The Vascular Quality Initiative
Improving Quality
Through Regional Collaboration
Jack L. Cronenwett, M.D.
Dartmouth-Hitchc...
Vascular Study Group of New England
 Initial Planning Meetings in 2001
 Agreed on mission and method:
 To improve the c...
Unique Aspects of VSGNE Database
 One year follow-up for key outcomes
• Completed in surgeon’s office
 Prospective, cons...
Focus on Quality Improvement
 Track key procedures
• CEA, CAS, EVAR, TEVAR, open AAA, lower
extremity bypass/intervention...
Recent Meeting Agenda
• AV access and TEVAR working groups report
• CLI treatment preference survey results
• Panel: Lower...
Dartmouth-Hitchcock
Medical Center
Fletcher Allen
Health Care
Eastern Maine Medical Center
Maine Medical Center
Catholic M...
Dartmouth-Hitchcock
Medical Center
Fletcher Allen
Health Care
Eastern Maine Medical Center
Maine Medical Center
Concord Ho...
>33,000 Procedures Reported
CEA, CAS, oAAA, EVAR, LEB, PVI, TEVAR, Access
0
5000
10000
15000
20000
25000
30000
35000 Jan-J...
Regional Quality Improvement
 Use registry as a tool for regional QI
• Different from most national registries
 Analyze ...
Regional Quality Improvement
 Can benchmarking change practice?
 Can we improve outcomes?
 Can we improve patient selec...
Changing Practice:
Medical Risk Reduction
 Statin treatment pre-operatively
• Discussed evidence for benefit at
semi-annu...
Pre-op Statin Use 2003
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 2...
Pre-op Statin Use 2009
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 2...
Pre-op Statin Use
54%
62%
70%
78%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Dec-98
Mar-99
Jun-99
Sep-99
Dec-99
Mar-00
Jun-00
Se...
Changing Practice to Change Outcome
 Patching conventional CEA
• Level I evidence shows reduced stroke
risk and less re-s...
3,427 CEAs in 3,304 Patients
>80% Stenosis at One Year
4.2
1.4
0
1
2
3
4
5
No Patch Angioplasty Patch Angioplasty
OneYearS...
13%
12%
10%
6%
5%
4%
0%
4%
8%
12%
2003 2004 2005 2006 2007 2008
Year
RestenosisRate
Conventional
CEA without
Patch
Percent...
3%
2%
1%
2%
1%
0%
13%
12%
10%
6%
5%
4%
0%
4%
8%
12%
2003 2004 2005 2006 2007 2008
Year
RestenosisRate
80-99%
Stenosis
p<0....
Improving Patient Selection:
Predicting Cardiac Complications
 In-hospital MI, CHF, serious arrythmia
 9,809 VSGNE patie...
Number of
RCRI
Risk
Factors
RCRI
Predicted
Risk (%)
VSGNE
Actual
Event
Rate (%)
0 0.4 2.6
1 0.9 6.7
2 6.6 11.6
≥ 3 11.0 18...
Risk of Adverse Cardiac Outcome, by
VSG-CRI Score
2.6
3.5
6.0 6.6
8.9
14.3
0
4
8
12
16
0-3 4 5 6 7 8 or
More
VSG-CRI Score...
New Knowledge  Practice Change
 Does protamine reduce re-operation
for bleeding after CEA?
 Re-operation for bleeding: ...
VSGNE Surgeon Practice
4587 Total CEAs
2087 (46%)
Protamine
2500 (54%)
No Protamine
-Stone et al, J Vasc Surg, 2010
Reoperation for Bleeding
%Patients
*P=0.001
0.6%
1.7%
-Stone et al, J Vasc Surg, 2010
Thrombotic Complications%Patients
*P=NS
-Stone et al, J Vasc Surg, 2010
Value of a Detailed Clinical Registry
 Only a very large registry with detailed
clinical information could answer a
quest...
VSGNE Protamine Use during CEA
Protamine use
increased from 46%
before 2009 to 61%
after 2009 (P<.001).
Protamine Use and Bleeding
46%
61%
0%
10%
20%
30%
40%
50%
60%
70%
Protamine Use Before 2009
After 2009
P<.001 1.2%
0.6%
0....
VSGNE- Lessons Learned
 Many registries have failed
• Failure to add value to clinician, hospital
 Comparison reports im...
Interest from Other Sites, Regions
Cooperative Regional Groups
 Vision:
• Regional groups for local control, data
ownership and responsibility
• Central dat...
Launched by SVS in 2011
• Mission: To improve the quality, safety,
effectiveness and cost of vascular health care by
colle...
• Patient Safety Organization
– Central data collection, analysis
– Protects data from discovery or disclosure
– Prevents ...
Demographic Data Entry – Office Nurse
Procedure Data Entry - Physician
Post-op Data Entry – Nurse Practitioner
Risk-Adjusted Benchmark Comparison
All Centers with at least 40 Procedures in SVS VQI
0%
1%
2%
3%
4%
5%
6%
7%
8%
* *
Death...
Selected Quality Measures for Each Procedure
Open Infrarenal AAA Repair Center = red, Region = blue
User-Defined Benchmark Comparison
Surgeons in SVS VQI
Select Complications to Include:
Lower Extremity Bypass Complications
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
A* B C* D E* F G H I J K L M N O P Q R S* T* U* V* W* X* Y* Z*
Percentage of P...
• Achieved PSO accreditation by AHRQ
• Established PSO structure, Governing Council
• Enabled international participation
...
Organization
Governing Council
4 SVS Representatives
2 AVF Representatives
15 Regional Group Representatives
Arterial Rese...
228 Centers, 45 States + Ontario
as of 5/1/2013
0
15
30
45
60
75
90
105
120
135
150
165
180
195
210
225
Growth of Particip...
Organized Regional Groups:
– New England
– Carolinas
– Florida-Georgia
– Southern California
– South
– Virginias
– New Yor...
Total Procedures Captured
(as of May 1st, 2013)
87,226
Carotid Endarterectomy 24,071
Carotid Artery Stent 3,099
Endovascul...
Endorsing Societies:
American Venous Forum
Canadian Society for Vascular Surgery
Eastern Vascular Society
Florida Vascular...
Very Different than ACS-NSQIP
SVS VQI ACS-NSQIP
PSO Protected Data Collection Yes No
Regional Quality Groups Yes No
Physic...
• Significant variation
found across VQI
participating centers
and regions
• Risk factors associated
with SSI:
– Skin prep...
Center Opportunity Profile for Improvement (COPI)
• Province would function as “Regional Quality Group”
– Anonymous comparison province, country, all U.S. sites
– Control o...
• National registries offer power of large database
for research, risk-adjusting, benchmarking
–Don’t operationalize quali...
2013session2 4
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2013session2 4

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2013session2 4

  1. 1. The Vascular Quality Initiative Improving Quality Through Regional Collaboration Jack L. Cronenwett, M.D. Dartmouth-Hitchcock Medical Center
  2. 2. Vascular Study Group of New England  Initial Planning Meetings in 2001  Agreed on mission and method:  To improve the care of patients with vascular disease by collecting and exchanging information.  Focus = quality improvement
  3. 3. Unique Aspects of VSGNE Database  One year follow-up for key outcomes • Completed in surgeon’s office  Prospective, consecutive cases • Audited against claims data  Surgeon and center level reports • Benchmark comparison with others  Detailed clinical data • Pre-, intra-, and post-op variables  Academic and community hospitals • Real world practice
  4. 4. Focus on Quality Improvement  Track key procedures • CEA, CAS, EVAR, TEVAR, open AAA, lower extremity bypass/interventions, access • Key procedures provide overall insight • Consecutive procedures must be entered  Semi-annual Meetings • Critical to success, durability of group • Stimulate cooperative quality projects • Overcome insular nature of practice with granular conversations about quality
  5. 5. Recent Meeting Agenda • AV access and TEVAR working groups report • CLI treatment preference survey results • Panel: Lower extremity bypass: Techniques that work • VSG CRI cardiac risk online prediction tool • Predicting respiratory failure after elective OAAA repair • Carotid patch and re-stenosis update • Intensive glucose management in LEB patients • Outcomes of LEB after previous interventional treatment • MI rates in diabetics after LEB • Clinical improvement vs. graft patency in LEB • Impact of increased beta blocker usage • Statin use working group report • New QI projects and clinical uses for registry • Variation in complication rates by center and procedure
  6. 6. 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 2003 9 Participating Hospitals
  7. 7. 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 MaineGeneral Medical Center Caritas St. Anne’s Hospital Yale-New Haven Hospital Baystate Medical Center VSGNE 2013 30 Participating Hospitals Berkshire Medical Center 15 Community - 15 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 Miriam Hospital Rhode Island Hospital “Real World Practice”
  8. 8. >33,000 Procedures Reported CEA, CAS, oAAA, EVAR, LEB, PVI, TEVAR, Access 0 5000 10000 15000 20000 25000 30000 35000 Jan-June03 Jul-Dec03 Jan-June04 Jul-Dec04 Jan-June05 Jul-Dec05 Jan-June06 Jul-Dec06 Jan-June07 Jul-Dec07 Jan-Jun08 Jul-Dec08 Jan-Jun09 Jul-Dec09 Jan-Jun10 Jul-Dec10 Jan-Jun11 Jul-Dec11 Jan-Jun12 Jul-Dec12
  9. 9. Regional Quality Improvement  Use registry as a tool for regional QI • Different from most national registries  Analyze natural variation in process and outcomes across centers  Develop QI projects in areas where substantial variation exists  Provide benchmark comparisons that stimulate everyone to improve
  10. 10. Regional Quality Improvement  Can benchmarking change practice?  Can we improve outcomes?  Can we improve patient selection?  Can we generate new knowledge?
  11. 11. Changing Practice: Medical Risk Reduction  Statin treatment pre-operatively • Discussed evidence for benefit at semi-annual meetings • Selected pre-op statin use as a quality measure • Reported benchmarked results to centers and surgeons
  12. 12. Pre-op Statin Use 2003 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Initial 25 Surgeons
  13. 13. Pre-op Statin Use 2009 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Initial 25 Surgeons
  14. 14. Pre-op Statin Use 54% 62% 70% 78% 20% 30% 40% 50% 60% 70% 80% 90% 100% Dec-98 Mar-99 Jun-99 Sep-99 Dec-99 Mar-00 Jun-00 Sep-00 Dec-00 Mar-01 Jun-01 Sep-01 Dec-01 Mar-02 Jun-02 Sep-02 Dec-02 Mar-03 Jun-03 Sep-03 Dec-03 Mar-04 Jun-04 Sep-04 Dec-04 Mar-05 Jun-05 Sep-05 Dec-05 Mar-06 Jun-06 Sep-06 Dec-06 Mar-07 Jun-07 Sep-07 Dec-07 Mar-08 Percent VSGNE Centers, 2003-2012 Developed Letters to PCPs Set QI Goal = 80% Started QI Initiative
  15. 15. Changing Practice to Change Outcome  Patching conventional CEA • Level I evidence shows reduced stroke risk and less re-stenosis • Discussed evidence for benefit at semi-annual meeting • Selected as a quality measure • Reported benchmarked results to centers and surgeons
  16. 16. 3,427 CEAs in 3,304 Patients >80% Stenosis at One Year 4.2 1.4 0 1 2 3 4 5 No Patch Angioplasty Patch Angioplasty OneYearStenosisRate(%) Patch: 3-Fold Reduction p=0.001 % % Multivariate Predictor of 80-100% Stenosis -Goodney et al, SAVS 2010
  17. 17. 13% 12% 10% 6% 5% 4% 0% 4% 8% 12% 2003 2004 2005 2006 2007 2008 Year RestenosisRate Conventional CEA without Patch Percentage of Patients Not Patched Decreased over Time p<0.003 -Goodney et al, SAVS 2010
  18. 18. 3% 2% 1% 2% 1% 0% 13% 12% 10% 6% 5% 4% 0% 4% 8% 12% 2003 2004 2005 2006 2007 2008 Year RestenosisRate 80-99% Stenosis p<0.001 One Year Stenosis Rate Also Decreased over Time Conventional CEA without Patch p<0.003 Process Improvement Outcome Improvement -Goodney et al, SAVS 2010
  19. 19. Improving Patient Selection: Predicting Cardiac Complications  In-hospital MI, CHF, serious arrythmia  9,809 VSGNE patients: 6.5% • CEA: 3.0% • EVAR: 4.7% • LEB: 8.4% • oAAA: 20.2% -Bertges et al, J Vasc Surg, 2010
  20. 20. Number of RCRI Risk Factors RCRI Predicted Risk (%) VSGNE Actual Event Rate (%) 0 0.4 2.6 1 0.9 6.7 2 6.6 11.6 ≥ 3 11.0 18.4 Predicting Cardiac Complications  MI,CHF, arrythmia  Revised Cardiac Risk Index – 6 factors: • CAD, CHF, IDDM, CVA, creat > 2, high risk surgery • Only 20% of operations in derivation set were vascular  Underestimates risk in vascular surgery patients in VSGNE -Bertges et al, J Vasc Surg, 2010
  21. 21. Risk of Adverse Cardiac Outcome, by VSG-CRI Score 2.6 3.5 6.0 6.6 8.9 14.3 0 4 8 12 16 0-3 4 5 6 7 8 or More VSG-CRI Score RiskofAdverseCardiac Outcome(%) 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 70-79 3 Age 60-69 2 CAD 2 CHF 2 COPD 2 Creatinine > 1.8 2 Smoking 1 Insulin Dependant Diabetes 1 Chronic β-Blockade 1 History of CABG or PCI -1 (Based on 10,000 Patients) www.VSGNE.org
  22. 22. New Knowledge  Practice Change  Does protamine reduce re-operation for bleeding after CEA?  Re-operation for bleeding: 1.2%   N= 4587 CEAs in VSGNE -Stone et al, J Vasc Surg, 2010
  23. 23. VSGNE Surgeon Practice 4587 Total CEAs 2087 (46%) Protamine 2500 (54%) No Protamine -Stone et al, J Vasc Surg, 2010
  24. 24. Reoperation for Bleeding %Patients *P=0.001 0.6% 1.7% -Stone et al, J Vasc Surg, 2010
  25. 25. Thrombotic Complications%Patients *P=NS -Stone et al, J Vasc Surg, 2010
  26. 26. Value of a Detailed Clinical Registry  Only a very large registry with detailed clinical information could answer a question where the event rate is low. • Clinical trial too expensive • Administrative databases lack clinical detail  Will this information change protamine use in our region?  Will this change reduce bleeding complications?
  27. 27. VSGNE Protamine Use during CEA Protamine use increased from 46% before 2009 to 61% after 2009 (P<.001).
  28. 28. Protamine Use and Bleeding 46% 61% 0% 10% 20% 30% 40% 50% 60% 70% Protamine Use Before 2009 After 2009 P<.001 1.2% 0.6% 0.0% 0.2% 0.4% 0.6% 0.8% 1.0% 1.2% 1.4% Re-operation for Bleeding P=.003
  29. 29. VSGNE- Lessons Learned  Many registries have failed • Failure to add value to clinician, hospital  Comparison reports important • Stimulates improvement • Valuable to hospitals and clinicians  Regional group meetings promote QI • Maintain momentum, enthusiasm • Develop group trust, cooperative projects  Research is an important derivative • Stimulates academic center participation
  30. 30. Interest from Other Sites, Regions
  31. 31. Cooperative Regional Groups  Vision: • Regional groups for local control, data ownership and responsibility • Central data collection, analysis Grp A Grp E Grp B Grp C Grp D Mechanism for Data Sharing Among Regional Groups
  32. 32. Launched by SVS in 2011 • Mission: To improve the quality, safety, effectiveness and cost of vascular health care by collecting and exchanging information. • Procedures: Carotid endarterectomy and stenting; open and endovascular AAA repair; lower extremity bypass and interventional Rx; thoracic aorta stent grafts; dialysis access; amputation; vena cava filters; varicose veins
  33. 33. • Patient Safety Organization – Central data collection, analysis – Protects data from discovery or disclosure – Prevents identification of patient, hospital, physician • Regional Quality Improvement Groups – Analogous to VSGNE • Web-based data collection - reporting system – Provided by M2S, Inc. 3 Components
  34. 34. Demographic Data Entry – Office Nurse
  35. 35. Procedure Data Entry - Physician
  36. 36. Post-op Data Entry – Nurse Practitioner
  37. 37. Risk-Adjusted Benchmark Comparison All Centers with at least 40 Procedures in SVS VQI 0% 1% 2% 3% 4% 5% 6% 7% 8% * * Death or Stroke Rate after Elective Primary CEA Observed and Expected by Centers 14,182 patient procedures, 2003 to September 2012 (Excludes: previous ipsilateral CEA, concomitant CABG) Observed Expected Overall stroke or death rate: VQI = 1.1% AUC = 0.65 Centers adjusted for: Hypertension, CABG/PTCA, ASA/Plavix, degree of contralateral stenosis and ipsilateral ICA stenosis, ipsilateral cortical symptoms Significantly lower or higher than expected: * p<0.05
  38. 38. Selected Quality Measures for Each Procedure Open Infrarenal AAA Repair Center = red, Region = blue
  39. 39. User-Defined Benchmark Comparison Surgeons in SVS VQI Select Complications to Include: Lower Extremity Bypass Complications
  40. 40. 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% A* B C* D E* F G H I J K L M N O P Q R S* T* U* V* W* X* Y* Z* Percentage of Patients with Length of Stay >1 Day after Elective Carotid Endarterectomy : Observed and Expected by Center 8,112 CEAs, 2003 thru 2011 (Excludes inhospital deaths) observed expected Overall LOS > 1 day= 23% AUC = 0.611 Medical Center adjusted for: age, gender, prior stroke, nursing home, prior vascular procedure, diabetes, creatinine, CHF, CAD In 11 centers the observed % of pateints with LOS > 1 day was significantly lower or higher than expected (*)
  41. 41. • Achieved PSO accreditation by AHRQ • Established PSO structure, Governing Council • Enabled international participation Results to Date (since February, 2011)
  42. 42. Organization Governing Council 4 SVS Representatives 2 AVF Representatives 15 Regional Group Representatives Arterial Research Advisory Committee 2 SVS Representatives 10 Regional Group Representatives Arterial Quality Committee 4 SVS Representatives 15 Regional Group Representatives Venous Quality Committee 3 AVF + 2 SVS Representatives 15 Regional Group Representatives Venous Research Advisory Committee 3 AVF + 2 SVS Representatives 10 Regional Group Representatives
  43. 43. 228 Centers, 45 States + Ontario as of 5/1/2013 0 15 30 45 60 75 90 105 120 135 150 165 180 195 210 225 Growth of ParticipatingCenters
  44. 44. Organized Regional Groups: – New England – Carolinas – Florida-Georgia – Southern California – South – Virginias – New York City – Rocky Mountains – Illinois – Wisconsin – Mid-Atlantic – Upstate New York – Chesapeake – Indiana – Great Lakes Organizing Regional Groups: – Northern California – Michigan – Missouri – Tennessee/Mississippi – Minnesota 15 Regional Quality Groups
  45. 45. Total Procedures Captured (as of May 1st, 2013) 87,226 Carotid Endarterectomy 24,071 Carotid Artery Stent 3,099 Endovascular AAA Repair 8,986 Open AAA Repair 3,834 Peripheral Vascular Intervention 25,554 Infra-Inguinal Bypass 12,691 Supra-Inguinal Bypass 3,774 Thoracic and Complex EVAR 1,086 Hemodialysis Access 4,003 0 500 1000 1500 2000 2500 3000 3500 4000 4500 5000 VQI Monthly Procedure Volume
  46. 46. Endorsing Societies: American Venous Forum Canadian Society for Vascular Surgery Eastern Vascular Society Florida Vascular Society Michigan Vascular Society Midwestern Vascular Surgical Society New England Society for Vascular Surgery New York Society for Vascular Surgery Peripheral Vascular Surgery Society Rocky Mountain Vascular Society Society for Clinical Vascular Surgery Society of Interventional Radiology Southern Association for Vascular Surgery Southern California Vascular Surgical Society Western Vascular Society
  47. 47. Very Different than ACS-NSQIP SVS VQI ACS-NSQIP PSO Protected Data Collection Yes No Regional Quality Groups Yes No Physician Benchmark Reports Yes No Number of Procedure Modules 11 6 Selection of Cases All Sampling Variables Recorded Detailed, Vascular Focused General, Apply to Multi-specialties Follow-up One year 30 days Annual Cost $10,000 $35,000
  48. 48. • Significant variation found across VQI participating centers and regions • Risk factors associated with SSI: – Skin prep not chlorhexidine – Operation > than 220 minutes – Transfusion > 3 units PRBC Surgical Site Infection after Infrainguinal Bypass 0% 1% 2% 3% 4% 5% 6% 7% 8% 9% 10% ** ** ** In-Hospital Surgical Site Infection Rate after Infra-Inguinal Bypass Procedure Observed and Expected by Regions 9,035 patient procedures, 2003 to October 2012 Observed Expected Overall Rate Wound Infection VQI = 4.5% VQI Regional Quality Groups adjusted for: skin preparation, ankle/brachial systolic pressure index, transfusion, length of procedure Significantly lower or higher than expected: * p<0.05 **p<0.01 Note: This patient safety work product generated within the SVS PSO, LLC, is considered privileged and confidential.
  49. 49. Center Opportunity Profile for Improvement (COPI)
  50. 50. • Province would function as “Regional Quality Group” – Anonymous comparison province, country, all U.S. sites – Control of data use for research and QI projects • De-identified patient data transmitted to SVS PSO via M2S site – Identification key kept by each site and province – Data copied to province for analysis • Data audits for consecutive cases by province • Representation on SVS PSO Governing Council, Committees • Access to all VQI data for research and quality improvement Quebec Province Participation
  51. 51. • National registries offer power of large database for research, risk-adjusting, benchmarking –Don’t operationalize quality improvement • Regional quality groups create local ownership, responsibility, vehicle for QI projects –Potential for international collaboration • Opportunity to combine both factors in VQI • www.svsvqi.org Conclusions

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