The Rise of Telehealth During COVID-19

June 4, 2020 – A recent paper details how telehealth has been implemented and should continue to be used through three stages of a pandemic.

Two DCRI fellows, one former and one current, recently contributed to a paper published in Journal of the American Medical Informatics Association on the role telehealth has played in U.S. health care during the COVID-19 pandemic.

Jedrek Wosik, MDThe paper, for which DCRI cardiology fellow Jedrek Wosik, MD, is the corresponding author, details how telehealth has transformed both within the Duke Health system and beyond through the collaboration of people, processes, and technology. The paper focuses on three distinct phases of the crisis caused by the novel coronavirus: outpatient care during the stay-at-home orders, the initial COVID-19 hospital surge, and recovery post-pandemic.

Throughout the stay-at-home orders, the authors write, outpatient care administered via telehealth has increased dramatically. Before the pandemic, telehealth visits accounted for less than 1 percent of visits at Duke; just four weeks later, telehealth visits account for 70 percent of visits with over 1,000 patients seen virtually per day. To streamline this transition, Duke created a centralized telehealth call center and deployed a “train the trainer” model to rapidly onboard over 1,300 providers in three weeks.

Telehealth has also been useful in caring for inpatients during a time when many hospitals have been overloaded. “Telehealth is ideally suited to meet the demands of inpatient care while at the same time reducing virus transmission, stretching human and technical resources, and protecting patients and healthcare workers in the inpatient care setting,” the authors write.

At Duke, specialists have been using a Tele-ICU system that enables them to remotely manage intubated patients. Physicians can see data describing ventilator settings and patient breathing while consulting with the bedside team from a remote location. This approach not only decreases exposure risk, but also conserves personal protective equipment (PPE).

Not much is known about telehealth in the third stage—recovery post-pandemic—because the pandemic is ongoing. However, the authors make recommendations about important areas of focus during this stage. While telehealth was leveraged quickly to respond to a crisis, it will be critical to ensure that data security and patient privacy remain paramount as telehealth becomes a sustained offering integrated into everyday care. This could present an opportunity to leverage the electronic health record, which already provides the infrastructure for patients to securely access test results. Health systems should proactively engage patients, the authors write, while also creating systems that allow for efficient use of hospital space and staff.

The COVID-19 pandemic has ushered in a new era of telemedicine, and “delivery of patient care by the American health system will be forever changed,” the authors write. There is more work ahead to determine how to administer telehealth most efficiently and equitably—for example, by linking rural hospitals to existing telehealth programs from larger hospitals.

Former DCRI fellow Marat Fudim, MD, and DCRI faculty member Ziad Gellad, MD, MPH, also contributed to this paper. Their Duke co-authors include Blake Cameron, MD; Alex Cho, MD, MBA; Donna Phinney, BSN, MS; Simon Curtis, MHA; Eric Poon, MD, MPH; Matthew Roman, MHA, MCCi; Jeffrey Ferranti, MD, MS; Jason Katz, MD, MHS; and James Tcheng, MD.

PTN, CTTI Partner on Study, Identify Risk Factors for Hospital-Acquired Pneumonia

June 3, 2020 – The study team used pediatric patients’ electronic health records to identify patients eligible for the study.

A paper recently published in the Pediatric Infectious Disease Journal sheds light on risk factors that make children more likely to contract hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

The study that identified the risk factors was conducted by the Pediatric Trials Network (PTN), for which the DCRI serves as a coordinating center, and the Clinical Trials Transformation Initiative (CTTI), which is hosted at the DCRI. CTTI also conducted the study in adult cohorts in the U. S. and Europe.

HABP/VABP can often be deadly for children, and these illnesses are often caused by drug resistant bacteria that require novel antibiotics. However, HABP/VABP can be difficult to diagnose, which leads to inefficient clinical trial enrollment and hinders new drug development. Identification of risk factors could aid in earlier and more accurate diagnosis of HABP/VABP and improve clinical trials in this area.
The study used pediatric patients’ electronic health records to identify which patients received qualifying respiratory support or antibiotics for either a lower respiratory infection or undifferentiated sepsis. The study then followed the selected patients until they were either diagnosed with HABP/VABP or discharged from the intensive care unit.

PTN logo“This study, which identifies factors that could place patients at a higher risk of developing hospital-acquired and ventilator-associated bacterial pneumonia, will be important both for diagnosis and prevention purposes,” said the DCRI’s Danny Benjamin, MD, PhD, principal investigator and chair of the PTN.

Of 862 newborns, infants, and children younger than 18 who were evaluated, 10 percent of patients receiving respiratory support and 12 percent overall developed HABP/VABP. While risk factors varied by age group, patients showed increased odds of developing HABP/VABP if they:

  • Were older
  • Were shorter
  • Spent a longer time in the intensive care unit
  • Were at risk of aspiration
  • Had received a blood product transfusion in the prior seven days
  • Had frequent suctioning

“This paper can potentially help improve diagnosis and identification of eligible pediatric participants for antibacterial pneumonia trials,” added Pamela Tenaerts, MD, MBA, executive director of CTTI. “Additional results from CTTI’s HABP/VABP studies project, including the results of this study’s U.S. and European adult cohorts, will be available in the coming months.”

DCRI Cardiologists Help to Define Care Pathway for Patients with COVID-19

May 28, 2020 – In response to a wide array of cardiovascular complications seen in patients with COVID-19, the Duke Health system has developed a framework which organizes its approach to caring for patients with COVID-19-related myocardial injury, heart failure, arrhythmias, and more.

Rahul Loungani, MDA recently published paper in American Heart Journal led by DCRI fellow Rahul Loungani, MD (pictured left), under the mentorship of Duke Heart Center Chief and DCRI faculty member Manesh Patel, MD (pictured right), details care pathways established in the Duke Health system for managing patients with cardiovascular complications caused by COVID-19.

“The model presented can provide a framework for other institutions to organize their own approaches and can be adapted to local constraints, resource availability, and emerging knowledge,” the authors write. Additional DCRI authors on the paper include Robert Mentz, MD; Schuyler Jones, MD; Sreekanth Vemulapalli, MD; and Jonathan Piccini, MD, MHS.

Cardiologists have seen a wide range of cardiovascular complications related to the novel coronavirus. Manesh Patel, MDPatients with a history of cardiovascular disease who contract COVID-19 are more likely to become critically ill, and potential therapies may also cause complications. The disease has also been known to directly result in complications, including myocardial injury, heart failure, and arrhythmias.

The Duke Division of Cardiology, in partnership with the Duke Heart Center, decided to create a care pathway for patients with COVID-19 to organize its approach to cardiovascular complications and “to streamline care, limit risk to personnel, ensure provision of limited resources (including diagnostics, invasive procedures, and service lines), and align clinical care across multiple divisions.”

The pathway outlines a framework for triaging and caring for patients based on the symptoms that have been seen within each group of complications. Not only is the framework helpful in providing advice for cardiologists, but it also helps provides clear guidance to frontline providers who may not routinely administer cardiovascular care. The model also advises that for high-risk phenotypes, clinicians should consider the opportunity to enroll these patients in clinical trials.

“The pathway we developed is based on expert opinion and the current evidence we have available, and our response will continue to evolve as new evidence emerges,” Loungani said. “In the meantime, we hope that by sharing this pathway, we can help other health systems in shaping their response to the wide-ranging cardiovascular impacts of COVID-19.”

Patel added, “We are all learning about COVID-19 at a rapid pace, and we appreciate the opportunity to share information and update approaches as we all work to help our communities.”

IPF-PRO Registry Continues to Shed Light on Devastating Lung Disease

May 18, 2020 – The registry, which has enrolled 1,002 patients with idiopathic pulmonary fibrosis, shares critical knowledge and insights to help combat lung disease.

Clinical researchers at the DCRI continue to uncover new information about idiopathic pulmonary fibrosis (IPF), a devastating, progressive lung disease with an unknown cause, by analyzing data collected through the IPF-PRO/ILD-PRO Registry.

The registry is sponsored by Boehringer Ingelheim (BI) and includes more than 1,000 patients with IPF. The registry’s principal investigator is Scott Palmer, MD, MHS. Other members of the DCRI team include Laurie Snyder, MD, MHS; Jamie Todd, MD; Megan Neely, PhD; Eric Yow, MS; Emily O’Brien, PhD; and Rosalia Blanco, MBA. Work with the registry has been ongoing since 2014 and has, to date, resulted in eight published manuscripts and 40 poster or abstract presentations. Below is a sampling of published findings from the past several months.

Scott Palmer, MD, MHS“Thanks to the partnership with BI and collaborative efforts of our DCRI team and site investigators over the last six years, we’ve made great progress in improving our understanding of idiopathic pulmonary fibrosis,” Palmer said. “We have been able to rapidly share the knowledge we gain through this registry in order to understand the impact of the disease and its mechanisms and to guide the development of new and improved approaches to patient care and treatment.”

Potential Biomarkers Could Help in Diagnosis, Outcome Predictions

Because timely diagnosis and management of IPF are both challenges, much of Todd’s research focuses on determining whether there are biomarkers that could help clinicians in diagnosis, prognosis, or predicting how patients will respond to treatment. In addition, these highly translational studies are providing new and fundamental insights into IPF disease mechanisms by leveraging the unique biosamples prospectively collected among patients enrolled in the registry.

Jamie Todd, MD, MHSA recent study led by Todd and published in BioMed Central Pulmonary Medicine compared blood samples of patients enrolled in the IPF-PRO Registry with the blood of patients without lung disease. The study, which quantified the expression of a broad array of matrix metalloproteinases (MMPs) and tissue inhibitors of MMPs (TIMPs), shed light on how the expression of single MMPs and TIMPs relates to status and severity of IPF. However, because almost all of the MMPs and TIMPs presented in elevated levels in patients with IPF, the study also sought to show how combinations of MMPs and TIMPs aid in diagnosis or prognosis in patients with IPF. Although further validation of the study’s results will be necessary, Todd said, this study is a step toward identifying biomarkers that could be useful in future diagnosis and treatment of IPF.

Other DCRI contributors to this study include Palmer, Neely, and Robert Overton. Duke’s L. Kristin Newby, MD, is principal investigator of the MURDOCK study, which provided the control group for this study and contributed to the publication.

Proteins in Plasma Found to be Associated with Death, Lung Transplant

Another study led by Todd found that, when considered along with clinical factors such as forced vital capacity and diffusion capacity, 65 proteins were significantly associated with the composite outcome of death or lung transplant. When proteins were considered without clinical factors, a set of 55 proteins could be used to predict the probability of respiratory death or lung transplant.

The study examined proteins in the plasma of 300 IPF-PRO Registry participants who had cases diagnosed or confirmed within a six-month timeframe. An abstract detailing the study was accepted at American Thoracic Society’s annual conference (ATS 2020) and was published in the ATS abstract edition of the American Journal of Respiratory and Critical Care Medicine online after the conference was canceled due to COVID-19. Neely and Palmer also contributed to this study, and Overton and Hillary Mulder, MS, provided statistical support.

Insights on Time to Diagnose IPF

Laurie Snyder, MDA study led by Snyder studied a cohort of IPF-PRO participants to determine how long it took for patients to receive an IPF diagnosis after the first symptom onset or imaging evidence of pulmonary fibrosis. The study also compared the time from enrollment in the registry to death or lung transplant between the two groups of patients. An abstract detailing the study accepted at ATS 2020 and was published in the ATS abstract edition of the American Journal of Respiratory and Critical Care Medicine online. Neely, Hellkamp, and DCRI fellow Christopher Mosher, MD, also contributed to this study.

Measures of IPF Severity Correspond to Patient-Reported Quality of Life

Emily O'Brien, PhDA study led by O’Brien and published in Chest examined the associations between objective disease severity measures collected as part of the IPF-PRO Registry—such as diffusing capacity for carbon monoxide, oxygen use at risk and with activity, and an index score determined by age, gender, and lung function—and patient-reported quality of life measures based on a questionnaire.

The study found that quality of life was worse in patients enrolled in IPF-PRO compared with the general population. Increasing disease severity was also associated with worse quality of life. Other DCRI contributors include Snyder; Todd; Palmer; Neely; Aparna Swaminathan, MD; and Anne Hellkamp, MS.

Expanding on the IPF-PRO Registry Model

A related group of respiratory illness that needs further investigation is the broader category of interstitial lung disease (ILD) other than IPF, as it is now clear a subset of these patients develop a relentless and progressive fibrosis similar to patients with IPF.

Building on the success of the IPF-PRO Registry, the DCRI, again in partnership with BI, expanded the registry to include patients with ILD who demonstrate evidence of progressive fibrosis. The ILD-PRO Registry, which will also be led by Palmer and the same leadership from the DCRI team, will enroll approximately 1,000 patients with ILDs across 45 sites nationwide, drawing on the infrastructure already established by the IPF-PRO Registry. An abstract detailing the design of the ILD-PRO Registry was accepted at ATS 2020 and was also published in the ATS abstract edition of American Journal of Respiratory and Critical Care Medicine online.

Neely, Snyder, O’Brien, and Todd also contributed to this abstract and will serve as co-investigators on the ILD-PRO Registry. Todd is the biomarker committee co-chair and Snyder is the publication committee co-chair for all of the registry studies.

Pediatric Trials Network Research Contributes to Three Recent Drug Label Changes

May 13, 2020 – Data provided to the FDA by the research network has helped to provide a fuller picture for prescribing these medications to pediatric populations.

Data from the Pediatric Trials Network (PTN) recently contributed to label changes for three different drugs, the culmination of months of research pursued by the NIH-supported research network.

PTN logoLabel changes occur when the U.S. FDA updates the prescribing information for a drug. In all three of these cases, the FDA added prescribing information to be used when treating children. The PTN, for which the DCRI serves as a coordinating center, is focused on conducting trials to improve drug labeling for children.

The three drugs that can now be used safely and effectively when treating children are:

  • Clindamycin. The label now includes dosing guidelines for children with obesity. While Clindamycin is a commonly used pediatric drug, it is important to consider dosing for children with obesity separately because their bodies may absorb and process drugs differently.
  • Caffeine citrate. The label now includes crucial information about age and dosing. Caffeine citrate is the most commonly used non-antimicrobial medication for premature infants used in the newborn intensive care unit. When given to premature infants, caffeine reduces episodes of apnea (forgetting to breathe) and bradycardia (slowing of the heart rate) that can result from an immature nervous system.
  • Doxycycline. This drug has never been well studied in children younger than 8, but thanks to data from a PTN study called PTN POPS, the label now contains better information on how to use this drug in treating young children. Doxycycline is an antibiotic used to treat diseases such as Rocky Mountain Spotted Fever and methicillin resistant staph aureus.

To date, the PTN has contributed to label changes for 15 drugs.

Kanecia Zimmerman, MD, MPH“With each label change, the PTN is giving pediatricians more of the critical information they need to improve the lives of their patients and give parents more confidence in their children’s care,” said the DCRI’s Kanecia Zimmerman, MD, MPH, associate professor of pediatrics at Duke University School of Medicine and chair of the PTN steering committee.

“These label changes reflect the flexible and creative approach that everyone working Daniel Benjamin, MD, PhDwith the PTN has collectively advanced,” said Danny Benjamin, MD, PhD, principal investigator for the PTN and director of DCRI Pediatrics. “The network is well-positioned for the next several years to continue to improve the health of children, thanks to legislation that supports pediatric research and the quality of our work.”

 

Novel Micra Pacemaker Found to Reduce Patient Risk

May 8, 2020 – A pragmatic comparative effectiveness study comparing Micra leadless pacemakers to conventional transvenous pacemakers found that for patients who received the novel leadless pacemakers, complication risks were reduced by two-thirds six months post-procedure.

Results from the Novel Micra Continued Evidence Development (Micra CED) post-approval study confirm the safety and efficacy of a novel tined leadless pacemaker and reveal promising insights about how this novel device can improve patient outcomes.

Results from the study, which were presented virtually as a late-breaking session at the Heart Rhythm Society 2020 Science program, showed that patients who were treated with the Micra Transcatheter Pacing System, a novel tined leadless pacemaker developed by Medtronic, had a lower rate of complications in follow-up compared to those patients who received a conventional transvenous pacemaker.

Jonathan Piccini, MD, MHSOne in eight patients may experience a complication with the traditional pacemakers, explained the DCRI’s Jonathan Piccini, MD, MHS, who led the study and gave the presentation. Leadless pacemakers eliminate the complications associated with pacemaker pockets and transvenous leads.

The Micra IDE study, a pivotal study conducted between 2013 and 2017 to assess the safety and efficacy of Micra, found a 48 percent reduction in complication risk when compared to historical studies of transvenous pacemakers. A key question was whether these same benefits would be identified or generalizable in routine clinical practice. The Micra CED pragmatic comparative effectiveness study sought to compare not only complications for patients at 30 days and at 6 months, but also the rate at which patients experienced a need for pacemaker system revision or all-cause mortality. Micra CED identified a 63 percent lower risk of complications in follow-up at 6 months.

Micra CED utilized a unique pragmatic design that focused on patients 65 years of age and older who received a de novo pacemaker within the Medicare program. In the nationwide cohort, 5,700 patients who received a Micra leadless pacemaker were compared to 9,600 patients who received a transvenous pacemaker. Because the investigators were interested in determining whether results from prior Micra studies, including the IDE trial, were generalizable to a wider population, they paid special attention to characteristics of the patient populations in each study. Patients in Micra CED had higher rates of comorbid illness, including a nearly three-fold higher prevalence of heart failure and a greater than two-fold higher prevalence of COPD when compared to the pivotal Micra IDE trial.

The Micra CED study team found no significant difference in overall complications between the two groups of patients 30 days after receiving the device. The group that received Micra had lower rates of device-related complications, but higher rates of complications related to the access site and higher rates of cardiac effusions/perforation. However, the latter event rate was less than 1 percent in both groups.

Patients who received Micra saw greater benefit six months after receiving the device, when their risk of complications was reduced by two-thirds as compared to patients who received transvenous pacemakers. This association with lower complication rates in follow-up is especially significant because the group of patients who received Micra tended to be sicker and had more comorbid illnesses than prior Micra studies.

The study team found no significant difference in the study’s other two objectives: rate of system revision and all-cause mortality.

“These results show promise for the many patients who rely on permanent pacing as an essential therapy,” Piccini said. “The Micra CED study reinforces what we have seen in prior studies. Patients who received Micra leadless pacemakers experienced improved outcomes over the long term, including lower rates of complications at six months. Not only does this study illustrate the feasibility of utilizing real-world data to generate evidence and measure the effectiveness of new technology, but it provides needed information that will help clinicians in shared decision-making with their patients.”

DCRI Welcomes New Executive Director

May 6, 2020 – A cardiologist and internationally recognized clinical research expert will become the Institute’s new leader.

After a nationwide search for a new leader for the Duke Clinical Research Institute, the Duke University School of Medicine announced today it has named an executive director for the Institute.

Adrian Hernandez, MD, MHSAdrian Hernandez, MD, MHS, a cardiologist and internationally recognized clinical research expert, will step into the role effective May 15. Hernandez, who has served as the Vice Dean for Clinical Research for the Duke University School of Medicine since 2017, will also maintain some responsibilities of this role as he continues to guide clinical research strategy for the School.

Hernandez has a long history with the DCRI, having joined as a cardiology fellow in 2002. “I learned the power of evidence, the importance of teams, and about the unmet needs of people with everyday health challenges,” Hernandez said while reflecting on the beginnings of his DCRI career. “This early experience continues to shape my vision and thinking today. Simply put, it’s great to be back home.”

Hernandez outlined parts of his vision for the DCRI’s future in creating and implementing new models for conducting clinical research. “Our value will be realized through more efficient studies and in creating new pathways for innovative health solutions and groundbreaking research,” he said. “The future of our work will emphasize programs that are large, leveraged, and embedded within health systems or the daily lives of people. We will practice new methods that enable research at home that is frictionless, flexible, and even fun. To accomplish this, we will continue to leverage the many strengths across Duke and the School of Medicine to innovate locally and scale globally.”

Lesley Curtis, PhD, will transition out of her Interim Executive Director role and resume her full-time work as Chair and Professor of Duke’s Department of Population Health Sciences. She will also remain an active DCRI faculty member through her leadership of the DCRI Think Tanks program and her work with the NIH Collaboratory, PCORnet, and other joint research projects between the DCRI and Population Health.

“Leading the DCRI has been a rewarding journey in so many ways, and together we have made terrific progress,” Curtis said. “I remain committed to the DCRI mission and its ongoing success. I am also delighted to hand over the reins to someone who is a leading clinical researcher, a close colleague, and a substantial contributor to the DCRI for many years.”

PTN to Study Pediatric Dosing for Potential COVID-19 Drugs

April 29, 2020 – In response to the COVID-19 pandemic, the POP02 study has expanded its protocol to include antiviral drugs that could be used to treat pediatric patients with COVID-19.

The Pediatric Trials Network (PTN) is expanding one of its existing studies to focus on pediatric dosing for six antiviral drugs that may be used in the treatment of COVID-19.

In a matter of weeks, Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POP02), was able to expand its protocol to focus on potential COVID-19 therapies and begin enrolling pediatric patients who are already taking these medications per standard of care. POP02 will collect data on azithromycin, chloroquine, hydroxychloroquine, lopinavir/ritonavir, ribavirin, and tocilizumab. The study, which will be led by Duke’s Chi Hornik, PharmD, Director of Clinical Research in the Division of Pediatric Critical Care Medicine, will include about 30 sites. Researchers aim to enroll 36 patients taking each drug.

The PTN, for which the DCRI serves as a coordinating center, is a research network focused on determining safe and effective drug dosing standards for children.

POP02 is an extension of another PTN study, PTN POPS. The aim of both studies is to leverage procedures conducted during routine patient care, such as blood draws, and use pharmacokinetic modeling to determine safe and effective dosing information for different pediatric age groups and special pediatric populations.

“PTN serves as a national collaborative resource, providing evidence for optimal dosing of commonly used medications in infants and children,” said Danny Benjamin, MD, PhD, MPH, principal investigator and chair of the PTN. “Our expanded POP02 work will be instrumental in helping inform the decisions parents and healthcare providers make when caring for our youngest patients with COVID-19.”

DCRI, Bayer Partner to Tackle Three Cardiovascular Conditions

April 15, 2020 – The collaboration will initially focus on projects related to heart failure, coronary and vascular disease, and atrial fibrillation.

New answers for patients with a range of heart conditions will soon be uncovered as part of a new collaboration between the DCRI and Bayer.

The collaboration will include ongoing projects in three broad disease areas—heart failure, coronary and vascular disease, and atrial fibrillation—in an effort to better understand these conditions and develop potential treatments.

Michael Felker, MD

“This partnership holds great promise,” said Michael Felker, MD, who is leading the DCRI side of the collaboration. “The DCRI can contribute thought leadership and access to data, while Bayer has a deep and growing pipeline of drug development in these areas. We’re looking forward to working with Bayer on conditions in which we have a long track record of research that has an impact on the health of patients.”

The projects included in the collaboration will be led by various faculty and operational members of the DCRI depending on the expertise required for each study. The fact that all of the projects will be a part of the same structure established by the alliance will result in continuity between the projects, more efficient study start-up, and may even lead to synergies among different studies, Felker said.

The projects will also draw on different data sources that the DCRI has access to, from molecular data to data from PCORnet®, the National Patient-Centered Clinical Research Network. A joint steering committee comprising representatives from both the DCRI and Bayer has been established to ensure the different workstreams of the collaboration are conducted in parallel.

“We are committed to further improve treatment options for patients suffering from cardiovascular diseases,” said Richard Nkulikiyinka, who is leading the Bayer side of the collaboration. “Access to data and growing analytic capacity make it possible to analyze a variety of information together for more medical knowledge and improved guidance regarding therapy selections, helping us to understand how certain patient populations respond to different types of medication before starting therapy, thus improving efficacy.”

DCRI-Led Registry Launches, Invites Healthcare Workers Nationwide to Fight COVID-19 Together

April 13, 2020 – The HERO registry, which can be joined at HeroesResearch.org, will enroll thousands of healthcare workers to answer crucial questions about the impact of novel coronavirus on their lives.

The DCRI-led Healthcare Worker Exposure Response & Outcomes (HERO) Registry launched today, inviting U.S. healthcare workers to share clinical and life experiences in order to understand the perspectives and problems faced by those on the COVID-19 pandemic front lines.

The registry will unite America’s healthcare workers into a community to facilitate rapid-cycle research projects, including an upcoming large study of hydroxychloroquine’s effectiveness in preventing coronavirus infections in healthcare workers. The HERO research program leverages PCORnet®, the National Patient-Centered Clinical Research Network, and is funded by the Patient-Centered Outcomes Research Institute (PCORI).

Adrian Hernandez, MD, MHS“Healthcare workers treat and protect all of us from COVID-19. With the HERO Registry we aim to develop better measures to protect and support them,” said the DCRI’s Adrian Hernandez, MD, MHS (pictured left), principal investigator of the HERO research program and Vice Dean for Clinical Research for the Duke University School of Medicine, of which the DCRI is part. “The 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.”

The HERO Registry is asking hundreds of thousands of healthcare professionals to participate, 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.

“We’re calling on all healthcare workers to share their perspectives so that we can understand and Emily O'Brien, PhDprovide answers to the problems they face in real time—and over time,” said the DCRI’s Emily O’Brien, PhD (pictured right), principal investigator of the HERO Registry and Assistant Professor in Duke’s Department of Population Health Sciences.

The goals of the registry are to engage healthcare workers in a research community, understand their experiences and interests, and track critical health outcomes associated with caring for patients with COVID-19, such as stress and burnout. The HERO Registry will help speed clinical studies that address unmet needs for healthcare workers, such as an upcoming study of hydroxychloroquine. HERO-HCQ, which will be led by the DCRI’s Susanna Naggie, MD, is a randomized clinical trial of approximately 15,000 HERO Registry participants that will evaluate whether hydroxychloroquine (brand name Plaquenil®) is better than placebo in preventing COVID-19 infection. It will be conducted through clinical research sites in PCORnet.

“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.”

There is no cost to join the HERO Registry and it takes only a few minutes to sign up. After joining, registry participants will receive surveys, opportunities to participate in future studies, and learnings from the HERO research community. Healthcare workers can 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.

“It is hard to think that by doing my daily job, not only can I get sick, but I can infect those that I love the most,” said Jorge Lascano, MD, associate professor of Pulmonary and Critical Care, University of Florida, in a video message. “This is the time to be proactive, to develop ways to stay safe on the front lines. I encourage everyone to be a part of HERO—and part of the solution.”

To learn more about the HERO Registry, visit https://heroesresearch.org.