Colorectal Surgery SSI Prevention Bundle and ERAS. NYSPFP Webinar

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Colorectal Surgery SSI Prevention Bundle and ERAS NYSPFP Webinar Christopher Mantyh, MD Duke University Medical Center Professor of Surgery Chief of Colorectal Surgery Chief of Quality

Who Cares About Quality in Surgery? The Government CMS ties reported outcomes to payment or penalties medicare.gov/hospitalcompare, Health Grades Current reported surgical outcomes Lower extremity bypass outcomes Colon surgery outcomes Outcomes in operations in patients > 65 years Insurance companies Using follow CMS on reimbursements New bundle payments for a disease state Complications will negatively effect this

Who Cares About Quality in Surgery? Hospitals Directly compare hospitals in an location: patient shoppers, referral shoppers Reimbursement: currently a bonus, soon penalties Change from Volume=Quantity/Cost based purchasing to Value=Quality/Cost based purchasing Surgeons Self-realization that surgical complications can be prevented Save money, morbidity, mortality American College of Surgeons established NSQIP to accurately compare outcomes It is the right thing to do Patients

Increasing Financial Penalty for HAIs 100% 80% 60% 40% 20% 0% VBP Domain Weights 2013 2014 2015 2016 Clinical Process Patient Experiences Outcome Efficiency 6% AMI = acute myocardial infarction; HAC = hospital-acquired condition; HF = heart failure; RRP = Readmission Reduction Program; VBP = Value-Based Purchasing Program. 1. CMS. Hospital-Acquired Conditions. Available at: http://www.cms.gov/medicare/medicare-fee-for-service-payment/hospitalacqcond/hospital-acquired_conditions.html. Accessed July 21, 2014. 2. CMS. Hospital Value-Based Purchasing Program Fact Sheet. Available at: http://www.cms.gov/outreach-and-education/medicare-learning- Network-MLN/MLNProducts/downloads/Hospital_VBPurchasing_Fact_Sheet_ICN907664.pdf. Accessed August 4, 2014. 3. CMS. Readmissions Reduction Program. Available at: http://www.cms.gov/medicare/medicare-fee-for-service-payment/acuteinpatientpps/readmissions-reduction-program.html. Accessed August 4, 2014. 4. Arkansas Foundation for Medical Care, Quality Improvements Organization. Available at: http://qio.afmc.org/linkclick.aspx?fileticket=8pse9ywchy0%3d. Accessed August 20, 2014. 2014 CareFusion Corporation or one of its subsidiaries. All rights reserved. 4

Improvement Initiative for NSQIP: Colorectal SSI Peri-operative bundle Increase laparoscopy ERAS Wound VAC over open cases Wound classification: critically important in risk stratification Use as a model system for general surgery Identify high risk SSI operations Liver, pancreas, gastric, groin node dissections, HIPEC

Colorectal Peri-operative Bundle Pre-operative Chlorhexidine (CHG) shower * Chart review- 61% of patients documented to have received pre-op scrub and 91% of those patients completed pre-operative scrub Mechanical bowel prep + oral antibiotics + pre-operative IV antibiotics CHG 70% alcohol prep Intra-operative Antibiotic: Ertapenem (no re-dosing) or Cipro + Flagyl Normothermia Alexis wound protectors (open cases) Change gown and gloves follow anastomosis or at fascial closure Wound closure tray Limit OR traffic *RN CIRCULATORS APPLYING SURGICAL SCRUB AND FOLEY PLACEMENT AS OF SEPTEMBER 2012

Peri-operative Bundle (cont.) Post-operative No re-dosing of antibiotics unless clearly documented reason Leave sterile dressings on for 48 hrs CHG wipes daily after dressing removal Strip VACs (trial)

Bundle Reduced SSI Post-op sepsis LOS Variable direct costs

Enhance Recovery After Surgery (ERAS)

Surgical Stress

Duke CRS ERAS Protocol

Duke CRS ERAS PREOP HOLDING, day of operation -IDENTIFY fast track patients and initiate protocol -THROMBOPROPHYLAXIS timed with epidural -EPIDURAL anesthesia placement INTRAOP -ANTIBIOTICS PROPHYLAXIS before skin incision -SCD s on before induction -GOAL-DIRECTED IVF THERAPY with ESOPHAGEAL MONITORING -TEMPERATURE regulation -NG/OG discontinued before leaving OR POSTOP -IDENTIFY ERAS patients for protocol participation -DIET begins night of surgery -AMBULATION begins night of surgery -HOB at 30 degrees at all times -IVF </= 1L/24hrs (70kg) -EPIDURAL and SCD continuation -post-op THROMBOPROPHYLAXIS begins POD 1

Goal Directed Fluid Management Reduce bowel edema Decreases POI Reduces pulmonary complications Especially useful in long procedures with expected extubation Is NOT fluid restrictive

Multi-modality Pain Management Previously opioids more opioids additional opioids American Society of Anesthesia 2004 Task Force: Opioid dose-sparing effects (reduced opioid-related adverse events) can be achieved via the use of non-opioid agents and regional blocks. Recommended all patients receive around the clock regimen of a non-opioid agent NSAIDs COXIBs Acetaminophen Consider supplemental regional anesthesia techniques Anesthesiology 2004, 100:1573-1581

Duke Peri-operative Pain Management: Low Thoracic Epidurals T10 region Give test dose once sited as normal 5000U SC heparin can be given immediately after placement Hydromorphone 0.4mg-0.6mg before induction of anesthesia Lidocaine bolus at least 10 minutes pre-incision (40-100mg) 1 g IV acetaminophen prior to incision Run infusion of 0.25% bupivacaine throughout case (3-6 ml/hr) No intraoperative iv opioids after induction without discussion with Attending Anesthesiologist Switch to bupivacaine 0.125%/hydromorphone 10mcg/ml in epidural pump before leaving for PACU at end of case. Settings: Infusion 4-6 ml/hour; 2ml bolus every 30 minutes Max dose set for infusion over 4 hours + 6 boluses (12ml) (example - infusion 5ml/hr; max 32ml over 4 hours)

Peri-operative Pain Management Post-operative Continue epidural for 2-3 days (bowel function) IV acetaminophen until tolerating orals Oral opioids with d/c epidural If tolerating liquids, solids move to oral acetaminophen Ibuprofen PRN Ketorolac used sparingly Dry, or elderly patients can push into kidney failure Gastric bleeding Surgical bleeding

OBJECTIVE The purpose of this study was to examine the impact of the implementation of the enhanced recovery pathway (ERP) and preventative surgical site infection bundle (SSIB) on colorectal surgery (CRS) outcomes at a single institution. Kennan et al, J Am Coll Surg. 221:404-414, 2015

THE PREVENTIVE SSI BUNDLE Kennan et al, J Am Coll Surg. 221:404-414, 2015

THE ENHANCED RECOVERY PATHWAY Kennan et al, J Am Coll Surg. 221:404-414, 2015

COMPLIANCE Kennan et al, J Am Coll Surg. 221:404-414, 2015

Duke ERAS Results Oral intake on the day of surgery 65.5% of ERAS patients vs. 18.8% (p <0.0001). Eating solids on POD1 49% of ERAS patients vs. 12.5% (p< 0.001). Ambulating on POD1 70% of ERAS patients were ambulating. Bowel movement 2.4 days in the ERAS group vs. 3.4 days (p=0.008).

30-day Post-Operative Outcomes of ACS-NSQIP Sampled Patients Who Underwent Major, Elective Colorectal Surgery, Stratified by the Presence of the Enhanced Recovery Pathway and/or Preventative Surgical Site Infection Bundle 30-day Post-Operative Outcomes Total Cohort 9/2006-3/2013 (n = 787) Pre-ERP/Bundle 9/2006-1/2010 (n = 337) Post-ERP/Pre-Bundle 2/2010-6/2011 (n = 165) Post-ERP/Bundle 7/2011-3/2013 (n = 285) p-value Length of stay (median, Q1, Q3) 5 (4, 8) 6 (4, 8) 5 (4, 8) 5 (3, 7) < 0.001 Mortality 7 (0.9%) 2 (0.6%) 1 (0.6%) 4 (1.4%) 0.615 Unplanned reoperation 37 (4.7%) 24 (7.1%) 4 (2.4%) 9 (3.2%) 0.025 Wound complication 150 (19.1%) 96 (28.5%) 32 (19.4%) 22 (7.7%) < 0.001 Superficial SSI 132 (16.8%) 83 (24.6%) 31 (18.8%) 18 (6.3%) < 0.001 Deep SSI 6 (0.8%) 5 (1.5%) 1 (0.6%) 0 (0%) 0.104 Organ space SSI 46 (5.8%) 28 (8.3%) 10 (6.1%) 8 (2.8%) 0.014 Deep venous thrombosis 10 (1.3%) 3 (0.9%) 7 (4.2%) 0 (0%) < 0.001 Pulmonary embolism 5 (0.6%) 1 (0.3%) 2 (1.2%) 2 (0.7%) 0.365 Stroke/CVA 6 (0.8%) 0 (0%) 3 (1.8%) 3 (1.1%) 0.035 Unplanned reintubation 17 (2.2%) 9 (2.7%) 4 (2.4%) 4 (1.4%) 0.535 Pneumonia 18 (2.3%) 10 (3%) 5 (3%) 3 (1.1%) 0.201 Myocardial infarction 9 (1.1%) 2 (0.6%) 3 (1.8%) 4 (1.4%) 0.380 Cardiac arrest 1 (0.1%) 0 (0%) 0 (0%) 1 (0.4%) 0.572 Sepsis 55 (7%) 30 (8.9%) 20 (12.1%) 5 (1.8%) < 0.001 Septic shock 11 (1.4%) 8 (2.4%) 2 (1.2%) 1 (0.4%) 0.087 Urinary tract infection 42 (5.3%) 25 (7.4%) 9 (5.5%) 8 (2.8%) 0.039

J Am Coll Surg. 221:404-414, 2015

Kennan et al, J Am Coll Surg. 221:404-414, 2015

DISCUSSION This study is the first examine the combined effect of the ERP and SSIB Our experience exemplifies how the process of quality improvement in surgery must be an ongoing effort, and that sequential adoption of separately studied care protocols can provide incremental improvements in patient care. Not only did patient outcomes improve with the introduction of the ERP and SSIB, but these measures also provided cost-savings in the care of CRS patients. Continual assessments and updates of existing evidence based care protocols such as the ERP and SSIB will lead to continual improvement in post-operative outcomes and increased value of care delivered.

DUH Variable Direct Cost/Case by Cost Group Inpatient Colectomy Primary Procedure Discharges COST_GROUP FY11 FY12 FY13 THRU FP9 % CHG F.SURGERY SVC 5083 5340 5764 8% A.INTERMEDIATE SVC 3373 3248 2704-17% C.PHARMACY SVC 2148 1820 1147-37% B.INTENSIVE NRS SVC 1331 981 745-24% J.LABS 615 667 582-13% O.BLOOD 327 357 258-28% I.RAD SVCS 364 308 239-23% G.RESP CARE 336 282 179-37% H.PT OT SPEECH SVCS 150 169 129-23% E.OTHER DIAG AND THERA 122 115 126 10% K.ER TRANSP 69 69 55-20% D.CARDIO SVC 75 36 50 37% M.MED SURG SUPPL 115 77 43-44% N.OP CLINIC 15 26 15-42% TOTAL VAR DIR COST/CASE 14124 13494 12035-11% ALOS 9.2 8.5 7.1-17% DISCHARGES 370 301 231 60% 50% 40% 30% 20% 10% 0% % of FY13 Total VDC/Case 48% 22% 10% 6% 5% 2% 2% 1% 1% 1% 9/3/2017 31 Data source = DSR/EPSI

ALOS and Variable Direct Cost by Primary Surgeon, FY12-FY13 YTD thru FP9, Colectomy Discharges MD DISCHARGES ALOS MEDIAN LOS AVG VAR DIR COST MEDIAN VAR DIR COST MD 1 150 7.9 5 $13,018 $10,019 MD 2 128 5.4 4 8,982 7,686 MD 3 115 6.7 4 11,577 9,343 MD 4 29 12.1 8 19,524 13,653 MD 5 17 10.8 9 18,541 15,946 MD 6 13 12.0 10 18,206 12,757 ALL OTHERS 80 10.5 7.5 16126 12619 Colorectal surgeons Non colorectal surgeons OVERALL 532 7.9 5 12861 9620 9/3/2017 32

30-day Post-Operative Outcomes of ACS-NSQIP Sampled Patients Who Underwent Major, Elective Colorectal Surgery in Pre-ERP/Bundle Vs. Post-ERP/Bundle Period After Inverse Proportional Weighting Characteristic Pre-ERP/Bundle 9/2006-1/20120 Post-ERP/Bundle 7/2011-3/2013 p-value Length of stay 7.9+/-7.4 5.8+/-5.5 <0.001 Mortality (30 d) 0.7% 1.9% 0.265 Unplanned reoperation 6.9% 2.8% 0.019 Wound complication 26.3% 8.3% <0.001 Superficial SSI 22.5% 7.1% <0.001 Deep SSI 1.5% 0.0% 0.023 Organ space SSI 7.6% 2.5% 0.003 Deep venous thrombosis 1.0% 0.0% 0.084 Pulmonary embolism 0.3% 0.7% 0.491 Stroke/CVA 0.0% 1.3% 0.092 Unplanned reintubation 2.7% 0.8% 0.057 Pneumonia 2.9% 1.0% 0.088 Myocardial infarction 0.5% 1.4% 0.277 Cardiac arrest 0.0% 0.5% 0.317 Sepsis 8.9% 1.7% <0.001 Septic shock 2.4% 0.5% 0.060 Urinary tract infection 7.6% 2.8% 0.008

HCAHPS: Duke Colorectal Surgery Trend in Pain Management 38% improvement since 2011

Do ERAS/Bundles Matter? National data Published studies NSQIP, STS Institutional data LOS Costs Readmissions Bundles/ERAS will succeed Incremental changes are unlikely to succeed

Pearls from ERAS/Bundles ERAS works Reduces LOS Reduces narcotics if use multimodality therapy Reduces wound infections Reduces overall complications May improve patient satisfaction It is coming to a hospital near you It usually involves tweaking the system, not reinventing the wheel

Pearls from ERAS/Bundles Each hospital/surgeon/group different Use what you have and what will work Need buy in from everyone ERAS is plastic: mold it Review every 6 months Talk to your administration, be pro-active Present your data Show the bad data and how to fix it

Getting Buy-In: Team Approach Anesthesia Pain management Epidurals, axial blocks Multi-modal treatment Peri-op IV fluids Normothermia, normoglycemia Surgical partners: Need to do collectively to avoid confusion with rest of support OR nurses OR time out (check list), wound classification Prep patient, Foley placement Floor Nurses Wound management Foley removal Ambulation, VTE prophylaxis Discharge education (prevent re-admissions)

The Hurdle: Why and How? Am I or we (division/institution) practicing best medicine? Avoid the buts my patients are sicker my partners are set in their ways too complicated, never work here I don t have time Establish a core group Surgeon, anesthesiologist, nurse (s) Database to track (NSQIP, institutional) Engage administration Set modest goals Present data as it comes in Be malleable and be patient! Celebrate success

The Hurdle: Why and How? The data Share it early and often What is working, what is not Administration Hospital Compare etc. Joint Commission Bundled cost to insurance Are your competitors doing this? Be diligent What is your compliance with bundles/eras? Tract LOS, complications, costs

ERAS/Bundles Conclusions Biggest advance in surgery over the last 20 years Cost (yes) Length of stay (yes) Return to work/daily activities (yes) Pain (yes) Reduction in complications (yes) SSI UTI VTE Patient satisfaction (probably) Poorly measured Survival (probably) Stay tuned studies coming

Thank You, Acknowledgements, Questions Surgery Julie Thacker, MD John Migaly, MD Jeff Sun, MD Jeff Keenan, MD Anesthesia Tim Miller, MD Nursing Regina Woody, RN Jill Haslam, RN