Postoperative DeliriumCONFUCIUSNCT01316965
Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
A study testing Multifaceted prevention program HELP(Hospital Elder Life Program) in people with Postoperative Delirium, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Postoperative Delirium
- What is being tested?
- Multifaceted prevention program HELP(Hospital Elder Life Program)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2011to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
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.
- Conditions
- Postoperative Delirium
- Being tested
- Multifaceted prevention program HELP(Hospital Elder Life Program)
- Keywords
- Postoperative delirium, elderly, prevention, stepped wedge design, healthcare workers
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifaceted prevention program HELP(Hospital Elder Life Program)Behavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| multifaceted prevention program | Experimental | Not described Receives: Behavioral: Multifaceted prevention program HELP(Hospital Elder Life Program) |
| usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative delirium rate within 7 days after surgery
Measured: 7 days after surgery
Secondary outcomes (5)
Mean delirium intensity within 7 days after surgery
Measured: 7 days after surgery
Length of hospital stay
Measured: Hospital discharge
Postoperative complications 30 days after surgery incidence
Measured: 30 days after surgery
Mortality 6 months after surgery
Measured: 6 months after surgery
Feasibility of the multidisciplinary prevention program
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: enrollment of patients insufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre KROLAK-SALMON, Pr, Principal investigator, Hospices Civils de Lyon- Hôpital des Charpennes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316965
- Sponsor's protocol ID
- 2009.577
- Acronym
- CONFUCIUS
- Status last verified
- May 2017
- First submitted
- 15 Mar 2011
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21592324
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONFUCIUS Study : Impact of a Multifaceted Program to Prevent Postoperative Delirium in the Elderly
- ClinicalTrials.gov ID
- NCT01316965
- Acronym / sponsor ID
- CONFUCIUS / 2009.577
- Conditions
- Postoperative Delirium
- Keywords
- Postoperative delirium, elderly, prevention, stepped wedge design, healthcare workers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: enrollment of patients insufficient
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multifaceted prevention program | Experimental | Behavioral: Multifaceted prevention program HELP(Hospital Elder Life Program) |
| usual care | No intervention | – |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a progressive and/or poorly managed psychiatric pathology (patients with stabilized depression could be included in the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | multifaceted prevention program |
Primary outcome
Postoperative delirium rate within 7 days after surgery
Time frame: 7 days after surgery
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: enrollment of patients insufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Derived from this study: PubMed 21592324Mouchoux 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre KROLAK-SALMON, Pr principal investigator
Hospices Civils de Lyon- Hôpital des Charpennes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multifaceted prevention program HELP(Hospital Elder Life Program) in people with Postoperative Delirium, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: enrollment of patients insufficient). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative delirium rate within 7 days after surgery (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01316965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.