by Randy Williams, MD FACC, CEO of Pharos Innovations
The results from the National Institutes of Health (NIH)-sponsored Tele-HF trial are in, and the findings are worth considering . The results are counter to most of the findings of other studies examining telemonitoring for heart failure and at face value are disappointing to us, and the industry. Upon closer examination, however, this study offers us an excellent opportunity for further innovation, refinement of solutions and continuous improvement. It also provides a snapshot of how significant the challenges remain in transforming U.S. healthcare – from a system that is episodic, reactive, acute care based to a system of care that incorporates proactive, interactive, continuum-based chronic care management.
The genesis for this study stretches back nearly 10 years, from conceptualization to the results we see reported today. This randomized, controlled multi-centered trial was designed to compare an automated, daily symptom and self-reported weight monitoring technology with “usual care” in reducing hospital readmissions and mortality among patients recently hospitalized with decompensated heart failure. The boldness of vision should not be underrepresented: Tele-HF is the largest study of a non-pharmacological intervention for heart failure ever conducted.
At a high level, the results showed “no significant differences” between the group receiving usual care and the group randomized to receive telemonitoring. I cannot say that these are the results we were hoping for. However, I urge those in our industry and other key stakeholders to take a closer, more informed view, and to reach their own conclusions and insights.
First, I want to thank and acknowledge the great work of the investigators, study sites and everyone involved in this trial. It was a long process and everyone worked with the utmost integrity and professionalism. We were privileged to have been selected for participation. I also want to acknowledge the value of conducting large, multi-centered, randomized, controlled trials in terms of advancing medical science.
The patient interventions in this study took place in 2006-09 and omit many of the processes and techniques Pharos uses today to achieve the necessary critical mass of physician and patient involvement. Here are the limitations of this particular study – from my perspective: