Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000883819
Ethics application status
Approved
Date submitted
30/09/2020
Date registered
8/07/2021
Date last updated
23/02/2024
Date data sharing statement initially provided
8/07/2021
Date results information initially provided
27/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementation of an intervention for the assessment, diagnosis, and management of urinary incontinence and lower urinary tract symptoms on wards that admit adult patients.
Scientific title
Implementation of an evidence-informed intervention for the assessment, diagnosis, and management of urinary incontinence and lower urinary tract symptoms on acute and rehabilitation wards that admit adult patients.
Secondary ID [1] 302436 0
Nil known
Universal Trial Number (UTN)
U1111-1258-8756
Trial acronym
I-SCAMP
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Urinary incontinence 319248 0
Lower urinary tract symptoms 319249 0
Condition category
Condition code
Stroke 317218 317218 0 0
Haemorrhagic
Stroke 317219 317219 0 0
Ischaemic
Physical Medicine / Rehabilitation 317221 317221 0 0
Other physical medicine / rehabilitation
Renal and Urogenital 320323 320323 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our practice-change package is designed to support clinicians and health services to deliver guideline-recommended UI and LUTS care. It consists of our 3-part SCAMP intervention that we developed as part of a stroke rehabilitation quality improvement project in 2009-10, and revised in 2018 with experts from stroke, continence, rehabilitation and urology to ensure they met current best-evidence UI and LUTS care for the majority of adult inpatient populations. It will be implemented using evidence-based implementation strategies.
SCAMP Intervention
a. the 4-page Structured Urinary Continence Assessment and Management Plan decision support tool
b. the associated Clinical Practice Guideline
c. Eight online education modules (content covers normal bladder function, why continence is an issue after stroke, and six common inpatient UI and LUTS types, hosted on https://informme.org.au/learning-modules/Continence%20Modules ) and a local module (PowerPoint slides with voice over) on how to use the SCAMP decision support tool.

The frequency and duration of these modules was not prescribed. it depended on the local site plan and based on local ward processes for clinician education. Attendance numbers at face-to-face sessions was recorded.

Implementation strategies
-Build a coalition: A coalition has been built that includes 15 wards across 12 hospitals, peak government and non-government bodies, and multiple universities.
-Work with educational institutions: Coalition members include institutions that provide tertiary and/or professional development education to the target groups.
-Develop academic partnerships, use data experts: Coalition members include academics from multiple institutions with expertise in implementation science, statistics, health economics, and data management.
- Centralise technical assistance- Sites will be supported by a centralised research team who will provide the evidence-based intervention (SCAMP); develop implementation resources in consultation with the team (including education materials, Implementation Training Workshops for site leaders); and evaluation resources (data collection tools, data storage, data analysis, reporting.
-Access new funding: Sites will be supported to conduct the audits with small grants secured by the research team.
-Identify and prepare champions- Each site will have a local project lead and site champions who will drive the project locally. Leads will be senior clinicians, managers or educators who have influence over local practice and will identify local champions.
-Recruit, designate, and train for leadership: at least one leaders/ champion from each site will attend two one-day training workshops which will include: an overview what is implementation research, strategies for implementing and sustaining evidence based practice, overcoming barriers, generating sponsorship, communication, and using mixed methods for evaluation. The first workshop will be held in the month following the pre-implementation data collection period. The second workshop will be held in the first month of the implementation period.
-Create a learning collaborative: A learning collaborative will be developed where sites learn from and share with each other to improve implementation.
-Develop resource sharing agreements: Sites will share any implementation resources they develop with other members of the collaborative. This will be facilitated by a shared cloud based repository.
-Organise clinician implementation team meetings, provide ongoing consultation: Project team members from each site will meet at two implementation workshops plus monthly teleconferences for education, consultation, and collaboration.
-Identify barriers and facilitators: Local sites will use the Behaviour Identification and Mitigation tool to develop a local implementation plan.
-Tailor strategies ,promote adaptability to meet local needs: Local implementation plans will tailor the implementation strategy and adapt the intervention to suit local needs.
-Distribute educational materials: Local sites will facilitate staff undertaking the education modules that inform the SCAMP decision support tool.
-Conduct educational meetings- Site leads/ champions will conduct local education meetings to educate staff.
-Change record systems: The SCAMP decision support tool will be implemented at all sites. Paper or electronic versions will be used based on local needs.
-Audit and provide feedback: audit data will discussed at project team meetings and fed back to each site (localised presentation) to be disseminated using local processes.
-Remind clinicians: A poster display of different continence types and possible management solutions will be made available to all sites. Reminders will also include at safety huddles, local posters, spot audits to identify areas for improvement then clinicians reminded by lead/ champion

Process evaluation
Measures will be collected to assess the process and fidelity of the implementation of the intervention. Spot check audits will be conducted to identify any issues with completing the SCAMP decision support tool. We will also record: attendance for ward education sessions and the project team implementation workshops (2 one-day workshops with a least one representative from each ward); the monthly project team meetings; the number and availability of identified champions throughout; the number and types of resources generated and reminder activities conducted; the number of audit and feedback sessions conducted; and any local changes made to the SCAMP intervention.
The selection of implementation strategies at each site will be based on local barrier assessment.
The implementation period will be 6 months in duration.
Intervention code [1] 318721 0
Diagnosis / Prognosis
Intervention code [2] 318722 0
Early detection / Screening
Intervention code [3] 318723 0
Treatment: Other
Comparator / control treatment
Before commencing the study, the investigators from each ward nominated the target adult inpatient population(s) from their ward to be included in the study acute stroke, acute medicine, and/ or rehabilitation for any condition, including stroke.
Medical records of adults aged 18 years old and over, with the ward-nominated condition(s) who are discharged from each participating ward will be included. To reduce selection bias, we will include consecutive records of patients discharged from each ward, for each month of the three month data collection period.
Pre-implementation data was collected from each ward from August to November 2018.
Post- implementation data was collected for the 3 subsequent months after the 6-month implementation period.
Maintenance data- will be collected 6 months after the end of the 6 month implementation period (for 3 months).
Control group
Historical

Outcomes
Primary outcome [1] 325287 0
The change in the proportion of inpatients with UI/ LUTS who have an individually-tailored urinary incontinence (UI)/ lower urinary tract symptom (LUTS) management plan, determined via medical record audit..
Timepoint [1] 325287 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [1] 387407 0
The change in proportion of inpatients with UI/ LUTS who have an assessment of UI/ LUTS, determined via medical record audit.,
Timepoint [1] 387407 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [2] 387408 0
The change in proportion of inpatients with UI/ LUTS who have a diagnosis of type(s) of UI/ LUTS, determined via medical record audit.,
Timepoint [2] 387408 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [3] 387409 0
The change in proportion of inpatients with UI/ LUTS, and their carers, who are involved in the development of the management plan, determined via medical record audit.
Timepoint [3] 387409 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [4] 387410 0
The change in in-hospital complication rates associated with UI/ LUTS or urinary catheterisation, determined via medical record audit.
Timepoint [4] 387410 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [5] 390461 0
The change in the proportion of clinicians who rate their knowledge in in assessing UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [5] 390461 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [6] 390462 0
The change in the proportion of clinicians who rate their knowledge in diagnosing UI/ LUTS type(s) as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [6] 390462 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [7] 390463 0
The change in the proportion of clinicians who rate their knowledge in managing UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [7] 390463 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [8] 390464 0
The change in the proportion of clinicians who rate their skills in assessing UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [8] 390464 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [9] 390465 0
The change in the proportion of clinicians who rate their skills in diagnosing UI/ LUTS type(s) as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [9] 390465 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [10] 390466 0
The change in the proportion of clinicians who rate their skills in managing UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [10] 390466 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [11] 390467 0
The change in the proportion of clinicians who rate their confidence in assessing UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [11] 390467 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [12] 390468 0
The change in the proportion of clinicians who rate their confidence in identifying diagnosing UI/ LUTS type(s) as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [12] 390468 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [13] 390469 0
The change in the proportion of clinicians who rate their confidence in managing UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [13] 390469 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [14] 390470 0
The change in the proportion of clinicians who rate their knowledge in identifying the types of UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [14] 390470 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [15] 390471 0
The change in the proportion of clinicians who rate their skills in identifying the types of UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire
Timepoint [15] 390471 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [16] 390472 0
The change in the proportion of clinicians who rate their confidence in identifying the types of UI/ LUTS as good or very good, as determined by the study-specific clinician questionnaire,
Timepoint [16] 390472 0
Before (T0) to 6 months after (T1) implementation of the intervention.
Secondary outcome [17] 390473 0
The change in the proportion of inpatients with UI/ LUTS who have an individually-tailored urinary incontinence (UI)/ lower urinary tract symptom (LUTS) management plan, determined via medical record audit..
Timepoint [17] 390473 0
From before implementation (T0) to after the sustainability period (T2), approximately 12 months post-implementation, and after implementation of the intervention (T1) to the end of the 6 months sustainability period (T2),
Secondary outcome [18] 390474 0
The change in proportion of inpatients with UI/ LUTS who have an assessment of UI/ LUTS, determined via medical record audit.,
Timepoint [18] 390474 0
From before implementation (T0) to after the sustainability period (T2), approximately 12 months post-implementation, and after implementation of the intervention (T1) to the end of the 6 months sustainability period (T2),
Secondary outcome [19] 396227 0
The change in proportion of inpatients with UI/ LUTS who have a diagnosis of type(s) of UI/ LUTS, determined via medical record audit.,
Timepoint [19] 396227 0
From before implementation (T0) to after the sustainability period (T2), approximately 12 months post-implementation, and after implementation of the intervention (T1) to the end of the 6 months sustainability period (T2),
Secondary outcome [20] 396228 0
The change in in-hospital complication rates associated with UI/ LUTS or urinary catheterisation, determined via medical record audit.
Timepoint [20] 396228 0
From before implementation (T0) to after the sustainability period (T2), approximately 12 months post-implementation, and after implementation of the intervention (T1) to the end of the 6 months sustainability period (T2),
Secondary outcome [21] 396239 0
Does implementation of our SCAMP intervention reduce in-hospital complications rates associated with UI/ LUTS or urinary catheterisation, determined by a cost -consequence analysis. We will obtain data on the costs of implementing the package (including staff training), the direct health costs attributable to eligible patients across each study time period for the management of UI/ LUTS and report any potential cost offsets related to the practice-change package. Costs will be valued based on the reference year 2019. Data sources will include: screening log and patient-level data from the medical record audits, hospital finance department data, research literature, expert opinion, and project management or administrative data.
Timepoint [21] 396239 0
Before (T0) to 6 months after (T1) implementation of the intervention.

Eligibility
Key inclusion criteria
Clinical practice change- Medical records of adults aged >= 18 years old, who are discharged from each participating ward will be included.
Implementation intervention- The population targeted by our practice-change package is clinicians (full time, part time, and casual) employed in each participating ward (including nurses, Nurse Unit Managers, physiotherapists, occupational therapists, speech pathologists, social workers and doctors). Participating clinicians are general medical, rehabilitation or neuroscience clinicians who are not identified as continence or urology specialists.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria

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



Intervention assignment
Other
Other design features
Before and after study.
Patients admitted before implementation would have received usual care.
Patients admitted after implementation has begun should receive the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome, 15 consecutive medical record audits per site per month (i.e. pooled sample of 675 audits anticipated per data collection period) will provide >90% power to detect a 10% absolute increase (from before-intervention) in the proportion of incontinent patients with a continence management plan (type 1 error rate of 5%). This calculation conservatively assumes 20% of patients in acute and 50% in rehabilitation sites have a plan before-intervention, based on Australian Stroke Foundation national audit results for included sites.
The Before-Intervention Group, After-Intervention Group and Maintenance Period Group results will be presented with descriptive statistics including site, clinician and medical record data for characteristics and demographics. No individual will be identifiable. All results will be presented as aggregates. Groups will be compared with respect to change, from baseline (T0) to immediately post-intervention period (T1) and from baseline to maintenance period (T2) using mixed effects logistic regression models, with a random intercept for site, and fixed effect for period. Results presented as odds ratios with 95% confidence intervals and p-values.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
14/12/2018
Date of last participant enrolment
Anticipated
24/12/2021
Actual
19/04/2019
Date of last data collection
Anticipated
29/04/2022
Actual
21/12/2021
Sample size
Target
2025
Accrual to date
Final
2792
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 17712 0
Armidale Rural Referral Hospital - Armidale
Recruitment hospital [2] 17713 0
Belmont Hospital - Belmont
Recruitment hospital [3] 17714 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [4] 17715 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [5] 17716 0
John Hunter Hospital - New Lambton
Recruitment hospital [6] 17717 0
Manning Rural Referral Hospital (Taree) - Taree
Recruitment hospital [7] 17718 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [8] 17719 0
Ryde Hospital - Eastwood
Recruitment hospital [9] 17720 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [10] 17721 0
Wingham Community Hospital - Wingham
Recruitment hospital [11] 17722 0
Wauchope District Memorial Hospital - Wauchope
Recruitment hospital [12] 17723 0
Rockhampton Base Hospital - Rockhampton
Recruitment postcode(s) [1] 31574 0
2122 - Eastwood
Recruitment postcode(s) [2] 31568 0
2280 - Belmont
Recruitment postcode(s) [3] 31569 0
2298 - Waratah
Recruitment postcode(s) [4] 31571 0
2305 - New Lambton
Recruitment postcode(s) [5] 31575 0
2340 - Tamworth
Recruitment postcode(s) [6] 31567 0
2350 - Armidale
Recruitment postcode(s) [7] 31576 0
2429 - Wingham
Recruitment postcode(s) [8] 31572 0
2430 - Taree
Recruitment postcode(s) [9] 31573 0
2444 - Port Macquarie
Recruitment postcode(s) [10] 31577 0
2446 - Wauchope
Recruitment postcode(s) [11] 31570 0
2450 - Coffs Harbour
Recruitment postcode(s) [12] 31578 0
4700 - Rockhampton

Funding & Sponsors
Funding source category [1] 306860 0
Government body
Name [1] 306860 0
Hunter New England Local Health District
Country [1] 306860 0
Australia
Funding source category [2] 306866 0
Government body
Name [2] 306866 0
New South Wales Agency for Clinical Innovation
Country [2] 306866 0
Australia
Funding source category [3] 306867 0
Government body
Name [3] 306867 0
New South Wales Ministry of Health
Country [3] 306867 0
Australia
Funding source category [4] 306868 0
University
Name [4] 306868 0
University of Newcastle
Country [4] 306868 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Local Health District
Address
Lookout Road,
New Lambton Heights. NSW. 2305
Country
Australia
Secondary sponsor category [1] 307425 0
None
Name [1] 307425 0
Address [1] 307425 0
Country [1] 307425 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307018 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 307018 0
Research Office, Hunter New England Local Health District, Level 3, POD, HMRI, Lot 1 Kookaburra Circuit, New Lambton Heights NSW 2305
Ethics committee country [1] 307018 0
Australia
Date submitted for ethics approval [1] 307018 0
27/09/2018
Approval date [1] 307018 0
29/10/2018
Ethics approval number [1] 307018 0
18/10/17/4.02
Ethics committee name [2] 307026 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 307026 0
University Drive
Callaghan NSW 2308
Ethics committee country [2] 307026 0
Australia
Date submitted for ethics approval [2] 307026 0
Approval date [2] 307026 0
28/02/2020
Ethics approval number [2] 307026 0
H-2020-0083

Summary
Brief summary
We aim to determine if our UI/ LUTS practice-change package is feasible and effective for delivering optimal UI/ LUTS care in the inpatient setting. Our package includes an intervention (SCAMP) synthesized from the best-available evidence on UI/ LUTS care, and a theoretically-informed implementation strategy targeting identified barriers and enablers. The package is targeted at clinicians working on the participating wards.

Trial website
NA
Trial related presentations / publications

Public notes

Contacts
Principal investigator
Name 105754 0
Dr Di Marsden
Address 105754 0
Hunter Stroke Service
Hunter New England Local Health District
Level 2, The Lodge,
Lookout Rd,
New Lambton Heights. NSW. 2305.
Country 105754 0
Australia
Phone 105754 0
+61 2 49223380
Fax 105754 0
Email 105754 0
Di.Marsden@health.nsw.gov.au
Contact person for public queries
Name 105755 0
Dr Di Marsden
Address 105755 0
Hunter Stroke Service
Hunter New England Local Health District
Level 2, The Lodge,
Lookout Rd,
New Lambton Heights. NSW. 2305
Country 105755 0
Australia
Phone 105755 0
+61 2 49223380
Fax 105755 0
Email 105755 0
Di.Marsden@health.nsw.gov.au
Contact person for scientific queries
Name 105756 0
Dr Di Marsden
Address 105756 0
Hunter Stroke Service
Hunter New England Local Health District
Level 2, The Lodge,
Lookout Rd,
New Lambton Heights. NSW. 2305
Country 105756 0
Australia
Phone 105756 0
+61 2 49223380
Fax 105756 0
Email 105756 0
Di.Marsden@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The medical record audits have been undertaken using data routinely collected in hospital. Patients have not given consent for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9338Study protocolMarsden DL, Boyle K, Jordan LA, Dunne JA, Shipp J, Minett F, Styles A, Birnie J, Ormond S, Parrey K, Buzio A, Lever S, Paul M, Hill K, Pollack MRP, Wiggers J, Oldmeadow C, Cadilhac DAM, Duff J, on behalf of the I-SCAMP Project Team Improving Assessment, Diagnosis, and Management of Urinary Incontinence and Lower Urinary Tract Symptoms on Acute and Rehabilitation Wards That Admit Adult Patients: Protocol for a Before-and-After Implementation Study JMIR Res Protoc 2021;10(2):e22902https://www.researchprotocols.org/2021/2/e22902Di.Marsden@health.nsw.gov.au



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Marsden DL, Boyle K, Birnie J, Buzio A, Dizon J, D... [More Details]
Study results articleYes Boyle K, Marsden DL, Waller A, Duff J. Barriers an... [More Details]

Documents added automatically
No additional documents have been identified.