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Trial registered on ANZCTR


Registration number
ACTRN12618001219279p
Ethics application status
Submitted, not yet approved
Date submitted
19/06/2018
Date registered
20/07/2018
Date last updated
20/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Optimise Study - randomised trial of the use of a decision aid to improve informed choice regarding the benefits of low-dose aspirin to prevent cardiovascular disease and colorectal cancer
Scientific title
The Optimise Study - randomised trial of the use of a decision aid to improve informed choice regarding the benefits of low-dose aspirin to prevent cardiovascular disease and colorectal cancer
Secondary ID [1] 295103 0
NHMRC APP1067062
Universal Trial Number (UTN)
U1111-1215-2690
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 308176 0
colorectal cancer 308177 0
gastrointestinal bleeding 308178 0
Condition category
Condition code
Cardiovascular 307212 307212 0 0
Coronary heart disease
Cancer 307213 307213 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 307214 307214 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Optimise study is an NHMRC funded double blinded randomised controlled clinical trial of a decision-aid tool regarding the use of aspirin to prevent both colorectal cancer and cardiovascular disease, while considering side effects such as gastrointestinal bleeding and patient preference regarding taking regular low dose aspirin.
The Optimise study will involve recruitment of patients aged 50-70 in general practice waiting rooms, and administering a personalised electronic decision–aid (on iPad), regarding use of aspirin to the intervention group, and attention placebo to the control group.
The intervention involves use of an an electronic decision aid which takes into account each participant's individual risk of cardiovascular disease and colorectal cancer, their personal risk of side effects such as gastrointestinal bleeding and their personal preferences regarding taking aspirin, and takes 5-10 minutes to administer at one occasion only.
Results of the decision aid are given to the participant and to their general practitioner, and it is up to the participant to decide whether to take aspirin, following discussion with their general practitioner if they do so. Aspirin will not be included as part of the intervention.
Intervention code [1] 301439 0
Behaviour
Comparator / control treatment
The control group will receive an an attention placebo - that is usual care including general preventive advice about prevention of colorectal cancer, including printed information about ways to prevent colorectal cancer.
Control group
Placebo

Outcomes
Primary outcome [1] 306161 0
Informed choice (using Multi-dimensional Measure of Informed Choice (MMIC)) - this will be measured by telephone questionnaire at 3 months post - intervention
Timepoint [1] 306161 0
Three months post intervention
Secondary outcome [1] 347745 0
Adherence to low-dose aspirin - this will be measured by reply to SMS regarding adherence at 3 month intervals to 12 months post - intervention, for all participants
Timepoint [1] 347745 0
Three months post intervention (email), 6,9,12 months post intervention (SMS)
Secondary outcome [2] 347746 0
Incidence of cardiovascular disease, colorectal cancer, gastrointestinal bleed, other health outcomes such as breast cancer prostate cancer and intracranial bleeds (effects for which there is some evidence about the role of aspirin), hospitalisation, death (composite outcome), as reported from data linkage from NSW Health datasets
Timepoint [2] 347746 0
1 year, 5 year, 10 year post - intervention

Eligibility
Key inclusion criteria
Adults aged 50-70, with access to email and SMS and ability to understand basic written English.
Minimum age
50 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to understand basic written English
Serious illness likely to impact on ability to participate
Known serious illness likely to impact on life expectancy over the next 10 years
Pregnant/ lactating women
Under Guardianship orders/ Power of Attorney or Legal Guardian
Cognitive or intellectual impairment not able to provide informed consent (as judged by qualified RN or GP – see above)
Colorectal cancer
Familial adenomatosis polyposis (FAP)
Current dyspepsia
Any history of peptic ulcer
Untreated helicobacter pylori infection
Aspirin allergy
Bleeding diathesis
Known increased risk of GI haemorrhage
Anticoagulant therapy
Antiplatelet therapy
Chronic renal impairment
Chronic liver disease
Current symptoms of colorectal cancer, such as anaemia, change on bowel habit or weight loss for no reason. People with these symptoms should see their general practitioner as possible to discuss their symptoms.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
Primary outcome is changes in measure of informed choice (MMIC) incorporating assessments of knowledge.
Secondary outcome is adherence to aspirin, which will be analysed according to demographics, lifestyle, and medical history.
Health outcomes will be assessed from data linkage to health datasets.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299683 0
Government body
Name [1] 299683 0
NHMRC APP1067062
Address [1] 299683 0
NHMRC, GHD Building Level 1, 16 Marcus Clarke St, Canberra ACT 2601
Country [1] 299683 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
School of Public Health
Ford Building A27
The University of Sydney
NSW 2006 AUSTRALIA
Country
Australia
Secondary sponsor category [1] 299024 0
None
Name [1] 299024 0
Not applicable
Address [1] 299024 0
Not applicable
Country [1] 299024 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 300586 0
University of Sydney Human Ethics Committee
Ethics committee address [1] 300586 0
The University of Sydney
NSW 2006 AUSTRALIA
Ethics committee country [1] 300586 0
Australia
Date submitted for ethics approval [1] 300586 0
02/07/2018
Approval date [1] 300586 0
Ethics approval number [1] 300586 0

Summary
Brief summary
The purpose of this study is to assess the effect of the 'Optimise' decision aid on choices regarding taking low dose aspirin for the prevention of cardiovascular disease and colorectal cancer.

Who is it for?
You may be eligible for this study if you are an adult aged 50-70 years who has not been diagnosed with a serious illness.

Study details
Participants will be recruited through their GP and randomised to one of two groups. All participants will complete a baseline questionnaire which involves individual risk calculations for cardiovascular disease and colorectal cancer. In one group patients will be taken through the 'Optimise' decision aid to consider the use of regular low-dose aspirin, weighing up the health benefits and the risk of side effects of aspirin, including gastrointestinal bleeding, along with personal preferences regarding taking aspirin.
The other group (the control group) will receive general information about prevention of colorectal cancer.

Participants will then be followed up after three months by telephone survey, including a measurement of informed choice regarding taking low - dose aspirin, and adherence to aspirin. They will also be followed up by SMS every 3 months for one year to assess adherence to aspirin. Patient data regarding health outcomes will be collected from health data sets for up to 10 years after enrolment.

Outcomes
It is hoped that the use of the Optimise decision aid will increase the proportion of participants making an informed choice about the use of aspirin to prevent cardiovascular disease and colorectal cancer.
Trial website
Not applicable
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 84130 0
Prof Lyndal Trevena
Address 84130 0
Room 321B
Ford Building A27
The University of Sydney
NSW 2006 AUSTRALIA
Country 84130 0
Australia
Phone 84130 0
+61 2 9351 7788
Fax 84130 0
+61 2 9351 5049
Email 84130 0
lyndal.trevena@sydney.edu.au
Contact person for public queries
Name 84131 0
A/Prof Rowena Ivers
Address 84131 0
Room 327
Ford Building A27
The University of Sydney
NSW 2006 AUSTRALIA
Country 84131 0
Australia
Phone 84131 0
+61 438894810
Fax 84131 0
+61 29351 5049
Email 84131 0
rowena.ivers@sydney.edu.au
Contact person for scientific queries
Name 84132 0
A/Prof Rowena Ivers
Address 84132 0
Room 327
Ford Building A27
The University of Sydney
NSW 2006 AUSTRALIA
Country 84132 0
Australia
Phone 84132 0
+61 438894810
Fax 84132 0
+61 29351 5049
Email 84132 0
rowena.ivers@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results