Executive War College, Project Santa Fe May 4, 2018 New Orleans, LA

Transcription

1 Executive War College, Project Santa Fe May 4, 2018 New Orleans, LA Presented by Geisinger Diagnostic Medicine Institute (DMI) Donna M. Wolk, MHA, Ph.D., D(ABMM)

2 Objectives Review background/relevant core measures for sepsis and their impact on hospitals. Review hypothesis that Microbiology laboratories efforts can support improvement in sepsis outcomes. Provide examples of Geisinger s Human Metrics Program in Microbiology. Review outcome variables to support rapid blood cultures processes

3 Perspective A Regional Core Laboratory

4 Perspective Integrated Delivery Network 4

5 Review background/relevant core measures for sepsis and their impact on hospitals.

6 E.g., Sepsis Bundle Microbiology Interest = Blood Cultures (BC) x 2 Identify Sepsis Syndrome Serum Lactate Blood Cultures x 2 in < 1 hr Antibiotics IV fluid bolus in < 6 hrs Plus a variety of other Chemistry and Hematology tests

7 Fraction of total patients 2006: Antimicrobial (Rx) Best Practices Survival Decreases as Time to Appropriate Antibiotic Increases Direct BC/Rapid Historic Most critical factor of the Surviving Sepsis attributes is rapid delivery of ANTIBIOTICS Survival Fraction Cumulative Effective Antimicrobial Initiation Rapid Rx Appropriate % decrease in survival/hr of delayed therapy Time from hypotension onset (hrs) Kumar A. et al., Crit Care Med 2006, 34:1286 N=2731

8 Microbiology laboratories support efforts to improve sepsis outcomes.

9 Blood Culture Best Practices, Mortality decreased with Gram stain speed* Decision Support = Actionable Microbiology Results The Laboratory Has Something to Offer Dx Rx *Barenfanger et al Am J Clin Pathol;130(6): Baron,E.J., et al, CID, July IDSA Guidelines, Guide to Utilization of the Microbiology Lab Buehler, et al Clin Microbiol Rev., 29(1)

10 2016: Evidence-Based Laboratory Medicine Laboratory Medicine Best Practices (LMBP) Meta-analysis Trend was Observed Related Links Agency for Healthcare Research and Quality The Community Guide The Cochrane Collaboration Clin Microbiol Rev Jan;29(1):

11 Provide examples of Geisinger s Human Metrics Program in Microbiology.

12 Analytic Framework Quality problem: For severe sepsis patients, lack of timely Gram stain results, to support timely targeting of antimicrobials, results in preventable adverse patient outcomes (e.g., mortality) Practices: Rapid collection, delivery, loading, Gram stain, and reporting in a controlled blood culture and sepsis alert infrastructure Intermediate outcomes: Time to detection, time to report Outcomes: Mortality, Length of stay, Costs, Broad spectrum use of antibiotics

13 Experimental Design Retrospective Cohort Design: A clinical data set for all sepsis alert subjects identified as MSDRG 870, 871, 872 for adults patients. Exclusions: Any subject without a blood culture collected, and MSDRGs, not listed Estimated size of the population? Sample size to conduct a sufficiently powered data comparison (Beta = 0.8 and Alpha = 0.05) and document a 15% to 20% improvement in time to actionable test result Analysis: Parametric and non-parametric analysis; bias and confounders compared or controlled Microbe identification Annotated by LOINC Codes Laboratory Diary and Methods

14 PICO for EBLMPG: Population Sepsis Cohort of 3 Medicare Severity Diagnosis Related Groups (MSDRG) 870 SEPTICEMIA OR SEVERE SEPSIS W MV >96 HRS SEPTICEMIA OR SEVERE SEPSIS W/O MV >96 HRS W MCC SEPTICEMIA OR SEVERE SEPSIS W/O MV >96 HRS W/O MCC MV = Mechanical Ventilation MCC = Medical Complications and Comorbidities

15 Intervention = Diagnostic PRIDE Sepsis Revised Sepsis Bundles, Education, Coding Standardization Diagnostic Intervention Revisit laboratory approach to BCs and reduce Time to Detection/Time to Report Data Analytics Document positive impact for severe sepsis cohort after laboratory interventions using secondary data

16 Pragmatic Experimental Design: Multiple Laboratory Post-Intervention Periods Historical 11/9/12-9/3/13 Existing BC Limited Effort Historical /Education COMPARATOR Pre-intervention 9/4/13-4/30/14 BACTEC, PRIDE, ED/ICU/Onc. Post-intervention 5/01/14-1/30/15 BACTEC, ALL Post intervention 2/1/15-8/14/15 ALL IP Units BACTEC, LEAN Post intervention 8/15/15-12/31/16 LEAN Loading Speed Loading Date Range: Admission 11/09/2012 though 12/31/2016 Standard Sepsis Condition and DRG Coding

17 Outcomes: Anticipated Measure of Success Primary Clinical Outcomes Mortality Reduction (expected reduction, 15-20%) Raw 28d, 90d, 120d O:E Ratios, Premier Improved Time to Wellness (reduced or similar) Length of Inpatient Stay Length of ICU stay Ventilator days Proportion of 1 to 120d Re-admissions O:E Ratios, Premier (reduced) Primary Operational Outcomes Total costs per visit (substratified by Laboratory, Radiology, Pharmacy, Respiratory Therapy, Other) Reduced Time to Antimicrobial Optimization (Expected Reduction) Time to Actionable Laboratory Result (reduced) Time to Therapeutic adjustment (Escalation or de-escalation), reduced Improvements in Stewardship (Reduction or Improvements) Laboratory: Reduced Number of tests Radiology: Reduced Numbers of Tests Pharmacy: Improved compliance with therapeutic decisions within 24 and 48 hours

18 Other Variables Patient Driven Patient Demographics Age, Gender, Race/Ethnicity, Socioeconomic status, Insurance provider BMI, Co-morbidities Clinical variables Severity scores and Emergency status Clinical indicators of sepsis (sepsis alert); Time to Sepsis Identification Clinical symptoms and test results Operational variables Source of admission and transport Clinical Service at Time of Admission Clinical Service after Admission Therapeutic decision for sepsis, that are NOT antibiotics; compliance with Sepsis bundle Therapeutic decision for sepsis, that are NOT antibiotics; compliance with stewardship directives Laboratory Driven Programmatic Quality Variables Other performance Indicators for Sepsis Bundles Total blood volume collected % Contamination of blood cultures Time to Actionable Laboratory Result Time to Detection, to Gram stain, to Identification, to Antimicrobial Susceptibility (AST) Longitudinal Fate of Blood Cultures Order to Collection, Collection to Delivery Delivery to Incubation, Incubation to Detection Detection to Gram Stain Report Detection to Identification Detection to AST

19 Results and Value

20 Associated Trend (Overall 18% Reduction) Observed in TTD Pre-intervention Post-intervention Time to Detection (TTD) Decreased with EACH Intervention Overall 18% Reduction in TTD 4.3 % decrease in mortality for ever hour sooner TTD similar or improved for 11/13 of the most common organisms

21 Severe Sepsis Mortality (Observed:Expected Ratio) was reduced ~ 40% p = Intervention Baseline Educ. Wait ICU/ED All In-patients Health organizations can leverage Microbiology Best Practices to Improve Outcomes (O:E ratio s)

22 Mean O:E Ratio for LOS ± SEM 1.4 Comparative Statistics Reduced LOS Ratio was Associated with New Blood Culture System/LEAN 14% Reduction in O:E, p = Pre Cohort A Post Cohort B

23 Mean O:E Ratio for Mortality ± SEM 1.4 Reduced Mortality Ratio was associated with intervention 26% Reduction in O:E, p = Pre Cohort A Post Cohort B

24 Reductions in Mortality O:E Ratio Continued with VMS and PCR 29 mos mos. 4 mos. Successive diagnostic Interventions by the Microbiology were associated with successive decreases in mortality n= 1817, p < 0.001

25 For Positive BCs, Collect to Result Time Decreased, p= (1.2d to 0.8 d, a 33% reduction) Pre-intervention Post-intervention Sepsis Alert: Microbiology Metrics 95 th percentile order to delivery = 3.6 min; Median = 1.2 min BCC < 0.8%; BC vol high compliance >85% Time to detection, time to incubation, and Time to Gram stain occurred more quickly in the LEAN post-intervention MEAN COLLECT TO PHONED RESULT

26 Top 6 Microbes Represent 88% of Total Organisms, (52% Gram Neg, 27% Gram Pos) No significant difference was observed between intervention periods.

27 14% 14% 32% 41% 46% 54% Antimicrobial de-escalation increased when additional information was provided sooner (despite no change in stewardship practices or guidelines) Pre-intervention Post-intervention DE-ESCALATE ESCALATE NO CHANGE

28 Raw Mean Variable Direct Costs Decreased in Post-Intervention, p < Similar p value for Laboratory, Pharmacy, and Radiology Costs Mean Avg Direct Variable Costs reduced from $18, 235 to $10,367 ($8,908 cost avoidance/day) Mean ICU LOS also dropped, by > 50% (2.7 to 1.5d) Crude Total LOS dropped from 52% (12.1 to 6.7d) Similar significance was observed for, ICU LOS, Antibiotic days, Ventilator days (Not adjusted for HC Cost increases by year)

29 Financial Value Laboratory Spend ~11% Recovered Costs: Based on Final Gram stain Intervention Period Value = Outcome/Cost = $3.2 Million recovered/$366k spent = $8.74 Saved per laboratory spend Human value = 198 Lives Saved Money saved Additional Projected Revenue: Calculating reduced costs of downstream speed vs. costs of mass spec and PCR Annualized Total Recovery $ > 3.2 Million/year

30 Review outcome variables to support rapid blood cultures processes

31 No Statistically Significant Changes Observed in Human Metrics for MSDRGs 870,871,872 APACHE II severity scores Compliance with sepsis bundles Principal diagnosis Sepsis DRG (ICD-9) coding practices remained uniform Age, gender, weight/height ratios Hospital service: 97% of all severe sepsis cases represented by Hospitalist service, Critical Care, Internal Medicine, Hematology/Oncology, and Pulmonary, in descending order

32 Blood Culture Metrics Remained Stable Enriched Data Set 25% and 28% positive for Historical and BACTEC Intervention, respectively, NSD; Order to Collect BC time consistently ranged from min (90 th %ile) Blood culture contamination rate low (0.6 to 0.8%) Volume (16 to 20 ml) commonly obtained from adults Pathogen diversity was similar Post-intervention, BD EpiCenter Data Management

33 Summary: Opportunity for Laboratory to Provide Leadership Critical Success Factors (CSFs) Homogenous patient cohorts Clean intervention periods with no other activity in sepsis program Progression of events continue to improve outcome metrics Future CSFs Need to reproduce in other time periods Need to reproduce with other hospital types Need to reproduce in multi-site studies Predictive Modeling

34 Limitations Expanded review of time to therapy is ongoing Further assessment with predictive modeling Not compared to another resin bottle More subjects in BACTEC arms* Population is mostly Caucasian *Mitigated by similar microbial diversity and use of non-parametric statistics

35 Conclusions O:E ratios for mortality & LOS Crude all-cause mortality for sepsis cohort, MSDRG 870 Reductions in Total Direct Variable Total Costs 11/13 microbes, present in both bottle types, had similar or improved TTD for 11/13 microbes Decreases in TTP for bloodstream pathogens were associated with improvements

36 Important Sidebars and Plans Institutional Diary of Any Changes Plan for Predictive Risk Modeling and Economic Modeling Patient And Clinician Outreach via Text Messaging/Education/Early Recognition QAL Index? (e.g., re-admission)

37 Acknowledgements Dr. Shravan Kethireddy Dr. Diana Hernandez Dr. Hosam Farag Dr. Jove Graham Dr. Susan Snyder Kayleigh Rygalski Jason Brown Geisinger Microbiology Becton Dickinson data extraction 37

38 38 Questions Advancing diagnostics.saving lives

39 References supporting Rapid Therapeutic Changes, and Laboratory Interventions Kumar A. et al., Crit Care Med 2006, 34:1286 Dellinger RP, et al Crit Care Med 2008;36: Jaeschke RZ, et al Pol Arch Med 2008;118: Kollef MH, et al Chest 1999;115: Garnacho-Montero J, et al, Crit Care Med 2003;31: Valles J, et al, J Infect 2008;56: There is strong evidence showing that the rapid administration of an effective antibiotic saves more lives than virtually any other medical intervention Lab and pharmacy drive de-escalation: Stewardship Dellinger RP, et al Crit Care Med 2008;36: Jaeschke RZ, et al Pol Arch Med Wewn 2008;118: Kollef MH, et al Chest 1999;115: Garnacho-Montero J, et al, Crit Care Med 2003;31: Valles J, et al, J Infect 2008;56:27-34.