When Research Fails: Integrating Research into EHR

Transcription

1 When Research Fails: Integrating Research into EHR HCCA Research Compliance Conference Austin, Texas Session 301 June 3, 2013 Presenters Marti Arvin, JD, CHC F, CPC, CCEP F, CHRC, CHPC Chief Compliance Officer, UCLA Health System & David Geffen School of Medicine Shanley Curran, RN, Esq., CHC, CCRP Clinical Research Billing Compliance Manager, UCLA Health System & David Geffen School of Medicine 1

2 Agenda EHR design and research The challenges of mixing existing processes into one solution The experiment of getting your CTMS and your EHR to talk to each other Your petri dish issue: changing the culture of your research community EHR Design and Research EHR are designed for patient care not for research. Research issues for EHRs were an added consideration One database versus multiple legacy systems Where is the data? How is it being entered and stored? 2

3 EHR Design Challenges EHR are designed for patient care, why does this matter? All services must generally be tied to an encounter The encounter is created using MRN and demographic information Not all research studies want information about the subject identified in the system Not all services are for human subjects EHR Design Challenges Better Late Than Never Academia was late to the party and so the focus on research for the EHR vendors was not as great. We are just now beginning to see EHR designs that consider research and its special needs EHRs will not likely ever have the added functionality of a CTMS so don t hold your breath. 3

4 EHR Design Challenges Legacy Systems When you merge multiple legacy systems into one database like EPIC you begin to see what was occurring in the legacy systems You need to involve multiple players to determine how to integrate past practices into the new systems Do you even want to do so? Do you give a pig an MRN? The Challenges Of Mixing Existing Processes Into One Solution Resourcing Selecting and authorizing protocol author(s) Overcoming decentralized models and legacy assumptions EHR functional capability (or lack of) Communication across the Enterprise Training and Support Unanticipated AEs Protocol conduct new/revised policy needs Continuing Review compliance oversight at every step 4

5 The Challenges Of Mixing Existing Processes Into One Solution Resourcing Selecting and authorizing the protocol author(s) Broad Knowledge and experience System functionality all applications Research administration and conduct Enterprise Structures and Leadership Institutional Research Administration Institutional Fund account management Communication, organization, and follow up skills With other system application build leaders With leadership, stakeholders and end users EHR Health System School of Medicine The Challenges Of Mixing Existing Processes Into One Solution Overcoming decentralized models Identifying legacy research workflows and presumptions Identifying and integrating stakeholders unravel the autonomy and come into the sandbox Hospital, School of Medicine, and Physician Leadership Hospital Finance and Revenue Cycle Leadership Professional Billing Office Cancer Center and other high research volume Department leaders IRB is this your only current existing database of all clinical studies? Identifying end users skills and needs 5

6 The Challenges Of Mixing Existing Processes Into One Solution Overcoming decentralized models (continued) Development of new centralized tools and resources Who owns, oversees, and where do they reside for access EHR Resource Website Research Page with Study Submission Form and Job Aides Standardized research rates and implementation policy Planning for Implementation Issues Coverage analysis review Include billing codes and modifiers? Access The Challenges Of Mixing Existing Processes Into One Solution EHR functional capability (or lack of) This is not a CTMS Continuing use of Department databases? Research account set up and what information must/should it hold? Submission form, process, and validation Self pay deceased patient account or Guarantor or Corporate Account Other study information/documents (ICF, subject protocol calendars ) Privacy Keeping research out of the medical record Which research service locations are captured? Research Record Numbers or other anonymization Research Notes Legal Medical Record v. Designated Medical Record Security templates and access issues Investigational drugs Protocol Order Entry Roles, Security, and Pending Order Entry 6

7 The Challenges Of Mixing Existing Processes Into One Solution Communication across the Enterprise Leadership Messaging to authorize, require, and direct participation Research Application Build Meetings attendees, date coordination, space Hospital billing team Professional billing teams, and Study Team Research study corrections Scheduling Issues Post service charge corrections check your back end correction process Refunds and recharges Coverage Analysis Subject Protocol Visit Dates Study Fund Account Issues Research Rates The Challenges Of Mixing Existing Processes Into One Solution Training and Support Initial and Ongoing Research Clinical Workflow Research Charge Review Security Access Templates Job Titles and Training Tracking Identifying new end users Include all involved Applications lab, pharmacy, radiology, scheduling, hospital and professional billing, other Dog and Pony Shows and Brown Bag Lunch Series etips Program Unanticipated AEs Campus Departments outside the Health System/EHR but conducting research within it MRN creation timing and process 7

8 The Challenges Of Mixing Existing Processes Into One Solution Protocol conduct new/revised policy needs Continuing Review Incident/Issue Hotline, Tracking, Response Work queue back log tracking and response Research Claim Denial tracking and response Research record updates/changes and approvals/validation Revenue Cycle Research Workgroup Optimization Efforts The Experiment Of Getting Your CTMS And Your EHR To Talk To Each Other Survey Total of 14 questions 61 total participants Not everyone answered every question 8

9 Who has a CTMS? 64% (39)of respondents have 1 or more CTMSs Of those that do not have a CTMS currently (21 respondents) 14% do not plan on acquiring one 10% will be acquiring one in the next 6 months 14% will be acquiring one in the next year 14% will be acquiring one in the next 2 years 48% will be acquiring on but they are not sure when 9

10 Importance of EHR/CTMS interface Of the 47 of respondents who indicated they were acquiring or moving to a new CTMS 4% did not consider the ability to interface with the EHR as important 21% indicated it was somewhat important 42% indicated it was very important 32% indicated it was a critical factor 10

11 Who created the CTMS? Of the 41 respondents to this question 12% had an internally created CTMS 63% had a vendor product 24% had a blend of both Who Are the Vendors? Of the 29 respondents who answered this question 28% (8) had Velos 38% (11) had OnCore 17% (5) had ClickCommerce 7% (2) had PeopleSoft 31% (9) had some other system 11

12 What is the trend for CTMSs? Of 41 respondents 90% of those that have a single CTMS now did not have multiple systems in the past Current Interface Components When asked which components currently interface between an existing EHR and the CTMS the responses were subject enrollment data from the CTMS to the EHR Subject demographics Protocol calendar Coverage analysis Informed consent Auto upload of the case report form 12

13 Importance of Interface Components When asked which items would be most important to interface 31 respondents indicated, by order of importance Coverage analysis Subject protocol calendar Subject demographic information from the EHR to the CTMS Subject enrollment data from the CTMS to the EHR Research fee schedule EHR results viewing in the CTMS Informed consent document Auto upload of the case report form from the EHR Study budget HIPAA authorization Series1 0 13

14 For this with an interface between the EHR and the CTMS How easy was it to create? 9% indicated it was easy 64% indicated somewhat difficult 27$ indicated it was very difficult Your Petri Dish Issue: Changing The Culture Of Your Research Community Fear and its many derivatives Crafting the best message Into the light trust, training, resources, compliance oversight Communication pathways New Responsibilities for End Users implications for HR Study pre award process change needs Front end accuracy and claim generation No more back end clean up Pursuit of a Clinical Research Compliance Committee Pursuit of a Central Clinical Studies Office 14

15 Questions and Answers 15