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Effect of Opt-In vs Opt-Out Framing on Enrollment in a COVID-19 Surveillance Testing ProgramThe COVID SAFE Randomized Clinical Trial

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

The SARS-CoV-2 (COVID-19) pandemic has caused workplaces and campuses to close or shift many people to remote work. To safely reopen, surveillance testing is needed to help to identify asymptomatic and presymptomatic cases.1,2 We conducted a clinical trial to rapidly implement and scale a saliva-based method for COVID-19 surveillance testing.3 However, participation in clinical trials is often suboptimal. In prior work,4,5 opt-out framed recruitment strategies have shown promise for increasing program enrollment; this approach may leverage status quo bias. In this randomized clinical trial, we tested the effect of an opt-out framed recruitment strategy compared with a conventional opt-in strategy on enrollment and initial adherence to a COVID-19 testing program.

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Article Information

Accepted for Publication: April 7, 2021.

Published: June 3, 2021. doi:10.1001/jamanetworkopen.2021.12434

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2021 Oakes AH et al. JAMA Network Open.

Corresponding Author: Allison H. Oakes, PhD, VA Health Services Research & Development Center for Health Equity Research and Promotion, Crescenz Veterans Affairs Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104 (alli.oakes@gmail.com).

Author Contributions: Drs Oakes and Patel had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Oakes, Epstein, Evans, Patel.

Acquisition, analysis, or interpretation of data: Oakes, Ganguly, Park.

Drafting of the manuscript: Oakes, Park, Evans.

Critical revision of the manuscript for important intellectual content: Oakes, Epstein, Ganguly, Park, Patel.

Statistical analysis: Oakes, Park.

Obtained funding: Epstein, Patel.

Administrative, technical, or material support: Epstein, Ganguly, Evans.

Supervision: Epstein, Evans, Patel.

Conflict of Interest Disclosures: Dr Oakes reported receiving support from the Department of Veterans Affairs Advanced Fellowship Program in Health Services Research & Development. Dr Patel reported being a founder of Catalyst Health, a technology and behavior change consulting firm; being an advisory board member for Healthmine Services Inc, LifeVest Health, and Holistic Industries; and receiving research funding from Deloitte, which is not related to the work described in this article. No other disclosures were reported.

Funding/Support: Funding for this work was provided by the Perelman School of Medicine at the University of Pennsylvania and the University of Pennsylvania Health System through the Penn Medicine Nudge Unit.

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Disclaimer: The contents of this manuscript do not represent the views of the US Department of Veterans Affairs or the US government.

Data Sharing Statement: See Supplement 3.

Additional Contributions: Sarah Fendrich, BA, Ai Leen Oon, BA, Kayla Clark, BA, Penn Medicine, and Andrew Parambath, BA (all at Penn Medicine), assisted with COVID SAFE program administration and management. Frederic Bushman, PhD (Penn Medicine), Scott Sherrill-Mix, PhD (Penn Medicine), and the University of Pennsylvania Rapid Assay Task Force provided guidance on assay development. Dorothy Leung, MA (Penn Medicine), assisted with program administration. None of these individuals was compensated beyond their regular salary.

References
1.
Rafiei  Y , Mello  MM .  The missing piece—SARS-CoV-2 testing and school reopening.   N Engl J Med. 2020;383(23):e126. doi:10.1056/NEJMp2028209PubMedGoogle Scholar
2.
Paltiel  AD , Zheng  A , Walensky  RP .  Assessment of SARS-CoV-2 screening strategies to permit the safe reopening of college campuses in the United States.   JAMA Netw Open. 2020;3(7):e2016818. doi:10.1001/jamanetworkopen.2020.16818PubMedGoogle Scholar
3.
Sherrill-Mix  S , Hwang  Y , Roche  AM ,  et al.  LAMP-BEAC: detection of SARS-CoV-2 RNA using RT-LAMP and molecular beacons.   medRxiv. Published online April 16, 2021. doi:10.1101/2020.08.13.20173757Google Scholar
4.
Mehta  SJ , Khan  T , Guerra  C ,  et al.  A randomized controlled trial of opt-in versus opt-out colorectal cancer screening outreach.   Am J Gastroenterol. 2018;113(12):1848-1854. doi:10.1038/s41395-018-0151-3PubMedGoogle ScholarCrossref
5.
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. 2018;32(3):745-752. doi:10.1177/0890117116671673PubMedGoogle ScholarCrossref
6.
Volpp  KG , Loewenstein  G , Buttenheim  AM .  Behaviorally informed strategies for a national COVID-19 vaccine promotion program.   JAMA. 2021;325(2):125-126.PubMedGoogle Scholar
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