Trial Protocol and Commentary on recruitment during the COVID-19 pandemic

In 2018, bowel cancer was the 2nd most common cause of cancer death in Australia. Low dose aspirin can reduce the risk of bowel cancer by up to 25% and chances of dying from bowel cancer by up to 33%. Guidelines were recently published by the Cancer Council that state that all Australians aged 50 to 70 years should consider taking aspirin for 2.5 to 5 years to prevent bowel cancer. Although the guidelines were published online, there was no accompanying plan to implement them. My study, the “Should I Take Aspirin?” (SITA) trial a randomised controlled trial, aims to implement these guidelines in general practice by showing patients information in a research consultation about how they can prevent bowel cancer which includes taking aspirin.

Since I started recruiting participants for my study, with the help of research assistants Lucy Boyd and Napin Karnchanachari, during the stage 4 restrictions in Victoria in 2020, I was stumped for how I could safely and effectively recruit during the COVID-19 pandemic. My plan was to originally approach people in general practice waiting rooms, as I’d done in my role as a research assistant for a previous trial and invite them to take part in the SITA trial. As it would have proven to be difficult with the COVID-19 restrictions, considering I was wearing a mask and social distanced, to approach people face to face, I had to quickly pivot. I lead the development of a new recruitment model to safely recruit participants. The recruitment model, a teletrial, included calling participants before their scheduled GP appointment, inviting them to take part in the study. Patients could participate in the study once they came into the general practice, or by joining a Zoom call with a research assistant.

I successfully recruited 264 participants into the trial, with a recruitment rate of 87%. A total of 92.8% of my participants were approached over the phone, and 20.8% joined over a Zoom consultation. The recruitment took place from October 2020 to May 2021. These novel recruitment methods were quickly published as a commentary to assist help others who may be faced with similar challenges due to the pandemic.

SITA Protocol paper- Milton S, McIntosh J,  Macrae F, Chondros P, Trevena L, Jenkins M, Walter F, M, Taylor N, Boyd L, Saya S, Karnchanachari N, Novy K, Forbes C, Gutierrez J, M, Broun K, Whitburn S, McGill S, Fishman G, Marker J, Shub M, Emery J. (2021). An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: A study protocol for The SITA (Should I Take Aspirin?) Trial. Trials.

SITA Commentary - Milton S, McIntosh J, Boyd L, Karnchanachari N, Macrae F, Emery JD. (2021). Commentary: Pivoting during a pandemic: developing a new recruitment model for a randomised controlled trial in response to COVID-19. Trials.