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Trial registered on ANZCTR


Registration number
ACTRN12618000810213p
Ethics application status
Submitted, not yet approved
Date submitted
24/04/2018
Date registered
11/05/2018
Date last updated
11/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can general practitioners increase patient participation in the National Bowel Cancer Screening Program? A pilot study examining the role of electronic reminders in general practice.
Scientific title
Using point-of-care clinical prompts in general practice to increase bowel cancer screening participation in Tasmania: A preliminary trial
Secondary ID [1] 294690 0
Nil known
Universal Trial Number (UTN)
U1111-1212-7434
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer Screening 307548 0
Condition category
Condition code
Cancer 306628 306628 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 306629 306629 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief intervention name: Point-of-care clinical prompt (Prompt)

Materials and Procedures:
A point-of-care clinical prompt stating “Encourage Participation in National Bowel Cancer Screening Program” will be attached to the electronic files of eligible patients (average risk patients turning 50, 60 and 70 years of age) within a general practice. These patients represent a sample of the population who will receive a National Bowel Cancer Screening Program (NBCSP) kit during the 12-month trial period.

The prompt will remind General Practitioners (GPs) to talk to their patients about using the free kit when it arrives in the mail on or around the time of their birthday.

National Bowel Cancer Screening Program (NBCSP) patient information brochures and posters will be available for general practitioner (GP) use as hard and/or electronic copies. Each GP in the trial will also recieve a sample NBCSP kit to show to patients during the consultation.

Mode of delivery:
The prompt will be set up by general practice administration staff within the electronic files of eligible patients. The prompt will be delivered to GPs as an electronic pop-up reminder at the start of a consultation.

When an eligible patient arrives for their consultation at a practice, the prompt will ‘pop-up’ over the patient’s electronic file. The GP will then decide whether to discuss screening at that point in time or whether to ‘close’ the prompt. If the prompt is closed, it will remain as an outstanding action each time the patient attends the practice until such time as the GP marks the task as ‘performed’ by checking the relevent box.

Additional resouces including patient information brochures and a sample/demonstration kit, will be made available by the GP during the consultation.

Frequency and duration:
The intervention will be trialled over 12 months. It is estimated that a total of 1750 patients will be eligible to have the prompt associated with their electronic file within the five intervention sites. This is the maximum number of times the prompt will be acted on by GPs.

Location:
The intervention will take place in five Tasmanian general practices located within Outer Regional and Remote Tasmania (Remoteness Areas 3 and 4).

Adherence:
GP adherence to using the prompt will be determined by the number of prompts that were marked as ‘performed’ compared to the number of prompts that were not.
Intervention code [1] 300988 0
Prevention
Intervention code [2] 300989 0
Behaviour
Comparator / control treatment
The control group consists of five general practices pair-wise matched with 5 intervention practices on size (number of full-time-equivalent GPs), rurality and socioeconomic disadvantage (based on location). These general practices will provide usual care, and screening participation rates will be compared to the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 305628 0
The proportion of eligibe patients who completed the NBCSP kit during the 12 month trial as determined by pathology results.
Timepoint [1] 305628 0
12 months post-commencement of intervention
Primary outcome [2] 305629 0
The proportion of eligible patients with whom a GP used the prompt, as determined by the number of prompts marked as 'performed' by the GP
Timepoint [2] 305629 0
12 months post-commencement of intervention
Secondary outcome [1] 345970 0
Attitudes of GPs towards receiving and using the prompt as determined by face-to-face or telephone interviews.
Timepoint [1] 345970 0
12 months post-commencement of intervention
Secondary outcome [2] 346722 0
Attitudes of patients towards receiving unsolicited bowel cancer screening advice from their GP, as determined by telephone interviews
Timepoint [2] 346722 0
12 months post-commencement of intervention

Eligibility
Key inclusion criteria
General Practices: Only general practices located in Remoteness Areas 3 and 4, and identified as not participating in other University of Tasmania research, will be invited to participate.

General Practioners: All GPs within a recruited practice will be invited to participate in the study. No exclusion criteria apply.

Patients:
All active patients of the five intervention practices who turn 50, 60 and 70 during the 12-month intervention will be eligible to receive the prompt. Exceptions to this are patients identified as having a higher than average risk of bowel cancer including patients with a known personal or family history of bowel cancer, or with existing bowel conditions (e.g. inflammatory bowel disease, crohn’s disease). The NPCSP recommends individuals at above-average risk for bowel cancer should discuss screening options with their GP rather than use the free kit.
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General Practices located outside Remoteness Areas 3 and 4, and currently participating in or earmarked to particpate in University of Tasmania research will not be invited to participate.

Patients outside the specified age groups and at higher than average risk of developing bowel cancer (as defined by the NBCSP) will be excluded from receiving the prompt from their GP.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a preliminary trial/pilot study, with no precedent to refer to, the sample size required to show an effect is difficult to determine. However, the number of patients who will potentially be encouraged to screen for bowel cancer as a result of the GP prompt will be maximised within the constraints of the study. Based on the number of eligible patients identified in one rural practice, we estimate we will potentially reach 1000 patients with the prompt.

Binary logistic regression will be used to model the likelihood of completing the NBCSP FOBT test among intervention versus control participants, controlling for potential covariates including age, gender, and socioeconomic status.

Time between patients being prompted by their GP and receiving the kit in the post will also be included as a covariate in the analysis.

Practice data will be used to compare NBCSP participation rates for patients during the 12 months prior to the intervention with data collected for the study period.

Data on GP use of the prompt will be analysed in terms of the proportion marked as ‘performed’ for all eligible patients who attend a GP consultation during the intervention period.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2018
Actual
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
30/06/2019
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 299297 0
Charities/Societies/Foundations
Name [1] 299297 0
Cancer Council Tasmania
Country [1] 299297 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Address
University of Tasmania, Centre for Rural Health
Newnham campus
Locked Bag 1322
Launceston TASMANIA 7001
Country
Australia
Secondary sponsor category [1] 298564 0
None
Name [1] 298564 0
Address [1] 298564 0
Country [1] 298564 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300208 0
Tasmanian Health and Medical Human Research Ethics Committee
Ethics committee address [1] 300208 0
Ethics committee country [1] 300208 0
Australia
Date submitted for ethics approval [1] 300208 0
16/04/2018
Approval date [1] 300208 0
Ethics approval number [1] 300208 0

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

Contacts
Principal investigator
Name 82914 0
Dr Simone Lee
Address 82914 0
Centre for Rural Health | School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322
Launceston TASMANIA 7250
Country 82914 0
Australia
Phone 82914 0
+61 3 6324 4025
Fax 82914 0
Email 82914 0
simone.lee@utas.edu.au
Contact person for public queries
Name 82915 0
Simone Lee
Address 82915 0
Centre for Rural Health | School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322
Launceston TASMANIA 7250
Country 82915 0
Australia
Phone 82915 0
+61 3 6324 4025
Fax 82915 0
Email 82915 0
simone.lee@utas.edu.au
Contact person for scientific queries
Name 82916 0
Simone Lee
Address 82916 0
Centre for Rural Health | School of Health Sciences
College of Health and Medicine
University of Tasmania
Locked Bag 1322
Launceston TASMANIA 7250
Country 82916 0
Australia
Phone 82916 0
+61 3 6324 4025
Fax 82916 0
Email 82916 0
simone.lee@utas.edu.au

No information has been provided regarding IPD availability


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.