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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
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Clinical Registriesin 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 STS Adult Cardiac Surgery Database Participation > 13,000 Johns Hopkins Adult Cardiac Operations submitted to STS from 1997- 2010
Patient Care STS Research NQF PQRI Clinical Documentation Leap Frog DATA Performance Improvement Payers Billing UNOS Maintenance of Certification Resident Education Admin Reports
STS Participation Clinical Data ICD 9 codes Performance Improvement Score Cards Maintenance of Certification Surgeon / Resident Portfolios DRG Codes LeapFrog / PQRI National Quality Forum Cardiac Database Payers , RFI / RFP’s REPORTS APRDRG codes Clinical Registries Administrative Reporting Billing / Resource Utilization CPT codes Research Data Consumers & Marketing Sources of Data and Reporting For Outcome Measurement & Research in Cardiac Surgery
Some Lessons Learned Must have strong clinical leadership and pervasive buy-in Must integrate with clinical workflow Must provide net benefit to clinicians Must stay within scope of readily known data Must have a stable and capable clinical team Must have a stable and capable data team Must audit for completeness Must give regular feedback Must pre-stage submissions
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 # Participants # Records Harvest Adult Cardiac 992 2.7+ million 4 times / year General Thoracic 81 185,508 operations 2 times / year Congenital 142 96,628 operations 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 992 STS Congenital Database 81 STS Thoracic Database 142 Total 1215
STS Composite Quality ScoreDistribution of Participant Site Ratings Percent March 2008
STS Composite Quality Ratings Jan – Dec 2009 * 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
PREMISES OF THIS PROPOSALFOR 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 Lung Cancer Database (M. Brock) STS Thoracic Database ORMIS Clinical Data Maryland Trauma Registry EPR Transplant Information Systems Teleresults UNOS / CTRD IDX SALAR POE Specialty Surgical Research Databases Surgery Core Anesthesia ADR NSQIP Clinical Trial Databases Casemix CVIEW Tumor Registry Cardiac Surgery Database STS Adult Cardiac / Congenital Research Data ISHLT VAD Registry Internal Data Sources and Internal Database Initiatives
Idea – Patient Registries From Dr. Adrian Puttgen Dept. Neurology, Critical Care http://www.youtube.com/watch?v=WQ2PFoHptK8
Clinical Registry Opportunities Unique patient population Unique patient tracking capability Unique patient detail or comprehensiveness Unique patient data integration Regional quality programs National quality programs