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Trial registered on ANZCTR


Registration number
ACTRN12617000090314
Ethics application status
Approved
Date submitted
13/01/2017
Date registered
17/01/2017
Date last updated
18/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing inappropriate catheterisation to prevent catheter-associated urinary tract infection (CAUTI) through a hospital-wide, bundled catheter care (BCC) approach: a non-randomised, controlled intervention study
Scientific title
Reducing inappropriate catheterisation to prevent catheter-associated urinary tract infection (CAUTI) through a hospital-wide, bundled catheter care (BCC) approach: a non-randomised, controlled intervention study
Secondary ID [1] 290908 0
Nil
Universal Trial Number (UTN)
Trial acronym
No CAUTI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter-associated urinary tract infection (CAUTI) 301625 0
Condition category
Condition code
Renal and Urogenital 301332 301332 0 0
Other renal and urogenital disorders
Infection 301353 301353 0 0
Other infectious diseases
Public Health 301354 301354 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention period is 6 months at each hospital.

The key component of the intervention is the evidence-based “No CAUTI” bundle:
N - NEED for catheter assessed – refer to indications, scan bladder, consider alternative, document reason.
O - OBTAIN patient consent, OFFER patient education including hygiene.
C - COMPETENCY – clinicians who insert catheters must have documented competency.
A - ASEPSIS – maintain asepsis & hand hygiene during insertion and while catheter is in place.
U - UNOBSTRUCTED flow - No kinks or loops, catheter secured, bag below bladder level and off the floor.
T - TIMELY catheter removal and documentation – May be nurse initiated.
I - INFECTION RISK – daily periurethral hygiene. Collect urine specimen only when clinically indicated.

The No CAUTI bundle will be displayed on posters within the hospitals.

To support implementation of the No CAUTI bundle, the following resources were developed as part of the intervention:
- IDC insertion criteria guidelines
- Indications for IDC specimen collection
- Nurse-led IDC removal guidelines
- Educational resources and compliance auditing tools

The distribution and standardised use of a cost-effective, generic IDC insertion pack forms part of the intervention. The insertion pack includes all equipment required for catheterisation, documentation stickers, and securing devices.

Routine assessment of clinician competency in urinary catheter insertion will be introduced as part of the multifaceted intervention.

Implementation strategies include:
- Education (train-the-trainer workshops and ward inservices)
- Monitoring and feedback (compliance audits and feedback, and feedback of point prevalence of IDC usage and CAUTI)
- Resources (No CAUTI bundle posters and badges, and catheter insertion DVDs)
- Facilitation (competency assessments and champions)

Implementation strategies are detailed below:
All intervention components will be delivered in participating facilities. The intervention will be delivered in all adult inpatient wards, emergency departments, and operating theatres in all four hospitals.

Train-the-trainer workshops: Train-the-trainer workshops will prepare nurse educators to present the “No CAUTI” bundle to ward-based staff, and to train educators to complete urinary catheterisation competency assessments. Mode-of delivery will be face-to-face (group), and workshops will be delivered by clinical nurse consultant – urology. 1x 2-3 hour workshop will be delivered at each hospital at the start of the intervention.

Ward in-services will be delivered to familiarise staff with the “No CAUTI” bundle and nurse-initiated removal flowchart, and to identify champions on each ward. In-services will be delivered face-to-face (group) by nurse educators, to an audience of nurses and medical officers from adult inpatient wards, operating theatres, and emergency departments. A minimum of 1x 20 minute in-service in each ward at the start of the intervention will be delivered.

Compliance audits and feedback will take place to monitor compliance with “No CAUTI” bundle and provide strategies to support implementation of the intervention. Mode of delivery will be individual patient audit, and face-to-face (group) feedback to clinicians. Champions (clinicians previously identified in in-services) will deliver this component in all inpatient wards. Compliance audits will be conducted for the first two months of the intervention and then monthly for the remaining four months of the intervention period.

Feedback of point prevalence indwelling urinary catheter usage and CAUTI: Face-to-face (group) and email feedback will be provided by research project staff to all clinicians at a ward, facility and district level. This will take place at baseline, 4 months, and 9 months.

Resources: “No CAUTI” bundle badges and posters will be disseminated throughout participating hospitals to prompt awareness of the intervention. Badges will also help to identify ward champions. Posters will be displayed in all participating wards, and badges will be worn by clinicians and champions. This is a passive intervention component. Ongoing throughout intervention period.

Resource – catheter insertion DVDs: DVDs to educate nurses about the correct catheterisation process will be made available on the intranet throughout the intervention period. This is a passive intervention component.

Competency assessments: competency assessments will increase the proportion of clinicians that are competent in urinary catheterisation. This component will be delivered by nurse educators to nurses on an individual face-to-face basis. These are an ongoing component of the intervention.

Champions: Champions will act as a resource for clinicians and promote the No CAUTI bundle to clinicians, and will also support implementation of the intervention. Nurses will act as champions, and will be an ongoing component of the intervention.
Intervention code [1] 296851 0
Prevention
Intervention code [2] 296865 0
Treatment: Devices
Comparator / control treatment
No intervention

This is a pre-implementation control. There will be a 4-month control period for Central Coast Local Health District.

Statewide clinical practice guidelines for urinary catheterisation exist, however there are no implementation strategies in place for the guidelines. Local clinical practice guidelines are out of date and incomplete.
Control group
Active

Outcomes
Primary outcome [1] 300738 0
Change in proportion of patients with indwelling urinary catheter in situ
Instrument: Point prevalence survey – bedside audit
Timepoint [1] 300738 0
Baseline, 4 months after intervention commencement, and 9 months after intervention commencement
Primary outcome [2] 300739 0
Change in rate of CAUTI as per CDC definition
Instrument: Point prevalence survey – electronic health-related records and patient history notes
Timepoint [2] 300739 0
Baseline, 4 months after intervention commencement, and 9 months after intervention commencement
Secondary outcome [1] 330758 0
Change in clinician knowledge and confidence
Instrument: online survey designed for this study
Timepoint [1] 330758 0
Baseline
6 months after intervention commencement
Secondary outcome [2] 330759 0
Identification of barriers and enablers to implementation
Instrument: focus group
Participants: nurses and medical officers from participating hospitals
Timepoint [2] 330759 0
6 months after intervention commencement

Eligibility
Key inclusion criteria
Adult inpatient in participating facility
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
N/A

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Multiple pre-post control intervention design
Implementation of the intervention across four acute care hospitals will be staged, with multiple clusters in each of two implementation stages. Pre and post point prevalence data comparison will occur within all hospitals pre and post intervention, as well as between the two Health Districts.
Two hospitals in the first Local Health District will commence intervention, and then 4 months later intervention will commence in the second Local Health District, providing a contemporaneous control.
The phased implementation of the intervention allows for a control between the two Health Districts.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size calculation has indicated that 500 patients per health district would be sufficient to detect a 40% fall (15% to 9%) in relative IDC insertion rates with a power of 0.8 and alpha 0.05. This is based on a 50% (39.5% to 14.6%) reduction observed in the pilot study. Estimated bed numbers of 860 in Health District 2 and 610 in Health District 1 should thus be more than adequate to provide sufficient power to detect a significant change. Further power will be obtained through having baseline control data from Phase 1 and from stratifying the analysis by hospital wards.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/11/2016
Date of last participant enrolment
Anticipated
1/01/2018
Actual
8/12/2016
Date of last data collection
Anticipated
30/03/2018
Actual
26/03/2018
Sample size
Target
1500
Accrual to date
Final
1500
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 7281 0
The Maitland Hospital - Maitland
Recruitment hospital [2] 7282 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [3] 7283 0
Gosford Hospital - Gosford
Recruitment hospital [4] 7284 0
Wyong Public Hospital - Hamlyn Terrace
Recruitment postcode(s) [1] 15053 0
2320 - Maitland
Recruitment postcode(s) [2] 15054 0
2340 - Tamworth
Recruitment postcode(s) [3] 15055 0
2250 - Gosford
Recruitment postcode(s) [4] 15056 0
2259 - Hamlyn Terrace

Funding & Sponsors
Funding source category [1] 295331 0
Government body
Name [1] 295331 0
NSW Ministry of Health Translational Research Grants Scheme
Country [1] 295331 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Nursing & Midwifery Research Centre, James Fletcher Campus, Gate Cottage, 72 Watt St, Newcastle 2300 NSW
Country
Australia
Secondary sponsor category [1] 294156 0
Government body
Name [1] 294156 0
Central Coast Local Health District
Address [1] 294156 0
CCLHD Nursing & Midwifery Directorate
67 Holden Street Gosford NSW 2250
Country [1] 294156 0
Australia
Other collaborator category [1] 279393 0
University
Name [1] 279393 0
University of Newcastle
Address [1] 279393 0
University Dr, Callaghan NSW 2308
Country [1] 279393 0
Australia
Other collaborator category [2] 279394 0
University
Name [2] 279394 0
University of New England
Address [2] 279394 0
Armidale NSW 2351
Country [2] 279394 0
Australia
Other collaborator category [3] 279395 0
Other Collaborative groups
Name [3] 279395 0
Hunter Medical Research Institute
Address [3] 279395 0
Locked Bag 1000. New Lambton, NSW, 2305
Country [3] 279395 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296667 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 296667 0
Ethics committee country [1] 296667 0
Australia
Date submitted for ethics approval [1] 296667 0
06/10/2016
Approval date [1] 296667 0
03/11/2016
Ethics approval number [1] 296667 0
16/10/19/5.09

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

Contacts
Principal investigator
Name 71694 0
Ms Michelle Giles
Address 71694 0
Hunter New England Nursing and Midwifery Research Centre
James Fletcher Campus
Gate Cottage
72 Watt St
Newcastle 2300
NSW
Country 71694 0
Australia
Phone 71694 0
+61249246702
Fax 71694 0
+61249246726
Email 71694 0
michelle.giles@hnehealth.nsw.gov.au
Contact person for public queries
Name 71695 0
Michelle Giles
Address 71695 0
Hunter New England Nursing and Midwifery Research Centre
James Fletcher Campus
Gate Cottage
72 Watt St
Newcastle 2300
NSW
Country 71695 0
Australia
Phone 71695 0
+61249246702
Fax 71695 0
+61249246726
Email 71695 0
michelle.giles@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 71696 0
Michelle Giles
Address 71696 0
Hunter New England Nursing and Midwifery Research Centre
James Fletcher Campus
Gate Cottage
72 Watt St
Newcastle 2300
NSW
Country 71696 0
Australia
Phone 71696 0
+61249246702
Fax 71696 0
+61249246726
Email 71696 0
michelle.giles@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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