Penn study will compare heart failure management technologies

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 to:
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.