Anil Jain, MD, FACP – 1 Electronic Health Records Facilitating Clinical Research Clinical Research...
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Anil Jain, MD, FACP – 1
Electronic Health RecordsFacilitating Clinical Research
Clinical Research Management Workshop
Tuesday, June 22, 2010
Anil Jain, MD, FACP
Senior IT Executive, Information Technology, Cleveland ClinicManaging Director, eResearch, eCleveland Clinic
Co-Director, Biomedical Informatics, CTSC, Case Western Reserve University
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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
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Anil Jain, MD, FACP – 3
The Cleveland Clinic The Cleveland Clinic
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Anil Jain, MD, FACP – 4
The Cleveland Clinic The Cleveland Clinic • Founded in 1921
• Not-for-profitgroup practice
• 2096 Professional Staffand 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:♦ 4th among nation’s 6,000 hospitals♦ Nation’s #1 heart program♦ 16 specialties ranked
The Cleveland Clinic The Cleveland Clinic
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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 Cleveland’s seven adjacent counties
– 1.5 M visits in the regional medical practice sites (community-based clinics)
• “Centers of Excellence” for numerous diseases areas
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Anil Jain, MD, FACP – 6
Cleveland Clinic EHR implementation Path
2000 2008
Ambulatory EMR CPOE + Documentation
20042002 2006
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
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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.)
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Anil Jain, MD, FACP – 8
Clinical Care Domain
EMR w/multiple interfacesAggregates ALL avail. dataOrganized around Patients
HIPAA PolicyHL7 a common
Messaging standard
Non-Structured & Structured
Clinical ResearchDomain
Independent DataOrganized around a Study
Well Behaved DataBiostatisticians Manage
Drug Trials21 CFR Part 11
Involves Sponsor and FDA+/- CDISC Standards
The Silos…
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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
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Anil Jain, MD, FACP – 10
Provides EMR-centric Resources for other groups
eAnalytics and
Research:Research
Standardization
eAnalytics and
Research:Research
Standardization
QuantitativeHealth
Sciences
QuantitativeHealth
Sciences
Quality & PatientSafety
Institute
Quality & PatientSafety
Institute
Center for Clinical Trials &
Clinical Operations
Center for Clinical Trials &
Clinical Operations
Clinical & Translational
Science Consortium
Clinical & Translational
Science Consortium
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Anil Jain, MD, FACP – 11
Leveraging the EHR to capture critical data for researchers
ElectronicHealthRecord
Personal Health Record
Clinical EventsAdverse ReactionsPatient Outcomes
Clarity
eResearch Db
Registries
DialysisCenter
Local“EMR”s
Genomics
Imaging
Registries
???
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Anil Jain, MD, FACP – 12
ResearchHypothesis
ProtocolDevelopment
Site Selection
SubjectRecruitment
Clinical Data
TrialManagement
DataAnalysis
KnowledgeDissemination
eResearchServices
ProtocolAssessment
Clinical Research Cycle
ResearchBilling
RegulatedDatabases
eCRFData Collection
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Anil Jain, MD, FACP – 13
Systems Analysts
ClinicalInformatician
DatabaseAdministrator
ClinicalAnalysts
Programmers
Biostats/Epi*
Multidisciplinary eResearch Team
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Anil Jain, MD, FACP – 14
ResearchInstitute
Biostats
HIPAA &Security
ResearchInformatics
eLearning& Training
GeneralCounsel
ClinicalResearch
Unit
CorporateCompliance
IRB
InternalAudit
eResearch
Guidance…
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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
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Analysis of Protocol Criteria
Inclusion and Exclusion Study Criteria
Data Source
Demo Vitals Dx/Proc Rx Lab Chart
Diabetes Type 2 X X
Age 18 to 65 X
Rx Naïve or mono-therapy X
No Uncontrolled Hypertension X
No Triglycerides >=1000 X
If being treated, stable dose of lipid-lowering agent
X
No Hx of MI/USA, CABG/PTCA X
No Insulin use (except gest DM) X X
No history of substance abuse X
Likely to complete study X
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Anil Jain, MD, FACP – 17
Ontology & Vocabulary
Information Standard VocabularyDiagnoses • ICD9 Codes
• IMO Terms• SNOMED Mapping (limited, via IMO)
Medications • First Data Bank / NDDF+• National Drug Code• RxNorm (limited, thru eResearch cross-
walk)
Laboratory • Local Codes• LOINC Mapping (limited, thru eResearch
cross-walk via RELMA tool)
Allergies • Local
Family History • Local
Procedures • CPT™, ICD9 Procedure Codes
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High-level Summary of the Impact of Each Criterion
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Anil Jain, MD, FACP – 19
Assess Each Criteria for Ethnic/Gender Diversity
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eResearchTools
ElectronicHealthRecord
Clinical Data Repository
ResearchCoordinator
Trial Support
TraditionalRecruitmentStrategies
e
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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.
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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
??
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Anil Jain, MD, FACP – 25
AUTOMATEDPROCESS
DURING THENIGHT
DURING THEOFFICE VISIT
Integrating study criteria with scheduling…
StudyCriteriaStudy
Criteria
Study Filter(patient &provider)
Study Filter(patient &provider)
PatientSchedules
(sites)
PatientSchedules
(sites)
ProviderClinical
Trial Alert
ProviderClinical
Trial Alert
SiteAdmin
SiteAdmin
SecureEmail
SecureEmail
EHR orderenrolls Ptinto Study
EHR orderenrolls Ptinto Study
PatientTrackedvia EHR
PatientTrackedvia EHR
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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.
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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.
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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
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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
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eResearch Facilitated Studies…
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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. http://www.explorys.net/
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The Explorys Unified Platform
ExplorysHealthcare Cloud
OLAPOLAPCompMatrix
CompMatrix
SearchEngine
SearchEngine
AlertEngine
AlertEngine
PopulationExploration
ComparativeEffectiveness
Business Intelligence
Pharma-covigilance
OpenModule
OpenModule
OpenModule
OpenModule
Securehigh-speed VPN
Questions: [email protected]
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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 Einstein’s Princeton University Office