Use of the Epic Electronic Health Record for Comprehensive Clinical Research Management at Duke

Transcription

1 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.

2 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

3 Duke Medicine Facts and Figures 3 Integrated hospitals using a single instance of Epic 2012 Duke University Hospital 924 beds (live June 22 nd 2013) Duke Raleigh Hospital 186 beds (March 1 st 2014) Duke Regional Hospital 369 beds (March 1 st 2014) 16,318 employees >7,000 simultaneous users of Epic (Epic s largest big bang golive) 2013 Clinical revenues $2.54B, 1.2m outpatient visits 2013 Total research revenues - $651m 2013 NIH funding $284m - ranked 10 th 2012 Industry funded research $215m (DCRI ++) About 350 clinical studies/year at Duke University Hospital ~1% of patients enrolled in clinical studies

4 The Duke School of Medicine was Unprepared for Epic. Clinical Systems Discovery Start $570m Clinical Implementation Research Systems Discovery Start Unbudgeted Research Implementation Go-Live Aug Aug June Epic was coming whether School of Medicine was ready or not

5 Our existing research management infrastructure would be swept away.. With 135 clinical systems Retiring Systems No paper system for scheduling, orders, billing!

6 Capture the Clinical Research workflow in the EHR using model Epic 2012 functionality Recruitment, Added Value (BPA s, RFD, MyChart) Study Order sets Study Approval Study Registry Subject Registry Scheduling & Encounters Study orders Study Drug Billing grid Study Labs/ Results SAP/ General Ledger fund code management Research billing review Separation of study and standard of care charges Study Documentation Data capture Research Security Model

7 harge code CPT Charge code CPT Excel Study Grid / study initiation Research Revenue Cycle Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Order Set/ Beacon build Standard Of Care Study Calendar Study Sponsor

8 Initial Timeline.. Clinical Systems Discovery Start Research Systems Discovery Start Current State Research Calendaring and Ordering Workgroup Future State Validation RAC RAC RAC RAC Aug 2011 Aug Sept Oct Nov Dec Jan Feb

9 Research Workflow Validation February 6th Stop Light Evaluations 90+ Subject Matter Experts and Stakeholders from across the Research Enterprise A success based on Feedback.

10 Epic s Research Implementation at Duke - Timeline Send staff to Epic for training and certification Maintenance Build Validation Feb 6 th Billing Calendar And Order Set Build (ongoing) Wave 4 Go Live June 22 nd Feb Mar Apr May June July 2013 Example build Curriculum development Super User Training Train 800 CRCs

11 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)

12 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 22 nd 2013

13 Go-live June 22 nd 2013 Command Center

14 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

15 Enrollment Some Stats about our Implementation The Research Engine continues to run! Month since go-live 610 Actively enrolling protocols 31 Closed protocols 13,289 actively enrolled subjects 25,803 encounters linked to protocols

16 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

17 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!

18 Charge Corrections Currently we have 93/644 studies with Charge correction rates of < 5% Overall correction rate 22.1%

19 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.

20 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

21 Duke Office of Clinical Research Epic: Clinical Research workflow Clinical Studies, Subjects, Research Charges, MyChart, BPAs RFD EDC: REDCap RFD SAP: FCs Click eirb Studies, Named Personnel Daily Export Studies, Subjects, Charges EDW/ Research Management Data Mart: All Velos data, All Epic data, All eirb data, All Reporting, (NCI reporting) Duke s 2015 Clinical Research Systems Custom Interface Velos eresearch: CTMS All clinical and nonclinical study registry, All subjects registry, Volunteer registry, Sample tracking, Invoicing, AE Management, Financial mgt ETL