IRIS Intelligent Research in Sight. A Clinical Registry Case Study
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1 IRIS Intelligent Research in Sight A Clinical Registry Case Study
2 Patient Registries Summit William L. Rich III, MD, FACS AAO Medical Director Health Policy Chair, IRIS Executive Committee
3 Gaps in Current Care No easy way to track performance and patient outcomes No feedback loop to improve performance No national benchmarks for comparison EHRs not targeting performance improvement Quality of care defines the AAO culture
4 The Big Idea: The Hawthorne Effect! If you can t measure it, you can t improve it. - Lord Kelvin, 1880
5 Solution: IRIS Registry Captures performance rates on accepted quality measures Provides real-time feedback Drives true improvements in quality and outcomes
6 Introduction to IRIS Registry IRIS Registry (Intelligent Research In Sight) is the nation s first comprehensive eye disease clinical database Enables ophthalmologists to use clinical data to improve care delivery and patient outcomes Uses HIPAA-compliant methods to collect data from patient records directly from electronic health record (EHR) systems( Utilizes an EHR agnostic systems integrator
7 IRIS Chronology November 2011-registry task force formed February 2012-development plan presented to Board November Board approved funding December 2012-December 2013-measures selected and tested, communication strategy delineated, data dictionary established
8 Launch March 2014 Goal: 2200 ophthalmologists by 2017 with 18 million patients
9 Current Stats December 6, 2015 Contracted 10,180 physicians from 3,555 practices Number of patient visits million, representing million unique patients
10 Integrated with 39 EHRs Amazing Charts ChartMaker Medical Suite Compulink Cybax DoctorSoft eclinicalworks EyeDoc EMR Eyefinity ExamWRITER EyeMD EMR GE Centricity EMR Greenway Intergy Greenway/Primesuite HCIT EHR ifa systems EMR imedicware Integrity EMR for Eyes IO Practiceware KeyChart EMR Lytec ManagementPlus MaximEyes by First Insight Mastermind EHR MDIntelleSys MDoffice MedEvolve Medent Medflow Medinformatix EHR My Vision Express NexTech NextGen Origin Prime Clinical System PrognoCIS SRS TriMed EHR VersaSuite Vitera EHR WebChart by MIE
11 Millions Unique Patients and Visits Timeline Patient Visits Unique Patients
12 Advantages of Clinical Registry Data Real world Big data Estimated 49% of national visit volume (2013-present) World s largest clinical registry Current data Estimates are now 48m patients and 148m visits 1/18 Clinical data: outcomes, VA, IOP, free text Across all payers
13 Why the rapid uptake?
14 Value Proposition Financial MOC-Part IV Better outcomes Research Informing public policy Population Health Surveillance
15 Financial
16 Quality Reporting Requirements IRIS Registry submits on behalf of members: Meaningful Use- Meaningful Use Clinical Quality Measures Meaningful Use Objective 10 - Public Health Reporting: Specialized Registry Reporting PQRS - Physician Quality Reporting System (PQRS) and PQRS reporting for the Value-Based Modifier Includes Patient Reported Outcome Measures for Cataract Measures Group
17 Financial IRIS enables ophthalmologists to avoid Medicare penalties for PQRS, VBM, MU, and survive in the new MACRA world.
18 Inform Public Policy
19 Anti-VEGF Agents ,084,306 injections provided to 174,891 unique patients Average age = 75.7 years Male = 41.9% ; Female = 58.1%
20 Endophthalmitis Rates Anti-VEGF Agents Bevacizu mab Ranibizum ab Aflibercep t Injectio ns 490, , ,48 2 Unique Patients Endophtha l- mitis at 30 days Rates (30 days) 95, % 44, % 34, %
21 Improved Outcomes
22 602,553 cataract surgeries Multivariate analysis: age, poor preop visual acuity, glaucoma diagnosis, lower volume hospitals. Overtime, all decreased. Lundstrom M, et al. Decreasing rate of capsule complications in cataract surgery : Eight-year study of incidence, risk factors, and data validity by the Swedish National Cataract Register JCRS, Volume 37, Issue 10, 2011,
23 EUREQUO project: European Registry of Quality Outcomes for Cataract and Refractive Surgery 368,258 cataract surgeries Variable 20/40 or Better 20/20 No. of pts without ocular comorbidity 98.2 % 69.9 % 274,155 with ocular comorbidity ,103 Comorbidity Macular degeneration ,029 Glaucoma ,088 Diabetic retinopathy ,299 Amblyopia ,650 Other ,214
24
25
26 Retinal Detachment Surgery Surgery Frequency % of RD Surgeries , % , % , % , % % , % , % , %
27 Return to OR in 90 Days Surgery % return within 90 Days % % % % % % % %
28 Research
29 Clinical research and registries IRIS is an outpatient clinical registry with the ability to follow patients longitudinally using probabilistic matching (94%). Most facility based registries record the short term evaluation of drugs, devices and procedures but are unable to measure their impact on the natural course of disease: IRIS will.
30 Research and Registries Despite rapid advances in the use of clinical registries for CER, surveillance and PBRN ( Practice Based Research Network) observational registries studies have historically lacked the rigor of randomization.
31 Randomized Registry Trial The Randomized Registry Trial-The Next Disruptive Technology in Clinical Research --Lauer & D Agostino, NEJM, Sept 2013 Time for recruitment and costs were dramatically less in the randomized registry arm of the trial. The incremental cost of the Thrombus Aspiration in ST-Elevation Myocardial Infarction in Scandinavia (TASTE) trial was $300,000, or $50 for each participant who underwent randomization!
32 Randomized Registry Trial Today we can no longer afford to undertake randomized effectiveness trials that cost tens or hundreds of millions of dollars. But today we also have registries and other powerful digital platforms. Today it may be possible to design and conduct mega-trials with what we have: bigger data and smaller budgets.
33 Population Health Guidelines
34 Improved Population Health Research Improved Pop Health Evidence Protocols Guidelines
35 Population Health IRIS enables real time feedback to physicians to improve care and decision support Guideline development time shortened IRIS can identify disparities in outcomes for populations are risk and point to new modalities of care.
36 Surveillance Devices and Drugs
37 PEW: Future Directions for Medical Device Registries 60% of Class III devices have mandated post market surveillance and only 6% are performed by independent specialty registries. UDIs ( Unique Device Identifiers) will be included in EHRs in 2015? Longitudinal EHR based registries ( Pinnacle, IRIS) have the capability to follow devices at the longitudinal point of care and can detect early signals. Patient reported outcome tools can pick up early symptoms before device failure occurs. Data should be made publicly available
38 IRIS and UDIs If CDC mandates UDIs in certified EHR fields in the next year, IRIS can extract them Currently IRIS collects device data inputted into a surgical template that is uploaded to the registry The majority of devices are inserted in ASCs without EHRs
39 Disease prevalence and surveillance CDC is utilizing the IRIS database to establish a updated scan of the prevalence of ophthalmic disease IRIS can be used to identify patients with rare diseases for device, drug or biologic research
40 Punch list Inadequate data points in EHRs-* Validation of data-* Data blocking: vendor fees & refusal to allow export of data-ongoing battle with two large vendors Importing UDI Implement PBRN-Practice Based Research Network-as a resource for target post market device studies.
41 Overcoming inadequate data points in EHRs Robust data dictionary >900 established upfront Process measures that address staging of diseases and actions that improve outcomes Mapping of measures from EHRs to the registry provides immediate feedback to practices of missing data points that result in poor performance when compared to national benchmark! Docs modify office templates Approach vendors on regular basis with optimal data points from data dictionary
42 Summary The IRIS ophthalmic clinical registry will represent a seminal change in how ophthalmology will improve performance and outcomes while shortening the timeline for the dissemination of important clinical knowledge, expand research opportunities and facilitate drug and device surveillance. To do so it must have broad input from specialists, have a viable business plan and not adversely affect physician work flow.
43 We re facing very challenging times in healthcare in the United States today. I believe that ophthalmology has an opportunity not only to play a part in the solution to those challenges, but also to be an example for the health professions in the way forward. Harvey Fineberg, MD, PhD President, Institute of Medicine Keynote Address 2008 AAO Joint Meeting Atlanta, GA
44 Thank You! For more information about the IRIS Registry Visit For questions, send an to
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