Sepsis 3.0: The Impact on Quality Improvement Programs Mitchell M. Levy MD, MCCM Professor of Medicine Chief, Division of Pulmonary, Sleep, and Critical Care Warren Alpert Medical School of Brown University Providence, RI This activity is jointly-provided by SynAptiv and the Colorado Hospital Association
Conflict of Interest Disclosure Statement I have no financial interest or other relationships with the industry relative to the topics being discussed. Why All This Attention To Sepsis?
Sepsis Has Higher Index Admissions, LOS, and Costs Than Other Measured Readmissions National Readmission Data Weighted Proportion of Cases in the United States No. of All Index Admissions Readmitted Within 30 Days Estimated Mean Length of Stay (95% CI), d Estimated Mean Cost Per Readmission (95% CI), $ Percentage of Index Admissions Readmitted Within 30 Days (95% CI) Percentage of Total Estimated Cost of All Readmissions (95% CI) Admissions associated with 30 d readmission 1,187,697 6.4 (6.4-6.5) 8,242 (8,225-8,258) NA 100.0 Primary analyses Sepsis 147,084 7.4 (7.3-7.4) 10,070 (10,021-10,119) 12.2 (11.9-12.4) 14.5 (14.2-14.8) Acute Myocardial infarction 15,001 5.7 (5.6-5.8) 9,424 (9,279-9,571) 1.2 (1.2-1.3) 1.4 (1.3-1.5) Heart Failure (HF) 79,480 6.4 (6.4-6.5) 9,051 (8,990-9,113) 6.7 (6.5-6.8) 7.5 (7.3-7.7) Pneumonia 59,378 6.7 (6.6-6.7) 9,533 (9,466-9,600) 5.2 (5.0-5.3) 5.5 (5.4-5.7) Chronic Obstructive Pulmonary Disease (COPD) 54,396 6.0 (5.9-6.0) 8,417 (8,355-8,480) 4.6 (4.5-4.8) 4.3 (4.1-4.4) Mayer FB, Talisa VB, Balakumar V, et al. J Am Med Assoc. 2017. Epub ahead of print. Sepsis Definitions
The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) The Sepsis Definitions Task Force Society of Critical Care Medicine European Society of Intensive Care Medicine Issues with the 1991 and 2001 Definitions SIRS based Severe Sepsis Different criteria yielding different results
SIRS Sensitivity SIRS is an appropriate response to infection or any other stimulus that activates inflammation Am J Respir Crit Care Med 2015; 192:958-964
Sepsis/Severe Sepsis Confusing Most people say sepsis when they mean severe sepsis What the initial two task forces called sepsis is what most people call infection Consensus Amongst the Task Force Beyond the remit of the task force to define infection Sepsis is not simply infection + two or more SIRS criteria Sepsis represents bad infection where: Bad = infection leading to organ dysfunction Severe sepsis is not helpful and should be eliminated
2016 Sepsis Definitions New Definitions aligned with clinical use Infection: Routine infection without organ dysfunction Sepsis: Infection progresses to organ dysfunction Septic Shock Sepsis requiring vasopressors with lactate > 2 mmol/l The Definition of Sepsis Sepsis is life-threatening organ dysfunction caused by a dysregulated host response to infection
Seymour CW, Liu VX, Iwashyna TJ et al. Assessment of Clinical Criteria for Sepsis For the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3) JAMA 2016; 315: 762-774 How do we identify infection? First episode of cultures, antibiotics Derivation - 1.3 million EHR records from UPMC 148,000 with suspected infection Validation almost 6 million records KPNC VA ALERTS database from Germany Kings County (Seattle) EMS > 700,000 with suspected infection
How to identify who is really sick? Infected Sepsis Infected Really Sick Possible Proxies for really sick Clinical review committees Death in the hospital Prolonged stay in the ICU Discharge diagnosis of sepsis Positive microbiologic cultures Developing New Criteria Focus on timeliness, ease of use, data driven Studied 21 variables from Sepsis-2 (Table 1) Multivariable logistic regression for in-hospital mortality UPMC EHR as derivation dataset Validated with EHR data - KPNC, VA, KC (Seattle) EMS, ALERTS (Germany) Respiratory rate 22 bpm Altered mentation Systolic blood pressure 100 mmhg
Sensitivity Fold change, in-hospital mortality 5/26/2017 Serum lactate Not retained during qsofa model build Serum lactate at various thresholds added to qsofa 100 All KPNC encounters N = 321,380 qsofa ³2 vs. qsofa <2 (qsofa + serum lactate) ³2 vs. (qsofa + lactate) <2 10 1 1 - specificity 1- Specificity Baseline risk qsofa + baseline qsofa + lactate 2.0 + baseline 0.1 Baseline risk (%) Median Minimum Maximum 1 2 3 4 5 6 7 8 9 10 1.0 1.9 2.7 3.4 4.2 5.0 5.8 6.7 7.9 10.4 0.6 Decile 1.4 2.3 of baseline 3.0 3.8 risk 4.6 of 5.4 in-hospital 6.2 7.3 8.9 1.4 2.3 3.0 3.8 4.6 5.4 6.3 7.3 8.9 30.3 mortality Decile of baseline risk for in-hospital mortality Septic Shock
4 patient groups based on 3 variables hypotension after fluids vasopressors lactate >2 Prevalence (SSC) Group 1 Yes Yes Yes 45.2% Group 2 Yes Yes No 21.2% Group 4 No No Yes 17.3% Group 5 No hypotension pre-fluid No Yes 14.3% Mortality 42.3 (41.2-43.3) 30.1 (28.6-31.5) 25.7 (24.2-27.2) 29.7 (28.0-31.5) Lactate cutoff rationale lactate mortality
New Clinical Criteria for Septic Shock Septic shock is a subset of sepsis in which profound circulatory, cellular and metabolic abnormalities are associated with a greater risk of mortality than with sepsis alone Despite adequate fluid resuscitation vasopressors needed to maintain MAP 65 mmhg AND lactate >2 mmol/l But There are Issues
Issues with new definitions How to use qsofa Coding CMS SEP-1 measures SIRS has its place.. though not for diagnosing sepsis White count, temperature etc. still useful in helping to form a provisional diagnosis of infection SIRS is an appropriate - but not necessarily dysregulated - host response to infection
qsofa and Sepsis Sepsis can be present without a qsofa score 2 Other organ dysfunction: Hypoxemia Renal failure Coagulopathy Elevated lactate Vincent JL, Martin GS, Levy MM Critical Care 2016 (in press)
How do we use qsofa? Needs prospective validation in different healthcare settings Current recommendation: A prompt to raise concern about impending clinical deterioration If confirmed prospectively, qsofa may be a useful rapid predictive tool (e.g. in resource-poor settings) Treat the patient in front of you NOT suggesting that infected patients shouldn t be actively managed until qsofa 2 or DSOFA 2 Treat infection, oliguria, hypoxemia, etc. as indicated Do not wait until criteria met
Issues with new definitions: Coding Code for Sepsis is lower acuity ICD-10 unlikely to change quickly Under re-imbursement For Hospitals and providers Coding In the Medical record: Cannot diagnose sepsis and bill for severe sepsis Insurers are downgrading claims because of confusion Less reimbursement
Issues with new definitions In the U.S. government regulatory agencies and insurers are not adopting sepsis 3.0 For quality improvement programs For payment CMS SEP-1 measures CMS has announced they will NOT be using new definitions for SEP-1 Issues with new definitions Two Primary Quality Improvement programs in U.S. New York State mandated public reporting U.S. government (CMS) SEP-1 measure SSC bundles CMS has announced they will NOT be using new definitions for SEP-1
U.S. Health Department (CMS) Response to Sepsis 3.0 CMS welcomes new research and innovative thinking to inform a transparent and iterative measure development and maintenance process. This careful and thoughtful process necessarily means any potential change developed from even the best research cannot immediately translate into actual measurement of clinical practice. Extensive real-world field testing must be completed to assess reliability, usability, and feasibility of measures and definitions. U.S. Health Department (CMS) Response to Sepsis 3.0 The SEP-1 measure underwent more than 8 years of development and critical review and has a robust body of evidence supporting its utilization. There is risk that changing these effective definitions and identification criteria could impede ongoing quality improvement efforts.
U.S. Health Department (CMS) Response to Sepsis 3.0 The existing sepsis definitions, including the use of SIRS criteria, have been instrumental in training clinicians and nurses on how best to identify the earliest stages of sepsis. The widespread teaching of these sepsis criteria and the adoption of screening and protocolized care processes have resulted in an unprecedented reduction in sepsis mortality. As such, the existing sepsis definitions have helped clinicians to identify, diagnose, and treat sepsis early, before a patient s condition worsens. U.S. Health Department (CMS) Response to Sepsis 3.0 As opposed to early identification, the proposed task force definitions may delay the diagnosis of sepsis until patients are much sicker. Although the task force s definition structure may identify patients with the highest likelihood of poor outcomes, it does not clearly identify patients in the early stages of sepsis when rapid resuscitation provides the greatest patient benefit and improves survival.
U.S. Health Department (CMS) Response to Sepsis 3.0 Prior to changing the widespread and understood definitions used in SEP-1, rigorous clinical investigation will be required of the task force s proposed definitions. In the coming years, CMS will track the research and field testing that the proposed definitions will inspire. So, We changed the definitions Just after ICD-10 was released In the midst of SEP-1 Just when we had proven that sepsis bundles improved survival
Making Sense of the New Definitions They do reflect our clinical use of sepsis Outside the U.S. there is no problem: CMS Making Sense of the New Definitions Septic Shock: Vasopressors and Lactate > 2 This is the most common clinical picture at the bedside For those few patients with lactate <2 Still consider septic shock
Making Sense of the New Definitions Only time will tell whether it s progress For now: Don t change your documentation You might lose money, AND, perform poorly on national measures Summary Quality improvement efforts in U.S. have not adopted sepsis 3.0 or qsofa ICD-10 codes are not consistent with sepsis 3.0 qsofa was not intended as a screening tool for infection and sepsis!! SIRS is overly sensitive but will identify more patients at risk for severe sepsis that qsofa Recent published studies with qsofa have mixed results
Thank You! 5/26/2017