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

This study is currently recruiting participants.
Verified March 2014 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01316965
First received: March 15, 2011
Last updated: March 4, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean delirium intensity within 7 days after surgery [ Time Frame: 7 days after surgery ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]
  • Postoperative complications 30 days after surgery incidence [ Time Frame: 30 days after surgery ] [ Designated as safety issue: No ]
  • Mortality 6 months after surgery [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
  • Feasibility of the multidisciplinary prevention program [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01316965

Contacts
Contact: Pierre KROLAK-SALMON, Pr. 4.72.43.31.13 ext +33 pierre.krolak-salmon@chu-lyon.fr

Locations
France
Hospices Civils de Lyon-Hôpital des Charpennes Recruiting
Villeurbanne, France
Contact: Pierre KROLAK-SALMON, Pr    4.72.43.31.13 ext +33    pierre.krolak-salmon@chu-lyon.fr   
Principal Investigator: Pierre KROLAK-SALMON, Pr         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Pierre KROLAK-SALMON, Pr Hospices Civils de Lyon- Hôpital des Charpennes
  More Information

No publications provided by Hospices Civils de Lyon

Additional 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
Study First Received: March 15, 2011
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014