Back to resultsImpact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly (CONFUCIUS)
Primary Purpose
Postoperative Delirium
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multifaceted prevention program HELP(Hospital Elder Life Program)
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Delirium focused on measuring Postoperative delirium, elderly, prevention, stepped wedge design, healthcare workers
Eligibility 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)
Sites / Locations
- Hospices Civils de Lyon-Hôpital des Charpennes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
multifaceted prevention program
usual care
Arm Description
Outcomes
Primary Outcome Measures
Postoperative delirium rate within 7 days after surgery
Secondary Outcome Measures
Mean delirium intensity within 7 days after surgery
Length of hospital stay
Postoperative complications 30 days after surgery incidence
Mortality 6 months after surgery
Feasibility of the multidisciplinary prevention program
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01316965
Brief Title
Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
Acronym
CONFUCIUS
Official Title
CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
enrollment of patients insufficient
Study Start Date
April 2011 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Delirium
Keywords
Postoperative delirium, elderly, prevention, stepped wedge design, healthcare workers
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multifaceted prevention program
Arm Type
Experimental
Arm Title
usual care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Multifaceted prevention program HELP(Hospital Elder Life Program)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative delirium rate within 7 days after surgery
Time Frame
7 days after surgery
Secondary Outcome Measure Information:
Title
Mean delirium intensity within 7 days after surgery
Time Frame
7 days after surgery
Title
Length of hospital stay
Time Frame
Hospital discharge
Title
Postoperative complications 30 days after surgery incidence
Time Frame
30 days after surgery
Title
Mortality 6 months after surgery
Time Frame
6 months after surgery
Title
Feasibility of the multidisciplinary prevention program
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre KROLAK-SALMON, Pr
Organizational Affiliation
Hospices Civils de Lyon- Hôpital des Charpennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon-Hôpital des Charpennes
City
Villeurbanne
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
21592324
Citation
Mouchoux C, Rippert P, Duclos A, Fassier T, Bonnefoy M, Comte B, Heitz D, Colin C, Krolak-Salmon P. Impact of a multifaceted program to prevent postoperative delirium in the elderly: the CONFUCIUS stepped wedge protocol. BMC Geriatr. 2011 May 18;11:25. doi: 10.1186/1471-2318-11-25.
Results Reference
derived
Learn more about this trial
Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
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