INPOD-NZ: INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand

Sponsor
Auckland City Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04840316
Collaborator
(none)
1
1
6
0.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    INcidence of PostOperative Delirium Incidence in Surgical Patients: an Observational Cohort Study in New Zealand
    Anticipated Study Start Date :
    Jun 30, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2021
    Anticipated Study Completion Date :
    Dec 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Post operative

    Nil Intervention - observational cohort study

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative delirium [January 1st 2007 to December 31st 2016]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Auckland City Hopsital Auckland New Zealand 1023

    Sponsors and Collaborators

    • Auckland City Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Auckland City Hospital
    ClinicalTrials.gov Identifier:
    NCT04840316
    Other Study ID Numbers:
    • A+ 9133
    First Posted:
    Apr 12, 2021
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Auckland City Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 22, 2021