Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000172404
Ethics application status
Approved
Date submitted
24/01/2025
Date registered
13/02/2025
Date last updated
13/02/2025
Date data sharing statement initially provided
13/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Treatment of Urinary Tract Infection with Intravenous Antibiotics at Home, as an Alternative to Ward based care by Hospital in the Home (HITH) Services for patients in Australian Capital Territory (ACT)
Scientific title
Is treatment of UTI with intravenous antibiotics at home via HITH at least as safe and effective as on the ward? A retrospective clinical audit of UTI patients admitted to ACT HITH services
Secondary ID [1] 313792 0
Nil known
Universal Trial Number (UTN)
U1111-1318-0462
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
urinary tract infection 336424 0
Condition category
Condition code
Public Health 333064 333064 0 0
Health service research
Infection 332946 332946 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective outcomes audit on patients admitted to the 2 Australian Capital Territory (ACT) Hospital in the Home (HITH) services (The Canberra Hospital HITH and North Canberra Hospital HITH) between Nov 2022 to June 2024 for the purpose of IV antibiotic treatment for urinary tract infection (UTI). Prior 12 month audit on same at TCH HITH only (71 patients), showed that patient outcomes in HITH were comparable to those published in the literature for similar patient cohort admitted to hospital wards for purpose of IV antibiotic treatment for UTI.
Measured outcomes will be mortality, hospital ward readmission rate during HITH admission and at 30 days post discharge (and reason for same), admission length of stay, including proportion of time spent in HITH versus ward, adherence to local and national antimicrobial resistance guidelines, demographic details/co-morbidities/investigation results/procedures/urological devices recorded to enable exploration of patient risk factors that could be associated with a longer length of stay to further assess complication and readmission rates
Intervention code [1] 330379 0
Not applicable
Comparator / control treatment
There is no active control group, however the collated data will be compared to published outcomes data on patients admitted to hospital for UTI generally (noting that whilst the HITH patients are physically located at home, they are admitted inpatients of The Canberra Hospital and North Canberra Hospital)
The retrospective data collection for this study will occur between November 2022 and June 2024 from the Canberra Health Services Digital Health Record (DHR)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340483 0
30 Day hospital readmission rate - noting reason for readmission and whether readmission is directly related to primary UTI diagnosis or unrelated
Timepoint [1] 340483 0
retrospective data collection from DHR from HITH discharge date until 30 days thereafter
Primary outcome [2] 340480 0
Mortality
Timepoint [2] 340480 0
Retrospective data collection - any death occurring during the patient's entire hospital admission for UTI (whether admitted to HITH or having been transferred back to a hospital ward from HITH)
Primary outcome [3] 340481 0
Total admission length of stay
Timepoint [3] 340481 0
retrospective data collection from DHR for duration of total hospital admission (ward plus HITH) for UTI
Secondary outcome [1] 444245 0
Adherence to local Canberra Health Services Antimicrobial Stewardship and HITH Antimicrobial Choice and Administration procedures.
Timepoint [1] 444245 0
retrospective data collection from DHR during duration of whole hospital admission (ward and HITH)
Secondary outcome [2] 444226 0
Need for hospital ward transfer from HITH during HITH admission and reason for same
Timepoint [2] 444226 0
retrospective data collection from DHR during the dates of the patients HITH admission
Secondary outcome [3] 444286 0
Any complications that occur during dates encompassing HITH admission for UTI
Timepoint [3] 444286 0
retrospective data collection from DHR during dates encompassing HITH admission for UTI
Secondary outcome [4] 444249 0
Explore patient risk factors that could be associated with prolonged LOS or adverse outcomes to assess complication and readmission rates. This is an exploratory outcome
Timepoint [4] 444249 0
retrospective data collection from DHR during duration of patients HITH admission for UTI
Secondary outcome [5] 444573 0
Primary outcome HITH length of stay
Timepoint [5] 444573 0
retrospective data collection from DHR for duration of HITH admission for UTI

Eligibility
Key inclusion criteria
All adult patients admitted to The Canberra Hospital or North Canberra Hospital HITH services for the purpose of IV antibiotic administration for UTI, whether for all or part of the entire hospital inpatient admission from November 2022 to June 2024
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria being retrospective audit study

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Outcome data will be descriptive and where possible inferential statistics will be done under guidance of a biostatistician
This section is stated to be "optional" hence only a short initial statement
The sample size is one of convenience in that the Canberra Health Services DHR commenced in November 2022 (hence data easier to access from this date when digital compared to prior paper based/scanned clinical notes system) and the business support unit was requested to pull a list of appropriate patients off the DHR soon after June 2024 - to therefore have as large a sample size as feasible with available resources and timeframe
A smaller (unpublished) pilot type study of 71 patients from TCH HITH from Nov 2022 to Dec 2023 showed good outcomes, hence it was decided to increase the time period of data collection for another 6 months and include patients from NCH HITH as well as TCH HITH to have a greater number of patients to include in the study and increase the power of the results

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
357
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 27518 0
The Canberra Hospital - Garran
Recruitment hospital [2] 27519 0
Calvary Public Hospital ACT - Bruce

Funding & Sponsors
Funding source category [1] 318257 0
Government body
Name [1] 318257 0
Canberra Health Services (The Canberra Hospital)
Country [1] 318257 0
Australia
Primary sponsor type
Government body
Name
Canberra Health Services
Address
Country
Australia
Secondary sponsor category [1] 320643 0
University
Name [1] 320643 0
Australian National University (ANU)
Address [1] 320643 0
Country [1] 320643 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316898 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 316898 0
Ethics committee country [1] 316898 0
Australia
Date submitted for ethics approval [1] 316898 0
13/08/2024
Approval date [1] 316898 0
21/08/2024
Ethics approval number [1] 316898 0
Regis Reference 2023/ETH02589 (extension approval to include NCH HITH patients and increase data collection time beyond 12 months after initial pilot trial completed over 2023/2024 holiday period at TCH HITH)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139362 0
Dr Karyn Cuthbert
Address 139362 0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Country 139362 0
Australia
Phone 139362 0
+61 0404 392522
Fax 139362 0
Email 139362 0
[email protected]
Contact person for public queries
Name 139363 0
Karyn Cuthbert
Address 139363 0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Country 139363 0
Australia
Phone 139363 0
+61 02 51240000
Fax 139363 0
Email 139363 0
[email protected]
Contact person for scientific queries
Name 139364 0
Karyn Cuthbert
Address 139364 0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Country 139364 0
Australia
Phone 139364 0
+61 02 51240000
Fax 139364 0
Email 139364 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Collected data will be de-identified for patient privacy reasons with no intention/need to share individual patient data publicly for the purposes of this study



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    7.1 - 2023.LRE.00211 - Cuthbert extension approval HITH UTI study.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.