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Trial registered on ANZCTR


Registration number
ACTRN12623000355673
Ethics application status
Approved
Date submitted
7/03/2023
Date registered
5/04/2023
Date last updated
20/09/2024
Date data sharing statement initially provided
5/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot of a general practice-led intervention to optimise National Bowel Cancer Screening Program (NBCSP) participation.
Scientific title
Pilot and evaluation of a general practice led intervention to optimise National Bowel Cancer Screening Program participation.
Secondary ID [1] 309140 0
Nil known.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal cancer screening 329241 0
Condition category
Condition code
Cancer 326198 326198 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘general practice-led intervention’ is a multi-component intervention identified in a synthesised evidence review of interventions effective at increasing Colorectal Cancer (CRC) screening participation and co-designed with general practice staff.

The co-design was completed in April 2023 with 38 General Practice Staff and from across Australia. Co-design participants discussed implementation barriers and enablers of intervention components with evidence-based effectiveness at increasing CRC screening.

The co-design results were analyzed against implementation science frameworks and the barriers assessed against implementation barriers identified in the evidence review. The final intervention to be delivered to general practice healthcare providers will comprise of a combination of the following components:

1. Decision-aid tools adapted from existing sources.
Anticipated completion time of 5 minutes per patient.
2. Reminder prompts activated within existing general practice software Medical Director
3. Integration of the National Cancer Screening Register (NCSR) within practice software systems and use of a Cancer Screening Toolkit and clinical audits of patient data based on existing resources used in the participating states. Anticipated time by practice staff 1 hr per fortnight for 6-month duration.
4. Learning modules and digital resources to educate on guideline-appropriate screening pathways for GPs:
- 2 x 1 hour online self-paced modules developed by GPEx with the learning outcomes:
- Be aware why General Practice needs to endorse participation in the National Bowel Cancer Screening Program and be able to explain to patients the risks in not completing the test.
- Be familiar with the impact GPs can have on bowel cancer screening rates.
- Have access to the resources your practice needs to encourage patients to screen for bowel cancer.
- Have increased knowledge of key points from the national colorectal guidelines and links to further clinical information.
All intervention components will be offered to practices allocated to the intervention arm of the trial however practice participants may choose to adhere to a minimum of one component. Clinical Trial Coordinators will support the implementation of and adherence to intervention components within practice with the use of strategies inclusive of identifying practice champions and reminding participants about the components.

The Clinical Trial Coordinators will provide participants education on how to use the intervention components and ongoing support and training for participants throughout the trial. The Clinical Trial Coordinators will be trained in strategies to improve the implementation of interventions in the primary healthcare setting.

The trial will commence in September 2024. The intervention will be provided after an initial five months of usual care and data collection - from Feb 2025. The intervention exposure period is four months and cease at end May 2025.
Intervention code [1] 325588 0
Early detection / Screening
Intervention code [2] 325589 0
Prevention
Intervention code [3] 325590 0
Behaviour
Comparator / control treatment
The intervention arm will be compared to a usual care arm. General Practices in the usual care arm will be monitored by a Clinical Trial Coordinator over a 10-month period. The General Practitioner will conduct a standard consultation and manage their patients eligible for colorectal cancer screening as per their usual process.

Usual processes that may be employed within general practice for management of patients eligible for colorectal cancer screening include:
- Provision of promotional resources in practice waiting rooms
- Verbal endorsement of screening by General Practitioner
- Quality Improvement activities such as establishing a recall and reminder system to identify patients due for screening
- Ordering replacement NBCSP test kits via the National Cancer Screening Register for patients
- Demonstrating to eligible patients how to use a NBCSP test kit
Control group
Active

Outcomes
Primary outcome [1] 334075 0
Co-primary Implementation Effectiveness Outcome
The co-primary implementation effectiveness outcome is guideline-appropriate CRC screening recommendations provided.

The co-primary implementation effectiveness outcome will be assessed using a study specific data collection tool integrated into Clinical Information Systems used in General Practice to undertake audits of medical records.
Timepoint [1] 334075 0
Co-primary Implementation Effectiveness Outcome will be measured mid-trial at 5-months duration since trial commencement and at post-trial, 10-months duration since trial commencement.
Primary outcome [2] 334076 0
Co-primary Clinical Effectiveness Outcome
The co-primary clinical effectiveness outcome is guideline-appropriate CRC screening tests completed by practice patients (inc. NBCSP kits, GP-initiated kits & colonoscopies).

The co-primary clinical effectiveness outcome will be assessed using Health Analytics software used in General Practice to undertake audits of medical records.
Timepoint [2] 334076 0
Co-primary Clinical Effectiveness Outcome will be measured pre-trial and post-trial after 10 months since trial commencement.
Secondary outcome [1] 419286 0
General practice awareness and understanding of guideline-appropriate screening (service outcome)

Assessed using study adapted validated questionnaires: Influences of Patient Safety Behaviors Questionnaire (IPSBQ)
Timepoint [1] 419286 0
Measured pre-trial and post-trial after 10 months since trial commencement.
Secondary outcome [2] 419287 0
CRC screening-related endorsement and promotion activities adopted within the practice (implementation outcomes) assessed using a questionnaire, The questionnaire to measure the implementation outcomes has been adapted from the Weiner 2017 Acceptability of Intervention Measure (AIM) scale.
Timepoint [2] 419287 0
Measured pre-trial, mid-trial (5-months since trial commencement) and post-trial (10-months since trial commencement).

Eligibility
Key inclusion criteria
General Practices inclusion criteria:
• Has at least two GPs (FTE) willing to participate in the trial
• Nominated Practice Champion who is willing and able to liaise with the Daffodil Centre research team
• Uses Medical Director or Best Practice software
• Uses Pen CS, Polar or Primary Sense
• Available over the trial period Sept 2024 – May 2025
• Windows 10 or higher, i5/i7 16GB processing or willing to upgrade
• Has over 1000 active patients and sees minimum of 35 adult patients per day

Adult patient inclusion criteria:
Inclusion criteria
• General Practice patients aged 45 to 74 years
Minimum age
45 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Practice exclusion criteria:
• Shares server with another practice
• Uses paper-based medical records
• Does not share data with PHN

Adult patient exclusion criteria:
Exclusion criteria
• Under 45 or over 74 years
• Previous or current diagnosis of CRC
• Previous or current diagnosis of inflammatory bowel disease – e.g., ulcerative colitis or Chron’s disease
Familial syndrome associated with increased risk of CRC: lynch syndrome, familial adenomatous polyposis (FAP), attenuated FAP (AFAP), MUTYH-associated polyposis, polymerase proof-reading associated polyposis (PPAP), NTHL1-associated polyposis (NAP), Peutz-Jeghers syndrome, Juvenile polyposis syndrome, Serrated polyposis syndrome, and Cowden syndrome

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation for this study will be carried out at the level of general practice. Each practice will be allocated to the intervention or usual care arm using a random computer-generated sequence by the research team. To account for differences in region-specific NBCSP screening rates, the randomisation will be stratified by participating Primary Health Network (PHN) Regions. In each region, the same number of practices will be allocated to the intervention and usual care arms. Accordingly, GPs, general practice staff and their patients will be assigned to the intervention or usual care arm based on the assignment of their general practice. The CTCs will be allocated to manage practices in both the intervention and in the usual care arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise the general practice characteristics for each trial arm and the outcome results.
Intention-to-treat analysis will be used, where all general practices allocated to the trial group will be included and analysed in the group that they were assigned. Both the co-primary and secondary outcomes will be compared between the intervention and control groups using poisson or negative binomial regression and generalised linear modelling with an identity link function and binomial family to estimate the odds ratio and difference in proportions respectively. The regression models will use generalised estimating equations with robust standard errors to allow for clustering by general practice and will adjust for the randomisation stratification factors (e.g., practice size, state, rurality, socioeconomic indexes for areas (SEIFA). Both the relative and absolute measures of the estimated intervention effect will be reported with their respective 95% confidence intervals, and a p value calculated from the logistic regression.
The intra-practice correlation, which quantities the proportion of the total variation in the outcome attributable to between-cluster variation in the outcome will also be estimated using mixed effects modelling and reported with 95% confidence intervals.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/01/2024
Actual
5/08/2024
Date of last participant enrolment
Anticipated
30/03/2024
Actual
6/09/2024
Date of last data collection
Anticipated
18/12/2024
Actual
6/09/2024
Sample size
Target
100
Accrual to date
Final
93
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA

Funding & Sponsors
Funding source category [1] 313342 0
University
Name [1] 313342 0
University of Sydney
Country [1] 313342 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 315089 0
None
Name [1] 315089 0
N/A
Address [1] 315089 0
N/A
Country [1] 315089 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312564 0
Human Research Ethics Committe - University of Sydney
Ethics committee address [1] 312564 0
Ethics committee country [1] 312564 0
Australia
Date submitted for ethics approval [1] 312564 0
20/02/2023
Approval date [1] 312564 0
23/08/2023
Ethics approval number [1] 312564 0

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

Contacts
Principal investigator
Name 125106 0
Dr Eleonora Feletto
Address 125106 0
The Daffodil Centre
153 Dowling St, Woolloomooloo, NSW 2011
PO Box 572 Kings Cross NSW 1340
Country 125106 0
Australia
Phone 125106 0
+61 293341409
Fax 125106 0
Email 125106 0
eleonora.feletto@sydney.edu.au
Contact person for public queries
Name 125107 0
Eleonora Feletto
Address 125107 0
The Daffodil Centre
153 Dowling St, Woolloomooloo, NSW 2011
PO Box 572 Kings Cross NSW 1340
Country 125107 0
Australia
Phone 125107 0
+61 293341409
Fax 125107 0
Email 125107 0
eleonora.feletto@sydney.edu.au
Contact person for scientific queries
Name 125108 0
Eleonora Feletto
Address 125108 0
The Daffodil Centre
153 Dowling St, Woolloomooloo, NSW 2011
PO Box 572 Kings Cross NSW 1340
Country 125108 0
Australia
Phone 125108 0
+61 293341409
Fax 125108 0
Email 125108 0
eleonora.feletto@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be de-identified and confidential.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18519Study protocol  eleonora.feletto@sydney.edu.au 385512-(Uploaded-25-08-2023-13-50-28)-Study-related document.pdf
18520Informed consent form  eleonora.feletto@sydney.edu.au 385512-(Uploaded-25-08-2023-13-52-54)-Study-related document.pdf
18521Ethical approval  eleonora.feletto@sydney.edu.au 385512-(Uploaded-25-08-2023-13-51-12)-Study-related document.pdf



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.