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
Population Health Research Institute
Adapting Clinical Trial Design to Meet the Needs of Learning Health Systems
Learning health system; Pragmatic clinical trial; Patient-Centered Care Transitions in Heart Failure (PACT-HF); Heart failure; Stepped-wedge cluster trial
- 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.
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.
Read more about the PACT-HF study and results in JAMA Network (Van Spall et al. 2019)