1. Experience of a Specialty PSO Using a Registry Format for Quality Improvement Jack L. Cronenwett, M.D

2. Society for Vascular Surgery –National society of 3600 vascular surgeons Launched Vascular Quality Initiative (2011) –To improve the quality, safety, effectiveness and cost of vascular health care by collecting and exchanging information. –Includes any specialty performing peripheral vascular procedures

3. Patient Safety Organization –Listed by AHRQ in February, 2011 Regional Quality Improvement Groups –Based on Vascular Study Group of New England Two Components:

4. Use a web-based registry format to collect clinical data for common major procedures –Carotid, aortic, lower extremity, dialysis access Both endovascular and open surgical procedures –In-hospital and one-year follow-up data Patient characteristics, processes of care and outcomes –All consecutive procedures Audited against hospital and physician claims data Provides denominator for event rate comparisons Patient Safety Organization:

5. Quality reports to centers and physicians –Key processes of care and outcomes Blinded benchmark comparison with others –Both center and physician benchmarking –Risk-adjusted comparisons for adverse events Analyze variation across centers –Identify processes associated with best outcomes –Make recommendations for best practice Methods:

6. Provides power of large, national database –Risk-adjustment, identification of best practices –On-line benchmarking reports for centers and physicians

7. Real Time Reports on Web Select Complications to Include: Lower Extremity Bypass Complications – Organized by Surgeon

8. Risk Adjusted Outcome Reports

9. Provides power of large, national database –Risk-adjustment, identification of best practices –On-line benchmarking reports for centers and physicians How can we translate these data into practice change and quality improvement? –How to use the registry as a tool for QI?

10. Regional quality improvement groups –Smaller groups, semi-annual meetings Physicians, nurses, data managers, quality officers –Ownership and trust of the data and process –Collaboration on regional quality projects –Natural competition in region for improvement Based on the 10 year experience of the Vascular Study Group of New England

11. Dartmouth-Hitchcock Medical Center Fletcher Allen Health Care Eastern Maine Medical Center Maine Medical Center Catholic Medical Center Concord Hospital Lakes Region Hospital Cottage Hospital Central Maine Medical Center VSGNE 2002 9 Participating Hospitals

12. Dartmouth-Hitchcock Medical Center Fletcher Allen Health Care Eastern Maine Medical Center Maine Medical Center Concord Hospital Lakes Region Hospital Cottage Hospital Central Maine Medical Center Mercy Hospital U. Mass. Medical Center Elliot Hospital Tufts Medical Center Boston Medical Center St. Francis Hospital Massachusetts General Hospital Rutland Regional Medical Center MaineGeneral Medical Center Caritas St. Anne’s Hospital Yale-New Haven Hospital Baystate Medical Center VSGNE 2012 30 Participating Hospitals Berkshire Medical Center 16 Community - 14 Academic Hartford Hospital St. Luke’s Hospital Charlton Memorial Hospital Beth Israel Deaconess Medical Center Hospital of St. Raphael Cardiothoracic Surgical Associates Brigham & Women’s Hospital Danbury Hospital St. Elizabeth’s Hospital Center “Real World Practice”

13. >25,000 Procedures Reported CEA, CAS, oAAA, EVAR, LEB, PVI, TEVAR, Access

14. Regional Quality Improvement Can we change physician practice? Can we change physician practice? By providing benchmark comparisonsBy providing benchmark comparisons By generating new clinical informationBy generating new clinical information Will this improve regional outcomes? Will this improve regional outcomes? Can we create tools to improve patient selection ? Can we create tools to improve patient selection ? Can we analyze regional variation to identify best practice? Can we analyze regional variation to identify best practice?

15. Regional Quality Improvement Power of benchmarking Power of benchmarking Pre-operative statin use to reduce risk and increase survivalPre-operative statin use to reduce risk and increase survival

16. Statin Treatment Preoperatively Discussed evidence for statin benefit at semi-annual meetings Discussed evidence for statin benefit at semi-annual meetings Discussed successful methods to initiate statin treatment Discussed successful methods to initiate statin treatment Reported benchmarked results to centers and surgeons Reported benchmarked results to centers and surgeons

17. Pre-op Statin Use 2003 Initial 25 Surgeons

18. Pre-op Statin Use 2009 Initial 25 Surgeons

19. Regional Quality Improvement Power of benchmarking Power of benchmarking Pre-operative statin use to reduce risk and increase survivalPre-operative statin use to reduce risk and increase survival Improve outcome by benchmarking Improve outcome by benchmarking Patch closure to reduce re-stenosis during carotid endarterectomyPatch closure to reduce re-stenosis during carotid endarterectomy

20. Patching Carotid Endarterectomy Level I evidence shows reduced stroke risk and less re-stenosis Level I evidence shows reduced stroke risk and less re-stenosis Discussed evidence for benefit at semi-annual meetingDiscussed evidence for benefit at semi-annual meeting Selected as a quality measureSelected as a quality measure Reported benchmarked results to centers and surgeonsReported benchmarked results to centers and surgeons

21. Re-stenosis > 80% at One Year after Carotid Endarterectomy Patch: 3-Fold Reduction p=0.001 % % Multivariate Predictor of 80-100% Stenosis

22. Conventional CEA without Patch Percentage of Patients Not Patched Decreased over Time p<0.003

23. 80-99% Stenosis p<0.001 One Year Re-Stenosis Rate Also Decreased over Time Conventional CEA without Patch p<0.003 Process Improvement  Outcome Improvement How can we translate these data into practice change and quality improvement? How to use the registry as a tool for QI?

24. Regional Quality Improvement Power of benchmarking Power of benchmarking Pre-operative statin use to reduce risk and increase survivalPre-operative statin use to reduce risk and increase survival Improve outcome by benchmarking Improve outcome by benchmarking Patch closure to reduce re-stenosis during carotid endarterectomyPatch closure to reduce re-stenosis during carotid endarterectomy New knowledge  practice change New knowledge  practice change Re-operation for bleeding after carotid endarterectomyRe-operation for bleeding after carotid endarterectomy

25. Bleeding after Carotid Endarterectomy Heparin anticoagulation is required during carotid endarterectomy (CEA) Heparin anticoagulation is required during carotid endarterectomy (CEA) Can be reversed with protamine at the completion of the procedure Can be reversed with protamine at the completion of the procedure Benefit: Reduce bleedingBenefit: Reduce bleeding Risk: Increase thrombosis (MI, stroke)Risk: Increase thrombosis (MI, stroke) Re-operation for bleeding: 1.2% Re-operation for bleeding: 1.2% Associated with 30 X higher mortalityAssociated with 30 X higher mortality

26. VSGNE Surgeon Practice 4587 Total CEAs 2087 (46%) Protamine 2500 (54%) No Protamine

27. Reduced Reoperation for Bleeding % Patients *P=0.001 0.6% 1.7%

28. Unchanged Thrombotic Complications % Patients *P=NS

29. New Knowledge  Practice Change? Would this information change protamine use in the VSGNE region? Would this information change protamine use in the VSGNE region? Would this reduce re-operation for bleeding after carotid endarterectomy? Would this reduce re-operation for bleeding after carotid endarterectomy? How long would this take? How long would this take?

30. VSGNE Protamine Use during CEA Protamine use increased from 46% before 2009 to 61% after 2009 (P<.001).

31. Re-operation for Bleeding after CEA Reduced by 50% P=.003

32. Regional Quality Improvement Improving patient selection Improving patient selection Accurately estimate preoperative riskAccurately estimate preoperative risk

33. Improving Patient Selection: Predicting Cardiac Complications Heart disease is prevalent in patients with peripheral vascular disease Heart disease is prevalent in patients with peripheral vascular disease Serious cardiac complications (MI, heart failure, arrhythmia): Serious cardiac complications (MI, heart failure, arrhythmia): 6.5% after VSGNE operations6.5% after VSGNE operations Carotid endarterectomy: 3.0%Carotid endarterectomy: 3.0% Endovascular aneurysm repair: 4.7%Endovascular aneurysm repair: 4.7% Lower extremity bypass: 8.4%Lower extremity bypass: 8.4% Open aortic aneurysm repair:20.2%Open aortic aneurysm repair:20.2%

34. Number of RCRI Risk Factors RCRI Predicted Risk (%) VSGNE Actual Event Rate (%) 00.42.6 10.96.7 26.611.6 ≥ 311.0 18.4 Predicting Cardiac Complications Revised Cardiac Risk Index (RCRI): Revised Cardiac Risk Index (RCRI): Underestimates risk in vascular surgery patients in all risk categories in VSGNE Underestimates risk in vascular surgery patients in all risk categories in VSGNE Developed VSGNE prediction model in 10,000 patients Developed VSGNE prediction model in 10,000 patients

35. Step 1: Calculate VSG-RCI Score Step 2: Use VSG-CRI Score To Predict Risk of Adverse Cardiac Outcome Example patient: 80 yr-old smoker with history of CAD. VSG-CRI score = 4 + 1 + 2 = 7 Vascular Study Group Cardiac Risk Index (VSG-CRI) VSG-CRI Risk Factors # Points Age ≥ 80 4 Age 70-793 Age 60-69 2 CAD 2 CHF2 COPD2 Creatinine > 1.82 Smoking1 Insulin Dependant Diabetes1 Chronic β -Blockade1 History of CABG or PCI -1 (Based on 10,000 Patients) www.VSGNE.org

37. Regional Quality Improvement Improving patient selection Improving patient selection Accurately estimate preoperative riskAccurately estimate preoperative risk Learning from regional variation Learning from regional variation Identify processes to reduce surgical site infectionIdentify processes to reduce surgical site infection

38. Center Variation in Complications Surgical Site Infection Rate

39. Infections after Leg Bypass Multivariate predictors: Multivariate predictors: Long operation, transfusionLong operation, transfusion Chlorhexidine skin prep  reduced infection rate by 50%!Chlorhexidine skin prep  reduced infection rate by 50%! May 2012 VSGNE meeting May 2012 VSGNE meeting Chlorhexidine skin prep adopted as best practice recommendationChlorhexidine skin prep adopted as best practice recommendation Expect reduction in future infection rateExpect reduction in future infection rate

40. Aggregate regional data –Analyze variation in processes of care and outcome to identify best practices Implement quality improvement projects –Based on identified best practice Provide benchmark comparison data to incent practice change Regional Quality Improvement Groups:

41. 192 Centers, 43 States + Ontario 3,500 procedures per month

42. 10 Accredited Regional Quality Groups Organized Regional Groups: –New England –Carolinas –Florida-Georgia –Southern California –South –Virginias –New York City –Rocky Mountains –Illinois –Wisconsin Organizing Regional Groups: –Mid-Atlantic –Upstate New York –Indiana –Chesapeake Valley –Northern California –Michigan –Ohio –Tennessee/Mississippi

43. By using a registry format, the SVS PSO can identify best practices and provide risk- adjusted benchmarks for key quality measures Regional quality groups create local ownership, responsibility, and a vehicle for regional quality improvement projects Both factors are combined in the SVS VQI to optimize patient safety and quality improvement Conclusions