Committee on Clinical Research (CCR)

October 20, 2014

Agenda

• EPIC for Research – Partners eCare (PeC) Research Council (Maurizio Fava)

• Role • Membership • Subcommittees

– Partners eCare (PeC) Subject Recruitment & Clinic / Research Interface Workgroup (Maurizio Fava and Tatiana Koretskaia) • Tools (RSVP for Health, HOPE, ResearchMatch) • Consent to Contact (opting in at registration)

– Partners eCare (PeC) Clinical Reports (Kay Ryan)

• CROI for Clinical Research (Maurizio Fava and Tatiana Koretskaia) • Biostatistics for Clinical Researchers (Maurizio Fava)

EPIC for Research

Partners eCare Research (PeC) Council

– Role

– Membership

– Subcommittees

EPIC for Research PeC Research Council (Role)

The PeC Research Council is designed to provide oversight, guidance and recommendations regarding how Partners can leverage the new Epic electronic medical record to conduct research and use clinical data in research activities.

The PeC Reserch Council – is composed of members from each Partners institution,

– meets on a monthly basis for 90 minutes and reports to the PeC Clinical Steering Committee,

– chaired by Dr. O’Neil Britton, Chief Health Information Officer Partners HealthCare and PeC Executive Director.

EPIC for Research PeC Research Council (Membership)

Council Members Entity

James Berry, MD PHS/MGH/BWH

Barbara Bierer, MD BWH

Ihor Bilyk, MD NSMC

Alisa Busch, MD, MS McLean

Merit Cudkowicz, MD, MSc MGH

George Demetri, MD DFCI

Kim Durniak, PhD PHS/MGH/BWH

Kathy Hall, RN MGH

Kim Fechtel MEEI

Elliot Israel, MD BWH

Andrew Karson, MD MGH/PHS

Anne Klibanski, MD PHS/MGH

Mary Mitchell PHS/BWH/MGH/S

RH/McL

Shawn Murphy, MD, PhD PHS/MGH

Council Members, cont. Entity

David Nathan, MD MGH

Harry Orf, PhD MGH

Pearl O'Rourke, MD PHS/MGH

Daniel Pallin, MD, MPH BWH Research

Deborah Schrag, MD, MPH DFCI

Benjamin Scirica, MD, MPH BWH

Stan Shaw, MD, PhD MGH

Nathaniel Sims, MD MGH

Scott Solomon, MD BWH

Theresa Stone PHS/BWH/MGH

Ravi Thadhani, MD, MPH PHS/MGH

Adam Wright, PhD BWH

Ross Zafonte, DO SRH

Council Chairs Entity

Maurizio Fava, MD MGH

Calum MacRae, MD, PhD BWH

Staff Entity

Andy Karson, MD, MPH PHS

Diane Keogh PHS

Holly Bar Vermilya PHS

Scott Collins ACN

EPIC for Research PeC Research Council (Subcommittees)

• Subject Recruitment and Clinic/Research Interface

• Genomics

• Research Patient Engagement

• Big Data

• Research Governance (no longer active)

EPIC for Research

PeC Subject Recruitment & Clinic/Research Interface

– Research BPAs

– Tools (RSVP for Health, HOPE, ResearchMatch)

– Consent to Contact (opting in at registration)

EPIC for Research

PeC Subject Recruitment & Clinic/Research Interface

– Research BPAs should:

• be developed using complex, solid algorithm with maximum sensitivity and specificity

• be presented to both providers and patients: patients should receive a summary of recommended studies at the end of the office visit

• not be geographically limited

Requires further discussion: Incentives for providers to use Research BPAs (advantages and disadvantages of monetary compensation)

EPIC for Research

PeC Subject Recruitment & Clinic/Research Interface

– Tools (RSVP for Health, HOPE, ResearchMatch) • On-line volunteer community; initially funded by PHS; supported by CRP and CCI

• Currently in the network: 24,000 potential volunteers

• Volunteers register to be contacted directly about studies when they

– Provide their contact preference (email of US Mail)

– Indicate therapeutic interests including healthy volunteer studies

• Researches can

– View aggregate, de-identified information to assess study feasibility (no IRB required)

– Send study announcements to volunteers when protocol and announcement is IRB approved. Immediate email contact; CRP and CCI support US mailings

EPIC for Research

PeC Subject Recruitment & Clinic/Research Interface

– Tools (RSVP for Health, HOPE, ResearchMatch) • On-line patient community connected to Patient Gateway (My Chart in EPIC)

• Patients will be able to:

– Join focused communities (diabetes, arthritis, etc.)

– See and request participation in all current IRB-approved research studies relevant to their health based on the information in their on-line profile

– Receive targeted health information (e.g. educational materials, summaries of relevant research articles) and learn about upcoming focused events

• Researchers will be able to:

– Invite patients to join one of the communities. They can then directly reach out to those that “opt-in” and recruit them to relevant human research studies

– Distribute one time surveys/longitudinal questionnaires (only IRB approved protocols)

EPIC for Research

PeC Subject Recruitment & Clinic/Research Interface

– Tools (RSVP for Health, HOPE, ResearchMatch) • On-line volunteer community funded by the NIH via CTSA (hosted at Vanderbilt)

• Currently in the network: 94 institutions (CTSAs &affiliates) and 62,000 volunteers

• Volunteers can:

– Register (basic information) for free

– Search for studies

• Researches can have:

– Feasibility Access (view aggregate, de-identified information, no IRB required)

– Recruitment Access (requires IRB-approved protocol and allows to Search registry for potential matches to their study and send message matching volunteers)

EPIC for Research

PeC Subject Recruitment & Clinic/Research Interface

– Consent to Contact (opting in at registration) • Lead by Elliot Israel

• Goal: Endorse a process that allows patients to consent to direct contact, as approved by the IRB

– Endorsed by E-Care committee

– Endorsed by BWH Medical Staff Executive Council and MGPO

– Endorsed by Partners’ Academic Executive Council

– Presentation to Patient Access Council (determines registration process)

EPIC for Research

• PeC Clinical Reports (workgroup members)

Dunkless, Debi R. Center for Quality/Safety

Lynch, Karen E.,R.N. Center for Quality/Safety; MGH LCS

Marotta, Sandra Center for Quality/Safety

Tull, Andrea Center for Quality/Safety

Wolf,Katie Chair; MGH eCare

Ryan, Kay MGH Clinical Research Program

Heffernan, James MGPO CFO

LaVoie, Karen MGPO

Lento, Janice Marie MGPO

Morella, Lisa N. MGPO Finance

Shaddock, Nettie Nursing Administration

Brady, Colleen E. Practice Improvement

Cramer, Mary O. Process Improvement

Garber, Annabaker,R.N.,Ph.D. Patient Care Services

Grasso, Antigone C. Patient Care Services

EPIC for Research

• PeC Clinical Reports (examples of clinical reports)

Title PurposePHS ED All Patients in Last 24 Hours

Report

Printable detailed list of all patients who arrived in the ED

within the last 24 hours.

PHS ED All Patients Today with Summary

Report

Find all patients who arrived in the ED today to get an

overview of throughput for the day broken down by key

patient and provider information.

PHS IP Timely Medication Administration

- CR

Monitor medications being administered early for a given

time period by Units and departments

PHS IP Pain Assessment: In House

Dashboard

Identify admitted patients who have upcoming or overdue

pain assessments.

PHS IP Low Temperature ReportReport of patients temperature falls below a threshold

with the last 24 hours.

PHS IP My Patients - Temperature >

101.5 in Last 24 Hours Report

Manage the care of patients whose care team you are a

part of and who have a recorded temperature greater

than 101.5 degrees in the last 24 hours.

Cardiology Non-Invasive Studies Today

Monitor a list of all non-invasive cardiology imaging orders

scheduled for today

Imaging Studies Today

Monitor a list of all imaging orders scheduled for today,

including their current statuses

CROI for Clinical Research (CROI dashboard)

Working Group Open New Resolved Closed Submitted

Animal Care 20 0 28 0 48

Central Data 2 0 0 0 2

Clinical Research 68 0 5 10 83

Communications 1 0 5 3 9

Compliance 2 0 5 1 8

Grant Tracking 0 0 1 0 1

Human Resources 7 0 12 5 24

Internet 3 0 1 0 4

Intranet 1 1 3 1 6

IT Infrastructure 8 0 24 0 32

Materials Management 17 0 20 24 61

Research Management 35 1 31 23 90

RVL 8 0 3 0 11

Safety 5 0 9 0 14

Space and Facilities 10 0 28 3 41

Totals 187 2 175 70 434

CROI for Clinical Research (members n=43) Chung, Raymond,M.D. Markmann, James, M.D.

Cole, Andrew,M.D. Michaelson, James, M.D.

Dodson, Thomas,D.M.D.,M.P.H. Nagurney, John, M.D.

Dougherty, Darin,M.D. Nathan, David, M.D.

Duncan, Lyn,M.D. Nierenberg, Andrew, M.D.

Ecker, Jeffrey,M.D. Ogilvy, Christopher, M.D.

Eikermann, Matthias,M.D. Ring, David, M.D.

Eskandar, Emad, M.D. Rosen, Bruce,M.D.

Evins, Anne Eden, MD Rosenberg, Eric, M.D.

Fava, Maurizio, M.D. (Co-Leader) Sharma, Nutan, M.D.,Ph.D.

Feldman, Adam, M.D. Sherry, Nicole, M.D.

Gerszten, Robert, M.D. Simon, Naomi, M.D.

Goldstein, Joshua,M.D.,Ph.D. Spencer, Thomas, M.D.

Greenberg, Steven, M.D.,Ph.D. Stowell, Christopher, M.D.

Grinspoon, Steven, M.D. Temel, Jennifer, M.D.

Jupiter, Jesse, M.D. Velmahos, George, M.D.

Kimball, Alexandra, M.D.,M.P.H. Wang, Thomas, M.D.

Koretskaia, Tatiana, MBA (Co-Leader) Wilhelm, Sabine, PhD

Kuo, Braden, M.D. Wills, Anne-Marie, M.D.

Lawson, Elizabeth, M.D. Winter, Harland, M.D.

Li, Guoan, Ph.D. Wozniak, Janet, M.D.

Linton, Pat

CROI for Clinical Research (suggestions)

TOTAL Suggestions N=83

IRB Operations N=40

eIRB N=12

General Resources N=17

PCRO/MGPO/RM N=14

CROI for Clinical Research (suggestions)

TOTAL Suggestions N=83 IRB Operations N=40 Some of the Issues – Turn-Around Time – Quality of Review – General Communication Current Status – PHS publishes quarterly metrics – IRB had setup a Help Line – PHS uses 3 commercial IRBs for Phase III & IV (Industry

initiated & Industry sponsored studies)

CROI for Clinical Research (suggestions)

TOTAL Suggestions N=83 eIRB N=12 Some of the Issues – Timeframe and anticipated review date – Status of all submissions – IRB should be allowed to make changes to protocol – Manual data entry should be minimized by populating system

data – Ancillary board should be added on Study Staff Amendment Current Status – Issues have either been fixed (current eIRB release) or slated for

next release

CROI for Clinical Research (suggestions)

TOTAL Suggestions N=83 General Resources N=17 Some of the Issues – More Statistical help, especially for small projects with limited funding – More Dept. Res. Admin Support – CRC, though a valuable resource, is difficult to use (scheduling, space,

personnel limitations, as well as cost-prohibitive) Current Status – MATLAB & Stata are available on the High Performance Computing

(HPC) Clusters – Admin support across departments is being reviewed by PHS – MGH establishes new Translational Research Center (TRC)18-bed unit

on White 12 co-located with CRC

CROI for Clinical Research (suggestions)

TOTAL Suggestions N=83 PCRO/MGPO/RM N=14 Some of the Issues – Sponsor Billing: need for centralized, transparent industry

sponsored clinical research billing system (CTMS) – PCRO: turnaround time (TAT) and status of the agreement – RM: Patient Care Correction Form Current Status – PHS has agreed to move forward with the purchase of a CTMS – PCRO is monitoring and working on reducing the TAT – PCRO made the status available online – RM: Patient Care Correction Form is available

CROI for Clinical Research

Submit a suggestion

suggest@research.mgh.harvard.edu

617-724-IDEA

Biostatistics for Clinical Researchers

• New Existing Service

– ongoing grant/research paper preparation support and guidance throughout the duration of K-awards

• Planned Service:

As a part of Simches 2 transformation into a “hub for clinical research”:

• Provide Biostatistician “on call”, also

• Create a CRC satellite

• Move/consolidate bioinformatics

• Establish IRB and Innovation office hours

Thank you!

Upcoming meetings:

Monday, January 26, 2015 8-9 am Trustees Room, Bulfinch 225A

Monday, April 27, 2015 7-8 am Trustees Room, Bulfinch 225A

Monday, August 10, 2015 8-9 am Trustees Room, Bulfinch 225A

Monday, October 26, 2015 8-9 am Trustees Room, Bulfinch 225A