Association Between Medicare's Sepsis Reporting Policy (SEP-1) and the Documentation of a Sepsis Diagnosis in the Clinical Record.

STUDY DESIGN: Interrupted time series analysis of a retrospective, electronic health record cohort. OBJECTIVE: To determine the association between the implementation of Medicare's sepsis reporting measure (SEP-1) and sepsis diagnosis rates as assessed in clinical documentation. BACKGROUND: The role of health policy in the effort to improve sepsis diagnosis remains unclear. PATIENTS AND METHODS: Adult patients hospitalized with suspected infection and organ dysfunction within 6 hours of presentation to the emergency department, admitted to one of 11 hospitals in a multi-hospital health system from January 2013 to December 2017. Clinician-diagnosed sepsis, as reflected by the inclusion of the terms "sepsis" or "septic" in the text of clinical notes in the first two calendar days following presentation. RESULTS: Among 44,074 adult patients with sepsis admitted to 11 hospitals over 5 years, the proportion with sepsis documentation was 32.2% just before the implementation of SEP-1 in the third quarter of 2015 and increased to 37.3% by the fourth quarter of 2017. Of the 9 post-SEP-1 quarters, 8 had odds ratios for a sepsis diagnosis >1 (overall range: 0.98-1.26; P value for a joint test of statistical significance = 0.005). The effects were clinically modest, with a maximum effect of an absolute increase of 4.2% (95% CI: 0.9-7.8) at the end of the study period. The effect was greater in patients who did not require vasopressors compared with patients who required vasopressors ( P value for test of interaction = 0.02). CONCLUSIONS: SEP-1 implementation was associated with modest increases in sepsis diagnosis rates, primarily among patients who did not require vasoactive medications.

Peripherally Infused Norepinephrine to Avoid Central Venous Catheter Placement in a Medical Intensive Care Unit: A Pilot Study.

BACKGROUND: Reducing central venous catheter (CVC) utilization can reduce complications in the intensive care unit (ICU). While norepinephrine (NE) is traditionally administered via a CVC, lower concentrations may be safely administered via peripheral intravenous (PIV) lines. OBJECTIVE: We aimed to describe the implementation of a pilot protocol utilizing PIVs to administer a low-dose and lower-concentration NE, review the number of CVCs avoided, and evaluate any adverse events. METHODS: In a quaternary medical intensive care unit (MICU), from March 1, 2019, to February 29, 2020, we reviewed charts for CVC placement and adverse events from the pNE infusion. We also measured unit-level CVC utilization in all MICU patients and assessed the change in utilization associated with the peripheral norepinephrine (pNE) protocol. RESULTS: Over a 1-year period, 87 patients received a pNE infusion. Overall, 44 patients (51%) never required CVC placement during their MICU stay. Three patients (3%) experienced adverse events, none of which were documented as serious and or required antidote for treatment. Implementation of the protocol was associated with a decrease in the number of patients at the unit level who received CVCs, even if they did not receive pNE. CONCLUSION AND RELEVANCE: In this small pilot study, we pragmatically demonstrated that pNE is safe and may reduce the need for CVC placement. This information can be used to aid in pNE protocol development and implementation at other institutions, but further research should be done to confirm the safety of routine use of pNE in clinical practice.

Treatment Patterns and Clinical Outcomes After the Introduction of the Medicare Sepsis Performance Measure (SEP-1).

BACKGROUND: Medicare requires that hospitals report on their adherence to the Severe Sepsis and Septic Shock Early Management Bundle (SEP-1). OBJECTIVE: To evaluate the effect of SEP-1 on treatment patterns and patient outcomes. DESIGN: Longitudinal study of hospitals using repeated cross-sectional cohorts of patients. SETTING: 11 hospitals within an integrated health system. PATIENTS: 54 225 encounters between January 2013 and December 2017 for adults with sepsis who were hospitalized through the emergency department. INTERVENTION: Onset of the SEP-1 reporting requirement in October 2015. MEASUREMENTS: Changes in SEP-1-targeted processes, including antibiotic administration, lactate measurement, and fluid administration at 3 hours from sepsis onset; repeated lactate and vasopressor administration for hypotension within 6 hours of sepsis onset; and sepsis outcomes, including risk-adjusted intensive care unit (ICU) admission, in-hospital mortality, and home discharge among survivors. RESULTS: Two years after its implementation, SEP-1 was associated with variable changes in process measures, with the greatest effect being an increase in lactate measurement within 3 hours of sepsis onset (absolute increase, 23.7 percentage points [95% CI, 20.7 to 26.7 percentage points]; P < 0.001). There were small increases in antibiotic administration (absolute increase, 4.7 percentage points [CI, 1.9 to 7.6 percentage points]; P = 0.001) and fluid administration of 30 mL/kg of body weight within 3 hours of sepsis onset (absolute increase, 3.4 percentage points [CI, 1.5 to 5.2 percentage points]; P < 0.001). There was no change in vasopressor administration. There was a small increase in ICU admissions (absolute increase, 2.0 percentage points [CI, 0 to 4.0 percentage points]; P = 0.055) and no changes in mortality (absolute change, 0.1 percentage points [CI, -0.9 to 1.1 percentage points]; P = 0.87) or discharge to home. LIMITATION: Data are from a single health system. CONCLUSION: Implementation of the SEP-1 mandatory reporting program was associated with variable changes in process measures, without improvements in clinical outcomes. Revising the measure may optimize its future effect. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

National Performance on the Medicare SEP-1 Sepsis Quality Measure.

OBJECTIVES: The Centers for Medicare and Medicaid Services requires hospitals to report compliance with a sepsis treatment bundle as part of its Inpatient Quality Reporting Program. We used recently released data from this program to characterize national performance on the sepsis measure, known as SEP-1. DESIGN: Cross-sectional study of United States hospitals participating in the Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting Program linked to Centers for Medicare and Medicaid Services' Healthcare Cost Reporting Information System. SETTING: General, short-stay, acute-care hospitals in the United States. MEASUREMENTS AND MAIN RESULTS: We examined the hospital factors associated with reporting SEP-1 data, the hospital factors associated with performance on the SEP-1 measure, and the relationship between SEP-1 performance and performance on other quality measures related to time-sensitive medical conditions. A total of 3,283 hospitals were eligible for the analysis, of which 2,851 (86.8%) reported SEP-1 performance data. SEP-1 reporting was more common in larger, nonprofit hospitals. The most common reason for nonreporting was an inadequate case volume. Among hospitals reporting SEP-1 performance data, overall bundle compliance was generally low, but it varied widely across hospitals (mean and SD: 48.9% ± 19.4%). Compared with hospitals with worse SEP-1 performance, hospitals with better SEP-1 performance tended to be smaller, for-profit, nonteaching, and with intermediate-sized ICUs. Better hospital performance on SEP-1 was associated with higher rates of timely head CT interpretation for stroke patients (rho = 0.16; p < 0.001), more frequent aspirin administration for patients with chest pain or heart attacks (rho = 0.24; p < 0.001) and shorter median time to electrocardiogram for patients with chest pain (rho = -0.12; p < 0.001). CONCLUSIONS: The majority of eligible hospitals reported SEP-1 data, and overall bundle compliance was highly variable. SEP-1 performance was associated with structural hospital characteristics and performance on other measures of hospital quality, providing preliminary support for SEP-1 performance as a marker of timely hospital sepsis care.

Host-Response Subphenotypes Offer Prognostic Enrichment in Patients With or at Risk for Acute Respiratory Distress Syndrome.

OBJECTIVES: Classification of patients with acute respiratory distress syndrome into hyper- and hypoinflammatory subphenotypes using plasma biomarkers may facilitate more effective targeted therapy. We examined whether established subphenotypes are present not only in patients with acute respiratory distress syndrome but also in patients at risk for acute respiratory distress syndrome (ARFA) and then assessed the prognostic information of baseline subphenotyping on the evolution of host-response biomarkers and clinical outcomes. DESIGN: Prospective, observational cohort study. SETTING: Medical ICU at a tertiary academic medical center. PATIENTS: Mechanically ventilated patients with acute respiratory distress syndrome or ARFA. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We performed longitudinal measurements of 10 plasma biomarkers of host injury and inflammation. We applied unsupervised latent class analysis methods utilizing baseline clinical and biomarker variables and demonstrated that two-class models (hyper- vs hypoinflammatory subphenotypes) offered improved fit compared with one-class models in both patients with acute respiratory distress syndrome and ARFA. Baseline assignment to the hyperinflammatory subphenotype (39/104 [38%] acute respiratory distress syndrome and 30/108 [28%] ARFA patients) was associated with higher severity of illness by Sequential Organ Failure Assessment scores and incidence of acute kidney injury in patients with acute respiratory distress syndrome, as well as higher 30-day mortality and longer duration of mechanical ventilation in ARFA patients (p < 0.0001). Hyperinflammatory patients exhibited persistent elevation of biomarkers of innate immunity for up to 2 weeks postintubation. CONCLUSIONS: Our results suggest that two distinct subphenotypes are present not only in patients with established acute respiratory distress syndrome but also in patients at risk for its development. Hyperinflammatory classification at baseline is associated with higher severity of illness, worse clinical outcomes, and trajectories of persistently elevated biomarkers of host injury and inflammation during acute critical illness compared with hypoinflammatory patients. Our findings provide strong rationale for examining treatment effect modifications by subphenotypes in randomized clinical trials to inform precision therapeutic approaches in critical care.

Effects of Changes in ICU Bed Supply on ICU Utilization.

BACKGROUND: The availability of intensive care unit (ICU) beds may influence the demand for critical care. Although small studies support a model of supply-induced demand in the ICU, there is a paucity of system-wide data. OBJECTIVE: The objective of this study was to determine the relationship between ICU bed supply and ICU admission in United States hospitals. RESEARCH DESIGN: Retrospective cohort study using all-payer inpatient records from Florida, Massachusetts, New Jersey, New York, and Washington from 2010 to 2012, linked to hospital data from Medicare's Healthcare Cost Reporting Information System. SUBJECTS: Three patient groups with a low likelihood of benefiting from ICU admission-low severity patients with acute myocardial infarction and pulmonary embolism; and high severity patients with metastatic cancer at the end of life. MEASURES: We compared the risk-adjusted probability of ICU admission at hospitals that increased their ICU bed supply over time to matched hospitals that did not, using a difference-in-differences approach. RESULTS: For patients with acute myocardial infarction, ICU supply increases were associated with an increase in the probability of ICU admission that diminished over time. For patients with pulmonary embolism, there was a trend toward an association between change in ICU supply and ICU admission that did not meet statistical significance. For patients with metastatic cancer, admission to hospitals with an increasing ICU supply was not associated with changes in the probability of ICU admission. CONCLUSIONS: Increases in ICU bed supply were associated with inconsistent changes in the probability of ICU admission that varied across patient subgroups.

An administrative model for benchmarking hospitals on their 30-day sepsis mortality.

BACKGROUND: Given the increased attention to sepsis at the population level there is a need to assess hospital performance in the care of sepsis patients using widely-available administrative data. The goal of this study was to develop an administrative risk-adjustment model suitable for profiling hospitals on their 30-day mortality rates for patients with sepsis. METHODS: We conducted a retrospective cohort study using hospital discharge data from general acute care hospitals in Pennsylvania in 2012 and 2013. We identified adult patients with sepsis as determined by validated diagnosis and procedure codes. We developed an administrative risk-adjustment model in 2012 data. We then validated this model in two ways: by examining the stability of performance assessments over time between 2012 and 2013, and by examining the stability of performance assessments in 2012 after the addition of laboratory variables measured on day one of hospital admission. RESULTS: In 2012 there were 115,213 sepsis encounters in 152 hospitals. The overall unadjusted mortality rate was 18.5%. The final risk-adjustment model had good discrimination (C-statistic = 0.78) and calibration (slope and intercept of the calibration curve = 0.960 and 0.007, respectively). Based on this model, hospital-specific risk-standardized mortality rates ranged from 12.2 to 24.5%. Comparing performance assessments between years, correlation in risk-adjusted mortality rates was good (Pearson's correlation = 0.53) and only 19.7% of hospitals changed by more than one quintile in performance rankings. Comparing performance assessments after the addition of laboratory variables, correlation in risk-adjusted mortality rates was excellent (Pearson's correlation = 0.93) and only 2.6% of hospitals changed by more than one quintile in performance rankings. CONCLUSIONS: A novel claims-based risk-adjustment model demonstrated wide variation in risk-standardized 30-day sepsis mortality rates across hospitals. Individual hospitals' performance rankings were stable across years and after the addition of laboratory data. This model provides a robust way to rank hospitals on sepsis mortality while adjusting for patient risk.

Effects of Physician-targeted Pay for Performance on Use of Spontaneous Breathing Trials in Mechanically Ventilated Patients.

RATIONALE: Pay for performance is an increasingly common quality improvement strategy despite the absence of robust supporting evidence. OBJECTIVES: To determine the impact of a financial incentive program rewarding physicians for the completion of daily spontaneous breathing trials (SBTs) in three academic hospitals. METHODS: We compared data from mechanically ventilated patients from 6 months before to 2 years after introduction of a financial incentive program that provided annual payments to critical care physicians contingent on unit-level SBT completion rates. We used Poisson regression to compare the frequency of days on which SBTs were completed among eligible patients and days on which patients were excluded from SBT eligibility among all mechanically ventilated patients. We used multivariate regression to compare risk-adjusted duration of mechanical ventilation and in-hospital mortality. MEASUREMENTS AND MAIN RESULTS: The cohort included 7,291 mechanically ventilated patients with 75,621 ventilator days. Baseline daily SBT rates were 96.8% (hospital A), 16.4% (hospital B), and 74.7% (hospital C). In hospital A, with the best baseline performance, there was no change in SBT rates, exclusion rates, or duration of mechanical ventilation across time periods. In hospitals B and C, with lower SBT completion rates at baseline, there was an increase in daily SBT completion rates and a concomitant increase in exclusions from eligibility. Duration of mechanical ventilation decreased in hospital C but not in hospital B. Mortality was unchanged for all hospitals. CONCLUSIONS: In hospitals with low baseline SBT completion, physician-targeted financial incentives were associated with increased SBT rates driven in part by increased exclusion rates, without consistent improvements in outcome.

Differences in Hospital Risk-standardized Mortality Rates for Acute Myocardial Infarction When Assessed Using Transferred and Nontransferred Patients.

BACKGROUND: One in 5 patients with acute myocardial infarction (AMI) are transferred between hospitals. However, current hospital performance measures based on AMI mortality exclude these patients from the evaluation of referral hospitals. OBJECTIVE: To determine the relationship between risk-standardized mortality for transferred and nontransferred patients at referral hospitals. RESEARCH DESIGN: This is a retrospective cohort study. SUBJECTS: Fee-for-service Medicare claims from 2011 for patients hospitalized with a primary diagnosis of AMI, at hospitals admitting at least 15 patients in transfer. MEASURES: Hospital-specific risk-standardized 30-day mortality rates (RSMRs) for 2 groups of patients: those admitted through transfer from another hospital, and those natively admitted without a preceding or subsequent interhospital transfer. RESULTS: There were 304 hospitals admitting at least 15 patients in transfer. These hospitals cared for 77,711 natively admitted patients (median, 254; interquartile range, 162-321), and 11,829 patients admitted in transfer (median, 26; interquartile range, 19-46). Risk-standardized mortality rates were higher for natively admitted patients than for those admitted in transfer (mean, 11.5%±1.2% vs. 7.2%±1.1%). There was weak correlation between hospital performance as assessed by RSMR for patients natively admitted versus those admitted in transfer (Pearson r=0.24, P<0.001); when performance was arrayed by quartile, 102 hospitals (33.6%) differed at least 2 quartiles of performance across the 2 patient groups. CONCLUSIONS: For Medicare patients with AMI, hospital-specific RSMRs for natively admitted patients are only weakly associated with RSMRs for patients transferred in from another hospital. Current AMI performance metrics may fail to provide guidance about hospital quality for transferred patients.

Association Between Preexisting Heart Failure With Reduced Ejection Fraction and Fluid Administration Among Patients With Sepsis.

Importance: Intravenous fluid administration is recommended to improve outcomes for patients with septic shock. However, there are few data on fluid administration for patients with preexisting heart failure with reduced ejection fraction (HFrEF). Objective: To evaluate the association between preexisting HFrEF, guideline-recommended intravenous fluid resuscitation, and mortality among patients with community-acquired sepsis and septic shock. Design, Setting, and Participants: A cohort study was conducted of adult patients hospitalized in an integrated health care system from January 1, 2013, to December 31, 2015, with community-acquired sepsis and preexisting assessment of cardiac function. Follow-up occurred through July 1, 2016. Data analyses were performed from November 1, 2020, to August 8, 2022. Exposures: Preexisting heart failure with reduced ejection fraction (≤40%) measured by transthoracic echocardiogram within 1 year prior to hospitalization for sepsis. Main Outcomes and Measures: Multivariable models were adjusted for patient factors and sepsis severity and clustered at the hospital level to generate adjusted odds ratios (aORs) and 95% CIs. The primary outcome was the administration of 30 mL/kg of intravenous fluid within 6 hours of sepsis onset. Secondary outcomes included in-hospital mortality, intensive care unit admission, rate of invasive mechanical ventilation, and administration of vasoactive medications. Results: Of 5278 patients with sepsis (2673 men [51%]; median age, 70 years [IQR, 60-81 years]; 4349 White patients [82%]; median Sequential Organ Failure Assessment score, 4 [IQR, 3-5]), 884 (17%) had preexisting HFrEF, and 2291 (43%) met criteria for septic shock. Patients with septic shock and HFrEF were less likely to receive guideline-recommended intravenous fluid than those with septic shock without HFrEF (96 of 380 [25%] vs 699 of 1911 [37%]; P < .001), but in-hospital mortality was similar (47 of 380 [12%] vs 244 of 1911 [13%]; P = .83). In multivariable models, HFrEF was associated with a decreased risk-adjusted odds of receiving 30 mL/kg of intravenous fluid within the first 6 hours of sepsis onset (aOR, 0.63; 95% CI, 0.47-0.85; P = .002). The risk-adjusted mortality was not significantly different among patients with HFrEF (aOR, 0.92; 95% CI, 0.69-1.24; P = .59) compared with those without, and there was no interaction with intravenous fluid volume (aOR, 1.00; 95% CI, 0.98-1.03; P = .72). Conclusions and Relevance: The results of this cohort study of patients with community-acquired septic shock suggest that preexisting HFrEF was common and was associated with reduced odds of receiving guideline-recommended intravenous fluids.

Adoption and Deadoption of Medications to Treat Hospitalized Patients With COVID-19.

OBJECTIVES: The COVID-19 pandemic was characterized by rapidly evolving evidence regarding the efficacy of different therapies, as well as rapidly evolving health policies in response to that evidence. Data on adoption and deadoption are essential as we learn from this pandemic and prepare for future public health emergencies. DESIGN: We conducted an observational cohort study in which we determined patterns in the use of multiple medications to treat COVID-19: remdesivir, hydroxychloroquine, IV corticosteroids, tocilizumab, heparin-based anticoagulants, and ivermectin. We analyzed changes both overall and within subgroups of critically ill versus Noncritically ill patients. SETTING: Data from Optum's deidentified Claims-Clinical Dataset, which contains multicenter electronic health record data from U.S. hospitals. PATIENTS: Adults hospitalized with COVID-19 from January 2020 to June 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Of 141,533 eligible patients, 34,515 (24.4%) required admission to an ICU, 14,754 (10.4%) required mechanical ventilation, and 18,998 (13.4%) died during their hospitalization. Averaged over the entire time period, corticosteroid use was most common (47.0%), followed by remdesivir (33.2%), anticoagulants (19.3%), hydroxychloroquine (7.3%), and tocilizumab (3.4%). Usage patterns varied substantially across treatments. For example, hydroxychloroquine use peaked in March 2020 and leveled off to near zero by June 2020, whereas the use of remdesivir, corticosteroids, and tocilizumab all increased following press releases announcing positive results of large international trials. Ivermectin use increased slightly over the study period but was extremely rare overall (0.4%). CONCLUSIONS: During the COVID-19 pandemic, medication treatment patterns evolved reliably in response to emerging evidence and changes in policy. These findings may inform efforts to promote optimal adoption and deadoption of treatments for acute care conditions.

Changes in Purchases for Intensive Care Medicines During the COVID-19 Pandemic: A Global Time Series Study.

BACKGROUND: Drug supply disruptions have increased during the COVID-19 pandemic, especially for medicines used in the ICU. Despite reported shortages in wealthy countries, global analyses of ICU drug purchasing during COVID-19 are limited. RESEARCH QUESTION: Has COVID-19 impacted global drug purchases of first-, second-, and third-choice agents used in intensive care? STUDY DESIGN AND METHODS: We conducted a cross-sectional time series study in a global pharmacy sales dataset comprising approximately 60% of the world's population. We analyzed pandemic-related changes in units purchased per 1,000 population for 69 ICU agents. Interventional autoregressive integrated moving average models tested for significant changes when the pandemic was declared (March 2020) and during its first stage from April through August 2020, globally and by development status. RESULTS: Relative to 2019, ICU drug purchases increased by 23.6% (95% CI, 7.9%-37.9%) in March 2020 (P < .001) and then decreased by 10.3% (95% CI, -16.9% to -3.5%) from April through August (P = .006). Purchases for second-choice medicines changed the most, especially in developing countries (eg, 29.3% increase in March 2020). Despite similar relative changes (P = .88), absolute purchasing rates in developing nations remained low. The observed decrease from April through August 2020 was significant only in developed countries (-13.1%; 95% CI, -17.4% to -4.4%; P < .001). Country-level variation seemed unrelated to expected demand and health care infrastructure. INTERPRETATION: Purchases for intensive care medicines increased globally in the month of the COVID-19 pandemic declaration, but before peak infection rates. These changes were most pronounced for second-choice agents, suggesting that inexpensive, generic medicines may be purchased more easily in anticipation of pandemic-related ICU surges. Nevertheless, disparities in access persisted. Trends seemed unrelated to expected demand, and decreased purchasing from April through August 2020 may suggest overbuying. National and international policies are needed to ensure equitable drug purchasing during future pandemics.