Presentation "Maximizing our IT Investments: Our Experience Integrating the Management of Research and Clinical Care Across the Health System and Practice" Tesheia Johnson, MBA, MHS Chief Operating Officer Yale Center for Clinical Investigation Associate Director for Clinical Research Yale School of Medicine iHT2 case studies and presentations illustrate challenges, successes and various factors in the outcomes of numerous types of health IT implementations. They are interactive and dynamic sessions providing opportunity for dialogue, debate and exchanging ideas and best practices. This session will be presented by a thought leader in the provider, payer or government space.

1. S L I D E 1
Maximizing our IT Investments:
Our Experience Integrating the Management
of Research and Clinical Care across the
Health System and Practice
2014 Health IT Summit
Tesheia Johnson, MBA, MHS
Associate Director for Clinical Research, Yale School of Medicine
Chief Operating Officer, Yale Center for Clinical Investigation

2. S L I D E 2
• Yale School of Medicine:
– 5th in NIH funding
– Research funding: $534 Million
– Total faculty: 1,408
• Yale New Haven Health System:
– 4 hospital campuses
– 3 campuses are primary teaching sites of School
– Strong partnership/affiliation with School
– Separate entities
A Little About Us

3. S L I D E 3
York Street Campus
Saint Raphael Campus
• 2,130 beds
• 18,529 employees
• 6,060 medical staff
• 111,396 inpatient discharges
• 1.6 million outpatient visits
• 289,000 ED visits

4. S L I D E 4
1. Answered our “W and H” Questions:
– “Why, What, Who, When, and How”
2. Defined an ideal future state and set a budget
3. Set priorities and decided how technology would be deployed?
(with support from Epic and CTMS vendor)
4. Developed a timeline
5. Established minimum standards
6. Setup structures and assigned roles / responsibilities for the
collaborative team (added resources where required)
7. Gathered feedback
8. Determined reporting
9. Evaluated progress
10. Developing plans to keep innovating
Our plan
Source: Yale clinical trial design project Huron Consulting

5. S L I D E 5
Answer the “W and H” questions
• Why are we doing this?
• What problems are we hoping to solve?
• Who can help?
• When can it be done?
• How much will it cost?
1
Improved financial performance?
Faster turnaround times?

6. S L I D E 6
Our Why: Our mission is innovation

7. S L I D E 7
How did we set our priorities
• What is important to you? (Leadership, Faculty, Administrators,
Compliance, etc.)
• What is working well? What can be improved?
• What are the short and long term investments required to meet goals?
• Who decides on priorities?
• What is the return on investment expected?
• How will success be judged? (improved process, increased revenue,
better compliance)

8. S L I D E 8
Research Flow – Prior to February 2014

9. S L I D E 9
WHERE ARE WE NOW?

10. S L I D E 10
IT investments - Current Status
Electronic Health Record – version Epic 2014
– Final go-live January 27, 2014 (Epic 2012)
– Four Hospitals, one health plan, one FQHC
– >300 ambulatory sites
– $290 M project. On time and $10 M under budget
Epic Stats
– 2,600 average daily office visits
– 76,000 average daily orders
– 43,459 MyChart patient portal users
– 4 million patients in Epic database

11. S L I D E 11
IT investments - Current Status
OnCore Clinical Trial Management System- version 13.5
– Final go-live January 27, 2014 (along with Epic 2012)
– Yale Practice, Four Hospitals, and all community practice
sites
– Over 100 multi-center studies (across the US and
international)

12. S L I D E 12
Research Flow – With Epic/OnCore

13. S L I D E 13
1. Reporting
2. Clinical research billing management
3. Medicare coverage analysis
4. Research sponsor payments, collections, and better revenue
management
5. Committee management for initial review (Cancer, Pediatrics,
High-Risk)
6. Adverse event reporting
7. ClinicalTrials.gov
8. Quality Assurance monitoring of research
9. Data and Safety monitoring board management
10. Recruitment and clinical research branding support
11. Subject payments for research participation
What functions are we leveraging from IT
investments?

14. S L I D E 14

15. S L I D E 15
Clinical Trials Unbilled Claims
OnCore
CTMS
Live
Epic
Live
Tools - Resources - Collaboration

16. S L I D E 16
$-
$2,000,000
$4,000,000
$6,000,000
$8,000,000
$10,000,000
$12,000,000
Prior to Fall / Winter
2012
Go-live February
2013
End of Second Level
February 2014
Pilot of Central
Review May 2014
Fully Implemented
Central Review
September 2014
Professional billing:
Clinical Trials Unbilled Claims

17. S L I D E 17
Subject: ADVERSE EVENT INFORMATION
Patient: John Smith [MR151000] (DOB: 12/16/1950)
Location: Yale New Haven Hospital Emergency Department
Attending Physicians:
Hospital Service: Emergency Medicine
Type of Event: ED Arrival
STUDY INFORMATION
Name: PHASE II STUDY OF CAFFINE DEPENDANCY RELATED TO PLANNING
EXTERNAL SCIENTIFIC ADVISORY BOARD MEETING
ID: 12070XMS701
From: Epic
Sent: Friday, March 07, 2014 9:31 AM
To: Study PI; Study Coordinator
Subject: ER or In-Pt status notification for research pt's
Epic Serious Adverse Event (SAE) alerts

18. S L I D E 18
Governance – Clinical Research Committee

19. S L I D E 19
• Decide what you want to be when you grow up and work hard
– What kind of things should your integration enable?
– Dreaming in phases is easier and has rewards along the way
• Compliance is important, but not the only thing
– Zero risk = zero research
– What do the faculty care about?
• You can’t do everything at once
– What is first and why?
– Message consistently and constantly
– Get help when you need it
– Allocate resources to your dream
Page 19
Lessons so far and roadmap for the future

20. S L I D E 20
Dreaming bigger, Plans for the future:
Working smarter
Interface Status
Epic EMPI demographic interface existing
Epic RPE study record interface existing
Epic protocol billing grid interface existing
Epic lab value interface (LabSoft) completing testing
Epic RFD interface (case report forms and clinical data exchange) planned
Intelligent recruitment alerts
SAE reporting
Safety alert and SAE reporting
Existing and planned
Epic alerts today,
exploring reporting
options
IRB management system interface planned
Grants and Contracts management system interface planned
BMS2000 Interface - sponsor invoicing existing
BMS2000 Interface - sponsor revenue received planned
Subject payment interface (Bank of America data exchange) planned
Epic alerts today,
exploring RFD interface
and reporting options

21. S L I D E 21
Thank you for your participation.
For further information, please contact:
Allen L. Hsiao MD, FAAP
Associate Professor of Pediatrics & of Emergency Medicine
Associate Chief Medical Information Officer
Yale School of Medicine | Yale New Haven Health System
phone: (203) 688-7303
email: allen.hsiao@yale.edu
Tesheia Johnson
Associate Director of Clinical Research for Yale School of Medicine
Chief Operations Officer for the Yale Center for Clinical Investigation
phone: 203 785-3482
email: tesheia.johnson@yale.edu
Questions?