The Radiation Oncology EHR of the Future Joel W. Goldwein, MD Senior Vice President and Director Medical Affairs Elekta, Inc. August 6, 2010
Future Radiation Oncology EHR: Agenda What s the current state of the art? What s driving progress? Where are we going?
State of the Art: Radiation Oncology EHR RT used in approx 50% of 1.4M US cancer patients ~ 2,100 RT facilities in US > 70% utilize dedicated information systems Represents ~ 500,000 new RT patients/yr managed using RO EHR RO highly EHR-dependent clinical specialty (V&R ) Degree of EHR use highly variable Two major EHR vendors (Elekta MOSAIQ, Varian Aria) Well established / managed Regulated QA systems support software development Numerous interfaces to devices/machines, TPS, HIS, PACS, lab Largely standards-based (DICOM-RT, HL7, AJCC, CTC(AE) ) IHE-RO participants (committed to interoperability)
RO EHR Features (Elekta MOSAIQ ) Clinical V & R CPOE Comprehensive noting/charting TPS interface/integration Medical oncology support Rule-based workflow management Numerous interfaces (lab, HIS, treatment machines ) Image Management (2D, 3D, 4D) Import/export/manipulate Treatment related image (IGRT) management Oncology PACS Integration
RO EHR Features (Elekta MOSAIQ ) Practice Management/Administrative Patient and Resource Scheduling Charge Capture/Billing Kiosk patient check in Inter/intra-product communications Research Data collection and reporting Data trending Outcome analyses support Graphical data exploration Clinical Trial management Interfaces out to Cancer Registry and RO data aggregation products Graphical Data Exploration Module
RO EHR Environment Architecture PC Based Desktop workstations, laptop carts, limited mobile devices Client/Server (MS-SQL) Workstations - five to hundreds LAN or WAN (Citrix) Device and imaging environment highly variable Cadre or product mix innumerable (linacs, protons, orthovoltage, TomoTherapy, TPS, HIS ) Workflow associated with evolving clinical trends Some FDA regulated EHR components MLC control systems, Image management components
EHR Clinical Trial Support Features TrialCheck (Coalition of Cancer Cooperative Groups) Determine patient eligibility for clinical trials active at your facility Based on clinical criteria (age, disease, stage, performance status ) available in EHR Trial data collection support import/export assessment templates DICOM-RT image export to cooperative groups (RTOG ) Integrated National Comprehensive Cancer Network (NCCN) guidelines Clinical Trial Eligibility Determination Screen
Web-centered Collaboration: Established Community of EHR Users Shareable Reports Sharable Document Templates Sharable Care Plans Listserver (independent) Infrastructure for future expansion
EHR Snapshots Patient Face Sheet (Chart Cover)
EHR Snapshots Patient Assessments (Labs, Vital Signs )
EHR Snapshots Treatment setup image verification (2D)
EHR Snapshots X-ray Volumetric Image Guided RT
RO EHR: Current Status Summary Widely deployed systems across entire specialty Largely standards based Device, HIS, TPS interconnectivity and interoperability comprehensive Modern UI, RO image-enabled Support clinical, research and administrative aspects of RO practice robust Mature, established vendors with regulated & structured development control systems
Seems like it s all there! What s next? How can we leverage today s products to build the system of the future?
Some Rad Onc EHR Drivers Health Information Technology for Economic and Clinical Health Act (HITECH) Meaningful use and ARRA certification $$$ Rapidly emerging technologies (device, imaging, techniques, software ) All expensive; proof of utility often limited Associated workflows will require EHR support Associated high costs implicate Comparative Effectiveness Research (CER) Recent safety-related incidents Incent development of safer EHR systems Rising costs with potential diminishing reimbursement Incents increased efficiency by improving workflow and the Human-Computer Interface
Meaningful Use (HITECH) Ambulatory Provisions Qualified Eligible Provider Requirements Meet ~ 20 MU criteria AND use certified EHR system e.g. - CPOE medications (e-prescribing), clinical rules engine (decision support), capture vital signs, provide patient EHR access, supply summary of care record Payout to qualified/eligible providers begin 2011 MEDICARE PAYMENT SCHEDULE Initial Qualifying Year Calendar Yr 2011 2012 2013 2014 > 2015 2011 $18,000 2012 $12,000 $18,000 2013 $8,000 $12,000 $15,000 2014 $4,000 $8,000 $12,000 $12,000 2015 $2,000 $4,000 $8,000 $8,000 $0 2016 $2,000 $4,000 $4,000 $0 TOTAL $44,000 $44,000 $39,000 $24,000 $0
Meaningful Use (HITECH) Effect on Future of RO EHR Certification is current major Vendor focus Expected Results Acceleration of EHR system enhancements Improvements in scope of (meaningful) use Overall: Limited (but important) effect on RO EHR features, development, and end-user adoption Already available or in progress
Emerging technologies as RO EHR drivers: Are we moving too quickly? Will there ever be sufficient supportive evidence? Can EHR systems help us obtain it? Will EHR s be able to accommodate ever changing workflow?
RO: Fodder for Comparative Effectiveness Research Economic Scene In Health Reform, a Cancer Offers an Acid Test By DAVID LEONHARDT Published: July 7, 2009 The prostate cancer test will determine whether President Obama and Congress put together a bill that begins to fix the fundamental problem with our medical system: the combination of soaring costs and mediocre results. If they don t, the medical system will remain deeply troubled, no matter what other improvements they make.
[Radiation] Oncology: A CER Priority? Cancer focus of 6 primary IOM CER topics Direct US cancer costs $80 Billion RO consumes approx. 10%; growing fast! Burden likely to fall on us to provide evidence basis A real-time registry capturing patterns-of-care data may represent part of the solution Distribution of the IOM's Recommended CER Priorities Iglehart J. N Engl J Med 2009;361:325-328
Radiation Oncology Data Registry Pilot Program Background Est. 10/2008 as derivative of more mature Med Onc data program Aim Demonstrate proof of concept for establishment of central RO data warehouse derived from live EHRs Establish basis for CER. Reduce costs of data collection Method Leverage widely deployed RO EHRs Aggregate de-identified data collected in EHRs in routine course of care Extensible/scalable design
Registry Architecture Small program installed on local EHR PC Scheduled service runs program at some regular interval Program runs => De-identified dataset created Dataset uploaded to central data warehouse Dataset aggregated Registry
RO Registry Pilot Results ASTRO 2009 Analysis 18 RO participants 121,000 patient records, 108,000 patient treatments Data completeness (quality) Date of Diagnosis: 29% complete Overall Stage: 21% complete Assessment Successful, but quality issues need to be addressed HITECH/MU may incent quality improvements If scaled, could represent real-time model dataset for CER, advocacy, administrative and clinical research Could serve as feed for higher-level multi-purpose registries and complement US Cancer Registry program
RO Registry Multi-Purpose Model Opportunities Specialized emerging technologies registries (SBRT, Protons ) CER registry Safety (near-hit) database cabig Grid
RO EHRs and Safety RO info systems have incorporated safety features such as V&R for decades Evidence suggests these features do indeed enhance safety * Contemporary systems designed top-down to minimize hazards This has not always been the case *Frass et al IJROBP - 1998
RO Control Systems: Vehicles of Safety? WIRED Nov 05 2 of 10 (and the only deaths by software ) were RO-related 1985 Therac 25 Linear Accelerator 5 deaths Significant changes in way RO software developed 2000 Multidata TPS (Panama) 8 deaths
RO EHR Systems and Safety The Radiation Boom Radiation Therapy Offers New Cures, and Ways to do Harm By WALT BOGDANICH Published: January 24, 2010 NY State Records 2001-2008 621 events, 1,264 causes, 2 notable deaths 46% - missed target 41% - wrong dose 8% - wrong patient # Cause 352 Flawed Q/A plan 252 Human data entry/calculation error 174 Wrong patient, wrong site 133 Wedge or collimator misused 60 Hardware malfunction 24 Software bug 19 Erroneous software override
RO Safety Record Event Type Any Errors w/ significant clinical consequences Errors w/ serious clinical consequences Events per million RT courses* ~ 10,000-20,000 ~ 1,000 10,000 ~5-10 Lots of caveats (e.g. under-dosing, under-reporting) Most events serious injury RT safe, but could/should always be safer [~ 1M RT courses yearly in US (IMV Report 2007)] * Munro BJR 2007
Why, in era of sophisticated EHRs, does this still happen? RO Highly Complex! Diseases varied Processes fluid Humans involved (both sides of table) EHRs can t anticipate it all Failure Mode and Effect Analysis (FMEA) 269 course process nodes 127 high risk failure modes Simplified RO Workflow Illustrating the multitude of opportunities to manage the RO process EVALUATION OF SAFETY IN A RADIATION ONCOLOGY SETTING USING FAILURE MODE AND EFFECTS ANALYSIS ERIC C. FORD, PH.D.,* RAY GAUDETTE, M.S.,* LEE MYERS, PH.D.,* BRUCE VANDERVER, M.D., LILLY ENGINEER, DR.P.H., M.D., M.H.A., RICHARD ZELLARS, M.D.,* DANNY Y. SONG, M.D.,* JOHN WONG, PH.D.,* AND THEODORE L. DEWEESE, M.D.* IJROBP, 2008
Hazard Mitigation Hierarchy of effectiveness Rules & Policies Training & Guess? Education Reminders & Checklists Simplification & standardization Automation & Computerization Forcing functions & Constraints (Interlocks) Mitigation Strategies
Leverage Hazard Mitigation Strategies to Reinforce EHR Safety Where human intervention is required Reduce dependence Increase dependence on most reliable hazard mitigation strategies Iterate! The EHR Solution? Less Automation Human Intervention Rules & Policies Reminders & Checklists Simplification & standardization Automation Training & Education & Computerization Forcing functions & Constraints (Interlocks) Safer System =>
Forcing Functions in Medicine: Interlocks, Timeouts and Checklists They work! Supplied throughout EHR, devices and applications Next generation EHR Roll your own! Graphical Workflow Design Toolkit MOSAIQ Universal Timeout Gamma Knife Treatment Console Checklist
MOSAIQ Workflow Manager Incorporate customized checkpoints w/ optional interlocks and alerts at any point Special attention to any/all high risk hazard nodes in work flow Requires iteration via ongoing FMEA EVALUATION OF SAFETY IN A RADIATION ONCOLOGY SETTING USING FAILURE MODE AND EFFECTS ANALYSIS ERIC C. FORD, PH.D.,* RAY GAUDETTE, M.S.,* LEE MYERS, PH.D.,* BRUCE VANDERVER, M.D., LILLY ENGINEER, DR.P.H., M.D., M.H.A., RICHARD ZELLARS, M.D.,* DANNY Y. SONG, M.D.,* JOHN WONG, PH.D.,* AND THEODORE L. DEWEESE, M.D.* IJROBP, 2008
MOSAIQ Workflow Manager Process Change Prescription Check Modality Automatic Script Customer Defined Ask for More Data with Task User-Defined Form Create QCL Item To Verify Info, etc.
The Human-EHR Interface: A few words Pen/paper hard to compete, but also hard to computerize PC / keyboard / structured data entry slow, awkward, interferes with MD-patient relationship BUT, structured data necessary for true benefits of EHR Dictation / voice recognition Faster, easier, more natural BUT, natural language processing that would provide for creation of structured data far off A number of solutions are on the horizon
The Human-EHR Interface: Teamwork! Software usability Improvements Mobile devices Hardware usability improvements Interfaces (Lab, HIS, Vitals ) MOSAIQ EHR Kiosks and PRO Interfaces Interfaces galore Dictation + Natural Language Processing Digital pen & paper
What s the Long Term Vision? EHRs as the Cornerstone Remote Care Monitoring and Delivery Driven by efficiency, cost containment, and Rx consistency requirements Facilitated via EHR Radiation Oncology Medical Home * Our processes are far to diverse, uncontrolled and unstructured Demands on our time will only increase Patients will demand more control of their care *An approach to providing comprehensive evidence-based, guideline-directed care... that facilitates partnerships between patients and providers
RO EHR Systems of the Future RO EHR systems are already (arguably) most sophisticated in medicine Managing complex tasks in an increasingly complicated environment The unique mix of technical and clinical specialists immersed in the explosion of advanced technologies will continue driving this trend. Which will be great for our patients!
The Radiation Oncology EHR of the Future Joel W. Goldwein, MD Senior Vice President and Director Medical Affairs Elekta, Inc. August 6, 2010