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

• Published in: Current controlled trials in cardiovascular medicine 2016-02, Vol.17 (1), p.87-87, Article 87
• Main Authors: Kalfon, Pierre, Mimoz, Olivier, Loundou, Anderson, Geantot, Marie-Agnès, Revel, Nathalie, Villard, Isabelle, Amour, Julien, Azoulay, Elie, Garrouste-Orgeas, Maïté, Martin, Claude, Sharshar, Tarek, Baumstarck, Karine, Auquier, Pascal
• Format: Article
• Language: English
• Subjects: Adult; Analysis; Clinical Protocols; Clinical trials; Critical Illness - therapy; Critically ill; Data Collection; Data Interpretation, Statistical; Economics and Finance; Endpoint Determination; Feedback; Health aspects; Human health and pathology; Humanities and Social Sciences; Humans; Intensive care; Intensive Care Units; Life Sciences; Management; Patient satisfaction; Performance evaluation; Post traumatic stress disorder; Psychiatrics and mental health; Psychology; Quality of life; Questionnaires; Santé publique et épidémiologie; Self Concept; Single-Blind Method; Stress (Psychology); Study Protocol; Ventilators
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-016-1211-x

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. 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). 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. ClinicalTrials.gov NCT02442934, registered 11 May 2015.