ACTION Registry

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ACTION Registry

• American College of Cardiology Foundation
• Washington, DC
• Duke Clinical Research Institute
• Durham, NC

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Objectives

• Provide an overview of the NCDR and the ACTION
  Registry
• Learn how to become a participant
• Review data inclusion criteria and patient
  identification
• Review the Data Collection Form (DCF) and
  Electronic Data Capture (EDC)
• Describe Quarterly Outcome Reports
• Summarize ACTION Registry participant resources

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ACTION Registry Overview of the
NationalCardiovascular Data Registry(NCDR)
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NCDR mission isTo 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.
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NCDR Overview

• Leader in Cardiovascular Health Outcomes
• 10th year in operation
• Four Registries CathPCI, ICD, CARE, ACTION
• 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
• HRS, SCAI, SIR, AAN

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NCDR Overview (contd)

• P4P - Government, Insurers, Regulators and
  Healthcare Providers are relying on the NCDR for
  quality data
• Meet Pay for Performance Quality Requirements
• CMS - Coverage with Evidence Development
• Meet State/Regulatory Requirements
• Quality Improvement
• New age of Prove It

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ACTION RegistryProgram Overview
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ACTION Registry

• Acute Coronary Treatment and
• Intervention Outcomes Network

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Registry Purpose

• Create a national surveillance system for ACS
  (STEMI/NSTEMI)
• 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

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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 outcomes

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Registry Objectives (contd)

• 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

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Registry Objectives (contd)

• 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 ACS
• Facilitate data collection for use in JCAHO core
  measures reporting requirements and for other
  performance measures

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ACTION REGISTRY Program Works
1.
Select a Certified Software Vendor or use EDC
2.
Hospital signs a participation agreement
Collect Data
3.
Receive quarterly benchmark reports
Submit data quarterly
4.
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ACTION RegistryEnrollment Process
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Enrollment Process

• Step 1 Download the NCDR-ACTION Registry
  enrollment packet
• www.accncdr.org
• ACTION Registry.How to Join
• Enrollment Packet includes
• Enrollment Letter,
• Master Agreement,
• ACTION Registry Specific Addendum, and
• Participant Contact Information Sheet

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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.

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Enrollment Process

•   Step 3 Receive welcome kit
• Complete online tool tutorial
• Questions???? Contact NCDR Email
  ncdr_at_acc.org
• Please include your full name, institution
  name, address, phone number and fax number

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IRB Considerations

• Discuss with your IRB whether review is required
• 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

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ACTION RegistryInclusion Criteria
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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
• And

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Inclusion Criteria (contd)

• STEMI
• Sustained ST-segment elevation ? 1 mm in two or
  more contiguous leads
• New left bundle branch block (LBBB)
• NSTEMI
• Positive cardiac markers in the absence of the
  above ECG changes
• May exhibit other ECG changes, but not required
  for enrollment

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Patient Identification StrategiesRetrospective
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 codes)

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Patient Identification StrategiesICD-9 Codes and
Patient Billing

• Typically retrospective typically primary dx
• Review admission/discharge diagnosis ICD-9 codes
• 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

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Patient Identification StrategiesICD-9 Codes and
Patient Billing (contd)

• 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

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Patient Identification StrategiesA Note about
Using Codes/Billing

• ICD-9 and billing codes are a means by which to
  generate a list of potentially eligible patients
• Relevant coding is not enough to indicate
  eligibility must review chart to verify
  presence of inclusion criteria

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Patient Identification StrategiesLab 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

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Patient Identification StrategiesCollaboration
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 changes
• Rapid, bedside troponin assays in the ED
• Manual triggers for unit nursing staff

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Patient Identification StrategiesCollaboration
within Your Hospital (contd)

• 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

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Patient Identification StrategiesCollaboration
within Your Hospital (contd)

• 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

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ACTION RegistryData Collection Form (DCF)
andElectronic Data Capture (EDC)
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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

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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

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Patient Tracking

• KEEP A PATIENT LOG
• 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)

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Medications First 24 Hours of Care

• First 24 hours of care is cumulative (i.e.
  transferring hospital, EMS, physicians office,
  participating hospital)
• 24-hour clock starts at beginning of first
  encounter
• Document all meds given, regardless of patient
  location
• 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

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MedicationsDischarge vs. Transfer/Death/AMA

• Transfers out, deaths
• Discharge meds and recs may be left blank
• Excluded programmatically should not be
  recorded as contraindications
• Patients signing out AMA
• Allowed d/c teaching and/or accepted rxs
  document as usual in DCF
• Refused or was unavailable for d/c teaching and
  rxs document as contraindication

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MedicationsContraindication 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

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MedicationsInterchangeable 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

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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
  records
• DCRI does not know how site uses these fields,
  will not review fields unless site requests
  assistance

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ACTION RegistryData Quality Reports
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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

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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

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ACTION RegistryOutcome Reports
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Quarterly Outcome ReportsData 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 data

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Quarterly Outcome ReportsGeneration

• 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)

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Quarterly Outcome ReportsContents

• 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

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Quarterly Outcome ReportsDashboard/Executive
Summary
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Quarterly Outcome ReportsTrend Graphs
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Quarterly Outcome ReportsDescriptive Tables
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Quarterly Outcome ReportsSubgroup Tables
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ACTION RegistryD-2-B Alliance
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D-2-B An Alliance for Quality

• American College of Cardiology (ACC)
• American Heart Association (AHA)
• National Heart Lung and Blood Institute (NHLBI)

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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. 

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D-2-B An Alliance for Quality

• Improve on CMS/JCAHO core measure results.
• 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
• Its the right thing to do for the STEMI
  patients!

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D-2-B An Alliance for Quality

• Internal reporting D-2-B
• Can use ACTION Registry or CathPCI Registry
• IHI D-2-B web base tool available
• More information or to join
• Email d2bstaff_at_acc.org
• Join at www.d2b.acc.org

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ACTION RegistryProgram Resources
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Resources and References

• Help Desk NCDR team first-line triage for
  site questions
• 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

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Resources and References (contd)

• Website www.accncdr.org/WebNCDR/Action/
• Public Page
• Private page Login Access
• Resource Documents
• FAQs
• Online HELP

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Resources and References (contd)

• Conferences and Workshops
• Annual Conference
• Orientation Mini Course - May 7, 2007
• Full Meeting - May 8 9, 2007
• Fall Workshop tbd

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Helpful Reference Materials

• Welcome Kit
• Program summary and/or overview
• DCF and instructions
• EDC training manual
• FAQs
• Sample quarterly report

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Contact Us!

• Any Questions?
• Call 800-257-4737
• or
• Email us at
• ncdr_at_acc.org