ANZCTR - Registration

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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]

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

Catheter associated asymptomatic bacteriuria

Condition category

Condition code

Infection

Studies of infection and infectious agents

Public Health

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]

Prevention

Intervention code [2]

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]

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]

Upon completion of data-collection (trial duration: 24 weeks)

Primary outcome [2]

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]

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]

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]

Upon completion of data-collection (trial duration: 24 weeks)

Secondary outcome [2]

The number of urinary catheters inserted per 100 patient admissions

Timepoint [2]

Upon completion of data-collection (trial duration: 24 weeks)

Secondary outcome [3]

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]

Secondary outcome [4]

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]

Secondary outcome [5]

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]

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]

The Townsville Hospital - Douglas

Recruitment postcode(s) [1]

4814 - Douglas

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Senver Pty Ltd

Address [1]

53/61-65 Glencoe St
Sutherland
NSW 2232

Country [1]

Australia

Primary sponsor type

University

Name

Avondale College of Higher Education

Address

185 Fox Valley Road
Wahroonga
2076

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Avondale College of Higher Education HREC

Ethics committee address [1]

582 Freemans Drive (PO box 19) 
Cooranbong NSw 2265 
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/07/2017

Approval date [1]

11/09/2017

Ethics approval number [1]

2017:15

Ethics committee name [2]

Human Research Ethics Committee Queensland Health: Townsville Hospital and Health Service Human Research Ethics Committee

Ethics committee address [2]

PO Box 670
Townsville Qld 4810
Australia

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

07/09/2017

Approval date [2]

06/10/2017

Ethics approval number [2]

HREC17/QTHS/198

Summary

Brief summary

 Indwelling urinary catheters are commonly used in healthcare facilities, with foundation work by two investigators indicating that 26% of patients admitted to an Australian hospital receive an indwelling urinary catheter and 1% of these patients develop catheter-associated urinary tract infections (CAUTIs). Healthcare associated urinary tract infections (HAUTIs), including CAUTIs have been associated with increased morbidity, mortality, higher hospital costs for patients and health systems.  In Australia, an estimated 380,000 bed days are lost each year due to HAUTIs, a large proportion of which are CAUTIs. Urinary tract infections (UTIs), specifically CAUTIs are associated with higher risk of antimicrobial resistance (AMR), making the treatment of patients difficult and compounding the effects of AMR when treatment is provided. A recent high-level meeting of the United Nations General Assembly addressed the issue of increasing AMR. This further emphasises the need to develop interventions to reduce the incidence of CAUTIs.

Despite advances in infection prevention and control, CAUTIs remain problematic, hence further research is needed to identify ways to reduce the burden they create. The greatest risk factor for CAUTIs is prolonged catheterisation, with catheters often placed unnecessarily, lacking documented reasons for insertion, and catheters remaining in place too long and not being promptly removed. Interventions that prompt removal of unnecessary catheters may therefore enhance patient safety. A reminder intervention is a mechanism used to remind either a physician or nurse that the catheter is still in place and that removal may be warranted if the catheter is no longer required.

The current study aims to evaluate the effectiveness of an electronic reminder system – the CATH TAG – to reduce urinary catheter use.

Trial website

Trial related presentations / publications

There are no trial related presentations or publications yet. 

The following publications/presentations are planned:

Protocol of the study: Australasian College for Infection Prevention and Control Conference,  Canberra, November 2017 

Protocol of the study: Infection Prevention Society Conference, Manchester, United Kingdom, September 2017 

Results of the study: To be decided

Public notes

Attachments [1]

/AnzctrAttachments/372401-Attachment A - Survey.pdf (Other)

Attachments [2]

/AnzctrAttachments/372401-Attachment B - Information for participants - Focus group.pdf (Participant information/consent)

Attachments [3]

/AnzctrAttachments/372401-Attachment C - Consent form - Focus group.pdf (Participant information/consent)

Attachments [4]

/AnzctrAttachments/372401-Attachment D - focus group - program outline.pdf (Supplementary information)

Attachments [5]

/AnzctrAttachments/372401-Protocol 1.1.pdf

Contacts

Principal investigator

Name

Prof Brett Mitchell

Address

Avondale College of Higher Education
Discipline of Nursing
Clinical Education Centre
185 Fox Valley Road
Wahroonga
NSW 2076

Country

Australia

Phone

+61 2 9480 3613

Fax

brett.mitchell@avondale.edu.au

Contact person for public queries

Name

Brett Mitchell

Address

Avondale College of Higher Education
Discipline of Nursing
Clinical Education Centre
185 Fox Valley Road
Wahroonga
NSW 2076

Country

Australia

Phone

+61 2 9480 3613

Fax

brett.mitchell@avondale.edu.au

Contact person for scientific queries

Name

Brett Mitchell

Address

Avondale College of Higher Education
Discipline of Nursing
Clinical Education Centre
185 Fox Valley Road
Wahroonga
NSw 2076

Country

Australia

Phone

+61 2 9480 3613

Fax

brett.mitchell@avondale.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Ethics approval does not extend to this.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4540	Study protocol	Fasugba, 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

Source	Title	Year of Publication	DOI
Embase	Reducing urinary catheter use: A protocol for a mixed methods evaluation of an electronic reminder system in hospitalised patients in Australia.	2018	https://dx.doi.org/10.1136/bmjopen-2017-020469
Embase	Reducing urinary catheter use using an electronic reminder system in hospitalized patients: A randomized stepped-wedge trial.	2019	https://dx.doi.org/10.1017/ice.2019.31

N.B. These documents automatically identified may not have been verified by the study sponsor.

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