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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial

Authors: Pierre Kalfon, Olivier Mimoz, Anderson Loundou, Marie-Agnès Geantot, Nathalie Revel, Isabelle Villard, Julien Amour, Elie Azoulay, Maïté Garrouste-Orgeas, Claude Martin, Tarek Sharshar, Karine Baumstarck, Pascal Auquier

Published in: Trials | Issue 1/2016

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Abstract

Background

It is now well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Improved identification of the discomforts of patients in intensive care units (ICUs) may have implications for managing their care, including consideration of ethical issues, and may assist clinicians in choosing the most appropriate interventions. The primary objective of this study was to assess the effectiveness of a multicomponent program of discomfort reduction in critically ill patients. The secondary objectives were to assess the sustainability of the impact of the program and the potential seasonality effect.

Methods/design

We conducted a multicenter, cluster-randomized, controlled, single (patient)-blind study involving 34 French adult ICUs. The experimental intervention was a 6-month period during which the multicomponent program was implemented in the ICU and included the following steps: identification of discomforts, immediate feedback to the healthcare team, and implementation of targeted interventions. The control intervention was a 6-month period during which any program was implemented. The primary endpoint was the monthly overall score of self-reported discomfort from the French questionnaire on discomforts in ICU patients (IPREA). The secondary endpoints were the scores of the discomfort items of IPREA. The sample size was 660 individuals to obtain 80 % power to detect a 25 % difference in the overall discomfort score of IPREA between the two groups (design effect: 2.9).

Discussion

The results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy in the management of care for critically ill patients.

Trial registration

ClinicalTrials.gov NCT02442934 , registered 11 May 2015.
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Metadata
Title
Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial
Authors
Pierre Kalfon
Olivier Mimoz
Anderson Loundou
Marie-Agnès Geantot
Nathalie Revel
Isabelle Villard
Julien Amour
Elie Azoulay
Maïté Garrouste-Orgeas
Claude Martin
Tarek Sharshar
Karine Baumstarck
Pascal Auquier
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1211-x

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