Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000333819
Ethics application status
Approved
Date submitted
25/11/2020
Date registered
24/03/2021
Date last updated
1/10/2023
Date data sharing statement initially provided
24/03/2021
Date results information initially provided
1/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Accuracy of discharge diagnosis codes in estimating true sepsis burden in NSW, Australia
Scientific title
Validation of International Classification of Diseases (ICD) codes in estimating sepsis epidemiology in patients admitted through Emergency Department (ED): A prospective, observational, cohort study in NSW, Australia
Secondary ID [1] 299782 0
‘Nil known’
Universal Trial Number (UTN)
Trial acronym
SICVaS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 315151 0
Condition category
Condition code
Infection 313470 313470 0 0
Other infectious diseases
Public Health 318091 318091 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The medical charts of the selected patients will be reviewed by a member of the research team at 96 hours after admission to apply clinical sepsis-3 criteria and at day 60 after admission to collect discharge diagnosis data. Hospitalization cases will be classified as clinical sepsis if they meet the gold standard clinical diagnosis via SEPSIS-3 criteria. The two ICD coding methods (IHME and Angus) will be compared with the gold standard clinical definition using Sepsis-3 criteria to measure their accuracy in sepsis diagnosis.
IHME is the newly proposed set of ICD codes by Global Burden of Disease group while Angus is the most commonly used ICD coding method for sepsis. Their details are mentioned in the protocols as appendices. Both these methods will be compared to clinical sepsis diagnosis (sepsis-3) criteria as gold standard.
All enrolled patients will be assessed till 60 days after their admission.
Intervention code [1] 316040 0
Diagnosis / Prognosis
Comparator / control treatment
Clinical sepsis definition using Sepsis-3 criteria will be used as the reference to assess the validity. This requires presence of presumed infection (antibiotic and culture order) plus organ dysfunction (indicated by increase of 2 or more in sequential organ failure assessment score 'SOFA' score)
Control group
Active

Outcomes
Primary outcome [1] 321938 0
Proportion of patients with sepsis ICD coding IHME method assessed from medical chart reviews
Timepoint [1] 321938 0
96 hours and 60 days post-admission
Secondary outcome [1] 376754 0
The true positive rate of sepsis identified by the IHME ICD coding method in comparison to the currently used Angus sepsis ICD coding method.
Timepoint [1] 376754 0
96 hours and 60 days post-admission

Eligibility
Key inclusion criteria
- Adult patients (aged 16 years old or more) admitted from Emergency Department (ED) with an expected duration of hospital stay >24 hrs
- An order of culture of body fluid plus intravenous administration of an antibiotic
- Presence of two of the following criteria (qSOFA)
o Altered mental status (GCS <15)
o Respiratory rate >22/min
o Systolic blood pressure <100 mmHg
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample size calculation is based on considerations for the width of a two-sided 95% confidence interval (CI) of reported sensitivity of explicit sepsis ICD-10 codes between 7-16%. We expect about 50% clinical sepsis cases (using SEPSIS-3 criteria) in our selected patient cohort and a sample size of 500 should provide about 250 cases of true sepsis cases. In lieu of limited overall evidence and nil from Australia on the predictive ability of our proposed eligibility criteria, we will conduct an initial analysis of first 100 patients to check the proportion of the clinical sepsis in our cohort. Based on the initial analysis results, study eligibility criteria will be modified, if required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/04/2021
Actual
1/05/2021
Date of last participant enrolment
Anticipated
30/04/2022
Actual
15/01/2023
Date of last data collection
Anticipated
Actual
31/03/2023
Sample size
Target
500
Accrual to date
Final
450
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18091 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 18092 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 18093 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 18094 0
Bowral Hospital - Bowral
Recruitment hospital [5] 18095 0
Fairfield Hospital - Prairiewood
Recruitment hospital [6] 25604 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 25605 0
St George Hospital - Kogarah
Recruitment hospital [8] 25606 0
Blacktown Hospital - Blacktown
Recruitment hospital [9] 25607 0
Sydney Adventist Hospital - Wahroonga
Recruitment postcode(s) [1] 32080 0
2170 - Liverpool
Recruitment postcode(s) [2] 32081 0
2200 - Bankstown
Recruitment postcode(s) [3] 32082 0
2560 - Campbelltown
Recruitment postcode(s) [4] 32083 0
2576 - Bowral
Recruitment postcode(s) [5] 32084 0
2176 - Prairiewood
Recruitment postcode(s) [6] 41429 0
2065 - St Leonards
Recruitment postcode(s) [7] 41430 0
2217 - Kogarah
Recruitment postcode(s) [8] 41431 0
2148 - Blacktown
Recruitment postcode(s) [9] 41432 0
2076 - Wahroonga

Funding & Sponsors
Funding source category [1] 304245 0
Other Collaborative groups
Name [1] 304245 0
The George Institute for Global Health
Country [1] 304245 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
Level 5, 1 King St, Newtown NSW 2042 Australia
Country
Australia
Secondary sponsor category [1] 308153 0
None
Name [1] 308153 0
Address [1] 308153 0
Country [1] 308153 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304703 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 304703 0
South Western Sydney Local Health District Executive Office
Liverpool Hospital Eastern Campus
Scrivener Street
LIVERPOOL NSW 2170
Ethics committee country [1] 304703 0
Australia
Date submitted for ethics approval [1] 304703 0
22/11/2019
Approval date [1] 304703 0
14/05/2020
Ethics approval number [1] 304703 0

Summary
Brief summary
Estimation of true burden of sepsis remains is largely unknown and relies on the use of discharge diagnosis administrative codes. We aim to develop reliable estimate of true sepsis burden in Australia by measuring the accuracy of a new administrative coding methodology by comparing with the gold standard of the clinical diagnosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97930 0
Dr Ashwani Kumar
Address 97930 0
The George Institute for Global Health
Level 5, 1 King St, Newtown NSW 2042 Australia
Country 97930 0
Australia
Phone 97930 0
+61 421845671
Fax 97930 0
Email 97930 0
[email protected]
Contact person for public queries
Name 97931 0
Dr Ashwani Kumar
Address 97931 0
The George Institute for Global Health
Level 5, 1 King St, Newtown NSW 2042 Australia
Country 97931 0
Australia
Phone 97931 0
+61 421845671
Fax 97931 0
Email 97931 0
[email protected]
Contact person for scientific queries
Name 97932 0
Dr Ashwani Kumar
Address 97932 0
The George Institute for Global Health
Level 5, 1 King St, Newtown NSW 2042 Australia
Country 97932 0
Australia
Phone 97932 0
+61 421845671
Fax 97932 0
Email 97932 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9856Ethical approval    378718-(Uploaded-22-03-2021-20-32-14)-Study-related document.pdf
9857Study protocol    378718-(Uploaded-25-09-2023-14-30-31)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.