coordinator training session: march 11, 2012
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Coordinator Training Session: March 11, 2012. Major Changes in Data EntryMyers. 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. - PowerPoint PPT PresentationTRANSCRIPT
Coordinator Training Session: March 11, 2012
Major Changes in Data Entry Myers
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 Entry Myers
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 Entry Myers
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 Entry Myers
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 Entry Naftel
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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 Entry Naftel
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 Entry Naftel
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 Entry Naftel
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 Entry Naftel
10
INTERMACS Coordinator Training
March 2012
Coordinator Training Session: March 11, 2012
Training for the Data Entry System
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Screening Log Demographic Pre-Implant Implant Follow-up Implant Discharge Rehospitalizations Listing for Transplant Patient Transfer Explant/Transplant/Recovery Death Adverse Events
Device Malfunction Infection Neurological Dysfunction Bleeding Non-Cardiac Organ Dysfunction Other Adverse Events Right Heart Failure
Quality of Life: EQ-5D, KCCQ Functional Capacity Neurocognitive Assessment
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
12
Gail Mertz, RNINTERMACS Nurse Monitor
GO TO PAGE 10 in the SITE USERS’ GUIDE
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March11, 2012
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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, 2012
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INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Added: Domestic Partner option for Marital Status
Page 13
New Version
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Lynne Stevenson, MDINTERMACS Co-Principal Investigator
GO TO PAGE 14 in the SITE USERS’ GUIDE
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Transplant Concerns/Contraindications
Page 15
New Version
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Implant Decision Date: REMOVED
IV Inotrope Therapy @ Implant:
Changed to within 48 hours of implant
Page 20
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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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, 2012
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6 Minute Walk: Added Gait Speed
Page 27
QOL: Added KCCQ
Page 28
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Robert Kormos, MDINTERMACS Co-Principal Investigator
GO TO PAGE 29 in the SITE USERS’ GUIDE
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Added: Associated Surgical Findings
page 30
Time in OR: REMOVED
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Associated Surgical Findings
page 30
New Version
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
24
Gail Mertz, RNINTERMACS Nurse Monitor
GO TO PAGE 31 in the SITE USERS’ GUIDE
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Doppler Opening Pressure
AE Triggers
Page 23
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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1 week visit window is now: +/- 3 Days!
Page 31
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Patient Location Options
Page 31
New Version
INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
FOLLOW UP VISITS AND DATA ENTRY GUIDELINESFOLLOW 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.)
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INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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Implant Discharge Date/Status at
Discharge
Page 48
To Add an event use the ICONLocated @ the top of the overview screen:
New Version
INTERMACS Coordinator Training
March 2012
REHOSPITALIZATION
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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
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
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INTERMACS Coordinator Training
March 2012
Coordinator Training Session, March 11, 2012
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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, 2012
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Page 56
Device malfunction
Infection
Device Thrombosis
Expanded Options
New Version
Coordinator Training Session, March 11, 2012
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Page 57
Added primary causes of death: MSOF Withdrawal of support
INTERMACS Coordinator Training
March 2012