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

Pierre Kalfon, Olivier Mimoz (), Anderson Loundou, Marie-Agnes Geantot, Nathalie Revel, Isabelle Villard, Julien Amour, Élie Azoulay (), Maïté Garrouste-Orgeas, Tarek Sharshar, Karine Baumstarck, Pascal Auquier () and Claude Martin ()
Additional contact information
Pierre Kalfon: Hôpital Louis Pasteur [Chartres]
Olivier Mimoz: Service d'anesthésie réanimation [Poitiers] - CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital, PHAR [Poitiers] - Pharmacologie des anti-infectieux - UP - Université de Poitiers = University of Poitiers - INSERM - Institut National de la Santé et de la Recherche Médicale
Anderson Loundou: Unité d'Aide Méthodologique - APHM - Assistance Publique - Hôpitaux de Marseille - CHU Marseille
Julien Amour: ICAN - Unité de Recherche sur les Maladies Cardiovasculaires, du Métabolisme et de la Nutrition = Research Unit on Cardiovascular and Metabolic Diseases - UPMC - Université Pierre et Marie Curie - Paris 6 - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP) - INSERM - Institut National de la Santé et de la Recherche Médicale - CHU Pitié-Salpêtrière [AP-HP] - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP) - SU - Sorbonne Université
Élie Azoulay: AP-HP - Hopital Saint-Louis [AP-HP] - AP-HP - Assistance publique - Hôpitaux de Paris (AP-HP)
Maïté Garrouste-Orgeas: Epidémiologie pronostique des cancers et affections graves - UJF - Université Joseph Fourier - Grenoble 1 - INSERM - Institut National de la Santé et de la Recherche Médicale
Tarek Sharshar: Service médical des soins intensifs [CHU Raymond Poincaré] - Hôpital Raymond Poincaré [AP-HP], UVSQ - Université de Versailles Saint-Quentin-en-Yvelines
Karine Baumstarck: AMU - Aix Marseille Université
Pascal Auquier: SPMC - Santé Publique et maladies Chroniques : Qualité de vie Concepts, Usages et Limites, Déterminants - AMU - Aix Marseille Université - APHM - Assistance Publique - Hôpitaux de Marseille

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Abstract: Background: It is now well documented that critically ill patients are ă exposed to stressful conditions and experience discomforts from multiple ă sources. Improved identification of the discomforts of patients in ă intensive care units (ICUs) may have implications for managing their ă care, including consideration of ethical issues, and may assist ă clinicians in choosing the most appropriate interventions. The primary ă objective of this study was to assess the effectiveness of a ă multicomponent program of discomfort reduction in critically ill ă patients. The secondary objectives were to assess the sustainability of ă the impact of the program and the potential seasonality effect. ă Methods/design: We conducted a multicenter, cluster-randomized, ă controlled, single (patient)-blind study involving 34 French adult ICUs. ă The experimental intervention was a 6-month period during which the ă multicomponent program was implemented in the ICU and included the ă following steps: identification of discomforts, immediate feedback to ă the healthcare team, and implementation of targeted interventions. The ă control intervention was a 6-month period during which any program was ă implemented. The primary endpoint was the monthly overall score of ă self-reported discomfort from the French questionnaire on discomforts in ă ICU patients (IPREA). The secondary endpoints were the scores of the ă discomfort items of IPREA. The sample size was 660 individuals to obtain ă 80 % power to detect a 25 % difference in the overall discomfort score ă of IPREA between the two groups (design effect: 2.9). ă Discussion: The results of this cluster-randomized controlled study are ă expected to confirm that a multicomponent program of discomfort ă reduction may be a new strategy in the management of care for critically ă ill patients.

Keywords: Quality (search for similar items in EconPapers)
Date: 2016-02
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Citations: View citations in EconPapers (1)

Published in Trials, 2016, 17, ⟨10.1186/s13063-016-1211-x⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-01482499

DOI: 10.1186/s13063-016-1211-x

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