e-Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2021

Running a trial remotely. An RCT of a decision aid to support informed choices about taking aspirin to prevent colorectal cancer and other chronic diseases: teletrial design and recruitment during COVID-19 (#402)

Shakira Milton 1 2 , Jennifer G McIntosh 3 , Finlay Macrae 4 5 , Patty Chondros 2 , Lyndal Trevena 6 , Mark Jenkins 7 , Fiona Walter 2 8 , Natalie Taylor 6 9 , Lucy Boyd 1 2 , Sibel Saya 1 2 , Napin Karnchanachari 1 2 , Kitty Novy 1 2 , Carmody Forbes 1 2 , Javiera M Gutierrez 1 2 , Kate Broun 10 , Sara Whitburn 11 , Sarah McGill 12 , George Fishman 13 , Julie Marker 13 , Max Shub 13 , Jon D Emery 1 2 8
  1. Centre for Cancer Research, University of Melbourne, Melbourne, Victoria, Australlia
  2. Department of General Practice, University of Melbourne, Melbourne, Victoria, Australia
  3. Department of Software Systems & Cybersecurity, Monash University, Melbourne, Victoria, Australia
  4. Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia
  5. Colorectal Medicine and Genetics, The Royal Melbourne Hospital, Melbourne, Victoria , Australia
  6. Faculty of Medicine and Health, School of Public Health, The University of Sydney, Sydney, New South Wales, Australlia
  7. Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Victoria, Australia
  8. The Primary Care Unit, University of Cambridge, Cambridge, United Kingdom
  9. Behavioral and Implementation Research and Evaluation, Cancer Council NSW, Woolloomooloo, New South Wales, Australia
  10. Early Detection and Immunisation, Prevention Department, Cancer Council Victoria, Melbourne, Victoria, Australia
  11. Belmore Road Medical Clinic, Melbourne, Victoria, Australia
  12. Cancer Screening and Prevention, Cancer Institute NSW, St Leonards, New South Wales, Australia
  13. PC4 Joint Community Advisory Group, University of Melbourne, Melbourne, Victoria, Australia

Background: Australian guidelines were recently changed to include a recommendation that all people aged 50-70 years old actively consider taking daily low-dose aspirin (100–300mg per day) for 2.5 to 5 years to reduce their risk of colorectal cancer (CRC). In 2019, we were funded to conduct a trial in general practice to test the efficacy of a health consultation and novel decision aid to implement these aspirin guidelines: the Should I Take Aspirin (SITA) trial.

The COVID-19 pandemic restricted our ability to recruit patients in general practice waiting rooms. We developed a novel teletrial model to allow us to continue the recruitment during the pandemic.

Methods: General practices in Victoria, Australia were recruited into the trial. We recruited 50-70 years old patients, who had an appointment with their general practitioner (GP). Usually, we would approach patients in the waiting room, and invite them to the study. The new teletrial method involved calling patients who were scheduled for an appointment and checking their eligibility over the phone. We developed videos of the intervention to deliver the trial in a standardised way which could be presented face-to-face or via a zoom teletrial consultation.

Results: Six general practices in Victoria, Australia have been recruited into the trial. Between October 2020 and April 2021, we screened 566 patients for eligibility, 532 (94%) by telephone and we approached 34 patients in the waiting rooms. We successfully recruited 264 people (87% of eligible patients). We delivered the trial consultations using the teletrial model for 57 (20%) participants.

Discussion: We have developed an effective teletrial model for the SITA trial which has allowed us to continue during the COVID-19 pandemic.  We are now applying this to other trials in general practice as an effective approach to increase participation and improve the external validity of our research.

  1. Milton S, Mcintosh J, Macrae F, Jenkins M, Walter FM, Taylor N, et al. 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. 2021; 10.1186/s13063-021-05365-8