NCT01316965

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 30, 2017

Status Verified

May 1, 2017

Enrollment Period

6.1 years

First QC Date

March 15, 2011

Last Update Submit

May 24, 2017

Conditions

Postoperative Delirium

Keywords

Postoperative deliriumelderlypreventionstepped wedge designhealthcare workers

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium rate within 7 days after surgery

    7 days after surgery

Secondary Outcomes (5)

  • Mean delirium intensity within 7 days after surgery

    7 days after surgery

  • Length of hospital stay

    Hospital discharge

  • Postoperative complications 30 days after surgery incidence

    30 days after surgery

  • Mortality 6 months after surgery

    6 months after surgery

  • Feasibility of the multidisciplinary prevention program

    24 months

Study Arms (2)

multifaceted prevention program

EXPERIMENTAL
Behavioral: Multifaceted prevention program HELP(Hospital Elder Life Program)

usual care

NO INTERVENTION

Interventions

Multifaceted prevention program HELP(Hospital Elder Life Program)BEHAVIORAL

* 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.

multifaceted prevention program

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon-Hôpital des Charpennes

Villeurbanne, France

Location

Related Publications (1)

  • 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.

    PMID: 21592324DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Pierre KROLAK-SALMON, Pr

    Hospices Civils de Lyon- Hôpital des Charpennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2011

First Posted

March 16, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

May 30, 2017

Record last verified: 2017-05

Locations

FR(1)