PITTSBURGH, October 19, 2007 Despite additional and sophisticated monitoring of heart failure patients in a community home setting, an interactive program failed to show any statistical effect in reducing cardiovascular deaths and readmission rates within six months after discharge in a group of elderly, non-Caucasian men and women with heart failure who were Medicare beneficiaries. University of Pittsburgh lead author, Z. Ozlem Soran, M.D., M.P.H., F.A.C.C., associate professor of medicine, associate professor of epidemiology/research, and director of the EECP Research Lab at the University of Pittsburgh Medical Center (UPMC) Cardiovascular Institute, presented these findings at the 11th Annual Scientific Meeting of the Heart Failure Society of America recently in Washington, D.C.
Disease management programs provide substantive benefit, especially for patients cared for by cardiologists at academic or community hospital-based tertiary care facilities. However, the typical heart failure patient is not treated by a cardiologist or by a chronic care team but instead, by a primary care physician in a community setting. Furthermore, information is even more limited regarding the success of home care disease management amongst women, non-Caucasian men, or patients in lower socio-economic groups compared to Caucasian men. Limitations of disease management programs need to be addressed and overcome so that care of heart failure patients can be successful, said Dr. Soran.
Home monitoring systems are not intended to replace medical office visits, but do hold the potential to reduce the number of hospitalizations.
The overall goal of the Heart Failure Home Care clinical trial was to determine if a heart failure disease management program utilizing a computer-based telephonic system for home monitoring, in addition to targeted and consistent physician/patient education, coupled with diligent efforts to utilize optimal medical therapy, would be successful in improving outcomes.
One unique aspect of this trial was that it assessed the utility of the sophisticated heart failure monitoring system in a real world setting rather than within the confines of an academic medical center, said Dr. Soran.
This study also was able to assess a large percentage of women. Conversely, patients with other heart failure telemonitoring settings have been predominantly white males recruited by specialists from academic medical centers.
The multi-center trial was conducted at three sites with affiliations at major academic medical centers including UPMC, Case Western Reserve University in Cleveland and Mount Sinai Medical Center in Miami.
In the heart monitoring trial, a total of 315 patients were randomized: 160 to A Day Link Heart Failure Monitoring System and 155 to standard heart failure care. Sixty five percent of patients were predominantly women. Both groups received patient one-on-one education, education to clinicians and an effort to use optimal medical care. In addition, patients randomized to heart failure monitoring system received an electronic scale and an individualized symptom response system linked to a computerized database operated by trained nurses. The primary study endpoint was treatment failure, defined as cardiovascular death or re-hospitalization for heart failure within six months of enrollment. Among patients re-hospitalized for heart failure, length of hospital stay also was considered a primary endpoint.
The study was unable to identify any useful benefits of a home monitoring system over a period of six months of follow-up when comparing outcomes in patients randomized to the home monitoring device to those with standard heart failure care.
Heart failure management programs hold tremendous promise for patients not receiving comprehensive care, but that does not mean that it is universally effective. Further clinical studies are needed to evaluate the effectiveness of enhanced primary care physician and patient education in determining clinical outcomes. Perhaps someday we will be able to better manage patients without including complicated devices if we can diminish the disease with medication and education, added Dr. Soran.
Other collaborators in this study include Ileana L. Pina, M.D., professor of medicine, Case Western Reserve University, Cleveland; Gervasio A. Lamas, M.D., director of cardiovascular research, Mount Sinai Medical Center, Miami; Sheryl F. Kelsey, Ph.D. and Faith M. Selzer, Ph.D., department of epidemiology, and Judith R. Lave, Ph.D., chair, department of Health Policy and Management, all of the Graduate School of Public Health, University of Pittsburgh; John Pilotte, Centers for Medicare and Medicaid Services, Baltimore; and Arthur M. Feldman, M.D., Jefferson Medical College, Philadelphia.
This study was supported by the U.S. Centers for Medicare and Medicaid.