# The effects of state sepsis mandates on hospital mortality, health care utilization, and costs

> **NIH AHRQ R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2020 · $380,420

## Abstract

ABSTRACT
Sepsis is a leading cause of morbidity and mortality in the United States, affecting over 750,000
Americans each year at an annual cost of over $20 billion. Several medical treatments are of proven
effectiveness in this population, including timely administration of antibiotics and early resuscitation
with intravenous fluids. However these treatments are inconsistently applied, creating an important
quality gap. Protocols for early recognition and treatment can help close this gap and save lives in
patients with sepsis, and in turn policy makers are increasingly using legal mechanisms to incentivize
the use of sepsis protocols. One such initiative is an unprecedented set of New York State regulations
implemented in June of 2013 and collectively known as “Rory's Regulations”. Named after Rory
Staunton, a 12-year-old boy who died of sepsis at a New York hospital, Rory's Regulations mandate
that all hospitals in the state implement evidence-based protocols for sepsis management and report
data on sepsis protocol adherence and outcomes to the state government. Rory's Regulations are an
innovative strategy for policy-based quality improvement in that they link traditional quality reporting
with specific mandates for evidence-based practice. They are also a leading-edge forerunner to
sepsis regulations in development in other states and at the national level, making it imperative that
we understand their clinical and financial impact. The overall goal of this proposal is to systematically
evaluate the impact of the New York state sepsis regulations. We plan a novel mixed methods
approach designed to yield information that policy makers can use not only to refine the existing policy
but also to design and implement future polices. First, we will use hospital emergency department and
inpatient data from New York and eight control states to assess the effects of the 2013 regulations on
mortality, complications of care, health care utilization and costs, controlling for case-mix and
temporal trends. Second, we will complement our quantitative analyses with a theory-driven
qualitative analysis in which we will perform and analyze semi-structured interviews with key
stakeholders in New York State, including clinicians, policy-makers, and patient advocates. This
qualitative analysis will serve to help interpret the overall policy effects and provide actionable
guidance to policy makers seeking to develop similar sepsis-related regulations. Together, these aims
will comprise the first rigorous evaluation of a landmark set of state-wide sepsis regulations. More
broadly, they will be the first evaluation of a novel strategy for state-wide quality improvement through
policy mandates for specific evidence-based practices, directly informing future efforts to improve the
quality of care not only in sepsis but also in other aspects of hospital medicine.

## Key facts

- **NIH application ID:** 9980342
- **Project number:** 5R01HS025146-04
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Jeremy M Kahn
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2020
- **Award amount:** $380,420
- **Award type:** 5
- **Project period:** 2017-09-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9980342

## Citation

> US National Institutes of Health, RePORTER application 9980342, The effects of state sepsis mandates on hospital mortality, health care utilization, and costs (5R01HS025146-04). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/9980342. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*
