WP 2 - Population-based Research and Innovation for System wide Management of Heart Failure (PRISM HF)

Dr. Justin Ezekowitz
  Dr. J. Ezekowitz
Dr. Dauglas Lee
  Dr. D. Lee

 

HF has been relatively understudied in the real-world community setting. Currently, the care provided is often not based on high quality evidence. We will work with CC1 to identify and curate a comprehensive TRANSFORM HF database, a platform for real world evaluations, with the following overarching questions: How can technology and other innovations be utilized to improve outcomes? How will novel strategies be evaluated and implemented using pragmatic intervention studies to examine their impacts on the health of individuals with HF?

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The Global Congestive Heart Failure (G-CHF) prospective cohort study of 25,000 patients (with 2000 patients from Canada) will enable: a) examination of differences in the pathogenic/etiologic factors for HF onset internationally; b) identification of areas where the care and prevention of HF can be improved; and c) evaluation of international innovations in care (CC3). Applying these insights in Canada can lead to implementation of new evidence-based strategies (WP3). Comparisons of G-CHF with Canadian data sources will lead to better understanding of the interactions between lifestyle, ethnicity and geography on the development of HF or its antecedents (e.g., DM, systemic hypertension, myocardial infarction). Collected blood samples will enable comparison of risk profiles between recently-arrived or longresiding Canadians in different provinces, setting the stage for targeted biomarker discovery (WP1) and interventions intended for at-risk populations within Canada—and potentially globally.
In conjunction with CC1, CC3 and the Vector Institute for AI, this theme will design studies to evaluate technological innovations developed by WP4. Machine learning/AI methods will be used to improve algorithms (e.g., management/treatment/advice). The e/t/m-health technology developed will provide a platform for embedded clinical trials, whereby patients can be randomized by the device itself to alternate interventions within the device (e.g., n-of-1 trial) or centrally (e.g., patient- or site-level randomization) to enable rapid cycle evaluation of new interventions and tools for health maintenance and care.
Innovative solutions to prevent readmissions and hospitalization will be developed using data (CC1) in conjunction with HTA (CC3), and informed by health policy (WP3). We will identify new ways of predicting patients’ future trajectories using AI methods such as biomarkers (WP1), machine learning, computer vision and natural language analysis. In conjunction with biomarker discovery (WP1) and the digital health platform (WP4), we will explore how access and care can be improved while focusing on enhancing patients’ QoL. Developed system interventions will be tested nation-wide using cluster randomized and/or stepped wedge study designs leveraging merged curated provincial databases (CC1).
Clinical trials remain the benchmark for new therapies; however, there are gaps in information (e.g., the impact of therapies on patient reported outcomes (WP4)), and increasingly, we need data and evidence that informs best practices where these gaps exist. For example, the realworld effectiveness of new drugs (e.g., ivabradine, sacubutril-valsartan, empagliflozin) has not been systematically evaluated despite their wide scale adoption and impact on healthcare budget. Thus, in cases where there is debate or non-uniformity of guidelines, pragmatic real-world studies—that assess data available in national-level databases (e.g., CC1, partner CIHI)—may be particularly informative to help guide clinical care and policy. Current and future therapies need a testing environment to rapidly generate evidence in understudied populations or where knowledge gaps exist. Evidence generated will inform policy approaches (WP3) to allow Canadians earlier access to currently available and newly developed drugs, devices, and procedures, where guidelines and clinical pathways have not been solidified.