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

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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

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22%

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% 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