Telemonitoring versus Usual Care in Patients with Heart Failure

Patients with heart failure require rehospitalization at a high rate, creating a need to develop strategies to improve outcomes in these patients. National initiatives aimed at reducing readmissions among patients with heart failure and government incentives in the Patient Protection and Affordable Care Act attest to the importance of developing successful methods to reduce readmissions and reduce the rate of death from any cause among patients discharged with a diagnosis of heart failure.

One promising strategy for improving outcomes in patients with heart failure is telemonitoring, enabling clinicians to use remote monitoring methods to facilitate intervention early when patients show signs of clinical deterioration. In a recent Cochrane review, it was estimated that telemonitoring of patients with heart failure resulted in reduction of the rate of death from any cause by 44% and the rate of hospitalizations related to heart failure by 21%. Because the quality of methods used in the studies included in the Cochrane review was variable, researchers recently conducted a multicenter, randomized, controlled trial to determine whether telemonitoring of patients recently discharged with a diagnosis of heart failure would reduce the combined end point of readmission or death from any cause in those patients. Results of the Tele-HF (Telemonitoring to Improve Heart Failure Outcomes) trial were reported online in the New England Journal of Medicine [2010;10.1056/NEJMoa1010029].

Patients were enrolled in the Tele-HF trial from 2006 through 2009 at 33 cardiology practices in the United States. Patients who had been hospitalized for heart failure in the previous 30 days were eligible for inclusion. Exclusion criteria included residence in a long-term nursing home, inability to participate in the study protocol for any reason, inability to stand on a scale, severe cognitive impairment, and a planned hospitalization for a procedure. The primary end point was hospital readmission for any cause or death from any cause within 180 days of enrollment. Secondary end points included hospitalization for heart failure, length of hospital stay, and the number of hospitalizations. Study participants were randomly assigned to receive usual care (n=827) or telemonitoring (n=826). Clinicians were told to treat patients according to national guidelines for the treatment of heart failure. At study onset, all patients were given a scale (if needed) along with materials developed by the Heart Failure Society of America. Those patients in the telemonitoring group were given detailed instructions and a demonstration of how to use the telemonitoring system and a touch-tone telephone (if needed). A commercial system, Tel-Assurance, was used for the telemonitoring group.

Telemonitoring was done via a telephone-based interactive voice-response system that collected daily information regarding symptoms and weight. The patient’s clinician reviewed the information each day. A 6-month interview was completed by 79% of study patients; there was no difference between the 2 groups in completion rate. A review of medical records for readmissions and virtual-status verification were completed for 100% of patients. The 2 groups had similar characteristics at baseline: median age was 61 years, 42.0% were female, 30.0% were black, and 70.6% had a depressed left ventricular ejection fraction (<40%). The most common comorbidities were diabetes mellitus, hypertension, and coronary artery disease; 46.0% had chronic kidney disease (glomerular filtration rate of <60 mL/minute). There was no significant difference observed between the 2 groups in the primary end point: 52.3% of patients (n=432) in the telemonitoring group and 51.5% (n=426) in the usual care group were readmitted to the hospital or died within 180 days of enrollment. The hazard ratio for the primary end point with telemonitoring versus usual care was 1.04 (95% confidence interval, 0.91-1.19). In the telemonitoring group, readmission for any cause occurred in 49.3% of patients versus 47.4% in the usual care group; death from any cause occurred in 11.1% of the telemonitoring group versus 11.4% of the usual care group. There were no significant differences between the groups in any of the secondary end points or in time to the primary end point or any of its components. There were no adverse events reported during the study period.

In summary, the researchers said, “among patients recently hospitalized for heart failure, telemonitoring did not improve outcomes. The results indicate the importance of a thorough, independent evaluation of disease-management strategies before their adoption.”