Coordinator Training Session: March 11, 2012 Major Changes in Data EntryMyers 1 What is the same? What is reduced/removed? What is added/expanded? INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Major Changes in Data EntryMyers 2 What is the same?  No changes in AE definitions (RHF levels added)  Structure remains the same:  FORMS: screening, demographic, pre-implant, follow-up, rehospitalization, discharge, etc.  Follow-up schedule remains the same:  1 week, 1 month, 3 month, 6 month and every 6 months thereafter INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Major Changes in Data EntryMyers 3 What is reduced/removed?  Streamlining of Adverse Event data entry by:  Removal of all AE reminders from: – Follow-up Forms – Implant Discharge Form – Rehospitalization Form  Providing a single data entry ‘place’ for adverse events – Look for this button at the top of the ‘patient overview screen’  Reduction of the implant discharge form  Comorbidities in Pre-Implant form more streamlined and well defined and merged with the contraindications for transplant INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Major Changes in Data EntryMyers 4 What is added/expanded?  We are using a ‘trigger’ process for some Adverse Events:  (Right heart failure, hemolysis, hepatic dysfunction, hypertension, renal dysfunction)  Still allows the Site to make the final decision on these adverse events  Patient transfer implemented  Device Malfunction and Device Parameters based on specific device (schematics) – easier to enter for a particular device  KCCQ – Kansas City Cardiomyopathy Questionnaire  Functional Capacity expanded  Gait speed INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Overview of Data EntryNaftel 5  This is to current members AND new members  Patient Eligibility  Prospective Design  Major End Points  Observational Study Monitoring Board (OSMB)  Site Enrollment  Data Entry  Training (form by form) paying special attention to the major changes INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Overview of Data EntryNaftel 6  This is to current members AND new members  Patient Eligibility –FDA approved durable devices –Informed Consent –No Exclusions Except Incarcerated Persons INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Overview of Data EntryNaftel 7  This is to current members AND new members  Major End Points –Death while a device is in place –Transplantation (connect to the OPTN Database) –Recovery (death and transplant for 1 year) –Device Exchange –Follow-up and Censoring INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Overview of Data EntryNaftel 8  This is to current members AND new members  Patient Eligibility  Prospective Design  Major End Points  Observational Study Monitoring Board (OSMB)  Site Enrollment  Data Entry  Training (form by form) paying special attention to the major changes INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 WHY? Naftel 9  Why are you participating in INTERMACS?  How are we monitoring data quality? INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Overview of Data EntryNaftel 10 INTERMACS Coordinator Training March 2012

Coordinator Training Session: March 11, 2012 Training for the Data Entry System 11 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  Gail Mertz, RN INTERMACS Nurse Monitor GO TO PAGE 10 in the SITE USERS’ GUIDE INTERMACS Coordinator Training March 2012

Coordinator Training Session, March11,  Screening Log –Included patients –Excluded patients Goal: To capture all MCSD patients at each institution  Screening Log –Included patients –Excluded patients Goal: To capture all MCSD patients at each institution INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Added: Domestic Partner option for Marital Status  Page 13 New Version INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  Lynne Stevenson, MD INTERMACS Co-Principal Investigator GO TO PAGE 14 in the SITE USERS’ GUIDE INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Transplant Concerns/Contraindications  Page 15 New Version INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Implant Decision Date: REMOVED IV Inotrope Implant:  Changed to within 48 hours of implant  Page 20 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Swan Hemodynamics:  Added Heart rate  Added cardiac index/CI  Page 23 & 24 Medications:  Added Loop Diuretics  Added Phospodiesterase inhibitors  Page 25 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Minute Walk:  Added Gait Speed  Page 27 QOL:  Added KCCQ  Page 28 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  Robert Kormos, MD INTERMACS Co-Principal Investigator GO TO PAGE 29 in the SITE USERS’ GUIDE INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Added: Associated Surgical Findings  page 30 Time in OR: REMOVED INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Associated Surgical Findings  page 30 New Version INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  Gail Mertz, RN INTERMACS Nurse Monitor GO TO PAGE 31 in the SITE USERS’ GUIDE INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  Doppler Opening Pressure  AE Triggers  Page 23 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  1 week visit window is now: +/- 3 Days!  Page 31 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  Patient Location Options  Page 31 New Version INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, 2012 FOLLOW UP VISITS AND DATA ENTRY GUIDELINES  The windows for visits are not the same as the guidelines for form completion.  The web-based data entry (WBDE) system is prospective and the forms should be filled out as the implant, follow-up dates, and events occur.  Forms should generally be completed within seven (7) days of an event, but always within 30 days. Follow Up Visit Acceptable Time Window for Visit 1 week  3 Days (4 – 10 days post implant) 1 month  7 Days (23 – 37 days post implant) 3 month  1 Month (2 – 4 months post implant) 6 months and beyond  2 Months (4 – 8 months post implant, etc.) 28 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, Implant Discharge Date/Status at Discharge  Page 48 To Add an event use the ICON the top of the overview screen: New Version INTERMACS Coordinator Training March 2012

REHOSPITALIZATION 30  Page  Discharge Date  Primary Reasons for Rehospitalizations additions: Syncope without known cause, Fever of unknown cause, Diagnostic procedure, Planned medical management  Rehospitalization Intervention: Transplantation Coordinator Training Session, March 11, 2012 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, 2012 Patient Transfers Sending Institution  Ensure All Forms and Visits Have Been Completed  Complete Patient Registry Status Form Receiving Institution  Patient must agree to continued participation in INTERMACS at the new institution  Receiving institution must have IRB approval for Amendment 1 Version 2.3 Dated: 9/15/2010  Obtain “Authorization to Release Information Consent” at the receiving institution.  Obtain INTERMACS Registry Consent Form at receiving institution.  Please forward copies of both consents to Mary Lynne Clark at the INTERMACS DCC 29 INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11, To be completed by the sending institution, after all the patients forms and visits have been completed. The Receiving hospital will have ‘read only’ access to the pre- transfer records.  Page 55 To access Patient Registry Status Form New Version INTERMACS Coordinator Training March 2012

Coordinator Training Session, March 11,  Page 56  Device malfunction  Infection  Device Thrombosis Expanded Options New Version

Coordinator Training Session, March 11,  Page 57 Added primary causes of death:  MSOF  Withdrawal of support INTERMACS Coordinator Training March 2012