In this episode of the NIH Collaboratory Grand Rounds podcast, Dr. Lesley Curtis speaks with Dr. Robert Califf, Head of Strategy and Policy at Verily Life Sciences and Google Health about whether the COVID-19 crisis can lead to reformation of the current healthcare delivery system. This discussion follows Dr. Califf’s keynote presentation of a Grand Rounds Series titled Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.
Click on the recording below to listen to the podcast.
Harriette G.C. Van Spall, MD, MPH, FRCPC
Associate Professor of Medicine
Department of Medicine, Division of Cardiology
Department of Health Research Methods, Evidence, and Impact
McMaster University
Population Health Research Institute
Topic
Adapting Clinical Trial Design to Meet the Needs of Learning Health Systems
Keywords
Learning health system; Pragmatic clinical trial; Patient-Centered Care Transitions in Heart Failure (PACT-HF); Heart failure; Stepped-wedge cluster trial
Key Points
Characteristics of a learning health system include:
Possessing a culture of knowledge and quality improvement
Encouraging research innovation by embedding research into clinical practice and generating knowledge at the point of care
Harnessing data from electronic health records and claims/administrative databases
Fostering trust between research and clinical teams
Engaging patients, clinicians, and key stakeholders
The Patient-Centered Care Transitions in Heart Failure (PACT-HF) trial evaluated the effectiveness of a group of transitional care services in patients hospitalized for HF within a publicly funded healthcare system.
Challenges of a learning health system include integrating care, intervention, and communications across silos; streamlining workflow; preventing “contamination” of usual care; and the limited interoperability of EHRs and slow updates to claims/administrative datasets.
Discussion Themes
Efficacy in explanatory randomized clinical trials (RCTs) does not equate to effectiveness in real-world settings.
Decisions about implementation of an intervention are not made “live”; you must wait until the study has ended, all the data are available for analysis, and analysis is complete before you can inform decision-maker partners about the risks and benefits of the intervention.
As the use of PROs in both research and routine patient care has grown, so has the use of mobile technologies (such as smartphones, tablet computers, and portable or wearable medical devices). These technologies, known collectively as “mobile health” or “mHealth” devices present a wide array of challenges and opportunities for medical research. The links below provide access to a series of short video segments on mHealth technologies that were adapted from a larger web seminar sponsored by AcademyHealth and the Robert Wood Johnson Foundation and used here with kind permission from AcademyHealth:
