Article | Published:

A Randomized Controlled Trial of Opt-in Versus Opt-Out Colorectal Cancer Screening Outreach

The American Journal of Gastroenterologyvolume 113pages18481854 (2018) | Download Citation




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.


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.


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).


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.

Access optionsAccess options

Rent or Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.


  1. 1.

    Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013;63:11–30.

  2. 2.

    Nishihara R, Wu K, Lochhead P, et al. Long-term colorectal-cancer incidence and mortality after lower endoscopy. N Engl J Med. 2013;369:1095–105.

  3. 3.

    Mandel JS, Bond JH, Church TR, et al. Reducing mortality from colorectal cancer by screening for fecal occult blood. Minnesota Colon Cancer Control Study. N Engl J Med. 1993;328:1365–71.

  4. 4.

    Schoen RE, Pinsky PF, Weissfeld JL, et al. Colorectal-cancer incidence and mortality with screening flexible sigmoidoscopy. N Engl J Med. 2012;366:2345–57.

  5. 5.

    Joseph DA, King JB, Miller JW, et al. Prevalence of colorectal cancer screening among adults-Behavioral Risk Factor Surveillance System, United States, 2010. MMWR Suppl. 2012;61:51–6.

  6. 6.

    USPST Force,Bibbins-Domingo K,Grossman DC, et al. Screening for colorectal cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016;315:2564–75.

  7. 7.

    White A, Thompson TD, White MC, et al. Cancer screening test use - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017;66:201–6.

  8. 8.

    Halm EA, Beaber EF, McLerran D, et al. Association between primary care visits and colorectal cancer screening outcomes in the era of population health outreach. J Gen Intern Med. 2016;31:1190–7.

  9. 9.

    Levin TR, Jamieson L, Burley DA, et al. Organized colorectal cancer screening in integrated health care systems. Epidemiol Rev. 2011;33:101–10.

  10. 10.

    Mehta SJ, Jensen CD, Quinn VP, et al. Race/ethnicity and adoption of a population health management approach to colorectal cancer screening in a community-based healthcare system. J Gen Intern Med. 2016;31:1323–30.

  11. 11.

    Green BB, Wang C, Anderson ML, et al. An automated intervention with stepped increases in support to increase uptake of colorectal cancer screening: a randomized trial. Ann Intern Med. 2013;158:301–11.

  12. 12.

    Sequist TD, Zaslavsky AM, Colditz GA, et al. Electronic patient messages to promote colorectal cancer screening: a randomized, controlled trial. Arch Intern Med. 2011;171:636–41.

  13. 13.

    Charters TJ, Strumpf EC, Sewitch MJ. Effectiveness of an organized colorectal cancer screening program on increasing adherence in asymptomatic average-risk Canadians. BMC Health Serv Res. 2013;13:449.

  14. 14.

    Klabunde C, Blom J, Bulliard J-L, et al. Participation rates for organized colorectal cancer screening programmes: an international comparison. J Med Screen. 2015;22:119–26.

  15. 15.

    Daly JM, Levy BT, Merchant ML, et al. Mailed fecal-immunochemical test for colon cancer screening. J Community Health. 2010;35:235–9.

  16. 16.

    Wilson FA, Villarreal R, Stimpson JP, et al. Cost-effectiveness analysis of a colonoscopy screening navigator program designed for Hispanic men. J Cancer Educ. 2015;30:260–7.

  17. 17.

    Elkin EB, Shapiro E, Snow JG, et al. The economic impact of a patient navigator program to increase screening colonoscopy. Cancer. 2012;118:5982–8.

  18. 18.

    Gupta S, Halm EA, Rockey DC, et al. Comparative effectiveness of fecal immunochemical test outreach, colonoscopy outreach, and usual care for boosting colorectal cancer screening among the underserved: a randomized clinical trial. JAMA Intern Med. 2013;173:1725–32.

  19. 19.

    Singal AG, Gupta S, Skinner CS, et al. Effect of colonoscopy outreach vs fecal immunochemical test outreach on colorectal cancer screening completion: a randomized clinical trial. JAMA. 2017;318:806–15.

  20. 20.

    Tversky A, Kahneman D. The framing of decisions and the psychology of choice. Science. 1981;211:453–8.

  21. 21.

    Mehta SJ, Asch DA. How to help gastroenterology patients help themselves: leveraging insights from behavioral economics. Clin Gastroenterol Hepatol. 2014;12:711–4.

  22. 22.

    Kahneman D, Tversky A. Prospect theory: an analysis of decision under risk. Econometrica. 1979;47:263–91.

  23. 23.

    Loewenstein G, Brennan T, Volpp KG. Asymmetric paternalism to improve health behaviors. JAMA. 2007;298:2415–7.

  24. 24.

    O’Donoghue T, Rabin M. Doing it now or later. Am Econ Rev. 1999;89:103–24.

  25. 25.

    Samuelson W, Zeckhauser R. Status quo bias in decision making. J Risk Uncertain. 1988;1:7–59.

  26. 26.

    Halpern SD, Ubel PA, Asch DA. Harnessing the power of default options to improve health care. New Engl J Med. 2007;357:1340–4.

  27. 27.

    Chapman GB, Li M, Colby H, et al. Opting in vs opting out of influenza vaccination. JAMA. 2010;304:43–44.

  28. 28.

    Johnson EJ, Goldstein D. Do defaults save lives? Science. 2003;302:1338–9.

  29. 29.

    Mehta SJ, Troxel AB, Marcus N, et al. Participation rates with opt-out enrollment in a remote monitoring intervention for patients with myocardial infarction. JAMA Cardiol. 2016;1:847–8.

  30. 30.

    Yudin MH, Moravac C, Shah RR. Influence of an “opt-out” test strategy and patient factors on human immunodeficiency virus screening in pregnancy. Obstet Gynecol. 2007;110:81–6.

  31. 31.

    Aysola J, Tahirovic E, Troxel AB, et al. A randomized controlled trial of opt-in versus opt-out enrollment into a diabetes behavioral intervention. Am J Health Promot. 2016;32:745–52.

  32. 32.

    Schwartz J, Mochon D, Wyper L, et al. Healthier by precommitment. Psychol Sci. 2014;25:538–46.

  33. 33.

    Milkman KL, Beshears J, Choi JJ, et al. Using implementation intentions prompts to enhance influenza vaccination rates. Proc Natl Acad Sci USA. 2011;108:10415–20.

  34. 34.

    Asch DA, Ziolek TA, Mehta SJ. Misdirections in informed consent - impediments to health care innovation. N Engl J Med. 2017;377:1412–4.

  35. 35.

    U.S. Census Bureau. Social Explorer [database online]. Social Explorer, Bronxville, NY. 2015. Accessed 28 Sep 2017.

  36. 36.

    Myers RE, Sifri R, Hyslop T, et al. A randomized controlled trial of the impact of targeted and tailored interventions on colorectal cancer screening. Cancer. 2007;110:2083–91.

  37. 37.

    Charlton ME, Mengeling MA, Halfdanarson TR, et al. Evaluation of a home-based colorectal cancer screening intervention in a rural state. J Rural Health. 2014;30:322–32.

  38. 38.

    Myers RE, Ross EA, Wolf TA, et al. Behavioral interventions to increase adherence in colorectal cancer screening. Med Care. 1991;29:1039–50.

  39. 39.

    Church TR, Yeazel MW, Jones RM, et al. A randomized trial of direct mailing of fecal occult blood tests to increase colorectal cancer screening. J Natl Cancer Inst. 2004;96:770–80.

  40. 40.

    Goldman SN, Liss DT, Brown T, et al. Comparative effectiveness of multifaceted outreach to initiate colorectal cancer screening in community health centers: a randomized controlled trial. J Gen Intern Med. 2015;30:1178–84.

  41. 41.

    Mehta SJ, Feingold J, Vandertuyn M, et al. Active choice and financial incentives to increase rates of screening colonoscopy: a randomized controlled trial. Gastroenterology. 2017;153:1227–9.

  42. 42.

    Narula T, Ramprasad C, Ruggs EN, et al. Increasing colonoscopies? A psychological perspective on opting in versus opting out. Health Psychol. 2014;33:1426–9.

  43. 43.

    van Roon AH, Hol L, Wilschut JA, et al. Advance notification letters increase adherence in colorectal cancer screening: a population-based randomized trial. Prev Med. 2011;52:448–51.

  44. 44.

    Cole SR, Smith A, Wilson C, et al. An advance notification letter increases participation in colorectal cancer screening. J Med Screen. 2007;14:73–75.

  45. 45.

    Fehr E,Gachter S, Fairness and retaliation: the economics of reciprocity. J Econ Perspect. 2000;14:159–81.

  46. 46.

    Kahneman D, Knetsch JL, Thaler RH. Experimental tests of the endowment effect and the Coase theorem. J Political Econ. 1990;98:1325–48.

  47. 47.

    Keller PA, Harlam B, Loewenstein G, et al. Enhanced active choice: a new method to motivate behavior change. J Consum Psychol. 2011;21:376–83.

  48. 48.

    Lansdorp-Vogelaar I, Knudsen AB, Brenner H. Cost-effectiveness of colorectal cancer screening. Epidemiol Rev. 2011;33:88–100.

  49. 49.

    Lairson DR, Dicarlo M, Deshmuk AA, et al. Cost-effectiveness of a standard intervention versus a navigated intervention on colorectal cancer screening use in primary care. Cancer. 2014;120:1042–9.

  50. 50.

    Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172:575–82.

Download references

Author information


  1. Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

    • Shivan J. Mehta MD, MBA, MSHP
    • , Tanya Khan MD
    • , Carmen Guerra MD, MSCE
    • , Catherine Reitz MPH
    • , Timothy McAuliffe BA
    • , Kevin G. Volpp MD, PhD
    •  & David A. Asch MD, MBA
  2. Penn Medicine Center for Health Care Innovation, University of Pennsylvania, Philadelphia, PA, USA

    • Shivan J. Mehta MD, MBA, MSHP
    • , Kevin G. Volpp MD, PhD
    •  & David A. Asch MD, MBA
  3. Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA

    • Shivan J. Mehta MD, MBA, MSHP
    • , Kevin G. Volpp MD, PhD
    •  & David A. Asch MD, MBA
  4. Leonard and Madlyn Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA

    • Shivan J. Mehta MD, MBA, MSHP
    • , Carmen Guerra MD, MSCE
    •  & Chyke A. Doubeni MD, MPH
  5. Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA

    • Tanya Khan MD
    • , Catherine Reitz MPH
    • , Timothy McAuliffe BA
    •  & Chyke A. Doubeni MD, MPH
  6. Center for Health Equity Research and Promotion, Philadelphia VA Medical Center, Philadelphia, PA, USA

    • Kevin G. Volpp MD, PhD
    •  & David A. Asch MD, MBA


  1. Search for Shivan J. Mehta MD, MBA, MSHP in:

  2. Search for Tanya Khan MD in:

  3. Search for Carmen Guerra MD, MSCE in:

  4. Search for Catherine Reitz MPH in:

  5. Search for Timothy McAuliffe BA in:

  6. Search for Kevin G. Volpp MD, PhD in:

  7. Search for David A. Asch MD, MBA in:

  8. Search for Chyke A. Doubeni MD, MPH in:

Guarantor of the article

Shivan J. Mehta, MD, MBA, MSHP.

Specific author contributions: S.J.M., T.K., C.G., C.R., T.M., and C.A.D. planned and conducted the study; all authors collected and/or interpreted the data; S.J.M., T.K., C.G., C.R., K.G.V., D.A.A., and C.A.D. drafted and revised the manuscript. All authors approved the final draft submitted.

Financial support: This trial was funded by a Breakthrough Bike Challenge award through the Abramson Cancer Center at the University of Pennsylvania. C.A.D.’s time is supported by grant number R01CA213645 from the National Cancer Institute of the National Institutes of Health. The sponsors had no role in the study design, collection, analysis and interpretation of the data, and in the writing of the report.

Potential competing interests: K.G.V. and D.A.A. are principals at the behavioral economics consulting firm VAL Health. K.G.V. has received consulting income from CVS Caremark and research funding from Humana, CVS Caremark, Discovery (South Africa), Hawaii Medical Services Association, Weight Watchers, and Merck. C.A.D. is a member of the US Preventive Services Task Force (USPSTF). This article does not necessarily represent the views and policies of the USPSTF. The other authors declare that they have no conflict of interest.

Corresponding author

Correspondence to Shivan J. Mehta MD, MBA, MSHP.

Electronic supplementary material

About this article

Publication history