Registry

Grand Rounds November 1, 2024: Congenital Heart Initiative: Redefining Outcomes and Navigation to Adult Centered Care (CHI-RON) Study (Thomas W. Carton, PhD, MS; Anitha S. John, MD, PhD)

Posted on by Sophia Ramirez

Speakers

Anitha S. John, MD, PhD
Medical Director
Washington Adult Congenital Heart Program
Professor of Pediatrics
Children’s National Hospital
George Washington University

Thomas W. Carton, PhD, MS
Chief Data and Strategy Officer
Louisiana Public Health Institute

Keywords

Adult Congenital Heart Disease; Registry; Patient Engagement

Key Points

  • The research team reviewed the current challenges in adult congenital heart disease (ACHD) clinical care, surveillance, and long-term outcomes research, including a demand for subspecialty care that outweighs the supply; the heterogeneity of CHD and its long-term outcomes; and changing treatment strategies.
  • Though there are several CHD registries in the U.S., very few focus on adults with CHD. The research’s teams efforts, beginning with the Congenital Heart Initiative (CHI) launch in 2020, came about in response to this gap.
  • The mission of the CHI is to create a digital hub collecting health data from patients and providers. The team seeks to involve patients in every aspect of the CHI registry, with the ultimate goal of creating a community of ACHD patients and providers with a shared understanding of research needs and medical outcomes.
  • As the registry initially lacked data from healthcare providers and the electronic health record, the team partnered with PCORnet to establish an ACHD surveillance system.
  • The CHI-RON study uses PCORnet data and patient-reported outcomes to determine whether ACHD patients who are receiving recommended care do better than those who are not and the impact of gaps in care on patient-reported outcomes.
  • Dr. Carton provided an overview of PCORnet, followed by a review of the data science innovations the team used to generate a computable phenotype, identify congenital heart providers, diversify demographic recruitment for the registry, and incorporate procedure results into the common data model for analysis.
  • One of the strengths of this project was the high degree of patient and partner engagement. This involvement led directly to programming such as the “ACHA Café,” a virtual coffee hour in which patients could engage with one another, and guided their social media content.

Discussion Themes

The ACHD patient population identified a few key topics that they hoped the CHI would explore, including long-term effects of congenital heart defects, the most effective therapeutics for treating CHD, and mental health care options. Patient partner feedback also helped the team refine their recruitment and outreach materials.

Given the tendency for some types of CHD to be given more attention than others, the research team sought to enroll a patient population that was inclusive of a variety of presentations. This presented some methodological challenges, e.g. when it came to drawing distinctions in the registry.

September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials

Posted on by Damon Seils
Headshot of Dr. Tor Biering-Sørensen
Dr. Tor Biering-Sørensen

In this Friday’s PCT Grand Rounds, Dr. Tor Biering-Sørensen of the University of Copenhagen will present “Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program.” The Grand Rounds session will be held on Friday, September 16, 2022, at 1:00 pm eastern.

Dr. Biering-Sørensen is professor and head of the Center for Translational Cardiology and Pragmatic Randomized Trials at the University of Copenhagen and head of the Cardiovascular Non-Invasive Imaging Research Laboratory at Copenhagen University Hospital – Herlev and Gentofte.

Join the online meeting.

February 2, 2022: This Friday in PCT Grand Rounds, the SPIRRIT-HFpEF Registry-Based Randomized Clinical Trial

Posted on by Damon Seils
Headshots of Dr. Adam DeVore and Dr. Lars Lund
Dr. Adam DeVore and Dr. Lars Lund

In this Friday’s PCT Grand Rounds, Dr. Adam DeVore of Duke University and Dr. Lars Lund of the Karolinska Institutet will present “SPIRRIT-HFpEF: Opportunities and Challenges in a Large Registry-Based Randomized Clinical Trial.” The Grand Rounds session will be held on Friday, February 4, at 1:00 pm eastern.

SPIRRIT-HFpEF is using a registry-based randomized clinical trial design to determine whether initiation of spironolactone plus usual care improves outcomes of patients with heart failure with preserved ejection fraction compared with usual care alone.

Join the online meeting.

May 3, 2021: HERO Registry and HERO-TOGETHER Expand Beyond Healthcare Workers

Posted on by Damon Seils

Logo for the Healthcare Worker Exposure Response & Outcomes (HERO) project.The Healthcare Worker Exposure Response & Outcomes (HERO) Registry and the HERO-TOGETHER study are now open to anyone who lives, works, or interacts with healthcare workers in their households or anyone in the surrounding community. The HERO program enables participants to share their experiences after receiving a COVID-19 vaccine, contribute to the science, and help to build vaccine confidence over time.

HERO-TOGETHER is a nationwide paid study focused on the long-term impact of the COVID-19 vaccines. Healthcare workers around the country have already signed up. Now all healthcare workers and anyone who lives, works, or interacts with them are invited to join the study. Participants answer brief surveys about how they’re feeling and any health changes since receiving a COVID-19 vaccine. Participants receive information back and up to $200 compensation for their time. Sign up here.

View the NIH Collaboratory’s recent COVID-19 Grand Rounds session on HERO-TOGETHER.

 

March 19, 2021: HERO-Learning Together about Vaccines for SARS-CoV-2 (Emily O’Brien, PhD; Robert Califf, MD)

Posted on by Gina Uhlenbrauck

Speakers

Emily O’Brien, PhD, FAHA
Associate Professor
Duke Clinical Research Institute
Duke University School of Medicine
 
Robert M. Califf, MD, MACC
Head of Clinical Policy and Strategy
Verily Life Sciences and Google Health

Topic

HERO-Learning Together about Vaccines for SARS-CoV-2

Keywords

COVID-19; Vaccine confidence; Side effects; Postmarketing surveillance; Long-term vaccine safety; Virus variants; PCORI; HERO Registry

Key Points

  • In the United States to date, more than 100 million doses of COVID-19 vaccine have been administered. Yet there remains concern about the increase in variants of the coronavirus.
  • Postmarket evidence generation around COVID-19 vaccines is critically important to understanding the long-term safety of vaccines and building confidence around their use.
  • A “pod” is the group of people you live with or relate to as family and have regular household contact with at least once per week for the past 3 months.

Discussion Themes

What does it mean to be a “safe vaccine”?

We’re still learning about how families are navigating the psychosocial aspects of this pandemic.

Over time, manual processes will be replaced by algorithms and automated systems. But we need to develop digital technologies that support human interactions in health.

What will be the key issues around COVID-19 in 2022?

HERO-TOGETHER is a paid observational research study for people aged 18 and older working in healthcare who have received a COVID-19 vaccine. Eligible participants include anyone who works in a setting where people receive healthcare. Read more about the HERO Program and how to join the registry.

Tags

#pctGR, #HEROTOGETHER, @Collaboratory1, @heroesresearch

April 17, 2020: The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence (Nakela Cook, MD, MPH; Josie Briggs, MD; Susanna Naggie, MD; Emily O’Brien, PhD; Russell Rothman, MD; Chris Forrest, MD, PhD)

Posted on by Gina Uhlenbrauck

Speakers

Nakela Cook, MD, MPH
Executive Director
PCORI

Josie Briggs, MD
Acting Chief Science Director
PCORI

Susanna Naggie, MD
Principal Investigator, HERO-HCQ Clinical Trial
Duke University

Emily O’Brien, PhD
Principal Investigator, HERO-Registry
Duke University

Russell Rothman, MD, MPP
Chair, HERO Steering Committee
Vanderbilt University

Chris Forrest, MD, PhD
Chair, HERO Registry
Children’s Hospital of Pennsylvania

Topic

The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence

Keywords

Coronavirus; Virus pandemic; COVID-19; PCORI; Patient-Centered Outcomes Research Institute; Frontline health workers; Hydroxychloroquine; Healthcare systems; HERO-HCQ

Key Points

  • With the onset of the coronavirus pandemic, the U.S. healthcare system faces an unprecedented stress test to adapt to meet new demands.
  • Those on the frontline of caring for patients—healthcare workers—are at risk of developing or transmitting COVID-19. Evidence is urgently needed to keep healthcare workers and their families safe and healthy, which ultimately will help protect us all.
  • The HERO (Healthcare Worker Exposure Response & Outcomes) Program has three broad focus areas to develop rapid evidence around healthcare workers’ outcomes related to COVID-19:
    • Emphasis on the adaptations in how healthcare is delivered
    • Emphasis on vulnerable populations
    • Emphasis on the well-being of the healthcare worker
  • HERO will consist of a registry study of healthcare workers and a randomized controlled trial called HERO-HCQ that will evaluate the safety and efficacy of hydroxychloroquine to prevent COVID-19 clinical infections in healthcare workers.

Discussion Themes

The goal of the HERO registry is to understand all aspects of healthcare workers’ lives—those with direct impact and those with indirect impact.

What mechanisms are you envisioning for new study proposals that would be conducted via the HERO platform?

Serologic testing will have a significant role in understanding prior infection and potential immunity.

The HERO Registry is open to any healthcare worker to join at https://heroesresearch.org/. Enrollment takes only a few minutes; participation is free and voluntary. It is not restricted by profession. All data are kept confidential.

Tags
#HeroRegistry, #pctGR, @Collaboratory1, @PCORI, @PCORnetwork, @HeroesResearch

April 15, 2020: NIH Collaboratory COVID-19 Grand Rounds Series Continues With Discussion of HERO Program for Healthcare Workers

Posted on by Damon Seils

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.

In this week’s COVID-19 Grand Rounds session, leaders of the Patient-Centered Outcomes Research Institute (PCORI) and investigators from the Healthcare Worker Exposure Response and Outcomes (HERO) registry and the HERO-HCQ randomized clinical trial will present “The HERO Program: PCORnet® at Work to Create a Healthcare Worker Community for Rapid Cycle Evidence.” The Grand Rounds session will be held on Friday, April 17, at 1:00 pm eastern. Join the online meeting.

Previous COVID-19 Grand Rounds:

Recent news announcements:

We will continue to share new research, resources, and guidance as they become available.

April 3, 2020: Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research (Harlan Krumholz, MD; Bala Hota, MD, MPH; Graham Nichol, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

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?

Tags
#pctGR, @Collaboratory1, @HMKYale, @BalaHota, @GrahamNichol