ARTICLE: COLON/SMALL BOWELA Randomized Controlled Trial of Opt-in Versus Opt-Out Colorectal Cancer Screening OutreachMehta, Shivan J. MD, MBA, MSHP1,2,3,4; Khan, Tanya MD1,5; Guerra, Carmen MD, MSCE1,4; Reitz, Catherine MPH1,5; McAuliffe, Timothy BA1,5; Volpp, Kevin G. MD, PhD1,2,3,6; Asch, David A. MD, MBA1,2,3,6; Doubeni, Chyke A. MD, MPH4,5Author Information 1Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 2Penn Medicine Center for Health Care Innovation, University of Pennsylvania, Philadelphia, PA, USA. 3Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA. 4Leonard and Madlyn Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. 5Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. 6Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, USA. Correspondence: S.J.M. (email: firstname.lastname@example.org) Received 14 February 2018; accepted 14 May 2018; Published online 21 June 2018 American Journal of Gastroenterology: December 2018 - Volume 113 - Issue 12 - p 1848-1854 doi: 10.1038/s41395-018-0151-3 Buy Metrics Abstract OBJECTIVES: Colorectal cancer (CRC) screening uptake is suboptimal, despite national efforts to increase screening rates. Behavioral economic approaches such as changing defaults may increase participation. We compare response rates to opt-in or opt-out messaging in mailed fecal immunochemical test (FIT) outreach. METHODS: This is a two-arm randomized controlled trial among 314 patients aged 50-74 years who had at least two primary care visits in the 2-year pre-enrollment period and were screening-eligible but not up-to-date. Eligible patients received invitation by electronic health record (EHR) portal or mail with randomization to receive mailed FIT: (1) only if they actively opted-in to do so (opt-in) or (2) unless they opted-out of screening (opt-out). The primary outcome was FIT completion rate within 3 months of initial outreach. RESULTS: Patients randomized to opt-in agreed to participate 23.1% of the time, and only 2.5% of those in opt-out chose not to participate. FIT kits were mailed to 22.4% and 93% of patients in opt-in and opt-out arms, respectively. In intention-to-screen analysis, patients in the opt-out arm had a higher FIT completion rate (29.1%) than in the opt-in arm (9.6%) (absolute difference 19.5%; 95% confidence interval, 10.9-27.9%;P< .001). Results were similar in subgroup analysis of those sent initial messaging through the EHR portal (9.5% opt-in versus 37.5% in opt-out). CONCLUSIONS: Mailed CRC screening outreach providing an option to opt-out had significantly higher participation rates than opt-in messaging. Opt-out messaging approaches can boost participation in population health outreach efforts. © The American College of Gastroenterology 2018. All Rights Reserved.