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Harlan Krumholz, MD, SM

Harold H. Hines, Jr. Professor of Medicine (Cardiology) and Professor in the Institute for Social and Policy Studies, of Investigative Medicine and of Public Health (Health Policy); Director, Center for Outcomes Research and Evaluation (CORE)

Research Summary

Dr. Krumholz has led his team at the Yale Center for Outcomes Research and Evaluation (CORE) in the architecture of national quality measures and measurement strategies in partnership with the Centers for Medicare & Medicaid Services; the promotion of patient-centric approaches to research and care; the creation of strategies and tools to enable open science and advance scientific integrity; the development of international collaborative efforts to create a national research network to improve the prevention and treatment of cardiovascular disease in China; and the advancement of regulatory science in partnership with the Food and Drug Administration.

Specialized Terms: Outcomes research in cardiovascular disease; open science; patient centricity

Extensive Research Description

The research team at the Yale Center for Outcomes Research and Evaluation (CORE), which Dr. Krumholz has directed since 1995, continues to expand its role as the chief architect of the national public reporting of hospital performance. The group has pioneered new approaches to measurement that are now widely accepted and publicly reported by the Centers for Medicare & Medicaid Services. The CORE team has also focused on harnessing the digital transformation in healthcare to accelerate knowledge generation and facilitate the delivery of care aligned with each patient’s unique needs and preferences. International initiatives include a decade-long collaboration with the Chinese National Center for Cardiovascular Diseases that is serving as a foundation for health reform and quality improvement efforts across China.

Other selected grants and projects, completed and ongoing at CORE, are detailed below.

Johnson & Johnson: Yale Open Data Access (YODA) Project and Janssen Research and Development Collaboration [Krumholz (PI): 01/06/14–01/06/2021]. This project addresses the problem of unpublished and selectively published clinical trial research, and is enabling scientists to gain access to clinical trial data assets. It establishes an independent process that promotes open science and seeks to leverage prior research investments to produce new knowledge.

National Institute of Biomedical Imaging Bioengineering (Texas A&M): SCH:INT: A Contextaware Cuffless Wearable Ambulatory Blood Pressure Monitor using BioImpedance Sensor Array [Jafari/Krumholz (Subaward Co-PI)/Spatz (PIs): 09/24/2018–06/30/2022]. This grant is developing and evaluating a new ambulatory blood pressure monitoring device for diagnosis of hypertension.

Agency for Healthcare Research and Quality through NYU School of Medicine: Understanding Hospital Value: Provider, Hospital and Community Effects [Horwitz/Krumholz (Subaward PI): 09/30/2019–07/31/2024]. This grant is exploring provider, hospital and community factors affecting the value (quality and cost) of inpatient care. A better understanding of what drives high-value care will help hospitals across the country to more rapidly transform to a value-based healthcare system, improving healthcare quality and cost for all Americans.

State of CT Department of Public Health: Surveillance Project to Estimate the Prevalence of SARS-CoV-2 in Connecticut [Krumholz (PI): 05/01/2020–04/30/2021]. The primary aim of this project is to determine the seroprevalence of SARS-CoV-2 among adults aged 18 and older in Connecticut to provide the information to the Connecticut Department of Health to inform public policy, support mitigation strategies, and assist in plans for future surveillance activities.

Foundation for a Smoke-Free World: Insights about the COVID Pandemic Using Public Data [Krumholz (PI): 06/01/2020–11/30/2020]. This project is building a platform that collects online chatter relating to COVID-19, integrates this unstructured data for trends analysis, and monitors early warning signals of COVID-19 outbreaks in the population.

Agency for Healthcare Research and Quality: Yale-CORE Career Development Program in Patient-Centered Outcomes Research [Krumholz (PI): 08/01/14–07/31/19]. This K12 training program developed scientists with the skills to become independent PCOR investigators and generate practical knowledge poised for application.

The Commonwealth Fund: Evaluating the STAAR Collaborative’s Impact on Hospitals’ Care Transition Practices and Ability to Reduce Readmissions [Krumholz/Curry/Bradley (Co-PIs): 01/01/13–06/30/15]. This project identified changes in the use of recommended practices for reducing readmissions; assessed the impact of hospital practices on readmission rates; and explored how STAAR may have led to changes in care transition practices and readmission rates.

United States Food and Drug Administration: Optimizing Medical Device Post-Market Surveillance for Public Value [Krumholz (PI): 09/30/12–09/29/17]. This project engaged experts in device safety and effectiveness surveillance, industry, academics, government, clinicians, and patients to develop critical methods to monitor medical devices as well as the policies that define roles/responsibilities of expert parties engaged in the device surveillance ecosystem.

Medtronic: Developing an Independent Program to Evaluate the Efficacy and Safety of Drugs and Devices [Krumholz (PI): 08/01/11–01/31/15]. This project developed a model to facilitate independent evaluation of the benefits and harms of drugs and devices, promoting a rigorous review of all available clinical trial and post-market surveillance data.

The Patrick and Catherine Weldon Donaghue Medical Research Foundation: Hospitalomics: A System-based Approach to Hospital Performance [Krumholz (PI): 01/01/11–12/31/14]. This project developed a multi-disciplinary, data-intensive, system-based approach to characterizing patterns of hospital care, linked patterns with performance, and identified targets for interventions to improve hospital performance.

National Heart, Lung, and Blood Institute: Center for Cardiovascular Outcomes Research at Yale University [Krumholz/Curtis (Co-PIs): 09/30/10– 07/31/15]. The focus of this Center was on research to promote hospital and regional excellence in patient outcomes and healthcare value, and to promote inter-institutional collaboration and development of early-stage investigators.

National Heart, Lung, and Blood Institute: Variation in Recovery: Role of Gender on Outcomes in Young AMI Patients (VIRGO/NCT00597922) [Krumholz (PI): 09/01/07–05/31/13]. The VIRGO study characterized sex differences in outcomes following acute myocardial infarction (including mortality, hospitalization and health status); determined sex differences in the prevalence of demographic, clinical and psychosocial risk factors; determined sex differences in quality of care; and determined sex differences in the prevalence of biological factors (including sex hormones, biomarkers and genetic variations).

National Heart, Lung, and Blood Institute: Telemonitoring to Improve Heart Failure Outcomes/NCT00303212 [Krumholz (PI): 04/01/05–10/31/10]. This multi-center, randomized controlled trial compared the effectiveness of telemonitoring with usual care in reducing re-hospitalizations and mortality among patients recently hospitalized for heart failure.

Robert Wood Johnson Foundation: Clinical Scholars Program [Krumholz (PI): 07/01/1996–06/30/16]. This fellowship, the flagship program of the Robert Wood Johnson Foundation for more than 40 years, prepared physicians dedicated to leading efforts toward positive change by addressing challenges and opportunities in the rapidly evolving healthcare system. Dr. Krumholz served as PI/Co-Director of the Yale site from 1996 until the Program's closure in 2016, and now serves as Director Emeritus of the Yale National Clinician Scholars Program.



Coauthors

Research Interests

Cardiology; Decision Making; Health Policy; Heart Failure; Myocardial Infarction; Health Care Quality, Access, and Evaluation; Access to Information; Machine Learning

Public Health Interests

Cardiovascular Diseases; Health Care Quality, Efficiency; COVID-19

Selected Publications

Clinical Trials

ConditionsStudy Title
COVID-19 Inpatient; COVID-19 OutpatientINSPIRE Study: funded by the CDC