NCT04840316

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

June 22, 2021

Status Verified

May 1, 2021

Enrollment Period

6 months

First QC Date

April 7, 2021

Last Update Submit

June 20, 2021

Conditions

Keywords

AnesthesiaDeliriumIncidenceCognitive decline

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative delirium

    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.

    January 1st 2007 to December 31st 2016

Study Arms (1)

Post operative

Nil Intervention - observational cohort study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participant patients will have been assigned procedure codes for surgery and anaesthesia. Patients who had multiple procedures during an episode of care will have each procedure and relevant postoperative course analysed. Patients were excluded if the procedure was performed under local anaesthesia infiltration. Procedures performed under regional or neuraxial techniques will be included in the analysis.

Eligible patients include those aged 18 years or over undergoing a surgical procedure in any of 71 public or private hospitals

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Auckland City Hopsital

Auckland, 1023, New Zealand

Location

MeSH Terms

Conditions

ConfusionPostoperative ComplicationsDeliriumCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesNeurocognitive DisordersMental DisordersCognition Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2021

First Posted

April 12, 2021

Study Start

June 30, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

June 22, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

As an observational study of encrypted data from the national data set there is no plan to provide individual participant data.

Locations