In this Friday’s PCT Grand Rounds, Madelaine Faulkner Modrow of the University of California, San Francisco, and Dr. Schuyler Jones of Duke University will present “Lessons Learned and Patient Partnership in ADAPTABLE.”
The Grand Rounds session will be held on Friday, October 8, at 1:00 pm eastern. Join the online meeting.
For webinar recordings and slides from previous Grand Rounds sessions, see the Grand Rounds hub.
In a new NIH Collaboratory study, 20 NIH Collaboratory Trials responded to a survey about challenges encountered when using the electronic health record (EHR) for pragmatic clinical research. The goal of the study was to elucidate challenges and develop solutions—or prerequisites for pragmatic research—to enable healthcare system leaders, policy makers, and EHR designers to improve the national capacity for generating real-world evidence.
The article was published in the Journal of American Medical Informatics Association (JAMIA).
The challenges identified by the projects fell into 6 broad themes, including inadequate collection of patient-centered data, lack of functionality for structured data collection, lack of standardization, lack of resources to support customization, difficulties aggregating data from multiple sites, and difficult and inefficient access to EHR data.
Researchers from the NIH Collaboratory’s EHR Core and colleagues from the Patient-Centered Outcomes and the Health Care Systems Interactions Core Working Groups discussed the issues and iterated possible solutions. The authors developed the following prerequisites for the conduct of pragmatic research:
The authors argue for the ability to tailor EHR systems to enable the collection of patient-centered outcomes and the extraction of high-quality, standardized data. Although the primary uses of the data are for clinical care and billing, high-quality data from the EHR also have the potential to improve clinical care and population health by providing reliable evidence and to support pragmatic research and learning within and across healthcare systems.
This work was supported within the National Institutes of Health (NIH) Health Care Systems Research Collaboratory by the NIH Common Fund through cooperative agreement U24AT009676 from the Office of Strategic Coordination within the Office of the NIH Director. This work was also supported by the NIH through the NIH HEAL Initiative under award number U24AT010961.
Leaders of the NIH Collaboratory’s Health Care Systems Interactions Core Working Group spoke in a recent interview about the impacts of the COVID-19 pandemic on the NIH Collaboratory Trials.
“Some of the projects are facing healthcare systems that are on pause for research,” said Leah Tuzzio, a senior research associate at Kaiser Permanente Washington Health Research Institute (KPWHRI) and a member of the Core. “It’s happened before when policy changes or when [electronic health record] systems change or when someone important leaves, but the pandemic has had a huge impact,” she said.
“Healthcare systems are strongly influenced by the environment and by changes in their environment, and so any pragmatic trial that’s really embedded in the healthcare system will be affected by the environment around it,” said Dr. Eric Larson, a KPWHRI senior investigator and the chair of the Core. Healthcare systems participating in the NIH Collaboratory NIH Collaboratory Trials have been overwhelmed by their number one priority, which—in addition to caring for their patients—is adapting to COVID, Larson said.
In addition to guiding the NIH Collaboratory Trials through pandemic-related challenges, the Health Care Systems Interactions Core has been working on several long-term projects.
“One of the things that we’re currently working on is a typology of the healthcare systems that have participated in [the GRACE and BeatPain Utah NIH Collaboratory Trials] as well as the projects that came before,” said Core project manager Rachel Hays. The Core is surveying NIH Collaboratory Trial investigators about what lessons they would pass on to future pragmatic trial investigators about building partnerships with their participating healthcare systems, she said.
In this Friday’s COVID-19 Grand Rounds session, Diana Berrent, Natalie Lambert, and Nick Guthe of Survivor Corps will present “Long Term COVID Patient Engagement: Best Practices Informed By Patients’ Experiences Seeking Medical Care.” The Grand Rounds session will be held on Friday, July 23, at 1:00 pm eastern. Join the online meeting.
Survivor Corps is an online community of 170,000 patients affected by COVID-19 and their families and friends. The advocacy group is using its members’ collective experience to build a repository of data sets and research tools to support COVID-19 research, including studies of post-COVID conditions, or “long COVID.” The group seeks to fill the gap between real-world evidence and scientific research to advance understanding of the disease and patients’ healthcare options.
“We have been sort of the canary in the COVID coal mine from the beginning,” said Berrent, who founded Survivor Corps in March 2020 after becoming one of the first people in the United States to be diagnosed with COVID-19.
Berrent will be joined during Grand Rounds by Survivor Corps research director Dr. Natalie Lambert and by Nick Guthe, a Survivor Corps member and adviser.
Survivor Corps’s website, which has been selected by the US Library of Congress for inclusion in the nation’s Coronavirus Web Archive, serves as a hub to provide support, information, and education about COVID-19, connect patients to researchers, and facilitate the nation’s COVID-19 response.
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. For previous COVID-19 Grand Rounds, and more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.
The NIH Collaboratory is pleased to share a new resource to help clinical investigators successfully partner with healthcare system leaders. The Quick Start Guide for Researcher and Healthcare Systems Leader Partnerships provides advice from NIH Collaboratory and healthcare system leadership and serves as an annotated table of contents for the Living Textbook, pointing readers to essential content.
The Quick Start Guide is part of a series of tools intended to support the successful conduct of ePCTs within healthcare systems. The first guide in the series, the Quick Start Guide for Investigators, is designed for clinical investigators interested in learning how to conduct an ePCT. The NIH Collaboratory Coordinating Center is developing more Quick Start Guides for different audiences and use cases.
In an article published today in the New England Journal of Medicine, Drs. Richard Platt, Adrian Hernandez, and Greg Simon of the NIH Collaboratory discuss barriers to healthcare system participation in embedded research and strategies for improvement.
“We advocate creating a robust national [embedded pragmatic clinical trial] capability to generate evidence to guide decisions by patients, clinicians, health systems, and regulators and respond to urgent national health crises, like COVID-19 or the opioid crises,” the authors wrote.
The article recommends a 4-pronged strategy that researchers and funders should consider to increase healthcare system participation in pragmatic clinical trials:
In another perspective piece by Simon, Platt, and Hernandez published in the April 2020 issue of the journal, the authors explored why randomized A vs B comparisons remain uncommon in clinical trials.
In a new article in Healthcare’s special issue on embedded research, Leah Tuzzio and colleagues use experiences from the NIH Collaboratory to describe how quality improvement activities may pose challenges for embedded pragmatic clinical trials (ePCTs), especially if there are overlapping goals and timelines.
For ePCTs to be rigorous, study teams must monitor, adapt, and respond to QI during the design and the trial implementation. Both ePCTs and QI happen within the same context and aim to improve patient care, and they are inherently interconnected. — Tuzzio et al, Healthcare, 2021
ePCTs tend to be larger and more broadly generalizable than quality improvement initiatives and may generate high-quality evidence for care and clinical practice guidelines. Quality improvement initiatives may address the same high-impact health questions, but if they co-occur with ePCTs, they may dilute or confound the ability to detect change. As a result, study teams may need to monitor, adapt, and respond to quality improvement initiatives during the design and conduct of the trial. The authors suggest that routine collaboration with healthcare system stakeholders can help align research and quality improvement to support high-quality, patient-centered care.
Publication of the special issue was supported by AcademyHealth.
For more, see the Living Textbook Chapters on Advice from Health Care System Leadership, Building Partnerships to Ensure a Successful Trial, and Monitoring Intervention Fidelity and Adaptations.
Panelists:
BeatPain Utah
Julie Fritz, PhD, PT
Associate Dean for Research, College of Health
Adjunct Professor, Orthopaedic Surgery
Distinguished Professor, Physical Therapy & Athletic Training
Adjunct Professor, Orthopaedic Surgery Operations
University of Utah
David Wetter, PhD, MS
Professor, Population Health Sciences
Adjunct Professor, Psychology
University of Utah
STOP CRC
Gloria Coronado, PhD
Distinguished Investigator Mitch Greenlick Endowed Scientist for Health Disparities
Kaiser Permanente Center for Health Research
Amanda Petrik, MS
Sr. Research Associate Center for Health Research
Kaiser Permanente Northwest
Guest Moderator:
Wendy Weber, ND, PhD, MPH
Chief, Clinical Research in Complementary and Integrative Health Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
National Institutes of Health (NIH)
Inclusion of Diverse Participants in Pragmatic Clinical Trials: Planning for Diversity – Stakeholder Engagement and Site Selection to Maximize Diversity
Participant diversity; Stakeholder engagement strategies; STOP CRC; BeatPain Utah; Health equity; Community health centers; Plan-Do-Study-Act
Sharing information and resources with community partners—and responding to their needs and building their capacity—helps to build trust around medicine and research.
To what extent is it important to show evidence of interest in and respect for the community beyond the specific focus of your initiative? For example, participating in important community activities and developing a deeper understanding of the culture.
We must design and plan for sustainability at the outset, and we must make targeted, specific efforts to ensure the inclusion of diverse populations in clinical trials.
Another way to increase diversity is to prepare and train more scientists and investigators from diverse populations.
Read more about the BeatPain Utah and STOP CRC Demonstration Projects.
#pctGR, @Collaboratory1
The NIA IMPACT Collaboratory has announced 3 new funding opportunities for researchers at all levels who are interested in pragmatic clinical trials embedded in healthcare systems (ePCTs). They include funding for NIH Collaboratory Trials, a new scholars program for junior and senior investigators, and a new cycle of funding for 1-year pilot studies.
The NIA IMPACT Collaboratory is supported by a grant from the National Institute on Aging. Its mission is to advance care for persons with dementia and their caregivers in real-world settings by building national capacity to conduct pragmatic clinical trials that test interventions embedded in healthcare systems.
Renato D. Lopes, MD, MHS, PhD
Professor of Medicine
Division of Cardiology
Duke University Medical Center
Duke Clinical Research Institute
Brazilian Clinical Research Institute
Generating High-Quality Evidence During a Pandemic: The Brazilian COALITION Experience
COVID-19; Patient outcomes; Cardiology; Randomized clinical trials; COALITION; Levels of evidence
How did you overcome contractual and regulatory concerns to execute your trials?
Instead of “publish or perish,” it should be “collaborate or perish.” Collaboration is the key to surviving in modern academic medicine.
Read more about the need for high-quality evidence to treat COVID-19 patients in Anticoagulation in COVID-19: It Is Time for High-Quality Evidence (J Am Coll Cardiol, 2020)
#pctGR, @Collaboratory1
