Abstract
BackgroundAustralian 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.MethodsApproximately 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.DiscussionThis 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 registrationThe Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965. Registered on 10 October 2020.
Highlights
Background and rationale {6a} In 2017, Cancer Council Australia published new guidelines recommending that people aged 50–70 years actively consider taking daily low dose aspirin to prevent colorectal cancer (CRC) [1]
The two co-primary outcomes, (1) proportion of participants who are taking regular aspirin at 6 months and (2) proportion of participants who make an informed choice about taking aspirin at 1 month, will each be compared between the two study arms using logistic regression with general practice, brochure type based on sex and mode of trial delivery included as covariates
Aspirin can reduce the risk of developing CRC by up to 25% and the benefits outweigh the risks of taking it for most people aged 50–70 years [48]
Summary
Background and rationale {6a} In 2017, Cancer Council Australia published new guidelines recommending that people aged 50–70 years actively consider taking daily low dose aspirin to prevent colorectal cancer (CRC) [1]. This was based on a systematic review of the evidence and pooled data from four aspirin cardiovascular prevention trials which demonstrated a 25% reduced relative incidence and 33% reduced relative mortality from CRC with a median follow-up of 18.3 years [2]. Australian guidelines recommend that all people aged 50–70 years old actively consider taking daily lowdose aspirin (100–300 mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). 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
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