Pierre Kalfon1, Karine Baumstarck2, Philippe Estagnasie3, Marie-Agnès Geantot4, Audrey Berric5, Georges Simon6, Bernard Floccard7, Thomas Signouret8, Mohamed Boucekine2, Mélanie Fromentin9, Martine Nyunga10, Achille Sossou11, Marion Venot12, René Robert13, Arnaud Follin14, Juliette Audibert15, Anne Renault16, Maïté Garrouste-Orgeas17, Olivier Collange18, Quentin Levrat19, Isabelle Villard20, Didier Thevenin21, Julien Pottecher22, René-Gilles Patrigeon23, Nathalie Revel24, Coralie Vigne25, Elie Azoulay12, Olivier Mimoz26, Pascal Auquier2. 1. Réanimation Polyvalente, Hôpital Louis Pasteur, CH de Chartres, Le Coudray, France. pkalfon@ch-chartres.fr. 2. Unité de Recherche EA3279, Aix-Marseille Université, Marseille, France. 3. Réanimation, Clinique Ambroise Paré, Neuilly/Seine, France. 4. Département d'Anesthésie Réanimation, CHU Dijon Bourgogne, Dijon, France. 5. Réanimation Polyvalente, Centre Hospitalier Intercommunal Toulon/La Seyne Sur Mer, Toulon, France. 6. Réanimation, CH Troyes, Troyes, France. 7. Réanimation Polyvalente, CHU Edouard Herriot, Hospices Civils de Lyon, Lyon, France. 8. Réanimation, Hôpital Européen de Marseille, Marseille, France. 9. Réanimation Chirurgicale, CHU Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France. 10. Réanimation Polyvalente, CH Victor Provo, Roubaix, France. 11. Réanimation, CH Emile Roux, Le Puy-En-Velay, France. 12. Réanimation Médicale, CHU Saint-Louis, AP-HP, Paris, France. 13. Réanimation Médicale, CHU La Milétrie, Poitiers, France. 14. Réanimation Chirurgicale, Hôpital Européen Georges Pompidou, AP-HP, Paris, France. 15. Réanimation Polyvalente, Hôpital Louis Pasteur, CH de Chartres, Le Coudray, France. 16. Réanimation Médicale, CHU Brest, Brest, France. 17. Médecine Intensive et Réanimation, Groupe Hospitalier Paris Saint-Joseph, Paris, France. 18. Réanimation Chirurgicale Polyvalente, Hôpital Civil, CHU Strasbourg, Strasbourg, France. 19. Réanimation, Groupe Hospitalier de La Rochelle-Ré-Aunis, La Rochelle, France. 20. Anesthésie Réanimation, CHU Beaujon, AP-HP, Clichy, France. 21. Réanimation, CH Lens, Lens, France. 22. Réanimation Chirurgicale, Hôpital Hautepierre, CHU Strasbourg, Strasbourg, France. 23. Réanimation, CH Auxerre, Auxerre, France. 24. Réanimation Médico-chirurgicale, Hôpital Pasteur, CHU Nice, Nice, France. 25. Réanimation Chirurgicale, CHU Hôpital Nord, Assistance Publique-Hôpitaux de Marseille, Marseille, France. 26. Réanimation chirugicale, CHU La Milétrie, Poitiers, France.
Abstract
PURPOSE:Critically ill patients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort. METHODS: In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge. RESULTS: During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was - 7.00 (95% CI - 9.89 to - 4.11, p < 0.001). After adjustment (age, gender, ICU duration, mechanical ventilation duration, and type of admission), the program effect was still positive for the overall discomfort score (difference - 6.35, SE 1.23, p < 0.001) and for 12 out of 16 items. CONCLUSIONS: This tailored multicomponent program decreased self-perceived discomfort in adult critically ill patients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT02442934.
RCT Entities:
PURPOSE:Critically illpatients are exposed to stressful conditions and experience several discomforts. The primary objective was to assess whether a tailored multicomponent program is effective for reducing self-perceived discomfort. METHODS: In a cluster-randomized two-arm parallel trial, 34 French adult intensive care units (ICUs) without planned interventions to reduce discomfort were randomized, 17 to the arm including a 6-month period of program implementation followed by a 6-month period without the program (experimental group), and 17 to the arm with an inversed sequence (control group). The tailored multicomponent program consisted of assessment of ICU-related self-perceived discomforts, immediate and monthly feedback to healthcare teams, and site-specific tailored interventions. The primary outcome was the overall discomfort score derived from the 16-item IPREA questionnaire (0, minimal, 100, maximal overall discomfort) and the secondary outcomes were the discomfort scores of each IPREA item. IPREA was administered on the day of ICU discharge with a considered timeframe from the ICU admission until ICU discharge. RESULTS: During a 1-month assessment period, 398 and 360 patients were included in the experimental group and the control group, respectively. The difference (experimental minus control) of the overall discomfort score between groups was - 7.00 (95% CI - 9.89 to - 4.11, p < 0.001). After adjustment (age, gender, ICU duration, mechanical ventilation duration, and type of admission), the program effect was still positive for the overall discomfort score (difference - 6.35, SE 1.23, p < 0.001) and for 12 out of 16 items. CONCLUSIONS: This tailored multicomponent program decreased self-perceived discomfort in adult critically illpatients. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT02442934.
Authors: Kathleen Puntillo; Shoshana R Arai; Bruce A Cooper; Nancy A Stotts; Judith E Nelson Journal: Intensive Care Med Date: 2014-06-04 Impact factor: 17.440
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Authors: Pierre Kalfon; Olivier Mimoz; Pascal Auquier; Anderson Loundou; Rémy Gauzit; Alain Lepape; Jean Laurens; Bernard Garrigues; Thierry Pottecher; Yannick Mallédant Journal: Intensive Care Med Date: 2010-05-26 Impact factor: 17.440