the vascular quality initiative: using pso registry data to improve

The Vascular Quality Initiative:Using PSO Registry Data to Improve Care

Adam W. Beck, M.D., FACSChair, Arterial Quality Council

Society for Vascular Surgery Patient Safety Organization

•No relevant disclosures

Disclosures

• Mission: To improve the quality, safety, effectiveness and cost of vascular health care by collecting and exchanging information.

• 3 Components:– National Registries in a Patient Safety Organization– Regional Quality Improvement Groups

• Based on Vascular Study Group of New England, 2002

– Web-based data collection - reporting system

Launched by Society for Vascular Surgery in 2011

• Allows patient identified information to be collected for quality improvement without informed consent

• Protects work product (any comparative data) from discovery to encourage honest reporting

• Precludes comparative data to be used for physician disciplinary purposes or marketing

• Allows non-identifiable data to be published– Statistical de-identification of patient, provider, hospital

• Ideal vehicle for quality improvement registry

Patient Safety Organization (Patient Safety Act)

National Registries in a Patient Safety Organization• Carotid disease

– Endarterectomy and stenting• Aortic disease

– Open and endovascular abdominal aneurysm repair– Endovascular repair thoracic aorta

• Lower extremity arterial disease– Bypass, interventional procedures, amputation

• Medical Management (in development)• Dialysis access• Vena cava filters• Varicose veins

• Allows data from all patients to be included– Not biased by those who only give consent

• Much more detailed information than claims data– Pre-, intra-, and post-op variables (> 150 per procedure)

• One year follow-up for key outcomes– Completed in physician’s office

• All consecutive procedures – allows rate calculation– Audited against hospital and physician claims data

• Longer follow-up with matched Medicare Claims– Survival also from Social Security Death Index

Advantages of SVS PSO Registry Data

0255075

100125150175200225250275300325350375

Number of Participating Centers • Reassure increasingly diverse and larger centers that their data were confidential, protected and would only be used for quality improvement.

Value of Patient Safety Organization

PSO

VQI Participating Centers

Academic

Teaching Affiliate

Community

Hospital Types

376 Centers, 46 States + Ontario

Big Data: 270,000 Procedures, 7,500

per Month

Total Procedures Captured (as of 2/1/2016)

271,819

Carotid Endarterectomy 62,986

Carotid Artery Stent 10,141

Endovascular AAA Repair 25,135

Open AAA Repair 7,861 Peripheral Vascular Intervention 85,682

Infra-Inguinal Bypass 28,585

Supra-Inguinal Bypass 9,676 Thoracic and Complex EVAR 5,614

Hemodialysis Access 23,376

Lower Extremity Amputations 4,740

IVC Filter 4,778

Varicose Vein 3,245

2500 Specialists All Procedures

1600 Specialists Interventional Procedures

Vascular Surgery

Vascular Surgery

Radiology Radiology

Cardiology Cardiology

Physician-Driven, Multi-Specialty Patient Safety Organization

• Leverage “Big Data” from the national registry to power analyses of processes that lead to best outcomes

• Promote physician practice change, ownership and connection to the PSO/registry by developing smaller, regional quality improvement groups

How to Grow and Sustain a Self-Funded PSO

New England QI Group Model - 2002• Semi-annual meetings of physicians, nurses,

researchers and administrators • Analyze variation in process and outcomes among

regional centers• Discuss potential causes for variation• Develop quality improvement projects in areas

where substantial variation exists• Promote ownership, collaboration, and greater

opportunity to translate data into practice change

Network of 17 Regional Quality Groups

AK

HI

Semi-annual meetings, Review variationRegional quality improvement projects

• Comparative feedback stimulates practice change– Physicians are naturally competitive– We all want to improve our results– We all want to have the best results

• Most vascular patients should be on a statin pre-op– Record statin use– Feedback results to surgeons

Regional Groups: Lessons Learned

VSGNE Pre-op Statin Use 2004

Initial 25 Surgeons

VSGNE Pre-op Statin Use 2007

Initial 25 Surgeons

Pre-op Statin Use VSGNE 2003-2008

Started QI Initiative

2003 2004 2005 2006 2007 2008

• Comparative feedback stimulates practice change• Large dataset can answer important clinical questions

– Should I use protamine to reverse heparin during carotid endarterectomy?

• Protamine reverses anticoagulant used during surgery, to promote clotting

– Re-operation for bleeding: 1.7%• Concern about causing too much clotting: stroke, MI

– Low frequency events cannot be studies in small series and randomized trials are unrealistic


VSGNE Surgeon Practice

4587 Total CEAs

2500 (54%)

No Protamine

-Stone et al, J Vasc Surg, 2010

Reoperation for Bleeding%

Pat

ient

s *P=0.001

0.6%

1.7%


Thrombotic Complications%

Pat

ient

s

*P=NS


• Comparative feedback stimulates practice change• Large dataset can answer important clinical questions• Trusted analyses, reports can rapidly change practice

– Physicians have ownership of regional group data– Protamine data were presented to regional group

and published


VSGNE Protamine Use During CEA

Protamine use increased from 46% before 2009 to 61% after 2009 (P<.001).

Presented - Published Results in 2009

http://files.abstractsonline.com/CTRL/36/B/529/115/614/45C/FBA/A62/416/E18/F22/B9/g39_1.gif

• Comparative feedback stimulates practice change• Large dataset can answer important clinical questions• Trusted analyses, reports can rapidly change practice• Changed practice can improve outcomes


Protamine Use and Bleeding

P=.003

-Patel et al, J Vasc Surg 2013

• Increasing use of antiplatelet and statin use pre-op and at DC• Decreasing myocardial infarction after arterial procedures• Optimizing graft type choice for leg bypass• Enhancing recovery after lower extremity amputation• Reducing length of stay after VQI procedures• Improving long term follow up of patients in VQI• Reducing preventable causes of readmissions• Preventing contrast-induced nephropathy after arteriography• Increasing smoking cessation after major arterial procedures

Current QI Projects in VQI Regional Groups

• COPI Reports – Center Opportunity Profile for Improvement

• Analyze and report variation in outcome• Multivariable model to define causes of outcome• Individual report to each center:

– How they compare with others for the outcome and each factor associated with the outcome

– Provides a customized, actionable improvement plan for each center

Improving Quality Across VQI Regions

• Significant variation found across VQI participating centers and regions

• Risk factors associated with SSI:– Operation > than 220

minutes– Transfusion > 2 units

PRBC– Skin prep not

chlorhexidine

In-Hospital Surgical Site Infection after Infrainguinal Bypass

30%

COPI Report for SSI after Lower Extremity Bypass

29

30

COPI Report for SSI after Lower Extremity Bypass

Chlorhexidine Skin Prep Use

31

COPI Report

Centers with Most Improvement in Chlorhexidine Use

32

Per

cent

age

Per

cent

age

% Patients with Length of Stay > 1 Day after Elective Carotid Endarterectomy

VQI Centers

Factors Associated with LOS> 1 Day after CEA

• Does participation in VQI (receiving benchmark reports, attending regional meetings, etc.) improve patient outcomes?

Value of VQI Participation

• 50,000 Patients in VQI who underwent– Leg bypass / intervention, oAAA / EVAR, CEA / CAS

• Evaluated pre-operative and discharge medications:– Antiplatelet agent (ASA, PY212 inhibitors)– Statins (HMG-CoA reductase inhibitors)

• Outcomes analyzed:– Effect on patient survival– Variation across centers– Impact of participation in VQI

Late Survival after Major Arterial Procedures

-De Martino et al, J Vasc Surg, 2015

81% Both75% AP 68% Statin 55% None

P<0.001 SE < 0.1

Years

26% Absolute improvement in 5-year survival when patients are

discharged on AP & Statin

Effect of Discharge Medications on Survival

-De Martino et al, J Vasc Surg, 2015

Variation in % Patients Discharged on Anti-platelet and Statin

VQI Centers

VQI Mean = 76%

30%

100%

Patients on Antiplatelet and Statin Pre-op and Discharge Based on Center Years Participation in VQI

Number of Years Participating in VQI

• Evaluating appropriateness of treatment

New VQI Initiatives

• Appropriate treatment requires not only good early and late outcomes, but also:– Correct patient selection – Correct procedure selection

• VQI provides an opportunity to analyze variation in patient and procedure selection– Feedback data to centers– Goal: regression toward the mean and reduced variation

• Current data show large variation!

Appropriate Treatment

Carotid Artery Treatment by Stent (vs endarterectomy)

1%

47%All VQI Centers Mean = 13% Stent Rx

Procedure Selection Variation

VQI Centers

Carotid Artery Treatment in Asymptomatic Patients

29% Asymptomatic

100%All VQI Centers Mean = 77% Asymptomatic

Patient Selection Variation

VQI Centers

Variation in Ultrasound Criteria for Severe Disease

Patient Selection Variation:Substantial Opportunity

PSV = 50 cm/sec

PSV = 550 cm/sec

• Evaluating appropriateness of treatment• Evaluating new medical devices in real world practice

New VQI Initiatives

• Many devices used to treat vascular disease (eg, stents)• Devices approved after limited testing in selected

patients in centers of excellence• In practice, devices may be used outside indications for

use and in less experienced centers• Data about device performance in real world practice can

inform physicians, FDA and manufacturers, to optimize treatment benefits for patients

• VQI is sharing non-identifiable data regarding new device outcomes with FDA and manufacturers

FDA, Device Manufacturer Collaboration

SVS PSO

Organizational Structure

Governing Council

Vascular Technology CouncilArterial Quality Council Venous Quality Council

Industry Project Steering Committees

Research Advisory Committee

Registry CommitteesRegistry Committees

Ad Hoc Committees

Executive Committee Communication Committee

EHR - Epic

Claims Data Integration

Long TermFollow-up

Cost Integration

SVS PSO Organizational

Chart

Roles of SVS PSO and M2SVQI

SVS PSO•Registry data specifications and definitions•Oversight of data use, including research project approval•Regional group administration•Advanced data analytics

• COPI reports•Regulatory interaction•Industry project approval and oversight

M2S•Technology platform

• Data entry mechanism• Reporting/analytics• EMR integration

•Sales, marketing, and contracting•Registry operations

• Site training and support• Claims validation• PQRS administration

•Industry project management

Governing Council





Ad Hoc Committees


EHR - Epic


Long TermFollow-up

Cost Integration


Chart

187 Approved Projects26 Approved in Q4 2015

Over 80 Peer-Reviewed

Publications

Governing Council





Ad Hoc Committees


EHR - Epic


Long TermFollow-up

Cost Integration


Chart

• Goal: determine late outcomes after initial vascular treatment using Medicare claims related to subsequent treatment

• Dartmouth Institute for Health Policy and Clinical Practice• Match claims data identifiers with VQI patient identifiers:

– CEA, CAS, EVAR, oAAA, TEVAR, PVI, leg bypass datasets – Match rates > 90% for procedures done 2003-2013, age > 65

• Social Security Death Index also matched in patients of all ages• Data available for VQI based research and industry projects

Matching Medicare Claims Data with VQI Registry

• Major outcomes and time to event after index procedure:• Carotid (CEA and CAS)

– Re-admission, death, stroke, re-intervention (CEA or CAS), imaging• Aorta (oAAA, EVAR, TEVAR)

– Re-admission, death, re-intervention (open or EVAR), abdominal surgery for complication after oAAA

• Leg (Infra, Supra, PVI)– Re-admission, death, re-intervention (open or EVAR), imaging,

amputation (major, minor)

Matching Medicare Claims Data with VQI Registry

Governing Council





Ad Hoc Committees


EHR - Epic


Long TermFollow-up

Cost Integration


Chart

• Goal: Provide centers with anonymous benchmark comparison of treatment costs when adjusted for disease severity and procedure details already collected in VQI

• Method: Partnered with MedAssets, a healthcare performance improvement company that focuses on finance and operations

• Pilot Project: – 17 VQI hospitals submitted UB-04 claims for 2014 EVARs– Using VQI clinical data, cases grouped as standard or complex, and with

and without post-treatment complications– MedAssets calculated costs from charge data using usual methods

• Currently preparing reports of total and component cost• Plan to offer for all procedures for all centers

Estimating Cost for Procedures Performed in VQI

Sample Cost Report

Governing Council





Ad Hoc Committees


EHR - Epic


Long TermFollow-up

Cost Integration


Chart

• Aligns with FDA recommendations to use registries to collect real world data for post approval surveillance

Use of VQI for Post Approval Surveillance

• “FDA believes that device registries should serve as the foundation of our National Medical Device Postmarket Surveillance System.”

Procedures and Devices CapturedProcedure Devices IncludedCarotid Endarterectomy Patch TypeCarotid Artery Stent Stent, Protection Device TypeEndovascular AAA Repair Stent Graft TypeOpen AAA Repair Prosthetic Graft TypePeripheral Vascular Intervention Balloon/Stent / Atherectomy DevicesInfra-Inguinal Bypass Prosthetic Graft TypeSupra-Inguinal Bypass Prosthetic Graft TypeThoracic and Complex EVAR Stent Graft TypeHemodialysis Access Graft TypeLower Extremity Amputation Bandage, prosthesis typeIVC Filter Device TypeVaricose Veins Ablation Device, Sclerosants Medical Management PAD (in development) Pharmacologic Agents


• Leverages an existing network of 2500 specialists in 350 potential centers experienced with data collection


• Aligns with FDA recommendations to use registries to collect real world data for post approval surveillance.

• Leverages an existing network of 350 potential centers and 2600 specialists experienced with data collection

• Uses existing VQI data forms supplemented as needed with additional variables, follow-up time points– Customized content for participating sites– New sites can join VQI for project if not already member




• Uses existing VQI data forms supplemented as needed with additional variables, follow-up time points

• Informed consent and IRB approval NOT required– Standard of care practice and PSO Quality Project– Allows all patients treated in center to be captured





• Informed consent and IRB approval NOT required• SVS PSO contracts with sites, facilitates recruitment

– Uniform contract, no separate site negotiations





• Informed consent and IRB approval NOT required• SVS PSO contracts with sites, facilitates recruitment• Result = Rapid, Efficient, Flexible, Cost-Effective


TEVAR Dissection Project Enrollment Rate

Expected

Actual

Existing Network of VQI Centers Allows Rapid Enrollment

• Scientific Steering Committee is appointed by SVS PSO with input from sponsor to insure experienced users

• Steering Committee reviews data and interacts with sites to adjudicate any data questions during analysis

• Steering Committee takes responsibility for scientific presentation and publication of final data analysis in consultation with sponsor

• Coordinated by specific Project Manager at M2S

Project Steering Committee

Protocol Development, Site Selection• Collaboration between SVS PSO Steering Committee, FDA and the

sponsor helps design a pragmatic surveillance protocol – Data collection requirements that fit real world registries– Follow-up time points appropriate for standard of care

• Steering Committee selects optimal sites for project– Physicians who have been trained to use the new device– Sites which meet resource requirements for data entry– Sites with known accurate and timely VQI data collection

• M2S Project Team monitors site performance, provides feedback

Data Ownership• SVS PSO provides sponsor with copy of “line by line” data

– De-identified for patient, provider, hospital– Dates converted to intervals since procedure, age, etc.

• Sponsor may use data for analysis, regulatory requirements and marketing– Marketing content must be approved by SVS PSO when

source of data is cited to insure accurate interpretation• Steering Committee produces scientific presentations,

publications, in consultation with sponsor

Additional Industry Uses for VQI Data:Supplementing Historical Data to Reduce Project Length

• Substantial data exists in VQI but might be missing some custom variables needed for a specific device project

• It is possible for sites to retrieve and add custom data elements to previously entered data forms, including additional follow-up

• VQI identifies relevant procedures, invites sites to supplement data for required number of procedures

• This allows projects to rapidly accrue procedures and shorten time required for follow-up and study completion

• One recent project completed, developed efficient on-line mechanism for sites to identify and enter needed data

Additional Industry Uses for VQI Data:Using Registry Data to Expand Device Indications• Many devices have been applied to arteries or patients not

tested in initial trials, and thus used “off-label”– Biliary stents in peripheral arteries, veins– EVAR devices for short, angulated aortic neck

• Individual physicians make decisions based on limited data• FDA recognizes need for a more efficient method to expand

indications potentially based on comprehensive registry data• Initial project underway to establish additional indication in PVI

treatment of SFA disease, without IDE requirement

Additional Industry Uses for VQI Data: Use of VQI for Premarket Clinical Trials• Must be conducted according to 21CFR 812 (IRB approval,

informed consent, investigational site monitoring, investigator and sponsor responsibilities, adverse event reporting and submission of periodic reports to FDA and IRBs)

• Benefit to leverage existing VQI network and avoid double data entry by sites into both VQI registry and industry CRF


• Opportunity to reduce study cost and time simply by using VQI for electronic data capture

Additional Industry Uses for VQI Data: FDA Medical Device Reporting• Current MDR system is costly, does not capture all device events,

and provides no denominator to calculate event rates• Potential exists to use registry to identify potential adverse

device-related events:– Capture “potential” serious device-related events by:

• Death, re-intervention, excess imaging studies after index procedure • Use both registry and claims data

– Fund centers to provide additional information about events• Drill down to establish cause of event and any device contribution

• Current discussions with FDA about potential pilot project

• The PSO structure facilitates growth of QI initiative• Regional groups promote physician ownership, trust• Comparative data stimulates practice change• Big Data provides new information• COPI reports provide actionable, site specific

opportunities for change that improves outcomes• Variation in appropriateness can be measured and will

hopefully lead to better patient, procedure selection• PSO data can serve multiple stakeholders for optimal

efficiency

Conclusions

One Platform. One Data Set. Many Stakeholders.

SVS PSO M2S

the vascular quality initiative: using pso registry data to improve

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