Use of the Epic Electronic

Health Record for

Comprehensive Clinical

Research Management at Duke

Iain Sanderson, BM, BCh, Denise Snyder, MS, RD, Terry Ainsworth, RN, MS, ACNP, Cory

Ennis, MS, Julie McCauley, Fabian Stone, MBA, MHA, MT, Leigh Burgess, MHA, MEd, MA, Beth McLendon-Arvik, Pharm.D, Colleen Shannon,

JD, and Mark Stacy, MD. Duke Medicine, Durham, NC.

Topics

• A few facts and figures about Duke Clinical Research

• Describe our implementation of Epic 2012 for research

administration at Duke

– Epic as a clinical research patient management system

– Planning, training, testing, go-live

• Candid revelations about our current state

• Conclusions

Duke Medicine Facts and Figures

• 3 Integrated hospitals using a single instance of Epic 2012

– Duke University Hospital 924 beds (live June 22nd 2013)

– Duke Raleigh Hospital 186 beds (March 1st 2014)

– Duke Regional Hospital 369 beds (March 1st 2014)

– 16,318 employees

• >7,000 simultaneous users of Epic (Epic’s largest big bang go-live)

• 2013 Clinical revenues $2.54B, 1.2m outpatient visits

• 2013 Total research revenues - $651m

• 2013 NIH funding $284m - ranked 10th

• 2012 Industry funded research $215m (DCRI ++)

• About 350 clinical studies/year at Duke University Hospital

• ~1% of patients enrolled in clinical studies

The Duke School of Medicine was

Unprepared for Epic….

Aug June Aug

2012 2013 2011

Clinical Systems

Discovery

Start

Research Systems

Discovery

Start Go-Live

Epic was coming whether School of Medicine was

ready or not…

$570m

Clinical

Implementation

Unbudgeted

Research

Implementation

Our existing research management infrastructure

would be swept away.. With 135 clinical systems

Retiring

Systems

No paper

system for

scheduling,

orders, billing!

Capture the Clinical Research workflow in the

EHR using model Epic 2012 functionality

Study

Approval

Study

Registry

Subject

Registry

Scheduling &

Encounters

Study

orders

Billing grid

Research Security Model

Separation of

study and standard

of care charges

Research

billing review

SAP/ General Ledger

fund code

management

Study

Labs/

Results

Study

Documentation

Data capture

Study

Drug

Recruitment, Added Value

(BPA’s, RFD, MyChart) Study

Order sets

Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6

Charg

e c

ode

C

PT

C

harg

e c

ode

C

PT

Standard

Of Care

Study

Sponsor

Excel Study “Grid”/ study initiation

Research Revenue Cycle

Order Set/ Beacon build

Study Calendar

Initial Timeline..

Aug Sept Oct Nov Dec Jan Feb Aug

2012 2013 2011

Clinical Systems

Discovery

Start

Research Systems

Discovery

Start

RAC RAC RAC RAC

Current State Future State

Research Calendaring and

Ordering Workgroup

Validation

Research Workflow Validation – February 6th

• Stop Light Evaluations

• 90+ Subject Matter Experts and Stakeholders from

across the Research Enterprise – A success based on

Feedback.

Epic’s Research Implementation at

Duke - Timeline

Feb Mar Apr May June July 2013

Billing Calendar

And Order Set

Build (ongoing)

Wave 4 Go

Live June 22nd

Validation

Feb 6th

Example

build

Curriculum

development Super

User

Training

Train

800

CRCs

Send staff to Epic for training

and certification

Maintenance

Build

Epic Build for Research

• Build artifacts

– Study registry, research security templates, study calendars, order sets, Beacon protocols

• Created a “war room” of co-located staff

– 6 staff from Duke Office of Clinical Research

– 8 staff from PRMO (Revenue staff)

– Contractors – 4 order set builders, 2 willow builders, 1 coordinator, 2 Beacon build

• 500+ study calendars built on time

• But Order sets and Beacon protocols were much harder….

– A $2m investment over 18 months and ongoing…

• And train over 900 staff ( CRC’s, PIs etc)

Other Preparations for Go-live

• Go live and training website and materials

– Tip Sheets, videos, command center information

– PI research order “sign off” instructions

– CRC training documentation

• Testing – needed to create test scripts

• Town Halls, “Research Wednesdays”, and a communication blitz led by the Dean

• Create the command center and staff it

• Cut over activities (500 appointments, 2000 security profiles, 9000 existing enrolled subjects)

• Go-live June 22nd 2013

Go-live June 22nd 2013 Command Center

Where are we now?

• Transformed workflow for the management of clinical

research across Duke

– Now dealing with the fall-out

• Achieved split billing with a complete revenue cycle for

research*

• Duke Office of Clinical Research (DOCR) established as

central administrative/operational body for research

support

• Epic as a Clinical Research Patient Management System

Some Stats about our Implementation E

nro

llment

Month since go-live

610 Actively enrolling protocols

31 Closed protocols

13,289 actively enrolled subjects

25,803 encounters linked to protocols

The Research Engine

continues to run!

But …We Remain on Bill Hold • Ending 100% bill hold is taking longer than expected

– Holding steady at about $11M since go live. Recently $16m

– 10 temporary staff in our central billing office review all

charges

…We still have Research Billing Errors and

need a significant staff to correct them..

• Correct research billing can break down:

– If clinic/clinical staff cancel the study order set and re-enter what

they think is right.

– CRC’s fail to link an encounter to a study

• Charges that have no linkage to a study get sent to

insurance by default.

• Our 100% bill hold captures these by casting a very wide

net for charge review by 10 charge review staff.

• We will remove 100% bill hold when:

– <5% billing corrections on a study AND

– Linkage compliance overall is >95%

• At least now we can MEASURE it all!

• Currently we have 93/644 studies with

Charge correction rates of < 5%

• Overall correction rate 22.1%

Charge Corrections

Conclusions (1) • Despite our current difficulties we will succeed – at least we

can measure progress and train targeted staff.

• This has been expensive for the SOM …>$2m, but

miniscule compared to the $570m clinical implementation.

• This degree of institutional commitment was only possible by

aligning our research go-live with the clinical go-live

• Research staff – 900 CRCs – are resistant to change and

not especially tech savvy. This is a paradigm shift for them

and many will not stay on.

• This effort has ruthlessly revealed all the flaws in our original

processes, and many questionable practices had to be

addressed head on. Eg zero enrolling studies

• Has also required scrupulous attention to detail in terms of

Study planning, coding, chargeables and orderables.

Conclusions (2)

• An unexpected bonding and collaborative experience with our researchers. Solidified central research management.

– “ at least we’re not suffering like the clinical side…”

• Caused us to question the role of our CTMS solution and the need for the RPE interface

• We are looking forward to the patient engagement, Data Capture, and recruitment enhancements in Epic ( BPAs, RFD, MyChart)

• I believe that Epic will inevitably expand in this space and assume much of the functionality of traditional CTMS

– They are already designing a WYSIWYG order set design tool for research for 2016 +

Duke’s 2015 Clinical

Research Systems

Epic:

Clinical Research

workflow

Clinical Studies,

Subjects,

Research

Charges,

MyChart,

BPAs

RFD

Velos

eResearch:

CTMS

All clinical and non-

clinical study registry,

All subjects registry,

Volunteer registry,

Sample tracking,

Invoicing, AE

Management,

Financial mgt EDW/ Research

Management Data

Mart:

All Velos data,

All Epic data,

All eIRB data,

All Reporting,

(NCI reporting)

EDC:

REDCap

RFD

Daily

Export

Studies,

Subjects,

Charges

ETL

Click

eIRB

Studies,

Named

Personnel

Duke Office

of Clinical

Research Custom Interface

SAP:

FCs