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Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly (CONFUCIUS)

This study has been terminated.
(enrollment of patients insufficient)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01316965
First Posted: March 16, 2011
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hospices Civils de Lyon
  Purpose
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. Several interventions have proved their effectiveness to prevent it but their combination within a multifaceted intervention needs to be assessed using rigorous methodology based on randomized study design. CONFUCIUS trial aims to measure the impact of a multifaceted program on the prevention of postoperative delirium in elderly.

Condition Intervention
Postoperative Delirium Behavioral: Multifaceted prevention program HELP(Hospital Elder Life Program)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly

Resource links provided by NLM:


Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Postoperative delirium rate within 7 days after surgery [ Time Frame: 7 days after surgery ]

Secondary Outcome Measures:
  • Mean delirium intensity within 7 days after surgery [ Time Frame: 7 days after surgery ]
  • Length of hospital stay [ Time Frame: Hospital discharge ]
  • Postoperative complications 30 days after surgery incidence [ Time Frame: 30 days after surgery ]
  • Mortality 6 months after surgery [ Time Frame: 6 months after surgery ]
  • Feasibility of the multidisciplinary prevention program [ Time Frame: 24 months ]

Enrollment: 175
Actual Study Start Date: April 2011
Study Completion Date: May 2017
Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: multifaceted prevention program Behavioral: Multifaceted prevention program HELP(Hospital Elder Life Program)
  • A. Structured geriatric consultation will be performed by geriatricians of the MGT(Mobile Geriatric Teams) before surgery, including clinical examination and geriatric assessment
  • B. All members of medical and nursing staffs will attend a two hours training session performed by the MGTs and HELP(Hospital Elder Life Program) will be implemented in the surgical wards
  • C. On a quarterly basis, all members of medical and nursing staffs and MGTs will gathered to analyze medical records of patients having experienced a postoperative delirium.
No Intervention: usual care

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female subject aged over 75 years
  • Admission for a scheduled surgery (i.e. all oncologic digestive surgery , ureterostomy, nephrectomy or cystectomy, total hip or knee replacement)
  • Participation agreement

Exclusion Criteria:

  • Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316965


Locations
France
Hospices Civils de Lyon-Hôpital des Charpennes
Villeurbanne, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pierre KROLAK-SALMON, Pr Hospices Civils de Lyon- Hôpital des Charpennes
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01316965     History of Changes
Other Study ID Numbers: 2009.577
First Submitted: March 15, 2011
First Posted: March 16, 2011
Last Update Posted: May 30, 2017
Last Verified: May 2017

Keywords provided by Hospices Civils de Lyon:
Postoperative delirium
elderly
prevention
stepped wedge design
healthcare workers

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders