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A randomized clinical trial to evaluate the effect of post-intensive care multidisciplinary consultations on mortality and the quality of life at 1 year

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Abstract

Purpose

Critical illness is associated with long-term increased mortality and impaired quality of life (QoL). We assessed whether multidisciplinary consultations would improve outcome at 12 months (M12) after intensive care unit (ICU) discharge.

Methods

We performed an open, multicenter, parallel-group, randomized clinical trial. Eligible are patients discharged alive from ICU in 11 French hospitals between 2012 and 2018. The intervention group had a multidisciplinary face-to-face consultation involving an intensivist, a psychologist, and a social worker at ICU discharge and then at M3 and M6 (optional). The control group had standard post-ICU follow-up. A consultation was scheduled at M12 for all patients. The QoL was assessed using the EuroQol-5 Dimensions-5 Level (Euro-QoL-5D-5L) which includes five dimensions (mobility, self-care, usual activities, pain, and anxiety/depression), each ranging from 1 to 5 (1: no, 2: slight, 3: moderate, 4: severe, and 5: extreme problems). The primary endpoint was poor clinical outcome defined as death or severe-to-extreme impairment of at least one EuroQoL-5D-5L dimension at M12. The information was collected by a blinded investigator by phone. Secondary outcomes were functional, psychological, and cognitive status at M12 consultation.

Results

540 patients were included (standard, n = 272; multidisciplinary, n = 268). The risk for a poor outcome was significantly greater in the multidisciplinary group than in the standard group [adjusted odds ratio 1.49 (95% confidence interval, (1.04–2.13)]. Seventy-two (13.3%) patients died at M12 (standard, n = 32; multidisciplinary, n = 40). The functional, psychological, and cognitive scores at M12 did not statistically differ between groups.

Conclusions

A hospital-based, face-to-face, intensivist-led multidisciplinary consultation at ICU discharge then at 3 and 6 months was associated with poor outcome 1 year after ICU.

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Availability of data and materials

Data available: yes. Data types: de-identified participant data. How to access data: de-identified patient data to reproduce results presented in the article. When available: with publication. Document types: none. Who can access the data: researchers whose proposed use of the data have been approved. Types of analyses: research projects with the same scientific purpose as the original study (post-intensive care follow-up), such as meta-analysis, for instance. Mechanisms of data availability: data will be made available upon approval of a proposal, and after a signed data access agreement with the trial sponsor. Any additional restrictions: none.

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Acknowledgements

The authors thank the members of the data and safety monitoring board (Nawal Derridj-Ait-Younes, Nabila Yasmine Domingo-Saidji, Abderraouf Hermez, Sonia Krim, Chanez Lazizi, Layidé Méaude, Karima Mesbahi, and Sonia Ouali) and Philippe Aegerter for his support and advice in the early stages of the trial, and the trial participants who were willing to be randomly assigned to either a standard follow-up or a multidisciplinary consultations. The authors also thank Fiona Caulfield and Clara Delplancke for their careful reading of the manuscript.

The authors are grateful to the investigators of all participating centers: Djilali Annane (Réanimation Médico-Chirurgicale, Hôpital Raymond Poincaré, 104 Boulevard Raymond Poincaré, 92380 Garches, France), Abdel Ben Salah (Réanimation Médico-Chirurgicale, Centre Hospitalier, 28000, Chartres, France), Camille Bernard (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France), Lila Bouadma (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France), Alain Cariou (Réanimation Médicale, 27, rue du Faubourg Saint-Jacques, 75014 Paris), Benoît Champigneulle (Réanimation Médicale, 27, rue du Faubourg Saint-Jacques, 75014 Paris, France), Bernard Cholley (Anesthésie-Réanimation, Hôpital Européen George Pompidou, 75015, Paris, France), Bernard Clair (Réanimation Médico-Chirurgicale, Hôpital Raymond Poincaré, 104 Boulevard Raymond Poincaré, 92380 Garches, France), Fabrice Daviaud (Réanimation Médicale, 27, rue du Faubourg Saint-Jacques, 75014 Paris, France), Estelle Doré (Réanimation Polyvalente, Centre Hospitalier Sud-Essonne, 26 avenue du Général de Gaulle, Etampes, 91150 France), Vincent Deiler (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France), Mélanie Escoffier (Réanimation Polyvalente, Centre Hospitalier Sud-Essonne, 26 avenue du Général de Gaulle, Etampes, 91150 France), Alexis Ferré (Réanimation Médicale, 27, rue du Faubourg Saint-Jacques, 75014 Paris, France), Stéphane Gaudry (Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, 92700, Colombes, France), Louis Marie Galerneau (Réanimation Médicale, 38000 Grenoble France), Guillaume Géri (Réanimation Médicale, 27, rue du Faubourg Saint-Jacques, 75014 Paris, France), Cyrille Hallier (Réanimation Médico-Chirurgicale, Centre Hospitalier, 28000, Chartres, France), Nicolas Heming (Réanimation Médico-Chirurgicale, Hôpital Raymond Poincaré, 104 Boulevard Raymond Poincaré, 92380 Garches, France), Tarik Hissem (Réanimation Polyvalente, Centre Hospitalier Sud-Essonne, 26 avenue du Général de Gaulle, Etampes, 91150 France), Laurent Jacob (Réanimation Chirurgicale, CHU Saint-Louis, 75010, Paris, France), Cécile Jourdain (Réanimation Polyvalente, Centre Hospitalier Sud-Essonne, 26 avenue du Général de Gaulle, Etampes, 91150 France ), Pierre Kalfon (Réanimation Médico-Chirurgicale, Centre Hospitalier, 28000, Chartres, France), Janik Le Denn (Réanimation Médico-Chirurgicale, Centre Hospitalier, 28000, Chartres, France), Sophie Letrou (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France ), Eric Magalhaes (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France), Louis Marie Galerneau (Réanimation Médicale, 38000, Grenoble, France), Nathalie Marin (Réanimation Médicale, 27, rue du Faubourg Saint-Jacques, 75014 Paris, France), Bénédicte Mauchien (Réanimation Médico-Chirurgicale, Centre Hospitalier, 28000, Chartres, France), Bruno Mégarbane (Réanimation Médicale et Toxicologique, Hôpital Lariboisière, 2 rue Ambroise Paré, 75010 Paris, France), Jonathan Messika (Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, 92700, Colombes, France), Tristan Morichau-Beauchant (Réanimation Médicale, 27, rue du Faubourg Saint-Jacques, 75014 Paris, France), Bruno Mourvillier (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France ), Haikel Oueslati (Réanimation Chirurgicale, CHU Saint-Louis, 75010, Paris, France), Sylvie Pecquerie (Réanimation Polyvalente, Centre Hospitalier Sud-Essonne, 26 avenue du Général de Gaulle, Etampes, 91150 France), Stéphanie Percheron (Réanimation Polyvalente, Centre Hospitalier Sud-Essonne, 26 avenue du Général de Gaulle, Etampes, 91150 France), Jean-Pierre Quenot (Médecine Intensive-Réanimation Médicale, CHU Dijon-Bourgogne, 2100, Dijon, France), Emile Quillien (Réanimation Médico-Chirurgicale, Hôpital Raymond Poincaré, 104 Boulevard Raymond Poincaré, 92380 Garches, France), Jean-Damien Ricard (Réanimation Médico-Chirurgicale, Hôpital Louis Mourier, 92700, Colombes, France), Ségolène Robin (Anesthésie-Réanimation, Hôpital Européen George Pompidou, 75015, Paris, France), Carole Schwebel (Réanimation Médicale, 38000, Grenoble, France), Shidasp Siami (Réanimation Polyvalente, Centre Hospitalier Sud-Essonne, 26 avenue du Général de Gaulle, Etampes, 91150 France), Tarek Sharshar (Neuroréanimation, GHU-Paris, Site Sainte-Anne, 1 rue Cabanis, 75014 Paris, France), Roland Smonig (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France), Romain Sonneville (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France), Véronique Sullet (Réanimation Médico-Chirurgicale, Hôpital Raymond Poincaré, 104 Boulevard Raymond Poincaré, 92380 Garches, France), Jean-François Timsit (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France), and Michel Wolff (Réanimation Médicale, Hôpital Bichat, 46 rue Henri Huchard, 75018 Paris, France).

Funding

This work was funded by Programme Hospitalier de Recherche Clinique 2010 of the French Ministry of Social Affairs and Health. SUIVI-REA ClinicalTrials.gov number, NCT01796509 registered 21 February 2013. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report, or in the decision to submit the article for publication.

Author information

Authors and Affiliations

  1. Anesthesia and Intensive Care Department, GHU Paris Psychiatrie et Neurosciences, Pole Neuro, Sainte-Anne Hospital, Paris, Institute of Psychiatry and Neurosciences of Paris, INSERM U1266, Université Paris Cité, Paris, France

    Tarek Sharshar

  2. Clinical Research Unit APHP. Paris-Saclay, Assistance Publique-Hôpitaux de Paris, UMR1018 Anti-Infective Evasion and Pharmacoepidemiology Team, University of Versailles Saint-Quentin en Yvelines, INSERM, Versailles, France

    Lamiae Grimaldi-Bensouda

  3. General Intensive Care Unit, Sud-Essonne Hospital, Etampes, France

    Shidasp Siami

  4. Medical Intensive Care Unit, Cochin Hospital, Assistance Publique-Hôpitaux de Paris-Centre (APHP-CUP), Université de Paris Paris-Cardiovascular-Research-Center, INSERM U970, 75014, Paris, France

    Alain Cariou

  5. Réanimation Polyvalente, Hôpital Louis Pasteur Hospital, Centre Hospitalier de Chartres, 28018, Chartres Cedex, France

    Abdel Ben Salah & Pierre Kalfon

  6. France Médecine intensive–réanimation, AP-HP, Hôpital Bichat-Claude Bernard, Université de Paris, INSERM UMR1148, Team 6, 7501875018, Paris, France

    Romain Sonneville

  7. INSERM CIC 1432, Clinical Epidemiology, DRCI, USMR, Francois Mitterrand University Hospital, University of Burgundy, Dijon, France

    Nicolas Meunier-Beillard & Jean-Pierre Quenot

  8. Department of Intensive Care, François Mitterrand University Hospital: INSERM LNC-UMR1231, INSERM CIC 1432, Clinical Epidemiology University of Burgundy, Dijon, France

    Jean-Pierre Quenot

  9. Department of Medical and Toxicological Critical Care, Lariboisière Hospital, INSERM UMRS-1144, Université de Paris, Paris, France

    Bruno Megarbane

  10. Réanimation Médico-Chirurgicale, Louis Mourier Hospital, Assistance-Publique-Hôpitaux de Paris, 92700, Colombes, France

    Stephane Gaudry

  11. Université de Paris. Epidémiologie Clinique-Évaluation Économique Appliqué Aux Populations Vulnérables (ECEVE, INSERM et, Centre d’investigation Clinique-Epidémiologie Clinique (CIC-EC) 1425, Paris, France

    Stephane Gaudry

  12. Department of Anesthesiology, Burn and Critical Care Medicine, AP-HP, Saint Louis and Lariboisiere University Hospitals, 75010, Paris, France

    Haikel Oueslati

  13. Anesthesiology and Intensive Care Department, European Hospital Georges-Pompidou, Université de Paris, 75015, Paris, France

    Segolene Robin-Lagandre

  14. UJF-Grenoble I, Medical Intensive Care Unit, University Hospital Albert Michallon, 38041, Grenoble, France

    Carole Schwebel

  15. Anesthesia and Intensive Care Department, Département Neurosciences, GHU Paris Psychiatrie et Neurosciences, Pole Neuro, Sainte-Anne Hospital, Institut Pasteur, Unité Perception et Mémoire, Université de Paris, Paris, France

    Aurelien Mazeraud

  16. General Intensive Care Unit, APHP, Raymond Poincaré Hospital, University of Versailles Saint-Quentin en Yvelines, 92380, Garches, France

    Djillali Annane & Diane Friedman

  17. Clinical Research Unit APHP. Paris-Saclay, Assistance Publique-Hôpitaux de Paris, Hôpital Ambroise Paré, Boulogne-Billancourt, France

    Lionelle Nkam

Authors
  1. Tarek Sharshar
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  2. Lamiae Grimaldi-Bensouda
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  3. Shidasp Siami
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  4. Alain Cariou
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  13. Segolene Robin-Lagandre
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  16. Djillali Annane
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  17. Lionelle Nkam
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  18. Diane Friedman
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on behalf of the Suivi-Rea Investigators

Contributions

DF and TS: conception of the work (PI), funding application, enrollment of participating centers, supervision of the data collection, participation in data analysis verification of the data and interpretation, writing of the manuscript, and critical revision of the manuscript. LG: methodology and data management. LN and LG: statistical analysis. AM: interpretation of the results, writing of the manuscript, and critical revision of the manuscript. Other authors: patients’ recruitment and data collection.

Corresponding author

Correspondence to Tarek Sharshar.

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Conflicts of interest

RS received grants from the French Ministry of Health, the French Society of Intensive Care Medicine (SRLF), and the European Society of Intensive Care Medicine (ESICM). All other authors declare no conflicts of interest.

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Sharshar, T., Grimaldi-Bensouda, L., Siami, S. et al. A randomized clinical trial to evaluate the effect of post-intensive care multidisciplinary consultations on mortality and the quality of life at 1 year. Intensive Care Med (2024). https://doi.org/10.1007/s00134-024-07359-x

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