Penn Study Will Compare Heart Failure Management
(Philadelphia, PA) – Researchers at the Hospital of the
University of Pennsylvania (HUP) have been awarded a $1.5 million
dollar grant from the Agency for Health Care Research and Quality and
the National Institutes of Health to study disease management technologies
in patients with heart failure, and patients with both heart failure and
diabetes. The principal investigator for the two-site trial is Lee
Goldberg, MD, MPH, Assistant Professor of Medicine and Medical
Director of the Heart-Lung Transplant Program.
The objective of this study is to assess the impact of health information
technologies on clinical and financial outcomes for patients with symptomatic
(NYHA Class II – IV) heart failure. The information technologies
include remote monitoring (telemonitoring) of vital signs and symptoms,
an electronic health record system and clinical decision support systems.
This study will test a scalable, reproducible model for technology-supported
heart failure management; and its results should assist purchasers, payers,
and policy makers in selecting health information technologies to improve
clinical and financial outcomes.
“An estimated 4.8 million Americans have heart failure, with an
estimated 400,000 new cases arising each year,” explains Dr. Goldberg.
“The costs of treating these patients are skyrocketing and are only
expected to grow as the population ages. In order to curb healthcare costs,
we hope to develop protocols by which we can provide patients with the
latest proven technologies to help them manage their homecare more effectively
in order to reduce emergency rooms visits and improve outcomes.”
The study will evaluate two different configurations of health information
technologies. One is Technology Supported Case Management,
a combination of telemonitoring and telephone nurse case management. The
other is Technology Supported Self Management,
which combines telemonitoring with an expert clinical-decision support
system that assesses vital signs and symptoms for risk of decompensation
– failure of the heart to maintain adequate blood circulation –
and guides patients through a step-by-step problem solving procedure.
The heart failure patients participating in the study will be randomized
1. Home technology including a scale, blood pressure cuff, heart rate
monitor (and glucometer, if diabetic) with the information going to a
nurse to evaluate and triage.
2. Home technology including a scale, blood pressure cuff, heart rate
monitor (and glucometer, if diabetic) with the information going into
a ‘smart box’ that evaluates a patient’s objective data
and then asks a series of subjective questions that are determined by
the data. The box then helps the patient self manage or guides them to
contact their physician or nurse.
3. Usual heart failure care.
A total of 325 subjects will be enrolled during the next 18 months at
the two study sites – HUP and Saint Vincent Healthcare in Billings,
Montana. The University of Louisville will be the data-coordinating center.
HUP based patients will be recruited from Philadelphia, its surrounding
suburbs and southern New Jersey. Saint Vincent Healthcare volunteers will
be enrolled from the urban, remote and rural catchment areas of southern
Montana and northern Wyoming, including the Indian Health Service.
Volunteers must be documented heart failure patients. Participants must
have had two symptomatic heart failure events within the past year requiring
a trip to an emergency room. A primary care physician or internist must
be managing each volunteer’s heart failure. Participants must also
have the physical and cognitive ability to use the telephone, a scale
(ability to stand unsupported for 20 seconds), a blood pressure monitor,
blood glucose monitor (if needed), or the once-daily presence of a caregiver
who is willing and able to assist with the procedures required by the
study, and a working telephone with touchtone line and phone jack, or
access to one.
Anyone interested should call Valerie Hatton RN, BSN, CCRP at (215) 615-0817
PENN Medicine is a $2.7 billion enterprise dedicated
to the related missions of medical education, biomedical research, and
high-quality patient care. PENN Medicine consists of the University of
Pennsylvania School of Medicine (founded in 1765 as the nation’s
first medical school) and the University of Pennsylvania Health System
(created in 1993 as the nation’s first integrated academic health
Penn’s School of Medicine is ranked #3 in the nation for receipt
of NIH research funds; and ranked #4 in the nation in U.S. News &
World Report’s most recent ranking of top research-oriented medical
schools. Supporting 1,400 fulltime faculty and 700 students, the School
of Medicine is recognized worldwide for its superior education and training
of the next generation of physician-scientists and leaders of academic
Penn Health System is comprised of: its flagship hospital, the Hospital
of the University of Pennsylvania, consistently rated one of the nation’s
“Honor Roll” hospitals by U.S. News & World Report; Pennsylvania
Hospital, the nation's first hospital; Presbyterian Medical Center; a
faculty practice plan; a primary-care provider network; two multispecialty
satellite facilities; and home health care and hospice.