In our multicenter, randomized, controlled trial involving patients recently hospitalized with heart failure, we found no reduction in the risk of readmission or death from any cause with telemonitoring as compared with usual care. Moreover, there were no reductions in the risk of hospitalization for heart failure, the number of days in the hospital, or the time to readmission or death. Subgroup analyses failed to identify a group for which the intervention was effective, despite efforts to include sites and patients who demonstrated enthusiasm for participation in a daily telemonitoring program and screening of the patients for their ability to follow the protocol. These results contrast with the findings of a recent Cochrane review of telemonitoring for patients with heart failure6
; however, our study was of higher methodologic quality and was larger than most of the studies included in the review.
The efficacy of complex interventions such as telemonitoring depends on the context in which they are applied.14,15
For our study, we chose a telemonitoring system that is currently in use, collected standardized clinical information, ensured that site personnel were thoroughly trained by the system vendor, paid sites for participation, and provided patients with ongoing support (including the provision of scales and telephones, as needed) in using the telemonitoring system. Only sites that were willing to make a strong commitment to integrating this system into their practices were included in the study, and we worked closely with them to ensure sustained adherence to the protocol. Moreover, each site was required to document its response to each variance, ensuring that an explicit clinical decision was made about each variance. These design features created a reasonable setting in which to determine the effect of telemonitoring, were it to be broadly used in an effort to reduce hospitalizations.
In interpreting our results, it is important to recognize that automated telemonitoring represents a single, focused approach to disease management. The American Heart Association developed a classification system for disease management, and several of the components of this system merit consideration.16
The intervention in our study consisted of providing physicians with increased information about their patients’ clinical status; it is possible that including formal education, medication management, or peer support would have enhanced the effectiveness of the intervention. The method of communication used was an interactive voice-response system, with contact by clinicians driven by their assessment of patients’ status; an intervention with more contact between clinicians and patients might have been more effective.
In a previous, small, single-site trial of remote monitoring of patients, our group found a 44-percentage-point reduction in the rate of readmission, which was associated with significant cost savings.17
However, we were concerned that, in that trial, reliance on a single, highly skilled and motivated nurse case-manager who deployed an intervention developed by the investigative team limited the generalizability and scalability of the findings. Moreover, the results prompted the question of whether an automated monitoring system with transmission of information to the clinicians responsible for the patients’ care, precluding the need for one-to-one telephone calls with a clinician, could provide a similar benefit with the potential for widespread dissemination.
Our results underscore the need for rigorous, independent evaluation of disease-management systems before their adoption. In an environment in which vendors promote their products to health systems that are under increasing pressure to reduce readmission rates, the knowledge that telemonitoring is ineffective suggests the need to consider alternative approaches to improving care. Our findings also raise questions about the value of findings that are based on a systematic review that includes many low-quality studies.
An important consideration is that 14% of our patients who were randomly assigned to undergo telemonitoring never used the system. Moreover, by the final week of the study period, only 55% of the patients were still using the system at least three times per week. This finding is important, given that considerable resources, which would be difficult to leverage outside a clinical trial, were directed toward optimizing patients’ engagement with the system. Thus, the adherence rates in this trial most likely represent the best-case scenario and are in fact similar to previously documented 18 rates of medication adherence.18
It is also possible that the telemonitoring strategy would be more effective were it embedded in cardiology practices with greater organizational capacity to implement it. diverse However, the sites in our study were selected on the basis of their ability to participate and their enthusiasm. Although sites were required to document their responses to variances, clinicians did not record these data in a systematic manner. We do know that variances were reviewed and purposeful decisions were made by the cardiologists responsible for clinical management of patients’ heart failure, including medication adjustments, education about dietary indiscretions, and referrals for office visits.
A total of 21% of the study patients did not complete the final telephone interview at 6 months. This rate is not surprising, given the severity of illness in the study population. Missing data for these patients should have had minimal influence on our assessment of hospitalization and vital status, which were verified through medical-record review and electronic databases.
In summary, a telemonitoring strategy failed to provide a benefit over usual care in a setting optimized for its use. Previous claims of success of similar strategies, based on studies with small populations of patients and methodologic weaknesses, are not supported by the results of our large, multicenter trial. There remains a need for strategies to improve heart-failure outcomes, and our findings indicate the importance of a thorough, independent evaluation of disease-management strategies before their widespread adoption.