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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 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: May 22, 2014
Last verified: May 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: April 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 22, 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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014