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Open Access Study protocol

Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol

Christelle Mouchoux123*, Pascal Rippert2, Antoine Duclos23, Thomas Fassier23, Marc Bonnefoy45, Brigitte Comte6, Damien Heitz7, Cyrille Colin23 and Pierre Krolak-Salmon1089

Author Affiliations

1 Pharmacie, Hôpital des Charpennes, Hospices Civils de Lyon, Villeurbanne, France

2 Pôle Information Médicale Évaluation Recherche, Hospices Civils de Lyon, Lyon, France

3 EA Santé-Individu-Société 4129, Université de Lyon, Lyon, France

4 Service de Médecin gériatrique, Equipe Mobile de Gériatrie, Centre hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France

5 Unité CarMeN, Université Claude Bernard Lyon 1, Villeurbanne, France

6 Service de Médecine gériatrique, Equipe Mobile de Gériatrie, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France

7 Pôle de Gériatrie, Equipe Mobile de Gériatrie, Hôpitaux Universitaires de Strasbourg, Strasbourg, France

8 Hôpital des Charpennes, Hospices Civils de Lyon, Villeurbanne, France

9 Université Claude Bernard Lyon 1, Villeurbanne, France

10 Inserm U821, Centre hospitalier Le Vinatier, Bron, France

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BMC Geriatrics 2011, 11:25  doi:10.1186/1471-2318-11-25

Published: 18 May 2011

Abstract

Background

Postoperative delirium is common in the elderly and is associated with a significant increase in mortality, complications, length of hospital stay and admission in long care facility. Although several interventions have proved their effectiveness to prevent it, the Cochrane advises an assessment of multifaceted intervention using rigorous methodology based on randomized study design. Our purpose is to present the methodology and expected results of the CONFUCIUS trial, which aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.

Method/Design

Study design is a stepped wedge cluster randomized trial within 3 surgical wards of three French university hospitals. All patients aged 75 and older, and admitted for scheduled surgery will be included. The multifaceted program will be conducted by mobile geriatric team, including geriatric preoperative consultation, training of the surgical staff and implementation of the Hospital Elder Life Program, and morbidity and mortality conference related to delirium cases. The primary outcome is based on postoperative delirium rate within 7 days after surgery. This program is planned to be implemented along four successive time periods within all the surgical wards. Each one will be affected successively to the control arm and to the intervention arm of the trial and the order of program introduction within each surgical ward will be randomly assigned. Based on a 20% reduction of postoperative delirium rate (ICC = 0.25, α = 0.05, β = 0.1), three hundred sixty patients will be included i.e. thirty patients per service and per time period. Endpoints comparison between intervention and control arms of the trial will be performed by considering the cluster and time effects.

Discussion

Better prevention of delirium is expected from the multifaceted program, including a decrease of postoperative delirium, and its consequences (mortality, morbidity, postoperative complications and length of hospital stay) among elderly patients. This study should allow better diagnosis of delirium and strengthen the collaboration between surgical and mobile geriatric teams. Should the program have a substantial impact on the prevention of postoperative delirium in elderly, it could be extended to other facilities.

Trial registration

ClinicalTrials.gov: NCT01316965