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

Postoperative Delirium Clinical Trial

— CONFUCIUS  

Official title:

CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01316965
• Other study ID #: 2009.577
• Status: Terminated
• Phase: N/A
• First received: March 15, 2011
• Last updated: May 24, 2017
• Start date: April 2011
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Delirium
• Postoperative Delirium

Intervention

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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon-Hôpital des Charpennes	Villeurbanne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative delirium rate within 7 days after surgery		7 days after surgery
Secondary	Mean delirium intensity within 7 days after surgery		7 days after surgery
Secondary	Length of hospital stay		Hospital discharge
Secondary	Postoperative complications 30 days after surgery incidence		30 days after surgery
Secondary	Mortality 6 months after surgery		6 months after surgery
Secondary	Feasibility of the multidisciplinary prevention program		24 months