NCDR NC programming system

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					     ACTION Registry™
American College of Cardiology Foundation
             Washington, DC

     Duke Clinical Research Institute
              Durham, NC
• Provide an overview of the NCDR™ and the
  ACTION Registry™
• Learn how to become a participant
• Review data inclusion criteria and patient
• Review the Data Collection Form (DCF) and
  Electronic Data Capture (EDC)
• Describe Quarterly Outcome Reports
• Summarize ACTION Registry™ participant
  ACTION Registry™

  Overview of the National
Cardiovascular Data Registry
NCDR™ mission is:

To be the leading provider of
services to improve the quality of
cardiovascular care through the
collection, analysis, and reporting
of data and providing educational
and research activities.
NCDR™: Overview
 • Leader in Cardiovascular Health Outcomes
 • 10th year in operation
 • Four Registries: CathPCI, ICD, CARE,
 • ICD Registry is the largest cardiovascular
   registry in the world led by a specialty
   organization (1400+ enrolled)
 • 89 abstracts and manuscripts to date
 • Forging partnerships with specialty societies
NCDR™: Overview (cont’d)
   • P4P - Government, Insurers, Regulators and
     Healthcare Providers are relying on the NCDR
     for quality data
      – Meet Pay for Performance Quality
      – CMS - Coverage with Evidence
      – Meet State/Regulatory Requirements
      – Quality Improvement
      – New age of “Prove It”
ACTION Registry™

 Program Overview
ACTION Registry™

 Acute Coronary Treatment and
 Intervention Outcomes Network
Registry Purpose
• Create a national surveillance system for ACS
• Facilitate efforts to improve the quality and
  safety of ACS care
• Optimize the outcomes and management of
  ACS patients
  – Translate evidence-based guidelines into
    clinical practice
  – Investigate quality improvement methods
Registry Objectives

• Monitor the characteristics, treatments, and
  outcomes of patients hospitalized with Acute
  Coronary Syndromes (STEMI/NSTEMI)
• Improve adherence to the ACC/AHA STEMI and
  NSTEMI guidelines recommendations
• Explore the association between evidence-based
  acute treatment strategies and risk-adjusted clinical
 Registry Objectives (cont’d)

• Assess utilization of diagnostic imaging and
  laboratory tests and invasive procedures, and track
  hospital/coronary care unit length of stay data
• Assess utilization of evidence-based discharge
  medications and risk factor modification interventions
• Assess trends in medication dosing patterns and
  improve drug safety through targeted quality
  feedback related to medication overdosing
 Registry Objectives (cont’d)

• Identify barriers to implementing guidelines
  recommendations for patients with ACS and develop
  effective strategies to overcome these barriers
• Provide a valuable resource for research designed to
  improve the treatment and outcomes for patients with
• Facilitate data collection for use in JCAHO core
  measures reporting requirements and for other
  performance measures
  ACTION REGISTRY™ Program Works

1.                            2.   Select a
Hospital signs a                  Software
participation agreement       Vendor or use

     3. Submit
          data                4.     quarterly
       quarterly                   benchmark
ACTION Registry™

 Enrollment Process
Enrollment Process
Step 1: Download the NCDR-ACTION Registry™
  enrollment packet
ACTION Registry™…….How to Join
   – Enrollment Packet includes:
      • Enrollment Letter,
      • Master Agreement,
      • ACTION Registry™ Specific Addendum, and
      • Participant Contact Information Sheet
                                     …Then Submit These Documents

If as of today your     NCDR         ACTION        ACTION Registry    Participant
are participating in   Participant    Registry       CRUSADE           Contact
these Registries …       Master       Standard       Addendum        Information
                       Agreement     Addendum                           Form
NCDR™                                    X                                X

NCDR™ and NRMI                           X                                X
NCDR™ and                                                 X               X
NCDR™ and NRMI                                            X               X
NRMI Only                  X             X                                X
CRUSADE Only               X                              X               X
New Enrollees              X             X                                X
Enrollment Process
Step 2: Complete your enrollment packet and
  submit the materials to the NCDR™

• Allow 10 to 14 business days for delivery of
  your enrollment materials.

 ** Please note there is no charge for enrollment in
              the ACTION Registry™. **
Enrollment Process

Step 3: Receive welcome kit
       Complete online tool tutorial

        Questions???? Contact NCDR™
     Please include your full name, institution name,
      address, phone number and fax number
IRB Considerations

• Discuss with your IRB whether review is
   – If deemed QI initiative – exempt from review
   – If deemed observational research – eligible
     for expedited review, with waiver of consent
     and authorization
• HIPAA compliance addressed via HIPAA
  appendix of site agreement
ACTION Registry™
  Inclusion Criteria
Inclusion Criteria

   • Ischemic symptoms lasting  10 minutes at
     rest within 24 hours prior to arrival
   • Presentation for initial ischemic event (i.e.
     not new onset after admission)
   • If incoming transfer – arrival at ACTION
     hospital within 24 hours of initial
     presentation to first facility
Inclusion Criteria (cont’d)
   • STEMI:
     – Sustained ST-segment elevation  1 mm
       in two or more contiguous leads
     – New left bundle branch block (LBBB)
     – Positive cardiac markers in the absence
       of the above ECG changes
     – May exhibit other ECG changes, but not
       required for enrollment
Patient Identification Strategies
Retrospective vs. Prospective

  • Retrospective – after patient discharge
  • Prospective – during hospitalization
  • Some methods work with either approach
    (e.g. cardiac marker review)
  • Some methods more effective with one
    approach than with another (e.g. ICD-9
Patient Identification Strategies
ICD-9 Codes and Patient Billing

 • Typically retrospective; typically primary dx
 • Review admission/discharge diagnosis ICD-9
    Acute MI (specified site)           410.0 - 410.6
    NSTE MI (subendocardial infarction) 410.7
    Other STEMI (non-specified site)    410.8
    Other MI (non-specified site)       410.9
Patient Identification Strategies
ICD-9 Codes and Patient Billing   (cont’d)

• Review Patient Billing for CCU, ICU, telemetry
  unit, cardiac floor, and laboratory charges
• Points to consider
   – Most common and thorough screening method
   – Involves only MR or billing department
   – May be done any time
   – May be lag time between patient discharge
     and availability of chart or billing data
Patient Identification Strategies
A Note about Using Codes/Billing
  • ICD-9 and billing codes are a means by
    which to generate a list of potentially eligible
  • Relevant coding is not enough to indicate
    eligibility – must review chart to verify
    presence of inclusion criteria
Patient Identification Strategies
Lab Results
  • Retrospective or prospective
  • Screen for patients with elevated cardiac
    marker levels (i.e. CK-MB or Troponin)
  • Points to consider
    – Identifies patients with tests specific to
      suspected ACS
    – Patients with ACS may not undergo early
      cardiac syndrome testing
Patient Identification Strategies
Collaboration within Your Hospital
   • Typically prospective
   • Review daily ED, chest pain unit, CCU,
     telemetry floor admission logs
      – Chest pain, MI, r/o MI
      – Elevated cardiac markers, dynamic ECG
      – Rapid, bedside troponin assays in the ED
      – Manual triggers for unit nursing staff
Patient Identification Strategies
Collaboration within Your Hospital       (cont’d)

• Review daily cath lab schedule for urgent/
  emergent caths
• Work with clinical trials coordinators screening a
  similar patient population
   – Procedures/medications dictated by clinical
     trial will not adversely affect adherence scores
   – Patients excluded from clinical trials due to co
     morbidities, etc. likely still eligible for ACTION
Patient Identification Strategies
Collaboration within Your Hospital   (cont’d)

   • Points to consider
     – Narrows number of charts to pull vs.
       retrospective review of codes/billing
     – Logs readily available
     – Admission diagnosis may not be accurate
     – Would need to ensure that all possible
       patient entry points are screened
   ACTION Registry™

Data Collection Form (DCF) and
 Electronic Data Capture (EDC)
Data Capture Methods
 • Currently v1.0 – Web-based data entry via
   DCRI Registry System
    – No charge for ACTION participants
    – Save records as complete by appropriate
      data deadline to submit for quarterly harvest
 • v2.0 – Anticipated release early 2008 (vendors
   will be engaged in the process accordingly)
 • Sites will be able to choose desired data
   capture method as options become available
Web-based Data Collection

  • Site responsible for assigning patient numbers,
    entering own data via Internet
  • Data collected include:
     – Patient risk factors/presenting symptoms
     – Use of medications, invasive procedures
     – In-hospital clinical outcomes
  • Built-in queries fire during data entry and upon
    submission of complete record
Patient Tracking
  – Medical record number
  – Arrival date
  – ACTION patient ID (unique, 4 digits)
     • System will not allow duplicate IDs
• Separate admissions for same patient may be
  submitted using different patient IDs – each
  admission must qualify independently
• Patient ID should NOT be associated with patient
  identifiers (e.g. MR #, DOB, SSN)
First 24 Hours of Care
  • First 24 hours of care is cumulative (i.e.
    transferring hospital, EMS, physician’s office,
    participating hospital)
  • 24-hour clock starts at beginning of first encounter
  • Document all meds given, regardless of patient
  • Meds taken at home and not repeated until the
    following day – check “Yes” for both Home Meds
    and Meds in First 24 Hours of Treatment
Discharge vs. Transfer/Death/AMA
• Transfers out, deaths
   – Discharge meds and rec’s may be left blank
   – Excluded programmatically – should not be
     recorded as contraindications
• Patients signing out AMA
   – Allowed d/c teaching and/or accepted rx’s –
     document as usual in DCF
   – Refused or was unavailable for d/c teaching and
     rx’s – document as contraindication
Contraindication vs. Recommended Population
• A patient not “needing” a medication or secondary
  prevention measure is not a contraindication
• Record contraindications as documented in the
  medical record
• DCRI programming will determine whether or not
  the patient is in the recommended population
e.g. Smoking counseling in a non-smoker is deemed
  “not applicable” by programming
“Interchangeable” Meds
• Patients given one class of med likely will not be
  given a similar class also
   -- ACE inhibitor vs. ARB -- Statin vs. non-statin
• DCRI programming gives credit in adherence
  scoring for use of either class of medication
   – Documentation of ACEI or ARB fulfills the quality
      indicator for “ACEI/ARB”
   – Documentation of statin or non-statin fulfills the
      quality indicator for “lipid-lowering agent”
Optional DCF Fields

  • Appear at the end of the online DCF
  • Site may use fields any way they choose
  • Recommend using simplified code list to track
    data of interest to minimize variance between
  • DCRI does not know how site uses these
    fields, will not review fields unless site requests
ACTION Registry™
Data Quality Reports
Data Quality Reports
 • Data Quality Report (DQR) posted at regular
   intervals in Reports section of data entry website
 • Designed to highlight patterns in data collection
   that may or may not be of concern
 • Site has option of correcting data using itemized
   list of potential errors
 • Corrections made prior to quarterly harvest
   improve data reliability for analysis, and are
   reflected on subsequent data quality reports
Data Submission Timelines
 • Harvest timing – records saved as complete
   within one month after the end of the quarter
 • Corrections based on DQR made prior to
   harvest are incorporated into outcomes reports
                                     Saved As
 Quarter  Discharge Dates            Complete By
   Q1    January, February, March    April 30th
   Q2    April, May, June            July 31st
   Q3    July, August, September     October 31st
   Q4    October, November, December January 31st
ACTION Registry™
  Outcome Reports
Quarterly Outcome Reports
Data Reporting to Sites
• Quarterly Outcome Reports to sites regarding
  adherence to ACC/AHA Guidelines
   – Focused on the ACC/AHA Guidelines treatment
     & management recommendations
   – Site confidentiality maintained – data supplied
     back to sites in a blinded fashion
   – Provides sites with benchmark performance
Quarterly Outcome Reports

 • Data harvested on quarterly basis according to
   data submission schedule
 • Analysis performed at DCRI
 • Paper and electronic copies produced
 • Electronic copies sent to ACCF for posting on
   NCDR participant website (password-protected)
Quarterly Outcome Reports
  • Dashboard: Summary of aggregate (average)
    adherence scores over previous 12 months
  • Trend graphs: Summary of adherence scores
    over previous 12 months, plotted quarterly
  • Descriptive tables: All data collected on DCF
  • Subgroup tables: Medication quality indicators
    over previous 12 months, by subgroup
Quarterly Outcome Reports
Dashboard/Executive Summary
Quarterly Outcome Reports
Trend Graphs
Quarterly Outcome Reports
Descriptive Tables
Quarterly Outcome Reports
Subgroup Tables
ACTION Registry™
   D-2-B Alliance
D-2-B: An Alliance for Quality

American College of Cardiology (ACC)

American Heart Association (AHA)

National Heart Lung and Blood Institute (NHLBI)
D-2-B: An Alliance for Quality
Goal – Hospitals treating STEMI patients with
 emergency PCI should reliably achieve a door-to-
 balloon time of 90 minutes or less
• Guidelines Applied in Practice (GAP) program
  – Provides hospitals with six key evidence-based
    strategies and supporting tools needed to begin
    reducing their door-to-balloon times.
  – Focuses on reducing the door-to-balloon times
    in U.S. hospitals performing primary PCI.
D-2-B: An Alliance for Quality
•   Improve on CMS/JCAHO core measure
•   Learn from and share with the D2B community
    of hospitals
•   Continuing Education Credits
    –   ABIM Credit - 20 Maintenance of Certification
        (MOC-4) points
    –   CME Credit - 20 Category 1 CME credits
    –   CE Credit – submitted request
•   Strategic Partners Focus on D2B
•   Publicity for your hospital and D2B team
•   No cost to hospitals
•   It’s the right thing to do for the STEMI patients!
D-2-B: An Alliance for Quality
• Internal reporting D-2-B
  – Can use ACTION Registry™ or CathPCI
  – IHI D-2-B web base tool available
• More information or to join:
  – Email
  – Join at
ACTION Registry™
 Program Resources
Resources and References
 Help Desk: NCDR™ team – first-line triage for site
   – Basic project questions resolved by NCDR™
     “help desk”
   – Contract questions referred to ACC legal team
   – Clinical, data questions, IT questions referred
     to DCRI team
 Monthly Calls
   • Orientation Calls and Site Calls
Resources and References (cont’d)

  • Website:
    – Public Page
    – Private page – Login Access
       • Resource Documents
       • FAQs
    – Online “HELP”
Resources and References (cont’d)

   • Conferences and Workshops
   – Annual Conference
      • Orientation Mini Course - May 7, 2007
      • Full Meeting - May 8 – 9, 2007
   – Fall Workshop: tbd
Helpful Reference Materials
       Welcome Kit
       Program summary and/or overview
       DCF and instructions
       EDC training manual
       FAQs
       Sample quarterly report
Contact Us!
              Any Questions?
              Call 800-257-4737


                Email us at

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