title: Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial.
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
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02442934, registered 11 May 2015.
authors.affiliation: Service de réanimation, Centre Hospitalier Louis Pasteur, Chartres, France. pkalfon@ch-chartres.fr.
authors.forename: Pierre
authors.initials: P
authors.lastname: Kalfon
authors.affiliation: Centre Hospitalier Universitaire (CHU) La Miletrie, Poitiers, France. olivier.mimoz@chu-poitiers.fr.
authors.forename: Olivier
authors.initials: O
authors.lastname: Mimoz
authors.affiliation: EA3279 Self-perceived Health Assessment Research Unit Aix-Marseille University, Marseille, France. anderson.loundou@univ-amu.fr.
authors.forename: Anderson
authors.initials: A
authors.lastname: Loundou
authors.affiliation: CHU Dijon Bourgogne, Dijon, France. marieagnes.geantot@chu-dijon.fr.
authors.forename: Marie-Agnès
authors.initials: MA
authors.lastname: Geantot
authors.affiliation: CHU Hôpital Saint-Roch, Nice, France. revel.n@chu-nice.fr.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Revel
authors.affiliation: CHU Beaujon, Assistance Publique - Hôpitaux de Paris (APHP), Clichy, France. isabelle.lc.villard@gmail.com.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Villard
authors.affiliation: CHU Pitié-Salpêtrière, APHP, Paris, France. julien.amour@psl.aphp.fr.
authors.forename: Julien
authors.initials: J
authors.lastname: Amour
authors.affiliation: CHU Saint-Louis, APHP, Paris, France. elie.azoulay@sls.ap-hop-paris.fr.
authors.forename: Elie
authors.initials: E
authors.lastname: Azoulay
authors.affiliation: Groupe Hospitalier Paris Saint-Joseph, Paris, France. mgarrouste@hpsj.fr.
authors.forename: Maïté
authors.initials: M
authors.lastname: Garrouste-Orgeas
authors.affiliation: CHU Hôpital Nord, Assistance Publique - Hôpitaux de Marseille, Marseille, France. cmartin@ap-hm.fr.
authors.forename: Claude
authors.initials: C
authors.lastname: Martin
authors.affiliation: CHU Hôpital Raymond Poincaré, APHP, Garches, France. tarek.sharshar@rpc.aph.fr.
authors.forename: Tarek
authors.initials: T
authors.lastname: Sharshar
authors.affiliation: EA3279 Self-perceived Health Assessment Research Unit Aix-Marseille University, Marseille, France. karine.baumstarck@univ-amu.fr.
authors.forename: Karine
authors.initials: K
authors.lastname: Baumstarck
authors.affiliation: EA3279 Self-perceived Health Assessment Research Unit Aix-Marseille University, Marseille, France. pascal.auquier@univ-amu.fr.
authors.forename: Pascal
authors.initials: P
authors.lastname: Auquier
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D016638:Critical Illness / Q000628:therapy*; D003625:Data Collection; D003627:Data Interpretation, Statistical; D023381:Endpoint Determination; D006801:Humans; D007362:Intensive Care Units; D012649:Self Concept; D016037:Single-Blind Method