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Randomized Controlled Trial
. 2017 Dec;43(12):1829-1840.
doi: 10.1007/s00134-017-4991-x. Epub 2017 Nov 27.

A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial

Pierre Kalfon  1 , Karine Baumstarck  2 , Philippe Estagnasie  3 , Marie-Agnès Geantot  4 , Audrey Berric  5 , Georges Simon  6 , Bernard Floccard  7 , Thomas Signouret  8 , Mohamed Boucekine  2 , Mélanie Fromentin  9 , Martine Nyunga  10 , Achille Sossou  11 , Marion Venot  12 , René Robert  13 , Arnaud Follin  14 , Juliette Audibert  15 , Anne Renault  16 , Maïté Garrouste-Orgeas  17 , Olivier Collange  18 , Quentin Levrat  19 , Isabelle Villard  20 , Didier Thevenin  21 , Julien Pottecher  22 , René-Gilles Patrigeon  23 , Nathalie Revel  24 , Coralie Vigne  25 , Elie Azoulay  12 , Olivier Mimoz  26 , Pascal Auquier  2 ; IPREA Study group
Collaborators, Affiliations
Randomized Controlled Trial

A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial

Pierre Kalfon et al. Intensive Care Med. 2017 Dec.

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.

Keywords: Cluster-randomized controlled trial; Critical care; Discomfort; ICU; Patient-reported outcome; Tailored program.

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