A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial
- 1.1k Downloads
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.
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.
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.
This tailored multicomponent program decreased self-perceived discomfort in adult critically ill patients.
Trial Registration: Clinicaltrials.gov Identifier NCT02442934.
KeywordsCritical care Discomfort Tailored program Patient-reported outcome ICU Cluster-randomized controlled trial
This research was financially supported by a grant from the Programme Hospitalier de Recherche Clinique National, 2012, 12-010-0554, funded by the French Ministry of Health. We thank all the nursing staff members and doctors whose enthusiasm and work have made this clinical trial possible. We particularly thank Anderson Loundou (Unité de recherche EA3279, Aix-Marseille Université) for participating in the statistical analysis, Bénédicte Mauchien (CH de Chartres) for her major and invaluable role in providing technical and educational support to all the investigators under the supervision of the lead investigator, and Claude Martin (CHU Hôpital Nord, AP-HM) for participating in the steering committee.
Members of the IPREA study group: Co-investigators and collaborators (alphabetically by institution, all in France) from Centre Hospitalier (CH) d’Auxerre: Karine Vie, Centre Hospitalier (CHU) de Brest: Gwenaëlle Lannuzel, CHU Beaujon, Assistance Publique-Hôpitaux de Paris (AP-HP): Hélène Bout, CHU Dijon Bourgogne: Jean-Philippe Parthiot, Isabelle Chazal, Philippe Charve, Caroline Prum, Jean-Pierre Quenot, Nora Perrot, Francis Augier, Niloufar Behechti, Claudine Cocusse, Céline Foulon, Laurence Goncalves, Abdesselem Hanchi, Etienne Legros, Ana Isabel Mercier, Nicolas Meunier-Beillard, Nathalie Nuzillat, and Alicia Richard, CH de Douai: Claire Boulle, Benjamin Kowalski, and Elisa Klusek, CHU Raymond Poincaré, AP–HP: Tarek Sharshar, Andrea Polito, Caroline Duvallet, and Sonia Krim, Groupe Hospitalier de La Rochelle-Ré-Aunis: Nicolas Girard, CH de Chartres: Juliette Audibert-Souhaid, Cécile Jourdain, and Stéphane Techer, CH Emile Roux, Le Puy-en-Velay: Corinne Chauvel, and Corinne Bruchet, CH de Lens: Johanna Temime, Stéphanie Beaussart, and Fabienne Jarosz, CHU Edouard Herriot, Hospices Civils de Lyon: Julien Crozon-Clauzel, Serge Olousouzian, Sylvie Pereira, Loïc Argentin, and Valérie Cerro, Hôpital Européen de Marseille: Déborah Levy, CHU Hôpital Nord, Assistance Publique Hôpitaux de Marseille: Sébastien Andre, Christophe Guervilly, Laurent Papazian, and Myriam Moussa, Clinique Ambroise Paré, Neuilly/Seine: Stéphanie Renoult, Delphine Biet, and Steve Novak, CHU Nice: Jean-Christophe Orban, Aminata Diop, and Carole Ichai, CHU Cochin, AP-HP: Antoine Tesniere, Jean-Pascal Goupil, and Frédérique Laville, CHU Hôpital Européen Georges Pompidou, AP-HP: Nadège Rutter, Groupe Hospitalier Paris Saint-Joseph: Sandie Brochon and Kelly Tiercelet, CHU Pitié-Salpêtrière, AP-HP: Julien Amour, Nora Ait-Hamou, and Marjorie Leger, CHU Saint-Louis, AP-HP: Virginie Souppart, CHU La Milétrie, Poitiers: Emilie Griffault, Marie-Line Debarre, Céline Deletage, Anne-Laure Guerin, Carole Guignon, and Sabrina Seguin, CH Victor Provo, Roubaix: Christophe Hart and Kathy Dernivoix, CHU Strasbourg: Caroline Wuiot, Karine Sanches, and Stéphane Hecketsweiler, Centre Hospitalier Intercommunal Toulon/La Seyne sur mer: Catherine Sylvestre-Marconville and Vincent Gardan, and CH de Troyes: Stéphanie Deparis-Dusautois and Yana Chaban.
Compliance with ethical standards
Conflicts of interest
Dr Kalfon received consulting fees from Philips Healthcare. On behalf of all remaining authors, the corresponding author states that the remaining authors have no conflicts of interest.
- 8.Schelling G, Stoll C, Haller M, Briegel J, Manert W, Hummel T, Lenhart A, Heyduck M, Polasek J, Meier M, Preuss U, Bullinger M, Schuffel W, Peter K (1998) Health-related quality of life and posttraumatic stress disorder in survivors of the acute respiratory distress syndrome. Crit Care Med 26:651–659CrossRefPubMedGoogle Scholar
- 10.Elliott D, McKinley S, Alison J, Aitken LM, King M, Leslie GD, Kenny P, Taylor P, Foley R, Burmeister E (2012) Health-related quality of life and physical recovery after a critical illness: a multi-centre randomised controlled trial of a home-based physical rehabilitation program. Crit Care 15:R142CrossRefGoogle Scholar
- 14.Chlan LL, Weinert CR, Heiderscheit A, Tracy MF, Skaar DJ, Guttormson JL, Savik K (2013) Effects of patient-directed music intervention on anxiety and sedative exposure in critically ill patients receiving mechanical ventilatory support: a randomized clinical trial. JAMA 309:2335–2344CrossRefPubMedPubMedCentralGoogle Scholar
- 18.Flodgren G, Parmelli E, Doumit G, Gattellari M, O’Brien MA, Grimshaw J, Eccles MP (2011) Local opinion leaders: effects on professional practice and health care outcomes. Cochrane Database Syst Rev 8:CD000125Google Scholar
- 19.Middleton S, McElduff P, Ward J, Grimshaw JM, Dale S, D’Este C, Drury P, Griffiths R, Cheung NW, Quinn C, Evans M, Cadilhac D, Levi C, Group QT (2011) Implementation of evidence-based treatment protocols to manage fever, hyperglycaemia, and swallowing dysfunction in acute stroke (QASC): a cluster randomised controlled trial. Lancet 378:1699–1706CrossRefPubMedGoogle Scholar
- 25.Kalfon P, Baumstarck K, Estagnasie P et al (2016) Reduction of self-perceived discomforts in critically ill patients in French intensive care units: a cluster-randomized controlled trial. Intensive Care Med Exp 4(Suppl 1):A924471Google Scholar
- 27.Kalfon P, Mimoz O, Loundou A, Geantot MA, Revel N, Villard I, Amour J, Azoulay E, Garrouste-Orgeas M, Martin C, Sharshar T, Baumstarck K, Auquier P (2016) Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial. Trials 17:87CrossRefPubMedPubMedCentralGoogle Scholar
- 28.Kalfon P, Mimoz O, Auquier P, Loundou A, Gauzit R, Lepape A, Laurens J, Garrigues B, Pottecher T, Malledant Y (2010) Development and validation of a questionnaire for quantitative assessment of perceived discomforts in critically ill patients. Intensive Care Med 36:1751–1758CrossRefPubMedGoogle Scholar