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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
3INTERMACS Coordinator
Training
March 2012
• We would like to welcome our new INTERMACS hospitals.
• We would also like to welcome any hospitals that are considering joining INTERMACS
INTERMACS Coordinator
Training
March 2012
We would like to welcome our new INTERMACS hospitals in Canada
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 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.
Sixth Annual Meeting, March 11, 2012
INTERMACS Coordinator
Training
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
INTERMACS Coordinator
Training
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
INTERMACS Coordinator
Training
March 2012
Original ContractMay 31, 2005 – May 30, 2010
Contract ExtensionMay 31, 2010 – November 30, 2010
Second ContractDecember 1, 2010 – November 30, 2015
Sixth Annual Meeting, March 11, 2012
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
COURSE OBJECTIVES
Obtain better understanding of WBDE System
Management of adverse event reporting
Review registry data compliance and data elements
11INTERMACS Coordinator
Training
March 2012
Coordinator Training Session, March 11, 2012
Nurse Monitors
12INTERMACS Coordinator
Training
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
13INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
Status of INTERMACS Re-Launch
14
INTERMACS Myers
pediMACS Naftel
Local IRB Submission Clark
and Hospital Enrollment
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
INTERMACS
Susan L. Myers
INTERMACS Database Administrator
15INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 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
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
INTERMACS Re-launch Status
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
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
INTERMACS Re-launch Status
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”
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
pediMACS
David C. Naftel, PhD
19INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 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.
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 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
21INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
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
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
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
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
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
INTERMACS Coordinator
Training
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
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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
INTERMACS Coordinator
Training
March 2012
Institutional Review Board
or
Ethics Board
Submission
Mary Lynne Clark
Regulatory Manager
INTERMACS
INTERMACS Coordinator
Training
March 2012
Coordinator Training, March 11, 2012
If you want to make enemies,
try to change something.
~Woodrow Wilson
INTERMACS Coordinator
Training
March 2012
INTERMACS Changes
• Protocol 3.0
• Consent Documents
• Users’ Guide
• Web Based Data Entry
Wednesday, April 4, 2012
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
INTERMACS Changes
• Protocol 3.0
• Consent Documents
• Users’ Guide
• Web Based Data Entry
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
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
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
INTERMACS Changes
• Protocol 3.0
• Consent Documents
• Users’ Guide
• Web Based Data Entry
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
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
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
INTERMACS Changes
• Protocol 3.0
• Consent Documents
• Users’ Guide
• Web Based Data Entry
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
Users’ Guide
Today’s discussion
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
INTERMACS Changes
• Protocol 3.0
• Consent Documents
• Users’ Guide
• Web Based Data Entry
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
Web Based Data Entry
Today’s discussion
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
First to provide IRB approval for the Protocol version 3.0
Univ. of Iowa Hospitals and Clinics
Received on 2/3/2012
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
I just submitted version 2.3 for approval.
What do I do now?
Enrolling Sites
Oh no!!
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
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
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
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
INTERMACS Coordinator
Training
March 2012
Busy: engaged in action; full of activity
www.merriam-webster.com, 3/9/2012
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012
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
Coordinator Training, March 11, 2012
INTERMACS Coordinator
Training
March 2012