Following the death of 12-year-old Rory Staunton in April 2012 from sepsis arising as a consequence of a minor sporting injury, his parents and others campaigning as the Rory Staunton Foundation successfully influenced the New York State Department of Health (DOH) to mandate the use of guidelines around sepsis.
‘Rory’s Regulations’ mandate acute care hospitals to implement protocols for the recognition and management of patients with sepsis, as well as to report performance metrics to the DOH. The regulations include protocols regarding the administration of antimicrobials within three hours, and intravenous fluid resuscitation within 6 hours.
Importantly, and in contrast with performance incentives introduced in some other countries such as in the U.K, there were no targets – improvement was expected through benchmarking. So, how did New York State fair?
A study published last week (Association Between State-Mandated Protocolized Sepsis Care and In-Hospital Mortality Among Adults with Sepsis) examines mortality within 30 days of admission with sepsis. This was a huge study, with over 1,000,000 patient episodes across more than 500 hospitals, with almost one third in New York State (NYS). It’s a retrospective cohort study with geographic controls - in other words, it compares data on patients in NYS admitted before the Regulations were issued (in 2013) and those after the regulations, with data from the same time periods in four other US States without such regulations. It also examines length of stay in hospital, in addition to unintended consequence such as intensive care unit (ICU) admission, central venous catheter (CVC) use, and the development of C. difficile colitis. It’s limited in part by the design, and in part by the fact that it uses ICD-9 coded data rather than ICD-10, but robustly attempts to mitigate against its limitations by controlling for temporal trends.
From a concerning starting point, in which NYS residents suffered higher mortality rates than those in control states (26.3% vs. 22.0%), continuous improvement in primary outcomes occurred in NYS at a greater pace than in the other states (in which, encouragingly, outcomes also improved). After the introduction of Rory’s Regulations, mortality in NYS fell to 22.0% whilst that in other states fell to 19.1%. These trends seemed to have been accelerating, with data from the last quarter year suggesting that mortality in NYS was actually over 3% lower than in the other states.
It’s interesting to note that the use of ICU beds and CVCs was lower in NYS before (and during) the study than in other states, which the authors attribute to a lack of bed availability. After the study, there were still fewer ICU beds or CVCs used in NYS. This strongly suggests that a focus on early recognition and immediate management may limit the maximum acuity of illness, which in turn may allow more resource-constrained settings to achieve outcomes which can as good or better than more resourced neighbors, just by focussing on the basics.
Unfortunately, this study was not designed to determine whether the governmental mandates actually increased iv fluid or antibiotic use. These specific protocol components were not included in the secondary outcomes, leaving any such relationship to supposition or assumption.
So, overall, it seems Rory’s Regulations work. This work illustrates how, as has been demonstrated in other countries, the critical interrelationship between the public, advocacy organizations, the media, health professionals, and policy makers can be harnessed to save lives. Whether this be through financial incentive encouraging local innovation, through systems change and benchmarked reporting as here, through the adoption of technological solutions or through a combination of strategies, it is vital - literally - that governments come together to act decisively on sepsis, and in doing so to deliver on the WHO Resolution on Sepsis issued in 2017.