Centre for Cancer Research, University of Melbourne, Melbourne, Australia.
Department of General Practice, University of Melbourne, Melbourne, Australia.
Trials. 2021 Jul 15;22(1):452. doi: 10.1186/s13063-021-05365-8.
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.
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.
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.
The Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620001003965 . Registered on 10 October 2020.
澳大利亚指南建议所有 50-70 岁的人积极考虑每天服用低剂量阿司匹林（100-300mg/天），持续 2.5-5 年，以降低结直肠癌（CRC）的风险。尽管国家 CRC 预防指南发生了变化，但这些指南尚未积极应用于临床实践。我们旨在测试健康咨询和决策辅助的效果，使用新型预期频率树（EFT）在 50-70 岁患者的全科医生就诊前展示低剂量阿司匹林的获益和危害，以促进知情决策和阿司匹林的使用。
澳大利亚维多利亚州大约有五到七家全科诊所将被招募参与。50-70 岁的患者，因任何原因预约全科医生就诊，将被邀请参与试验。258 名符合条件的参与者将按照全科诊所、性别和试验交付方式（面对面或远程试验）分层，使用计算机生成的分配序列进行 1:1 随机分组，分配到干预组或主动对照组。有两个主要结局：随机分组后 1 个月的知情决策，用多维知情选择衡量工具（MMIC）测量；6 个月时的每日阿司匹林自我报告使用率。次要结局包括 1 个月时的决策冲突以及两个时间点降低 CRC 风险的其他行为改变。
该试验将测试实施国家指南的新方法的效果，以支持 50-70 岁人群中关于服用阿司匹林以降低 CRC 和其他慢性疾病风险的知情决策。
澳大利亚和新西兰临床试验注册中心（ANZCTR）ACTRN12620001003965。于 2020 年 10 月 10 日注册。
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