PCORnet®-Enabled HERO Registry Tops 20K Participants as Pfizer Partners for Vaccine Safety Study

The Healthcare Worker Exposure Response & Outcomes (HERO) Registry, which unites healthcare workers to better understand and stop COVID-19, has enrolled over 22,000 participants. HERO 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. Its goal is to use the experiences of frontline health workers to develop fast knowledge to keep these workers and their communities safe and healthy in the COVID-19 pandemic.

"We are thrilled to see the HERO Registry continue to grow, a clear indication that frontline health workers across the nation are united in their commitment to fight COVID-19, both in and out of the hospital setting," said Emily O’Brien, principal investigator for the HERO Registry. "Their experiences are tremendously valuable in helping the research community better understand the physical and mental toll of this virus, which will improve COVID-19 care across the board."

The partnership with PCORnet Network Partners has been central to the registry’s success. Network Partners have ties to a well-established community of healthcare systems with experience collaborating on large clinical studies engaging patients and clinicians alike. This community’s support ensures that any interested healthcare or emergency worker can easily join the registry.

Targeting the next phase of COVID-19: long-term vaccine safety

An advantage of real-world registries is their ability to evolve naturally as the pandemic progresses. For example, now that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization of COVID-19 vaccines, the HERO Registry is serving as a key tool in understanding the real-world experiences of healthcare workers taking vaccines.

In December, Pfizer funded the HERO-Together study, which is using the HERO Registry to follow healthcare workers for two years to assess their experiences after receiving one of the COVID-19 vaccines such as the Pfizer-BioNTech COVID-19 vaccine. Like previous studies that leveraged the HERO Registry, HERO-TOGETHER is making participation easy, allowing vaccinated health workers to quickly and securely provide information about their health and any unexpected medical care they have received.

What’s next for the HERO Registry?

The HERO Registry will continue to evolve in the coming years, and its community of engaged healthcare workers are certain to help answer more important questions about the short- and long-term impacts of COVID-19 within this essential community.

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.”