the key to success: intermacs hospitals site utilization of intermacs data and reports for local qi...

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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

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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

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The Key to Success: INTERMACS

Hospitals!

Sixth Annual Meeting, March 12, 2012

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The Key to Success: INTERMACS Hospitals

•Site Utilization of INTERMACS Data and Reports for local QI Naftel

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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

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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

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The Key to Success: INTERMACS Hospitals

•Quality Assurance and data quality Naftel

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Hospital Perspective – Deliverables

CoordinatorsClinical TeamQuality Assurance OfficerOffice of Risk ManagementFinancial Officers / AdministratorsOffice of AccreditationResearchers

Fifth Annual Meeting, April 12, 2011

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A Workshop for Researchers and INTERMACS Hospitals

QA Report

8 INTERMACS Data Workshop – April 12, 2011

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March 2012

A Workshop for Researchers and INTERMACS Hospitals

QA Report

9 INTERMACS Data Workshop – April 12, 2011

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March 2012

A Workshop for Researchers and INTERMACS Hospitals

10 INTERMACS Data Workshop – April 12, 2011

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March 2012

A Workshop for Researchers and INTERMACS Hospitals

11 INTERMACS Data Workshop – April 12, 2011

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The Key to Success: INTERMACS Hospitals

•Evaluation of Site Data: Audits, Complete Enrollment, Complete Data, etc. Naftel

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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%

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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

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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

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Coordinator Training Session: March 11, 2012

 

Overview of Data Entry Naftel

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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.

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Days from Implant to Entry into INTERMACS

Jun 2006 – Dec 2011

Sixth Annual Meeting, March 12, 2012

Median (days) n %< 30 50 40%30 – 59 30 24%60 – 89 13 10%90 – 119 6 5%> 120 26 21%Total hospitals 125 100%

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Days from Implant to Entry into INTERMACS

Jun 2006 – Dec 2011

Sixth Annual Meeting, March 12, 2012

Median (days) n %< 30 50 40%30 – 59 30 24%60 – 89 13 10%90 – 119 6 5%> 120 26 21%Total hospitals 125 100%

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4. Completeness of data elements

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.

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Completeness of Quality of Life Data will be addressed by

Dr. Grady

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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.

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Update on New INTERMACS/NIH Initiatives

• MedaMACS• PumpKIN• PediMACS• IMACS• Revive-IT

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Update on New INTERMACS/NIH Initiatives

• MedaMACS (15 min) Stewart

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MEDAMACS Update 2012:MEDAMACS Update 2012:

Medical Arm of Mechanical Medical Arm of Mechanical Circulatory SupportCirculatory Support

INTERMACS - 6th Annual Meeting

March 12, 2012

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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

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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

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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

MEDAMACS Study Sites

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MEDAMACSMEDAMACS ROADMAPROADMAP11 REVIVE-ITREVIVE-IT22

SizeSize 350 100 ~50

DesignDesign Prospective observational,

OMM only

Prospective observational,

Thoratec HM2 vs. OMM

Randomized trial,

Heartware HVAD vs. OMM

Inclusion Inclusion CriteriaCriteria

HF symptoms >12m

NYHA III-IV

Optimal med rx

≥1 HF admission in 12m

AND one

1.) Additional HF Hosp

2.) Peak VO2 <16 men, or <14 women

3.) BNP >1000

4.) 6MW <300m

5.) SHF Score ≥ 1.5

EF ≤35%

Can be eligible for transplant, but not listed

NYHA IIIB-IV

≥1 HF hospitalization in 12m, or 2 unscheduled EW visits for HF

6MW <300m

EF ≤25%

Not currently listed, not planned in 12m

HF symptoms >12m

NYHA III for 3m

Optimal med rx

≤1 HF hosp within 6m, no admit in 30d

CRT if QRS >120

Peak VO2 < 16men, <14women

6MW <350m

SHF Score ≥ 1.5

EF ≤35%

Not a transplant candidate

LVAD candidate by CMS criteria

1. clinicaltrials.gov/NCT014528022. clinicaltrials.gov/NCT01369407IN

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MEDAMACSMEDAMACS ROADMAPROADMAP11 REVIVE-ITREVIVE-IT22

Exclusion Exclusion criteriacriteria

Non-cardiac diagnosis limits prognosis ≤2 yrs

Current inotrope use

Listed for transplant

QRS >120 and planned CRT, or CRT within 3m

Other condition that limits survival to ≤2 yrs

Inotrope in 30d

Listed for transplant

Inability to perform 6MW

Severe illness limiting prognosis to ≤2 yrs

STEMI within 3m

Inotrope within 3m

GFR <30, cerebrovasc dz

A transplant candidate

Plt <100K, alb <3, PVD

CRT if QRS >120 must have been >90d previously

Liver, pulm dysfunction

Mechanical AVR

PVR >6 Wood units

EndpointsEndpoints Primary at 1 yr

Integrated endpoint of survival, requirement for advanced therapies, functional capacity, QOL, patient preferences

Primary at 1yr

Survival at 1yr with improvement of at least 75m in 6MW

Actuarial survival and survival free of stroke

Primary at 2 yrs

Composite of survival, freedom from moderately disabling stroke, and 6MW improvement >75m

1. clinicaltrials.gov/NCT014528022. clinicaltrials.gov/NCT01369407IN

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6MWGait speed

Euroqol+KCCQVAD Survey

EventsRisk ScoresTreatments

BaselineB

MEDAMACS Encounters

Inpt oroutpt

1 MonthRe-Look Baseline

6 mosPhone

Interview

1 YrFace-to-face

18m 2 Yrs PhoneInterview

outptA B

CTimeZero

D

Telephone ContactTelephone Contact

6MWGait speed

Euroqol+KCCQVAD SurveyRisk Scores

6MWGait speed

Euroqol+KCCQVAD Survey

EventsTreatments

BaselineA

6MWGait speed

Euroqol+KCCQVAD Survey

EventsRisk ScoresTreatments

Study Site Phone Calls 6 and 18 mosEvents (hosp, stroke, transplant, vad, inotropes, death)

Meds, Euroqol, NYHA/INTERMACS profile

Onemonth

Consent 1mo. 12mos 24mos

Fac

e-to

-fac

e

enco

un

ters

End1-Yr Visit

C2-Yr Visit

D

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MedaMACS Pilot

2012 2013 2014 2015

EnrollmentN=350 x 12sites

Design MedaMACS 2.0

2016

OS

MB

Re

vie

w &

DC

C I

RB

(11

-12

/20

11

)

6M Telephone 18M Telephone

1 Year Visit

2 Year Visit & Closeout

WB

DE

Pro

gra

mm

ing

Do

ub

le B

as

eli

ne

sC

om

ple

ted

DA

TA

BA

SE

CL

OS

ED

1 Y

r D

ata

C

om

ple

te

IRB

ST

UD

Y S

ITE

S

TU

DY

SIT

E

DC

C +

ST

EE

RIN

GD

CC

+ S

TE

ER

ING

MEDAMACS Timeline

Pil

ot

Co

mp

lete

La

te-B

rea

kin

gS

ub

mis

sio

n

Ba

se

lin

e D

ata

IS

HL

T/A

CC

Fin

al P

ilo

t A

nal

ysis

SpringTraining

Annual Mtg@ISHLT

Annual Mtg@ISHLT

Annual Mtg@ISHLT

La

te-B

rea

kin

gS

ub

mis

sio

n

6M D

ata

Co

mpl

ete

Estimated # Active Pts 0 90 160 250 270 260 250 235 210 180 150

ISHLT

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MEDAMACS at ISHLT 2012:Screening Pilot Data

• 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.)

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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

Event of Interest

Stewart et al. ISHLT 2012INTERMACS A

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Su

rviv

al F

ree

of

VA

D o

r T

ran

spla

nt

0

25

50

75

100

0 2 4 6 8

Months since Enrollment

INTERMACS Profiles Risk Stratify AmbulatoryAdvanced Heart Failure Patients

INTERMACS 6/7

INTERMACS 5

INTERMACS 4

P<0.001

Stewart et al. ISHLT 2012INTERMACS A

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0

20

40

60

80

100

Eve

nt-

free

su

rviv

al (

%)

0 3 6 9

Months post-enrollment

SHFM < 1.5 SHFM 1.5-2.5 SHFM > 2.5

p = 0.0003

by Seattle HFM categoryEvent-free Survival

Teuteberg et al. ISHLT 2012REVIVE-IT INTERMACS A

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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

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Investigator SiteAmrut Ambardekar U Colorado

Chetan Patel Duke

Eddie Rame U Penn

Frances Johnson U Iowa

Garrick Stewart Brigham and Women's

Jeffrey Testani U Penn

Jeffrey Teuteberg U Pitt

Jennifer M. Cowger U Michigan

JoAnn Lindenfeld U Colorado

Jon Kobashigawa Cedars-Sinai

Joseph Rogers Duke

Keith Aaronson U Michigan

Leslie Miller U South Florida

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

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Coordinator Training Session: March 11, 2012

 pediMACS

David C. Naftel, PhD

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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

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• It became clear that the pediatric VAD patients needed a different web-based data entry system.

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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

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Coordinator Training Session: March 11, 2012

 

pediMACS Launch Status

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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

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Coordinator Training Session: March 11, 2012

 

pediMACS Launch Status

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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

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Coordinator Training Session: March 11, 2012

 

pediMACS Launch Status

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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

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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

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