Testing Technology vs. Enabling a System of Chronic Care – Results of the NIH Tele-HF Trial

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. 

The Details

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: 

Limitation #1 –Study Methodology. The Tele-HF trial was a randomized clinical trial that was designed using the intent-to-treat methodology. While intent-to-treat is designed to eliminate potential biases of patient selection that might be relevant in drug trials, its validity is highly impacted by the level of engagement of enrolled participants, especially in studies where patient actions and clinician reactions are required. If individuals are never exposed to the intervention, they can’t benefit from it. Yet, in an intent-to-treat design like this study, they are still counted in the intervention group as a participant. In Tele-HF, nearly 15% of those randomized to receive the intervention never began the trial!  This is despite the fact that they agreed and signed a lengthy study consent form.  Perhaps behavioral change techniques to patient engagement might have helped! 

In commercial settings, a randomized trial design is often not feasible.  As a result we are frequently asked about viable alternative study methodologies.  There are several, but we have chosen to use those of the quality and process improvement science.  In this approach, a “process” is monitored over time and compared to mean and standard deviation ranges of outcomes for that process either during a reasonable and stable baseline period or during a concurrent timeframe for a matched cohort that is not involved in the process.  We assume that the process will evolve over time, but using techniques such as six sigma, one can monitor a causal relationship to those changes. 

For constantly evolving systems of care, this method seems to avoid some of the structural limitations of a randomized controlled trial.  We accept the concern about patient selection bias, but stand by our position that ANY program involving behavioral change will by definition involve an act of the patient.  So those that choose not to enroll are not likely to benefit and other processes need to be offered to them. 

Limitation #2 – Study Setting. The first point here is that this study was designed back when healthcare structures were much different than where it is heading – when care was episodic and acute compared to today when it is proactive, continuum-based chronic care management.   Few hospitals considered it important to reduce readmissions; today, most are taking active steps to set up systems and programs to impact readmissions.  So when TELE-HF was conducted, care delivery processes were just beginning to evolve into a system of coordinated chronic care. 

Imagine this. You give a musical novice a concert piano and provide 15 lessons on how to play, spaced out over a three-year period. After the last lesson, would you ever expect that individual to play a Mozart concerto? Of course not. Given that two-thirds of the study sites had fewer than 15 people who used the intervention at any given time during the three years of the trial period, it is small wonder that they did not see optimal performance.  Even the sites with the highest volume experience were generally well short of the enrollment numbers of our own commercial clients. 

Much like the musical illustration, the Tele-HF trial didn’t include the support and structure that we now know is necessary for programmatic success. Behavior change is possible – but it takes monitoring, rapid feedback, and continuous improvement.  However, a randomized controlled trial, by design removes this continuous feedback loop and takes a static picture of a process: in this case, as it existed in 2004-2005. Thankfully today, these care delivery improvement activities are going on throughout the country. 

In contrast, our commercial implementations, as well as those of other successful offerings, include work flow process and protocol development support to help organizations build systems of care around the technology platform – instead of retrofitting the technology into an underperforming system of care. The results of this study are really more about an outdated, under-optimized, very specific system of care, not the current evolving system of care where chronic care management, enabled by remote patient monitoring technologies and processes exist, as underpin Pharos’ commercial Tel-Assurance offering today. 

Additionally, successful models, like Tel-Assurance, also include ongoing program support to optimize organizational impact. Another implication of the randomized controlled trial design is that no feedback loop could be created to evaluate the system of care, monitor effectiveness and rapidly make modifications or process adjustments, to ensure that the program is achieving the intended organizational impact.   In contrast, today Pharos sees consistent organizational impact on utilization and costs by monitoring and informing our clients about their performance at the organizational level. 

Limitation #3 – Enrollment and Engagement Process.  We now know that technology alone will not cause patients to become engaged in their self-care.  In order to get patients to use technology, behaviors must change.  This process begins with endorsement by physicians, includes readiness to change assessment, and troubleshooting and support to overcome barriers to change.   Fourteen percent of those assigned to the intervention group never used Tel-Assurance.  And in the final week of the study period, only 55% of the patients were still using the system at least three times per week. The lower engagement rate, coupled with the lower participation rate than we see in our commercial experience, were the most concerning and in the end, disappointing, results of this trial.  

Where we would have expected nearly 100% initial participation—using our current standard processes for this type of deployment—the study investigators achieved significantly lower enrollment.  This challenge at one point led to an expansion of study sites in order to meet enrollment quota.  In addition, we would have expected substantially higher participation rates at 6 months using our current commercial processes.  The low rates of long term participation seen in Tele-HF suggest to me a concern that patients were never fully engaged with or understood the value of participation.  These issues: enrollment and ongoing participation perhaps require a different set of skills and processes than was available within the study sites. 

The implications of this “fatal flaw” in process design are profound.  It means that at any point in time during the three-year trial, only one or two patients may have been using Tel-Assurance at two-thirds of the study sites. It is hard to imagine a change of clinician behavior or care processes occurring with so few users of the technology. As a point of reference, Pharos’ client enrollment for Tel-Assurance is a minimum of 50 patients per month, with many clients far exceeding that number. In addition, enrollment and engagement of patients was suboptimal.  It is even harder to imagine that self-care behaviors would have been impacted under these circumstances. However, this design flaw is not at all unexpected without specific programs and processes to optimize activation and ongoing engagement, much like those in our commercial offering. 

What We Can Learn

The results from the NIH Tele-HF study reaffirm the importance of understanding the complexities of transforming healthcare systems from episodic, reactive and acute care based, to chronic, coordinated and technology enabled care systems. By ensuring that we learn from the past, this trial can help our industry move forward as we continue to improve processes, provide better care and produce better outcomes. 

So what does this study mean for Pharos? From my perspective, it confirms what we had presumed to be true: “bolting on” a piece of technology to an old, sub-optimally designed system of care won’t change behavior. This is why we developed a behavior change solution in the first place: one that optimizes opportunities to engage patients in their own healthcare and provides care managers/nurses with real-time information to intervene before symptoms escalate. When done with an eye toward rapid-cycle feedback and improvement, we see not only patient behaviors change, but those of our healthcare system clients and organizations as well. As I like to say frequently in these posts, it is not as much about technology as it is about process. In this case, Tele-HF reinforces that point.

Please take some time to read the article and think about the results and implications. I encourage you to post comments. This is an important discussion that we look forward to continuing.

This post first appeared on Pharos Innovations blog, The Collaborative Forum. Disclosure: Pharos Innovations is a client of  Better Health Technologies.