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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

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

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

Published in: Trials | Issue 1/2017

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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.
Appendix
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Metadata
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
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
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-2283-y

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