Duke Maestro Care and Clinical Research: 1 st Town Hall Meeting

Transcription

1 6// Duke Maestro Care and Clinical Research: st Town Hall Meeting Dean Nancy Andrews, MD, PhD Dr. Iain Sanderson, Chief Research and Academic Information Officer. Dr. Mark Stacy, Vice Dean for Clinical Research Tuesday th June Panelists Terry Ainsworth, MS, RN, NP, Associate Director of Research Operations, Duke Office of Clinical Research (DOCR) Leigh A. Burgess, MHA, MEd, MA, Chief Research Operations Officer Duke Cancer Institute Cory Ennis, MS, Senior Manager, IT Denise Snyder, MS, RD, CSO, LDN, Assistant Dean for Clinical Research, Duke Office of Clinical Research (DOCR) Mark Stacy, MD, Vice Dean for Clinical Research Fabian Stone, MBA,MHA, MT(ASCP), Senior Director, Revenue Cycle Management, PRMO Town Hall Format Introduction Dean Nancy Andrews, MD, PhD Epic for Research How did we get here? Questions for the Panel What does this mean for me and what happens at Go live? Questions for the Panel What does this mean for Clinical Research and patients at Duke? Questions for the Panel

2 6// How did we get here? We mapped Current Workflow for Managing Clinical Research. It s complicated. but this started a valuable collboration! We examined the Workflow of Research Billing Retiring Systems!

3 6// We decided to use Model Epic Research Functionality RAC Executive Committee Nov Order Sets And Billing Calendars = New in Epic We agreed to a Future State Workflow in a large workgroup of the Research Advisory Council Epic Screens Study Grid Result Much Simplification and Integration Retiring Systems Epic

4 6// Clinical Research and Maestro Timeline Research Systems Discovery Start Current State Research Calendaring and Ordering Workgroup Future State Validation RAC RAC RAC RAC Aug Sept Oct Nov Dec Jan Feb Research Workflow Validation February 6 th Stop Light Evaluations 9+ Subject Matter Experts and Stakeholders from across the Research Enterprise feedback We are going to need some definitions... "Study grid" the mandated grid of cycles, actions, drugs and tests that is required for IRB approval of a clinical research protocol. Submitted by study teams and maintained by DOCR. "Clinical template" the collection of clinically relevant actions, comments and notes that accompany the cycles of an oncology protocol and are used by providers as part of clinical care. "Grillendar" a modified study grid, with added Epic specific fields, charges, EAP and procedure codes verified by the PRMO and corresponding to the cycles of a research protocol. Created by a combination of the PRMO and DOCR, it is the necessary substrate for a study calendar. "Study Calendar/AKA Billing calendar is the instantiation in Epic of a built research protocol, either through Beacon or through an order set, combining the cycles of the protocol with detailed charge, payer and coding mapped so that as orders are fulfilled, charges are routed appropriately to the corresponding payer. 4

5 6// Grillendar How Does it Work? Visit Visit Visit Visit 4 Visit 5 Visit 6 Order Set/ Beacon Protocol Study Calendar Charge code CPT Charge code CPT Standard Of Care Study Sponsor Which studies need order sets and billing calendars by Go live? 447 Active studies in eirb Excluding: Exempt studies No CRU oversight (i.e. DCRI) Data analysis only Retrospective Studies Completed but data analysis ongoing Completed but subject follow up 85 Build these First! High Priority Non oncology 55 High Priority Oncology (Beacon) PRMO feedback:.high charges AND IDEs. Blue grids (other payers). Striped grids 4. Charges > $4, 5. Yellow/green/pink grids 6. Two color grids 7. One color grids CRU feedback: External sponsors Recent enrollment? Total Enrollment? Active after June? 787 Maestro for Research Timeline since Validation Maintenance Planning Validation Feb 6 th Billing Calendar, Beacon Protocol And Order Set Build Wave 4 Go Live June nd Feb Mar Apr May June July Curriculum development Train users Integrated Testing Reporting Cutover 5

6 6//...Questions for the Panel Terry Ainsworth, MS, RN, NP, Associate Director of Research Operations, Duke Office of Clinical Research (DOCR) Leigh A. Burgess, MHA, MEd, MA, Chief Research Operations Officer Duke Cancer Institute Cory Ennis, MS, Senior Manager, IT Denise Snyder, MS, RD, CSO, LDN, Assistant Dean for Clinical Research, Duke Office of Clinical Research (DOCR) Mark Stacy, MD, Vice Dean for Clinical Research Fabian Stone, MBA,MHA, MT(ASCP), Senior Director, Revenue Cycle Management, PRMO 6 What does this mean for me and What happens at Go live? 7 Training 55+ Clinical Research Coordinators have registered and will receive 4 hours classroom training 5 of these have received Medication Administration Training Online training for over 5 research staff who need view only access to Maestro for Chart Review Online Training for PI s, faculty and other research staff Over PRMO and Compliance Office Staff will have received classroom training Maestro.duke.edu Clinical Research 8 6

7 6// Maestro.duke.edu Clinical Research 9 What Happens at Go live? Maestro IS ALREADY LIVE IN PRODUCTION All new appointments are in Maestro CRCs are associating encounters with the research flag June nd is a Saturday Command Center Blue Shirts are st Level of User Support in the field and are dispersed across clinics. Zone Captains liaise with Command Center. DHTS Helpdesk & Maestro Care Command Center staff perform st level of centralized support. Research Super Users perform nd level of support and interface with builders and other Maestro Care support teams in the Command Center. Help will be close at Hand Building JUST IN TIME order sets and Beacon Protocols It s been hard to build and validate order sets and Beacon Protocols in Maestro Much harder than the clinical build Requires QA and validation at every step Study calendars are all built So we have been building order sets and Beacon Protocols JUST IN TIME based on criteria such as inpatient study or study has an appointment in June and July as we improve our build velocity 7

8 6// Grillindar Contingency Planning. Ad Hoc Ordering.. Visit CRC places Ad Hoc orders based On Grillindar Study Calendar Charge code CPT Charge code CPT Standard Of Care Study Sponsor...Questions for the Panel Terry Ainsworth, MS, RN, NP, Associate Director of Research Operations, Duke Office of Clinical Research (DOCR) Leigh A. Burgess, MHA, MEd, MA, Chief Research Operations Officer Duke Cancer Institute Cory Ennis, MS, Senior Manager, IT Denise Snyder, MS, RD, CSO, LDN, Assistant Dean for Clinical Research, Duke Office of Clinical Research (DOCR) Mark Stacy, MD, Vice Dean for Clinical Research Fabian Stone, MBA,MHA, MT(ASCP), Senior Director, Revenue Cycle Management, PRMO What does this mean for Clinical Research and patients at Duke? 4 8

9 // 5/9/ 5// 5// 6// 6/4/ 6/5/ 6/6/ 6/7/ 6// 6// Beacon Build Process for an oncology protocol.. Building these is HARD and requires multiple steps.. Clinical and Billing Build Beacon & Billing Build Validation Clinical Build Review DG Pharmacist Review Needed ICS Pharmacist Review Needed Building Establish & Prioritize Protocol Arms Protocol Arms Successfully Reconciled & QA Complete Ready for Beacon Review Protocol Arms Ready for End User Validation DOCR/PRMO Review Needed Study Team Review Needed In Beacon Review Grillendar Build Review Billing Build Ready for Billing Build Protocol Arms Successfully Validated. But the hard work is worth it! Cycle and Day View Cycle and Category View 6 Non Oncology Research Studies that involve Inpatients enrolling in June/July IP Just in Time (Studies with Known Patients) IP Just In Time Technical Orders Orders Willow Willow Grillindar In Grillindar Design Not Started Grillindar QA Technical QA Technical QA Technical QA Technical QA Complete. Design. QA Design Complete Complete Started Complete Started 5 % % % % % 6% 4% % % % Orders Build in Orders Build Willow Build in Willow Build All Build. Build Progress Complete Progress Complete Complete 4. Validate Ready to Validate Validation Complete Re Build Re Validate Approved 9% % % 4% % 4% 6% 48% % 9% 4% 4% Overall IP Just In Time Content Design and Build Progression (Manual Weekly Update) Total: Approved Re Validate Re Build Validation Complete Ready to Validate Willow Technical QA Complete Willow Technical QA Started Orders Technical QA Complete Orders Technical QA Started All Build Complete Willow build complete Willow Build in Progress Orders Build Complete Orders Build In Progress Technical QA Complete Design Complete In Design Not Started Most Moved from build to Validate We are increasing our velocity Next up Just In Time August studies, then JIT September. Then hopefully catch up. 9

10 6// Fiscal Result of Research Bill Hold % research bill hold Jun Jul Aug Sept Clinical and Research Revenue Revenue Temporary Revenue Gap and increase in Accounts Receivable For both research revenues ( from sponsor) And from payers ( for standard of care charges) PRMO has hired 7 temporary staff to process research related charges Hopefully our new system will make it very easy to manage and reduce the need for % bill hold and any delay! Longer term effects of Maestro for Clinical Research Maestro has forced a degree of discipline and precision in study planning/coding/ordering not seen before We will need to build grillindars, order sets or beacon protocols, and study calendars for all new studies This will start on IRB submission An investment by the SOM and DOCR in the central management of Site Based Research at Duke Maestro will become the final common path to study initiation and patient enrollment Maestro will become our Research Patient Management System Patients should see a streamlined process with more opportunities to participate in research 9 Maestro s Potential for Clinical Research Epic s Research Patient Management improve research efficiency, conduct and workflow, and facilitate compliant study billing. Maestro will simplify data stewardship at the enterprise scale (vs. 5 separate systems). Maestro s Best Practice Advisories can be harnessed to search for inclusion and exclusion criteria for clinical studies, enhancing recruitment during clinical workflow Collection of patient reported outcomes will be enhanced by Maestro s My Chart patient portal. Maestro s clinical Registries provide opportunities for focused research. We will explore Maestro s capability of retrieving a case report form for a clinical trial participant during normal clinical workflow using a standards based mechanism called Retrieve Form for Data Capture (RFD) Coming Soon in Optimization BPA s, MyChart Questionnaires, RFD forms As services provided by DOCR (similar to REDCap services).

11 6//...Questions for the Panel Terry Ainsworth, MS, RN, NP, Associate Director of Research Operations, Duke Office of Clinical Research (DOCR) Leigh A. Burgess, MHA, MEd, MA, Chief Research Operations Officer Duke Cancer Institute Cory Ennis, MS, Senior Manager, IT Denise Snyder, MS, RD, CSO, LDN, Assistant Dean for Clinical Research, Duke Office of Clinical Research (DOCR) Mark Stacy, MD, Vice Dean for Clinical Research Fabian Stone, MBA,MHA, MT(ASCP), Senior Director, Revenue Cycle Management, PRMO