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临床试验/NCT04506268
NCT04506268已完成不适用

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

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2020年9月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
412
试验地点
2
主要终点
Proportion Enrolled

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Proportion Enrolled

时间窗: 4 weeks

The proportion of those invited that enroll in the study

次要结局

  • Participant Age(4 weeks)
  • Participant Race/Ethnicity(4 weeks)
  • Participant Income(4 weeks)
  • Test Completion(8 weeks)
  • Participant Sex(4 weeks)
  • Participant Education(4 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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