Sixth Annual Meeting Coordinator Training Session March 11, 2012 5:00pm to 9:00pm Arlington, VA 1 INTERMACS Coordinator Training March 2012

Sixth Annual MeetingCoordinator Training Session

March 11, 2012

5:00pm to 9:00pm

Arlington, VA

1INTERMACS Coordinator

Training

March 2012

Conflict of InterestPresenters and panel members are members of Hospitals, National Heart, Lung and Blood Institute, Food and Drug Administration, United Network for Organ Sharing, and Device Manufacturers.

Financial Disclosures from presenters and panel members include equity interests in the form of stocks and employment, and significant payments to individuals and institutions for consulting and clinical trials.

Please contact INTERMACS for a full list of disclosures.

Sixth Annual Meeting, March 11, 2012

INTERMACS Coordinator

Training

March 2012

Coordinator Training Session: March 11, 2012

Welcome

David C Naftel, PhD

Co-PI INTERMACS

Director of the DCC


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March 2012

• We would like to welcome our new INTERMACS hospitals.

• We would also like to welcome any hospitals that are considering joining INTERMACS


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March 2012

We would like to welcome our new INTERMACS hospitals in Canada


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March 2012


Handouts Agenda Site Users’ Guide Evaluation form All slides from today’s meeting and

tomorrow’s Annual Meeting will be on the INTERMACS website

6

What is INTERMACS ?

INTERMACS is the United States national registry for patients who are receiving durable, FDA approved mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives.



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March 2012

• Facilitate the refinement of patient selection to maximize outcomes with current and new device options.

• Identify predictors of good outcomes as well as risk factors for adverse events after device implantation.

• Develop consensus “best practice” guidelines to improve clinical management by reducing short and long term complications of MCSD therapy.

• Guide clinical application and evolution of next generation devices.

• Utilize Registry information to guide improvements in technology, particularly as next generation devices evolve.

Goals of the Registry


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March 2012

“Perhaps the most successful example of a coordinated effort to study newly introduced devices has been the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), established to capture detailed clinical data on all patients receiving implantable ventricular assist pumps in the United States.”

Postmarketing Surveillance of Medical Devices - Filling in the GapsFrederic S. Resnic, M.D., and Sharon-Lise T. Normand, Ph.D.

February 14th, 2012


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March 2012

Original ContractMay 31, 2005 – May 30, 2010

Contract ExtensionMay 31, 2010 – November 30, 2010

Second ContractDecember 1, 2010 – November 30, 2015



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March 2012


COURSE OBJECTIVES

Obtain better understanding of WBDE System

Management of adverse event reporting

Review registry data compliance and data elements


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March 2012

Coordinator Training Session, March 11, 2012

Nurse Monitors


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March 2012

We Listened (Evaluation from last year’s Coordinator Training and Annual Meeting and

everything we heard throughout the year)

Made changes to the Site Users’ Guide

Handouts

Online Training

Coordinator Training on a Separate Day and Keep the Presentations on Time

WBDE entry modifications

Expansions to the QA Site reports


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March 2012


Status of INTERMACS Re-Launch

14

INTERMACS Myers

pediMACS Naftel

Local IRB Submission Clark

and Hospital Enrollment


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March 2012


INTERMACS

Susan L. Myers

INTERMACS Database Administrator


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March 2012


INTERMACS Re-launch Status

16

Our Goals: Reduce the number of elements and forms Streamline the data entry process Clarify elements that were confusing in the past Examine the AE definitions for current clinical

relevance


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March 2012



17

We (INTERMACS PIs, NIH, various committees, Site Coordinators, Site Administrators, etc.) have spent 1 year reviewing the WBDE in all aspects: AE definitions and other definitions Screens / Forms Data Elements Patient Flow through the WBDE


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March 2012



18

Live test site Currently available (March 9, 2011) Testing by INTERMACS Nurse Monitors Testing by the DCC Data Managers Testing by the INTERMACS Co-PIs Testing by 3 Hospitals (Beta Sites) Testing NOW during this live training session

Target Launch Date: April 4, 2012 Training will be available before launch date

Live Test SiteMarch 9, 2012

LAUNCHApril 4, 2012

Mar 11 - Mar 30

“March Madness”


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March 2012


pediMACS

David C. Naftel, PhD


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March 2012


INTERMACS Re-Launch Status

Our Goals: Reduce the number of elements and forms Streamline the data entry process Clarify elements that were confusing in the past Examine the AE definitions for current clinical

relevance

20

• It became clear that the pediatric VAD patients needed a different web-based data entry system.


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March 2012


pediMACS Launch Status

Pediatric Committee Betsy Blume, MD - Chair David Morales, MD David Rosenthal, MD Peter Wearden, MD Christopher Almond, MD Robert Jaquiss, MD Jonathan Chen, MD Dee Dee Epstein, RN Heidi Moses, MEd, CCRA David Naftel, PhD Tim Baldwin, PhD


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March 2012



22

We (Pediatric Committee, NIH, INTERMACS Co-PIs) have spent 1 year reviewing the WBDE in all aspects: AE definitions and other definitions Screens / Forms Data Elements Patient Flow through the WBDE


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March 2012



23

pediMACS will follow the structure of INTERMACS

A few important changes from INTERMACS: Pediatric patients (< 19 yrs. at time of implant) Includes both durable and temporary support

MCSDs Modifications of AE definitions Possible expansion of quality of life instruments


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March 2012



24

Target Live test site: July 1, 2012 Testing by INTERMACS Nurse Monitors Testing by the DCC Data Managers Testing by the INTERMACS Co-PIs Testing by 3 Hospitals (Beta Sites) Testing by Pediatric Committee

Target Launch Date: August 1, 2012 Online training will be available Training Session in September 2012

Target: Live Test Site

July 1, 2012

Target: LAUNCH Date

Aug 1, 2012Jul 1 - Jul 31


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March 2012



25

Training Session for pediMACS “Mechanical Cardiac Support in Pediatric Heart Disease –

State of the Art 2012”: September 20-22, 2012 The St. Louis Children’s and Washington University

Heart Center


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March 2012

Institutional Review Board

or

Ethics Board

Submission

Mary Lynne Clark

Regulatory Manager

INTERMACS


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March 2012

Coordinator Training, March 11, 2012

If you want to make enemies,

try to change something.

~Woodrow Wilson


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March 2012

INTERMACS Changes

• Protocol 3.0

• Consent Documents

• Users’ Guide

• Web Based Data Entry

Wednesday, April 4, 2012



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March 2012

INTERMACS Changes

• Protocol 3.0


• Users’ Guide




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March 2012

Protocol 3.0• Revised Contract Number

• Increased number of participating sites

• Increased number of contract years

• Revised site enrollment requirements

• Revised annual renewal requirements

• Clarified Inclusion Criteria

• Added Kansas Cardiomyopathy Questionnaire (KCCQ)

• Increased Quality of Life Questionnaire

• Removed Blood and Tissue Collection



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March 2012

INTERMACS Changes

• Protocol 3.0


• Users’ Guide




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March 2012

Consent Documents• Increased number of sites• Increased number of potential subjects• Increased number of contract years• KCCQ• 6 minute walk and gait speed• Increased time for QoL and functional tests• Changed Study to Registry



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March 2012

INTERMACS Changes

• Protocol 3.0


• Users’ Guide




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March 2012

Users’ Guide

Today’s discussion



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March 2012

INTERMACS Changes

• Protocol 3.0


• Users’ Guide




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March 2012

Web Based Data Entry

Today’s discussion



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March 2012

First to provide IRB approval for the Protocol version 3.0

Univ. of Iowa Hospitals and Clinics

Received on 2/3/2012



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March 2012

I just submitted version 2.3 for approval.

What do I do now?

Enrolling Sites

Oh no!!



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March 2012

• Continue with the version 2.3 approval then follow up with the version 3.0 as an amendment.

• Retract the version 2.3 submission

and replace it with the version 3.0



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March 2012

Coordinator Training

UNOS

Jo Smith Rochelle Taylor

Susan Groff Ruth Henson

Kathryn Philibin

DCCKathryn Hollifield Gail MertzJessica Robinson Mary Lynne

Clark

www.intermacs.org


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March 2012

http://www.intermacs.org/

Busy: engaged in action; full of activity

www.merriam-webster.com, 3/9/2012



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March 2012

http://www.merriam-webster.com/

133 Activated Sites (currently 131)

1,705 INTERMACS Personnel

1,267 IRB Approvals since 2006

1,590 Informed Consent, HIPAA, Revoke Authorization, Transfer, Blood / Tissue documents

1,490 Human Subjects Training Certificates

1,805 Financial Disclosure / Conflict of Interest



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March 2012