Informes del proyecto
Fight COVID MKE Project Update for CTSI External Advisory Committee | November 30, 2022
To: Fight COVID MKE participants and the community
From September 2020 to September 2022, NCATS awarded the MCW CTSI with a $5M grant to perform “Randomized COVID-19 Testing in Vulnerable Communities and Risk Tool Creation.” The project is called Fight COVID MKE. This report summarizes activities and preliminary results and outcomes by specific aims.
Aim 1: Use randomized COVID antibody testing in Milwaukee to measure the population proportion infected and how this proportion varies over time and with patient demographic and health characteristics. Partner with 20 primary care health centers and with local churches to conduct community outreach and engagement and oversample minority, poor, and elderly populations to obtain more precise estimates for these groups.
Major activities
- MCW IRB approved protocol, consent form, survey instrument, antibody testing, health record linkages, as well as focus groups. MCW IRB reliance by research partners Progressive, Outreach and 16th St community health centers as well as Northwestern and Indiana universities and William & Mary College.
- Research agreement partnerships with 20 primary care health centers, 3 community agencies, and 2 faith conventions/jurisdictions (including 50 churches in the Milwaukee area) for recruitment of participants in the antibody test/survey/health record study
- Establishment of the MCW Fight COVID MKE website home page with REDCap eligibility, consent and survey forms in English and Spanish; also established web-based risk assessment tool, for both individual and group risks
- Participation of 72 diverse adults in focus groups about communicating COVID risks and vaccine benefits/risks; plan additional focus groups/interviews of media reporters and producers, and public health officials
- Established Community Advisory Board with 8 diverse community leaders; sought advice of Campus Community Partnerships for Health
- Collaboration with other Milwaukee community partners including 5 community agencies, public health collaborative with 11 local health departments, philanthropic Civic Action Teams, and MCW All of Us Research program
Significant results: Preliminary survey results: From March – November 2021, 1,880 adults living in Milwaukee County participated in the survey and antibody test study with the following highlighted results:
Personal, household and family experiences with COVID
- 17% had a positive COVID infection test; 19% of them moved in the past 12 months
- 91% have received a COVID vaccine
- 9% of all participants have chronic symptoms t> 3 months that they think are from COVID such as fatigue, shortness of breath, anxiety, and sleep problems
- 11% had someone who lives with them have a COVID infection
- 39% had someone in their family living outside their home who had COVID; 10% of family members were hospitalized for COVID; 6% have family members who died of COVID
Demographics
- Age: average 59, range 18-89; 66% female
- Race/ethnicity: 71% White, 19% Black/African American, 8% Hispanic/Latinx, 4% Asian, 3% Mixed
- Health insurance (some dual enrolled): 54% Medicare, 29% employer-sponsored,16% Medicaid
Self-reported health
- General health: 51% excellent/very good; 15% fair/poor
- 40% high blood pressure, 26% depression, 26$ diabetes, 20% asthma, 18% cancer
Key outcomes
Number of antibody/survey study participants enrolled March 23, 2021 – January 19, 2022:
- 2,886 consents; 825 four-month follow ups
- 22% black, 8% Hispanic; 22% Medicaid
- 11% non-Froedtert
- COVID antibody tests
- 2,096 baseline (73% of consents): 7% positive nucleocapsid = past infection; 94% positive spike protein = response to vaccine/infection
- 895 follow up: 6% positive capsid; 97% positive spike
Preliminary results from 6 community focus groups
- Recommended use charts instead of data tables for COVID risk estimator (recommendation implemented); liked our comparison of COVID risk of death relative to cancer and car crashes
- White groups generally felt safe with vaccines, interested in antibody protection, frustrated with people who refuse vaccines; African American groups generally noted medical mistrust due to historical occurrences, need for representation in research, more personal and family adverse impact of COVID infections
Aim 2: Use extensive data linkages to assess risks for infection to progress to symptoms, hospitalization, ICU stay, or death and corresponding population rates as a function of patient and community characteristics
Major activities
- The Wisconsin Department of Health Services executed data use agreements with MCW and Northwestern University (Professor Bernie Black, JD, MS is co-PI) for all Milwaukee County adults for records since 2018 for COVID viral test results (both positive and negative), COVID and influenza vaccines, Medicaid claims, and death records (statewide) to address our specific aims.
- Froedtert Health system, 2 MCW family health centers at Ascension-WI, Progressive and Outreach community health center have established MCW research agreements to share electronic health records for all adult patients living in Milwaukee since 2018 to address our specific aims. 16th St Community Health Center will provide EHR data for all patients who are consenting participants.
- CTSI programmers are using Datavant to link the participant surveys, antibody test results, and electronic health records to the state data, then deidentifying the linked data to send to Northwestern U for analyses and to Duke CDCC for NIH data sharing.
Significant results and key outcomes: In December, some of the above data sets were securely transferred from MCW to NU and to Duke. We have accomplished the following impactful work:
- Built out the COVID risk calculator, using individual mortality data from Milwaukee County, Cook County, Illinois, and the state of Indiana including Delta variant in July; currently analyzing death data including Omicron variant through December
- Linked mortality outcomes to demographic characteristics and mortality estimates at the 5-digit zip code level, using data from the American Community Survey and Medicare fee-for-service claims records for a 5% national sample
- We analyzed the COVID pandemic, years of life lost, and life expectancy with decomposition using individual-level mortality data. Life expectancy loss exceeded 3 months for persons age 75+ and was substantially higher for blacks and Hispanics than for whites at all ages. Mean age at death was 80 during 2020. It fell to 69 overall and 57 for Latino men during 2021. We submitted the manuscript for publication. It is posted at http://ssrn.com/abstract=3795801.
- We analyzed the effects of short-term air pollution exposure on US COVID mortality observing that one standard deviation higher aerosol optical depth over 2 weeks predicts 6% higher COVID mortality. The manuscript has been submitted for publication. The paper is posted at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4006616.
Aim 3: When COVID vaccines become available, use the risk assessment tool to estimate individual risk, work with community partners to encourage vaccination of higher risk individuals; measure antibody response to vaccination.
Major activities
- The MCW website with COVID individual risk estimator is live and publicly available on the Fight COVID MKE Individual Risk Estimator page and the Fight COVID MKE Group Risk Comparison Tool page.
Significant results and key outcomes
- From March 19, 2021-February 2, 2022, the website has had a total 38,500 sessions including 27,500 COVID individual risk estimator sessions.
From March-July 2021, 1,018 adults living in Milwaukee County participated in the Fight COVID MKE survey and antibody test study. This report summarizes their answers to questions:
Personal, household and family experiences with COVID
- 17% tested positive for COVID
- 90% have received a COVID vaccine
- Wear a face mask indoors when outside their home:
- 69% always/almost always
- 10% seldom/never
- 11% of all participants have chronic symptoms that they think are from COVID such as fatigue, difficulty concentrating, and anxiety
- 10% had someone who lives with them have COVID
- 10% of spouses/roommates were hospitalized for COVID
- none died
- 39% had someone in their family living outside their home who had a positive COVID infection test; 10% of family members were hospitalized for COVID; 6% of family members died of COVID
Demographics of participants
- Average age: 59
- Race/ethnicity:
- 72% White
- 16% Black/African American
- 9% Hispanic/Latinx
- 5% Asian
- 4% Mixed
- 92% straight/heterosexual
- 74% have other adults in home
- 23% have children in home
- Employment:
- 26% health care worker
- 24% job with daily contact with people
- 14% job interacting in person with customers
- 25% no work-related in-person contacts
- Health insurance: 55% Medicare, 28% employer-sponsored, 27% other private, 15% Medicaid
Self-reported health
- General health: 50% excellent/very good; 16% fair/poor
- 38% high blood pressure
- 27% depression (10% currently depressed)
- 20% asthma
- 17% cancer
- 15% diabetes
- 10% take medicine or get treatment that may affect immune system
- 7% smoke cigarettes now
- 1% problem with alcohol or drug abuse
Acknowledgements: The NIH funds the project led by the MCW Clinical and Translational Science Institute, in partnership with Northwestern University, with enrollment supported by clinical research coordinators, and data management and analyses done by experts in CTSI and the Institute for Health & Equity.
Fight COVID MKE is a Medical College of Wisconsin Clinical and Translational Science Institute (CTSI) project funded by a supplemental National Institutes of Health grant that runs from September 2020 – September 2022. The principal investigators are John Meurer, MD, MBA; Reza Shaker, MD, at MCW; and Bernie Black, JD, MS, at Northwestern University. CTSI hired 13 new staff in January to launch the study.
The project recruits adults living in Milwaukee County who are either patients at one of 12 primary care health centers or are enrolled in Wisconsin Medicaid/BadgerCare. Seven Froedtert & MCW clinics are currently recruiting patient participants. Two clinics at Ascension, and Outreach, Progressive, and 16th Street Community Health Centers will begin enrollment expected in June. This summer, we will also recruit through churches and community centers to include adults enrolled in Medicaid/BadgerCare who do not get care at the participating clinics.
With consent, thousands of participants will be compensated to answer survey questions and get COVID antibody tests to assess past infection and response to vaccine. We want to enroll people who had COVID and those who didn’t as well as people who got a COVID vaccine and those who didn’t.
This study is important because it especially engages vulnerable communities that have had an extra burden of suffering from COVID such as people of Black/African American, Hispanic/Latino, or Native American backgrounds. We also want to better understand how challenges like housing problems, food insecurity, and losing a job affect COVID risks and outcomes.
MCW and Northwestern researchers will confidentially analyze antibody test results, surveys, health records, and data from Wisconsin Department of Health Services to answer several questions:
- What percent of adults in MKE have ever been infected by COVID? (The CDC estimates 34%.)
- How long do COVID antibodies last and protect people from reinfection? (Studies suggest at least 6-12 months.)
- What factors affect the risk of severe illness and death from COVID infection? (Older age, people of color, chronic conditions, and housing and food insecurity are associated with higher risk. But little is known how combined factors influence risk of hospitalization and death. Moreover, we are learning how to best communicate this risk, and benefits of vaccine to diverse audiences.
- After COVID vaccination, do adults get infected with new variants? (Time will tell. Our study will continue through late 2022.)
For more information, visit the Fight COVID MKE website to find out if you are eligible for the study.
The project, Fight COVID MKE, will conduct antibody testing, measuring who has been infected with the SARS-CoV-2 virus in the past. Fight COVID MKE will recruit patients at 12 primary healthcare centers throughout Milwaukee County and conduct more than 20,000 COVID-19 antibody tests and surveys in 2021 on a randomized basis. This will enable researchers to estimate the true population infection rate, expected to be much higher than the infection rate based on viral testing. Fight COVID MKE aims to find out exactly how much higher. Fight COVID MKE is part of the NIH Rapid Acceleration of Diagnostics (RADx) initiative and funded through September 2022 as part of the RADx Underserved Populations (RADx-UP) program, which focuses on vulnerable populations affected by the pandemic.
Fight COVID MKE aims to better understand infection rates and outcomes in Milwaukee, especially among vulnerable communities, to assess disparities in infection rates, disease progression and outcomes, and to develop strategies to reduce these disparities.
Principal investigators are Reza Shaker, MD, MCW Senior Associate Dean, Associate Provost of Clinical and Translational Research, and Director of the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI); John Meurer, MD, director of the MCW Institute for Health & Equity, who leads the testing effort, and Professor Bernard Black of Northwestern University, who brings causal inference expertise and leads the data analysis.
“Our RADx-UP study will let us measure the proportion of adults infected by COVID-19, assess risks for hospitalization, ICU stay and death, develop a web-based risk assessment tool, and measure antibody levels after a vaccine is available,” Dr. Meurer said. “The support of our many community partners, including community health centers and the faith-based community, will allow us to recruit diverse individuals in Milwaukee for testing to achieve these aims.”
Researchers will conduct the study throughout Milwaukee with outreach to and oversampling of vulnerable communities with the help of the community health centers and the CTSI Faith-based Trusted Messenger Network of churches. With participant consent, this project will link antibody and survey data to healthcare and Medicaid records, COVID-19 viral test results, and create a web-based risk assessment tool that will allow individuals to assess their own COVID-19 risks.
“Working collaboratively with the faith community and church leaders is a uniquely effective and important way to inform, engage and involve our citizens in advancing the health of our communities through research and discovery,” Dr. Shaker said. “We are fortunate and grateful for their participation in this important project.”
FightCOVIDMKE benefits from MCW’s established community partnerships. For several years, MCW has engaged diverse communities in Milwaukee through partnerships with 150 church congregations. The strong foundation of trust that community members have in their ministers and parish nurses will help Fight COVID MKE recruit minority individuals for antibody testing and eventually vaccine distribution.
Additionally, since the beginning of the pandemic, MCW has worked with trusted community centers and churches to offer vulnerable communities a web-based resource center and public health messaging, and to develop evidence-based guidelines for businesses and schools to reduce infection risks. MCW also holds virtual community town hall meetings with scientists and community leaders.
Progressive Community Health Centers is one of Fight COVID MKE’s many partners and serves under-represented populations who experience high rates of health disparities linked to greater risk of COVID-19 infection. “We are proud to work with other local organizations serving on the frontlines of COVID-19 testing and research,” said Dr. Allison Kos, Progressive chief medical officer. “The Fight COVID MKE project is an important next step in learning more about the virus and how it impacts our community.”
Fight COVID MKE will hire research coordinators from the affected communities, hold COVID-19 information sessions remotely with churches, recruit study participants through trusted primary care health centers, establish a community advisory council, hold focus groups on communicating COVID-19 risks and risk-reduction steps, and promote the study through trusted partners’ social media accounts. Preliminary findings will be discussed quarterly with the affected community for their views on validity, implications, and more effective outreach. Study enrollment, the individual COVID-19 risk assessment tool, and evidence-based guidelines will be housed on the FightCOVIDMKE website.
“Fight COVID MKE is an important opportunity to advance our knowledge of COVID-19 and its impact on public health,” said Joseph E. Kerschner, MD, dean of the School of Medicine and executive vice president and provost of MCW. “Furthermore, it is a strong testament to MCW’s community engagement efforts and trusting relationships with partners.”
Fight COVID MKE will leverage data from many sources to recruit patients from Milwaukee County. Researchers will perform population and cohort analyses and develop a web-based risk assessment tool that will provide both individuals and healthcare professionals with important information about person-specific COVID-19 risk factors. Fight COVID MKE will engage the Wisconsin Health Information Organization for Medicaid and other claims data, Wisconsin Electronic Disease Surveillance System for viral testing results, Wisconsin Vital Records data for deaths and causes, and Wisconsin Department of Health Services for Medicaid enrollment data. Primary care sites will query their databases for eligible participants to enable random selection for contact about study enrollment. Participants will complete surveys and receive antibody tests. The analysis and web-tool development will rely on de-identified data on patient populations and tested persons.
The Child Advancement Network (CAN)/Vroom Wisconsin Initiative is an example of an MCW CTSI community partnership improving community health, by fostering early brain development among children with partners in childcare, healthcare, schools, nonprofit and faith-based sectors. The program has more than 150 community-based partners. The first CTSI Pastoral Conference, pictured above, was held with pastors to discuss ways to integrate the program into their congregations and various ministries.
To respond to the COVID-19 (hereafter, COVID) pandemic, it is critical to have accurate knowledge of infection rates, the population proportion that will develop antibody response, and the proportion that will progress to various stages- symptomatic infection, hospitalization, ICU admission, and death. We propose a study at several levels. First, we will conduct large-scale randomized antibody testing of adults in Milwaukee County (MKE), linked to detailed data on health, demographics, viral testing, and mortality. We will determine how many people are seropositive for COVID antibodies, and how these proportions vary with patient characteristics (including age, sex, race/ethnicity, income, comorbidities). For seropositive participants, we will assess intrafamily transmission by testing households. MKE has a substantial proportion of underserved and vulnerable residents. We will partner with primary care health centers and local churches to engage and oversample racial/ethnic minorities and low-income persons, to obtain more accurate estimates for these groups and compensate for difficulties in reaching these populations. We will use statistical methods to adjust for persons who decline to be tested to obtain unbiased estimates. We will match antibody test results to viral test records to determine the proportion of infected persons who are seronegative. Through repeat testing of seropositive persons, we will assess antibody decay rates and new infection and reinfection rates.
Second, we will use data from MKE, other sites that perform randomized COVID testing, and other sources to build a web-based individual risk-assessment tool, similar to the risk calculators used by physicians to decide on treatment and screening for cardiovascular and other diseases. This evidence-based tool will allow individuals and health care professionals to assess progression risk and household transmission risk, as a function of personal and household characteristics. This tool will be valuable nationwide. Granular risk assessment is crucial for individuals in deciding what protection steps to take, and to policy makers for assessing the costs and benefits of reopening or reclosing steps. This assessment is not possible with currently available data. One needs randomized antibody testing, linked to health, viral testing, demographic, hospitalization, and mortality data.
Third, when vaccines become available, health care systems and centers and public health departments nationwide can use the risk assessment tool to prioritize outreach to and provide initially limited vaccine supplies to persons at highest risk, who will be some combination of elderly, minority, disabled, and with comorbidities. We will also use test vaccinated persons to assess seropositivity after vaccination and measure post-vaccination infection risk.
Aim 1: Use randomized COVID antibody testing in MKE to measure the population proportion infected and how this proportion varies over time and with patient demographic and health characteristics. Partner with 12 primary care health centers and with local churches to conduct community outreach and engagement and oversample minority, poor, and elderly populations to obtain more precise estimates for these groups.
- Aim 1.1. Conduct antibody testing for a minimum of 18,000 adults in year 1 and 5,000 in year 2; determine the proportion who are seropositive as a function of personal and community characteristics; measure reinfection risk.
- Aim 1.2. Test known-infected persons to measure the proportion who are antibody negative; use this information to improve estimates of the proportion infected and measure decay over time of antibody response to infection.
Aim 2: Use extensive data linkages to assess risks for infection to progress to symptoms, hospitalization, ICU stay, or death and corresponding population rates as a function of patient and community characteristics.
- Aim 2.1. Develop a web-based risk assessment tool (in English and Spanish) to allow individuals, families, and health care professionals to assess individual and household risk; advise high-risk individuals on risk mitigation.
- Aim 2.2. Assess the extent to which race/ethnicity and poverty predict progression, controlling for other risk factors (age, gender, comorbidities)
- Aim 2.3. Assess within-household transmission risk; include this risk and mitigation advice in the assessment tool.
Aim 3: When COVID vaccines become available, use the risk assessment tool to estimate individual risk, work with community partners to encourage vaccination of higher risk individuals; measure antibody response to vaccination.
- Aim 3.1. Use the community engagement process developed in Aim 1 to support vaccination outreach.
- Aim 3.2. Use the risk assessment tool to determine priority candidates for vaccination.
Public health policy significance: Understanding COVID infection and progression rates and how they vary with a full set of patient characteristics is critical to policy responses to the COVID pandemic and planning for future infection outbreaks. Randomized antibody testing, with links to health, demographic, mortality and other data is essential for obtaining unbiased estimates of these rates. The risk assessment tool will be usable on a national basis. The empirical methods developed for the risk assessment will be usable for other infection outbreaks.