Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001191381
Ethics application status
Approved
Date submitted
8/08/2017
Date registered
15/08/2017
Date last updated
6/09/2019
Date data sharing statement initially provided
6/09/2019
Date results provided
6/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Reducing urinary catheter use: a randomised controlled study on the efficacy of an electronic reminder system in hospitalized patients
Scientific title
Reducing urinary catheter use: a randomised controlled study on the efficacy of an electronic reminder system in hospitalised patients
Secondary ID [1] 291237 0
Nil known
Universal Trial Number (UTN)
U1111-1200-0687
Trial acronym
CATH TAG study
Linked study record
N.A.

Health condition
Health condition(s) or problem(s) studied:
Uinrary catheter usage
304011 0
Catheter associated asymptomatic bacteriuria 304012 0
Condition category
Condition code
Infection 303342 303342 0 0
Studies of infection and infectious agents
Public Health 303689 303689 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The CATH TAG is an electronic device that adhesively attaches to the catheter bag. It has a non-intrusive green light that flashes intermittently for a period of 24 hours upon activation. After 24 hours the green flashing light changes to red, flashing with increased rapidity and visibility. The light will flash red for 4 hours and subsequently change back to green, slower flashing, restarting the cycle. The red flashing light is an indication for the nurse to reassess the need for a urinary catheter and remove it when it is no longer required. This circle will continue for 10 days and then change permanently to the red flashing light to indicate that the battery of the CATH TAG is exhausted. There is no option for nurses to manipulate the flashing light or amend the circle.
Intervention code [1] 298590 0
Prevention
Intervention code [2] 298860 0
Treatment: Devices
Comparator / control treatment
The proposed study has adopted a stepped wedge randomised controlled design. This design enables each group to act as its own control.

During control phases no intervention is carried out, i.e. the CATH TAG will not be used. Usual practices according to local policies of the hospital regarding catheter removal will be followed.
Control group
Active

Outcomes
Primary outcome [1] 302731 0
Duration of catheterisation (defined as the mean duration of catheterisation, calculated from the number of days from insertion of catheter to censor date).
Timepoint [1] 302731 0
Upon completion of data-collection (trial duration: 24 weeks)
Primary outcome [2] 302732 0
Perceptions of nurses about ease of use of the CATH TAG. This will be assessed by means of an anonymous online survey, as well as through a focus group. The survey has been designed specifically for this study.
Timepoint [2] 302732 0
The survey will be conducted when all intervention phases of the trial are completed. This will be 6 months post commencement of data-collection (presumably March/April 2018).

The focus group will be conducted 2 months post completion of all intervention phases, 8 months post commencement of data-collection (presumably June 2018).
Secondary outcome [1] 336843 0
The number of cases of catheter associated asymptomatic bacteriuria (CA-ASB) per 100 catheter days.
Number of cases of CA-ASB will be assessed by collecting the following additional datafrom patients who have a urinary sample taken: date of specimen collection, species isolated and colony count and white cell count.
Timepoint [1] 336843 0
Upon completion of data-collection (trial duration: 24 weeks)
Secondary outcome [2] 336844 0
The number of urinary catheters inserted per 100 patient admissions
Timepoint [2] 336844 0
Upon completion of data-collection (trial duration: 24 weeks)
Secondary outcome [3] 336845 0
Perceptions of nurses about the effectiveness of the CATH TAG. This will be assessed by means of an anonymous online survey, as well as through a focus group. The survey has been designed specifically for this study.
Timepoint [3] 336845 0
The survey will be conducted when all intervention phases of the trial are completed. This will be 6 months post commencement of data-collection (presumably March/April 2018).

The focus group will be conducted 2 months post completion of all intervention phases, 8 months post commencement of data-collection (presumably June 2018).
Secondary outcome [4] 336846 0
Perceptions of nurses about changes in ownership or interest by patients in catheter management. This will be assessed by means of an anonymous online survey, as well as through a focus group. The survey has been designed specifically for this study.
Timepoint [4] 336846 0
The survey will be conducted when all intervention phases of the trial are completed. This will be 6 months post commencement of data-collection (presumably March/April 2018).

The focus group will be conducted 2 months post completion of all intervention phases, 8 months post commencement of data-collection (presumably June 2018).
Secondary outcome [5] 336847 0
Perceptions of nurses about barriers to the CATH TAG working successfully in varied types of patients. This will be assessed by means of an anonymous online survey, as well as through a focus group. The survey has been designed specifically for this study.
Timepoint [5] 336847 0
The survey will be conducted when all intervention phases of the trial are completed. This will be 6 months post commencement of data-collection (presumably March/April 2018).

The focus group will be conducted 2 months post completion of all intervention phases, 8 months post commencement of data-collection (presumably June 2018).

Eligibility
Key inclusion criteria
The hospital must meet the following inclusion criteria:
1. Must have an intensive care unit
2. Must have at least ten wards
3. More than 30,000 patient admissions per year

Potential wards and units eligible for inclusion are medical wards, surgical wards and intensive care units.

All hospitalized patients, admitted to a ward eligible for inclusion in the study, who require a urinary catheter as part of their usual care will be included in the study.

All nurses, who have worked on an intervention ward (i.e. who have worked with the CATH TAG), will be invited to participate in the survey and focus group.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for hospitals
Hospitals will be excluded from the study if they do not meet any of the inclusion criteria.

Day-stay units and psychiatric wards will be excluded.

Neonates (<2 years old) may be excluded if the CATH TAG is too large for the catheter tubing or interferes with patient care.

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)
Allocation of wards, crossing over to the intervention will be concealed. The order in which the individual wards cross over to the intervention will be randomised by computer. Randomisation of the cross over dates for the wards will be performed independently by one of the investigators, who will not be involved in assessment or delivery of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation). All suitable wards in the hospital will be randomly assigned to cross over to the intervention every four weeks over the trial duration of 24 weeks,

following an initial period of four weeks where no wards are exposed to the intervention. All included wards will be provided with sufficient notice of the dates to cross over to the intervention. Computer-generated randomisation of the cross over dates for the wards will be performed independently by one of the investigators, who will not be involved in assessment or delivery of the intervention. Wards will not be blinded because it is not feasible to blind staff to the intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The proposed study has a stepped wedge randomised controlled deisgn. A mixed methods approach will be used, as a qualitative approach is included. The clusters in the study are pairs of individual hospital wards. The stepped wedge design includes an initial period where no wards are exposed to the intervention. Afterwards, at regular intervals (the “steps”) two wards, forming one cluster, are randomised to cross over from the control to the intervention, approximately every four weeks, with the process continuing until week 20, when all enrolled wards have crossed over. The study design enables each ward to act as its own control, which removes the potential for some confounders such as variations in ward size and case mix. Staggered commencement and duration of the intervention, supports feasibility while maintaining the rigour of the study. This design will allow research staff to work with individual wards as they change over, maximising consistency of the intervention and aiding implementation. In addition, data collection continues throughout the study, so that each cluster contributes observations under both control and intervention observation periods. In month 6 of the study, an online survey of nursing staff will be administered. Approximately two months after the stepped wedge study is completed, a focus group will be conducted.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Objective 1: To determine the efficacy of an electronic reminder system in reducing urinary catheter usage.

The primary outcome measure is the duration of catheterisation, and the study aims to evaluate the effect of the intervention. The analysis will be performed using the generalised estimating equations, using the duration of catheterisation as the dependent variable and intervention as the independent variable. Duration of the intervention will be treated as a confounding variable. It is anticipated that duration of catheterisation will be normally distributed, but exploratory analyses (and where necessary transformation) will be performed. Robust standard errors will be used to adjust for correlation at ward level and autocorrelation in time. There is no expected delay in the effect of the intervention on the outcome.

Objective 2: To determine whether the CATH TAG has an effect on nurses’ ability to deliver patient care.

Survey:
Data from the anonymous online survey will be analysed using SPSS. It is anticipated that data will be normally distributed but exploratory analyses will be performed, including testing of assumptions of linearity, homoscedasticity, multi-collinearity and normality of errors and if necessary transformation of data. Validity and reliability will be examined. Subsequently a general satisfaction score and individual satisfaction scores for the four dimensions of nurses’ experiences with the CATH TAG (Ease of use, Effectiveness, Changes in ownership, Barriers) will be calculated. Regression analysis will be conducted to determine if the duration of the intervention or the ward nurses primarily work on had an effect on nurses’ experiences with the CATH TAG.

Any problems reported in the open questions will be taken into the focus group to be discussed and subsequently analysed qualitatively (see below).

Focus group:
Audio files from the focus group will be transcribed and these data will form the basis of data analysis. Data gathered from the focus group/s will be coded and analysed using qualitative analysis software (NVivo). The data analysis process will aim to identify and investigate both, pre-determined and emerging themes, in the data. The pre-determined themes will be drawn from the broad responses to the open questions in the survey, as well as from the study’s objectives and will be reflected in the focus group questions. As themes are identified in the data, constant comparison analysis will be utilised. This process reduces redundancy in the analysis results by collapsing similar themes, identifies any relationships between the themes and ensures saturation is achieved. In this way, the essence of the hospital personnel’s perceptions will be determined.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The 6 month period for data collected has concluded.
Date of first participant enrolment
Anticipated
1/09/2017
Actual
1/11/2017
Date of last participant enrolment
Anticipated
1/06/2018
Actual
30/04/2018
Date of last data collection
Anticipated
1/07/2018
Actual
15/06/2018
Sample size
Target
2100
Accrual to date
Final
1621
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 8538 0
The Townsville Hospital - Douglas
Recruitment postcode(s) [1] 16632 0
4814 - Douglas

Funding & Sponsors
Funding source category [1] 295687 0
Commercial sector/Industry
Name [1] 295687 0
Senver Pty Ltd
Country [1] 295687 0
Australia
Primary sponsor type
University
Name
Avondale College of Higher Education
Address
185 Fox Valley Road
Wahroonga
2076
Country
Australia
Secondary sponsor category [1] 295986 0
None
Name [1] 295986 0
Address [1] 295986 0
Country [1] 295986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296998 0
Avondale College of Higher Education HREC
Ethics committee address [1] 296998 0
Ethics committee country [1] 296998 0
Australia
Date submitted for ethics approval [1] 296998 0
27/07/2017
Approval date [1] 296998 0
11/09/2017
Ethics approval number [1] 296998 0
2017:15
Ethics committee name [2] 298362 0
Human Research Ethics Committee Queensland Health: Townsville Hospital and Health Service Human Research Ethics Committee
Ethics committee address [2] 298362 0
Ethics committee country [2] 298362 0
Australia
Date submitted for ethics approval [2] 298362 0
07/09/2017
Approval date [2] 298362 0
06/10/2017
Ethics approval number [2] 298362 0
HREC17/QTHS/198

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1955 1955 0 0
/AnzctrAttachments/372401-Attachment A - Survey.pdf (Other)
Attachments [2] 1956 1956 0 0
/AnzctrAttachments/372401-Attachment B - Information for participants - Focus group.pdf (Participant information/consent)
Attachments [3] 1957 1957 0 0
/AnzctrAttachments/372401-Attachment C - Consent form - Focus group.pdf (Participant information/consent)
Attachments [4] 1958 1958 0 0
/AnzctrAttachments/372401-Attachment D - focus group - program outline.pdf (Supplementary information)
Attachments [5] 1963 1963 0 0
/AnzctrAttachments/372401-Protocol 1.1.pdf

Contacts
Principal investigator
Name 72662 0
Prof Brett Mitchell
Address 72662 0
Avondale College of Higher Education
Discipline of Nursing
Clinical Education Centre
185 Fox Valley Road
Wahroonga
NSW 2076
Country 72662 0
Australia
Phone 72662 0
+61 2 9480 3613
Fax 72662 0
Email 72662 0
[email protected]
Contact person for public queries
Name 72663 0
Brett Mitchell
Address 72663 0
Avondale College of Higher Education
Discipline of Nursing
Clinical Education Centre
185 Fox Valley Road
Wahroonga
NSW 2076
Country 72663 0
Australia
Phone 72663 0
+61 2 9480 3613
Fax 72663 0
Email 72663 0
[email protected]
Contact person for scientific queries
Name 72664 0
Brett Mitchell
Address 72664 0
Avondale College of Higher Education
Discipline of Nursing
Clinical Education Centre
185 Fox Valley Road
Wahroonga
NSw 2076
Country 72664 0
Australia
Phone 72664 0
+61 2 9480 3613
Fax 72664 0
Email 72664 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
Ethics approval does not extend to this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4540Study protocolFasugba, O., Cheng, A. C., Russo, P. L., Northcote, M., Rosebrock, H., & Mitchell, B. G. (2018). Reducing urinary catheter use: a protocol for a mixed methods evaluation of an electronic reminder system in hospitalised patients in Australia. BMJ open, 8(5), e020469.  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseReducing urinary catheter use: A protocol for a mixed methods evaluation of an electronic reminder system in hospitalised patients in Australia.2018https://dx.doi.org/10.1136/bmjopen-2017-020469
EmbaseReducing urinary catheter use using an electronic reminder system in hospitalized patients: A randomized stepped-wedge trial.2019https://dx.doi.org/10.1017/ice.2019.31
N.B. These documents automatically identified may not have been verified by the study sponsor.