Harlan M Krumholz MD

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

Research Interests

Outcomes research in cardiovascular disease

Current Projects

National Heart, Lung, and Blood Institute
Telemonitoring to Improve Heart Failure Outcomes
The aim of this multicenter, randomized controlled trial, in which we plan to recruit 1,640 patients from community-based cardiology practices across the United States, is to examine a telemonitoring strategy that facilitates communication between patients and health care providers and the general education of patients about managing their conditions. Using a telephone system that does not require Internet access, we will determine whether use of this strategy for 6 months, added to usual medical care, reduces rates of all-cause readmission in patients who had been hospitalized for heart failure in the previous 30 days.
Role: PI

Robert Wood Johnson Foundation
Clinical Scholars Program
The primary goal of this two-year fellowship is to prepare a group of physicians dedicated to addressing challenges and opportunities in our rapidly evolving medical and health care system.
Role: PI

National Heart, Lung, and Blood Institute
Variation in Recovery: Role of Gender on Outcomes in Young AMI Patients (VIRGO)
The aims of this study are to characterize sex differences in outcomes following AMI (including mortality, hospitalization and health status); determine sex differences in the prevalence of demographic, clinical and psychosocial risk factors; determine sex differences in quality of care; and determine sex differences in the prevalence of selected biological factors (including sex hormones, biomarkers and genetic variations).
Role: PI

Agency for Healthcare Research and Quality and United Healthcare Foundation Hospital Strategies to Improve Outcomes Performance
The primary goal of this project is to determine hospital-specific efforts and activities that distinguish higher performing hospitals in terms of risk-adjusted 30-day mortality rates for patients with acute myocardial infarction.
Role: Investigator

Research Summary

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.

Selected Publications

  • Fazel R, Krumholz HM, Wang Y-F, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med 2009;361:849-857.
  • Krumholz HM, Wang Y, Chen J, Drye EE, Spertus JA, Ross JS, Curtis JP, Nallamothu BK, Lichtman JL, Havranek EP, Masoudi FA, Radford MJ, Han LF, Rapp MT, Straube BM, Normand S-LT. Reduction in acute myocardial infarction mortality in the United States: risk-standardized mortality rates from 1995-2006. JAMA 2009;302:767-773.
  • Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA 2008;299:1800-1812.
  • Jackevicius CA, Tu JV, Ross JS, Ko DT, Krumholz HM. Use of ezetimibe in the United States and Canada. N Engl J Med 2008;358:1819-1828.
  • Chan PS, Krumholz HM, Nichol G, Nallamothu BK; American Heart Association National Registry of Cardiopulmonary Resuscitation Investigators. Delayed time to defibrillation after in-hospital cardiac arrest. N Engl J Med 2008;358:9-17.
  • Bradley EH, Herrin J, Wang Y-F, Barton BA, Webster TR, Mattera JA, Roumanis SA, Curtis JP, Nallamothu BK, Magid DJ, McNamara RL, Parkosewich J, Loeb JM, Krumholz HM. Strategies for reducing the door-to-balloon time in acute myocardial infarction. N Engl J Med 2006;355:2308-2320.

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