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

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

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

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

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?

S L I D E 6

Our Why: Our mission is innovation

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)

S L I D E 8

Research Flow – Prior to February 2014

S L I D E 9

WHERE ARE WE NOW?

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

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)

S L I D E 12

Research Flow – With Epic/OnCore

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?

S L I D E 14

S L I D E 15

Clinical Trials Unbilled Claims

OnCore

CTMS

Live

Epic

Live

Tools - Resources - Collaboration

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 / Winter2012

Go-live February2013

End of Second LevelFebruary 2014

Pilot of CentralReview May 2014

Fully ImplementedCentral Review

September 2014

Professional billing:

Clinical Trials Unbilled Claims

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: EpicSent: Friday, March 07, 2014 9:31 AMTo: Study PI; Study CoordinatorSubject: ER or In-Pt status notification for research pt's

Epic Serious Adverse Event (SAE) alerts

S L I D E 18

Governance – Clinical Research Committee

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

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

S L I D E 21

Thank you for your participation.

For further information, please contact:

Allen L. Hsiao MD, FAAPAssociate Professor of Pediatrics & of Emergency Medicine

Associate Chief Medical Information OfficerYale School of Medicine | Yale New Haven Health System

phone: (203) 688-7303email: allen.hsiao@yale.edu

Tesheia JohnsonAssociate Director of Clinical Research for Yale School of Medicine

Chief Operations Officer for the Yale Center for Clinical Investigationphone: 203 785-3482

email: tesheia.johnson@yale.edu

Questions?