Key result
The SITA trial protocol outlines a planned randomized controlled trial to evaluate whether a novel decision aid increases informed decision-making and aspirin uptake for colorectal cancer prevention.
Why the study?
Australian guidelines recommend low-dose aspirin for colorectal cancer prevention in people aged 50-70 years, but there has been no active implementation into clinical practice.
Does a health consultation and decision aid using an expected frequency tree improve informed decision-making and uptake of low-dose aspirin in patients aged 50-70 years?
RCT (n=258)
Single-blind
1:1 computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery
Yes
Does a health consultation and decision aid using an expected frequency tree improve informed decision-making and uptake of low-dose aspirin in patients aged 50-70 years?
This study protocol outlines a randomized controlled trial to test whether a novel decision aid improves informed decision-making and the uptake of low-dose aspirin for the prevention of colorectal cancer and other chronic diseases in primary care.
BACKGROUND: Australian guidelines recommend that all people aged 50-70 years old actively consider taking daily low-dose aspirin (100-300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). Despite the change of national CRC prevention guidelines, there has been no active implementation of the guidelines into clinical practice. We aim to test the efficacy of a health consultation and decision aid, using a novel expected frequency tree (EFT) to present the benefits and harms of low dose aspirin prior to a general practice consultation with patients aged 50-70 years, on informed decision-making and uptake of aspirin. METHODS: Approximately five to seven general practices in Victoria, Australia, will be recruited to participate. Patients 50-70 years old, attending an appointment with their general practitioner (GP) for any reason, will be invited to participate in the trial. Two hundred fifty-eight eligible participants will be randomly allocated 1:1 to intervention or active control arms using a computer-generated allocation sequence stratified by general practice, sex, and mode of trial delivery (face-to-face or teletrial). There are two co-primary outcomes: informed decision-making at 1-month post randomisation, measured by the Multi-dimensional Measure of Informed Choice (MMIC), and self-reported daily use of aspirin at 6 months. Secondary outcomes include decisional conflict at 1-month and other behavioural changes to reduce CRC risk at both time points. DISCUSSION: This trial will test the efficacy of novel methods for implementing national guidelines to support informed decision-making about taking aspirin in 50-70-year-olds to reduce the risk of CRC and other chronic diseases. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020.
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Milton et al. (2021) conducted an RCT in Colorectal cancer prevention (n=258). Expected frequency tree (EFT)-based decision aid vs. General CRC prevention information was evaluated on Informed decision-making at 1 month and self-reported daily use of aspirin at 6 months. The SITA trial protocol outlines a planned randomized controlled trial to evaluate whether a novel decision aid increases informed decision-making and aspirin uptake for colorectal cancer prevention.
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