Download - Implantable Cardioverter Defibrillator: Overview of the NCDR Data Methodology Christie Lang, RN, MSN Associate Director, ICD Registry American College.

ImplantableCardioverterDefibrillator:

Overview of the NCDR Data Methodology Christie Lang, RN, MSNAssociate Director, ICD RegistryAmerican College of Cardiology

Heart Rhythm Society ConferenceSan Francisco, CaliforniaMay 15, 2008

Objectives

• Review the development process of an NCDR Registry Product

• Understand NCDR committee structures• Provide update regarding V2.0 Leads and

Peds.

National Cardiovascular Data Registry• NCDR is initiative of the American College

of Cardiology with partnerning support from many societies, for the ICD Registry: Heart Rhythm Society.

• NCDR mission is to improve the quality of CV patient care by providing information, knowledge and tools, implementing quality initiatives; and supporting research that improves patient care and outcomes.

Uses of NCDR Data Registries

– Quality Improvement• Measure/manage individual patient care• Study, develop and monitor care processes• Track outcomes of care.• Assess hospital and provider performance

– Public Reporting• Quality-base payment• Certification & privileging, meet regulatory needs

– Post Market Surveillance & Clinical Trials– Influence Clinical Practice Guidelines

NCDR Management BoardNCDR Management Board

Scientific Oversight CommitteeScientific Oversight Committee

Research &Research &PublicationsPublications

Clinical Supp.Team Clinical Supp.Team

SteeringSteeringCommitteeCommittee

Registries

CathPCCathPCI I

RegistrRegistryy

CARE CARE RegistrRegistr

yy

ICD ICD RegistrRegistr

yy

Committee Structure for each Registry

Includes 30dayoutcomes

ACTIOACTION N

RegistrRegistryy

IC3Steering CommitteeSteering Committee

Registry Projects

ACHIEVEACHIEVESteering CommitteeSteering Committee

ICD Longit.Steering CommitteeSteering Committee

TAKE ACTIONPlanning Work GroupPlanning Work Group

QI Projects

D2BProject managed through Project managed through ACTION and PCI Steering ACTION and PCI Steering

committeescommittees

ambulatory

longitudinal

longitudinal

Committee Structure and Project Summary

Over 130 of our nation’s CV Outcomes experts involved

Governance: NCDR Management Board

• Each NCDR Registry is governed by NCDR’s Management Board and a committee structure that provide oversight and direction dedicated to its mission.

• NCDR Management Board provides oversight and direction for NCDR activities, which include:– Accountability for financial performance,– Accountability for the quality of the Registry products and

services.– Review and approval of Registry policies and strategic and

operational plans,– Advocate, promote and influence key groups regarding the

Registry’s activities; and – Set the high level agenda for the NCDR within the ACC

community.

The ICD Steering Committee shall provide scientific and clinical support

to the development of the National ICD Registry.

• Their tasks include the following:– Identify and approve list of quality indicators reported to

participating institutions as well as CMS.– Identify data elements /definitions needed to calculate

selected quality indicators and enhance the utility of the registry.

– Determine appropriate report content and display format.– Provide guidance in developing content for training manuals.– Assist in providing relevant and consistent answers to user

questions on data elements.

Research &Research &PublicationsPublications

Clinical Supp.Team Clinical Supp.Team

SteeringSteeringCommitteeCommittee

Committee Structure for each Registry

Governance: ICD Steering Committee

The Steering Committee consists of a chair and 6-8 members including 2 ACC representatives, 2 HRS representatives, and one biostatistician specializing in cardiovascular care.

• Stephen Hammill, MD, FHRS Chair 2007-2010• Ralph Brindis, MD, MPH, FACC Member 2007-2010• Alan Kadish, MD, FACC Member 2007-2010• Mark Kremers, MD, FACC Member 2007-2010• Bruce Lindsay, MD, FACC Member 2007-2010• Michael Mirro, MD, FACC Member 2007-2010• Martha Radford, MD, FACC Member 2007-2010• Lynne Warner Stevenson, MD, FACC Member 2007-2010• Joel Harder, MBA Liason:HRS 2007-2010• Christine Lang, RN, MSN Liason:ACC 2007-2010

It Takes a Team!How many people are involved prior to an NCDR Registry product launch?

Staff

Working GroupExternal

Peer reviewersα-testers

Β-testers

CSO

CMO

RegistrySteering Committee

Data Set Registry Product

Vendors

Staff

Science oversight Committee

Launch

ICD Registry V1.08 Product Development

ScientificScientificDevelopmentDevelopment

Technical Development

TestingTool ReleaseTool Release

IT Application Development & Testing

Alpha Pilot

MaintenanceMaintenance

Launch

CharterCharterDevelopmentDevelopment

Each Registry develops a Each Registry develops a Charter that provides:Charter that provides:•PurposePurpose

•Business CaseBusiness Case

•Project OverviewProject Overview

•Goals and ObjectivesGoals and Objectives

•BudgetBudget

•Stakeholder IdentificationStakeholder Identification

•Milestone ScheduleMilestone Schedule

•Project AssumptionsProject Assumptions

•Project ConstraintsProject Constraints

•RisksRisks

•Source DocumentsSource Documents

•Document Version HistoryDocument Version History

•

During Scientific Development Phase:• Steering Committee reviews list of key

outcomes measures, clinical questions, etc to be reported:

• ICD Registry was developed as part of CED by CMS to determine if patients receiving ICDs in the general population (“real world”) were comparable to patients enrolled in the randomized clinical trials of ICD therapy?

• Specifically were the Patients, hospitals, indications, complications, and outcomes comparable to the studies

ScientificDevelopment

Scientific Development

MEASUREMENT IS KEY!

Scientific Development: Data Elements1. Based on Hypothesis and

Executive Summary Metrics establish preliminary list of data elements for registry inclusion

2. Use existing Clinical Data Standards. ICD Registry data elements are derived from ACC/AHA Electrophysiology Data Standards.

3. Review clinical trials, practice guidelines, performance measures, existing registries

4. Include fields for patient, device, facility and provider information, disease process.


ICD Registry Key Outcomes Measures:Incidence of Lead Dislodgement


• Dataset review, recommendations and approval: • Alpha testers • Steering Committee• Science Oversite Committee• Chief Medical Officer• Chief Science Officer


Scientific Development


Timeline


Technical Technical DevelopmentDevelopment

Testing Tool ReleaseTool Release


Alpha Pilot


Launch


Technical Development: Data Collection Tool• Map dataset against current

NCDR registries for consistency of key core data elements

• Format data elements in consistent sections – Patient demographic– History/risk factors– ICD Procedural information– Medications– Device – Adverse Events– Discharge

• Technical Specifications created


Technical Development – data dictionary


Online data collection tool features include:

• Access from any web browser

• Submit data to the NCDR™

• Data completeness reminders

Online data collection tool features include:

• Access from any web browser

• Submit data to the NCDR™

• Data completeness reminders

Data Collection• Hospital collects

and submits to DQR• Successfully

submitted data is analyzed

• Data is pooled for many uses

• Algorithms are used to combine data for participants’ reports and other uses

• Data is returned to Hospital as an Outcome Report

3. NCDR Data Analysis Computer

2. NCDR Data Quality

Computer

1. Hospital collects,

harvests, and submits data

5. Participant Hospital's

Outcome Report

Dat

a Fl

ow

Dat

a Fl

ow

Data Flow 4. National Data Pool

Submitted data is checked and Hospital resubmits (if needed)

Data that “Passed” checks sent for

analysis

Hospital data

aggregated,

algorithms applied

and stored

Data combined for

Hospital, Comparison

Group, and National

Outcome Report

generated and posted

on Hospital’s website


Timeline


Technical Technical DevelopmentDevelopment

Testing Tool ReleaseTool Release


Alpha Pilot


Launch


Testing

• Alpha Testing• Pilot testing of the form • Assessing flow of form in practice• Feasibility of data collection• Comprehension of data elements and definitions in

practice• Beta Testing• Vendor certification

Usability Check

Feasibility Check

Consistency Check

Testing


Timeline


Technical Technical DevelopmentDevelopment Testing Tool ReleaseTool Release


Alpha Pilot


Launch


Release

• Training and Roll out needed: Webinars, Training Manuals, FAQ’s developed.

• Client and Contract support for Participants.

• Software Vendors go thru intensive certification process.

• Medications and devices tables are up to date and subject for review as needed

Tool Release

ICD Registry V1.08 DevelopmentTimeline

ScientificScientificDevelopmentDevelopment Technical Technical

DevelopmentDevelopmentTesting Tool ReleaseTool Release


Alpha Pilot


Launch


Maintenance Phase- Evaluation

• Quarterly Outcome Reports• Participant FAQ’s for clarification• Feedback from Committees

– Steering Committee– Research and Publications Committee

• Metric change• Literature Review• Guideline Recommendations

Maintenance

Is it Time for a Revision?

Enhancements needed for V 1.08

• Specific data element oversights– Long QT, HCM etc

• Pulse generator focused– No lead information except CS lead placement

• Medicare primary prevention focus– Secondary prevention, non-Medicare– Pediatric

Coming Soon!Version 2.0: Peds and Leads

• The ICD Registry Working Group met bi-weekly for the past year to revise the data collection form.

• May 07: Working Group met with the FDA

to begin discussion to incorporate Leads.

• November 07 at AHA ICD Registry Working group met with PACES (Pediatric and Congenital Electrophysiology Society ) and the FDA to incorporate Pediatrics and Leads in to the ICD Registry.

• Version 2.0 launch scheduled mid 2009.

Coming Soon!Version 2.0: Peds and Leads

• Includes pediatric patients receiving ICDs

• Data will provide insight on pediatric SCD and ICD impact

• Adding Leads will clarify the benefits, risks and performance of this technology in adults and pediatric patients.

Version 2.0: Leads and Pediatrics

Data to be collected will include:• Atrial, ventricular, defibrillator,

and left ventricular leads at the time of implantation, revison, replacement and removal.

• This will improve lead surveillance following implantation.

• Lead ID• Lead Data• Lead Location• Lead Placement Issues• Lead Function Issues• Lead Integrity Issues

Maintenance Phase- Audit

• The purpose of the Data Quality Program is to ensure that data submitted to the NCDR are complete, consistent, and accurate ultimately to improve the overall quality of the Registry.

• For a participant’s data submission to be included in national and peer group benchmarks, the submission must pass all composite category inclusion thresholds of completeness established in the threshold reports.

• This report presents the threshold results for all core elements, as well as the number of unique records, % valid and invalid values, as well as missing values.

• Inclusion threshold criteria were chosen for their clinical and structural pertinence.

Maintenance

Maintenance Phase- Audit

• Onsite Auditing will begin 2008.• 10% Hospitals will be randomly selected for the audit

to compare the data entered into the Registry with the original patient data in the hospital record system.

• Also, auditing will include selected hospitals where the data is inconsistent.

• Examples of inconsistent data will include hospitals reporting no complications or reporting an MD as board certified in EP who is not listed with the ABIM

• Each hospital will receive a confidential audit report which displays their audit score and individual accuracy for each element.

Maintenance

Take Home Message

• Process is long, thorough, but 100% guided by science.

• Incredible teamwork needed for ultimate

success.

• Your feedback and involvement is the key to its success!

THANK YOU