Colorectal Surgery SSI Prevention Bundle and ERAS
NYSPFP Webinar
Christopher Mantyh, MDDuke University Medical Center
Professor of SurgeryChief 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
0%
20%
40%
60%
80%
100%
2013 2014 2015 2016
VBP Domain Weights
Clinical Process Patient Experiences Outcome Efficiency
AMI = acute myocardial infarction; HAC = hospital-acquired condition; HF = heart failure; RRP = Readmission Reduction Program; VBP = Value-Based Purchasing Program.
6%
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.
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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 ERASPREOP 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 theimplementation of the enhanced recovery pathway (ERP)and preventative surgical site infection bundle (SSIB) oncolorectal 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 OutcomesTotal 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 theERP and SSIB
◊ Our experience exemplifies how the process of qualityimprovement in surgery must be an ongoing effort, and thatsequential adoption of separately studied care protocols canprovide incremental improvements in patient care.
◊ Not only did patient outcomes improve with the introductionof the ERP and SSIB, but these measures also providedcost-savings in the care of CRS patients.
◊ Continual assessments and updates of existing evidencebased care protocols such as the ERP and SSIB will lead tocontinual improvement in post-operative outcomes andincreased 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
48%
22%
10%6% 5% 2% 2% 1% 1% 1%
0%
10%
20%
30%
40%
50%
60%
% of FY13 Total VDC/Case
Data source = DSR/EPSI9/3/2017 31
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
OVERALL 532 7.9 5 12861 9620
Colorectal surgeons
Non colorectal surgeons
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 <0.001Mortality (30 d) 0.7% 1.9% 0.265Unplanned reoperation 6.9% 2.8% 0.019Wound complication 26.3% 8.3% <0.001
Superficial SSI 22.5% 7.1% <0.001Deep SSI 1.5% 0.0% 0.023Organ space SSI 7.6% 2.5% 0.003
Deep venous thrombosis 1.0% 0.0% 0.084Pulmonary embolism 0.3% 0.7% 0.491Stroke/CVA 0.0% 1.3% 0.092Unplanned reintubation 2.7% 0.8% 0.057Pneumonia 2.9% 1.0% 0.088Myocardial infarction 0.5% 1.4% 0.277Cardiac arrest 0.0% 0.5% 0.317Sepsis 8.9% 1.7% <0.001Septic shock 2.4% 0.5% 0.060Urinary 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 re-
inventing 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
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