Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
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)
Query!
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
Query!
Secondary ID [1]
313792
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1318-0462
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
urinary tract infection
336424
0
Query!
Condition category
Condition code
Public Health
333064
333064
0
0
Query!
Health service research
Query!
Infection
332946
332946
0
0
Query!
Studies of infection and infectious agents
Query!
Intervention/exposure
Study type
Observational
Query!
Patient registry
False
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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
Query!
Intervention code [1]
330379
0
Not applicable
Query!
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)
Query!
Control group
Uncontrolled
Query!
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
Query!
Assessment method [1]
340483
0
As recorded on Digital Health Record (DHR)
Query!
Timepoint [1]
340483
0
retrospective data collection from DHR from HITH discharge date until 30 days thereafter
Query!
Primary outcome [2]
340480
0
Mortality
Query!
Assessment method [2]
340480
0
Documentation on Digital Health Record (DHR) that patient is deceased during hospital admission
Query!
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)
Query!
Primary outcome [3]
340481
0
Total admission length of stay
Query!
Assessment method [3]
340481
0
As recorded on Digital Health Record (DHR)
Query!
Timepoint [3]
340481
0
retrospective data collection from DHR for duration of total hospital admission (ward plus HITH) for UTI
Query!
Secondary outcome [1]
444245
0
Adherence to local Canberra Health Services Antimicrobial Stewardship and HITH Antimicrobial Choice and Administration procedures.
Query!
Assessment method [1]
444245
0
As recorded on DHR - collect data on prescribed antibiotics during admission and organisms cultured in urine or blood
Query!
Timepoint [1]
444245
0
retrospective data collection from DHR during duration of whole hospital admission (ward and HITH)
Query!
Secondary outcome [2]
444226
0
Need for hospital ward transfer from HITH during HITH admission and reason for same
Query!
Assessment method [2]
444226
0
As recorded on Digital Health Record (DHR)
Query!
Timepoint [2]
444226
0
retrospective data collection from DHR during the dates of the patients HITH admission
Query!
Secondary outcome [3]
444286
0
Any complications that occur during dates encompassing HITH admission for UTI
Query!
Assessment method [3]
444286
0
As recorded on DHR - collect data on potential complications eg sepsis, IV line complications, abnormal vital signs, renal dysfunction
Query!
Timepoint [3]
444286
0
retrospective data collection from DHR during dates encompassing HITH admission for UTI
Query!
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
Query!
Assessment method [4]
444249
0
As recorded on DHR - collect data on age, gender, co-morbidities, procedures, urological devices
Query!
Timepoint [4]
444249
0
retrospective data collection from DHR during duration of patients HITH admission for UTI
Query!
Secondary outcome [5]
444573
0
Primary outcome HITH length of stay
Query!
Assessment method [5]
444573
0
As recorded on Digital Health Record (DHR)
Query!
Timepoint [5]
444573
0
retrospective data collection from DHR for duration of HITH admission for UTI
Query!
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
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
No exclusion criteria being retrospective audit study
Query!
Study design
Purpose
Query!
Duration
Longitudinal
Query!
Selection
Defined population
Query!
Timing
Retrospective
Query!
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
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
17/02/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/03/2025
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2025
Query!
Actual
Query!
Sample size
Target
357
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
ACT
Query!
Recruitment hospital [1]
27518
0
The Canberra Hospital - Garran
Query!
Recruitment hospital [2]
27519
0
Calvary Public Hospital ACT - Bruce
Query!
Funding & Sponsors
Funding source category [1]
318257
0
Government body
Query!
Name [1]
318257
0
Canberra Health Services (The Canberra Hospital)
Query!
Address [1]
318257
0
Query!
Country [1]
318257
0
Australia
Query!
Primary sponsor type
Government body
Query!
Name
Canberra Health Services
Query!
Address
Query!
Country
Australia
Query!
Secondary sponsor category [1]
320643
0
University
Query!
Name [1]
320643
0
Australian National University (ANU)
Query!
Address [1]
320643
0
Query!
Country [1]
320643
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316898
0
ACT Health Human Research Ethics Committee
Query!
Ethics committee address [1]
316898
0
https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
Query!
Ethics committee country [1]
316898
0
Australia
Query!
Date submitted for ethics approval [1]
316898
0
13/08/2024
Query!
Approval date [1]
316898
0
21/08/2024
Query!
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)
Query!
Summary
Brief summary
The aim of this project is to demonstrate that for patients with a UTI in whom intravenous antibiotic therapy is clinically indicated, there is a subset of these patients who can be safely managed at home by Hospital in the Home (HITH). The hypothesis is that HITH treatment for appropriately chosen patients with UTI has comparable (or even better) clinical outcomes when compared to available data on UTI treatment in a hospital ward setting in terms of length of stay, morbidity and mortality. It also aims to determine what patient factors may be associated with prolonged length of stay and poorer clinical outcomes. How well antibiotic prescription concurs with recommended antibiotic prescribing practices will also be assessed
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
139362
0
Dr Karyn Cuthbert
Query!
Address
139362
0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Query!
Country
139362
0
Australia
Query!
Phone
139362
0
+61 0404 392522
Query!
Fax
139362
0
Query!
Email
139362
0
[email protected]
Query!
Contact person for public queries
Name
139363
0
Karyn Cuthbert
Query!
Address
139363
0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Query!
Country
139363
0
Australia
Query!
Phone
139363
0
+61 02 51240000
Query!
Fax
139363
0
Query!
Email
139363
0
[email protected]
Query!
Contact person for scientific queries
Name
139364
0
Karyn Cuthbert
Query!
Address
139364
0
The Canberra Hospital, Hospital in the Home Unit, Yamba Drive, Garran ACT 2605
Query!
Country
139364
0
Australia
Query!
Phone
139364
0
+61 02 51240000
Query!
Fax
139364
0
Query!
Email
139364
0
[email protected]
Query!
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?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
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.
Download to PDF