ANZCTR - Registration

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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 provided

23/02/2024

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]

Nil known

Universal Trial Number (UTN)

U1111-1258-8756

Trial acronym

I-SCAMP

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Urinary incontinence

Lower urinary tract symptoms

Condition category

Condition code

Stroke

Haemorrhagic

Stroke

Ischaemic

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Renal and Urogenital

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]

Diagnosis / Prognosis

Intervention code [2]

Early detection / Screening

Intervention code [3]

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]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [1]

The change in proportion of inpatients with UI/ LUTS who have an assessment of UI/ LUTS, determined via medical record audit.,

Timepoint [1]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [2]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [3]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [4]

The change in in-hospital complication rates associated with UI/ LUTS or urinary catheterisation, determined via medical record audit.

Timepoint [4]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [5]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [6]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [7]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [8]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [9]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [10]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [11]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [12]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [13]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [14]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [15]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [16]

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]

Before (T0) to 6 months after (T1) implementation of the intervention.

Secondary outcome [17]

Timepoint [17]

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]

The change in proportion of inpatients with UI/ LUTS who have an assessment of UI/ LUTS, determined via medical record audit.,

Timepoint [18]

Secondary outcome [19]

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]

Secondary outcome [20]

The change in in-hospital complication rates associated with UI/ LUTS or urinary catheterisation, determined via medical record audit.

Timepoint [20]

Secondary outcome [21]

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]

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?

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)

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

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]

Armidale Rural Referral Hospital - Armidale

Recruitment hospital [2]

Belmont Hospital - Belmont

Recruitment hospital [3]

Calvary Mater Newcastle - Waratah

Recruitment hospital [4]

Coffs Harbour Base Hospital - Coffs Harbour

Recruitment hospital [5]

John Hunter Hospital - New Lambton

Recruitment hospital [6]

Manning Rural Referral Hospital (Taree) - Taree

Recruitment hospital [7]

Port Macquarie Base Hospital - Port Macquarie

Recruitment hospital [8]

Ryde Hospital - Eastwood

Recruitment hospital [9]

Tamworth Rural Referral Hospital - Tamworth

Recruitment hospital [10]

Wingham Community Hospital - Wingham

Recruitment hospital [11]

Wauchope District Memorial Hospital - Wauchope

Recruitment hospital [12]

Rockhampton Base Hospital - Rockhampton

Recruitment postcode(s) [1]

2350 - Armidale

Recruitment postcode(s) [2]

2280 - Belmont

Recruitment postcode(s) [3]

2298 - Waratah

Recruitment postcode(s) [4]

2450 - Coffs Harbour

Recruitment postcode(s) [5]

2305 - New Lambton

Recruitment postcode(s) [6]

2430 - Taree

Recruitment postcode(s) [7]

2444 - Port Macquarie

Recruitment postcode(s) [8]

2122 - Eastwood

Recruitment postcode(s) [9]

2340 - Tamworth

Recruitment postcode(s) [10]

2429 - Wingham

Recruitment postcode(s) [11]

2446 - Wauchope

Recruitment postcode(s) [12]

4700 - Rockhampton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Hunter New England Local Health District

Address [1]

Lookout Road,
New Lambton Heights. NSW. 2305

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

New South Wales Agency for Clinical Innovation

Address [2]

1 Reserve Road
St Leonards. NSW. 2065.

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

New South Wales Ministry of Health

Address [3]

1 Reserve Road
St Leonards NSW 2065
Australia

Country [3]

Australia

Funding source category [4]

University

Name [4]

University of Newcastle

Address [4]

University Drive
Callaghan NSW 2308

Country [4]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

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]

Australia

Date submitted for ethics approval [1]

27/09/2018

Approval date [1]

29/10/2018

Ethics approval number [1]

18/10/17/4.02

Ethics committee name [2]

University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

University Drive
Callaghan NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

28/02/2020

Ethics approval number [2]

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

Dr Di Marsden

Address

Hunter Stroke Service
Hunter New England Local Health District
Level 2, The Lodge,
Lookout Rd,
New Lambton Heights. NSW. 2305.

Country

Australia

Phone

+61 2 49223380

Fax

[email protected]

Contact person for public queries

Name

Di Marsden

Address

Hunter Stroke Service
Hunter New England Local Health District
Level 2, The Lodge,
Lookout Rd,
New Lambton Heights. NSW. 2305

Country

Australia

Phone

+61 2 49223380

Fax

[email protected]

Contact person for scientific queries

Name

Di Marsden

Address

Hunter Stroke Service
Hunter New England Local Health District
Level 2, The Lodge,
Lookout Rd,
New Lambton Heights. NSW. 2305

Country

Australia

Phone

+61 2 49223380

Fax

[email protected]

Data sharing statement

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

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.	Type	Citation	Link	Email	Other Details	Attachment
9338	Study protocol	Marsden 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):e22902	https://www.researchprotocols.org/2021/2/e22902	[email protected]

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.

Trial Review

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Documents added automatically