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

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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.

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Acknowledgements

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.

Author information

Authors and Affiliations

  1. Réanimation Polyvalente, Hôpital Louis Pasteur, CH de Chartres, Le Coudray, France

    Pierre Kalfon & Juliette Audibert

  2. Unité de Recherche EA3279, Aix-Marseille Université, Marseille, France

    Karine Baumstarck, Mohamed Boucekine & Pascal Auquier

  3. Réanimation, Clinique Ambroise Paré, Neuilly/Seine, France

    Philippe Estagnasie

  4. Département d’Anesthésie Réanimation, CHU Dijon Bourgogne, Dijon, France

    Marie-Agnès Geantot

  5. Réanimation Polyvalente, Centre Hospitalier Intercommunal Toulon/La Seyne Sur Mer, Toulon, France

    Audrey Berric

  6. Réanimation, CH Troyes, Troyes, France

    Georges Simon

  7. Réanimation Polyvalente, CHU Edouard Herriot, Hospices Civils de Lyon, Lyon, France

    Bernard Floccard

  8. Réanimation, Hôpital Européen de Marseille, Marseille, France

    Thomas Signouret

  9. Réanimation Chirurgicale, CHU Cochin, Assistance Publique-Hôpitaux de Paris (AP-HP), Paris, France

    Mélanie Fromentin

  10. Réanimation Polyvalente, CH Victor Provo, Roubaix, France

    Martine Nyunga

  11. Réanimation, CH Emile Roux, Le Puy-En-Velay, France

    Achille Sossou

  12. Réanimation Médicale, CHU Saint-Louis, AP-HP, Paris, France

    Marion Venot & Elie Azoulay

  13. Réanimation Médicale, CHU La Milétrie, Poitiers, France

    René Robert

  14. Réanimation Chirurgicale, Hôpital Européen Georges Pompidou, AP-HP, Paris, France

    Arnaud Follin

  15. Réanimation Médicale, CHU Brest, Brest, France

    Anne Renault

  16. Médecine Intensive et Réanimation, Groupe Hospitalier Paris Saint-Joseph, Paris, France

    Maïté Garrouste-Orgeas

  17. Réanimation Chirurgicale Polyvalente, Hôpital Civil, CHU Strasbourg, Strasbourg, France

    Olivier Collange

  18. Réanimation, Groupe Hospitalier de La Rochelle-Ré-Aunis, La Rochelle, France

    Quentin Levrat

  19. Anesthésie Réanimation, CHU Beaujon, AP-HP, Clichy, France

    Isabelle Villard

  20. Réanimation, CH Lens, Lens, France

    Didier Thevenin

  21. Réanimation Chirurgicale, Hôpital Hautepierre, CHU Strasbourg, Strasbourg, France

    Julien Pottecher

  22. Réanimation, CH Auxerre, Auxerre, France

    René-Gilles Patrigeon

  23. Réanimation Médico-chirurgicale, Hôpital Pasteur, CHU Nice, Nice, France

    Nathalie Revel

  24. Réanimation Chirurgicale, CHU Hôpital Nord, Assistance Publique–Hôpitaux de Marseille, Marseille, France

    Coralie Vigne

  25. Réanimation chirugicale, CHU La Milétrie, Poitiers, France

    Olivier Mimoz

Authors
  1. Pierre Kalfon
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  2. Karine Baumstarck
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  3. Philippe Estagnasie
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  4. Marie-Agnès Geantot
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  5. Audrey Berric
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  6. Georges Simon
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  7. Bernard Floccard
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  8. Thomas Signouret
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  9. Mohamed Boucekine
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  10. Mélanie Fromentin
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  11. Martine Nyunga
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  12. Achille Sossou
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  13. Marion Venot
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  14. René Robert
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  15. Arnaud Follin
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  16. Juliette Audibert
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  17. Anne Renault
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  18. Maïté Garrouste-Orgeas
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  19. Olivier Collange
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  20. Quentin Levrat
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  21. Isabelle Villard
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  22. Didier Thevenin
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  24. René-Gilles Patrigeon
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  26. Coralie Vigne
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  27. Elie Azoulay
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  28. Olivier Mimoz
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  29. Pascal Auquier
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Consortia

on behalf of the IPREA Study group

  • Karine Vie
  • , Gwenaëlle Lannuzel
  • , Hélène Bout
  • , Jean-Philippe Parthiot
  • , 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
  • , Alicia Richard
  • , Claire Boulle
  • , Benjamin Kowalski
  • , Elisa Klusek
  • , Tarek Sharshar
  • , Andrea Polito
  • , Caroline Duvallet
  • , Sonia Krim
  • , Nicolas Girard
  • , Juliette Audibert-Souhaid
  • , Cécile Jourdain
  • , Stéphane Techer
  • , Corinne Chauvel
  • , Corinne Bruchet
  • , Johanna Temime
  • , Stéphanie Beaussart
  • , Fabienne Jarosz
  • , Julien Crozon-Clauzel
  • , Serge Olousouzian
  • , Sylvie Pereira
  • , Loïc Argentin
  • , Valérie Cerro
  • , Déborah Levy
  • , Sébastien Andre
  • , Christophe Guervilly
  • , Laurent Papazian
  • , Myriam Moussa
  • , Stéphanie Renoult
  • , Delphine Biet
  • , Steve Novak
  • , Jean-Christophe Orban
  • , Aminata Diop
  • , Carole Ichai
  • , Antoine Tesniere
  • , Jean-Pascal Goupil
  • , Frédérique Laville
  • , Nadège Rutter
  • , Sandie Brochon
  • , Kelly Tiercelet
  • , Julien Amour
  • , Nora Ait-Hamou
  • , Marjorie Leger
  • , Virginie Souppart
  • , Emilie Griffault
  • , Marie-Line Debarre
  • , Céline Deletage
  • , Anne-Laure Guerin
  • , Carole Guignon
  • , Sabrina Seguin
  • , Christophe Hart
  • , Kathy Dernivoix
  • , Caroline Wuiot
  • , Karine Sanches
  • , Stéphane Hecketsweiler
  • , Catherine Sylvestre-Marconville
  • , Vincent Gardan
  • , Stéphanie Deparis-Dusautois
  •  & Yana Chaban

Corresponding author

Correspondence to Pierre Kalfon.

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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.

Additional information

Participating centers, principal investigators, members of the trial steering committee are listed in Electronic Supplementary Material (ESM)1.

Take-home message: This is the first cluster-randomized controlled study involving medical, surgical, and mixed ICUs aimed to assess the efficacy of a tailored multicomponent program based on a simultaneous approach to reduce discomfort from multiple sources, by combining assessment of self-perceived discomfort, feedback to the healthcare teams, and tailored site-targeted measures under control of a duo of local champions. Our intervention, easily reproducible in different settings, reduced perceived overall discomfort in unselected adult critically ill patients. Based on this positive result, the study paves the way for a new strategy for care management in the ICU.

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Kalfon, P., Baumstarck, K., Estagnasie, P. et al. A tailored multicomponent program to reduce discomfort in critically ill patients: a cluster-randomized controlled trial. Intensive Care Med 43, 1829–1840 (2017). https://doi.org/10.1007/s00134-017-4991-x

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  • DOI: https://doi.org/10.1007/s00134-017-4991-x

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