COVID-19 SAFE Enrollment (COVID SAFE)

Opt-In Versus Opt-Out for COVID Screening Assessment for Exposure

In order to safely and effectively reopen businesses and universities across the US, institutions will need to develop approaches to rapidly identify COVID-19 cases and manage their spread while balancing program effectiveness, feasibility, costs, and scalability.

The investigators will evaluate the implementation of a COVID-19 screening program that coordinates several existing systems at the University of Pennsylvania including saliva-based viral testing and test different outreach strategies (opt-in vs opt-out) to improve program enrollment.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Behavioral: Opt-in Recruitment Email; Behavioral: Opt-out Recruitment Email

Detailed Description

The coronavirus disease 2019 (COVID-19) pandemic has resulted in close to 10,000,000 reported cases worldwide, including more than 2,000,000 aggregated reported cases and 120,000 deaths in the United States. Initial efforts to address the COVID-19 pandemic were aimed at testing symptomatic individuals, implementing stay-in-place orders, and at increasing hospital capacity to meet surge demands. While the US continues to confront the current crisis, we must plan for the future by putting in place tools to enhance our ability to conduct effective screening, containment, and case management.

Widespread COVID-19 testing is needed to safely and effectively reopen schools and businesses across the US. However, currently approved testing options require reagents that are limited in supply, severely hindering scalability. Emerging evidence indicates that saliva testing with the option of at-home sample collection can accurately identify COVID-19 viral infection. Additional diagnostic testing options will continue to increase patient access. Moreover, this approach provides an option for the easy, safe and convenient collection of samples required for testing without traveling to a doctor's office, hospital, or testing site. Collection by the patient also reduces exposure of health care workers to the virus and preserves limited personal protective equipment.

With access to expanded testing, health systems and universities will need to test alternative methods to manage COVID-19 spread while balancing program effectiveness, feasibility, costs, and scalability. Insights from the field of behavioral economics offer promise for designing and sustaining these kinds of policies. Specifically, research has demonstrated that an opt-out framed recruitment strategy compared to a conventional opt-in strategy can improve enrollment and adherence to behavioral interventions.

For these reasons, the investigators propose to evaluate the implementation of a COVID-19 screening program that uses saliva-based testing and to test approaches to improve program enrollment.

• Study Type: Interventional
• Enrollment (Actual): 412
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Penn Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

•University of Pennsylvania staff, faculty, and trainees that have returned to work on campus who have been identified by leadership at the University of Pennsylvania Perelman School of Medicine.

Exclusion Criteria:

•Participants will not be eligible for the study if they identify any reason they are unable to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opt-in Recruitment Email; Participants will receive a recruitment email that describes the objectives of a new COVID-19 voluntary screening program, and invites them to enroll.	Behavioral: Opt-in Recruitment Email; Standard, opt-in framed recruitment email
Experimental: Opt-out Recruitment Email; Participants will receive a recruitment email that describes the objectives of a new COVID-19 voluntary screening program, and informs them that they have been conditionally enrolled.	Behavioral: Opt-out Recruitment Email; Behaviorally informed, opt-out framed recruitment email

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion Enrolled	The proportion of those invited that enroll in the study	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Age	The average age of participants enrolled in the study	4 weeks
Participant Sex	The proportion of females enrolled in the study	4 weeks
Participant Race/Ethnicity	The proportion of enrolled participants belonging to specified categories of race (e.g., Alaska Native, Asian, Black or African American, Native Hawaiian or other Pacific Islander, White or Caucasian) and ethnicity (i.e., Hispanic or Latino, Non-Hispanic or Latino)	4 weeks
Participant Income	The proportion of enrolled participants belonging to specified categories of income (e.g., Less than $10000, $10000 to $19999, $20000 to $29999, $150000 or more)	4 weeks
Participant Education	The proportion of enrolled participants belonging to specified categories of education (e.g., less than high school, some high school, high school grad, college: 4 year degree, post-college education)	4 weeks
Test Completion	The proportion of enrolled participants that submit a saliva sample	8 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Mitesh S Patel, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Actual): October 30, 2020
• Study Completion (Actual): October 30, 2020

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; opt-in; opt-out; behavioral science
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 843565

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No