The Key to Success: INTERMACS Hospitals • Site Utilization of INTERMACS Data and Reports for local QI • Quality Assurance and data quality • Evaluation of Site Data: Audits, Complete Enrollment, Complete Data, etc. Sixth Annual Meeting, March 12, 2012 INTE RMACS Annual Meet ing Marc h 2012
45
Embed
The Key to Success: INTERMACS Hospitals Site Utilization of INTERMACS Data and Reports for local QI Quality Assurance and data quality Evaluation of Site.
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
The Key to Success: INTERMACS Hospitals
• Site Utilization of INTERMACS Data and Reports for local QI
• Quality Assurance and data quality
• Evaluation of Site Data: Audits, Complete Enrollment, Complete Data, etc.
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
The Key to Success: INTERMACS
Hospitals!
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
The Key to Success: INTERMACS Hospitals
•Site Utilization of INTERMACS Data and Reports for local QI Naftel
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
Hospitals
• What services do the hospitals receive for their participation fee?• Services
• Meets CMS/Joint Commission requirement for Destination Therapy Certification
• Meets FDA required submission of Medical Device Reports (MDRs) by hospitals
• Provides clinical summaries of patients• Provides quality assurance reports• Provides electronic data transfer• Provides standardized datasets• Provides benchmarking• Provides training and continuing education units
INTERMACS A
nnual Meetin
g
March 2012
Hospitals (Continued)
• What benefits do the hospitals receive for their participation fee?• Benefits
• Fulfills CMS DT Certification requirement• Become part of the national dialogue on the evaluation
and evolution of MCSDs• Invited to participate in the INTERMACS Annual
Meeting• Invited to join the INTERMACS Committees
• Coordinators Council and other committees• Select Hospital Administrators will have the opportunity
to serve on the Business Advisory Committee
INTERMACS A
nnual Meetin
g
March 2012
The Key to Success: INTERMACS Hospitals
•Quality Assurance and data quality Naftel
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
Hospital Perspective – Deliverables
CoordinatorsClinical TeamQuality Assurance OfficerOffice of Risk ManagementFinancial Officers / AdministratorsOffice of AccreditationResearchers
Fifth Annual Meeting, April 12, 2011
INTERMACS A
nnual Meetin
g
March 2012
A Workshop for Researchers and INTERMACS Hospitals
QA Report
8 INTERMACS Data Workshop – April 12, 2011
INTERMACS A
nnual Meetin
g
March 2012
A Workshop for Researchers and INTERMACS Hospitals
QA Report
9 INTERMACS Data Workshop – April 12, 2011
INTERMACS A
nnual Meetin
g
March 2012
A Workshop for Researchers and INTERMACS Hospitals
10 INTERMACS Data Workshop – April 12, 2011
INTERMACS A
nnual Meetin
g
March 2012
A Workshop for Researchers and INTERMACS Hospitals
11 INTERMACS Data Workshop – April 12, 2011
INTERMACS A
nnual Meetin
g
March 2012
The Key to Success: INTERMACS Hospitals
•Evaluation of Site Data: Audits, Complete Enrollment, Complete Data, etc. Naftel
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
1. Regulatory Requirements Regulatory requirements must be met. Assessment: UNOS collects and the DCC evaluates all regulatory documents Goal: 100% of participating hospitals meet all regulatory requirements Minimal Standard: 100%
2. Timely Follow-up data Assessment: will focus on submission of follow-up forms. Goal: 100% of follow-up forms submitted within 30 days of the date of expected follow-up. Minimal Standard: 90% of follow-up forms must be submitted within 30 days of the date of expected follow-up
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
Coordinator Training Session: March 11, 2012
Overview of Data Entry Naftel
16
INTERMACS A
nnual Meetin
g
March 2012
3. All Device Implants Complete Accounting of all eligible device implants. Assessment: Matching hospital enrollment to industry counts. Goal: 100% of eligible devices enrolled. Minimal Standard: 90% of eligible devices enrolled. Note1: All eligible DT devices must be entered. Note2: Informed consent is a barrier to the minimal standard.
Assessment: The web-based application requires that all elements be addressed (either a data value entered or “not done” selected) before the form can be submitted. The proportion of captured data values will be calculated. Goal: 100% completion of data elements. Minimal Standard: To be determined after consultation with HSC.
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
Completeness of Quality of Life Data will be addressed by
Dr. Grady
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
The Key to Success: INTERMACS Hospitals
•Risk adjustment:
Will require an in-depth, collaborative effort among the INTERMACS Collaborators including hospital representatives. The approach will be modeled after the SRTR evaluation of post heart transplant survival.
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
Update on New INTERMACS/NIH Initiatives
• MedaMACS• PumpKIN• PediMACS• IMACS• Revive-IT
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
Update on New INTERMACS/NIH Initiatives
• MedaMACS (15 min) Stewart
Sixth Annual Meeting, March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
MEDAMACS Update 2012:MEDAMACS Update 2012:
Medical Arm of Mechanical Medical Arm of Mechanical Circulatory SupportCirculatory Support
INTERMACS - 6th Annual Meeting
March 12, 2012
INTERMACS A
nnual Meetin
g
March 2012
The MEDAMACS MissionThe MEDAMACS Mission
• Map terrain of ambulatory advanced heart failure
• Improve selection and timing of MCS by studying outcomes with medical therapy
• Support IOM mandate for patient-centered care and shared decision making
• Design integrated endpoints that move beyond survival alone
• Define a broader context for the next generation of MCS clinical trials
INTERMACS A
nnual Meetin
g
March 2012
Evolution of MEDAMACS
INTERMACSSpecific Aim
2006, 2011
MEDAMACSMEDAMACSStudyStudy
2012-20152012-2015
n=350n=35012 centers12 centers
2 yrs follow-up2 yrs follow-up
Screening PilotScreening Pilot
2010-122010-12
n=168n=16810 centers10 centers
1 yr follow-up1 yr follow-up
INTERMACS A
nnual Meetin
g
March 2012
Brigham and Women’s U. of Alabama Birm. U. of PittsburghCedars-Sinai U. of Colorado U. of PennsylvaniaCleveland Clinic U. of Iowa U. of South FloridaDuke U. of Michigan U. of Texas Southwestern
• High Event Rates in Medically Managed Advanced Heart Failure Patients Followed at VAD Centers (Stewart et al.)
• Prediction of Events in Patients with Advanced Heart Failure: Application of the Seattle Heart Failure Model to the Medamacs Population (Teuteberg et al.)
• Patients with INTERMACS 4-7 Heart Failure Have Reduced Quality of Life (Patel et al.)
• Uric Acid Elevation is Associated with Severity of Congestion in Advanced Heart Failure (Guglin et al.)
• Tricuspid Regurgitation is a Measure of Right Heart Dysfunction and is Associated with Event Free Survival in Stage D Heart Failure (Testani et al.)
INTERMACS A
nnual Meetin
g
March 2012
Ev
ent-
Fre
e S
urv
iva
l
0
25
50
75
100
0 2 4 6 8
Months since Enrollment
Death
Death, Transplant,or VAD
Death, Transplant,VAD or Inotrope
68%
64%
84%
Event-Free Survival in AmbulatoryAdvanced Heart Failure
Euroqol VAS Score by HF SeverityEuroqol VAS Score by HF Severity
INTERMACS; Grady K, et al J Heart Lung Trans 2009;28:S269.MEDAMACS: Patel P, et al. ISHLT 2012.HF Action; Flynn K, et al. Am Heart J 2009;158:564-71.IN
Lynne Stevenson - PILynne Stevenson - PI Brigham and Women's
Maria Mountis Cleveland Clinic
Mariell Jessup U Penn
Mark Drazner U Texas Southwestern
Maya Guglin U South Florida
Michele Hamilton Cedars-Sinai
Michelle Kittleson Cedars-Sinai
Parag Patel U Texas Southwestern
Randy Starling Cleveland Clinic
Salpy Pamboukhian U Alabama Birmingham
Team MEDAMACS
UAB/DCC UAB/DCC David NaftelMary Lynne ClarkSusan MyersCraig CollumKathryn Hollifield
NHLBI/NIHNHLBI/NIHMonica ShahTim BaldwinMarissa Miller
Thoratec CorporationThoratec Corporation
INTERMACS A
nnual Meetin
g
March 2012
Coordinator Training Session: March 11, 2012
pediMACS
David C. Naftel, PhD
39
INTERMACS A
nnual Meetin
g
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
40
• It became clear that the pediatric VAD patients needed a different web-based data entry system.
INTERMACS A
nnual Meetin
g
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
41
INTERMACS A
nnual Meetin
g
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
42
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 A
nnual Meetin
g
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
43
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 A
nnual Meetin
g
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
44
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 A
nnual Meetin
g
March 2012
Coordinator Training Session: March 11, 2012
pediMACS Launch Status
45
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