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

Subjects

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.

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Author information

Affiliations

  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

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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.

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DOI

https://doi.org/10.1038/s41395-018-0151-3