Meaux, France
  • Medical-Surgical ICU, Hospital Robert Boulin, Libourne, France
  • Medical ICU, Albert Michallon University Hospital, Grenoble, France
  • Medical ICU, University Hospital Paris-Sud, Beclère University Hospital, Clamart, France
  • Group of medical ICUs, Lille University Hospital, Lille, France
  • Surgical ICU, Henri Mondor University Hospital, Créteil, France
  • Surgical ICU, Lille University Hospital, Lille, France
  • Medical ICU, François Mitterrand University Hospital, Dijon, France
  • LMGE UMR CNRS 6023, University of Clermont-Ferrand, Clermont Ferrand, France
  • EA 4569, University Paris Descartes, Paris, France
  • Medical ICU, Raymond Poincaré University Hospital, Garches, France
  • CRICS group, Medical-Surgical ICU, Tours University Hospital, Tours, France
  • Medical ICU, Cochin University Hospital, Paris, France
  • Medical-Surgical ICU, General Hospital, Périgueux, France
  • Department of Intensive Care, Dieppe General Hôpital, Dieppe, France
  • Medical-Surgical ICU, Rangueil University Hospital, Toulouse, France
  • Medical ICU, General Hospital Robert Ballanger, Aulnay-Sous-Bois, France
  • Medical-Surgical ICU, General Hospital, Troyes, France
  • INSERM U-1096, University of Rouen, Rouen, France
  • Medical-Surgical ICU, General Hôpital, Melun, France
  • Medical-Surgical ICU, General Hospital Victor Dupouy, Argenteuil, France
  • Medical ICU, Saint Louis University Hospital, Paris, France
  • Medical ICU, Les Oudaries Hospital, La Roche-sur-Yon, France
  • 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
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-017-2283-y

    DOI

    http://dx.doi.org/10.1186/s13063-017-2283-y

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1092692971

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/29141694


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    37 schema:description BackgroundPost-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.MethodsA 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.DiscussionThis 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 registrationClinicalTrial.gov, ID: NCT02519725. Registered on 13 July 2015.
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    44 DiscussionThis study
    45 Event Scale
    46 French intensive care units
    47 Hospital Anxiety
    48 ICU admission
    49 ICU diaries
    50 ICU discharge
    51 ICU stay
    52 ID
    53 MethodsA
    54 acute conditions
    55 admission
    56 anxiety
    57 arm
    58 care unit
    59 cases
    60 cases of death
    61 center
    62 challenges
    63 cognitive impairment
    64 comparative study
    65 conditions
    66 consequences
    67 content
    68 control group
    69 criticism
    70 death
    71 depression symptoms
    72 depth
    73 diary
    74 discharge
    75 disorders
    76 effect
    77 effectiveness
    78 endpoint
    79 family
    80 family members
    81 grid
    82 group
    83 impact
    84 impairment
    85 insights
    86 intensive care unit
    87 intensivists
    88 interpretation
    89 intervention arm
    90 interviews
    91 members
    92 memory
    93 memory of patients
    94 memory recollection
    95 months
    96 multicenter
    97 multicenter comparative study
    98 multiple consequences
    99 new challenges
    100 new insights
    101 objective
    102 participation
    103 patient stories
    104 patients
    105 phone interviews
    106 phones
    107 post-traumatic stress disorder
    108 post-traumatic stress syndrome
    109 prevention programs
    110 previous studies
    111 primary objective
    112 program
    113 psychologists
    114 questionnaire
    115 recollection
    116 results
    117 samples
    118 scale
    119 scale questionnaire
    120 secondary objective
    121 staff
    122 stay
    123 story
    124 stress disorder
    125 stress syndrome
    126 study
    127 symptoms
    128 syndrome
    129 tool questionnaire
    130 units
    131 use
    132 wellbeing
    133 wellbeing of patients
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