Dataset Information

A Roadmap for Successful State Sepsis Regulations-Lessons From New York.

ABSTRACT: New York state implemented the first state-level sepsis regulations in 2013. These regulations were associated with improved mortality, leading other states to consider similar steps. Our objective was to provide insight into New York state's sepsis policy making process, creating a roadmap for policymakers in other states considering similar regulations.

Design

Qualitative study using semistructured interviews.

Setting

We recruited key stakeholders who had knowledge of the New York state sepsis regulations.

Subjects

Thirteen key stakeholders from three groups included four New York state policymakers and seven clinicians and hospital association leaders involved in the creation and implementation of the 2013 New York state sepsis regulations, as well as two members of patient advocacy groups engaged in sepsis advocacy.

Interventions

None.

Measurements and main results

We used iterative, inductive thematic analysis to identify themes related to participant perceptions of the New York state sepsis policy, factors that influenced the policy's perceived successes, and opportunities for improvement. We identified several factors that facilitated success. Among these were that policymakers engaged a diverse array of stakeholders in development, allowing them to address potential barriers to implementation and create early buy-in. Policymakers also paid specific attention to the balance between the desire for comprehensive reporting and the burden of data collection, narrowly focusing on "essential" sepsis-related data elements to reduce the burden on hospitals. In addition, the regulations touched on all three major domains of sepsis quality-structure, process, and outcomes-going beyond a data collection to give hospitals tools to improve sepsis care.

Conclusions

We identified factors that distinguish the New York sepsis regulations from less successful sepsis polices at the federal level. Ultimately, lessons from New York state provide valuable guidance to policymakers and hospital officials seeking to develop and implement policies that will improve sepsis quality.

SUBMITTER: Gigli KH

PROVIDER: S-EPMC8423398 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:OBJECTIVES:Under "Rory's Regulations," New York State Article 28 acute care hospitals were mandated to implement sepsis protocols and report patient-level data. This study sought to determine how well cases reported under state mandate align with discharge records in a statewide administrative database. DESIGN:Observational cohort study. SETTING:First 27 months of mandated sepsis reporting (April 1, 2014, to June 30, 2016). PATIENTS:Hospitalizations with sepsis at New York State Article 28 acute care hospitals. INTERVENTION:Sepsis regulations with mandated reporting. MEASUREMENTS AND MAIN RESULTS:We compared cases reported to the New York State Department of Health Sepsis Clinical Database with discharge records in the Statewide Planning and Research Cooperative System database. We classified discharges as 1) "coded sepsis discharges"-a diagnosis code for severe sepsis or septic shock and 2) "possible sepsis discharges," using Dombrovskiy and Angus criteria. Of 111,816 sepsis cases reported to the New York State Department of Health Sepsis Clinical Database, 105,722 (94.5%) were matched to discharge records in Statewide Planning and Research Cooperative System. The percentage of coded sepsis discharges reported increased from 67.5% in the first quarter to 81.3% in the final quarter of the study period (mean, 77.7%). Accounting for unmatched cases, as many as 82.7% of coded sepsis discharges were potentially reported, whereas at least 17.3% were unreported. Compared with unreported discharges, reported discharges had higher rates of acute organ dysfunction (e.g., cardiovascular dysfunction 63.0% vs 51.8%; p < 0.001) and higher in-hospital mortality (30.2% vs 26.1%; p < 0.001). Hospital characteristics (e.g., number of beds, teaching status, volume of sepsis cases) were similar between hospitals with a higher versus lower percent of discharges reported, p values greater than 0.05 for all. Hospitals' percent of discharges reported was not correlated with risk-adjusted mortality of their submitted cases (Pearson correlation coefficient 0.11; p = 0.17). CONCLUSIONS:Approximately four of five discharges with a diagnosis code of severe sepsis or septic shock in the Statewide Planning and Research Cooperative System data were reported in the New York State Department of Health Sepsis Clinical Database. Incomplete reporting appears to be driven more by underrecognition than attempts to game the system, with minimal bias to risk-adjusted hospital performance measurement.

Project description:ObjectiveTo illuminate the key components of multi-sector reform to address the obesogenic environment in New York City during the administration of Mayor Michael Bloomberg from 2002 to 2013, we conducted a case study consisting of interviews with and a critical analysis of the experiences of leading decision makers and implementers.MethodKey informant interviews (N = 41) conducted in 2014 were recorded, transcribed, coded, and thematically analyzed. Participants included officials from the Health Department and other New York City Government agencies, academics, civil society members, and private sector executives.ResultsParticipants described Mayor Bloomberg as a data-driven politician who wanted to improve the lives of New Yorkers. He appointed talented Commissioners and encouraged them and their staff to be bold, innovative, and collaborative. Multiple programs spanning multiple sectors, with varied approaches and targets, were supported. This study found that much of the work relied on loose coalitions across City Government, with single agencies responsible for their own agendas, some with health co-benefits. Many policies were implemented through non-legislative mechanisms such as executive orders and the Health Code. Despite support from academic and some civil society groups, strong lobbying from industry and an unfavorable media led to some reforms being modified, legally challenged or blocked completely, particularly food environment modifiers. In contrast, reforms of the physical environment were described as highly consultative across and outside government and resulted in slower but more sustained reform.ConclusionThe Bloomberg administration was a "window of opportunity" with the imprimatur of the executive to progress a long-term, multi-faceted obesity prevention strategy, which has successfully reversed childhood trends. Through the involvement of external researchers and the extensive use of empirical data from a wide range of participants, this study offers a unique insight into the ways in which this was achieved. While some of the aspects of the reforms in New York City are unique to that setting at that time, there are important lessons that are transferable to other urban settings. These include: strong and consistent leadership; a commitment to innovative approaches and cross-sectoral collaboration; and a context to support and encourage this approach.

Project description:ImportanceThe death of a pediatric patient with sepsis motivated New York to mandate statewide sepsis treatment in 2013. The mandate included a 1-hour bundle of blood cultures, broad-spectrum antibiotics, and a 20-mL/kg intravenous fluid bolus. Whether completing the bundle elements within 1 hour improves outcomes is unclear.ObjectiveTo determine the risk-adjusted association between completing the 1-hour pediatric sepsis bundle and individual bundle elements with in-hospital mortality.Design, settings, and participantsStatewide cohort study conducted from April 1, 2014, to December 31, 2016, in emergency departments, inpatient units, and intensive care units across New York State. A total of 1179 patients aged 18 years and younger with sepsis and septic shock reported to the New York State Department of Health who had a sepsis protocol initiated were included.ExposuresCompletion of a 1-hour sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour.Main outcomes and measuresRisk-adjusted in-hospital mortality.ResultsOf 1179 patients with sepsis reported at 54 hospitals (mean [SD] age, 7.2 [6.2] years; male, 54.2%; previously healthy, 44.5%; diagnosed as having shock, 68.8%), 139 (11.8%) died. The entire sepsis bundle was completed in 1 hour in 294 patients (24.9%). Antibiotics were administered to 798 patients (67.7%), blood cultures were obtained in 740 patients (62.8%), and the fluid bolus was completed in 548 patients (46.5%) within 1 hour. Completion of the entire bundle within 1 hour was associated with lower risk-adjusted odds of in-hospital mortality (odds ratio [OR], 0.59 [95% CI, 0.38 to 0.93], P = .02; predicted risk difference [RD], 4.0% [95% CI, 0.9% to 7.0%]). However, completion of each individual bundle element within 1 hour was not significantly associated with lower risk-adjusted mortality (blood culture: OR, 0.73 [95% CI, 0.51 to 1.06], P = .10; RD, 2.6% [95% CI, -0.5% to 5.7%]; antibiotics: OR, 0.78 [95% CI, 0.55 to 1.12], P = .18; RD, 2.1% [95% CI, -1.1% to 5.2%], and fluid bolus: OR, 0.88 [95% CI, 0.56 to 1.37], P = .56; RD, 1.1% [95% CI, -2.6% to 4.8%]).Conclusions and relevanceIn New York State following a mandate for sepsis care, completion of a sepsis bundle within 1 hour compared with not completing the 1-hour sepsis bundle within 1 hour was associated with lower risk-adjusted in-hospital mortality among patients with pediatric sepsis and septic shock.

Project description:ObjectivesInitial evidence suggests that state-level regulatory mandates for sepsis quality improvement are associated with decreased sepsis mortality. However, sepsis mandates require financial investments on the part of hospitals and may lead to increased spending. We evaluated the effects of the 2013 New York State sepsis regulations on the costs of care for patients hospitalized with sepsis.DesignRetrospective cohort study using state discharge data from the U.S. Healthcare Costs and Utilization Project and a comparative interrupted time series analytic approach. Costs were calculated from admission-level charge data using hospital-specific cost-to-charge ratios.SettingGeneral, short stay, acute care hospitals in New York, and four control states: Florida, Massachusetts, Maryland, and New Jersey.PatientsAll patients hospitalized with sepsis between January 1, 2011, and September 30, 2015.InterventionsThe 2013 New York mandate that all hospitals develop and implement protocols for sepsis identification and treatment, educate staff, and report performance data to the state.Measurements and main resultsThe analysis included 1,026,664 admissions in 520 hospitals. Mean unadjusted costs per hospitalization in New York State were $42,036 ± $60,940 in the pre-regulation period and $39,719 ± $59,063 in the post-regulation period, compared with $34,642 ± $52,403 pre-regulation and $31,414 ± $48,155 post-regulation in control states. In the comparative interrupted time series analysis, the regulations were not associated with a significant difference in risk-adjusted mean cost per hospitalization (p = 0.12) or risk-adjusted mean cost per hospital day (p = 0.44). For example, in the 10th quarter after implementation of the regulations, risk-adjusted mean cost per hospitalization was $3,627 (95% CI, -$681 to $7,934) more than expected in New York State relative to control states.ConclusionsMandated protocolized sepsis care was not associated with significant changes in hospital costs in patients hospitalized with sepsis in New York State.

Project description:ImportanceMore evidence on associations between mandated paid sick leave and health service utilization among low-income adults is needed to guide health policy and legislation nationwide.ObjectiveTo evaluate the association between New York City's 2014 paid sick leave mandate and health care utilization among Medicaid-enrolled adults.Design setting and participantsThis retrospective cohort study used New York State Medicaid administrative data for adults 18 to 64 years old continuously enrolled in Medicaid from August 1, 2011, through July 31, 2017. A difference-in-differences approach with entropy balancing weights was used to compare New York City with the rest of New York State to assess the association of the paid sick leave mandate with health care utilization, and for those 40 to 64 years old, with preventive care utilization. The data analysis was performed from June through August 2020.ExposuresTemporal and spatial variation in exposure to the mandate.Main outcomes and measuresAnnual health care utilization (emergency care, specialist visits, and primary care clinician visits) per Medicaid-enrolled adult. Secondary outcomes include categories of emergency utilization and utilization of 5 preventive services.ResultsOf 552 857 individuals (mean [SD] age, 43 [12] years; 351 130 [64%] women) who met inclusion criteria, 99 181 (18%) were White, 162 492 (29%) Black, and 138 061 (25%) Hispanic. Paid sick leave was significantly associated with a reduction in the probability of emergency care (-0.6 percentage points [pp]; 95% CI, -0.7 to -0.5 pp; P < .001), including a 0.3 pp reduction (95% CI, -0.4 to -0.2; P < .001) in care for conditions treatable in a primary care setting and an increase in annual outpatient visits (0.124 pp; 95% CI, 0.040 to 0.208 pp; P < .001). Among those 40 to 64 years old, the mandate was significantly associated with increased probabilities of glycated hemoglobin A1c level testing (2.9 pp; 95% CI, 2.5-3.3 pp; P < .001), blood cholesterol testing (2.7 pp; 95% CI, 2.5-2.9 pp; P < .001), and colon cancer screening (0.4 pp; 95% CI, 0.2-0.6 pp; P < .001).Conclusions and relevanceThis retrospective cohort study of nonelderly adults enrolled in Medicaid New York State showed that mandated paid sick leave in New York City was significantly associated with differences in several dimensions of health care services use.