November 16th, 2010
“Phone It In” Heart-Failure Monitoring Offers No Advantage Over Usual Care
Larry Husten, PHD
CardioExchange welcomes Sarwat I. Chaudhry, first author of an NHLBI-funded trial in which 1653 recently hospitalized heart-failure patients were randomized to telemonitoring or usual care. The findings, published in the New England Journal of Medicine, failed to show an advantage of telemonitoring in the primary endpoint: rehospitalization for any reason or death from any cause within 180 days after enrollment (52.3% for telemonitored patients, 51.5% for usual-care patients).
Telemonitoring was conducted via a telephone-based voice-response system. Every day, patients in the telemonitoring group phoned in information about their symptoms and weight, which was reviewed on weekdays by site coordinators. Predetermined, clinically relevant “variances” in patients’ responses flagged clinicians’ attention. Here, Chaudhry answers questions about the trial, posed by CardioExchange editor Anju Nohria, MD.
Q: You report that adherence to the telemonitoring system deteriorated over time: Only 55% of patients were still using it at least 3 times per week by the end of the trial. Physicians’ rate of adherence (attention) to the flagged “variances” is not reported — can you share that information with us? Also, how often did the physicians actually change therapy in response to a variance, and how often did they simply document a noted variance and choose not to intervene?
A: Our protocol required clinicians to check the telemonitoring information every business day and to document their responses to variances. The study Coordinating Center examined this documentation every 2 to 3 weeks to ensure that the variances were being reviewed. Therefore, we can say with confidence that the information was being carefully considered in a timely manner. Although physicians were required to document their management of variances, they didn’t record the information systematically. We do know that the cardiologists responsible for clinical management of patients’ heart failure made purposeful decisions about medication adjustments, education about dietary indiscretions, referrals for office visits, and so on.
Q: Do you think the findings might have been different if the telemonitoring system had required patients to call in weekly rather than daily? For example, might a once-a-week protocol have improved both patient and physician adherence, and also allowed patients a chance to perceive changes in how they felt, such that their responses would trigger a variance?
A: It is difficult to know whether less frequent monitoring would have produced a different result. Part of the goal of a daily monitoring intervention is that it becomes part of a patient’s daily habit. In fact, patients were instructed to phone into the telemonitoring system shortly after measuring their body weight in the morning, so that the call would become routine. Also, the opportunity to detect early changes in health may be lost with a less frequent intervention.
Q: The article does not describe the “usual care.” Did it typically involve a nurse-based heart-failure management program, or individual physicians who responded to patient calls as needed?
A: Similar to national practice patterns, “usual care” did not typically include nurse-based heart-failure management programs. Our sites were general cardiology practices, and such resources are not widely available. As in standard clinical settings, patients in usual care contacted physicians when they felt they needed to do that. There were no proactive contacts by clinicians.
Q: Does your study allow you to draw any broader conclusions about clinical management?
A: It’s important to keep in mind that our study was a rigorous examination of one approach to telemonitoring. It should not be misapplied to telemonitoring or disease management in general. Other components — such as patient education, medication support, or interventions aimed at patients’ caregivers — may ultimately prove to be more effective. Such strategies for supporting patients and physicians must be carefully tested before they are adopted widely.
CardioExchange readers, what conclusions do you draw from the telemonitoring in heart failure trial and its negative findings?
Editorial Note: CardioExchange editor Dr. Harlan Kumholz was the senior investigator on this trial.
Tele-monitoring includes automatic systems that read the memory of ICD weekly.
One system is Latitude bedside monitor working with Guidant Pacemaker/ICD.
This is followed by 6 month in-office monitoring with Pacemaker technician (and doctor as needed).
Any comparison studies versus only in-office visits?
Competing interests pertaining specifically to this post, comment, or both:
None
There are so many systems out there – and what is becoming clear is that there is a real need to evaluate them rigorously – and to determine their marginal benefit. So you are asking the right question -what do we really know about the comparative advantage of the system. And pre-post or anecdotal experience is just not good enough.
While I’m pleased that telemonitoring via a telephone-based voice-response system was rigorously tested, I’m not certain where to go next. What’s the next iteration of out-patient monitoring/follow up we should be testing? Based on the results of this study – and your personal experience – what process is most likely to prevent rehospitalization or death in CHF patients? Of course, we’d want to evaluate it rigorously, but I’m interested in hearing what you think would most likely be effective.
Continuous Left ATrial pressure monitoring is the new frontier that has to be explored. Whether titration of medical management in relation to hard data rather than surrogate clinical “symptoms” will truly, effectively minimize heart failure exacerbation and recurrence need to be trialed and explored.