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

Overview

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.

Full Title of Study: “CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2017

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: multifaceted prevention program
  • No Intervention: usual care

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative delirium rate within 7 days after surgery
    • Time Frame: 7 days after surgery

Secondary Measures

  • Mean delirium intensity within 7 days after surgery
    • Time Frame: 7 days after surgery
  • Length of hospital stay
    • Time Frame: Hospital discharge
  • Postoperative complications 30 days after surgery incidence
    • Time Frame: 30 days after surgery
  • Mortality 6 months after surgery
    • Time Frame: 6 months after surgery
  • Feasibility of the multidisciplinary prevention program
    • Time Frame: 24 months

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 75 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospices Civils de Lyon
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pierre KROLAK-SALMON, Pr, Principal Investigator, Hospices Civils de Lyon- Hôpital des Charpennes

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