Coordinating Study Evaluating Outcomes of Advising and Counseling in HF
Description: The goal of the trial was to evaluate the effect of two intensity levels of nursing heart failure support compared with a control group.

Hypothesis: High-intensity nursing heart failure support would lead to a reduction in important cardiac outcomes.

Drugs/Procedures Used: Patients were randomized to one of three groups: 1) intensive nurse support group (n = 353), 2) basic nurse support group (n = 348), and 3) cardiologist only control group (n = 348).

Concomitant Medications: For the three groups at baseline—intensive nurse support, basic nurse support, and control, respectively: angiotensin-receptor blockers (81, 85, 82%), beta-blockers (63, 70, 65%), diuretics (95, 97, 96%), digoxin (29, 32, 30%), and statins (35, 42, 37%)

Principal Findings: In all three groups, the number of contacts with cardiologists and nurses was more than anticipated: 10% more in the intensive support group, 40% more in the basic support group, and 33% more in the control group. Over 18 months of follow-up, the primary endpoint occurred in 38% of the intensive support group, 41% of the basic support group, and 42% of the control group (hazard ratio [HR] 0.96 and 0.93, p = 0.73 and 0.52, respectively, for intensive vs. control and basic vs. control groups). The number of days lost to death or hospitalization for heart failure was 34,268 for the intensive group, 33,731 for the basic group, and 39,960 for the control group (p = 0.49 and p = 0.81, respectively, for intensive vs. control and basic vs. control groups). All-cause mortality was 24% in the intensive support group, 27% in the basic support group, and 29% in the control group (HR 0.88, 95% confidence interval [CI] 0.66-1.18, p = 0.39 for the intensive vs. control groups and HR 0.81, 95% CI 0.60-1.08, p = 0.15 for the basic vs. control groups).

Interpretation: Among heart failure patients with New York Heart Association functional class II-IV, intensive and basic nursing support compared with cardiology only support did not reduce the incidence of mortality or hospitalization for heart failure over 18 months of follow-up. A significant limitation was insufficient power due to a lower than anticipated event rate in the control group. The lack of a significant finding may have also been influenced by the optimized care that patients were already receiving upon enrollment. This study will influence future guideline recommendations regarding the use of nurse-management programs.

Conditions:
• Heart failure / Idiopathic
• Heart failure / Ischemic
• Prevention/Secondary
• Prevention

Study Design

Randomized.

Patients Screened: 2,957

Patients Enrolled: 1,049

NYHA Class (% I, II, II, IV): Class II, 50%; class III, 46%; and class IV, 4%

Mean Follow-Up: 18 months

Mean Patient Age: 23-93 years (mean 71 years)

% Female: 38%

Mean Ejection Fraction: 34%

Primary Endpoints: The first primary endpoint was a composite of heart failure hospitalization or all-cause mortality. The second primary endpoint was the number of "unfavorable days" lost, defined as days lost because of death or hospitalization during the 18 months of follow-up.

Secondary Endpoints: Major secondary endpoints were the individual components of the composite endpoint.

Other Design Considerations: N/A

Patient Population: Admission to the hospital for heart failure (New York Heart Association functional class II-IV), structural heart disease as evidenced by cardiovascular imaging, and age >18 years

Exclusions: Participation in other research trials, invasive intervention performed in the last 6 months or planned in the next 3 months, and evaluation for heart transplantation

References: Jaarsma T, van der Wal MH, Lesman-Leegte I, et al. Effect of Moderate or Intensive Disease Management Program on Outcome in Patients with Heart Failure: Coordinating Study Evaluating Outcomes of Advising and Counseling in Heart Failure (COACH). Arch Intern Med 2008;168:316-24.