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Anil Jain, MD, FACP – 1 Electronic Health Records Facilitating Clinical Research Clinical Research Management Workshop Tuesday, June 22, 2010 Anil Jain,

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Presentation on theme: "Anil Jain, MD, FACP – 1 Electronic Health Records Facilitating Clinical Research Clinical Research Management Workshop Tuesday, June 22, 2010 Anil Jain,"— Presentation transcript:

1 Anil Jain, MD, FACP – 1 Electronic Health Records Facilitating Clinical Research Clinical Research Management Workshop Tuesday, June 22, 2010 Anil Jain, MD, FACP Senior IT Executive, Information Technology, Cleveland Clinic Managing Director, eResearch, eCleveland Clinic Co-Director, Biomedical Informatics, CTSC, Case Western Reserve University

2 Anil Jain, MD, FACP – 2 Objectives Provide an overview of eResearch at the Cleveland Clinic Review our experience with simulation of clinical trial protocols using EHR data Demonstrate our ability to enhance clinical trial recruitment with EHRs Show how we have leveraged EHR data for comparative effectiveness research

3 Anil Jain, MD, FACP – 3 The Cleveland Clinic

4 Anil Jain, MD, FACP – 4 The Cleveland Clinic Founded in 1921 Not-for-profit group practice 2096 Professional Staff and scientists Innovations include: First coronary angiography Development and refinement of coronary bypass surgery First minimally invasive aortic heart valve surgery First successful larynx transplant Discovery of first gene linked to coronary artery disease CCHS Statistics (2009): Operating Revenue: ~ 5.6 Billion Clinical visits: Nearly 4 Million Admissions: 155,000 U.S.News & World Report rankings: 4 th among nations 6,000 hospitals Nations #1 heart program 16 specialties ranked The Cleveland Clinic

5 Anil Jain, MD, FACP – 5 Cleveland Clinic and Research (2009) Funding & Scope – $272 M Total Research Funding – $91 M in Federal NIH Awards – Over 2,200 active projects – 434 Active Registries with avg. 4 – 6 cohorts per registry Generalizability of Patient Population – 75% of patients came from Clevelands seven adjacent counties – 1.5 M visits in the regional medical practice sites (community-based clinics) Centers of Excellence for numerous diseases areas

6 Anil Jain, MD, FACP – 6 Cleveland Clinic EHR implementation Path 20002008 Ambulatory EMR CPOE + Documentation 200420022006 Tethered Patient Portal Inpatient CPOE Scheduling & Registration Integrated Lab/Radiology Results Reporting Inpt Notes Enterprise Master Patient Index Electronic Prescriptions Document Scanning 20101999 HIE Clinical Decision Support and Quality Reporting Billing & Reimbursement ADT OR IS

7 Anil Jain, MD, FACP – 7 EHR Data Reports EHR data is routinely used at our Institution… Health Wellness and Prevention – Immunizations, Osteoporosis, Diabetes and Cancer screening Disease-based Reporting – Diabetes, Hypertension, Heart Failure, Asthma Patient Safety – Adverse Drug Events and sentinel events – FDA Public Health Advisories (e.g., Vioxx ® and Ortho- Evra ® ) – Local Consensus (e.g., Avandia ® notification) Public Reporting – Pediatric Immunizations (SIRS), Communicable Diseases, process measures and quality indicators (JCAHO, HEDIS, CMS, etc.)

8 Anil Jain, MD, FACP – 8 Clinical Care Domain EMR w/multiple interfaces Aggregates ALL avail. data Organized around Patients HIPAA Policy HL7 a common Messaging standard Non-Structured & Structured Clinical Research Domain Independent Data Organized around a Study Well Behaved Data Biostatisticians Manage Drug Trials 21 CFR Part 11 Involves Sponsor and FDA +/- CDISC Standards The Silos…

9 Anil Jain, MD, FACP – 9 Our investigators want the EHR to help them! Identify current research subjects in the EHR Develop tools to help recruit potential research subjects Appropriately bill activity occurring in EHR-managed visits to the sponsor for research activity versus usual payor for standard of care. Develop Single Source capability with extraction to eCRF Capture rich structured data from the EHR (phenotypic) and combine with bio-informatics data (genotypic) Easily move valid data from EMR into research registries Facilitate secure EMR access for research monitors

10 Anil Jain, MD, FACP – 10 Provides EMR-centric Resources for other groups e Analytics and Research : Research Standardization e Analytics and Research : Research Standardization Quantitative Health Sciences Quantitative Health Sciences Quality & Patient Safety Institute Quality & Patient Safety Institute Center for Clinical Trials & Clinical Operations Center for Clinical Trials & Clinical Operations Clinical & Translational Science Consortium

11 Anil Jain, MD, FACP – 11 Leveraging the EHR to capture critical data for researchers Electronic Health Record Personal Health Record Clinical Events Adverse Reactions Patient Outcomes Clarity eResearch Db Registries Dialysis Center Local EMRs Genomics Imaging Registries ???

12 Anil Jain, MD, FACP – 12 Research Hypothesis Protocol Development Site Selection Subject Recruitment Clinical Data Trial Management Data Analysis Knowledge Dissemination eResearch Services Protocol Assessment Clinical Research Cycle Research Billing Regulated Databases eCRF Data Collection

13 Anil Jain, MD, FACP – 13 Systems Analysts Clinical Informatician Database Administrator Clinical Analysts Programmers Biostats/Epi* Multidisciplinary eResearch Team

14 Anil Jain, MD, FACP – 14 eResearch Research Institute Biostats HIPAA & Security Research Informatics eLearning & Training General Counsel Clinical Research Unit Corporate Compliance IRB Internal Audit Guidance…

15 Anil Jain, MD, FACP – 15 A Research Study Scenario (These parameters and numbers are purely fictional and intended only to demonstrate the scenario) Inclusion – Diabetes Type 2 – Age 18 to 65 at screening – Treatment Naïve or Oral mono-therapy Exclusion – Uncontrolled Hypertension – Triglycerides >= 1000 mg/dl – Lipid-lowering therapy not stable for 1 year – History of myocardial infarction or unstable angina – History of coronary artery bypass graft surgery or angioplasty – History of insulin use (other than gestational diabetes) – History of substance abuse or unlikely to finish study

16 Anil Jain, MD, FACP – 16 Analysis of Protocol Criteria Inclusion and Exclusion Study Criteria Data Source DemoVitalsDx/ProcRxLabChart Diabetes Type 2XX Age 18 to 65X Rx Naïve or mono-therapyX No Uncontrolled HypertensionX No Triglycerides >=1000X If being treated, stable dose of lipid-lowering agent X No Hx of MI/USA, CABG/PTCAX No Insulin use (except gest DM)XX No history of substance abuseX Likely to complete studyX

17 Anil Jain, MD, FACP – 17 Ontology & Vocabulary InformationStandard Vocabulary DiagnosesICD9 Codes IMO Terms SNOMED Mapping (limited, via IMO) MedicationsFirst Data Bank / NDDF+ National Drug Code RxNorm (limited, thru eResearch cross- walk) LaboratoryLocal Codes LOINC Mapping (limited, thru eResearch cross-walk via RELMA tool) AllergiesLocal Family HistoryLocal ProceduresCPT, ICD9 Procedure Codes

18 Anil Jain, MD, FACP – 18 High-level Summary of the Impact of Each Criterion

19 Anil Jain, MD, FACP – 19 Assess Each Criteria for Ethnic/Gender Diversity

20 Anil Jain, MD, FACP – 20 eResearch Tools Electronic Health Record Clinical Data Repository Research Coordinator Trial Support Traditional Recruitment Strategies e

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22 Anil Jain, MD, FACP – 22

23 Anil Jain, MD, FACP – 23 Physician attitudes… Embi PJ, Jain AK, Harris CM. Physicians' perceptions of an electronic health record-based clinical trial alert approach to subject recruitment: A survey. BMC Med Inform Decis Mak. 2008 Apr 2;8:13.

24 Anil Jain, MD, FACP – 24 What are the characteristics of the alert? False Positives – Many referrals made for each enrollee – excessive false positives… – EHR may not capture key criteria. – Chart review may not validate computable criteria – Patients may not necessarily be good candidates or willing to consent False Negatives – Documentation gap – Time lag between presentation and documentation – Only patients who have come in for a visit ??

25 Anil Jain, MD, FACP – 25 AUTOMATED PROCESS DURING THE NIGHT DURING THE OFFICE VISIT Integrating study criteria with scheduling… Study Criteria Study Criteria Study Filter (patient & provider) Study Filter (patient & provider) Patient Schedules (sites) Patient Schedules (sites) Provider Clinical Trial Alert Provider Clinical Trial Alert Site Admin Site Admin Secure Email Secure Email EHR order enrolls Pt into Study EHR order enrolls Pt into Study Patient Tracked via EHR Patient Tracked via EHR

26 Anil Jain, MD, FACP – 26 EHR-data based recruitment lists work! Cleveland Clinic involved in multi-site clinical trial for safety of NIH - H1N1 vaccine among children with severe asthma. Comparison of the eResearch services to the Severe Asthma Research Program (SARP) network registry. eResearch led to higher enrollment, 93/540 (17.2%) eResearch vs. 24/109 (22%) for SARP. Performance was similar to the volunteer registry without significant increase in costly screen failures Diversity in terms of race/ethnicity of the subjects was increased using EHR-based identification Parikh P, Jain A, et al. Recruitment and Enrollment of Asthmatics in a Phase II Clinical Trial, ATS Meeting, May 17, 2010.

27 Anil Jain, MD, FACP – 27 Increasing participation and diversity… (U Pitt) Over a 22-month period, EMR-prompts for recruitment: – PCPs referred 794 patients via EMR-prompts and 176 (22%) met study inclusion criteria and enrolled, – 8,095 patients were approached by wait room-based recruiters of whom 193 (2.4%) enrolled. – Subjects enrolled by EMR-prompted PCPs were more likely to be non-white (23% vs 5%; P < 0.001), male (28% vs 18%; P = 0.03) Rollman BL et al. Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment. J Gen Intern Med. 2008 Apr;23(4):447-50.

28 Anil Jain, MD, FACP – 28 Three recent outcomes and CER projects… Projects: – Modeling cardiovascular outcomes in patients on oral hypoglycemic agents – Modeling cardiovascular complication rates in patients admitted to the hospital with acute coronary syndrome – Identifying determinants of progression of kidney disease in patients with chronic kidney disease Why was the EHR used? – Size and scope of required electronic data was mostly already in the EHR – Competitive advantage for obtaining sponsors

29 Anil Jain, MD, FACP – 29 Strategies to Overcome EHR Data Reliability Issues RELIABILITY CHALLENGES Death is not always reliably captured in an EHR derived data set. Documentation of certain exclusions and adverse events are generally not captured as structured data Prescription medication dispensed and taken including OTC Patients may have fragmented care with some clinical data outside institutional EHR. POTENTIAL SOLUTIONS EHR data can be linked to SSDI assuming appropriate permissions Text mining/analysis of progress notes, discharge summaries, operative reports can identify some events/adverse events Widespread adoption of Medication-Reconciliation Leveraging Health Information Exchanges or inclusion of payer data can mitigate the problems with fragmented care

30 Anil Jain, MD, FACP – 30 eResearch Facilitated Studies…

31 Anil Jain, MD, FACP – 31 Explorys Population Explorer Cleveland Clinic spin-off - Software-as-a-Service offering… Explore: Search, browse, and define cohorts based on clinically normalized dataset from multiple providers. Compare: Analyze temporal measures between cohorts. Collaborate: Safely connect and share with trust peers and sponsors. Engage: Analyze in-depth HIPAA compliant datasets or recruit across internal or distributed trusted networks.

32 Anil Jain, MD, FACP – 32 The Explorys Unified Platform Explorys Healthcare Cloud OLAP Comp Matrix Comp Matrix Search Engine Search Engine Alert Engine Alert Engine Population Exploration Comparative Effectiveness Business Intelligence Pharma- covigilance Open Module Open Module Open Module Open Module Secure high-speed VPN Questions:

33 Anil Jain, MD, FACP – 33 Questions? Anil Jain, MD, FACP Cleveland Clinic Not everything that can be counted counts, and not everything that counts can be counted. -Sign hanging on Albert Einsteins Princeton University Office

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