HERO Registry & Trial: Healthcare Worker Exposure Response and Outcomes

Study Updated 03/28/2024
Research Question(s):

Can a research registry of people working in healthcare help to answer important questions about the COVID-19 pandemic on medications, vaccines and healthcare worker well-being?

Primary Publication(s):
Design of the Healthcare Worker Exposure Response and Outcomes (HERO) research platform
Friedland A, Hernandez AF, Anstrom KJ, et al. Design of healthcare worker exposure response and outcomes (HERO) research platform. Contemp Clin Trials, 2021; 109:106525.

Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ)
Naggie S, Milstone A, Castro M, et al. Hydroxychloroquine for pre-exposure prophylaxis of COVID-19 in health care workers: a randomized, multicenter, placebo-controlled trial (HERO-HCQ). Medrxiv, 2021. doi: https://doi.org/10.1101/2021.08.19.21262275

 

PCORnet®-Enabled HERO Registry Launched, Unites Frontline Healthcare Workers to Fight COVID-19

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry launched today, marking the first major milestone in a rapid-response effort to answer important questions about protecting healthcare workers from COVID-19. The HERO program is funded by the Patient-Centered Outcomes Research Institute (PCORI) coordinated by the Duke Clinical Research Institute (DCRI) and enabled by PCORnet®, the National Patient-Centered Clinical Research Network.

“The HERO Registry will leverage PCORnet® resources and capacity to help us develop fast knowledge to keep healthcare workers safe and healthy, which ultimately will help protect us all,” said Adrian Hernandez, MD, MHS, principal investigator for the PCORnet Coordinating Center and the HERO program.

With the launch of the registry, the HERO program is seeking participation from hundreds of thousands of healthcare workers, including nurses, therapists, physicians, emergency responders, food service workers, environmental services workers, interpreters, and transporters—anyone who works in a setting where people receive health care. Participants will receive surveys and could be selected to participate in clinical trials. Healthcare workers can sign up via the registry and participate as much or as little as they like. The registry will follow a protocol developed by the DCRI and data guidelines to keep healthcare worker information secure.

“We’re calling on all healthcare workers to share their perspectives so that we can understand and provide answers to the problems they face in real time—and over time,” said Emily O’Brien, PhD, principal investigator of the HERO Registry and assistant professor in Duke University’s Department of Population Health Sciences.

The first rapid-cycle clinical trial using the registry, HERO-HCQ, is slated to start enrolling healthcare workers at the end of April, when sites within the PCORnet network will use the registry to identify about 15,000 interested healthcare workers to participate. The trial will randomize eligible participants to either one month of hydroxychloroquine or one month of placebo and will examine whether the drug is effective in preventing COVID-19 infection. Study results will be shared widely with the healthcare community.

Using PCORnet to conduct the study offers several major advantages over traditional trials. The network has a wealth of information to draw on in setting up the registry. It also has a well-established community of healthcare systems with experience collaborating on large clinical studies engaging patients and clinicians alike. This community will facilitate the oversight essential to ensure the study is carried out ethically and allow any interested healthcare or emergency worker to easily join the registry.

“Hospitals, health systems, and health plans that participate in PCORnet have worked in partnership for years and are well poised to deliver fast, reliable research infrastructure to study COVID-19,” said Chris Forrest, MD, PhD, co-chair of the HERO Registry and principal investigator of PEDSnet, one of multiple PCORnet Partner Networks participating in HERO-HCQ. “Infrastructure issues that might cause lag time for other studies are hurdles PCORnet has already crossed. PCORnet was developed for exactly this type of research challenge, and the network is ready to meet the moment.”

PCORnet® Tapped to Deliver Fast Answers in New Research Evaluating the Health and Outcomes of Healthcare Workers on the Front Lines of COVID-19

HERO logoAs the coronavirus disease (COVID-19) pandemic intensifies across the United States, the need for fast, reliable answers to support national health and safety has never been more important. This is exactly the type of environment PCORnet®, the National Patient-Centered Clinical Research Network, was developed to navigate. The Patient-Centered Outcomes Research Institute (PCORI) today announced up to $50 million in  funding for the Healthcare Worker Exposure Response & Outcomes (HERO) research program, which will use PCORnet resources to explore important questions about preventing healthcare workers from contracting COVID-19. It will include building a registry of  U.S. healthcare workers and a randomized clinical trial of the effectiveness of hydroxychloroquine (HCQ) in preventing COVID-19 infections in healthcare workers.  The HERO research program will be led by the Duke Clinical Research Institute (DCRI).

Details about the initial announcement of this critical research initiative can be found at PCORI’s website. Further information on HERO research, its use of PCORnet resources, and how healthcare workers can participate, will be announced next week. Stay tuned for more details!