Enhancing an Electronic Medical Record System for Use in Clinical Research Trials

Presented to University Health CareBy BCM Informatics ConsultingNovember 29, 2011

MMI 498 Capstone ProjectChad Hodge, Mary McConville, Bryan Watson

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Fundamental Change is Needed

• Challenge of translating myriad of scientific advances from

workbench to bedsideo Clinical trial research participation is flagging (investigators

and subjects)

o Discovery research stymied by interoperability barriers

o Institutional effectiveness plagued by inefficiency

• Burgeoning increase in healthcare delivery needs*o Cancer – 1 in 3 will develop some form of cancer

o Dementia - 20% age 75+ suffer from Alzheimer’s

o Heart Disease – near 50% mortality after 1st heart attack

* Source: GE Healthcare

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Focus of change

• Clinical Research Effectivenesso Improve EMR capabilities to support participation in randomized

clinical trials

o Improve knowledge engineering support for participation in discover

research

• Technology Support Improvement through Clinical Engagemento Intensify clinical involvement in all aspects of patient-related HIT

o Increase informatics literacy at UHC

• Position UHC for Genetics/Genomics Capability o Improve outcomes via genomic support in diagnosis and treatment

o Begin with peripheral arterial disease specialty

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Personalized Healthcare – the promise of genetics/genomics information in clinical settings

• Personalized Healthcare describes processes by which healthcare

providers can customize treatment and management plans for

patients based on their unique genetic makeup.o Consumers and clinicians gain useful predictive information

o Clinicians benefit from linking large, medically – related datasets to

individual-level genetic/genomics data.

o Educational materials and other guidance is developing.

o Genetic/genomic information can be helpful in health maintenance,

prevention and disease management.

AHIC Personalized Healthcare Detailed Use Case March 21, 2008

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Evolving Paradigm of careD

isease

Bu

rden

Time

Cost

1/

reve

rsib

ilit

y

Typical Current Intervention

Earliest Clinical Detection

Earliest Molecular Detection

Initiating Events

Baseline Risk

Decision Support Tools:

Baseline Risk

Preclinical Progression

Disease Initiation and Progression

Assess Risk

Refine Assessment

PredictDiagnose

Track ProgressionPredict EventsInform Therapeutics

Sources of New Biomarkers:

Stable Genomics: Single Nucleotide Polymorphisms Haplotype Mapping Gene Sequencing

Therapeutic Decision Support

Source: “Personalized Medicine: Current and Future Perspectives,” Patricia Deverka, MD, Duke University, Institute for Genome Sciences and Policy; and Rick J. Carlson, JD, University of Washington

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Primary & Secondary Use of Data

• Technology Advancements (Better, Faster, Cheaper)

o The $1,000 Complete Genome

o BioMarker testing: POC/Continuous

o Superior molecular imaging

o Integrate with the EHR for early detection and

treatment guidance

o Automated screening upon visit and initial

eligibility determined

o Prospective use of research for treatment

pathways

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How do we improve care with great data…

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Holistic Data ApproachKnowledge Repository

Interface to Model

Terminology

Transition, Decision

Support & Business

Rules

Unified Data

Repository of Models

& Terminolog

y Based Data

Data Assembled from User Generated

Alerts, Queries,

and Forms

Standard Models & Terminology

Coded, Computable Clinical Data

Configured by Knowledge

Workers

Shareable & Reusable Assets

InterfaceEngine

HL7XDS

CDAPDQ

ATNA

Maps

Models

Codes

Rules

QueriesFormsConstraints

2 3 4 51

Source: GE Healthcare

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Advanced Integration

Stakeholders Technology Benefits

Clinicians

ResearchersInformaticis

tsCommunity

Infrastructure• Terminology• Content• Genomic

Extensions• Advanced CDSS

eHealth• Portal• HIE• Collaboration• Patient Access

• Disruptive and visionary development of integrated genomics/clinical repository

• Foundation for Personalized Medicine

• Prepares CDR for target analytics, outcomes research, and trials recruitment

• Drives bioresearch and discovery

Source: GE Healthcare

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NLP Processes Support Computable Knowledge

Source: Using electronic health records to drive discovery in disease genomics. Kohane, Isaac S. s.l. : Nature Reviews Genetics, 2011, Vol. 12.

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Envisioned Data Workflow

Source: Using electronic health records to drive discovery in disease genomics. Kohane, Isaac S. s.l. : Nature Reviews Genetics, 2011, Vol. 12.

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Program Management RecommendationFocus   

Gain consensus on roadmap and funding levels Q1 2012

Implement organizational restructuring Q3 2012Secure near term funding  Q4 2012

Monitor performance of Clinical Engagement program and adapt if necessaryQ1 - 2013

Clinical Engagement Document requirements for E H R changes to accommodate researchQ1-2 2012

Develop Terminology/Standards management process Q4 2012Develop Implementation Management Q3 2012

Institutionalize Implementation ManagementQ2 – 2013

IT Infrastructure Build initial Clinical Engagement portalQ1 2012

Implement E H R changes including NLP Q1-2 2013

Implement genomics data integration planQ4 2013 – Q2 2014

Advancement of Science and Health Care

Develop requirements and specifications for genomics biobankQ2-3 2012

Implement genomics biobank Q3-4 2013

Pilot PAD genomics trialQ3 – 2014

Use Case Driver ONC/CDISC Use of Electronic Health Records in Clinical Research: Core Research Data Element Exchange Use Case

AHIC Personalized Healthcare Use Caseexchange of personal health, family health history,

AHIC Personalized Healthcare Use Caseexchange of genetic/genomic testing information

Specification Package Target

HITSP IS158 – Clinical Research

HITSP IS08- Personalized Medicine

HITSP IS08 - Personalized Medicine

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Roadmap Trajectory

① Terminology for Genomics

a) Define and integrate terminology assets

b) Define key use cases for stakeholders

② CDR Genomic Extensions

a) Extend terminology assets and clinical data model to support genomic content

b) Implement use cases and overall infrastructure

③ Repository Utilization and Discovery

a) Feed system with genomic research data and basic clinical data for proof-of-concept

b) Implement basic analytics

④ Extend Use Cases to Clinical Domain

a) Extend data integration into full, longitudinal record

b) Implement analytics to support basic data correlations between genomic and clinical

information

⑤ Pilot Clinical Genomic Platform

a) Explore targeted opportunities in areas, such as trials recruitment or outcomes research

b) Access opportunities to rollout integrated offering to target facility

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Holistic Informatics Management Approach

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Ethical & Legal Implications

• Questions to be vettedo Who should get these tests?

o Who should pay for these tests?

o How should this data be stored?

o How will this data be used?

Process Step EHR Role

HIPAA Privacy and confidentiality of records

21 CFR Part 50 & Part 56

FDA protection of human subjects

21 CFR Part 11 FDA electronic records and e-signature rules

45 CFR Part 46 OHRP protection of human subjects

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Financial Projections

• Estimates through 2016o Medical education deficit – increase by 18%

o Research funding loss – increase by 14%

o Clinical care margin – decrease by 8%

• Drivers increasing shortfallso NIH funding reductions

o Public economic decline (affects endowments and philanthropy)

o Increased infrastructure and regulatory expenses

o Medical education costs are outpacing inflation and tuition

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Leveraging interoperability specifications…

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Personalized Medicine Use Case

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Future directions…

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Through Aggregated Data Analysis

• Risk Predictiono Recommendation - Avoid high fat content in diet

• Pharmacogenomicso Rx Treatment - Drug dosages determined by

genetic profile

• New Therapies Discoveredo Gene therapy for PAD

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Discussion…