Research shows 'Rory's Regulations' are saving lives, but one physician urges other states to 'proceed with caution.'
New York's statewide sepsis protocols appear to be working, according to a new study out this week in JAMA.
The protocols–known as Rory's Regulations–became law in 2013, following the death of 12-year-old Rory Staunton from undiagnosed, untreated sepsis. The protocols mandate that all hospitals adopt evidence-based practices for the identification and treatment of sepsis.
University of Pittsburgh researchers examined more than a million sepsis admission records from New York and four control states–Florida, Maryland, Massachusetts, and New Jersey– in the years before and after Rory’s Regulations took effect. They found that sepsis mortality rates dropped 4.3% in New York and 2.9% in the control states, according to the JAMA report.
The Pitt researchers showed that New York's sepsis death rate was 3.2% lower following the regulations than would have been expected, relative to the control states.
Lead author Jeremy Kahn, MD, says the study is the first to conclusively link improvements in sepsis outcomes with the implementation of holistic, evidence-based regulations.
Kahn spoke with HealthLeaders about the study findings, what they're doing right in New York state, and how that model might –or might not– work for other states.
HLM: What specifically is it that they're doing in New York that is driving success?
Kahn: Three things. One is all hospitals are mandated to implement protocols for evidence-based treatment and recognition, and more patients are getting these evidence-based therapies, specifically, early antibiotics and early resuscitation. That's really the core element of the protocols.
They're also educating staff at all hospitals in New York state so that people are going to recognize and treat sepsis better.
The third thing is they're just paying attention to it. Sepsis has been not on the public health radar for many years that focuses on heart attacks and strokes and other things that are easier to recognize, and perhaps easier to treat. Just by turning our lens to sepsis, we're able to think about it in new ways, recognize it earlier and treat it more effectively.
HLM: Does the New York model shed any light on how people acquire sepsis in the first place?
Kahn: That's still is a big unknown, and the regulations don't address that. We don't yet understand why two people get the same infection, but one gets horrible sepsis and one seems to do fine. That's a much stickier wicket and another pressing public health issue.
HLM: How many states have these sepsis initiatives?
Kahn: Two other states have pulled the trigger. One is Illinois and the others New Jersey. There are 10 to 12 states that are actively considering these regulations, including my own state, Pennsylvania. This study will prompt the rest of the states to take a harder look at whether this regulatory approach to sepsis care is useful, because we show that at least in New York, it appears to have been.
HLM: As you note, sepsis is getting more attention, but the sepsis caseload also appears to be growing. What's going on?
Kahn: Part of the answer is we're looking for it more. Whenever you look for something, you're more likely to find it. Another part is that healthcare is just shifting over the last few decades. We're doing more high-risk surgeries, doing more chemotherapy, creating more immunosuppressed patients, and those things all increase the risk of sepsis.
HLM: Are you recommending that other states take up the New York model?
Kahn: My belief is that we proceed with caution. We now have very rigorous evidence that these policies can work, but we don't yet know whether they will work in other states, and we don't yet know what makes them work so well in New York. It's reasonable for other states to proceed, but with abundant caution, because there are downsides to these policy-based approaches to sepsis care.
HLM: What are those downsides?
Kahn: There are two downsides. One is the straightforward risk of overtreatment. There's the concern that when you're forcing hospitals through regulatory mandate to do the right thing, that we will treat people too aggressively.
We found evidence of that in New York because more patients got invasive central venous catheters and those have risks. More patients were admitted to the ICU and admission to the ICU has risks.
Those things also carry costs. Are we giving too many people antibiotics? Are we giving too many people fluids? The antibiotic issue is such a sticky wicket because there's antibiotic resistance concerns.
The other downside is a bit more conceptual, which is that this is quite a heavy hand. We're mandating that hospitals adopted these evidence-based practices. In the United States, we've not been so aggressive with our health policies in the past. We use more gentle nudges to get providers to do the right thing; things like financial incentives in the form of pay for performance and value-based purchasing.
We use public reporting, which is a market-driven approach, to get providers to better adopt evidence-based practices. This is a much blunter approach. And it raises concerns because the evidence might change. These regulations need to be flexible enough to accommodate those changes.
It does give pause for us to ask if this is how we want to get providers to do the right thing? My personal belief is that physicians and hospitals have had decades to do the right thing on their own, and if there's any consistent observation in healthcare in the last 20 years, it's the gap between evidence and practice. Given that sepsis is a public health crisis, it's not unreasonable to at least try these somewhat heavy-handed policies if we go in with an open eye and make sure they're not causing more harm than good.
HLM: What are some of the roadblocks to more widespread adaptation of aggressive sepsis measures?
Kahn: We need more resources. This is an unfunded mandate. We're not asking hospitals. We're telling hospitals to engage in quality improvement, and that's very expensive. That is particularly concerning for small hospitals, rural hospitals, safety-net hospitals. My concern then is by incentivizing this very extensive quality improvement, we might be widening health disparities. There's some evidence of that in New York.
One way to change these regulations is to include provisions that create a regional quality improvement collaborative that facilitates hospitals working together so we make sure that this rising tide lifts all boats, as opposed to most of the quality improvement happening in only selected hospitals.
HLM: How much did the New York model cost to implement? Is there a breakdown on the per-patient cost?
Kahn: No, we don't have data on that. We don't know either for the patient level, or the overall cost. We did find evidence that that the regulations lead to more intensive treatment, and obviously there's a cost to implementing those.
The real cost for hospitals is the effort in developing and maintaining these protocols. A lot of hospitals use IT to support responding to the regulations if they build in a sepsis alert into their electronic health records. Those things are very costly.
We also found a lot of hospitals are hiring dedicated sepsis coordinators to oversee sepsis quality improvement and that's a very, very expensive thing. When a hospital can afford it, it's likely to have an impact. But those costs are typically absorbed by the hospital, and that lowers overall margins. It's not to the point where it's threatening the financial health of any hospital, but it is important to consider that this is, at its core, an unfunded mandate.
HLM: Where should other states start if they want to emulate the New York model?
Kahn: The first thing is to get the right people at the table. One of the things that was most successful about the New York experience was that it wasn't just the regulators developing and implementing this policy. The health systems, the clinicians and the patients' advocates were all at the table in an exceptionally collaborative effort to develop and implement these policies.
“We now have very rigorous evidence that these policies can work, but we don't yet know whether they will work in other states, and we don't yet know what makes them work so well in New York”
Jeremy Kahn, MD, University of Pittsburgh
John Commins is a content specialist and online news editor for HealthLeaders, a Simplify Compliance brand.
Researchers found that sepsis mortality rates dropped 4.3% in New York and 2.9% in four control states.
Pitt researchers say their study is the first to conclusively link improvements in sepsis outcomes with the implementation of holistic, evidence-based regulations.
However, the researchers warn that aggressive sepsis protocols could lead to overtreating some patients, which apparently has happened in New York.