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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04840316
Registration number
NCT04840316
Ethics application status
Date submitted
7/04/2021
Date registered
12/04/2021
Date last updated
22/06/2021
Titles & IDs
Public title
INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand
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Scientific title
INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand
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Secondary ID [1]
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A+ 9133
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Universal Trial Number (UTN)
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Trial acronym
INPOD-NZ
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Delirium Confusional State
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Complication,Postoperative
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Condition category
Condition code
Neurological
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Other neurological disorders
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Mental Health
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Other mental health disorders
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Mental Health
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Psychosis and personality disorders
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Surgery
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Post operative - Nil Intervention - observational cohort study
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of postoperative delirium
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Assessment method [1]
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Clinical outcomes are coded by trained clinical coders at each individual hospital and reported to the Ministry of Health as per standard practice. Delirium will be defined by the ICD-9 and ICD-10 coding of delirium as an outcome [12]. POD will be defined as the presence of an ICD-9 or ICD-10 delirium code following surgery until seven days postoperatively or discharge, whichever occurs earlier. If a patient received multiple eligible operations during the captured time frame, each surgical event postoperatively will be analysed individually.
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Timepoint [1]
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January 1st 2007 to December 31st 2016
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Eligibility
Key inclusion criteria
Eligible patients include those aged 18 years or over undergoing a surgical procedure in
any of 71 public or private hospitals
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Unknown status
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
30/06/2021
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2021
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Actual
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Sample size
Target
1
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Auckland City Hospital
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
As the population of older adults increases, so too with the number of older adult patients
that present for anesthesia and surgery. The development of delirium following surgery has
some significant potential effects on patient outcomes; however, POD is often under
diagnosed. Some studies reported that more than 50% of patients with delirium were
undiagnosed by clinical teams. POD is associated with cognitive decline, increased hospital
length of stay, discharge to institutional care, mortality and higher healthcare costs. POD
contributes significantly to healthcare inefficiency; a diagnosis of POD is estimated by the
Australian Commission on Quality and Safety in Healthcare to cost an additional $27,791 AUD.
The incidence of POD reported in clinical trials depends on the risk profile of the study
population, the frequency and duration of delirium assessments as well as the surgical
procedure. Reported incidence may also vary due to the presence of high-risk pathways
involving multi-specialty management and intervention. POD may present as either hyperactive
or hypoactive subtypes, the latter being more difficult to detect.
There are few reports on the incidence of POD in New Zealand national level datasets, with
single centre studies primarily looking at in-hospital delirium and demonstrating an
incidence of 11.2 to 29% on mixed and/or medical wards. A review of elderly patients with
neck-of-femur fractures found the incidences of POD to be as high as 39%. The current data
suggests a significant level of morbidity due to POD in New Zealand hospitals, however there
is lack of national level data in the surgical population; which is crucial for establishing
demographic and regional need for effective intervention.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04840316
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04840316
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