The Healthcare Worker Exposure Response & Outcomes (HERO) Registry invites both clinical and nonclinical healthcare workers to share their life experiences in order to understand the perspectives and problems faced by those on the COVID-19 pandemic frontlines. HERO Registry participants could have the opportunity to participate in future research studies to improve the understanding of COVID-19 and beyond, generating evidence to help healthcare workers stay safe and healthy.
The HERO Registry is open to all healthcare workers, including nurses, therapists, physicians, emergency responders, food service workers, environmental service workers, interpreters, transporters — anyone who works in a setting where people receive health care.
In case you missed the May 1 keynote address by Robert M. Califf, MD, MACC, you can now listen to the recorded webinar and Q&A. Dr. Califf, head of strategy and policy for Verily Life Sciences and Google Health, kicked off the Collaboratory’s Grand Rounds workshop series, Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.
His presentation outlined several opportunities to drive change and rebuild clinical research in the aftermath of COVID-19, including:
Evaluate what has and has not worked in the changes that have been made in response to the crisis
Allocate a significant part of recovery funding to transition issues in evidence generation, especially at the interface of medicine and public health
Do everything possible to fix the “purposefulness issue”:
Create methods for deciding the most important questions
Reward behavior that gets important questions answered quickly
Develop inclusive networks driven by people with the health problems of interest; increase incentives for clinicians and investigators that lead to reliable and faster evidence generation (balance financial focus with purpose); and automate mapping of EHR data beyond individual systems
“The effective use of digital information such as electronic health records, telehealth, applications, and patient-reported outcomes should free up effort to fix the human components that are holding us back.” – Dr. Robert Califf
Recording June 30, Available July 7, 2020: Podcast: Summary Expert Panel Discussion (Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH; Moderator: Lesley H. Curtis, PhD)
Clinicians and researchers at Seattle’s Harborview Medical Center documented their experiences in the early weeks of the COVID-19 outbreak in King County, Washington. Their report offers lessons from clinical and research personnel, patients, and peer interventionists during the evolving pandemic response in an early US COVID-19 epicenter.
The article, published online in Psychiatry, presents a case series of experiences of frontline clinical and research teams in incorporating COVID-19 prevention strategies in the context of an ongoing comparative effectiveness trial of multidisciplinary, peer-integrated care coordination for patients with severe injury. The report also describes key themes from qualitative data collected during daily team meetings for the Trauma Survivors Outcomes and Support (TSOS) study, a pragmatic clinical trial also underway at Harborview. TSOS, an NIH Collaboratory Trial, is a stepped-wedge, cluster randomized pragmatic trial testing the delivery of screening and intervention strategies for patients with posttraumatic stress disorder and comorbid conditions at 24 level I trauma centers in the United States.
The case series offers evidence that primary and secondary prevention strategies can be integrated into ongoing clinical and research interventions during pandemic response. Procedures can also be developed to support team members who are adapting to rapidly changing individual, organizational, and societal demands.
This work was supported in part by the Patient-Centered Outcomes Research Institute (PCORI). TSOS is supported within the NIH Collaboratory by a cooperative agreement from the National Institute of Mental Health and by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director.
For more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.
Robert Califf, MD, MACC Head of Strategy and Policy Verily Life Sciences and Google Health
Topic
Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keynote-Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?
Keywords
Electronic health records; Digital health; Mobile health; Coronavirus; COVID-19; Ecosystem; Clinical trials; Evidence generation
Key Points
The HERO Registry and RECOVERY Trial are good examples of a rapid clinical research response to the urgent COVID-19 health crisis.
Among the essential steps to move the evidence generation system in the right direction:
Evaluate what has and has not worked in the changes made in response to the crisis
Allocate a significant part of recovery funding to transition issues in evidence generation, especially at the interface of medicine and public health
Increase purposefulness by creating methods for deciding the most important questions and rewarding behavior that gets those questions answered quickly
Discussion Themes
The COVID-19 pandemic has shone a spotlight on disparities in our current healthcare delivery system. How can we avoid leaving the most vulnerable of society behind?
Telemedicine can be a framework for the integration of research and clinical care. But the digital element must be integrated with the human element. The routine and effective use of digital information should free up effort to fix the human components that are holding us back.
We’ve been trying to modernize clinical trial design for decades (factorial/sequential/adaptive designs for example). While some positive movement in the past month has been made, the research enterprise remains largely conservative when it comes to design modernization. How do we make more rapid progress?
Between March 10 and April 3, 2020, the RECOVERY team developed the protocol, obtained regulatory and ethics approval, and enrolled 1,000 patients.
COVID-19 presents an unprecedented clinical challenge to the health system, staff, and patients. Even moderate effects from this study will be worthwhile in the generation of robust evidence.
RECOVERY follow up will involve linkage to national data sources for vital status and death certificates; coded hospital episode statistics (diagnoses, procedures); intensive care audit data and SARS-CoV-2 PCR laboratory results; and primary care and national outpatient prescribing data.
Discussion Themes
Informed consent for participants in the RECOVERY trial consists of a 2-page information sheet and single form written in plain language.
The urgency of this pandemic requires everyone to focus on what matters and leave orthodoxy, habits, and traditional practices behind. Our mindset has been altered by the COVID-19 disruptions and this public health crisis of extraordinary proportion.
Researchers in ADAPTABLE pursued the unanswered question of whether a low dose or high dose of aspirin is optimal for secondary prevention of atherosclerotic cardiovascular disease. Complexities of running a randomized clinical trial and the expenses associated with it have previously prevented researchers from answering this question.
The capabilities of PCORnet have aided in this research. Though not all randomized clinical trials can be designed as PCTs, ADAPTABLE demonstrates the possibility of incorporating pragmatic elements into future studies with the goal of producing real-world evidence.
A key objective of involving PCORnet in ADAPTABLE was the ability for large-scale recruitment (15,000 participants) using electronic health records and electronic informed consent. The PCORnet component permitted complete electronic participation, from randomization to data collection. Patients reported their own data during scheduled electronic follow-ups, which replaced conventional follow-up visits.
NIH Collaboratory Coordinating Center co–principal investigator Dr. Adrian Hernandez also serves as co–principal investigator of ADAPTABLE and contributed to the article.
See the accompanying editorial describing lessons learned from the design features of ADAPTABLE.
The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.
Harlan M. Krumholz, MD
Harold H. Hines Jr. Professor of Medicine, Yale University
Director, Yale New Haven Hospital Center for Outcomes Research and Evaluation
Co-Founder Hugo Health
Bala Hota, MD, MPH
Professor of Internal Medicine, Rush University
Chief Analytics Officer, Rush University Medical Center
Graham Nichol, MD, MPH
Medic One Foundation Endowed Chair for Pre-hospital Emergency Care
Professor of Emergency Medicine
University of Washington
Other Panelists:
Jacqueline Rollin, Administrative Fellow
Rush University Medical Center
Wade Schulz, MD, PhD
Assistant Professor of Laboratory Medicine
Director, CORE Center for Computational Health
Matthew J. Thompson, MB, ChB, DPhil
Helen D. Cohen Endowed Professorship in Family Medicine
Professor of Global Health and Medicine, University of Washington
Deb R. Chromik, Participant Experience
Hugo Health
Dave Hutton, Product Lead
Hugo Health
Topic
Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research
Keywords
Coronavirus; Virus pandemic; INSPIRE Registry; COVID-19 directed research program; SARS-COV-2; Longitudinal data; Hugo Health digital research platform
Key Points
In the face of the coronavirus pandemic, there is an urgent need for rapid knowledge generation and actionable insights. Evidence needed includes:
The number of cases, including milder ones
Risk factors and timing of transmission
Severity and attack rate
Risk factors for infection and severe outcomes, including death
Infectiousness timing and intensity
Patients must be considered part of the team; involved, engaged, and respected, with agency over their data.
To better understand the experience of people with COVID-19, Rush University Medical Center and Hugo health are piloting the COVID INSPIRE registry. INSPIRE is a rapidly-deployed, digitally-enabled, participant-centered platform to collect longitudinal data and facilitate observational and experimental studies.
Discussion Themes
Even with social distancing, the coronavirus is in a rapid escalation phase; this rapid pace has our attention.
People are interested in participating in research now more than ever. The call to action is to build a human-connected system that treats patients compassionately and supports patients in real time.
Are there existing systems that could be built on or adapted for COVID-19? Are there potential for linkages to other systems?
The Collaboratory recently interviewed Kevin Weinfurt, PhD, co-chair of the Patient-Centered Outcomes Core working group, to hear about the Core’s plans for supporting the PRISM Demonstration Projects. In this video, Dr. Weinfurt says one challenge for embedded trials of pain is in obtaining high-quality, complete patient-reported outcome data on pain intensity and functioning. Along with other national initiatives focused on pain research, such as the NIH-DoD-VA Pain Management Collaboratory, a chief task of the Core will be to look at efforts to harmonize pain outcomes across studies.
“The Core serves as a convener of expertise in pain management within the Collaboratory. We keep an eye on issues across the Demonstration Projects that might also be of interest to the broader pragmatic trial community.”
Abhinav Sharma, MD, PhD
Assistant Professor of Medicine
McGill University
Christopher B. Granger, MD, FAHA, FACC
Professor of Medicine
Director, Cardiac Intensive Care Unit
Duke University Medical Center
Topic
Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus–Lessons Learned and Future Directions
Keywords
Type 2 diabetes; Regulatory; Cardiovascular risk; Food and Drug Administration; FDA; Patient outcomes; Anti-hyperglycemic medications
Key Points
The hallmark of type 2 diabetes mellitus is insulin resistance and relative insulin deficiency. Ninety percent of all cases of diabetes are type 2 diabetes, and the diagnosis can occur at any age.
While people with type 2 diabetes can often initially manage their condition through exercise and diet, over time most people will require oral drugs or insulin.
Strategies are needed reduce the burden of cardiovascular outcomes in patients with diabetes.
Is the cardiovascular protection of some anti-hyperglycemic drugs independent of the effect on blood glucose?
How can regulators, industry, academia, payers, and patient advocacy groups assure that evidence generation to improve care is incentivized without undue regulatory burdens?
Should post-marketing studies include comparative effectiveness pragmatic trials in order to improve translation into clinical practice?
