UTHSC receives $14 million for study of congestive heart failure
Congressman Henry Bonilla worked to ensure inclusion in U.S. defense appropriations
The Health Science Center signed a $14 million contract May 18 with the U.S. Department of Defense (DOD). The contract funds a major UTHSC-coordinated study of congestive heart failure management. U.S. Rep. Henry Bonilla, R-San Antonio, worked with his colleagues on the Defense Appropriations Subcommittee to make sure the funding was included in last year's defense appropriations bill.
"San Antonio, with its military, state, county and private medical institutions and large population of military retirees and active military, is the logical place for this study," Congressman Bonilla said.
This is the largest federally funded contract ever received by the Health Science Center. The DOD award will have a direct impact on the 4.5 million Americans who suffer from congestive heart failure because it seeks to improve management of day-to-day variations in symptoms.
Congestive heart failure is increasingly frequent in the elderly population. It is the primary cause of death among the elderly and the most costly chronic disease. More than 400,000 new cases are reported each year in the United States. Contemporary treatment of congestive heart failure has been successful at extending life, but has been less than successful at managing daily variations in symptoms.
The 27-month study is titled "A Demonstration Project to Evaluate an Integrated System of Disease Management Among a Population of Veterans, Military and Medicaid Patients in South Texas."
Individuals or families interested in study eligibility may call ext. 7-9700 or toll free 1-888-699-4877.
"This major study, made possible through the leadership of Congressman Bonilla during meetings of the Defense Appropriations Subcommittee, will give patients control over their disease when they are at home, in between appointments with their physicians," said Dr. John P. Howe, III, president of the Health Science Center. "We are indeed grateful to Congressman Bonilla for sponsoring this medical research project for the benefit of all the people of South Texas.
"There is no doubt that this Department of Defense project and Congressman Bonilla's sponsorship of the appropriation measure will benefit thousands of people. This landmark study of congestive heart failure will help not only the study subjects, military retirees and those on active duty, but all citizens of this country who are recuperating from experiences with congestive heart failure," he added.
Jose R. Coronado, FACHE, director of the South Texas Veterans Health Care System (STVHCS), said the study will make a major difference in the lives of the nation's veterans, many of whom have chronic health problems brought on by congestive heart failure. "By obtaining substantial funding for this program, Congressman Bonilla has assured the best treatment for our veterans," Coronado said.
The commanders of Brooke Army Medical Center (BAMC) and Wilford Hall Medical Center (WHMC) in San Antonio said the contract could have worldwide impact on improving the treatment of congestive heart failure. Col. Gary R. Ripple, interim commander of BAMC, noted that the disease management strategy will help active-duty personnel who are experiencing symptoms leading to the disease. Maj. Gen. Earl W. Mabry, II, of WHMC said study outcomes might help reduce the high morbidity and mortality of the disease with better prevention and early intervention knowledge.
One study goal is to reduce the number of emergency room visits made by patients with congestive heart failure. "Several factors may precipitate a hospital admission for these patients. These individuals may not be watching their diets as well as they should or they may not be taking their medicines as prescribed. This study will attempt to improve these behaviors," said Dr. Gregory L. Freeman, principal investigator for the study. He is professor and chief of the Division of Cardiology in the Department of Medicine at UTHSC and staff physician with the Audie L. Murphy Division of the STVHCS.
"The incidence of congestive heart failure is increasing as we become more successful at preventing death from other forms of heart disease," Dr. Freeman added. "Fewer people are dying of acute heart attacks today, yet many of these survivors end up facing the risk of developing congestive heart failure as a result of the initial damage."
Congestive heart failure results from impairment of the heart's ability to pump oxygenated blood through the body. Patients accepted to the study must have an ejection fraction less than 45 percent (a normal, healthy value is 55 percent). The ejection fraction, which is determined by an echocardiogram, is a measurement of the amount of blood pumped by the heart during each beat.
The Health Science Center is partnering with BAMC, WHMC, the STVHCS, the University Health System and private physicians in South Texas. Study coordinators seek to enroll 1,500 people by 2001.
Participants' physicians will continue to direct treatment, including decisions on hospitalizations and selection of drug regimens. "The idea of our study is to improve management of the disease through frequent contact with nurses and case managers, who will report any problems immediately to the patients' doctors," Dr. Freeman said. "This is an integrated health care delivery model for congestive heart failure. If our study is successful, it can be applied to other chronic diseases such as depression, asthma, arthritis and, especially important in South Texas, diabetes."
"We are detecting debilitating situations before they become life threatening," said Dr. Autumn Dawn Galbreath, instructor of medicine at UTHSC, director of the project's U. T. Disease Management Center and staff physician with the STVHCS. "The home health nurses and disease managers in the study are following very specific treatment guidelines. However, all treatment decisions, such as changes in medications, are decided by the patient's physician."
The home health nurses and disease managers look for congestive heart failure warning signs. Dr. Galbreath cited weight gain as an example. Because the heart is damaged and not pumping properly, other body organs tend to retain fluid. Patients whose weight increases two or three pounds in a day may need immediate medical attention, despite the lack of other symptoms of the disease, she said.
Three study groups
The trial is randomized and controlled, which means that patients are randomly assigned to the study's two intervention groups or to its control group. Individuals in one intervention group receive in-person and telephone contact with nurse case managers.
Individuals in the second intervention group receive this contact but also benefit from in-home medical technology. An Actigraph® watch, worn on the wrist, provides a constant measurement of the patient's activity level, for example. The watch contains a memory chip that stores research data.
Study investigators will contrast the outcomes of patients in the intervention groups with participants assigned to the control group. The latter individuals will continue to see their primary physicians but receive no home intervention.
There is no cost to patients who enroll in the program, nor are they compensated for their participation.
"The disease management idea has never been proven in a trial of this size or with this scientific design," Dr. Freeman said.