Clinical Registries in Cardiac Surgery

Peter S. Greene, MD CMIO, Johns Hopkins Medicine Diane Alejo Information Systems Manager Division of Cardiac Surgery September 15, 2010 ICTR Clinical Registry Workshop

Cardiac Surgery Data Management

Cardiac Surgery Database spans 1944 - 2010

• Clinical and administrative data tracking • Supports IRB approved clinical research activities • Allows longitudinal outcome follow-up

STS Adult Cardiac Surgery Data / STS Congenital Data Heart and Heart- Lung Transplant Database UNOS Registry ISHLT / INTERMACS VAD Registry Collaborative Transplant Research Database

History of Cardiac Surgery Database

933 15,010 7,738 18,934

42, 615

1944-1950 1950-1982 1983-1994 1996-2010

Total

Blalock-Taussig Registry Cardiac Registry Medical Archive’s Operative Logs Cardiac Surgery Database & Cardiac Transplant Database Expanded Data Collection - Point of Care / Work Flow Integration

Operations recorded in the Databases STS Adult Cardiac Surgery Database Participation > 13,000

Johns Hopkins Adult Cardiac Operations submitted to STS from 1997- 2010

Patient Care Clinical Documentation Performance Improvement Billing Research

DATA

Resident Education Maintenance of Certification Admin Reports STS NQF PQRI Leap Frog Payers UNOS

ICD 9 codes DRG Codes APRDRG codes CPT codes

Clinical Data STS Participation Performance Improvement Score Cards Maintenance of Certification Surgeon / Resident Portfolios LeapFrog / PQRI National Quality Forum Payers , RFI / RFP’s Cardiac Database REPORTS Research Data Clinical Registries Administrative Reporting Billing / Resource Utilization Consumers & Marketing Sources of Data and Reporting For Outcome Measurement & Research in Cardiac Surgery

Some Lessons Learned

1. Must have strong clinical leadership and pervasive buy-in 2. Must integrate with clinical workflow 3. Must provide net benefit to clinicians 4. Must stay within scope of readily known data 5. Must have a stable and capable clinical team 6. Must have a stable and capable data team 7. Must audit for completeness 8. Must give regular feedback 9. Must pre-stage submissions

Outcome Data

STS National Database

Standardized information on cardiac & thoracic surgical procedures Data analyzed by separate, independent, objective data analysis center (DCRI) Opportunities to improve patient care Adult Cardiac 992 General Thoracic 81 Congenital # Participants # Records Harvest 142 2.7+ million 185,508 operations 96,628 operations 4 times / year 2 times / year 2 times / year

STS National Database

STS Pilot Pay For Performance (P4P) Program Incentive payments for achievement of thresholds in performance measures

A model of quality improvement with 3 types of measures: Structureal: IT, database participation, volume Process: IMA use, discharge beta blockers Outcomes: Mortality, Morbidity: CVA, renal failure

Blended STS NCD and financial (UB-92) database NQF performance measures 2007 PQRI Initiative – CMS New 2007 STS Composite Scoring System

STS National Database

DCRI – Data Warehouse and Analysis Center Data transmitted electronically National, Regional and “Like Institution” benchmarking Reports include site specific, risk adjusted, regional and national aggregate date including morbidity, mortality and LOS for CABG, Valves and CABG/Valve surgery Statistical Analysis – Risk Modeling- Logistic Regression, Hierarchical regression modeling

STS National Database

STS Auditing Risk factor model variables NQF measures Op log procedures Operative deaths and morbidity

STS National Database Participation

STS Adult Database STS Congenital Database STS Thoracic Database Total 992 81 142 1215

STS Composite Quality Score Distribution of Participant Site Ratings 100 25 0 75 50 12 77 11 March 2008

STS Composite Quality Ratings

Jan – Dec 2009 Overall

Avoidance of Mortality Avoidance of Morbidity

Use of IMA Medications JHH 95.3 % 97.3 % 82.6 % 98.5 % 80.2 % STS 95.3 % 97.9 % 84.5 % 94.5 % 76.0 % Rating * Participant is significantly lower than the STS mean * * Participant is not significantly different than the STS mean * * * Participant is significantly higher than the STS mean

Research Informatics Department of Surgery

PREMISES OF THIS PROPOSAL FOR A SURGERY DATA CENTER

• Almost every faculty member and research trainee has a need for accessing clinical data for research purposes • There is insufficient revenue to support a centralized research database – There is a modest amount of research database activity in the department • There is an extensive amount of clinical information within JHMI in an electronic format, but these exist in multiple sources • There is an extensive amount of surgical patient data being collected and analyzed for non-research activities (e.g.: safety, accreditation, payers, training)

Departmental Prototype

ORMIS

Clinical Data

IDX SALAR Anesthesia ADR Casemix CVIEW

Surgery Core Research Data EPR POE Tumor Registry Lung Cancer Database (M. Brock) STS Thoracic Database Maryland Trauma Registry Transplant Information Systems Teleresults UNOS / CTRD Specialty Surgical Research Databases NSQIP Clinical Trial Databases Cardiac Surgery Database STS Adult Cardiac / Congenital ISHLT VAD Registry Internal Data Sources and Internal Database Initiatives

Idea – Explore Influence of Randomness

Idea – Quality Collaborative

Idea – Patient Registries

From Dr. Adrian Puttgen Dept. Neurology, Critical Care http://www.youtube.com/watch?

v=WQ2PFoHptK8

Clinical Registry Opportunities

1. Unique patient population 2. Unique patient tracking capability 3. Unique patient detail or comprehensiveness 4. Unique patient data integration 5. Regional quality programs 6. National quality programs