Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000917639
Ethics application status
Approved
Date submitted
2/08/2023
Date registered
28/08/2023
Date last updated
28/08/2023
Date data sharing statement initially provided
28/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating if the use of an antiseptic wipe can prevent catheter-associated infections in the community.
Scientific title
Addressing catheter-associated urinary tract infections in participants who self-catheterise : A randomised double-blind crossover study investigating if the use of an antiseptic wipe can prevent catheter-associated urinary tract infections in the community
Secondary ID [1] 310271 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter-associated infections 330965 0
Urinary tract infection 330966 0
Condition category
Condition code
Infection 327766 327766 0 0
Studies of infection and infectious agents
Public Health 327876 327876 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized, double-blind, cross-over placebo-controlled study will be undertaken over 12 months. Participants will enter one arm of the study for 6 months before crossing over for another 6 months.

In the intervention period, wipes provided to participants will contain 0.1% chlorhexidine solution - containing no alcohol, soap or equivalent. Participants will use a wipe to clean the meatal area prior to self-catheterisation twice daily (first and fourth catheterisation of the day), with control wipes for any other catheterisations on that day. Chlorhexidine has some residual bactericidal effect, hence it is important to determine whether once a day or use prior to catheterisation is needed. Chlorhexidine has been used safely in clinical trials in the past, and is commonly used at higher concentrations than proposed in this study.

There will be a washout period between transitioning between the phases between 1-3 weeks. This is purely pragmatic, to allow time for the intervention to be changed. In the washout period patients will use their regular wipes. We do not anticipate any residual or carry-over effect between the two arms of the study.

Participants will be posted the wipes from the research team to their home address. Products will be supplied, such that usage can be monitored and that the correct wipes are being used. Instructions on how to use the wipe will be provided to participants and included in the product supply. During the washout phase, participants will be asked to tell researchers how many wipes are remaining, and then to put all provided wipes in the bin. They will then be supplied with a new set of wipes to be used.

Wipe packaging and wipe appearance will be the same, allowing participants to be blinded to the control and intervention wipes.
Intervention code [1] 326651 0
Prevention
Intervention code [2] 326752 0
Treatment: Other
Comparator / control treatment
The control will be a wipe soaked in saline. The wipe will be used according to the standard practice which is prior to each catheterisation.
Control group
Placebo

Outcomes
Primary outcome [1] 335565 0
To evaluate the efficacy in reducing the incidence of UTI of a 0.1% chlorhexidine solution, compared with normal practice for meatal cleaning before urinary catheter insertion.

A survey with screening questions will be used to identify the potential of a UTI. A follow-up phone call with participants will occur monthly when needed, based on the self reporting of symptoms in the survey.
Timepoint [1] 335565 0
This outcome will be monitored monthly, through monthly follow up of participants throughout the study. This will occur until the end of the study i.e. 12 months.
Secondary outcome [1] 424966 0
To estimate the cost-effectiveness of using antiseptics for meatal cleaning.

Cost-effectiveness will be assessed from data obtained from the study and existing literature. Data obtained from the study will include the additional cost of the product used (chlorhexidine), duration of infection; details on any consultation/s with general practitioner; treatment costs, including antibiotic therapy (type, dose, duration) and detail on any admission to hospital (or ED attendance) relating to the UTI. These details would include presentation reason, time in hospital, and recall of any diagnostic tests. These data will be sourced from a follow-up phone call with participants, monthly when needed, based on the self reporting of symptoms in the routine monthly survey.

Data on quality of life of participants with a UTI will also be used in the cost-effectiveness evaluation. These data will be obtained from the study, in addressing another secondary outcome (described below).
Timepoint [1] 424966 0
This outcome will be evaluated at the end of the trial i.e. 12 months.
Secondary outcome [2] 424967 0
To explore the personal experience of participants who undertake intermittent catheterisation, either themselves (self-catheterisation) or by a caregiver or healthcare worker.
Semi structured audio recorded interviews by a member of the research team will be used to evaluate this outcome. Interviews are expected to take 30 minutes.
Timepoint [2] 424967 0
The interview will be conducted at the completion of the trial i.e. 12 months
Secondary outcome [3] 424968 0
To explore the effect of UTIs on the quality of life of participants who undertake intermittent catheterisation, either themselves (self-catheterisation) or by a caregiver or healthcare worker.
Timepoint [3] 424968 0
The interview will be conducted when (if) a person has a UTI.

Assessment of the impact of UTIs on quality of life will use EQ-5D, a questionnaire measuring 5 dimensions of health. This will be undertaken by a member of the research team and would be expected to take less than 10 minutes. This will occur when a participant has a UTI over the 12 month study period. Follow up will cease once at 12 months.
Secondary outcome [4] 425342 0
Time to UTI (in days).
Timepoint [4] 425342 0
This outcome will be monitored monthly, through monthly follow up of participants throughout the study via a survey. The survey has been designed for this study. The outcome is self-reported. If the survey indicates a self reported UTI, a follow up phone call will occur. This will occur until the end of the study i.e. 12 months.

Eligibility
Key inclusion criteria
• 18 years and older.
• Undertake intermittent catheterisation, either themselves (self-catheterisation) or by a caregiver or healthcare worker
• Are likely to be undertaking self-catheterisation for >12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent due to cognitive impairment.
• Hospital in-patient.
• Receiving palliative care.
• Less than 18 years old.
• Has a medical condition contraindicating them from participation, including a known allergy to any ingredient in the supplied product
• Fails sensitivity testing for chlorhexidine.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following randomisation, the allocation of participant to groups will be restricted to a password protected file, only accessible by one researcher. Data on allocation will only accessible by one researcher not involved with data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised (double-blind) in a 1:1 ratio and allocated to either a usual care followed by intervention or intervention followed by usual care. Randomisation and blinding will be coordinated by a researcher not involved with data collection, through computer generated randomisation by another researcher not involved in data collection.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The difference in the incidences of urinary tract infections (UTI) between treatment groups will be assessed using a generalised linear mixed model. The model will include fixed effects that describe treatment allocation in each 6-monthly study period, to account for the order in which patients receive the control of intervention. A random intercept will be specified to account for within-subject correlation related to the study design. The outcome is assumed to follow a Poisson distribution with a log (canonical) link function. If there are higher than expected numbers of patients with no UTI’s being observed or the outcome is overly dispersed, either a zero-inflated Poisson model or negative binomial model will be used to estimate intervention effectiveness. The effect of the intervention will be interpreted from the incidence rate ratio (IRR) which compares the incidence of UTI between two groups as a ratio. An intention to treat analysis will be performed.

Descriptive statistics of the sample will compare demographics and clinical characteristics between treatment sequences to investigate potential confounders. Continuous statistics will be examined using means and medians with 95% confidence intervals and interquartile ranges, with T-tests and Wilcoxon sun rank tests used to assess differences in characteristics between treatment sequences. Categorical variables will be presented as frequencies and percentage and compared using either Chi-square test or fisher’s exact test. All hypothesis testing will be two sided, with an alpha threshold of 0.05 used to define statistical significance. Reported results will comprise relevant estimates with corresponding 95 % confidence intervals.

The occurrence of any UTI for each cross-over treatment period will be modelled using generalised linear mixed model assuming a binary outcome and a logit canonical link function. Treatment and study characteristics will be included in the model as fixed effects and within-subject correlation will be modelled with a random intercept. Intervention effectiveness will be reported as an odds ratio, which compares the odds of contracting a UTI between intervention and control.

Time to UTI infection will be calculated from the start of a cross-over arm to the date when the participant contracts a UTI infection. A descriptive analysis will measure the median time to infection, stratified by cross-over period and treatment randomisation. Due to the cross-over design, survival assumptions are expected not to be met and likely introduce biases when estimating difference in hazards.

The purpose of the cost-effectiveness analysis is to summarise the expected changes to health service costs in AUD from a decision to adopt 0.1% chlorhexidine compared to normal practice. We will also assess the impact on mortality risk and health-related quality of life as quantified by the EQ-5D5L questionnaire. The factors that drive these changes to costs and health outcomes will be changes to risks of UTI and associated bloodstream infection (BSI). The intervention cost will be defined as the additional cost of using chlorhexidine instead of saline for each participant. Cost savings from reducing infections will include reduction in antimicrobial use, reduction in GP consultations, microbiology costs and reduction in usage of secondary health services such as ED visits and hospital admissions. Health benefits will be shown by quality-adjusted life years (QALY) arising from reduced risks of UTI and BSI. The UTI outcomes will be observed directly from the trial data and the change to BSI outcomes will be modelled from existing data. Estimates of the risk of developing BSI conditional on having a UTI for this patient population will be harvested from a review of the literature and, if necessary, augmented with expert opinion. The probability of death conditional on having a BSI and the downstream cost outcomes of BSI will be identified from evidence-synthesis activities.

A decision tree will be used to evaluate cost effectiveness using trial data and other sources of information. The cost-effectiveness evaluation will represent a societal perspective. The time horizon in this study will be from the point of urinary catheterisation until infection resolution. Uncertainties in parameter estimates will be captured using appropriate statistical distributions to describe uncertainty: beta or Dirichlet for probabilities, gamma for costs, beta for health utilities, and uniform for parameters updated with expert opinion. The probability distributions will be subject to 10,000 random re-samples to estimate a joint distribution of ‘change to costs’ and change to QALYs. To aid interpretation for decision making, a net monetary benefits framework will be used, including common thresholds for the maximum willingness to pay for health benefits.

A reflexive thematic approach will be used, in line with the method described by Braun and Clarke. Researchers will first familiarise themselves with the dataset, through multiple readings of the data. Through immersion in the data, patterns will be recognised, and semantic and latent codes generated by labelling important features of the data that are relevant to answering the research question. Codes will be collated and clustered to identify broader patterns of meaning and develop potential themes. Themes will then be refined and checked against the dataset, to determine if they answer the research question. Themes will finally be constructed and defined by competing a detailed analysis and determine the scope and focus of each theme and finally the themes will be names. Data will be managed in NVivo ® software (QSR International ©). Two researchers will be involved in the development of themes who are experienced in qualitative methods. All authors will review and agree on final themes, and note any relationships and overlaps between the themes. Sample size will be determined by the point at which data saturation is achieved, which is when the researchers deem that collecting more data would have no further interpretative value, and further coding would not be feasible. Participants will be invited to read their transcript and edit for completeness and accuracy as a form of member checking to improve the accuracy of the ideas represented in the data and to ensure that the data closely resembles the participants’ original intentions when they were interviewed. Participants will be sent their transcript within one month of completing the interview. They will be asked to return any edits within two weeks of receipt of their transcript.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
Date of last participant enrolment
Anticipated
8/01/2025
Actual
Date of last data collection
Anticipated
8/01/2026
Actual
Sample size
Target
32
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 314478 0
Government body
Name [1] 314478 0
NHMRC
Country [1] 314478 0
Australia
Primary sponsor type
University
Name
Avondale University
Address
582 Freemans Drive, Cooranbong New South Wales 2265
Country
Australia
Secondary sponsor category [1] 316433 0
None
Name [1] 316433 0
Address [1] 316433 0
Country [1] 316433 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313529 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 313529 0
Ethics committee country [1] 313529 0
Australia
Date submitted for ethics approval [1] 313529 0
Approval date [1] 313529 0
03/05/2023
Ethics approval number [1] 313529 0
2023/ETH00100

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

Contacts
Principal investigator
Name 128462 0
Prof Brett Mitchell
Address 128462 0
Avondale University, School of Nursing and Health, 582 Freemans Drive Cooranbong NSW 2265
Country 128462 0
Australia
Phone 128462 0
+61 249802213
Fax 128462 0
Email 128462 0
[email protected]
Contact person for public queries
Name 128463 0
Brett Mitchell
Address 128463 0
Avondale University, School of Nursing and Health, 582 Freemans Drive Cooranbong NSW 2265
Country 128463 0
Australia
Phone 128463 0
+61 249802213
Fax 128463 0
Email 128463 0
[email protected]
Contact person for scientific queries
Name 128464 0
Brett Mitchell
Address 128464 0
Avondale University, School of Nursing and Health, 582 Freemans Drive Cooranbong NSW 2265
Country 128464 0
Australia
Phone 128464 0
+61 249802213
Fax 128464 0
Email 128464 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
To protect the privacy of participants no individual participant data will be made available.


What supporting documents are/will be available?

No Supporting Document Provided



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.