Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000683831
Ethics application status
Approved
Date submitted
22/02/2021
Date registered
4/06/2021
Date last updated
23/08/2024
Date data sharing statement initially provided
4/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Exploring the educational, self-monitoring and self-management needs of community dwelling patients living with indwelling urinary catheters: a mixed methods study
Scientific title
Investigating the effect of a bundle of care intervention on community dwelling patients' ability to self-manage their indwelling urinary catheters at home
Secondary ID [1] 303456 0
none
Universal Trial Number (UTN)
Trial acronym
The IQ IDC Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long-term indwelling urinary catheter
 320764 0
Urinary catheter blockage 320839 0
Urinary tract infection 321326 0
Urine leakage 321327 0
Catheter dislodgement or accidental removal of the catheter
 321328 0
Bladder spasms, pain/discomfort
 321329 0
Urethral trauma or rupture, bladder perforation, stricture formation, development of false passage and incidence of para-phimosis
 321330 0
Urethral erosion and hypergranulation tissue around supra pubic catheter site
 321331 0
Condition category
Condition code
Renal and Urogenital 318593 318593 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patient Group
Patients who meet the criteria will be delivered a bundle of care interventions focused on patients and caregivers designed from the findings of explorative data collected from patient interviews/surveys and the scoping review to optimise self-management of patients with a urinary catheter. These interventions will be underpinned by a pedagogical approach to increase self-efficacy to improve self-management practices, whereby education is one component. Principles of the appreciative inquiry model will be used to partner with patients in supporting change in self-management practices focusing on patient empowerment to maximise adherence to best catheter self-management practices. The utilisation of digital technologies such as email and SMS information sharing and reminders will also be used in this phase to deliver the newly designed bundle of care interventions using ‘Goshare Healthcare’, with resources and functionalities tailored to the needs of these patients.

During these six months, patients who are participating will receive the following bundle of care interventions:

- The nurse/research team member will provide a 15-20 minutes face to face catheter self-management instructions to patients/carers during their 4-6 weekly routine catheter change appointments

- The nurse/research team member will explain and demonstrate to patients regarding how
the Goshare platform works and the benefits of using this platform to access information at
their convenience as needed.

- The nurse will send the relevant information from the care bundle to patient/carer
electronically using Goshare digital platform based on their needs. This will help the
participant to self-administer the remaining components of catheter self-managment by
accessing these information on their personal devices.

- Using Goshare, nurses will share information such as patient information sheets/booklets,
patient stories, links to credible websites, and the prevention and management strategies for
the typical catheter-related problems and how to get further help if required.

- Using Goshare, patients will be able to provide their feedback on each content delivered to
them and receive further clarification from the research team.

- By accessing the Goshare application/web-portal analytics, nurses and research team will
monitor the usage of the information sent out, such as how many patients accessed the
information and how often they opened each resource. Based on this information, nurses
will be able to send reminders to patients to improve patient outcome

- Other interventions such as a catheter passport (A booklet containing individualised
catheter self-management instructions for each patient) and a facilitated group session for
catheter users organised by the research team will be considered based on the exploratory
data findings.

Nurse group
Nurse participants will receive the training 8 weeks prior to patient interventions and the training will help the nurses to upskill their knowledge and deliver interventions to patients.

Nurse participants will be provided a bundle of care intervention underpinned by the evidence-based pedagogy using learning encounters known as ‘spaced learning’ characterised by ‘repeated learning over time’ (spaced educational pedagogy). Case-based catheter-related scenarios will be developed as part of the care bundle by clinical and academic experts and will be delivered online using Qstream™. This clinical platform ‘pushes’ clinical questions to participants' email and takes less than 10 minutes to answer, with immediate feedback to responses. This mode of delivery has been shown to boost knowledge retention and at the same time, positively influence entrenched clinical practices.

The research team will provide a 20 minute face-to-face or zoom information session to participating nurses to explain the Qstream modules. Six to eight case scenarios with multiple-choice questions will be developed based on the following key areas;
- Anatomy and Physiology
- Indication for urinary catheter insertion
- Common catheter-associated complications and management
- Methods for avoiding catheter-associated urinary tract infections
- Plan for early removal of IDC and clear documentation
- Patient Education
Six to eight case scenario questions will be delivered to participants over the course of six weeks, using a standardised QStream algorithm of two questions per delivery, delivered every 2 days. Incorrectly answered questions are repeated after 7 days, while those correctly answered are repeated after 13 days. Retirement of questions occur when there are two consecutive correct answers and a maximum of 3 attempts are given before a question is retired permanently. It is estimated that 10 minutes is required to answer the questions and read supplementary information.

While the delivery of QStream questions are delivered using a spaced algorithm, it is received by the participant by push notification of which they have the option to access in their own time. The two-day period in which the next set of questions is delivered will occur once the participant engages and answers the question. The pattern of delivery will therefore be be individualised due to each participant's learning process. There will be instances where participants can finish earlier than the 6 weeks.

Upon answering the questions participants will be provided with answers including detail information regarding the topic, references, further readings, and resources. The spaced and repetition of question delivery is aimed to reinforce learning and knowledge retention. By accessing the application/web-portal analytics, the research team can monitor the usage and the performance level of nurses and promote adherence to the interventions by sending reminders.

The nurses receiving a bundle of interventions will be upskilled to provide safe, effective catheter self-management strategies to patients living with IDCs and thus, contribute to minimising catheter-associated complications.

Nurses provided with the intervention bundle of care will be the same nurses delivering the intervention to patient participants. Nurses participating in the intervention will be delivering the following information to support patients’ self-management and improve their quality of life:

- Explain how the catheter works (addressing the information needs of patients), discuss
choices of catheters, and drainage system suitable for the patient to adjust their life with
the catheter
- Address the importance of self-monitoring and self-management in specific aspects, such as
fluid management, constipation management, hygiene, and securement of the catheter,
and its significance in minimising catheter-related problems.
- Demonstrate how to access information via Goshare and share individualised bundle of
interventions based on patients’ needs

Information materials that will be used in the intervention will be designed specifically for this study from the findings of explorative data and the scoping review except the standard catheter care booklet used in the health district named "Caring for your urinary catheter at home, information for clients and cares".
Intervention code [1] 319748 0
Behaviour
Intervention code [2] 319802 0
Prevention
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326570 0
Patients:
Primary outcome for patients will be measured by change in patients’ catheter self-management as indicated by the C-SMG scale
Timepoint [1] 326570 0
Baseline and 6 month post-intervention
Secondary outcome [1] 391926 0
Patients:
Change in patients’ self-efficacy, including help-seeking behaviour in catheter care will be assessed by using Urinary Catheter Self-Efficacy Scale (C-SE)
Timepoint [1] 391926 0
Time points will be:
baseline and 6 months post-intervention
Secondary outcome [2] 394575 0
Nurses:
Changes in knowledge and skills of nurses in providing catheter care to patients. This will be assessed by using 'questionnaire for staff' developed by Oswald (2020)
Timepoint [2] 394575 0
Before completion of Qstream modules, after completion of Qstream modules and 6 months post-intervention
Secondary outcome [3] 394842 0
Patients:
Changes in patient's number of hospital presentations with catheter associated complications by extracting demographic and clinical data from the electronic medical records, and auditing patient’s electronic medical records.
Timepoint [3] 394842 0
Base line, 6 months and 12 months post intervention

Eligibility
Key inclusion criteria
Patients
Adult patients (18 years and over)
• Patients living in the community with indwelling urinary catheters
• Patients attending one of the five Community health centres (CHC) in Western Sydney Local Health District (WSLHD) or Hospital in the Home (HITH) within WSLHD

Nurses
• Nurses working in Community Health Centres across the Western local Health District or Blacktown Hospital or the Hospital In the Home (HITH) service
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients
• Patients with cognitive impairment (Identified through documentation, e.g. dementia)
• Patients using intermittent, self-catheterisation
• Paediatric patients (Under 18 years)

Nurses
• Nurses aged under 18 years old

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



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome measure is the improvement in patients’ self-management, as indicated by the C-SMG scale.

Secondary outcomes are improvement in patients’ self-efficacy, improvement in nurses’ knowledge, attitude and practices in catheter care, and a reduction in ED presentations for catheter-related complications.

These outcome measures will be analysed using descriptive and inferential statistics. Pre- and post-patient survey data collected at baseline and six months post intervention will be analysed using a thematic analysis procedure in NVivo™. Based on previous findings, to detect a significant change in self-management practices from baseline to the 6-month follow-up, a total combined target number of 260 participants including both patients and nurses are needed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/12/2022
Actual
28/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
253
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18775 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 19030 0
Mt Druitt Community Health Centre - Mount Druitt
Recruitment hospital [3] 19031 0
Blacktown Community Health Centre - Blacktown
Recruitment hospital [4] 19032 0
Auburn Community Health Centre - Auburn
Recruitment hospital [5] 19033 0
Parramatta Community Health Centre - Parramatta
Recruitment hospital [6] 19034 0
The Hills Community Health Centre - Castle Hill
Recruitment postcode(s) [1] 33221 0
2148 - Blacktown
Recruitment postcode(s) [2] 33577 0
2770 - Mount Druitt
Recruitment postcode(s) [3] 33578 0
2141 - Auburn
Recruitment postcode(s) [4] 33579 0
2150 - Parramatta
Recruitment postcode(s) [5] 33580 0
2154 - Castle Hill

Funding & Sponsors
Funding source category [1] 307874 0
Government body
Name [1] 307874 0
Research and Education Network, Western Sydney Local Health District.
Country [1] 307874 0
Australia
Funding source category [2] 307937 0
Government body
Name [2] 307937 0
Integrated and Community Health Research Launchpad Grant, Western Sydney Local Health District,
Country [2] 307937 0
Australia
Funding source category [3] 307938 0
Charities/Societies/Foundations
Name [3] 307938 0
Westmead Hospital Charitable Trust
Country [3] 307938 0
Australia
Primary sponsor type
Government body
Name
Integrated and Community Health, Western Sydney Local Health District,
Address
Integrated and Community Health Directorate, Western Sydney Local Health District
PO Box 792
Seven Hills
NSW 2147
Country
Australia
Secondary sponsor category [1] 308605 0
Hospital
Name [1] 308605 0
Western Sydney Nursing and Midwifery Research Centre
Address [1] 308605 0
Western Sydney Nursing and Midwifery Research Centre,
Blacktown Hospital Campus
Marcel Cres, Blacktown NSW 2148
Country [1] 308605 0
Australia
Secondary sponsor category [2] 308657 0
University
Name [2] 308657 0
Western Sydney University
Address [2] 308657 0
Western Sydney University
Locked Bag 1797
Penrith NSW 2751
Country [2] 308657 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307875 0
Western Sydney Local Health District
Ethics committee address [1] 307875 0
Ethics committee country [1] 307875 0
Australia
Date submitted for ethics approval [1] 307875 0
29/05/2020
Approval date [1] 307875 0
12/11/2020
Ethics approval number [1] 307875 0
Ethics Ref: 2019/ETH12575, Research Office File No: (6175), Governance Ref: 2019/STE16065 and 2019/STE16064

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

Contacts
Principal investigator
Name 108778 0
Mr Joby Alex
Address 108778 0
Western Sydney LHD - Mount Druitt Community Health Centre
Cnr Buran and Kelly Close
Mount Druitt NSW 2770
Country 108778 0
Australia
Phone 108778 0
+61 0405509197
Fax 108778 0
Email 108778 0
[email protected]
Contact person for public queries
Name 108779 0
Joby Alex
Address 108779 0
Western Sydney LHD - Mount Druitt Community Health Centre
Cnr Buran and Kelly Close
Mount Druitt NSW 2770
Country 108779 0
Australia
Phone 108779 0
+61 0405509197
Fax 108779 0
Email 108779 0
[email protected]
Contact person for scientific queries
Name 108780 0
Caleb Ferguson
Address 108780 0
Senior Research Fellow
Heart Foundation Postdoctoral Fellow
NHMRC Emerging Leadership Fellow
Western Sydney Nursing and Midwifery Research Centre, WSU/WSLHD
Blacktown Clinical & Research School, Blacktown Hospital
18 Blacktown Rd, Blacktown NSW 2148
Country 108780 0
Australia
Phone 108780 0
+61 0410207543
Fax 108780 0
Email 108780 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Primary and secondary outcome data
When will data be available (start and end dates)?
Available from completion of trial with no end date determined
Available to whom?
At the discretion of the Principal Investigator
Available for what types of analyses?
At the discretion of the Principal Investigator
How or where can data be obtained?
Access subject to approval by Principal Investigator (email: [email protected]), followed by a request to, and approval by, Ethics Review Committee.


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.