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

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

doi:10.1186/s13063-016-1211-x

Abstract

BackgroundIt 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/designWe 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).DiscussionThe 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 registrationClinicalTrials.gov NCT02442934 , registered 11 May 2015.

Highlights

It is well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources
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
Oral consent will be collected for each participant. To our knowledge, this is the first study assessing the effectiveness of a program of discomfort reduction for intensive care unit (ICU) patients using a randomized controlled design, which is the most appropriate design to demonstrate the efficacy of a new experimental intervention in accordance with the levels of evidence classification of the Evidence-Based Medicine Working Group

Summary

Introduction

It is well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Some authors have distinguished the discomforts into two other categories: physical (pain, sleep deprivation, thirst, hunger, feeling of cold, feeling of heat) and psychological (communication restriction, lack of autonomy, isolation, anxiety, no respect for intimacy) [3] These may have significant short-term and long-term consequences for the patients, such as agitation and/or confusion during the ICU stay, which is called ICU delirium [8,9,10,11], or various degrees of anxiety and/or depression [12] or posttraumatic stress disorder after the ICU stay [13,14,15] that may affect their quality of life [16]. This could lead to late admissions to the ICU and worsened organ functions, which may impact patient outcomes

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