COVID-19 Citizen Science Expansion Project
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|ClinicalTrials.gov Identifier: NCT05548803|
Recruitment Status : Enrolling by invitation
First Posted : September 21, 2022
Last Update Posted : October 4, 2022
COVID-19 Citizen Science (CCS), launched in March 2020, supports collaborative research on symptoms, risk factors, surveillance, biomarkers and testing for COVID-19 using the Eureka Research Platform. CCS maintains IRB approval with UCSF's IRB (UCSF IRB# 17-21879).
This CCS Expansion Project, which is funded jointly by the National Institutes of Health (NIH), the Patient-Centered Outcomes Research Institute (PCORI), and the Bill and Melinda Gates Foundation, will invite patients at health systems across the US to contribute their health records data and then join the established CCS study, allows for linked analysis of CCS data and health records data, and provides the scientific rationale and plan for the project.
|Condition or disease|
Shelter-in-place orders, social distancing, and mandatory closure of non-essential businesses across the country have suppressed transmission of SARS-CoV-2 and limited direct health impact of the COVID-19 Pandemic. These policies, however, exact an enormous societal cost and cannot be maintained indefinitely. When and how to lift restrictions represents the defining challenge of our time for local, state and national leaders, and requires excruciating decisions that balance lives lost from coronavirus infection against economic, social and indirect health effects of restrictive policy. To understand the impact of these decisions, we must hear from patients. We propose to recruit a large population-based sample of PCORnet patients into our digital cohort of "COVID-19 Citizen Scientists," gather patient-reported outcomes with linked electronic health record (EHR), and analyze it to answer the following critical research questions (RQs):
RQ1: What is the comparative impact of different shelter-in-place/reopening policies, overall and in vulnerable populations, on patient-reported financial insecurity, mental health, and other subjective outcomes important to patients? The natural experiment that occurs as state governors and local county health departments across the US differentially lift and/or reinstate shelter-in-place policies, and that is ongoing today as the US considers reopening fully (despite threats from new coronavirus variants), represents an analytic opportunity to estimate and compare benefits and harms of different policies, both overall and for vulnerable subsets of the population. To leverage this opportunity, we will collect a detailed record of county- (and state-) level COVID-19-related policies, including shelter-in-place (aka containment & closure), economic response and public health policies, starting at the beginning of the Pandemic in March 2020 and continuing through the end of the year into 2021. We have selected 119 counties for data collection where we have the most patient-reported survey responses through 2020, and where we expect to enroll many new participants through Fall 2021. We will use these data to analyze the impact on patient-reported outcomes, and then make them available to other investigators.
RQ2: What is the comparative effectiveness of county-level containment and mitigation strategies at achieving timely access to COVID-19 vaccination (overall and among previously hesitant persons), testing, healthcare, information, and contact tracing, overall and in vulnerable populations? Timely access to containment and mitigation strategies were (and will continue to be) critical to quickly detect and slow transmission of coronavirus and future pandemics in communities, and to effectively care for patients who become infected. Unlike shelter-in-place policies that are highly publicized, containment and mitigation strategies are about resource allocation and operational effectiveness. Decision-making may be hidden, but we can measure the effectiveness of these strategies by asking patients. For example, we can assess reasons for vaccination among participants that were previously hesitant, delays in coronavirus testing after patients develop symptoms using our daily symptom survey data to provide the denominator (all symptomatic patients) and the anchor time point (time of symptom onset); and weekly surveys will assess access to critical information (e.g., "Do you know how to get a COVID-19 test?") and contact tracing after testing positive.
|Study Type :||Observational|
|Estimated Enrollment :||150000 participants|
|Official Title:||Comparing Patient-reported Impact of COVID-19 Shelter-in-place Policies and Access to Containment and Mitigation Strategies, Overall and in Vulnerable Populations|
|Actual Study Start Date :||November 24, 2020|
|Estimated Primary Completion Date :||June 1, 2023|
|Estimated Study Completion Date :||June 1, 2023|
- Difficulty paying "for the very basics" [ Time Frame: Over the course of the pandemic, up to 5 years ]This outcome is assessed by asking the following question monthly: "How hard is it for you (and your family) to pay for the very basics like food, rent or mortgage, heating, etc over the past 30 days?" Possible scores range from 1 (very hard) to 4 (not very hard), "Don't know" and "Prefer not to state."
- Time-to-testing if symptomatic [ Time Frame: Over the course of the pandemic, up to 5 years ]Time-to-testing, measured by number of days, will be calculated by subtracting COVID-19 testing date from date of symptom onset.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05548803
|United States, California|
|Sacramento, California, United States, 95833|
|University of California, San Francisco|
|San Francisco, California, United States, 94158|
|United States, Illinois|
|Advocate Aurora Health|
|Downers Grove, Illinois, United States, 60515|
|United States, Louisiana|
|Ochsner Health System|
|New Orleans, Louisiana, United States, 70121|
|United States, New York|
|Albert Einstein College of Medicine|
|Bronx, New York, United States, 10467|
|NYC Health + Hospitals|
|New York, New York, United States, 10004|
|New York University|
|New York, New York, United States, 10016|
|United States, Texas|
|Baylor Scott and White Health|
|Dallas, Texas, United States, 95246|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Mark Pletcher, MD, MPH||University of California, San Francisco|