Harlan M Krumholz MD, SM
Harold H. Hines, Jr. Professor of Medicine (Cardiology) and Professor of Faculty of Arts and Sciences, of Investigative Medicine and of Public Health (Health Policy); Co-Director, Clinical Scholars Program; Director, Yale-New Haven Hospital Center for Outcomes Research and Evaluation
Outcomes research in cardiovascular disease
Robert Wood Johnson Foundation: Clinical Scholars Program
Krumholz (PI): 07/01/14 – 06/30/16
The primary goal of this two-year fellowship is to prepare physicians dedicated to leading efforts toward positive change by addressing challenges and opportunities in our rapidly evolving healthcare system.
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 is 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.
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
The goal of this project is to develop a multi-disciplinary, data-intensive, system-based approach to characterizing patterns of hospital care, linking patterns with performance, and identifying targets for interventions to improve hospital performance.
Medtronic: Developing an Independent Program to Evaluate the Efficacy and Safety of Drugs and Devices
Krumholz (PI): 08/01/11 – 01/31/15
The aim of this project is to develop 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.
Johnson & Johnson: YODA Project and Johnson & Johnson Collaboration
Krumholz (PI): 01/06/14 – 01/05/15
This project seeks to address the problem of unpublished and selectively published clinical trial research and will enable scientists to gain access clinical trial data assets. It establishes an independent process that promotes open science and seeks to leverage prior research investments to produce new knowledge.
Food and Drug Administration: Optimizing Medical Device Post-Market Surveillance for Public Value
Krumholz (PI): 09/30/12 – 09/29/17
This project will engage 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.
The Commonwealth Fund: Evaluating the STAAR Collaborative’s Impact on Hospitals’ Care Transition Practices and Ability to Reduce Readmissions, Phase 2
Krumholz/Curry/Bradley (Co-PIs): 01/01/13 – 06/30/15
The primary goal of this work is to identify changes in use of recommended practices for reducing readmissions; assess the impact of hospital practices on readmission rates; and explore how STAAR may have led to changes in care transition practices and readmission rates.
Medtronic (FDA Supplemental): Medical Device Post-Market Surveillance Enhancement Collaboration
Krumholz (PI): 04/30/13 – 04/29/18
Supplemental effort to engage experts in device safety and effectiveness surveillance, industry, academics, government, clinicians, and patients to develop the critical methods needed to proactively monitor medical devices as well as the policies that define roles and responsibilities of expert parties engaged in the medical device surveillance ecosystem.
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 develops scientists with the skills to become independent PCOR investigators and generate practical knowledge poised for application.
My research is focused on determining optimal clinical strategies and identifying opportunities for improvement in the prevention, treatment and outcome of cardiovascular disease with emphasis on under-represented populations. Using methods of clinical epidemiology and health services research, I have sought to illuminate the balance of risks, benefits and costs of specific clinical approaches. The research efforts are intended to provide critical information to improve the quality of health care, monitor changes over time, and guide decisions about the allocation of scarce resources.
Extensive Research Description
The research team at the Yale-New Haven Hospital Center for Outcomes Research and Evaluation (CORE), which I have directed since 1995, continues to expand its role as the chief architect of the national public reporting of hospital performance. We have pioneered new approaches to measurement that are now widely accepted and publicly reported by the Centers for Medicare & Medicaid Services (CMS). We have provided the scientific basis for these measures and participated in efforts to display them effectively. The measures are also leading to research that is providing insight into key determinants of performance among our nation’s hospitals. We are continuing to develop new measures, with attention to ensuring that they are scientifically strong and relevant to efforts to improve care.
We continue work on a four-year grant funded by the Agency for Healthcare Research and Quality, UnitedHealthcare, and the Commonwealth Fund to investigate the factors associated with the outstanding performance of hospitals in the care of patients who have had a heart attack. This study was built upon prior work assessing the differentiating features of institutions that excel in specific areas, with the current focus on those hospitals with outstanding records in patient survival. The work is directly related to the CMS measures described above, with the intent of generating knowledge that can be used by poorer performing hospitals in their efforts to improve. Our work in this area is generating attention for an approach that some may call ‘positive deviance.’ The notion is that the wisdom about best practice may already exist within a community of practitioners and hospitals. We need to identify top performance, learn from those who achieve it, test it in rigorous ways, and, if deemed worthy, find ways to disseminate it.
We continue our work as the central analytic center for national databases addressing the use of cardiovascular procedures. We are the lead center for a database that was mandated by CMS, and in this role we are pursuing research that provides insight into the adoption and application of new technology. We are also serving as experts to guide the next generation of these databases.
CORE devotes extensive efforts toward research directed at improving quality of life and outcomes as well as empowering patients through more active participation in their own care. We successfully completed our targeted enrollment in this final year of the “Telemonitoring to Improve Heart Failure Outcomes” project, a federally-funded study of an innovative approach to monitor patients with heart failure. This study is the only National Institutes of Health (NIH)-funded effort to evaluate disease management in patients with heart failure and will add critical information to inform payment policy.
We completed enrollment and began data analysis for another NIH-funded study designed to characterize the outcomes of patients after a hospitalization for a heart attack, with particular attention to their quality of life and ability to perform daily activities. This study is helping us understand trajectories of recovery experienced by patients after suffering a heart attack, and the determinants of adverse outcomes.
We recently completed the final year of a grant from the Commonwealth Fund to evaluate the Door-to-Balloon (D2B) Alliance, designed to produce knowledge that will guide future large-scale national initiatives. During the course of this initiative, we achieved remarkable improvements in the timeliness of the treatment of heart attacks that benefit from emergency angioplasty. We engaged more that 1,000 hospitals in the United States and many others internationally, with gratifying results. We have submitted the final results for publication and expect for this project to be a catalyst for other efforts that target key processes of care.
In another major federally funded project, we continue our work to construct an unprecedented database of the experience of Medicare patients over time, with the intent of creating a series of national surveillance studies. In addition, we are working directly with CMS to develop strategies for monitoring healthcare outcomes in the Medicare population.
In mid-2008, we completed the start-up phase and began enrollment for the VIRGO project (www.virgostudy.org), a multi-site five-year study through which we will determine key factors that influence the survival and health of women younger than 55 years of age who suffer heart attacks. Comparing 2,000 women and 1,000 similarly aged men, all of whom have had a heart attack, we will identify how women who have heart attacks differ from men, what factors contribute to premature heart disease in women, how delays in seeking care for a heart attack affect a woman’s risk and outcome, and whether the quality of care received by women is comparable to that of men. In addition to its unique population, the study is novel in that it bridges basic science, clinical science, and social science – and this approach should yield some very interesting findings about what matters most in the successful recovery of such patients.