First, Do No Harm
MInnesota monthly

A visit to Doris Coward's house is a lot like visiting Grandma, if Grandma lives near Lake Superior, where seagulls are as common as robins. Coward, 73, is witty and conversant, holding court from a comfy lounger.

"I wake up every day, and say, 'I'm alive!'" says Coward, her feet up, oxygen tubing draped over her ears and her walker within reach. "Hurray!"

Hurray, indeed. For decades, Coward, 73, has battled cancer, diabetes, and chronic obstructive pulmonary disease. She has had a heart attack and has a pacemaker. And now she has heart failure.

As people continue to live longer, heart failure is becoming more prevalent. It is a chronic, progressive condition in which the heart is too weak to circulate the amount of blood the body needs. Symptoms include shortness of breath, fatigue, and fluid retention. The weight gain caused by retaining fluid is an indicator that the heart is further strained. Medications help manage heart failure symptoms, but there is no cure.

From December 1999 through March 2000, 25 patients in the heart failure program at St. Mary's/Duluth clinic (also known as SMDC health system) participated in a pilot project that tested a promising new way to monitor and treat this complex illness. Cardiocom, a Minneapolis medical company worked with the hospital and clinic on the project.

A small scale is installed in each patient's home and it taps into their telephone line. Daily, patients step on the scale to weigh themselves (Coward calls it her "tattle scale") and answer 10 questions, such as "Are you feeling short of breath?" and "Are your ankles or feet swollen?"

The answers plus the patient's weight transmits by telephone to a computer at St. Mary's/Duluth Clinic that compiles the information and alerts nursing staff if weight or symptoms are outside of the norms established for that patient. A nurse from the clinic then calls those at-risk patients and assesses what needs to be done to get them back on track, usually a shift in diet or medication.

Even if all is well according to the Telescale, participants are encouraged to call in with questions or concerns. The study's conclusion: The program works.

Participants had an 80-plus percent decrease in hospitalizations, days hospitalized, and emergency room visits. That was more than two and a half years ago, and the dramatic results of the four-month pilot have been replicated with 125 of nearly 400 program participants since.

Coward, who typically faced multiple hospitalizations each year, hasn't been hospitalized since joining the program in September 2000.

One heart failure patient from the study is in his late 50's and has returned to his job on an ore freighter, traveling the Great Lakes with his scale in tow.

For 73 percent of study participants, the severity of their illness has lessened. More than half of the participants have seen an improvement in their stamina, and for 63 percent, the function of the heart itself has improved.

"Five or six years ago, as physicians, we were not taking care of these patients and their community appropriately," says Carl Heltne, M.D., cardiologist and medical director of the SMDC heart failure program. In the Duluth service area, heart disease and heart failure is more prevalent among seniors then elsewhere in the state.

"We had no tools to make sure that our growing number of heart failure patients, as a population, were getting the drugs they should be on or whether this or that course of treatment was making a difference, across the board," Heltne says. We saw patients every three or four months in clinic, or in an acute situation. When in fact, these patients' conditions can change rapidly, far more rapidly than our scheduled interventions could affect."

Kristine Ryan, M.A., certified nurse practitioner and coordinator of the heart failure program, emphasizes the importance of immediate information and quick action. "The sooner we can find out if a patient's condition is changing, the quicker we can assess what is happening and make adjustments that should get them back into balance, "she says. "We want to avoid the teeter-totter of an unstable condition, which puts them in and out of the hospital."

"St. Mary's/Duluth Clilnic have been pioneers in adopting this technology, "says Dan Cosentino, Cardiocom's president. "Duluth has had a big impact on patients at risk for frequent visits to the hospital."

The Telescale system, which Cardiocom began developing in1997, required FDA registration, an extensive process that include proof that the device delivers as promised but is a different process than is required for approval of new medications. It does not "require the phased clinical trials required of a new drug," says Cosentino.

"The pilot project in Duluth is typical of the kind of testing we do to see if the product, the data base, software, and program design will accomplish what we set out to do," he says. " Our own retrospective study of 1,026 patients at 19 different sites bears out the Duluth experience. Very sick heart failure patients have their hospital admissions drop from nearly two times a year to 0.234 times a year. "With the sizeable decrease in hospitalization, unnecessary costs have been avoided. Blue Cross/Blue Shield of Minnesota has taken note, stepping forward to pay for the 29 patients in the program covered by its plans.

"We really saw the folks at SMDC conducting this program for all the right reasons, says Douglas Hiza, M.D., medical director for provider relations with Blue Cross/Blue Shield. "They are very altruistic, initially covering program costs without reimbursement. The results are very positive, and in fact lower overall costs, while increasing patient quality of life. We hope to see this care model replicated elsewhere."

Heltne says, "Yes, it's great we've reduced costs. But for the patient it is a huge quality of life improvement. We can take so much better care of our patients."

"It is the right mix of a team approach: nurses, doctors, the patient, and technology," he says. " I can manage the ongoing care of 400-plus people in a manner I could never have done with 40 people before we enlisted this technology. And this way we are far more certain that we have patients on the right medication, at the right dose, at the right time."