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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
3
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
4
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
5
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
7
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
8 April 5, 2016
Longitudinal Tracking of Procedures/Devices
9 April 5, 2016
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
11 April 5, 2016
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
12 April 5, 2016
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
13 April 5, 2016
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
14 April 5, 2016
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
16 April 5, 2016
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
17 April 5, 2016
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
18
ICOR Catalog Framework: Knees
19
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
20
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
22
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
24
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
25
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
26
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
27
Developing a Coordinated Registry Network
AJRR– Large volume with comprehensive implant collection
FORCE-TJR– Patient reported outcomes
Kaiser Permanente– Long-term follow-up
28
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
29
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?
31
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
32
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
33