The LEAD trial-The effectiveness of a decision aid on decision making among citizens with lower educational attainment who have not participated in FIT-based colorectal cancer screening in Denmark: A randomised controlled trial.

Abstract

This trial tested the effectiveness of a self-administered web-based decision aid, targeted at citizens with lower educational attainment, on informed choice about colorectal cancer screening participation as assessed by group levels of knowledge, attitudes and uptake. The randomised controlled trial was conducted among 2702 screening-naïve Danish citizens, 53-74 years old, with lower educational attainment. Baseline questionnaire respondents (62%) were allocated to intervention and control groups. Intervention group citizens received the decision aid. Outcomes were informed choice, worries and decisional conflict. Analyses were conducted among 339 eligible citizens. The mean difference in knowledge score change between intervention and control group was 0.00 (95% confidence interval (CI): -0.38;0.38). Trends towards more positive screening attitudes (mean difference in score change: 0.72, 95% CI: -0.38;1.81) and higher screening uptake (7.6%, 95% CI:-2.2;17.4%) were observed. Worries (-0.33, 95% CI: -0.97;0.32) and decisional conflict (mean difference: -3.5, 95%CI: -7.0;-0.1) were slightly reduced. The decision aid did not affect informed choice or knowledge. However, there were trends towards increased screening uptake and more positive screening attitudes. Being a simple intervention and easily administered, the decision aid could represent a cost-effective way of enhancing screening uptake, and some elements of informed decision-making.