Building Capacity for Rapid COVID-19 Scientific Research: Clinical Research Units and HOPE

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Abstract

Building Capacity for Rapid COVID-19 Scientific Research
Cheryl Dennison Himmelfarb RN PhD, Suzanne Jan de Beur MD, Cassie Lewis Land MS, Dan Ford MD MPH, Mark Sulkowski MD

The Johns Hopkins Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland

Background: The Johns Hopkins Health System (JHHS) and University has led a robust response to the COVID-19 pandemic including administering 201,669 COVID-19 tests, providing care to 3,547 patients hospitalized with COVID-19, investing $6 million in COVID-19 Research Response Program funding, and approving 338 COVID-19 related research protocols. To support COVID-19 research, we have built a research infrastructure to enhance research participation across our health system, avoid duplicative requests to potential research subjects, expand the number of COVID-19 clinical trials, prioritize supplies such as PPE and reagents for specimen collection, and minimize risks to patients, study participants, and staff.

Methods: To support COVID-19 research studies, we developed a centralized research recruitment registry and two dedicated COVID-19 Clinical Research Units (CRU) within the Johns Hopkins Institute for Clinical and Translational Research (ICTR). The HOPE (Hopkins Opportunities for Participant Engagement) registry connects potential research participants with COVID-19 research study teams. The participants are empowered to choose the studies that best meet their needs. To conduct safe, efficient and convenient COVID-19 related research, CRUs at two locations with medical isolation units (PODS) were established to accommodate participants with active SARS-CoV-2 infection.

Results: The HOPE registry successfully enrolled 4548 individuals and matched 681 individuals with 8 research teams. Most participants were recruited to the HOPE registry through 50,256 electronic health record messages sent via the MyChart patient portal (76%) to COVID-tested individuals. Email (7.7%), social media/website (6.4%), advertisement (5%), and text message (4%) yielded the balance of participants. Daily outreach to potential participants continues via MyChart, email, text, and phone calls to COVID-19 positive individuals. To date, the COVID-19 CRUs have provided space and personnel infrastructure for 455 COVID-19 related research visits and 10 COVID-19 related clinical research protocols. These studies include observational, prevention, biobanking, vaccine and therapeutic protocols.

Conclusion: The Johns Hopkins ICTR’s existing infrastructure and expertise was leveraged to implement a successful centralized research recruitment registry (HOPE registry) for COVID-19 research and provide innovative space and specialized staffing to conduct safe and efficient COVID-19 research through a network of COVID-19 Clinical Research Units.

Authors
Cheryl
Dennison Himmelfarb
Professor and Associate Dean for Research; Deputy Director, Johns Hopkins Institute for Clinical and Translational Research
Suzanne
Jan de Beur
Deputy Director Clinical Research Unit Network
Cassia
Lewis-Land
Program Administrator Recruitment Innovation Unit
Daniel E.
Ford, MD, MPH
CTSA PI and Vice Dean for Clinical Investigation