Sunday, May 13, 2012

Ask: What's the business case and the clinical case?

I was engaged in consulting in the environmental field in the 1990s, and there was a land rush level of interest in producing new smokestack-based technology that could achieve dramatic reductions in power plant emissions.  The theory offered by entrepreneurs at the time was that, if we can invent a gizmo that will result in a thousand-fold reduction in emissions, the EPA will force all power plants to use it, and we will make a fortune.

I can't think of any of those companies that now exist.  Why?  Well, even if the technology was sound, it was often a technology in search of a solution. The science of environmentally caused disease did not exist to prove that a reduction of, say, parts per million to parts per billion would mean anything in terms of public health.  The idea that a regulatory agency would demand adoption of such a technology as "best available control technology" was naive.  And, even if the agency sought to do so, it would take years of scientific evaluation and rule-makings to cause it to occur.  None of the start-ups was well capitalized enough to wait.

I see similar things happening in the health care field.  Well meaning and intelligent engineers are coming up with interesting gizmos in the hope that their features will be so persuasive that hospitals will either buy them on their own or they will become the "standard of care" enforced by regulators or accreditation bodies.

One such genre of devices is remote patient monitors.  Perhaps inspired by the Dr. Bones McCoy on Star Trek, several companies have designed prototypes or more advanced machines that provide remote monitoring of patients' vital signs without electronic connections to the patients themselves.  Their hope is that hospitals will employ these continuous input collecting devices to take the place of the periodic evaluations carried out by nurses or other health care professionals.

While I am impressed by the technical prowess of those involved in these devices, I have wondered aloud to some colleagues as to whether there was a business or clinical case to be made for them.  Two of my most sophisticated and thoughtful correspondents answered.  The first said:

I'm not a fan of increasing the amount of monitoring using extra equipment.  It's a technical "fix" for a cultural/professional problem -- not having the time/focus/skill to know a patient well and to recognize when a patient is telling you or showing you that something is going wrong.  

I am unaware of any scientific literature that clearly demonstrates additional monitoring such as this adds value to the patient in terms of improving outcome.  But we love to add technical monitoring as a substitute for skilled personnel at the bedside. What has been proven to be of value is the implementation of a structured graduated response by a team of clinical experts that is triggered by early identification of something going wrong. We should be investing in the implementation of early warning systems combined with accountability across the professions for recognizing and responding. We should also be investing in releasing time to care (aka "the productive ward" or "transforming care at the bedside"),  freeing up our nurses' time and energy so they can do what they want and should be doing -- assessing and interacting with their patients, so that they can recognize and call for help when patients develop signs of impending doom. 

Its also all about creating a just culture and safety culture where everyone is supported and able to call for help whenever they need to. That means patients, families, nurses, respiratory therapists, and housekeepers.

So I wouldn't be going to my hospital asking for them to purchase this system.

The second agreed and expanded on the topic:

I have met with a bunch of these companies over the years … there are a few technologies that are promised to provide noncontact or low-contact vital sign monitoring.  One might be based on radar, another that’s ultrasound, and another goes under the bed and senses vibration.  I suspect the forces of “more technology is better” will inevitably win, but I agree that at this point there’s no data supporting the need for additional monitoring in the general hospital population.  Our work and others have shown that organizing the clinical monitoring and response to decompensation can reduce that rate of unexpected inpatient mortality to really low levels, so the cost-benefit of additional reductions is going to be hard to show in any case.  Certainly I haven’t advocated for more technology based on existing data.

On the other hand, the absence of evidence isn’t the evidence of absence. I do think there’s a particularly missing ability to reliably monitor respiratory rate in most non-ICU, non-OR settings. And it is pretty clear that respiratory rate is both extraordinarily predictive of bad things happening, and very frequently ignored in general care settings.  So, I think it would be a testable hypothesis (and reasonable to actually test) that, among a general med/surg population, heart rate, heart rate variability, and respiratory rate monitoring, coupled with integrated “early warning” algorithms coupled with a defined, graded, and systematic clinical response (an effector arm for the detection) might be of demonstrable benefit.  Or it might be a long run for a short slide.


Anonymous said...

I think this is often a cultural/educational issue on the part of hospital C suite people, also (present company excepted). I remember my COO over the lab always asked us how/when we were going to replace as many lab personnel as possible with 'automation'. It was clearly his dream.

nonlocal MD

Sunil Hazaray said...

Your commentators on this issue clearly have not done their homework. Two large studies, one in the VA and other other with UK NHS clearly demonstrated significantly reduced readmissions with lower costs when patients were put under Remote Monitoring. Humana recently did a major study with 1400 patients and found similar results.

Paul Levy said...

Please clarify. Was that remote monitoring at home after leaving the hospital, or remote monitoring at the hospital? I could see how remote monitoring at home could help on the readmissions front. I don't understand how hospital-based remote monitoring would necessarily help on readmissions. Would love to learn more.

Paul Levy said...

I've now done a Google search for those studies you mentioned. They seem to be a about home-based remote monitoring for specific chronic diseases. If that's what you meant, that is not the topic of this blog post.

MBM said...

I recall seeing an "innovation" at a national obstetrical meeting: a device to measure progress in a laboring woman. It was a pair of calipers clipped to the cervix and attached to a computer, of course. In what way would this be an improvement over a gentle hand and the emotional supprt of a clinician?

clsmt said...

Having been a patient, I can say I would have met this technology with great enthusiasm if it prevented my nurse from waking me for change of shift. Seriously – what is the point of waking everyone at midnight for their temp and BP and then again at 4 or 6 for AM lab draws. I’d love to see a study that just looked at whether the increased ability to rest undisturbed hastened healing.

Brad F said...

This is a recent remote monitoring study via JAMA in critically ill folks.


Paul Levy said...

Thanks, Brad. I can't tell from the abstract if these are the kind of wireless gizmos now being touted, or the traditional monitors attached to patients.

Anonymous said...

The tele-ICU article referenced by Brad F studied extended specialized telehealth: medical care by bedside healthcare providers in one location augmented by ICU specialists in a remote location assisted by the review of electronic charting, audio and video links, and best-practices care pathways and protocols. That's a somewhat different concept than a wireless patient monitor that substitutes for a bedside provider.