Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001178538p
Ethics application status
Submitted, not yet approved
Date submitted
9/08/2024
Date registered
25/09/2024
Date last updated
25/09/2024
Date data sharing statement initially provided
25/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The IDC-IMPROVE Project: Addressing indwelling urinary catheter care in residential aged care
Scientific title
Addressing indwelling urinary catheter care in residential aged care homes: A clustered randomised control feasibility trial of a person-centred catheter care bundle
Secondary ID [1] 309679 0
MRFF Application ID: 2023825
Universal Trial Number (UTN)
Trial acronym
IDC-IMPROVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Indwelling urinary catheter 330044 0
Condition category
Condition code
Public Health 326948 326948 0 0
Health service research
Renal and Urogenital 330795 330795 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The IDC-IMPROVE Catheter Care Bundle:
The study will be conducted in 24 residential aged care homes (RACH) across three Australian states: Victoria, Queensland and South Australia. Residential aged care managers, registered nurses (RN), enrolled nurses (EN) and personal care workers (PCW) in the intervention group within each RACH will have access to a multicomponent intervention ("IDC-IMPROVE Catheter Care Bundle") for five months. The Bundle will be implemented in two consecutive phases: (1) education and (2) application to practice.

The Bundle intervention includes access to the following components:
a. The IDC-IMPROVE Catheter Care Course for Nurses:
This course is specifically designed for RNs & ENs working in RACHs. It consists of five modules and is available online. The content is designed to equip nurses with the knowledge and confidence to:
• Emotionally support a person living with an indwelling urinary catheter.
• Apply clinical decision making prior to urinary catheterisation.
• Understand and apply principles of insertion and/or removal of a urethral or suprapubic catheter.
• Know and implement evidence-based nursing interventions to promote physical and emotional wellbeing.
• Minimise and troubleshoot common issues related to urinary catheterisation.
The course will be self-paced and will take approximately 5-8 hours in total to complete. The content is interactive and includes a combination of text, short videos, voiceovers, quizzes, scenario-based reflective exercises, and links to further resources (e.g., catheter care guidelines, helplines, and discussion forums). It will be delivered online. Participants will access the course by entering a username and password on the NARI online learning management system. Participating nurses will be required to complete this online course within 8 weeks following baseline data collection. Once they have completed the online course, nurses are eligible to attend the catheterisation skills workshop. Adherence to the learning modules will be monitored via the online learning management system’s reporting and analytic features.

b. The Catheterisation Skills Workshop for Nurses:
The workshop has been designed by the Continence Foundation of Australia, a key partner in this Project. The workshop allows participants to practice the skill of indwelling catheterisation insertion on both male and female manikins as well as suprapubic catheterisation and to receive to feedback. Workshops will be conducted in-person to nurses (registered and enrolled) and delivered by facilitators employed by the Foundation. Facilitators are advanced practice nurses who have postgraduate expertise and/or advanced clinical skills in continence or urology nursing. There will be 4 participants per workshop, with 1 facilitator. Workshop facilitators will use a comprehensive checklist to ensure that all areas of the procedure are addressed and to rate learners’ performance. The skills workshop will take approximately 4-5 hours in total to complete and will be conducted either at the participating RACH, or if a suitable room is unavailable, at a nearby alternative venue suitable for those attending.

c. The IDC-IMPROVE Catheter Care Course for PCWs:
An online course designed to take account of PCWs’ role in RACHs. The content is designed to equip them with the knowledge and confidence to:
• Understand the lived experience of having an indwelling urinary catheter.
• Understand what person-centred catheter care is and why it is important.
• Support a person with a urinary catheter and their families.
• Understand the basics of the urinary system and urinary catheters.
• Understand their role in caring for the person with a urinary catheter.
• Apply principles of infection prevention and control to a person with a catheter.
• Deliver everyday care to a person with a urinary catheter, i.e. know how to empty the urine drainage bag, add or detach a night bag to a leg bag.
• Know when to seek help.
Participating PCWs at the intervention sites will complete their own IDC-IMPROVE Catheter Care Course that consists of three learning modules that have been designed to take account of their roles and responsibilities in RACHs. The learning material has been validated by expert nurses. We estimate it will take up to 1 hour to complete each module. The content is interactive and includes a combination of text, short videos, voiceovers, quizzes, scenario-based reflective exercises, and links to further resources (e.g., catheter care guidelines, helplines, and discussion forums). It will be delivered online. Participants will access the course by entering a username and password on the NARI online learning management system. Participating PCWs will be given 8 weeks to complete this course.

d. The IDC-IMPROVE Catheter Care Toolkit for Managers/Senior Leaders:
This Toolkit is a knowledge translation resource designed by the Project team to support RACH Managers and Senior Leaders to coordinate, supervise and manage catheter care in the workplace. It will be delivered online via a PDF document, available only to participants. Given the lack of evidence and guidance about IDC care, we anticipate RACH Managers and Senior Leaders require the information we have collated in order to influence the quality of catheter care. The toolkit provides information on the following topics:
• The risks associated with IDCs.
• Best practice recommendations for high quality person-centred catheter care.
• Aged Care Quality Standards related to catheter care.
• The IDC-IMPROVE Catheter Care Bundle.
• Staff capabilities required to deliver person-centred catheter care.
• Scope of practice as it applies to coordinating, supervising, managing catheter care in the workplace.
• Meeting the specific needs of a resident living with cognitive impairment and a catheter.
• Integrating person-centred catheter care into practice.
• Evaluating organisational alignment with best practice recommendations.

e. Application to Practice Support
The education phase of the Bundle implementation will be followed by phase two which involves supporting Managers/Senior Leaders and nurses to apply the Bundle to practice (‘Application to Practice phase’). As nurses and managers/senior leaders will be required to drive changes in ICS care in their aged care home, an IDC-IMPROVE Evidence-to-Practice Support Model has been designed to support them. The model is a coaching program designed to build Managers/Senior Leaders’ and nurses’ capacity to adopt and consistently use learnings from the Bundle in everyday practice. This is a formal short-term arrangement.

For nurses, the purpose of coaching is to reinforce what they have learnt in the IDC-IMPROVE Catheter Care Course and the Catheterisation Skills Workshop and to build their knowledge and confidence to deliver person-centred catheter care. For managers/senior Leaders, the purpose of coaching is to reinforce what they have learnt from the IDC-IMPROVE Catheter Care Toolkit for Managers/Senior Leaders, and to invite them to reflect on their current organisational policies and practice related to catheter care.

The coaching will be available for three months after nurses have completed the IDC-IMPROVE Catheter Care Course and the Catheterisation Skills Workshop. Each site will have access to up to 15 hours of coaching, which will be provided by Advanced Practice Nurses who have expertise in continence or urology nursing, practice development and education.

Coaching will be available on an individual basis and offered online and by phone, depending on the nurses’ and managers’/senior leaders’ individual preferences. The frequency will also be flexible and responsive to their preference. The duration of support on each occasion will also be flexible e.g. 10 min conversation on 1 day, 20 min on another. For nurses, the most appropriate form of communication will be established at the end of the Catheterisation Skills Workshop. For managers/senior Leaders, it will be established during site enrolment.

Coaching sessions will be voluntary. Discussion will centre on the following topics:
• Confidence in having achieved course learning outcomes:
• Alignment between course content and current policies/guidelines:
• Navigating potential misalignment between course content and current policies/guidelines:
• Possible gaps in knowledge/confidence:

Participants will also be encouraged to seek out suitable professional mentors in their organisation to support them in their ongoing professional development. The coaching will not extend to providing clinical advice about individual’s living in an aged care home. Rather nurses will be encouraged to refer to and use guidelines and resources such as clinical decision-support tools to increase their knowledge and confidence in troubleshooting. The National Continence Helpline will be promoted as a source of clinical information, and they will be advised to follow the usual care escalation policy within their organisation. The feasibility of the model will be evaluated through post intervention interviews with: (i) Advanced Practice Nurses, (ii) nurses, and (iii) participating managers/senior leaders.

Adherence:
Adherence to the intervention will be monitored by (i) online learning management system's reporting and analytics features; (ii) workshop attendance records; and (iii) completion of data collection at each time point. Intervention fidelity will be assessed through qualitative semi-structured interviews with participants, workshop facilitators, and experts delivering the online/phone support.
Intervention code [1] 326123 0
Prevention
Intervention code [2] 326127 0
Behaviour
Comparator / control treatment
The control group will be usual care during the 5-month intervention period. After data collection is complete at their site, they will be given access to all the resources except the Catheterisation Skills Workshops for nurses about catheter insertion and Application to practice supports. If they wish to complete the Workshop after the research has concluded, they will be referred to the Continence Foundation of Australia to discuss their individual needs.
Control group
Active

Outcomes
Primary outcome [1] 334793 0
The feasibility of implementing the intervention (IDC-IMPROVE Catheter Care Bundle) into Australian residential aged care homes. The following feasibility outcomes will be assessed as a composite primary outcome:
(i) The acceptability of the Bundle
(ii) The fidelity of the implementation
(iii) The compatibility of the Bundle with standard RACH IDC care
(iv) The effects of the Bundle
Timepoint [1] 334793 0
Feasibility outcomes will be assessed at the conclusion of the study (6 months)
Primary outcome [2] 338615 0
The acceptability of the Bundle intervention, assessed through a post-implementation qualitative interviews with Managers/Senior Leaders’, nurses’ and PCWs’. The interview will explore participants' experience and acceptability of the intervention, barriers and enablers to the adoption and sustained use of the intervention in residential aged care, and contextual factors that contribute to/impede the delivery of the intervention.
Timepoint [2] 338615 0
5 months after intervention commencement.
Primary outcome [3] 338617 0
Implementation fidelity, assessed through an analysis of recruitment and retention rates, participant adherence rates, adherence to the intervention, and qualitative interviews with Managers/Senior Leaders, nurses, and PCWs to explore their experiences of adhering to the research protocol and the implementation of the intervention.

Recruitment and retention rates will be calculated from an audit of study records, i.e. comparing participant enrolments with participant withdrawals and participants who are lost to follow up.

Adherence rates for each stage of the intervention will be calculated by monitoring participants’ engagement with the learning management system, workshop attendance records, and completion of outcome measures.

Qualitative data about adherence to the intervention will be collected via semi-structured interviews with participants and analysed through a process evaluation.
Timepoint [3] 338617 0
Recruitment rates will be calculated at baseline. Retention will be continually monitored by the research team to track trial progress. The final recruitment and retention rates will be calculated at the conclusion of the study.

Participant adherence rates will be monitored by the research team throughout the study (e.g. after the intervention is delivered to sites, after outcome measures are reported) to track trial progress and identify/troubleshoot potential problems with the implementation of the trial and/or the intervention. Final participant adherence rates will be calculated upon conclusion of the study.

Qualitative data on intervention adherence will be collected in semi-structured interviews conducted 5 months after intervention commencement.
Secondary outcome [1] 422109 0
The compatibility of the Bundle with current residential aged care catheter care practices, procedures and policies. This will be assessed through a pre- and post-intervention audit of each RACH IDC-related organisational policies and practices and post-intervention semi-structured interviews with Managers/Senior Leaders about their organisational IDC policies and practices.
Timepoint [1] 422109 0
Audit: Baseline and 5 months after intervention commencement.

Interview: 5 months after intervention commencement.
Secondary outcome [2] 422112 0
Pilot data on the effects of the Bundle on rates of IDC-related complications, assessed through a pre- and post-retrospective review of medical records of residents with an IDC.
Timepoint [2] 422112 0
Baseline and 5 months after intervention commencement.
Secondary outcome [3] 422113 0
Pilot data on the effects of the Bundle on nurses’ confidence to provide IDC care, assessed through the confidence component of the ‘Nurses’ Catheter Care Knowledge and Confidence Scale’ (KCS-Nurse), a study-specific survey of nurses’ knowledge and confidence.
Timepoint [3] 422113 0
Baseline, immediately after course completion at 2 months, and 5 months after intervention commencement.
Secondary outcome [4] 440085 0
Pilot data on the effects of the Bundle on nurses’ knowledge about IDC care, assessed through the knowledge component of ‘Nurses’ Catheter Care Knowledge and Confidence Scale’ (KCS-Nurse), a study-specific survey of nurses’ knowledge and confidence.
Timepoint [4] 440085 0
Baseline, immediately after course completion at 2 months, and 5 months after intervention commencement.

Eligibility
Key inclusion criteria
Residential aged care homes (RACH): RACHs must be approved aged care providers and have a site located in either Victoria, South Australia or Queensland; a minimum of 4 nurses (RNs and/or ENs) at the study site available for the 6 months of the intervention and data collection periods; one or more residents with an IDC at the time of enrolment in the study.

Managers/Senior Leaders: employed in a RACH that has enrolled in the study and have responsibilities in managing or coordinating the overall quality of care (e.g. infection control, staff development).

Nurses (ENs and RNs): employed in a RACH that has enrolled in the study; registered to practice in Australia as an EN or RN with the Nursing and Midwifery Board of Australia; are planning to be employed at the site for duration of the study intervention.

Personal care workers: employed in a RACH that has enrolled in the study.

Aged care residents with IDCs: all permanent residents with IDCs who reside in a participating RACH.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
RACH: they are located outside Victoria, South Australia and Queensland; are for sale (the potential individual site); have not had a resident with an IDC in prior 3 months; have fewer than 4 nurses in total (ENs and RNs) employed on the site.

Managers/Senior Leaders: they anticipate leaving the RACH study site within the 5 months intervention period

Nurses (ENs and RNs): they anticipate leaving the RACH study site within the 5 month intervention period or they cannot commit to completing the online IDC-IMPROVE Catheter Care Course and the Catheterisation Skills Workshops (intervention clusters only).

Personal care workers: they anticipate leaving the RACH study site within the 5 month intervention period or they cannot commit to completing the online IDC-IMPROVE Catheter Care Course (intervention clusters only)

Aged care residents with IDCs: have a mental illness, cognitive impairment or intellectual disability that affects their ability to provide consent or they do not have proxy consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The research team will not be aware of randomised allocation when determining if residential aged care homes are eligible for inclusion in the trial. Randomisation of homes will occur following completion of residential aged care home baseline.

The randomisation sequence will be concealed from the research team. Identifying site details will be concealed from the statistician performing randomisation. It is not possible to conceal allocation from sites or the study team due to the nature of the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using blocks of 4, stratifying by three site sizes, based on the Australian Institute of Health and Welfare (AIHW) categories: small (60 or less residents), medium (61-100 residents), and large (101 or more residents) homes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A minimum sample size of 24 clusters (12 per arm), with 4 registered nurses per cluster (48 per arm) has been selected for this pilot trial. This is based on what is logistically possible for the organisation that is responsible for delivering the site-based skills training is able to deliver, given the trial timeline and budget constraints. The selected sample size is enough to detect a mean difference of 0.65 (ICC = 0.05, sigma = 1, alpha = 0.05, power = 0.8). Power calculations were obtained in the statistical software R using the CRTSize package. We recognise this will be insufficiently powered to determine the effectiveness of this intervention. However, this sample is sufficient to provide a good understanding of the feasibility of conducting a similarly designed study as a definitive RCT.

An estimation of the intracluster correlation coefficient (ICC) and approximate sample size of a definitive cluster RCT will be assessed through data collection and synthesis. The 'Nurses' Catheter Care Knowledge and Confidence Scale' (KCS-Nurse) scores from the trial data will be loaded as a data frame into the statistical software R. The ‘psyche’ package will be used to calculate the KSC-Nurse ICC.

To measure the construct and internal validity of the KCS-Nurse, outcomes from the KCS-Nurses will be correlated with the Nurse Professional Competence (NPS) Scale Short Form (NPC Scale-SF). The NCP Scale-SF contains 35-items that measure nurses’ self-reported competences in 6 key domains: (i) nursing care, (ii) value-based nursing care, (iii) medical and technical care, care, (iv) pedagogics, (iv) documentation and administration of nursing care and (v) development, leadership and (vi) organisation of nursing care. All factors show Cronbach's alpha values of>0.70. The confirmative factor analysis goodness-of-fit indexes were for root mean square error of approximation 0.05 and for comparative fit index 0.89 (25). Use of the NPC Scale-SF will enable examination of the relationship between nurses’ self-report competence and the findings from the KCS-Nurse. A sample size of 30 nurses from intervention and control groups who complete the KCS-Nurse at T1 will be invited to additionally complete the NPC Scale-SF.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC

Funding & Sponsors
Funding source category [1] 313871 0
Government body
Name [1] 313871 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 313871 0
Australia
Primary sponsor type
Other
Name
National Ageing Research Institute
Address
Country
Australia
Secondary sponsor category [1] 315714 0
None
Name [1] 315714 0
Address [1] 315714 0
Country [1] 315714 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 313020 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 313020 0
Ethics committee country [1] 313020 0
Australia
Date submitted for ethics approval [1] 313020 0
29/07/2024
Approval date [1] 313020 0
Ethics approval number [1] 313020 0

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

Contacts
Principal investigator
Name 126706 0
Prof Joan Ostaszkiewicz
Address 126706 0
National Ageing Research Institute, 34-54 Poplar Road, Gate 4, Building 8, Parkville, VIC, 3052
Country 126706 0
Australia
Phone 126706 0
+61 414 975 440
Fax 126706 0
Email 126706 0
[email protected]
Contact person for public queries
Name 126707 0
Caitlin Tay
Address 126707 0
National Ageing Research Institute, 34-54 Poplar Road, Gate 4, Building 8, Parkville, VIC, 3052
Country 126707 0
Australia
Phone 126707 0
+61 414 975 440
Fax 126707 0
Email 126707 0
[email protected]
Contact person for scientific queries
Name 126708 0
Joan Ostaszkiewicz
Address 126708 0
National Ageing Research Institute, 34-54 Poplar Road, Gate 4, Building 8, Parkville, VIC, 3052
Country 126708 0
Australia
Phone 126708 0
+61 414 975 440
Fax 126708 0
Email 126708 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


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.