1. Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol
- Author
-
Damien Heitz, Antoine Duclos, Marc Bonnefoy, P. Rippert, Brigitte Comte, Thomas Fassier, Christelle Mouchoux, Pierre Krolak-Salmon, Cyrille Colin, Pharmacie, Hospices Civils de Lyon (HCL)-Hôpital des Charpennes [CHU - HCL], Hospices Civils de Lyon (HCL), Santé Individu Société - SIS (SIS), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Jean Monnet [Saint-Étienne] (UJM)-Hospices Civils de Lyon (HCL)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université Lumière - Lyon 2 (UL2), Pôle Information Médicale Evaluation Recherche (IMER), Service de médecine gériatrique, Hospices Civils de Lyon (HCL)-Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Institut National de la Recherche Agronomique (INRA)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hospices Civils de Lyon (HCL), Hospices Civils de Lyon (HCL)-Hôpital Edouard Herriot [CHU - HCL], Pôle de Gériatrie, CHU Strasbourg, Hôpital des Charpennes [CHU - HCL], Dynamique Cérébrale et Cognition, Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale (INSERM), The CONFUCIUS study is funding by the National French Program of Hospital Quality Research (Programme de Recherche en Qualité Hospitalière), Université Lumière - Lyon 2 (UL2)-Université Jean Moulin - Lyon 3 (UJML), Université de Lyon-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet [Saint-Étienne] (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Institut National des Sciences Appliquées (INSA)-Université de Lyon-Institut National des Sciences Appliquées (INSA)-Université de Lyon-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Institut National de la Recherche Agronomique (INRA), Santé Individu Société (SIS), Université de Lyon-Hospices Civils de Lyon (HCL)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM), and BMC, Ed.
- Subjects
medicine.medical_specialty ,Postoperative Complications/prevention & control ,medicine.medical_treatment ,MEDLINE ,Psychological intervention ,lcsh:Geriatrics ,Disease cluster ,law.invention ,03 medical and health sciences ,Study Protocol ,0302 clinical medicine ,Postoperative Complications ,Randomized controlled trial ,law ,Intervention (counseling) ,mental disorders ,medicine ,Cluster Analysis ,Humans ,030212 general & internal medicine ,Cluster randomised controlled trial ,Postoperative Period ,Geriatry and gerontology ,Aged ,Aged, 80 and over ,Patient Care Team ,Rehabilitation ,[SDV.MHEP.GEG] Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology ,business.industry ,[SDV.MHEP.GEG]Life Sciences [q-bio]/Human health and pathology/Geriatry and gerontology ,Postoperative Complications/psychology ,Age Factors ,Delirium ,3. Good health ,lcsh:RC952-954.6 ,Delirium/prevention & control ,Gériatrie et gérontologie ,Physical therapy ,Delirium/psychology ,Geriatrics and Gerontology ,medicine.symptom ,business ,Patient Care Team/trends ,030217 neurology & neurosurgery - 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
- Published
- 2011
- Full Text
- View/download PDF