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Translating Research into the Standard of Care

William E. Smoyer, M.D.

C. Robert Kidder Chair,

Vice President and Director,

Center for Clinical and Translational Research

The Research Institute at Nationwide Children’s Hospital

Professor of Pediatrics,

The Ohio State University

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Overview

• Summarize major trends and barriers to integrating clinical care and research

• Describe the “Learn from Every Patient” (LFEP) Program mission, model, structure, and flow

• Share NCH experience with a LFEP Pilot Program

• Outline resources needed to ensure LFEP success

• Share lessons learned and opportunities !

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Background

• Major trend toward merging clinical care and medical research Information

• Conversion to electronic medical records

• Data use to improve and personalize health care, and reduce costs

• Overarching Goal:

• Improving patient outcomes through integration of clinical care and research

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Background

• Major Barriers to Merging Clinical Care and Research Information

• Inadequate organizational readiness

• Infrastructure-related / financial / political

• Inadequate information standards

• Differing terminologies, data models, data architectures

• Inadequate technology integration

• Differing IT systems

• Inadequate workflow integration

• Differing clinical care and research processes

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“Learn From Every Patient” Program

A Model for Full Integrationof Research and Clinical Care

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“Learn from Every Patient”Program Mission

To fully integrate knowledge gained from clinical care with research to systematically advance the care of children

In other words…

“We will learn from every patient at every visit

and use that knowledge to improve the care of the children that follow”

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Alignment of LFEP with Strategic Goals

Goal: To fully integrate knowledge gained from clinical care with research to systematically

advance the care of children at NCH

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“Learn from Every Patient”Program Model

Data Mart

TranslationalResearch

QualityImprovement

Patient receives evidence-based

standardized care

Clinical + research data collection integrated into provision of care

Leverage data sources, including EMR and EDW

With IRB oversight

Drive incremental improvements in standard of care

Systematically improve care of all patients

Peer Reviewed

Publications

(Disease-specific data set derived from multiple data sources)

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Perspective on LFEP Program…

“… inspiration is easy. Implementation is the hard part.”

Bob Taylor (Taylor Guitars)

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Building the Team

• Pilot Program Identified• Cerebral Palsy Program

• Small

• Charged with “improving clinical care” • Key Stakeholders for Pilot Program Identified

• Physicians• Nurses / Clinical staff• Program administrators• Hospital EMR (EPIC) team • Enterprise Data Warehouse (EDW) team• Research informatics systems (RIS) team• Hospital informatics systems (HIS) team

• Recruited a Project Manager

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Setting Expectations

• Biweekly meetings convened• Scope of LFEP program detailed for CP Program

• Advantage: EMR had not yet been rolled out in program

• Benefits to organization and patients emphasized• Individual expectations for roles in program clarified

• Altered clinical practices required for physicians• Altered clinical practices required for nurses / staff• Altered interactions between hospital and research

informatics teams• Altered rollout of EMR (“We’ve never done this…”)

• “This is a lot of change !!!”

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Volume Growth

% increase in unique

CP patients to NCH

% of CP patients at NCH with a

completed Comprehensive Team Evaluation

n = 1,023 17%

1% 20%

2% 20%

3% 40%

4% 60%

5% 75%

KPIs Improved Patient Care

Metric

% decrease in NCH hospitalizations among CP

team clinic patients for:1) Failure to Thrive2) Psychosocial Issues3) Aspiration Pneumonia

Current 0%

2011

2012

2013

2014

2015 25%

Standard of Care

Evidence-Based

Written Standard of

Care

% of team evaluation

patients follow written standard

of care

Completed 90%

100%

Operations

Key Performance Indicators (KPIs) toTrack Success of LFEP Program

IntegrationResearchQuality & Safety

Increased Academic Productivity

Increase in number of peer-

reviewed abstracts

presented at national meetings

Increase in number of

publications in peer-

reviewed journals

Increase in number of CP Program team

members participating in

national committees

related to CP research

6 abstracts per year

2 papers per year

2 members per year

12 abstracts per year

4 papers per year

4 members per year

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IRB / HIPAA Compliance

• Working group developed to address issues• Legal Services / IRB Chair

• Research Institute Administration

• Research Informatics / CP Program Director

• Reviewed similar processes at other research institutions

• IRB Database Protocol Created• Provide oversight structure for IRB as “gatekeeper” of data

• Requires IRB application to access data (or samples) for research or QI purposes

• Ensures consultation between IRB and Legal Services regarding data use to ensure HIPAA and Human Subjects Research compliance

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Project Management

• Routine clinical care-related data fields developed (per standard process)

• Physicians charged with several key tasks:• Commit to initial standard of care (evidence + opinion-based)• Determine three high-value research questions that would

advance their field • Develop research data fields to collect key info for above• Develop research data elements to populate these fields

• Hospital EMR team charged with building these into EMR• Clinical team in-serviced for clinical / research data entry• Project rollout: April, 2010

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Data Management

• Clinical + research data fields entered at point of care• Part of a billable patient encounter

• Data collected in EMR migrated to Data Mart• Data extraction functional but still being refined• # of patients “enrolled” in first year already

comparable to a similar NIH-funded multi-site clinical trial over three years!

• Preliminary analysis suggests LFEP program implementation alone showing positive trends• ~ Reduced ER utilization• ~ Reduced hospitalizations• Initial manuscript being developed

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Development of Standardized Program

• LFEP implementation created new requests for service• Two programs now using LFEP• 10 additional programs have expressed interest !

• Opportunity to develop a standardized LFEP program• Applicable to variety of settings

• Pediatric or adult programs• Medical or surgical programs• Academic or private medical centers

• Able to incorporate biological sample collection• Able to incorporate multiple datasets into data mart

• Clinical / Lab / Radiology / Etc.• Genomic / Proteomic / Metabolomic / Etc.

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Clinician completes web-based intake form

Intake form routed to LFEP Executive Committee for review

Committee provides follow up questions to clinician or investigator within 2 weeks

Select committee members and clinician/investigator meet to discuss project, project requirements and the development/implementation process

Clinician, with guidance from committee, prepares final application complete with clinical and research outcomes, financials, and overall ROI to organization and community

Formal presentation to LFEP Executive Committee for approval

LFEP Program Structure and Flow

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Resources Required for LFEP Program

5 Major Components

• Oversight / Implementation

• Development of EMR [EPIC (“Clarity”)] fields

• Data Mart Build

• Data Extraction

• Reporting Tool

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Key Positions for LFEP Program

• LFEP Project Manager

• Research EMR Specialist

• Research EDW Specialist

• Report Specialist

• Point-of-Care Support / Data Quality Specialist

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Summary

• Broad-based “buy-in” essential for programmatic success• Clinical / Financial / Political

• “Integration” requires significant culture change !!!• Physicians (drop-down menus; radio buttons; etc.)• Nurses / Clinical Staff (documentation; etc.)• Administrators (clinic flow; charge documentation; etc.)• Among biggest challenges to realization of goals of PHC

• Huge opportunities for those willing / able to change !• Systematic improvement in clinical care• Unprecedented phenotyping of biologic samples • Career advancement of academic faculty (publications)• Expected market advantage for true evidence-based care

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Perspective on LFEP Program…

… inspiration is easy. Implementation is the hard part.

Bob Taylor (Taylor Guitars)