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

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ClinicalTrials.gov Identifier: NCT01316965
Recruitment Status : Terminated (enrollment of patients insufficient)
First Posted : March 16, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Delirium Behavioral: Multifaceted prevention program HELP(Hospital Elder Life Program) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
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
Actual Study Start Date : April 2011
Actual Primary Completion Date : May 2017
Actual Study Completion Date : May 2017

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Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   75 Years and older   (Older Adult)
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
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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
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France
Hospices Civils de Lyon-Hôpital des Charpennes
Villeurbanne, France
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Pierre KROLAK-SALMON, Pr Hospices Civils de Lyon- Hôpital des Charpennes
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01316965    
Other Study ID Numbers: 2009.577
First Posted: March 16, 2011    Key Record Dates
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:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders