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Join Robert Scoggins, a physician executive, as we discuss the challenges of diagnosing and treating sepsis in the emergency department compared to other emergent conditions like stroke and heart attack. We’ll discuss the latest advancements in diagnostic technology and care protocols, as well as innovative approaches like host response technology and rapid sepsis diagnosis tests. Discover how hospitals are implementing these tools to improve outcomes and the impact of recent government initiatives on sepsis management.

Robert Scoggins is a physician executive.

He discusses the KevinMD article, “Sepsis protocols coupled with rapid host response technologies are the key to improving patient outcomes.”

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Transcript

Kevin Pho: Hi, and welcome to the show. Subscribe at KevinMD.com/podcast, and get CME for this episode by clicking on the CME link in the show notes. Today we welcome Robert Scoggins. He’s a physician executive. Today’s KevinMD article is “Sepsis protocols coupled with rapid host response technologies are the key to improving patient outcomes.” Robert, welcome to the show.

Robert Scoggins: Thanks for having me, Kevin.

Kevin Pho: So we’ll talk about your article in a little bit. First off, let’s start with your story and journey.

Robert Scoggins: All right. Yeah, I’m a pulmonary critical care physician. I currently practice at Kootenai Health in Coeur d’Alene, Idaho, which is a regional medical center, independent hospital, with a large referral area which is mostly critical access hospitals in the very northern tip of Idaho. So we don’t have a lot of other referral centers around us, and really very few academic centers, closest place is about Seattle.

I’m the medical director of the ICU, also medical director of the sepsis program there, been past chief of staff of the hospital, and been in practice since about 2008.

I really initially, when I went into medicine, I thought I was going to be a researcher, but found a passion for taking care of patients, especially in the ICU. And over the years have developed into several administrative roles, including some of the hospital operations, especially during COVID. And then got involved with research through a company called Cytovale, on sepsis and sepsis diagnostics, and I’ve been working with them for several years now.

Kevin Pho: All right. So give us some context before talking about your article. What are some of the challenges clinicians face when diagnosing sepsis?

Robert Scoggins: I think sepsis is a really hard diagnosis, especially in the emergency department, where most septic patients come in to the hospital, they travel through the emergency department. They have a lot of different presentations, and they don’t come in with the signs of, like, STEMI with ST elevation on their EKG, or a stroke with the physical exam findings.

And so we don’t have the tools to identify septic patients currently. In most hospitals we use the SIRS criteria, which is really not a validated criteria to recognize patients with sepsis, but that’s what we have, and we use that for sepsis screening. And what we end up doing is missing patients, and a lot of times overdiagnosing patients and using a lot of hospital resources.

So it’s a difficult diagnosis, and we have all these metrics with SEP-1 now that we are required to do and get graded on, and it’s soon to affect hospital reimbursement with value-based purchasing.

Kevin Pho: All right. So we’re going to talk more about that intersection between sepsis and technologies in your KevinMD article, “Sepsis protocols coupled with rapid host response technologies are the key to improving patient outcomes.” Now, for those who didn’t get a chance to read your article, tell us what it’s about.

Robert Scoggins: Yeah. So basically we have developed a diagnostic test for sepsis risk stratification in the emergency department. And like I said before, sepsis is very difficult. Almost every hospital has some sort of sepsis screen to identify patients at risk for sepsis, but what we lack is the ability to see that true sepsis diagnosis, or that immune dysfunction related to sepsis.

And so what we have done is really tried to make that easier for the clinician up front, being able to give them a piece of information that they haven’t had before, which is insight into that immune dysregulation related to sepsis, so that the protocols and processes that we implement in the emergency department to treat patients with sepsis can actually be applied to the appropriate patient population, and the one that’s most likely going to benefit.

It also allows for us to identify patients who are at low risk for sepsis that we might have thought were septic, or were going to treat that way, and look for a separate diagnosis, and things such as heart failure.

As an ICU physician, I see this all the time, that patients get admitted with hypotension and shock which was thought to be septic shock. They get a ton of fluids, they get antibiotics, and then 24, 48 hours later we’re changing direction because we’ve identified them to be really in cardiogenic shock. And then we’ve essentially harmed the patient by overloading them with fluids and giving them antibiotics that they probably didn’t need, when we probably could have helped them earlier in the hospital stay by focusing on that heart failure.

So it’s really trying to get the diagnosis early for patients and getting them on the right track, so we can get them through the hospital and out of the hospital quicker.

Kevin Pho: All right. So tell us, in terms of the evidence behind this particular technology when it comes to diagnosing sepsis, how much more accurate it is, sensitivities, things like that, compared to the standard of care before this technology.

Robert Scoggins: Yeah. So the technology looks at white blood cells, and actually looks at how they change shape and squish in microfluidic channels. And it’s really new technology that’s not in the laboratories of any hospitals at this point.

It is video data, it’s really cool. They measure about 50,000 cells in a few seconds, and get about 20 gigabytes of video data, looking at these cells traveling down a microfluidic channel and then stopping, and looking at how they change shape, and measure a bunch of different parameters on those cells.

That gives us an ability to make an index from 0.1 to 10. And that index, when it’s low, we say those patients have low risk, their cells are essentially normal and not activated. And then as that index increases, they’re at higher risk. So we divide it up into band one, band two, and band three. So band three results are suggestive of a high risk of sepsis.

The negative predictive value of the test, if you’re a band one, which is low deformability of the cells, it’s about 97.5 percent negative predictive value. And the positive predictive value in band three is about 55 percent. This is based on an observational trial with physician adjudicated sepsis of over a thousand patients that presented to the emergency department with signs and symptoms of infection.

The positive predictive value caveat is, about another 25 percent of those patients in band three are infected and have worse outcomes than band one and band two, but it didn’t get adjudicated as sepsis. But they have that biology that’s associated with sepsis, that immune dysregulation, and worse outcomes.

Kevin Pho: So give us a sample case study, story, or example of this technology being used, and how that influenced patient outcomes.

Robert Scoggins: Yeah. So currently the test is FDA cleared and it’s in commercial use in Baton Rouge, Louisiana, Our Lady of the Lake Hospital. And they have made it part of their sepsis triage screening process.

So patients come into the emergency department, they get screened by a nurse at triage. If they meet two of the four SIRS criteria, or altered mental status or shock, they essentially get screened positive for possible sepsis, and they get blood tests, CBC, lactic acid, and the IntelliSep test.

And so this happens very early in their ED. The test only takes about eight minutes once it gets to the lab, so the turnaround is about the same time as the CBC comes back. And then that information is given to the physician.

And what they’ve been able to do, and really have shown, is that they’re able to identify these patients and get them started down that sepsis pathway quicker. And also, if they’re negative, especially if they’re in shock and it’s a band one patient, which would be a low probability of sepsis, they’re able to pursue alternative diagnoses such as heart failure, which is probably the number one thing that they find in those patients in band one who are in shock. And so that’s been probably one of the most surprising things, they’ve seen several cases of heart failure.

The other thing that they found is that patients in band three aren’t always who they expect. So there’s patients who are sitting in the emergency room waiting room, that came in, they didn’t have a bed for them, got triaged and sent back out, that are coming back as those high-risk sepsis patients. The majority of those people in the waiting room are getting admitted and diagnosed with sepsis, but now they’re able to see those patients and bring them back and treat them quicker, and get those patients down that sepsis pathway.

We’re still in the process of determining whether that’s affecting outcomes of those patients, but what they have seen is that those patients move through the system faster, they’re seeing a decrease in length of stay, they’re also seeing a decrease in cost in those patients in the patient population they’re testing now.

Kevin Pho: How about the cost of the test and equipment itself?

Robert Scoggins: Yeah, the cost of the test is somewhere around $150, $200. I think it depends on the setup, but not too much. The average savings that they’ve seen in Baton Rouge has been around $1,400 per patient that they’ve run the test on. So it does make sense. And so of course that’s one center, and so we’re still trying to gather data to see where the best return on investment is on these patients.

Kevin Pho: So what do you see as some of the barriers that would preclude a test like this being adopted widespread?

Robert Scoggins: Well, I think that barriers are definitely cost. It’s definitely a barrier in most institutions, because it’s going to be used quite a bit in emergency departments.

I think that Baton Rouge, which sees somewhere around 70,000 patients a year, they run the test approximately 20 to 25 times a day on patients for screening. About 40 to 50 percent of those patients come back as band one and low risk, and of the remaining 50 percent, it’s about 25 percent band two, which is that intermediate risk of sepsis, and then band three. So they’re running it quite often, and so I think that’s a barrier in many institutions.

When you look at that long term, however, if you can get patients through the ED faster, through the hospital faster, and better outcomes. And the other thing that’s important to realize about this is, it’s really, instead of following metrics, which is also a barrier that we see as people wonder how this is going to affect their SEP-1 metrics, and is it going to make it worse or better, but we’re really switching that care from metric-centered care to patient-centered care. We’re treating the patients for what they have, and identifying what they need to get, and getting them down that diagnostic pathway so they’re getting the right treatments faster, instead of trying to fulfill a metric.

Kevin Pho: So as it stands now, is a test like this covered by private insurers or Medicare? And if not, what do you see the pathway is when it comes to it being reimbursed?

Robert Scoggins: Yeah, I think that that is what we’re in the process of doing right now, is going to CMS and that whole process, which has been quite amazing to me as a practicing physician, to be involved with that process of, how do you get a new diagnostic or a new test reimbursed and adopted, both from CMS from a payment standpoint, but also in the guidelines? And so usually this would be covered under the DRG that would come in, but we’re working on getting it the actual code and assigned a value at this time.

Kevin Pho: We’re talking to Robert Scoggins. He is a physician executive. And today’s KevinMD article is “Sepsis protocols coupled with rapid host response technologies are the key to improving patient outcomes.” So Robert, what do you see as the next steps when it comes to this technology? What’s on the horizon?

Robert Scoggins: I think that getting the CMS SEP-1 to recognize that these diagnostics, such as the IntelliSep, which is the name of the test that I’ve been involved with, but there’s some others that are either on the market or coming on the market, getting those into the guidelines so that they can be utilized to identify patients as sepsis, or time zero, or to rule them out as being part of this SEP-1. I think that would encourage hospitals to make the investment in the test.

And also it’s really just getting clinicians to know that these technologies are out there. I think one of the things that’s been amazing to me, being involved on the industry side some, is that there’s a lot more technology out there that could be utilized in hospitals to improve care and patient outcomes that we don’t know about, and doesn’t come up through our normal medical literature that we review. And I think technologies such as these are the future.

I think one of the most surprising things to me, doing this sepsis research and getting this new way to look at white blood cells, you realize that our CBC, or white count, is really not the best way to be looking for infection, and especially sepsis. It’s something that we have learned to rely on. But with new technologies coming out, new ways to look at these dynamic biological changes that occur, we have the opportunity to really advance the treatment of sepsis and likely other diseases in the future.

Kevin Pho: My final question, let’s leave with your take-home messages to the KevinMD audience.

Robert Scoggins: I think the take-home message is that we are on the cusp of really changing the practice of how we take care of sepsis and who we take care of as sepsis. And I think that will lead to better patient outcomes in the future, and hopefully we can make sepsis a disease that is vastly better treated, and with a lot less mortality than we currently do.

Kevin Pho: Robert, thank you so much for sharing your perspective and insight, and thanks again for coming on the show.

Robert Scoggins: Yeah, thank you.