Artificial Intelligence Predictors of Death from COVID-19

Researchers at MedStar Health led an international team that used artificial intelligence to evaluate cardiac images from patients across the globe who had COVID-19. Artificial intelligence derived heart measurements on echocardiograms were able to predict COVID-19 (SARS-CoV-2) mortality in an international cardiac ultrasound study of COVID-19 patients. The Echocardiographic Correlates of in-hospital Death in Patients with Acute COVID-19 Infection: The World Alliance Societies of Echocardiography (WASE-COVID) Study was presented at the American College of Cardiology (ACC) 2021 virtual Scientific Session.

This is an international, multi-center study conducted by the World Societies of Echocardiography to determine the clinical and echocardiographic phenotype of acute cardiac disease in COVID-19 patients, to explore phenotypic differences in different geographic regions across the world, and to identify parameters associated with in-hospital mortality. New research has revealed key insights into the varying international use of cardiac ultrasound on COVID-19 patients, and how artificial intelligence derived heart measurements were able to predict COVID-19 mortality. Federico Asch, M.D., director of the cardiovascular and echo core labs at MedStar Health Research Institute is the lead principal investigator.

This study looked at the crossover between COVID-19 and cardiac measurements among 870 patients from 13 medical centers in nine countries throughout Asia, Europe, United States, Latin America. Clinical and laboratory data were collected along with patient outcomes. The echocardiograms were analyzed with automated, machine learning-derived algorithms to calculate various data points.

The results showed significant regional differences in terms of patient co-morbidities, severity of illness, clinical biomarkers, and left ventricular and right ventricular echocardiographic metrics. In-hospital mortality rates varied by region, 11% in Asia, 19% in Europe, 27% in Latin America, and 26% in U.S.. Parameters associated with mortality were age, previous lung disease, left ventricular longitudinal strain, lactic dehydrogenase, and right ventricular free wall strain. The regional differences in cardiac phenotype highlight the significant differences in patient acuity as well as echocardiographic utilization in different parts of the world.

"Our original WASE Study first set out to see the state of healthy normal hearts across the world. It took us a few years to manually review all of that data," said Dr. Federico Asch, Director of the Cardiovascular and Echo Core Labs at MedStar Health Research Institute. "When the pandemic began, we knew that the clinical urgency to learn as much as possible about the cardiovascular connection to COVID-19 was incredibly high, and that we had to find a better way of securely and consistently reviewing all of this information in a timely manner."






MedStar Health Investigates New Algorithm for Electrical Injury Treatment

Researchers from the Firefighters’ Burn and Surgical Research Laboratory at MedStar Washington Hospital Center examined the utility of an electrical injury treatment algorithm.  This examination compared the incidence of testing done on a cohort of burn patients before and after implementation. Published in the Journal of Burn Care & Research, “Institutional Experience Using a Treatment Algorithm for Electrical Injury” sought to assess the utility of this electrical injury treatment algorithm in identifying patients at risk for complications while reducing unnecessary testing, monitoring, and admissions.

Electrical injury can be associated with high morbidity and mortality but due to its low incidence, evidence-based guidelines to triage and treat electrical injuries are lacking.  Diagnostic tests such as electrocardiogram, serum troponin, and creatine kinase are used in the emergency room to determine the patient’s risk of negative cardiac outcomes. However, the predictive efficacy of these tests is not understood and there is high variability in diagnosis and management among clinicians.

In July 2015, The Burn Center implemented a new algorithm for triage and management of electrical injury. This retrospective cohort study involves patients admitted to The Burn Center over a course of 5 years. The study team hypothesized that protocolized treatment for electrically injured patients will improve quality of care by reducing unnecessary tests, hospital admissions, and ultimately healthcare costs.

Fifty-six patients with electrical injury were admitted to The Burn Center pre-algorithm implementation and 38 patients were admitted post-algorithm implementation. There were no significant differences between groups in terms of age, sex, race/ethnicity, proportion of work-related injuries, or voltage exposure. Furthermore, there were no significant differences between groups in presence or extent of cutaneous burn area, Glasgow coma scale on arrival to the hospital, or proportion of patients with loss of consciousness immediately after sustaining electric shock.

The result show there was no difference in the proportion of patients who received electrocardiogram testing after implementing the algorithm. However, the proportion of patients who received testing in the pre-algorithm cohort was significantly higher for troponin (79% vs 34%), urinary myoglobin (80% vs 45%), and creatine kinase (82% vs 47%). Of 44 patients who had troponin levels tested in the pre-algorithm cohort, only 14% had abnormal results. The results also show there were more days of telemetry monitoring and greater intensive care unit length of stays, prior to algorithm implementation. There were no significant differences in total hospital lengths of stay, incidence of intensive care unit admissions, in-hospital mortality, or 30-day readmissions.

The study team concluded that use of this algorithm allowed for reduction in testing and health care costs without increasing mortality or readmission rates. Further data collection, targeted quality improvement and the use of actual cost-differences vs cost-savings estimates would be considered for future research.

The study team included Saira Nisar, MBBS, MS; John W. Keyloun, MD; Sindhura Kolachana, BS; Melissa M. McLawhorn, RN, BSN; Lauren T. Moffatt, PhD; Taryn E. Travis, MD; Jeffrey W. Shupp, MD; and Laura S. Johnson, MD.

Journal of Burn Care & Research, DOI: 10.1093/jbcr/irab020

MedStar Health Teaching and Research Scholars Capstone

The first virtual MedStar Health Teaching and Research Scholars Capstone program was held on Thursday, May 20th to celebrate education, innovation, and scholarship from our Teaching & Research Scholars. This event culminates the two years of research done by the scholars while in either program. It was also chance to view the works in progress of the scholars who have completed their 1st year. 

The evening started with an open poster session to view the research of our graduating Teaching and Research Scholars as well as those in their first year. Following this, the formal presentations began with opening remarks from our very own Dr. Stephen Evans, Executive Vice President and Chief Medical Officer.   

Next, we had our Teaching Scholars and Research Scholars presentations.

Research Scholar, Heather Hartman-Hall, PhD, is a clinical psychologist on the MedStar Health Internal Medicine (MHIM) faculty as well as a behavioral health consultant in the Primary Care Center at MedStar Franklin Square Medical Center. As an assistant professor of Clinical Medicine in the Georgetown University School of Medicine, she teaches didactics and mentors research projects on well-being and behavioral health topics. Heather presented "We don’t really talk about it: Role Modeling and Coping with Patient Deaths in the ICU" (see poster).  The purpose of this study is to better understand what attendings are intending to teach and what residents perceive they are learning about how to cope with death. The primary findings identified gaps in role modeling about coping with patient deaths in the intensive care unit, creating an informal curriculum that may leave residents unprepared to cope. Also, team briefings after a difficult patient death could bridge these gaps.  Next steps include piloting team debriefings after patient deaths in the intensive care unit to clarify the best methods and address potential barriers.

Teaching Scholar, Pashna N. Munshi, MD, is an Assistant Professor of Oncology at Georgetown University and is the associate director of the MedStar Georgetown Stem Cell Transplant and Cellular Immunotherapy Program at MedStar Georgetown University Hospital (MGUH). Her clinical and research interests focus on management of cellular immunotherapy toxicities focused in improvements in patient and caregiver health-related quality of life.  Pashna presented, "We’re in This Together: Self-Preparedness, Caregiver Burden, and Patient-Reported Outcomes in Patient/Caregiver Dyads in the Hematopoietic Stem Cell Transplantation Setting" (see poster). The purpose of this study is to examine health-related quality of life trajectory in patient/primary caregiver to explore associations between patient and primary caregiver perceptions of preparedness and health-related quality of life domains (anxiety, depression, fatigue, sleep, physical functioning and pain) using validated tools. The primary findings indicate that poor caregiver preparedness post-transplant negatively affects patient and caregiver health related quality of life 3 months post-transplant. Also, high caregiver burden 3 months post-transplant negatively affects patient sleep and physical functioning at 3 months post-transplant. Next steps for further research are to identify interventions targeted towards improving health-related quality of life for patients/primary caregivers and decreasing primary caregiver burden.

The evening concluded with closing remarks by Aviad Haramati, PhD, Professor of Integrative Physiology in the Departments of Biochemistry, Molecular & Cellular Biology and Medicine (Nephrology), Founding Director of the Center for Innovation and Leadership in Education (CENTILE), and co-director of the Integrative Medicine and Health Sciences Graduate Program at Georgetown University Medical Center. 

If you were unable to attend, you can view the capstone booklet here and the recording here.

The scholars’ posters and alumni accomplishments can still be viewed our webpage.

Congratulations to all of our Teaching and Research Scholars for their achievement!

MedStar Health-Georgetown University Research Symposium and CENTILE’S Colloquium for Educators in the Health Professions

In May, investigators, educators, innovators, and associates came together virtually for three days at the 2021 MedStar Health-Georgetown University Research Symposium and CENTILE’S Colloquium for Educators in the Health Professions.

Nearly 300 research posters and abstracts were submitted by MedStar investigators and residents in eleven research areas. The first day started with a viewing session for all posters and abstracts followed by opening remarks by both Kenneth Samet (President and Chief Executive Officer, MedStar Health) and Jack DeGioia (President, Georgetown University).  Our keynote address was presented by Dr. David J. Skorton, President of the Association of American Medical Colleges and past president of the Smithsonian Institutes. The first day also included the highest-scoring resident and oral presentations followed by a moderated research poster session and networking. These presentations allow residents and fellows to gain the experience of presenting their research and allow them to share their work with the larger MedStar Health & Georgetown University communities.

Day 2 began with the Colloquium for Educators in the Health Professions, with opening remarks from Pamela A. Saunders, PhD, Programs Chair, CENTILE, Center for Innovation and Leadership in Education (CENTILE), Dr. Aviad Haramati, PhD, Director, Center for Innovation and Leadership in Education (CENTILE), and Dr. Edward B. Healton, Executive Vice President for Health Sciences, GUMC, Executive Dean, Georgetown University School of Medicine. After welcoming remarks, there was a presentation on racial and health justice discussing “Diversity, Inclusion and Anti-Racism: A Journey through Undergraduate Medical Education” including speakers Michelle Roett, MD; Sarah Kureshi, MD; Susan Cheng, Ed.L.D., MPP; Keisha Bell, MD; and Megha Fitzpatrick, MD. This was followed by educational plenary speakers including our new Dean of the Medical School, Dr. Lee Jones and Dr. Stephanie Detterline, along with workshops and networking.  

The Symposium wrapped up on day 3, with research plenary speakers Jay Khanna, MD, MBA, and Aviram M. Giladi, MD, MS, followed by additional research posters and educational sessions. 

You can still view the posters on the Attendee Hub for a limited time!  We will be able to offer all sessions as recordings in the future. For now, we are pleased to share the main stage remarks with you here, to watch, share or re-watch.

In order to make future events better, we’d love to get your feedback in a short, anonymous survey: Complete the survey here.

Thank you for your attendance, patience, and engagement in advancing health through research!

May Peer-Reviewed Publications from MedStar Health

Congratulations to all MedStar researchers who had articles published in May 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.  Sex and Racial Disparities in the Treatment and Outcomes of Muscle-invasive Bladder Cancer. 
    Urology, 2021. DOI: 10.1016/j.urology.2020.06.08
    Marinaro J, Zeymo A, Egan J, Carvalho F, Krasnow R, Stamatakis L, Lynch J, Hwang J, Williams S, Kowalczyk K.

  2.  Orthobiologics in Hand Surgery.
    Journal of Hand Surgery, 2021. DOI: 10.1016/j.jhsa.2021.01.006
    Karim KE, Wu CM, Giladi AM, Murphy MS.

  3.  HER2-positive breast cancer and tyrosine kinase inhibitors: the time is now.
    NPJ Breast Cancer, 2021. DOI: 10.1038/s41523-021-00265-1
    Schlam I, Swain SM.

  4.  The impact of COVID-19 patients with troponin elevation on renal impairment and clinical outcome.
    Cardiovascular Revascularization Medicine, 2021. DOI: 10.1016/j.carrev.2021.05.004
    Case BC, Yerasi C, Forrestal BJ, Chezar-Azerrad C, Shea C, Rappaport H, Medranda GA, Zhang C, Satler LF, Ben-Dor I, Hashim H, Rogers T, Weintraub WS, Waksman R.

Congratulations Gebremedhin Melaku, Our John L. Green Scholarship Recipient!

Each year, MedStar Health associates have the opportunity to win a John L. Green Generation of Leadership Scholarship. The scholarship is for five MedStar Health associates, each equaling up to $3,500. Recipients of the scholarship may use funds for tuition and/or fees for the current academic semester for the upcoming academic semester.

Established in 2003, the John L. Green Generation of Leadership Scholarship awards academic scholarships to highly-motivated, MedStar associates who strive to advance their leadership career in health care. 

The scholarship is reserved for exceptional individuals who share Green’s traits of excellence, leadership, and commitment to the vision, mission, and values of MedStar Health. This targeted scholarship reflects Green’s commitment to increasing minority representation in leadership positions in health care.

We are pleased to share that Gebremedhin Melaku, Senior Coronary Imaging Research Analyst, MedStar Health Research Institute is one of the 2021 John L. Green Scholarship recipients.

Gebremedhin Melaku, is a physician from Ethiopia. He was born in very small village called Qunzila, 30 miles northwest of Bahir Dar along the shore of Lake Tana, source of the Blue Nile river. He received his medical degree at University of Gondar and attended Ob-Gyn residency at Addis Ababa University. He worked as a lecturer at the University of Gondar and later as Maternal Child health/Prevention of mother to child transmission of HIV Advisor for three different international organizations.

He joined Medstar Health as a Clinical Research Associate and was promoted to Research Analyst within three months of joining. He is currently working as a lead on clinical trials based on angiography, physiologic parameters such as Quantitative Flow Ratio (QFR) and vFFR (vessel Fractional Flow Reserve). He has authored/co-authored 20+ publications in his professional career.

He is currently seeking his master’s degree in data science/Analytics at Kansas State University. He decided to join the program after he completed a certificate program of “python for Data Science” online and found out how powerful python is in the field of Research, Analytics, Machine Learning and Visualizations.

The John L. Green Generation of Leadership Scholarship honors the late John L. Green, executive vice president, Corporate Services. From 1983 to 2002, Green held executive leadership roles at Medlantic Health Care Group and MedStar Health, as well as on the Morgan State University Board of Regents in Baltimore. He served as chairman of the Morgan State University board from 1990 to 1995. The scholarship is funded entirely by a grant from the MedStar Health Board of Directors to commemorate Green’s contributions and his legacy of excellence.

Protecting Learners as Part of Research Protocols

By Martekuor Dodoo, MD

As an academic healthcare system, we have a large number of trainees (including students, residents and fellows) as part of our internal teams and research population. In addition, MedStar Health includes a dedicated cohort of investigators focused on research of education in healthcare and learning in clinical settings. As researchers, it is important to consider the requirements of the Common Rule and ethical guidance for the protection of research participants when designing and conducting research involving Human Subjects. Trainees may be part of a research participant population and may provide valuable data on field-specific research as learners. In order to protect trainees that are also research participants, it is important to be aware of aspects of recruitment, consent and the conduct of research that can impact study participation in additional to protections for their safety and privacy.

One concern for trainees as research participants is the potential for coercion or undue influence. Some have referred to trainees as “captive participants” that may be in a dependent or restricted relationship with a researcher. In this context, the participants ability to consent may be compromised by vulnerability to the power of the researchers if the research also serves in some supervisory capacity over the trainee. Consider the power dynamic between trainees and their program director, preceptors, attending, or professors. This dynamic could also be extended to employees that may serve as research participants if the researcher is in a supervisory role, either directly or indirectly, for the employees.

This dynamic can create unintended pressure for potential participants and may result in individuals agreeing to participate in research when they would otherwise decline consent or to continue when they would otherwise withdraw consent.  In one publication, the authors state that 10-25% of university students report feeling coerced to participate in research and 33% report they would feel coerced if asked to participate in their own professor’s research (Leentjens & Levenson, 2013). Some incentives to research participation (ex.: extra credit for course work, required course credit, promise of letters of reference or excessive research stipends) may also lead trainees to agree to research participation when they would otherwise decline.

Researchers should also consider the generalizability of research conducted with only trainees as participants. Results from these studies may not generalize to the larger population.   Even generalization within student populations may be difficult and may be influenced by incentives to participate. For example, if students receive extra credit for research participation this may serve as a self-selecting element for students with lower scores or those that need the extra credit to improve to the next grade (improve from an C to a B average).

The Common Rule does not provide special protections for students or trainees as it does for children, pregnant women or prisoners. However, it does state “The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.”  While students, trainees and employees are not specifically mentioned as potentially vulnerable to coercion or undue influence in the regulations it is important to understand the dynamic that can exist between researchers and potential research participants based on relationships outside of the research context. Researchers should consider these dynamics when developing research protocols and build in protections to avoid. It is best whenever possible to avoid even the proception of coercion or undue influence in research.

Below are some recommendations for Participant Safeguards that should be considered when designing research protocols. While this is a good start for items to consider this is not an exhaustive list.

  • Ensure that students / trainees are essential to the research population, not just a convenient sample for the research team.
  • Engage multiple researchers/staff for consent process. This allows for removal of direct relationship between one professor / supervisor / mentor & students / trainees as part of the consent process.
  • Have an explicit and stated process in the protocol for voluntary/informed consent.
  • Ensure that there are explicit protections for the privacy of data. Consider what demographic information is required for the research. In small programs, it may be easy for professors to identify students / trainees based on the broadest of demographic information. Is this information necessary? If yes can some researchers be blinded to some of the data so that they are not aware of participation of individuals they supervise?
  • All research involving human subjects must have IRB approval

Please contact the MedStar Health Research Institute, Office of Research Integrity for additional guidance.

 

 

Reference

Leentjens, A. F. G., & Levenson, J. L. (2013). Ethical issues concerning the recruitment of university students as research subjects. Journal of Psychosomatic Research, 75(4), 394–398. https://doi.org/10.1016/j.jpsychores.2013.03.007

 

MedStar Health—Georgetown University Research Symposium and the Colloquium for Educators in the Health Professions – Register Today!

Don’t forget to register for the MedStar Health—Georgetown University Research Symposium and the Colloquium for Educators in the Health Professions, taking place NEXT WEEK: Monday, May 10, 2021 through Wednesday, May 12, 2021.

This three-day event brings together the MedStar Health and Georgetown University communities to celebrate the great work of our colleagues. It offers the unique opportunity to connect with researchers, educators, residents, executive leaders, and collaborative partners from across the region and our system to build meaningful relationships to further advance the health of our community.

You may register and find other details including the agenda at http://bit.ly/MSH-GUMC.

Hosted by the MedStar Health Research Institute, MedStar Health Academic Affairs, CENTILE, and Georgetown University Medical Center.

      
2021 Symposium and Colloquium Agenda
Monday, May 10
1 pm Welcome and Opening Remarks

  • Stephen R. T. Evans, MD 
    Executive Vice President, Medical Affairs, and Chief Medical Officer, MedStar Health 
  • Kenneth A. Samet, FACHE 
    President and CEO, MedStar Health 
  • John J. DeGioia 
    President, Georgetown University 
2 pm       Keynote Speaker
Dr. David J. Skorton, AAMC President
3 pm      Resident & Fellow Oral Presentations
As part of the MedStar Health system-wide resident research day, residents and fellows with the top scoring abstracts are invited to give a short oral presentation on their research to attendees. These presentations allow residents and fellows to gain the experience of presenting their research and allow them to share their work with the larger MedStar Health & Georgetown University communities.
4 pm      Moderated Poster sessions
Research Symposium & CENTILE Colloquium 
4 pm      Networking Sessions
Tuesday, May 11
10 am to 12 pm      Colloquium for Educators in the Health Professions
Hosted by GUMC’s Center for Innovation and Leadership in Education (CENTILE), the Colloquium for Educators in the Health Professions Colloquium is an opportunity for those across the system focused on education to gather, share ideas, and learn together.
1 pm     

Plenary Speakers

  • Leon “Lee” Jones, MD
    Dean for medical education, Georgetown University School of Medicine
  • Stephanie Detterline, MD
    Program Director,  MedStar Health Internal Medicine Baltimore Residency Program
1:30 pm      Educational Workshops
Research Symposium & CENTILE Colloquium

  • Demystifying the IRB
    This session will provide an overview of the joint IRB system, including tips for success when utilizing the new platform to facilitate a smooth submission process.
  • Stats Fundamentals
    Led by an experienced MHRI biostatistician, this session will provide an overview of statistical approaches used most commonly in clinical research. The session serves as an introduction to the topic of biostatistics and resources at MedStar.
  • Tips for Funding Success
    A successful grant application requires an innovative idea from an investigator, strong administrative support, and a willing funder. In this session, we will present these three perspectives and how they work together for funding success. We will also cover different mechanisms and strategies for funding support.
  • Abstracts, Manuscripts, Journals…Oh my!
    Conducting research is only the first step…preparing your scholarship for publication or presentation will follow! This session will provide helpful pearls, as well as identify avoidable pitfalls, in taking your results from “data” to paper, poster, or the presentation screen.
  • Feedback in the Clinical Setting 
  • Privilege and Intersectionality 
Following your registration, you will receive a separate email with the virtual event instructions and platform link. The platform will allow you to attend any portion of the event, including all of the educational workshops.
2:30 pm      Moderated Poster sessions
Research Symposium & CENTILE Colloquium 
3 pm      Networking Sessions
Wednesday, May 12
1 pm      Plenary Speakers

  • Jay Khanna, MD, MBA
    Physician Executive Director, MedStar Orthopaedic Institute, DC; Chair and Professor, Department of Orthopaedic Surgery
  • Aviram M. Giladi, MD, MS
    Hand Surgery and Plastic Surgery
    Research Director, The Curtis National Hand Center, MedStar Union Memorial Hospital
1:30 pm      Educational Workshops
Research Symposium & CENTILE Colloquium

  • GUMC Academic Appointments & Promotions Updates
    Learn about all the different faculty career paths available to you at GUMC and how you can continue to advance and develop your academic career through this informative workshop.
  • Demystifying the IRB 
    This session will provide an overview of the joint IRB system, including tips for success when utilizing the new platform to facilitate a smooth submission process.
  • Stats Fundamentals 
    Led by an experienced MHRI biostatistician, this session will provide an overview of statistical approaches used most commonly in clinical research. The session serves as an introduction to the topic of biostatistics and resources at MedStar.
  • Tips for Funding Success
    A successful grant application requires an innovative idea from an investigator, strong administrative support, and a willing funder. In this session, we will present these three perspectives and how they work together for funding success. We will also cover different mechanisms and strategies for funding support.
  • Abstracts, Manuscripts, Journals…Oh my!
    Conducting research is only the first step…preparing your scholarship for publication or presentation will follow! This session will provide helpful pearls, as well as identify avoidable pitfalls, in taking your results from “data” to paper, poster, or the presentation screen.
  • Clinical Specialty Disrespect
  • Bias in Clinical Grading
Following your registration, you will receive a separate email with the virtual event instructions and platform link. The platform will allow you to attend any portion of the event, including all of the educational workshops.
2:30 pm      Moderated Poster sessions
Research Symposium & CENTILE Colloquium 
3 pm      Networking Sessions

 

Advancing Health through Research, Education, and Clinical Care Delivery

To learn more, visit MedStarHealth.org/Symposium
Questions? Contact [email protected]

 

 

MedStar Health Investigator Develops Risk Assessment Tool for Resuming Research in Low Resource Settings During the COVID-19 Pandemic

This collaborative research project sought to develop a framework to assess the risk of conducting clinical trial activity during the COVID-19 pandemic in rural, low resource settings. This research specifically looked at the continuation of the multi-country Household Air Pollution Intervention (HAPIN) trial, which is a randomized controlled trial in rural areas of Guatemala, India, Peru, and Rwanda that is assessing the health benefits of providing liquefied petroleum gas (LPG) stoves and an 18-month supply of free LPG to 3200 households that otherwise depend on solid biomass fuel (wood, animal dung, or crop residue) for cooking. While the study was conducted overseas, it has application for any rural area.

In 2020, the spread of COVID-19 led to the temporary suspension of many non-COVID-19 related research activities worldwide. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk. The goal of this study is to maximize the integrity of research aims while minimizing infection risk based on the latest scientific understanding of the virus.

The HAPIN study collects measurements of cooking behavior, personal and in-home exposure to air pollution, biological samples and clinical measurements from pregnant women and their newborns in every household, along with an older, non-pregnant adult woman, if she resides in the house. The study involves home visits, as well as visits to health centers and hospitals during the woman’s pregnancy and the first year of the child’s life.

In developing the risk assessment tool in the context of COVID-19, the research team used a combination of expert consultations, risk assessment frameworks, institutional guidance and literature and systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework.

The framework assessed risk based on staff proximity to the participant, exposure time between staff and participants, and potential viral aerosolization while performing the activity. For each activity, one of four risk levels, from minimal to unacceptable, was assigned and guidance on protective measures was provided.

The researchers assessed research activities that included LPG fuel delivery, administration of tablet-based surveys, data downloads from environmental monitors, personal exposure assessment to household air pollution, biological sample collection (e.g. urine, nasal swabs, venous blood) and lab processing of biological samples in the field laboratories, clinical, observations in homes of pregnant women/new mothers, children, and vascular procedures in adults.

The study results show that almost all of the research activities were deemed to pose potentially manageable risks. The activities with the highest level of risk were those that potentially aerosolize the virus during the procedure.

The study team concluded that by applying a systematic, procedure-specific approach to risk assessment for each research activity, it can minimize the disruption in trials due to the pandemic and continue to protect participants and research team and support the completion of primary outcomes. The study team also believes their framework can be applied be tailored to other research studies conducted in similar settings during the current pandemic to guide investigators in assessing the risk of each research activity and implementing appropriate safety measures, where the level of risk is acceptable.

This research was led by one of our newest MedStar Health investigators, Suzanne M. Simkovich MD, MS, Physician Investigator, MedStar Health Research Institute, Assistant Professor of Medicine, Georgetown University.

MedStar Health Researchers Examine Feasibility of a Telemedicine-Enabled Mental Health Intervention for Adults With Type 2 Diabetes

Collaborative research from MedStar Diabetes Institute, MedStar Health Research Institute, and the Georgetown University Department of Psychiatry examined the feasibility of co-delivering a mental health intervention with an evidence-based type 2 diabetes (T2DM) boot camp care management program. The research team also examined the preliminary impact of participation on symptom scores for depression and anxiety and A1C.

In the United States, over half of the adults living with type 2 diabetes mellitus have at least 1 other chronic physical or mental health condition. Depression is one of the most prevalent comorbities of type 2 diabetes. To improve type 2 diabetes outcomes, it is important to diagnose and treat both diabetes and depression/anxiety when patients present with both.

The study was a 12-week pilot intervention with African American adults with uncontrolled type 2 diabetes and moderate depression and/or anxiety, who were participating in an existing Diabetes Boot Camp program. The participants were then enrolled in the diabetes and mental health co-management (DM-MH) pilot study. This program was offered via a combination of 2 initial on-site visits and subsequent remote telehealth visits using telephone, text, or email. The mental health intervention component involved 6 structured sessions with a mental health interventionist, who was also trained to recognize worsening mental health symptoms, identify and evaluate safety concerns, seek consultation, and make appropriate referrals. The structured mental health component targeted depression and/or anxiety symptoms based on the PHQ-9 and GAD-7 baseline scores. Participants were assessed at baseline and 90 days.

The study results showed significant improvements in mental health outcomes, as measured by a reduction in Patient Health Questionnaire − 9 scores of 2.4 ± 2.9 (P = .01) and in Generalized Anxiety Disorder − 7 scores of 2.3 ± 1.9 (P = .001). The pre-post intervention mean A1C improved by 3.4 ± 2.1units from 12% ± 1.4% to 8.5% ± 1.7% (P < .001).

The study team concluded that the data supports the feasibility of delivering a diabetes and mental health co-management intervention using a combination of in-person and telemedicine visits to engage adults with T2DM and coexisting moderate depression and/or anxiety. Further research with a control group and a larger sample size could show potential in improving glycemic and mental health outcomes in patients with T2DM via co-management of their T2DM and moderate anxiety and/or depression.

The research team included Michelle F. Magee, MD, MBBCh, BAO, LRCPSI from MedStar Diabetes Institute, MedStar Health Research Institute, and the Georgetown University School of Medicine; Carine M. Nassar, RD, MS from MedStar Diabetes Institute and MedStar Health Research Institute; Mihriye Mete from MedStar Health Research Institute and Georgetown University Department of Psychiatry; and Stacey I. Kaltman, PhD from Georgetown University Department of Psychiatry.

Funding for the study was provided by an intramural grant from the MedStar Health Research Institute.