07 Aug CTSI Insider | 2020, Quarter 2
Introduction & Welcome
Welcome to CTSI Insider, the newsletter of the Clinical & Translational Science Institute of Southeast Wisconsin! In this issue you will find news and announcements, including upcoming opportunities and events, and research trainings, as well as an overview of services available to support you. Happy reading!
CTSI & You
CTSI is here to serve you! We offer a variety of resources and services to augment the myriad of research infrastructure options available to research teams across CTSI partner institutions. CTSI offers more than 20 different services and resources all aimed at supporting you and your clinical and translational research. These include recruitment and study support services offered through our Clinical Trials Office and Adult Translational Research Unit, Biomedical Informatics consulting services, Biostatistical consults and mini-grants, research process improvement consults, Community Engagement consults, and research funding available through our Pilot Translational & Clinical Studies program. Visit the CTSI website for more information.
News & Announcements for You
National Institutes of Health renews MCW’s five-year Clinical and Translational Science Award
This memo is from Joseph E. Kerschner, MD, Provost, Executive Vice President and Dean of the School of Medicine, and Reza Shaker, MD, senior associate dean for clinical and translational research and director of the Clinical and Translational Science Institute of Southeast Wisconsin
June 3, 2020 MCW News – We are extremely pleased to share with you that MCW has been awarded a five-year, $24.4 million Clinical and Translational Science Award (CTSA) from the National Institutes of Health. This competitive grant renewal will fund the work of the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI), a consortium of eight regional organizations. The mission of the CTSI is to develop an integrated, shared home for clinical and translational research and research training, hallmarked by a borderless, collaborative, synergistic and investigator/community/patient-friendly research environment that is functionally integrated into regional and national CTSA networks.
This achievement marks the third five-year CTSA awarded to MCW, demonstrating our strength as an innovative and cutting-edge research institution, collaborative partner and national thought leader.
The CTSI, which was founded in 2010 with a $20 million five-year award – followed by a five-year, $22.5 million award in 2015 – comprises Children’s Wisconsin, Clement Zablocki VA Medical Center, Froedtert Hospital, Marquette University, MCW, Milwaukee School of Engineering, the University of Wisconsin-Milwaukee and Versiti Blood Center of Wisconsin. The composition of the CTSI is unique nationally because of the engagement of three degree-granting academic institutions not affiliated with MCW, three large hospital/healthcare systems and a large research-intensive blood center. This allows for research resources and opportunities for collaboration for MCW students and faculty as well as for the faculty and students of our seven partnering institutions.
The CTSI is advancing health in Wisconsin through research and discovery by bringing together leaders across the translational research spectrum to share resources, research, technology and expertise. The CTSI has accelerated the translation of research discoveries into patient care and has created a solid foundation that brings new therapies/interventions to patients, improves health outcomes and builds training programs and community engagement.
Using innovative mechanisms, CTSI members work to translate research discoveries more quickly into preventive, diagnostic and therapeutic interventions for patients. During the past five years, CTSI service centers have supported almost 1,300 research studies/projects.
Among the achievements of CTSI’s past five years are:
- CTSI Biomedical Informatics (BMI)
BMI has established requisite capacities to provide our clinical and translational research community with a number of tools and related services. During the past five years, CTSI BMI has supported almost 1,025 research studies/projects.
- Expansion of the MCW/CTSI Clinical Trials Office (CTO)
The CTSI/MCW Clinical Trials Office was expanded to include all non-cancer studies, providing investigators with several new resources and holistic support. CTSI has systematized the approach to clinical trials by incorporating Informatics; Biostatistics, Epidemiology and Research Design (BERD); translational research workforce training and education, study management tools/resources and regulatory compliance under one roof. During the past five years, MCW/CTSI CTO has supported about 185 research studies/projects.
- Translational Research Units (TRU)
Since 2015, 151 NIH-funded studies have been supported through TRUs, CTO and BMI services. CTSI Pediatric TRU has averaged 2,030 research visits annually over the last four years and has executed 100 protocols; research topics ranged from observational pathophysiologic studies to phase three trials. The Geriatric/Veteran TRU at the Zablocki VA has been the major driver of the Million Veterans project and has supported clinical/translational studies involving veterans and the elderly averaging almost 1,900 visits per year. During the past five years, CTSI Adult TRU has supported nearly 220 research studies/projects.
- Community Engagement (CE)
CTSI expanded the reach of its Discovery Radio and podcast programs to include national/international reach. CTSI’s novel 500 Stars Initiative, a student/family engagement program, targeting the under-represented minority (URM) workforce, reached 236 students in two years and established a year-round “Students Modeling a Research Topic” (SMART Teams) Program with 104 students. The CTSI CE Science Café Program includes a strong Community Science Cafés Program, with 34 events conducted in three years and attended by more than 1,000 community members, as well as a new and innovative “Faith-based Science Café Program.” Also, CTSI’s innovative Child Advancement Network (CAN) held 22 CAN Science Cafés with almost 900 participants in one year’s time.
- Multidisciplinary Team-based Integrated Clinical and Research Ensembles
CTSI successfully piloted a novel approach to team science (working in parallel with our traditional academic approach) which actively affords the formation of multidisciplinary “Ensembles” to study/address patient unmet needs/problems that can be addressed by skilled multidisciplinary teams.
- Translational Workforce Development
Career development and education and training programs include our CTSA KL2, TL1 (pre- and post-docs), Clinical Scholars Program (CRS), two PhD and two master’s degree programs. At any given time, about 100 trainees are enrolled in our multi-pronged training and career development programs. For the investigators, a total of 158 trainees have completed our career development and educational programs in the past five years, and about 105 are currently enrolled in these programs. Graduates have collectively published 423 manuscripts, received 56 awards and obtained nearly $15 million in grant funding.
- START (TL1) Mentored Research Training Program
From 2016-2019, 30 START Scholars from regional MD/PhD and PhD programs, 14 of whom are URM, have participated in multiple mentored research training programs across CTSI.
- Clinical Research Scholars Program
Scholars are accepted into the program every two years. Between 2013-2019, 62 students enrolled in the Clinical Research Scholars Program and 48 graduated. Scholars include nursing, medicine and pharmacy students from MCW, University of Wisconsin-Milwaukee and Marquette University.
- CTSI-Mentored Career Development (KL2)
Over the past five years, CTSI has awarded a total of 10 new KL2 scholars. Two of these new awards were funded by the NIH and seven were funded through the Advancing a Healthier Wisconsin Endowment. Six scholars completed the two-year KL2 Mentored Career Development Program. All participants continue to be engaged in clinical and translational research and each has obtained at least one grant from the NIH.
- CTSI Advancing Medical Product Development (AMPD) Module
CTSI’s AMPD Module is a multi-institutional collaboration that aggregates and makes readily accessible essential medical product development resources within partnering institutions and the community. The initiative is designed to overcome inefficiencies in developing innovative academic discoveries into healthcare products by more effectively linking biomedical science researchers with commercialization and development experts and potential investors.
- All of Us Research Grant
CTSI of Southeast Wisconsin and ICTIR (UW-Madison’s CTSA collaboration) resulted in a $5.4 million NIH “All of Us” research grant that benefits communities across the state of Wisconsin and the country to aid in engagement and recruitment of research participants for this important national agenda.
Only about one-third of all US medical schools have received a CTSA award since the program’s inception in 2003. In the federal government’s fiscal year 2019, there were 60 CTSA awards nationwide at academic medical centers. This extremely competitive award reflects MCW’s role as a national leader in building academic and research partnerships to address the community’s greatest health needs. The collaborations and partnerships fostered through the CTSI already have paid off in innovation and translation of new technologies and advancements.
We are deeply grateful to our faculty, staff, students and many partners across region for their invaluable contributions to the CTSI as we continue to build healthier communities.
CTSI COVID-19 Research Initiative
The COVID-19 pandemic has changed all our lives dramatically and CTSI – likewise – also experienced a dramatic transformation. On March 16th, nearly 100% of CTSI personnel began working virtually from home. However, far from experiencing a lag to adjust to the new normal, CTSI embarked on an ambitious project that would mobilize resources throughout Southeast Wisconsin and drive research on COVID-19.
Beginning on March 23rd, planning began to carry out an initiative to facilitate and support nucleation of basic, clinical/translational and community researchers in team science – based integrated clinical and research ensembles to address the unmet health needs of our patients, our communities and health systems during the acute and post-COVID-19 periods.
Invitation and Town Hall Meetings
The initiative began with an email invitation and REDCap questionnaire that was sent on April 7th to all faculty of the Medical College of Wisconsin, and six other Southeastern Wisconsin health center and academic institutions. Investigators selected areas of potential research interest by choosing from a collection of 32 Topics and Questions. On April 8th, two COVID-19 Research Initiative Town Hall meetings were convened to present the process for coalescing teams and describe supports that would be provided by CTSI.
CTSI Supports for COVID-19 Research Initiative
Each team (also referred to as pre-Ensembles) was equipped with a CTSI project manager and a variety of additional supports were made available to facilitate research, including: (1) Guidance to Create Operational Plan, (2) Clinical Trial Protocol Development Support, (3) Clinical Trial Execution Support, (4) Biomedical Informatics Support, (5) Community Engagement & Research Support, and (6) Biostatistics Support. CTSI also created a comprehensive process to curate COVID-19 funding opportunities and provide teams with daily updates for new RFA opportunities. In addition, CTSI created a robust REDCap data capture tool and Power BI dashboards to track the lifecycle of teams, record key performance indicators, and provide data for a comprehensive evaluation plan.
Initial Results of Coalescing Teams
In a matter of days, 205 investigators responded to the questionnaire, with 120 investigators from Medical College of Wisconsin and 85 from CTSI partner institutions. This resulted in the formation of 32 teams that ranged in size from 3-35 members per team. CTSI personnel set up virtual meeting rooms using the Microsoft Teams videoconferencing platform, so that members throughout all partner institutions could easily meet. On April 10th, 14 of the 32 teams held their first pre-Ensemble meetings using the Microsoft Teams virtual meeting platform.
After an initial peak of 205 team members, some investigators migrated to different teams or withdrew from teams due to interest level, time commitment, or other reasons. Additionally, teams continued to evolve by merging or splitting, depending on the number of team members, and the need to strategically facilitate multiple research projects dealing with similar research questions. For some teams, there was a natural attrition and these teams were inactivated due to interest levels, scheduling conflicts among members, investigator bandwidth, or other reasons due to interest levels, scheduling conflicts among members, investigator bandwidth, or other reasons.
Current Status of Teams
|Treatment and Vaccine: 8 teams|
|Team Name||Project Manager|
|Approaches for mitigating the severity and morbidity of COVID-19 disease||Dian Mitrayani|
|Translational research into the inflammatory response and multi-systemic pathophysiology in COVID-19||Tanya Aigner|
|Explore technologies that are in final stages of R&D to manage COVID-19||Dr. Amit Gode|
|Develop unique model systems to diagnose, treat or prevent HLB (Heart, Lung & Blood) conditions affected by COVID-19||Dr. Shankar Srinivasan|
|Collect feasibility data for conduct of future innovative Phase 1/2 clinical trials using existing drugs and biologics||Dr. Amit Gode|
|Epidemiology, genetic hypertension and multi-scale computer modeling||Rebecca Gasper|
|Antiviral Therapies||Rebecca Gasper|
|Percutaneous RVAD (right ventricular assist device) for COVID-19 ARDS (Acute Respiratory Distress Syndrome)||David Zimmerman|
|Health System Reform: 2 teams|
|Team Name||Project Manager|
|What changes will COVID-19 bring to clinic workflow in post pandemic environment?||Memory Bacon|
|Community responsive communications to inform at-risk Milwaukee populations about COVID-19 and how to survive, recover and thrive throughout the crisis||David Zimmerman|
|Clinical Environment: 3 teams|
|Team Name||Project Manager|
|Health implications of the clinical environment and personal protective equipment||Renee McCoy|
|What is psychological stress from COVID-19 on healthcare workers?||Angie Holtz|
|Reallocation of Operating Room (OR) resources during COVID-19 and the impact on healthcare systems||Dian Mitrayani|
|Epidemiology: 5 teams|
|Team Name||Project Manager|
|Develop COVID-19 Diagnostic Tools||Ciara Davis|
|Develop Point of Care testing for COVID-19 and other infectious diseases||Tanya Aigner|
|Study life history of COVID-19 to develop better predicative models of spread, transmissibility and interventions||Memory Bacon|
|Impact of the COVID-19 Pandemic on Family Caregiving and Wellbeing||Louann Sullivan|
|Use of biomedical informatics and biologic data for prediction of COVID-19 disease risk||Kate Woods|
|Community Engagement: 5 teams|
|Team Name||Project Manager|
|Health disparities: Health inequity challenges for African Americans during COVID-19||Dr. Dessie Levy|
|HIV/AID and LGBTQA Communities During and Post COVID-19||Dr. Orsolya Garrison|
|Use of technology to address health disparities related to COVID-19||Dr. Dessie Levy|
|Genetic susceptibility to COVID-19 through race, ethnicity, and gender||David Zimmerman|
|Substance use changes in drug and alcohol use during COVID-19||Dr. Dessie Levy|
Currently, we have 23 teams and 160 active participants, with several members belonging to multiple teams. The 23 teams were grouped according to their original Research Topic or Question into 5 Research Themes: (1) Treatment and Vaccine, (2) Health System Reform, (3) Clinical Environment, (4) Epidemiology, and (5) Community Engagement. Teams are shown below with their project manager.
Early Results of Research Efforts
As of Friday, June 12th, active teams have met a total of 146 times, an average of 7 meetings per team, resulting in 9 grant applications submitted, for a total of $1.7M. One team already received an award to establish a virtual clinic for addressing mental health challenges faced by healthcare workers, and the new clinic began assisting patients on Monday, June 15th. Testing of three drugs (salmeterol, ezogabine, and N-acetylcysteine) for treatment of COVID-19 is currently in progress, and 14 COVID-19 patients have been treated using percutaneous right ventricular assist device. Two IRBs have been submitted and approved at Medical College of Wisconsin and some research teams are beginning to collect biospecimens and data.
For more details on COVID-19 Research Initiative teams, please click https://ctsi.mcw.edu/COVID-19/COVID-19-research-index/. If you would like information on joining a research team, please contact Mike Anello, Sr. Project Manager for the COVID-19 Research Initiative (414-704-0209; firstname.lastname@example.org).
CTSI COVID-19 Research Initiative Planning Committee
|Tanya Aigner email@example.com
Mike Anello firstname.lastname@example.org
Memory Bacon email@example.com
Ciara Davis firstname.lastname@example.org
Rebecca Gasper email@example.com
Dr. Orsolya Garrison firstname.lastname@example.org
Dr. Amit Gode email@example.com
Angie Holtz firstname.lastname@example.org
Dr. Dessie Levy email@example.com
Renee McCoy firstname.lastname@example.org
|Dian Mitrayani email@example.com
Dr. Ramez Rashid firstname.lastname@example.org
Dr. Reza Shaker email@example.com
Dr. Shankar Srinivasan firstname.lastname@example.org
Louann Sullivan email@example.com
Brad Taylor firstname.lastname@example.org
Dr. Doriel Ward email@example.com
Katherine Woods firstname.lastname@example.org
David Zimmerman email@example.com
News & Announcements for You
Froedtert & MCW All of Us Research Program COVID-19 Efforts
Participating in research and discovery is a core principle in our Froedtert & MCW health network’s vision and mission. The COVID-19 pandemic has reinforced the critical importance of medical research. Participants in our All of UsResearch Program volunteer their health data to help scientists understand how lifestyle, environment, and biology interact to affect health and disease. Here are a few ways All of Us is conducting important COVID-19 research:
- Antibody testing on stored blood samples: Testing will be done on 10,000 or more blood samples from All of Us The results may help researchers learn more about when and where COVID-19 arrived in the United States.
- Online surveys about COVID-19: Over 300,000 All of Us participants have been invited to participate in online surveys to assess the impact of COVID-19 on their physical and mental health over time.
- Electronic health record information: Putting the electronic health record data from more than 200,000 All of Usparticipants into a standard format will help researchers find patterns and learn more about COVID-19 symptoms and associated health problems.
Thank you to those of you who already participate in these and other All of Us efforts. For those of you who are not participating in the All of Us Research Program, we invite you to sign up online at www.joinallofus.org or via the All of Us app from the Apple or Android App Store.
If you would like to talk to a member of our Milwaukee team personally, please reach out by email at firstname.lastname@example.org call (414) 955-2689.
CTSI at Your Service: Highlights
CTSI A-TRU COVID-19 USER STATEMENT
As a valued user of the CTSI Adult Translational Research Unit (A-TRU), we appreciate the trust you place in us to provide a safe and welcoming environment for your clinical research needs. Towards this end, we want to inform you about how we are addressing the COVID-19 situation.
Our clinic is following all recommended guidance from The Medical College, Froedtert Hospital, FDA, and the CDC, which includes best practices for personal protective equipment (PPE), COVID-19 screening, conduct of clinical trials during COVID-19 and infection control. We are closely monitoring events in our local community and continuously updating our policies and protocols as a result of new information.
We feel confident in our ability to safely welcome back visitors and support staff to the CTSI A-TRU through the creation and the implementation of the following:
- A-TRU NEW REGISTRATION FORM (attached)
- A-TRU COVID POLICIES
- A-TRU COVID CLINICAL PRECAUTIONS CHART
- A-TRU COVID FOOD & BEVERAGE POLICY
The A-TRU will use the New Registration Form and the Clinical Precautions Chart to distinguish between high/medium/low risk research participants so we are able to make the necessary accommodations related to mobility, oxygen requirements, isolation precautions, and PPE. A-TRU staff will acquire and wear appropriate PPE when working with any type of research participants. We will also provide PPE for study participants and study staff upon request (to the best of our abilities).
We have designated spaces and marked rooms for COVID-19 participants in clinic which will be sanitized after each COVID-19 participant visit and deep cleaned by EVS each night. Our staff members have also been trained to implement recommended measures to reduce the risk of COVID-19 transmission on an ongoing basis including wiping down surfaces in exam rooms and equipment between each participant encounter as well as proper hand hygiene before and after each visit.
Physical distancing measures, in space and in time, have also been implemented in order to maximize safety for our participants and staff.
At the recommendation of CDC, we will also be taking temperatures (max 100.4 degrees) and asking the following screening questions prior to any visitors entering the A-TRU:
- Have you traveled to a COVID-19 affected geographic area within 14 days of symptom onset?
- Have you had close contact with a person who traveled to high risk sites or has COVID-19?
- Do you have fever and/or respiratory symptoms such as cough, congestion, sore throat, or shortness of breath?
Should anyone meet these criteria, they will be asked to leave and re-schedule.
Per Froedtert/MCW Policy:
- All participants and visitors, as well as all physicians and staff, are required to wear masks (cloth or surgical) in our facilities, in accordance with state and federal health guidelines.
- Family members and friends of participants should wait in their vehicles to reduce congestion within the clinic. *In the event a research participant has special needs requiring assistance, one person is allowed to accompany the participant to ensure their safety and well-being.
If you have any questions about this notification or an upcoming appointment, please contact the A-TRU at 414-805-7300 or A-TRUScheduling@mcw.edu.
The Staff of the Adult Translational Research Unit
“We are all in this together.”
The A-TRU would like to welcome these 3 new employees on March 31st:
- Tricia Schmidt, Research Nurse II
- Annahi Rocha, Lab Tech II
- Sherin Uthuppan, Research Nurse II
Jesse Chavez-Penaloza, LPN, A-TRU
Rae Ann Petersen, Core Lab Supervisor, A-TRU
CTSI Child Advancement Network (CAN) Update: Riverworks Development Corporation (RDC) drives social and economic development by aligning residents and businesses with resources that strengthen Harambee, Riverwest, and surrounding communities. RDC envisions a vibrant and diverse community of residents, businesses, and stakeholders who jointly create and maintain a prosperous neighborhood and quality of life.
A major part of the success of this initiative is the families of the districts and their interest in health matters. They are one of the CTSI CAN/Vroom Trusted Messenger Network partners. This year, the ‘Health Matters Series’ will offer virtual CAN/Vroom moments during each of their four sessions. Families will learn about accessing Vroom activities. All are invited to Zoom in on one of the virtual education sessions.
Thursday, June 18, 2020, 6:30 pm – 7:30 pm
Thursday, July 23, 2020, 6:30 pm – 7:30 pm
Thursday, August 20, 2020, 6:30 pm – 7:30 pm
Thursday, September 17, 2020, 6:30 pm – 7:30 pm
CTSI Community Science Café Program
We continue to hold our CTSI Science Cafés utilizing virtual platforms. With the establishment of our novel CTSI Faith-based Community Science Café Program in 2019, we have developed a new series addressing COVID-19 related research and health information. Thus far, 2 Science Cafés were held on June 15th and 22nd, with a third on June 27th. This series is in collaboration with one of CTSI’s Trusted Network partners, the General Baptist State Convention of Wisconsin; and represents sessions for church leaders, who subsequently inform their membership/constituents on a broad scale, in collaboration with CTSI Community Engagement leaders.
“As many businesses have started reopening since May, so has Faith-based organizations. In collaboration with the Clinical & Translational Science Institute of Southeast Wisconsin and the General Baptist State Convention of Wisconsin, we are offering a three-part Science Café series on how to safely re-open churches to the various African American church congregations in the Milwaukee area. The purpose of these Science Cafés is to present topics examining the complexity of the COVID-19 disease and what pastors and community members have to know to successfully combat it; how to disinfect the church environment for safe re-entry and finally, how to address sensitive topics and answer difficult questions related to the outbreak, based on CDC guidelines and other recommendations from reliable sources. We will also present information on ongoing COVID-19 research to community members, offering participation in the clinical and translational research process”, says Dr. Orsolya Garrison who directs the CTSI Community Science Café Program.
Look out for upcoming virtual Science Cafés for the Faith-based community, soon to be announced! Everyone is invited to join these sessions!
CTSI Facts at Your Fingertips
MCW COVID-19 Onsite Daily Screening Tool
As many of you who have been coming into work and entering an MCW facility know, you are now required to be deemed CLEARED for onsite work using a daily health self-screening assessment survey built in REDCap. The REDCap survey being used is a highly modified version of a similar tool developed at the Marshfield Clinic. CTSI BMI leadership worked with several stakeholders across the institution to make the necessary refinements in the specific language used, the wording of the ailments to be selected, and the notification preferences.
The survey must be completed within 2 hours of entering an MCW work or learning location. The survey simply asks the employee to enter their first/last name, email, and to check off any symptoms they may have at that time. Based on the symptoms checked (‘No Symptoms’ is an option) the survey will tell you if you are cleared for work or not. If not cleared you are instructed to contact your health provider and your supervisor or the MCW Student Health and Wellness Office.
Data collected from the survey – name, email, symptoms and status – may be used to compare with badge access data to identify employees or learners who are not routinely completing the Daily Screening Tool.
The screening tool is intended to create a heightened sense of self awareness and accountability regarding your health status and whether you have symptoms that may indicate if you have an infectious and/or communicable disease, including COVID-19. Many other organizations have also implemented screening tools.
Did you Know?
In response to the COVID-19 Coronavirus and its impact on our local, state, national and international communities, recent CTSI Discovery Radio episodes have focused on various topics related the pandemic.
As we were first experiencing the pandemic, our April program (episode #72) features insights from several MCW experts and thought leaders on the COVID-19 Coronavirus, including perspectives in the areas of infectious disease, global health, family & community medicine and more.
Our May program (episode #73) explores the psychological impacts on adults and children caused by the social distancing and isolation of the COVID-19 Coronavirus pandemic.
Then, our June program (episode #74) examines how treating the COVID-19 Coronavirus is impacting patients pre-existing conditions related to cardio-oncology. Additionally, we learn how recovered COVID-19 patients can make a difference in treatment and research by donating convalescent plasma.
CTSI Discovery Radio airs the third Friday of every month at 12pm noon (CST) on 91.7 FM WMSE. The show can also be streamed on the WMSE website. Immediately following its airing, a podcast of the show posts on our CTSI website or wherever you listen to your other favorite podcasts, such as Apple Podcasts, Google Podcasts, iHeart Radio Podcasts, SoundCloud, and more.
Please explore our CTSI Website: https://ctsi.mcw.edu/