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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04840316
Registration number
NCT04840316
Ethics application status
Date submitted
7/04/2021
Date registered
12/04/2021
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
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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
Government body
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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/study/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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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
As an observational study of encrypted data from the national data set there is no plan to provide individual participant data.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04840316