COVID-19: Results from the MedStar Health CDC Community Research Partnership (CRP) Study of COVID-19

MedStar Health has been conducting a large scale, multi-site Centers for Disease Control and Prevention (CDC) funded Community Research Partnership (CRP) study, “A Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records”. The goal of the study is to determine how much of the population has been exposed to the COVID-19 virus by utilizing daily syndromic surveillance, monthly serologic testing, and electronic health record data. The CDC COVID-19 CRP is an at-home research study to help us better understand the best ways to treat and prevent COVID-19.

The study began in November of 2020 and has gained more than 60,000 participants, over 4.5 million daily symptom updates, received over 150,000 serology results, and collected more than 17 million electronic health record data elements. At MedStar Health, there are 11,095 participants who remain engaged in daily syndromic surveillance. There are 8,538 participants enrolled in monthly serology testing with over 44,000 serology kits distributed. More than 50% of these participants have been participating in monthly serology for at least six months – representing incredible engagement from our community that allows the research team to evaluate antibody development and decay over time.

Preliminary study results show that antibodies are identified at a detectable level around two weeks after natural infection or vaccination and these antibodies take longer to develop in older participants. The results also show that in participants with natural infection, antibodies drop to undetectable levels within two to three months as compared to vaccinated individuals with detectable antibodies lasting at least eight months. For patients who were infected with the SARS-CoV-2 virus, antibody decay is more rapid in participants with no or few symptoms as compared to more significant infection.

For participants who seroconverted (serology results were first negative then positive), 35% reported symptoms in the month prior to seroconversion. Participants with positive serology results reported symptom combinations like congestion and anosmia or ageusia (loss of smell or taste). However, symptom combinations like diarrhea and nausea were strongly associated with negative serology. Cumulative reports of symptoms logged by participants in their daily symptom surveillance showed that self-reported symptoms persist weeks after seroconversion with runny nose, muscle pain, headache, fever, and fatigue being commonly reported.

Significant work of the study team is focusing on vaccine effectiveness (with a research letter to be published in the New England Journal of Medicine on October 6, 2021). Looking at both the Pfizer-BioNTech and Moderna RNA vaccines in a case control evaluation, infections were significantly higher in unvaccinated than vaccinated participants, with effectiveness in preventing over 90% of self-reported positive tests for COVID-19. The study team is currently analyzing breakthrough infections and sharing findings to the CDC highlighting the need for ongoing surveillance, screening for novel variants, and possible booster vaccination programs.

As part of daily symptom surveillance, participants self-report symptoms, healthcare utilization, COVID-19 exposures, and public health behaviors including mask use and social distancing. The research team found that mask use is higher in vaccinated participants than unvaccinated, regardless of the month of their first vaccination dose. Mask use remained relatively stable from December 2020 through April 2021 and declined in all groups beginning in mid-May 2021. In all groups, mask use increased again in July 2021, which aligns with public health concerns around the Delta variant. Independent predictors of higher mask use include vaccination, aged 65 and older, female sex, racial or ethnic minority group, and healthcare worker occupation, whereas a history of self-reported prior COVID-19 illness was associated with lower use.

Supplemental surveys were distributed to participants in the winter of 2020 to collect self-reported information on protective behaviors while gathering with friends and family outside their immediate household and if they engaged in protective behaviors including hand washing, social distancing, mask wearing, gathering outdoors, and COVID-19 testing. Significant findings include self-report of gathering with non-household members at Thanksgiving (47%) and during the winter holidays (69%). Only 30-40% of participants wore masks and less than 1/5th were tested prior to gathering.

The study team also distributed a supplemental survey to identify vaccine hesitancy. Results showed that 76% of those who responded intended to get the vaccine, but the data also identified hesitancy in African Americans, suburbanites, women, and those with prior infection. Participants most frequently cited concern over safety and lack of testing. Vaccine updates from participants were monitored through May of 2021. Subsequent vaccine uptake was 99% in non-hesitant participants and more than 50% in those who were initially resistant.

The MedStar Health study site is led by William S. Weintraub, MD, Director of Population Health Research, MedStar Health Research Institute; and Kristen E. Miller, DrPH, Scientific Director, National Center for Human Factors in Healthcare, MedStar Health Research Institute.

COVID-19: MedStar Health Receives FDA Clearance to Trial an Oral Immunomodulatory Drug for COVID-19

Over the past year, our research team Dr. Thomas Fishbein, Dr. Khalid Khan and Dr. Alexander Kroemer from the MedStar Georgetown Transplant Institute has been working to develop a therapeutic to treat mild to moderate COVID-19 with the aim of reducing symptoms, eliminating disease progression, and preventing hospitalization.

The research team were initially motivated by the vulnerability of their immunocompromised transplant patients to COVID-19. The team demonstrated that SARS-CoV-2 infection results in acute inflammasome and caspase-1 activation – which in patients with existing chronic disorders leads to inflammatory cell death and subsequently both hyperinflammation and adaptive immune dysfunction. The team was able to identify a compound that could inhibit caspase-1 activation and thereby potentially attenuate the devastating immune effects of COVID-19.

With sponsorship from MedStar Health and in partnership with the MedStar Health Research Institute, the team has overseen the manufacturing of the drug, designed a clinical trial, and secured Investigational New Drug (IND) clearance from the FDA on September 24th.

The Phase 2, double-blind, placebo controlled, randomized, proof of concept trial will investigate the safety and treatment effect of the caspase-1 inhibitor belnacasan. Starting in mid-October, high-risk outpatients who present to MedStar Washington Hospital Center and MedStar Franklin Square Hospital with mild to moderate COVID-19 symptoms will be offered the opportunity to enroll in the trial under principal investigators Drs. Glenn Wortmann and Christopher Haas at their respective institutions.

This is the first time in MedStar Health history that the organization is serving as the sponsor in a commercial drug development program. If effective, the tablet being investigated would fill a key gap in the COVID-19 therapeutic arsenal as it can be taken orally and is more targeted than current, broad-based immunomodulatory treatments.

COVID-19: MedStar Health Investigators Evaluate Substance Use Trends during the COVID-19 Pandemic

Collaborative research from MedStar Health Research Institute, MedStar Washington Hospital Center, Georgetown University School of Medicine and the Rutgers New Jersey Medical School evaluated trends in the number of patients with positive substance use screens and those presenting with a clinical diagnosis of acute alcohol or substance intoxication/overdose in the Emergency Departments (EDs) of the MedStar Health system before and after the first wave of the COVID-19 pandemic (March 2019-2020, April 2020-June 2020). “Impact of COVID-19 pandemic on emergency department substance use screens and overdose presentations” was published in The American Journal of Emergency Medicine.

The health system utilizes a validated screening program for substance use, Screening, Brief Intervention, and Referral to Treatment (SBIRT), for emergency department patients who are clinically stable and willing to complete screenings. SBIRT is a comprehensive public health approach to deliver intervention and treatment for individuals who are at risk for or who currently use alcohol or other substances.

The retrospective chart review included all emergency visits data from seven EDs. The results showed that out of 107,930 screens performed in the EDs, positive SBIRT screens increased from 12.5% to 15.8% during COVID. Alcohol intoxication presentations increased as a proportion of positive screens from 12.6% to 14.4%. A higher percentage of screened patients reported problem drinking during the pandemic (2.4% pre vs 3.2% post). Substance intoxication/overdoses among all screened increased from 2.1% to 3.1% and as a percentage of positive screens during the pandemic (16.8% to 20%). The proportion of opioid vs. non-opioid overdoses remained unchanged before (67%) and during the pandemic (64%).

The study team concluded that there was a significant increase in positive substance use screens and visits for acute overdose and intoxication during the first wave of COVID-19 in the EDs. With the increase in substance abuse associated with the COVID-19 pandemic, there is a need to expand the already limited availability of resources for substance use disorders, early intervention, and treatment. Additional focus is needed to increase access to these resources for patients with substance use disorders.

The research team included Maryann Mazer-Amirshahi, PharmD, MD, MPH, PhD, from MedStar Washington Hospital Center; Mihriye Mete, PhD and Sameer Desale, MS from MedStar Health Research Institute; Kira Chandran and Nikash Shankar from Georgetown University School of Medicine and Lewis Nelson, MD from Rutgers New Jersey Medical School.

The American Journal of Emergency Medicine, DOI: 10.1016/j.ajem.2021.08.058

COVID-19: A New AHRQ R21 Award will Study When is it Safe to Discharge a COVID-19 Patient from the Emergency Department

In her first federal award (AHRQ R21), Jessica E. Galarraga, MD, MPH will  study, “An EHR-Based Screening Tool to Support Safe Discharges of COVID-19 Patients in the Emergency Department”. This study will develop a screening tool with electronic health record data using artificial intelligence/machine learning techniques to predict the risk of emergency department return and associated morbidity or mortality for COVID-19 patients. By developing a health IT solution that combines the use of natural language processing with a decision support tool, Dr. Galarraga seeks to turn unstructured clinical data into knowledge that can be applied to practice.

Oftentimes emergency clinicians must make rapid clinical decisions with limited information, which has heightened due to the challenges of COVID-19. Using predictive modeling with natural language processing and machine learning techniques can leverage the data-rich environment of the emergency department to improve the quality of care delivered to patients with COVID-19.  This study has three aims: 1) Iteratively develop a concept map using mixed methods which will serve as the ontology categorizing predictive factors for COVID-19 emergency department returns and inform machine learning model development; 2) Develop and evaluate machine learning algorithms predictive of emergency department return risk for COVID-19 patients; 3) Prospectively validate a COVID-19 emergency department return screening tool (CERST) using real-time data.

This study will generate findings to improve the quality of care for COVID-19 patients in the emergency department. Findings will also be used to further optimize machine learning model, operationalize CERST as an EHR-integrated tool to support COVID-19 emergency department disposition decisions, and evaluate CERST’s performance on patient outcomes. Future studies will also employ mixed methods to develop guidelines on interventions by clinical and care transition staff using the tool to prevent emergency department returns and adverse outcomes among COVID-19 patients.

The study team hypothesizes that developing and operationalizing the proposed COVID-19- emergency department return screening tool (CERST) can help emergency department clinicians avoid premature discharges and engage in evidence-based discussions with COVID-19 patients regarding discharge plans. It may also reduce strain on hospital capacity by identifying patients safe for discharge and reserving resources for higher-risk COVID-19 patients.

2022 MedStar Health Teaching & Research Scholars Program – Applications Open!

The MedStar Health Teaching Scholars Program and the MedStar Health Research Scholars Program are entering their 13th and 8th year, respectively.  These programs provide multi-faceted educational support and mentorship to our clinical faculty as they develop their academic and research career pathways. Many of our alumni have successfully demonstrated their accomplishments through publications, national presentations, grant funding and more.  All of their scholarly activities are highly influential on their professional well-being while also bringing well-deserved recognition to them individually, to MedStar Health, and to their home departments and institution/hospital.  

While we recognize the value of these programs, we also know the challenges of finding dedicated scholarly time in an environment that is often focused on clinical productivity. We are therefore very excited to share with you that we have secured funding for the programs to support 20% of scholars’ salaries to ensure they have the dedicated time to focus on their research/academic endeavors. This dedicated time will result in an actual amendment to their employment agreement. 

The next cohort of scholars will begin in January 2022.  Of note, for this transitional year, scholars enrolled in either program will need to commit for approximately 2.4 years (as opposed to the 2.0 years) as we make schedule adjustments and use the extra time to ensure success and sustainability.  Applications for this new cohort are due October 29, 2021. 

MedStar Health Teaching Scholars Program - Apply Here

MedStar Health Research Scholars Program - Apply Here

September Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in September 2021. The selected articles and link to PubMed provided below represent the body of work completed by MedStar Health investigators, physicians, and associates and published in peer-reviewed journals last month. The list is compiled from PubMed for any author using “MedStar” in the author affiliation. Congratulations to this month’s authors. We look forward to seeing your future research.

View the full list of publications on PubMed.gov here.

  1. Effects of Maryland's global budget revenue model on emergency department utilization and revisits.
    Academic Emergency Medicine, 2021. DOI: 10.1111/acem.14351
    Galarraga JE, DeLia D, Huang J, Woodcock C, Fairbanks RJ, Pines JM.
  1. Beyond burnout: Understanding the well-being gender gap in general surgery by examining professional fulfillment and control over schedule
    The American Journal of Surgery, 2021. DOI:10.1016/j.amjsurg.2021.08.033
    Mete M, Dickman J, Rowe S, Trockel MT, Rotenstein L, Khludeney G, Marchalik D.
  1. Making Patient Safety Event Data Actionable: Understanding Patient Safety Analyst Needs
    Journal of  Patient Safety, 2021. DOI: 10.1097/PTS.0000000000000400
    Puthumana JS, Fong A, Blumenthal J, Ratwani RM. 

  1. Endocrine Surgery Patients' and Providers' Perceptions of Telemedicine in the COVID Era
    Journal of Surgical Research, 2021. DOI: 10.1016/j.jss.2021.07.018
    Zheng H, Rosen JE, Bader NA, Lai V.

MedStar Health Investigator Receives 5 Million Dollar Award from the Centers for Disease Control and Prevention to Reduce Inequities in Cancer Outcomes

Hannah Arem, PhD, Scientific Director of Implementation Science at the MedStar Health Research Institute, was selected for funding from the Centers for Disease Control and Prevention for her five-year project entitled, “Reducing Inequities in Cancer Outcomes through Community-Based Interventions on Social Determinants of Health.”

The purpose of this award, in collaboration with George Washington University and Howard University, is to conduct research to further institutionalize screening and follow up for social determinants of health among cancer survivors in DC at three cancer institutes.  Additionally, the researchers will conduct anti-bias training at the three cancer institutes with all providers interacting with patients. The long-term goal of this study is to develop scalable interventions to identify and address social needs for cancer survivors. This project is intended to establish sustainable clinical-community linkages and improve survivor health and well-being. This research aims to advance our understanding of what works in different settings, for whom and why.

Understanding the burden of social needs in our population, the available community resources, and solidifying integrated, closed-loop referral systems to address those needs is critical to improving quality of life for cancer survivors and reducing disparities in outcomes.

Announcing Dr. Hunter Groninger as NEW Scientific Director for MedStar Palliative Care

Since 2014, MedStar Palliative Care has grown to provide expert interdisciplinary care for patients with advanced illness, such as cancer or heart failure, and their families across.  Our interdisciplinary approach spans our system – last year alone, Palliative Care clinicians completed over 9000 consultations across hospitals, clinics, and telehealth settings.

Medical assessment and management, complex communication strategies, and innovative healthcare delivery models are all part of the science of palliative care. For several years, MedStar Palliative Care clinicians have been advancing this science through grant-funded and investigator-initiated clinical research. Examples of ongoing research include telehealth strategies for home-based palliative care delivery, virtual reality for cancer pain management, and massage therapy to improve self-efficacy in left ventricular assist device recipients.

To leverage the ongoing scientific work while growing the palliative care research portfolio to achieve national recognition, the MedStar Health Research Institute is pleased to announce the appointment of Dr. Hunter Groninger as Scientific Director for MedStar Palliative Care. Dr. Groninger currently serves as Director of Palliative Care at MedStar Washington Hospital Center, as Professor of Medicine at Georgetown University Medical Center and as a funded investigator at MHRI. In his new role as Scientific Director, Dr. Groninger will engage investigators and stakeholders across the MedStar-Georgetown system to explore opportunities for scientific collaboration and to elevate the interdisciplinary success of palliative clinical research.

August Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in August 2021. The selected articles and link to PubMed provided below represent the body of work completed by MedStar Health investigators, physicians, and associates and published in peer-reviewed journals last month. The list is compiled from PubMed for any author using “MedStar” in the author affiliation. Congratulations to this month’s authors. We look forward to seeing your future research.

View the full list of publications on PubMed.gov here.

Selected research:

  1. Delayed Digit Replantation: What is the Evidence?
    The Journal of Hand Surgery, 2021. DOI: 10.1016/j.jhsa.2021.07.007
    Harbour PW, Malphrus E, Zimmerman RM, Giladi AM. 

  2. Circulating Syndecan-1 and Tissue Factor Pathway Inhibitor, Biomarkers of Endothelial Dysfunction, Predict Mortality in Burn Patients. 
    Shock, 2021. DOI: 10.1097/SHK.0000000000001709
    Keyloun JW, Le TD, Pusateri AE, Ball RL, Carney BC, Orfeo T, Brummel-Ziedins KE, Bravo MC, McLawhorn MM, Moffatt LT, Shupp JW

  3.  Single-Center Experience With the LOTUS Edge Transcatheter Heart Valve. 
    Cardiovascular Revascularization Medicine, 2021. DOI: 10.1016/j.carrev.2021.04.024
    Medranda GA, Rogers T, Case BC, Shults CC, Cohen JE, Satler LF, Ben-Dor I, Waksman R.
     
  4. Defining a Minimum Hospital Volume Threshold for Minimally Invasive Colon Cancer Resections. 
    Surgery, 2021. DOI: 10.1016/j.surg.2021.06.031
    Bader NA, Sweeney M, Zeymo A, Villano AM, Houlihan B, Bayasi M, Al-Refaie WB, Chan KS.