Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12624001429549p
Ethics application status
Submitted, not yet approved
Date submitted
21/10/2024
Date registered
6/12/2024
Date last updated
6/12/2024
Date data sharing statement initially provided
6/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility, acceptability and preliminary efficacy of implementing streamlined colonoscopy surveillance practices in South Australia for individuals who are at an increased risk for bowel cancer (the SCOPES program).
Scientific title
Feasibility, acceptability, and preliminary efficacy of establishing a streamlined digital surveillance colonoscopy program across South Australia - the SCOPES program.
Secondary ID [1] 313228 0
None
Universal Trial Number (UTN)
Trial acronym
SCOPES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal diseases 334556 0
Bowel cancer surveillance 335578 0
Condition category
Condition code
Public Health 331161 331161 0 0
Health service research
Oral and Gastrointestinal 332151 332151 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 332152 332152 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The SCOPES digital intervention aims to streamline colonoscopy surveillance through automating processes and reduce manual data entry.
This will include data linkage, natural language processing, and rule-based algorithms. Natural language processing will be used to create structured data fields from unstructured colonoscopy and pathology reports. Data linkage will link together hospital electronic medical records (e.g. patient demographics and relevant clinical details, colonoscopy and pathology reports) for storage in the SCOPES clinical records. Rule-based algorithms (created based on national colonoscopy surveillance guidelines) will be used provide appropriate timings for the next colonoscopy.

Digital Components:
- SCOPES System: A centralised platform that consolidates patient data and flags individuals requiring surveillance.
- Natural language processing (NLP): Transforms unstructured colonoscopy and pathology reports into structured data and integrates it into the SCOPES system, streamlining data entry.
- Rule-Based Algorithms: Integrated into the SCOPES system to determine the timing of the next colonoscopy based on national guidelines as a decision support tool for the nurse.

After the colonoscopy, using the data stored within the SCOPES system, the tailored surveillance plan will be generated and shared with the patient and their general practitioner via letter, detailing the recommended timing for the next colonoscopy based on the patient's risk profile and clinical guidelines. The SCOPES system flags patients who require colonoscopy within the next 3 months. Patients will then receive reminders (e.g., SMS, email, or letters) to arrange their next surveillance colonoscopy. The SCOPES system will automatically send surveys in the month prior and 2-3 months after Colonoscopy.

Each hospital site will implement the SCOPES digital intervention for a minimum of 6 months and a maximum of 3 years, covering both the initial implementation and subsequent evaluation phases. The intervention will be deployed in a stepped wedge design, with a scheduled, sequential roll-out across the following South Australian health networks at 3 to 6-month intervals:
Southern Adelaide Local Health Network: Flinders Medical Centre and Noarlunga Health Service.
Northern Adelaide Local Health Network: Lyell McEwin Hospital and Modbury Hospital.
Central Adelaide Local Health Network: Royal Adelaide Hospital and The Queen Elizabeth Hospital.
Riverland Mallee Coorong Local Health Network: Riverland General Hospital.
Port Lincoln, Eyre and Far North Local Health Network: Port Lincoln Hospital.

The implementation order for each health network will follow a predetermined sequential schedule at the discretion of the lead researchers. This will be coordinated centrally and will ensure a systematic roll-out across all sites, allowing for the assessment of each stage of implementation.

For each hospital, an audit of colonoscopy surveillance practices, consumer acceptability, and cost effectiveness, will be conducted before (baseline) and at least 6 months after the implementation of the intervention.

- Colonoscopy surveillance practices for quality and timeliness of procedure and appropriateness of surveillance recommendation will be compared against the Australian Commission on Safety and Quality in Health Care Standards, and the NHMRC Colorectal Cancer Surveillance Guidelines. These measures include:
- The prevalence of colonoscopies given surveillance recommendations that are compliant with national guidelines. Target greater than or equal to 90%
- The prevalence of on-time surveillance colonoscopy bookings. Target all booked within 6 months.
- The median time taken to review the colonoscopy outcomes and to communicate the recall decision with the patient and GP. Target less than 1 month
- Consumer acceptability of the implementation will be assessed with surveys to evaluate satisfaction (e.g. communication speed, ease of understanding of information provided and experience of colonoscopy procedure), along with health-related quality of life measured with the validated EQ-5D-5L questionnaire.
- Cost effectiveness will be assessed for direct costs (e.g. staffing time to maintain a surveillance colonoscopy program; costs for colonoscopy procedures) and indirect costs (e.g. number of complications prevented through quality and timely surveillance colonoscopies).
Intervention code [1] 329136 0
Prevention
Comparator / control treatment
The comparator for the intervention is ‘standard of care’ in existing colonoscopy surveillance practices at each participating hospital site prior to the implementation of the intervention. This data includes colonoscopy surveillance recommendations, adherence to national surveillance recall guidelines, assessment of patient-reported measures, cost effectiveness and efficiencies in existing processes.

Collection of historic colonoscopy data and surveillance practices will be collected using data from each participating hospital from the year 2023 (prior to intervention). This will inform colonoscopy surveillance practices and program costs. Administration of patient surveys will be conducted over a 6-month period prior to implementation at any site (early 2025).

Participating hospitals include Flinders Medical Centre, Noarlunga Health Service, Lyell McEwin Hospital, Modbury Hospital, Royal Adelaide Hospital, The Queen Elizabeth Hospital, Riverland General Hospital, Port Lincoln Hospital.
Control group
Historical

Outcomes
Primary outcome [1] 338954 0
The consistency of surveillance colonoscopy recall recommendations with NHMRC guidelines.
These data will be gathered from audit of colonoscopy reports and clinical notes.
Timepoint [1] 338954 0
At 6 months post-colonoscopy
Primary outcome [2] 338955 0
Patient satisfaction with surveillance colonoscopy care.
Patient satisfaction with surveillance colonoscopy care will be assessed using a survey developed specifically for this study.
Timepoint [2] 338955 0
One month before and 2-3 months after the colonoscopy.
Primary outcome [3] 339841 0
Cost-effectiveness in surveillance colonoscopy care.
This will be calculated from the number of colonoscopies performed, the staffing time burden, and the findings at colonoscopy. These data will be gathered from audit of colonoscopy reports and clinical notes.
Timepoint [3] 339841 0
Evaluations will be pre-implementation and at 6 months post-implementation for each hospital site.
Secondary outcome [1] 438021 0
Patient health related quality of life with surveillance colonoscopy care.
It will be assessed using patient surveys with questions from the validated EQ-5D-5L questionnaire.
Timepoint [1] 438021 0
One month before and 2-3 months after the surveillance colonoscopy.
Secondary outcome [2] 441615 0
Proportion of surveillance colonoscopies that are booked within 6 months of the recommended date.
These data will be gathered from audit of colonoscopy reports and clinical notes.
Timepoint [2] 441615 0
At 6 months post-colonoscopy.
Secondary outcome [3] 441616 0
The time taken to communicate the colonoscopy surveillance plan to the patient and their general practitioner.
These data will be gathered from audit of clinical notes.
Timepoint [3] 441616 0
At 6 months post-colonoscopy.

Eligibility
Key inclusion criteria
All patients who undergo lower gastrointestinal procedures (e.g. colonoscopy, flexible sigmoidoscopy, colorectal surgery) at participating hospitals, will have their procedure related data included into the SCOPES clinical data collection.

Individuals will be eligible for participation in the baseline surveys if they are scheduled for a colonoscopy.

Individuals will be eligible for participation in the feasibility surveys or interviews if they have undergone a surveillance colonoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who are not undergoing lower gastrointestinal procedures (e.g. colonoscopy, flexible sigmoidoscopy, colorectal surgery) through one of the participating hospitals

Individuals who opt-out of receiving any further surveys, will be excluded from being sent any further surveys.

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
The comparator for the intervention is ‘standard of care’ in existing colonoscopy surveillance practices at each participating hospital site prior to the implementation of the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This project involves a clinical data collection. It is anticipated that 2,000 – 5,000 individuals will undergo colonoscopy at each site per year.
Post-hoc power estimates will be calculated where relevant. All individuals undergoing colonoscopy (or similar lower gastrointestinal procedures) at participating sites will be included in the clinical data collection.

Recruitment targets to assess the SCOPES program for performance and sustainability:
- Baseline audit of surveillance practices: 4000 colonoscopies (500 colonoscopies per hospital)
- Baseline assessment of patient-reported measures before and after colonoscopy: 800 completed surveys (100 colonoscopies per hospital)
- Post-implementation assessment of patient-reported measures before and after colonoscopy: Everyone having surveillance colonoscopy (~10,000/year)
- End of study assessment of consumer satisfaction via interview: 80 colonoscopy consumers (10 consumers from each site) and 10 clinical team members.
- End of study assessment of consumer satisfaction with the SCOPES program: 400 (50 consumers from each site)

Analysis: Acceptance of the digital surveillance program by consumers will be assessed through calculating the interaction with the survey platform. Survey responses at pre- and post-surveillance colonoscopy will be analysed for satisfaction of each measure, and will be compared to the baseline measures of each site with chi-square tests.

Analysis with multivariable generalised linear models will assess the association between patient-reported measures and acceptance and engagement. Thematic analysis of the interviews will be performed with Nvivo software to establish preferences and opinions on the surveillance program.

The analysis also includes cost-effectiveness, acceptability, net benefit and expected net loss curves to inform decision-makers of the optimal strategy at any threshold for different subgroups and the uncertainty around this decision.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2025
Actual
Date of last participant enrolment
Anticipated
31/08/2029
Actual
Date of last data collection
Anticipated
28/02/2030
Actual
Sample size
Target
1290
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 310443 0
Government body
Name [1] 310443 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 310443 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 311597 0
Government body
Name [1] 311597 0
SA Health
Address [1] 311597 0
Country [1] 311597 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310082 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 310082 0
Ethics committee country [1] 310082 0
Australia
Date submitted for ethics approval [1] 310082 0
21/06/2024
Approval date [1] 310082 0
Ethics approval number [1] 310082 0

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

Contacts
Principal investigator
Name 116418 0
A/Prof Erin Symonds
Address 116418 0
Bowel Health Service, Level 3, Flinders Centre for Innovation in Cancer, Flinders Drive, Bedford Park, South Australia 5042
Country 116418 0
Australia
Phone 116418 0
+61 8 8275 1075
Fax 116418 0
Email 116418 0
Erin.Symonds@sa.gov.au
Contact person for public queries
Name 116419 0
Erin Symonds
Address 116419 0
Bowel Health Service, Level 3, Flinders Centre for Innovation in Cancer, Flinders Drive, Bedford Park, South Australia 5042
Country 116419 0
Australia
Phone 116419 0
+61 8 8275 1075
Fax 116419 0
Email 116419 0
Erin.Symonds@sa.gov.au
Contact person for scientific queries
Name 116420 0
Erin Symonds
Address 116420 0
Bowel Health Service, Level 3, Flinders Centre for Innovation in Cancer, Flinders Drive, Bedford Park, South Australia 5042
Country 116420 0
Australia
Phone 116420 0
+61 8 8275 1075
Fax 116420 0
Email 116420 0
Erin.Symonds@sa.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


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.