Patricia D. Franklin MD, MBA, MPHUniversity of Massachusetts Medical School (2011-14) Supplemental grants awarded/under review. 1. Develop a comprehensive TJR registry with sustainable

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FORCE-TJRFunction and Outcomes Research/Registry for

Comparative Effectiveness in TJR

Patricia D. Franklin MD, MBA, MPH

MDEpiNet/ICOROctober, 2015


Team at University of Massachusetts Medical School; FORCE-TJR

• David Ayers, MD Orthopedics

• Wenjun Li, PhD Biostatistics

• Hua Zheng, PhD Informatics

• Jeroan Allison, MD MS Health Services

• Milagros Rosal, PhD Behavioral Med

• John Ware, PhD Psychometrics

• Norm Weissman, PhD Health Services

• Celeste Lemay, RN MPH Nursing

2


Exponential growth in TJR utilization overall and in adults <65 years

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Ten-Year Trend Volume THR and TKR

THR TKR

0

50,000

100,000

150,000

200,000

250,000

300,000

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012

Ten-Year Trend Volume THR and TKR <65

THR <65 TKR <65

Source: HCUP.net

• TJR procedures dramatically improve quality of life, relieve pain, improve function.

• Projected cost increase by 2015• 340% to $17.4 billion for THR• 450% to $40.8 billion for TKR.

• TJR procedures are #1 procedural cost in the Medicare budget.

• Patients under 65 years are fastest growing group of TJR patients.


FORCE-TJR: platform for TJR outcomes monitoring

Competitive Application: $12 million AHRQ P50 award

Department of Orthopedics and Physical Rehabilitation

University of Massachusetts Medical School (2011-14)

Supplemental grants awarded/under review.

1. Develop a comprehensive TJR registry with sustainable data infrastructure for comprehensive TJR outcome monitoring and feedback to providers.– UMass is the TJR data coordinating center for the next 20+ years

2. UMass TJR research team conducting comparative effectiveness research in TJR quality and outcomes.– Participating on CMS expert panels and national TJR leadership groups


Today’s goals

1. FORCE-TJR is both a comprehensive TJR outcomes Registry and conducts Comparative Effectiveness Research

2. FORCE-TJR and appropriate TJR timing and use.

3. FORCE-TJR and value/safety to patients, clinicians, hospitals and policy makers.

4. Collaborations with ICOR/MDEpiNet in post-marketing implant surveillance.


FORCE-TJRParadigm Shift: PROs are primary outcome

JAMA 2012; 308(12): 1217-18 JBJS 2014; 96:1567-9


FORCE-TJR: National Benchmarks from >200 representative Surgeons

in 28 States• 75% of surgeons are community

-based

• Fellowship-trained, general orthopedic surgeons

• High and low volume surgeons/hospitals; urban and rural hospitals

• Teaching hospitals, non-teaching hospitals

• Patients with private, public and HMO insurance

• All major implant manufacturers

• Primary TJR, revision TJR, Uni, PF, HR, all types of procedures

Core Clinical Centers

UMass Medical School, Worcester, MA

Connecticut Joint Replacement Institute, Hartford, CT

The University of Rochester Medical Center, Rochester, NY

Medical University of South Carolina, Charleston SC

Baylor College of Medicine, Houston, TX

Community Sites currently enrolled

Map of Participating Core Centers and Community Sites

ID

MT NDMN MI

MISD

NE

KS

TX LA

AL GA

SC

NC

VA

PA

NY

VTNH

ME

MA

RICT

NJ

DE

MDDC

WV

FL

MS

OK

IA

MO

ILIN

OH

KY

TN

WI

AR

NV UT

AZ NM

CO

WY

CA

OR

WA

Community Sites


FORCE-TJR proven methods• 96% pre-TJR• 85% completion post-TJR*• Web-based surveys with real-time scores• Completed in Office or at Home• PC or Tablet*other US registry PRO follow-up rates from 20-30%. Franklin et al, JBJS, 2014.

Effective procedures for PRO collection


BeforeSurgery

Surgery 30 -90 days 6 months Annual

PatientSurgeon Hospital Direct to Patient (validate EHR)

• PROGlobal health(VR12; PROMIS)HOOS/KOOS

• CLINICAL RISKSMedical &MSK risksDemographic

• CLINICALImplantOperative Notes

• PROPain

• CLINICALComplication (if any)

• PROGlobal health (VR12; PROMIS)HOOS/KOOS

• CLINICALComplication(if any)

• PROGlobal health (VR12; PROMIS)HOOS/KOOS

• CLINICALComplication (if any)

Revision

FORCE-TJR Data collected across TJR Care Cycle>25,000 patients

CMS DATA ANNUALLY


FORCE-TJR Registry with quality improvement feedback to surgeons

1. Comparative reports to anticipate

public reporting

2. PROs for incentives, insurer/ACO

models

3. FORCE-TJR is a Qualified Clinical Data

Registry (PQRS); Submit FORCE data.

4. US News acknowledging FORCE-TJR

hospitals (and surgeons)

1. Quality monitoring

– Patient risk factors

– Pre-op pain/function

– 30 day readmissions

– 90 day complications

– Revisions

– Post-op pain/function

Public DATA USES Hospital DATA USES


Risk-adjusted Post-TJR Outcomes

Site Outcome Summary (SF/PCS)• Site pre-op mean PCS is comparable to national norm.

• Site post6m mean PCS = 44• Post6m risk-adjusted PCS= 43• National post 6m PCS= 45

Risk adjustment is critical if scores are used for public reporting or reimbursement.


Site level variation: MSK, SES, BMI Key

29


FORCE-TJR: RESEARCH AND POLICY1. PROs: TJR Appropriateness and Value

Validated assessment of pain and function before and after TJR to improve health, reduce cost, and increasevalue.

1. Timing/Need: Reduce untimely and/or inappropriate procedures by identifying patients unlikely to benefit from TJR.

2. Episode Costs: Reduce post-operative complications and readmissions by identifying high risk patients before surgery who can be managed to reduce risk.


FORCE-TJR Site Report: Pre-TKR Function

Site Pre-TKR Patient Profile:

• National Norm for Healthy = 50 (SD=10) Green arrow

• Site Median PCS = 32 • National Median PCS for TJR = 32

(2SD below healthy; Red arrow)

• Site 75th%ile PCS = 38• National 75th%ile PCS = 39

Patient selection matches national norms; >83% have PCS scores reflecting disability.

Patients in yellow (1SD): evaluate clinical circumstances warranting TJR.

Pre-op


2. Predicting post-TJR readmission morbidity and costs (CMS/AAHKS)

• Post-TJR hospital complication and readmission rates first posted on Hospitalcompare.gov in 2013-14.

• FORCE-TJR documented that 1 in 4 (25%) of patients who are readmitted do not go to hospital where TJR was performed.

• Patients report post-TJR events (ER visit, return to OR, readmission to any hospital); accuracy validated.

• Post-TJR readmissions – Prevalence: 2 - 8%; mean 5.4%– $17,000 per readmisison


Combined CMS + FORCE data 30 day post-TJR risk-adjustment

Readmission- overall 4.7% of patientsKey new predictors of readmission:• Pre-TJR function (PRO)• BMI • Medical and Musculoskeletal

Co-morbidities C= 0.79 (TKR); C= 0.86 (THR)

CMS readmission risk models based only on ICD/CC codes are less discriminating (CMS C= .64)

0.0

00.2

50.5

00.7

51.0

0

Sen

sitiv

ity

0.00 0.25 0.50 0.75 1.001 - Specificity

Area under ROC curve = 0.7881


3. PROs in post-market implant surveillance (FDA)

• New Zealand registry reported that patients with significant pain at 6 months post-TJR were 7 times more likely to have revision in 5 years.

• Metal on metal implant failure- pain was first symptom

• FORCE will identify sub-group at risk

• Monitor for revision rates


12 month post-TKR Pain and Function:Patients <65 years with Implant X

28% of patients have 12 month pain score <75


Goals/FDA ICOR (new UO1)• Aim Enhance device surveillance using PRO and validate

claims based surveillance. FORCE-TJR will define comprehensive post-marketing TJR implant surveillance program to go beyond safety and include implant effectiveness metrics.

(a) Patients report post-TJR adverse events, including implant revision and complications, via web or a smartphone App and validated by CMS or insurer claims data.

(b) Evaluate if pain and functional limitation at 6 months vary by implant materials (e.g., ceramic vs. metal hip) or design (e.g., mobile vs. static knee).

(c) Severity of post-TJR pain at 6 months post-TJR will predict risk of revision at 2 and 5 years after adjusting for BMI and medical and musculoskeletal comorbidities.


FORCE-TJR

Independent, unbiased, expert data collection and reporting to guide best

TJR surgical practices to assure patients achieve optimal pain relief and

functional gain with minimal adverse events and implant failures.

• 4 Years of experience with Pre and Post-TJR PROs on >25,000 patients

• Post-op adverse event surveillance

• Implant library and revision surveillance

• CONTINUING TO ADD NEW HOSPITALS AND SURGEONS

MISSION


Contact Us

[email protected]

1-508-856-5748

1-855-99FORCE

www.force-tjr.org

mailto:[email protected]

Documents

Patricia D. Franklin MD, MBA, MPHUniversity of Massachusetts Medical School (2011-14) Supplemental grants awarded/under review. 1. Develop a comprehensive TJR registry with sustainable