Why telemonitoring can’t clear the RCT hurdle

For many advocates of digital medicine, the gold standard of randomized controlled trials can sometimes lack a certain luster.
The most recent example of this is the failure of a large, well-conducted study to show the benefits of telemonitoring and telehomecare with patients who have chronic heart failure.
Even as Canadian networks such as the Ontario Telehealth Network (OTN) expand their use of remote monitoring and coaching for patients with the clear-headed conviction that such an approach can reduce re-hospitalizations and even mortality rates for those with heart failure – large trials say otherwise.
There is no conundrum here. The big trials are measuring outcomes in a telemonitoring group against those receiving usual care without telemonitoring, whether or not patients randomized into the telemedicine group use the technology effectively or at all. So, the positive results from patients who work with providers to use the technology appropriately are cancelled out by those who, for whatever reason, choose not to use the telemonitoring tools.
Let’s look at this in most recent randomized controlled trial – the Better Effectiveness After Transition – Heart Failure (BEAT-HF) study reported at the high-profile American Heart Association (AHA) scientific sessions in Orlando.
In BEAT-HF, 1,437 individuals age 50 or older who were hospitalized in one of six academic health systems in California and receiving active treatment for decompensated heart failure agreed to participate and were randomized into the trial.
Those in the study group had regularly scheduled telephone coaching from a nurse practitioner on managing their condition as well as telemonitoring of weight, blood pressure, heart rate and any symptoms. They were compared with those who receive no telemonitoring or remote coaching.
The primary outcome measured was the 180-day, all-cause hospital readmission rate, with secondary outcomes of all-cause readmission and mortality being measured at 30 days. No significant differences were seen between the two groups in the hospital readmission rates at either 30 or 180 days.
But when the researchers looked at those in the intervention group who actually participated in the majority of calls with the nurses and who provided their data on a regular basis, large benefits were seen, with significant reductions on both hospital readmission rates and in mortality compared with those not using the technology.
These findings demonstrate the difficulty in empirically demonstrating the benefits of an intervention when positive outcomes are dependent on patients consciously making use of the tools being evaluated.
“Patients who stay in the program are probably more likely to take better care of themselves,” was the comment made by Dr. James Januzzi Jr. from Massachusetts General Hospital, who commented on the BEAT-HF meeting in an interview.
“The whole point of this kind of intervention is to engage, educate and motivate patients to improve their behaviours and self-management skills,” commented Dr. Ed Brown, CEO of the OTN in a recent online post.
Given that the very nature of RCTs is to randomize patients and not select in advance those likely to benefit from an outcome, it is not surprising the findings have been as they have.
But these findings are useful for tempering the enthusiasm of those who feel remote medicine and digital interventions cannot help but work well.
As Dr. Micheal Ong, head of the BEAT-HF study group, noted, what the study has shown is that telemonitoring is not appropriate with all heart failure patients after hospital discharge.
More work needs to be done to assess who is likely to have issues in using new technologies to be monitored in their home and help motivate them to take better care of themselves.


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