Kaiser Permanente Registry Contribution to National CRNsMDEpiNet Meeting, March 2016

Liz Paxton, Director, National Implant Registries

NATIONAL IMPLANT REGISTRIES

Integrated health care delivery system

32 hospitals and medical centers

9 million members

140,000+ employees

7 regions serving 8 states and D.C.

12,000+ physicians

Nation’s largest nonprofit health plan

Hawaii

Northern California

Southern California

Washington

Georgia

Oregon

Colorado

Mid-Atlantic 430+ medical offices

2 | © Kaiser Permanente 2010-2011. All Rights Reserved.April 5, 2016

About Kaiser Permanente

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A Learning Health Care System

Evidence iscontinually refinedas a byproduct of

care delivery

Information-rich, patient focused enterprises

Information andevidence transforminteractions from

reactive toproactive (benefits

and harms)

Actionable information available – to clinicians AND

patients – “just in time”From “A Learning Health Care System for Cancer

Care” by Carolyn Clancy, MD, Agency for Healthcare Research and Quality

Registries

Goals Kaiser Permanente Registries

Identify patients at risk for poor outcomes Identify clinical best practices for quality improvement Identify best performing/outlier devices for our patients Device recalls/notifications Comparative effectiveness research

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Kaiser Permanente Registries Developed in 2001 Modeled after Swedish Hip Register Methods

– Standardized documentation– Leveraging existing EHR data

Patient information Procedures/diagnoses Implant data and clinical attributes library Labs Medications

– Adverse event electronic screening methods– Stringent quality control processes– Chart review validation of outcomes

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Extracted from Electronic Health Record

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Patient DemographicsMedical Record #

DOBGenderRace

Implant ComponentsCompany Name

Catalog #Lot/Serial #

Quantity

Registry FormsElectronic SmartForm/Paper

ProceduresDiagnoses

Surgical CharacteristicsFixation Types

RegistrySQL

Database

Company NameCatalog #

DescriptionName

Attributes

Implant LibraryClaims

Diabetes RegistriesMembership

MortalityGEMS

Other Data Systems

Catalog #

Registry DeliverablesAnnual Reports

Ad-Hoc Requests

Web-Based Reports

Risk Calculators

Research Projects

Recalls/Advisories

Personalized Surgeon Profiles

Outlier Implants

Risk adjusted hospital outliers

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Orthopedic Registries

Total Joint 250,000

Hip Fracture 28,000

ACLR 30,300

Spine 19,500

Shoulder 9,400

Cardiac/Vascular

ICDS 30,900

Pacemakers 69,000

Leads 140,120

Heart Valve 24,500

EVAR 3,260

KP Tools for Enhancing Quality & Patient care Medical center reports Individualized surgeon profiles Quarterly quality reports Patient risk calculators Outlier implant reports Recall/advisory identification/tracking Newsletters/meetings/conferences Publications

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Longitudinal Tracking of Procedures/Devices

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Total Joint Replacement 10-year Survival % (CI)

Registry Hip Knee

KP (2001-2013) 95.4 (95.1-95.7) 95.4 (95.2-95.6)

Australia (1999-2013) 93.2 (93.1-93.4) 94.4 (94.3-94.6)

Sweden (2003-2012) 94.6 (94.3-94.9) 94.6 (94.3-94.9)

New Zealand (1999-2013) 93.10% 95.7

NJR (2002-2013) 94.25 (94.09-94.45) 96.7 (96.6-96.8) uncemented

Risk Factors for Revisions and Complications

10 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2016

Identification of Clinical Best Practices

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Pulmonary Embolism Prophylaxis in More Than30, 000 Total Knee Arthroplasty Patients:Is There a Best Choice?Monti Khatod, MD,* Maria C.S. Inacio, MS, Stefano A., MD,and Elizabeth W. Paxton, MA

Acta Orthopaedica2014; 85 (1): x–x

Can total knee arthroplasty be safely performed in patients with chronic renal disease? An evaluation of perioperative morbidity in 2,686 procedures from a Total Joint Replacement RegistryAlexander Miric, Maria CS Inacio, and Robert S Namba

Device Comparative Effectiveness

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Acta Orthopaedica2013; 84 (2): x–xAlternative bearings in total knee arthroplasty: risk of early revision compared to traditional bearings An analysis of 62,177 primary cases Maria C S Inacio, Guy Cafri, Elizabeth W Paxton, Steven M Kurts, and Robert S Namba

ORIGINAL ARTICLEEvaluation of total hip arthroplasty devices using a total joint replacement registryElizabeth W. Paxton1*, Christopher F. Ake1, Maria C.S. Inacio1, Monti Khatod2, Danica Marinac-Dabic3 and Art Sedrakyan3,4

Early Identification of Outlier Devices and Changes in Clinical Practice

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Registry findings:– HRs had a

higher risk of revision than THA (HR=3.51, 2.02-6.10), p<.001

Reduction in HR program-wide

Encounters: Revision Early Warning Signal

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Individual Adjusted Models for Total Hip Replacement Associations of Inpatient and Outpatient Encounters (1-90 days) and Aseptic Revision

Encounter

Adjusted Hazard Ratio

(95% CI)(P<0.001)

Hospital emergency admission ≥ 1 1.9 (1.2-3.0)Hospital outpatient encounter ≥ 1 (e.g., MRI)

3.1 (2.2-4.4)

Ortho allied health, Nurse, Office visit ≥ 3* Within 3.5 yearsAfter 3.5 years

5.0 (3.1-8.1)10.4 (5.7-18.7)

Occupational medicine/PT ≥ 9 2.5 (1.6-3.8)Orthopedics medicine ≥ 6 15.7 (5.7-42.9)Family practice ≥ 7 2.6 (1.7-4.0)Internal medicine ≥ 1 2.7 (1.8-4.1)Office visits ≥ 6 4.1 (2.8-6.2)Urgent care ≥ 1 2.4 (1.6-3.6)

Opioid Use as an Indicator of Revision

15 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2016

5 Years Revision

Time Period QuartilesOMEs (mg range) Adjusted HR (95%CI) P Value

Days 91‐180 <100 1.99 (1.14‐3.47) 0.016100‐219 2.69 (1.57‐4.60) <0.001220‐533 1.95 (1.02‐3.74) 0.045≥534 3.61 (2.13‐6.10) <0.001

Days 181‐270 <90 2.13 (0.98‐4.63) 0.05590‐214 2.50 (1.35‐4.62) 0.004215‐559 2.32 (1.26‐4.25) 0.007≥560 1.46 (0.54‐3.92) 0.451

Days 270‐360 <85 2.20 (1.09‐4.46) 0.02885‐209 1.10 (0.44‐2.74) 0.832210‐579 3.08 (1.77‐5.37) <0.001≥580 1.83 (0.77‐4.38) 0.171

Individual Adjusted Associations for Total Hip Replacement of Oral Morphine Equivalent (OME) Amounts Taken Post-Operatively and Risk of 5 Year Revision

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KP Strengths & Limitations Strengths

– 100% capture rate of all encounters– Long term follow-up with low attrition

<8% loss to follow-up over 15 years– Data quality

Rigorous quality control Endpoints are validated through chart review Linkage to medications, labs, etc in all encounter settings

Limitations– National contract for devices limit exposure to all devices and manufacturers– Success based on integrated health system infrastructure

Other health care system may not be able to replicate

Opportunities for Orthopedic CRN: The Perfect Storm

ICOR Success– Distributed data network approach– Global standardized implant database

US total joint registries quality metrics US total joint registries interest and

dedication to enhancing patient safety and quality of care

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ICOR Global Standardization Database

Previously, each registry developed and maintained own clinical attributes reference database: No standardization ICOR developed global, standardized classification

system of hip and knee implantable devices based on their clinical attributes and characteristics to advance the implementation of UDI and FDA postmarket surveillance

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ICOR Catalog Framework: Knees

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Component Identification

Femoral Component(Unicompartmental,Trochlea, Total)

Tibial Component

Baseplate(Unicompartmental, Total)

Knee Insert(Unicompartmental, Total)

Non-Modular (Monoblock)(Unicompartmental, Total)

Patella

Insert

Material

Conventional Polyethylene

Highly-CrosslinkedPolyethylene

Vitamin E Infused Highly-Crosslinked Polyethylene

Thickness

XXXmm x XXXmm

Size

XXmm or S/M/L

Stability

Cruciate Retaining

Posterior Stabilized

Constrained/Hinged

Mobility

Fixed

Rotating

Sliding

Total Knee Implants: Insert

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Application of ICOR Database to Surveillance:International Consortium of Orthopaedic Registries

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U.S. Registry Network

US registries consensus on need for US national quality metrics Collaborative model

– Guiding principles and priorities– Distributed data network with aggregate level data

Common data model with key quality metrics– Data survey of registry data elements, codes, definitions– Comparison of data elements, codes and definitions

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Patient demographics

23 | © 2011 Kaiser Foundation Health Plan, Inc. For internal use only.April 5, 2016

Procedure and Implant

Procedure ICD-9 codeICD-9 Code and Description ICD-9 Code x

Surgeon reported; confirmed with ICD-9 codes

ICD-9 Code and Description

CPT Code and description

Procedure limited to ICD-9 procedure codes 81.51, 81.54, 81.53, 81.55; exclude UKA cases by CPT code or implant information

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AJRR CJRR FORCE-TJR HealthEast KP TJRR MARCQI Virginia

Proposed Measures in Common

Reference/ Catalog Number x x x x x x x

Implant catalog/ reference numbers

Manufacturer x x x x x x x Manufacturer

Key Quality Metrics

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AJRR CJRR FORCE-TJR HealthEast KP TJRR MARCQI VirginiaProposed Measures in Common

Mortality

Mortality during index procedure stay

Mortality during index procedure hospital stay, or a readmission, ED visit, or clinic visit at index procedure hospital within 90 days if visit coding includes CJRR ICD‐9‐CM triggering codes

Patient reported adverse events (ER, readmissions, dislocation, DVT/PE, infection, revision, mortality, functional improvement) at 8 w, 6 m, 12 m, and annually, validated against clinical records x

90-day mortality from EHRs and SSDI

90-day mortality captured by abstractors from EHRs

Mortality during index procedure stay

ED Visits

ED visit at index procedure hospital within 30 days if visit coding includes CJRR ICD‐9‐CM triggering codes See above

ED visits within 30 days of discharge

# of cases with >=1 ED visit for any reason within 30 days; if readmitted through ED case is counted under readmissions and excluded from ED visit rate

First ER visit for any reason within 90 days. If patient is readmitted, do not record ER visit but choose readmission instead ED Visit within 30 days

Readmission

Readmission at index surgery hospital within 30 days if visit coding includes CJRR ICD-9-CM triggering codes See above x

# of cases with unplanned readmission that meets CMS criteria within 30 days

Readmitted for any reason (other than another total elective joint procedure) within 90 days and billed as “inpatient”

Readmission within 30 days

Key Quality Metrics

DVT

90-day DVT rate based on ICD-9 codes

90-day DVT rate based on ICD-9 codes from readmission, ED, or clinic visit at index procedure facility See above x

90-day DVT based on AHRQ PSI 12 codes and chart review

Diagnosis, confirming imaging study, and treatment

PE

90-day DVT rate based on ICD-9 codes

90-day PE rate based on ICD-9 codes from readmission, ED, or clinic visit at index procedure facility See above x

90-day PE based on AHRQ PSI 12 codes and chart review

Diagnosis and confirming imaging study

PE during hospital stay determined by ICD-9 diagnosis code

Revision If reportedIf at index procedure hospital x x x x Revision

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AJRR CJRR FORCE-TJR HealthEast KP TJRR MARCQI VirginiaProposed Measures in Common

Proposed Common Data Elements

Patient characteristics

Procedural Surgeon Hospital Implants Outcomes

AgeGenderBMIDiagnosisComorbidities

ProcedureFixation

Surgical ApproachFellowship trainingCase volume

Case volumeHospital setting

Catalog #NameCompanyDescriptionClinical attributes (linkage to ICOR global database)

MortalityRevisionRe-operationRe-admissionED visitsDVT/PE

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Developing a Coordinated Registry Network

AJRR– Large volume with comprehensive implant collection

FORCE-TJR– Patient reported outcomes

Kaiser Permanente– Long-term follow-up

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Challenges

Registries developed for different purposes using different methodologies Different data elements with various definitions, codes Loss to follow-up is a critical issue Long-term follow-up not yet available for most registries Concerns regarding data security, privacy, legal issues

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Steps to Collaboration Create a common data model with harmonized data elements across

existing US registries to provide the infrastructure for signal detection, comparative effectiveness research and a national post market surveillance system.

Apply ICOR global implant database to US registries to standardize and harmonize total joint devices and their clinical attributes

Conduct linkages to claims and other data sources for longitudinal follow-up

Conduct a series of comparative effectiveness studies examining new technologies and total joint outcomes using a distributed US data network

Conduct confirmatory signal detection methods using existing US registry data and develop framework for a International signal detection network30

Opportunities

Patient safety – Are enhanced porous cups in THA failing?

Post market surveillance of devices when new device features are added to market

– Vitamin E and anti-oxidant polyethylene Comparative effectiveness research

– Which perform best over time: monoblock all-poly tibias or modular metal-backed tibias?

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Keys to Success Data security, propriety, privacy and legal concerns

– Data integrity/security Data sources need to be accurate and validated Minimum necessary data shared Secure data transfer mechanisms Healthcare systems to authorize all use of data

– Privacy Adherence to US privacy requirements/HIPAA

– Distributed data network reduces these concerns Centers have operational and physical control of data at all time

Linkage to high quality data for longitudinal outcomes assessment Conflicts of interest stated and addressed

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Keys to Success Participating registries need to be formalized and equal

partner in MdEpiNet structure– Lead with academics strategic planning, project selection, study

design, data analysis and interpretation, publications– Lead role in dissemination of findings/ translating evidence into

clinical practice– Key partner in governance and decision making

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Thank You

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