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Coordinator Training Session: March 11, 2012. Major Changes in Data Entry Myers. 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 Entry Myers.

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slide1

Coordinator Training Session: March 11, 2012

Major Changes in Data Entry Myers

  • What is the same?
  • What is reduced/removed?
  • What is added/expanded?

INTERMACS Coordinator Training

March 2012

slide2

Coordinator Training Session: March 11, 2012

Major Changes in Data Entry Myers

  • 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

slide3

Coordinator Training Session: March 11, 2012

Major Changes in Data Entry Myers

  • 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

slide4

Coordinator Training Session: March 11, 2012

Major Changes in Data Entry Myers

  • 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

slide5

Coordinator Training Session: March 11, 2012

Overview of Data Entry Naftel

  • 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

slide6

Coordinator Training Session: March 11, 2012

Overview of Data Entry Naftel

  • 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

slide7

Coordinator Training Session: March 11, 2012

Overview of Data Entry Naftel

  • 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

slide8

Coordinator Training Session: March 11, 2012

Overview of Data Entry Naftel

  • 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

slide9

Coordinator Training Session: March 11, 2012

WHY? Naftel

  • Why are you participating in INTERMACS?
  • How are we monitoring data quality?

INTERMACS Coordinator Training

March 2012

slide10

Coordinator Training Session: March 11, 2012

Overview of Data Entry Naftel

INTERMACS Coordinator Training

March 2012

slide11

Coordinator Training Session: March 11, 2012

Training for the Data Entry System

INTERMACS Coordinator Training

March 2012

slide12

Coordinator Training Session, March 11, 2012

INTERMACS WBDE SCREENING LOG

  • Gail Mertz, RN
    • INTERMACS Nurse Monitor

GO TO PAGE 10 in the

SITE USERS’ GUIDE

INTERMACS Coordinator Training

March 2012

slide13

Coordinator Training Session, March11, 2012

  • Screening Log
    • Included patients
    • Excluded patients

Goal: To capture all MCSD patients at each institution

INTERMACS WBDE SCREENING LOG

INTERMACS Coordinator Training

March 2012

slide14

Coordinator Training Session, March 11, 2012

INTERMACS WBDE SCREENING LOG

INTERMACS Coordinator Training

March 2012

slide15

Coordinator Training Session, March 11, 2012

DEMOGRAPHICS FORM

  • Added: Domestic Partner option for Marital Status
  • Page 13

INTERMACS Coordinator Training

March 2012

New Version

slide16

Coordinator Training Session, March 11, 2012

PRE-IMPLANT FORM

  • Lynne Stevenson, MD
    • INTERMACS Co-Principal Investigator

GO TO PAGE 14 in the

SITE USERS’ GUIDE

INTERMACS Coordinator Training

March 2012

slide17

Coordinator Training Session, March 11, 2012

PRE-IMPLANT FORM

  • Transplant Concerns/Contraindications
  • Page 15

New Version

INTERMACS Coordinator Training

March 2012

slide18

Coordinator Training Session, March 11, 2012

PRE-IMPLANT FORM (cont.)

Implant Decision Date: REMOVED

  • IV Inotrope Therapy @ Implant:
  • Changed to within 48 hours of
  • implant
  • Page 20

INTERMACS Coordinator Training

March 2012

slide19

Coordinator Training Session, March 11, 2012

PRE-IMPLANT FORM (cont.)

  • 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

slide20

Coordinator Training Session, March 11, 2012

PRE-IMPLANT FORM (cont.)

  • 6 Minute Walk:
  • Added Gait Speed
  • Page 27
  • QOL:
  • Added KCCQ
  • Page 28

INTERMACS Coordinator Training

March 2012

slide21

Coordinator Training Session, March 11, 2012

IMPLANT FORM

  • Robert Kormos, MD
    • INTERMACS Co-Principal Investigator

GO TO PAGE 29 in the

SITE USERS’ GUIDE

INTERMACS Coordinator Training

March 2012

slide22

Coordinator Training Session, March 11, 2012

IMPLANT FORM

  • Added: Associated Surgical Findings
  • page 30

Time in OR: REMOVED

INTERMACS Coordinator Training

March 2012

slide23

Coordinator Training Session, March 11, 2012

IMPLANT FORM

  • Associated Surgical Findings
  • page 30

New Version

INTERMACS Coordinator Training

March 2012

slide24

Coordinator Training Session, March 11, 2012

FOLLOW UP FORMS

  • Gail Mertz, RN
    • INTERMACS Nurse Monitor

GO TO PAGE 31 in the

SITE USERS’ GUIDE

INTERMACS Coordinator Training

March 2012

slide25

Coordinator Training Session, March 11, 2012

FOLLOW UP FORMS

  • Doppler Opening Pressure
  • AE Triggers
  • Page 23

INTERMACS Coordinator Training

March 2012

slide26

Coordinator Training Session, March 11, 2012

FOLLOW UP FORMS

  • 1 week visit window
  • is now: +/- 3 Days!
  • Page 31

INTERMACS Coordinator Training

March 2012

slide27

Coordinator Training Session, March 11, 2012

FOLLOW UP FORMS

  • Patient Location Options
  • Page 31

New Version

INTERMACS Coordinator Training

March 2012

slide28

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.)

INTERMACS Coordinator Training

March 2012

slide29

Coordinator Training Session, March 11, 2012

IMPLANT DISCHARGE FORM

  • Implant Discharge Date/Status at Discharge
  • Page 48

To Add an event use the ICON

Located @ the top of the overview screen:

INTERMACS Coordinator Training

March 2012

New Version

rehospitalization

Coordinator Training Session, March 11, 2012

REHOSPITALIZATION
  • Page 52-53
  • Discharge Date
  • Primary Reasons for
  • Rehospitalizations additions:
  • Syncope without known cause,
  • Fever of unknown cause,
  • Diagnostic procedure,
  • Planned medical management
  • Rehospitalization Intervention:
  • Transplantation

INTERMACS Coordinator Training

March 2012

patient transfers

Coordinator Training Session, March 11, 2012

Patient Transfers

Sending Institution

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

  • Ensure All Forms and Visits Have Been Completed
  • Complete Patient Registry Status Form

INTERMACS Coordinator Training

March 2012

slide32

Coordinator Training Session, March 11, 2012

PATIENT REGISTRY STATUS FORM

To access Patient Registry Status Form

New Version

  • 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

INTERMACS Coordinator Training

March 2012

slide33

Coordinator Training Session, March 11, 2012

EXPLANT

  • Page 56
  • Device malfunction
  • Infection
  • Device Thrombosis

Expanded Options

New Version

slide34

Coordinator Training Session, March 11, 2012

DEATH

  • Page 57
  • Added primary causes of death:
  • MSOF
  • Withdrawal of support

INTERMACS Coordinator Training

March 2012