ACC: Mixed Messages on Heart Failure Disease Management

NEW ORLEANS, April 2 -- Nurse-led education and counseling in disease-management programs may improve outcomes for heart failure patients, but setting and patient age may be determining factors, according to separate studies.

One found benefit to such a group program among a relatively young patient population in Brazil. The other reported no benefit to individual counseling of older patients in the Netherlands. Both were presented at the American College of Cardiology meeting here.

In the Brazilian REMADHE study, education and counseling sessions conducted every six months by a team of nurses and followed with individual telephone monitoring every two weeks improved survival, hospitalization rates, and quality of life, said Edimar A. Bocchi, M.D., of So Paulo University.

He and colleagues randomized 350 ambulatory chronic heart failure patients in a 2:1 ratio to the group sessions or no intervention. At the hour-long group sessions, patients were given education about their disease, medications, rationale for restricting fluids, and other daily self-care measures, as well as what to do if symptoms worsened. Both groups had standard follow-up medical visits.

After an average of three years of follow-up (range up to seven), the findings were:

• Intervention significantly prolonged time to first unplanned hospitalization or death (hazard ratio 0.563, 95% confidence interval 0.36 to 0.738, P<0.0001).
• Intervention improved quality of life scores on the Minnesota Living With Heart Failure Questionnaire (P=0.002).
• Survival improved with intervention compared with the control group (HR 0.587, 95% CI 0.383 to 0.845, P=0.005).There was no difference in sudden death or death because of progressive heart failure (P=NS for both).
• The education program reduced hospital admissions (P=0.007), days in hospital (P=0.002), and visits to the emergency department (P<0.0001).
• Adherence to medication and other self-care measures among those in the education group was significantly higher (P=0.0001).

In contrast, researchers in Holland found that individual counseling had no effect on outcomes in the COACH study (Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure), said Tiny Jaarsma, R.N., Ph.D., of University Medical Center Groningen.

In this multicenter study, 1,023 symptomatic heart failure patients were randomized to basic nurse-led advising and counseling, intensive nurse-led advising and counseling, or standard care by cardiologists only.

Those in all three groups had four visits to a cardiologist. The basic intervention group received an additional nine visits with a nurse specially trained to work with heart failure patients. The intensive intervention group had 18 visits with the nurse plus two additional home visits, and two visits with multidisciplinary nurses.

At 18 months, the findings were:

• Basic counseling did not significantly improve the primary endpoint of mortality and heart failure-related hospitalization versus control (HR 0.96, 95% CI 0.76 to 1.21, P=0.73).
• Intensive intervention was no better than basic intervention for mortality and hospitalization (HR 0.93, 95% CI 0.73 to 1.17, P=0.52).
• The co-primary endpoint of "unfavorable days" during which patients were dead or hospitalized showed a 15% decrease for both intervention groups compared with control, but this was not significant (P=NS).
• All-cause mortality was likewise 15% lower for the combined intervention groups but not significantly so (HR 0.85 versus control, 95% CI 0.66 to 1.08, P=0.18).

The study, the largest done in this field, did not support previous mostly single-center studies that found benefit for nurse-led advising, Dr. Jaarsma said.

"However," she added, "close intensive nurse-led advising and counseling in chronic heart failure patients might decrease mortality at the 'cost' of more-shorter-hospitalizations."

The difference between the REMADHE and COACH studies may indicate patient selection and components of the intervention are crucial, commented Mandeep R. Mehra, M.D., of the University of Maryland in Baltimore, who participated in the session.

"How do we reconcile these two very disparate results?" he asked. "I think that it's important for us to understand the population in whom the intervention was being conducted. For example, the population should be one that needs the intervention, such as the low socioeconomic condition population, the low literacy population."

Dr. Jaarsma also noted that there may have been a difference in usual care between the two studies, and that the REMADHE study had a much younger patient population (average age 51 versus about 71 in the Dutch study).

Furthermore, a group setting may offer advantages to patients, Dr. Mehra noted.

"I think they made a difference because people were learning from each other," he said. "The bottom line is we need to learn what the best method of changing behavior is."