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Multi-center Assessment of the Utilization of SPECT Myocardial Perfusion Imaging Using the ACCF Appropriateness Criteria: The ACCF and United Healthcare SPECT Pilot Study Robert C. Hendel, Manual Cerqueira, Kathleen Hewitt, Karen Caruth, Joseph Allen, Neil Jensen, Michael Wolk, Pamela S. Douglas, Ralph Brindis, American College of Cardiology Foundation, Washington, DC, UnitedHealthcare, Minneapolis, MN Robert C. Hendel, MD, FACC Midwest Heart Specialists Winfield, IL Chairman, ACCF/UHC SPECT-MPI Pilot Study Late Breaking Clinical Trials American College of Cardiology Scientific Sessions 2009 March 29, 2009

Late Breaking Clinical Trial Presentation at ACC 2009

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Page 1: Late Breaking Clinical Trial Presentation at ACC 2009

Multi-center Assessment of the Utilization of SPECT Myocardial Perfusion Imaging Using the ACCF Appropriateness Criteria:

The ACCF and United Healthcare SPECT Pilot Study

Robert C. Hendel, Manual Cerqueira, Kathleen Hewitt, Karen Caruth, Joseph Allen, Neil Jensen, Michael Wolk, Pamela S. Douglas, Ralph Brindis, American College of Cardiology Foundation, Washington, DC, UnitedHealthcare, Minneapolis, MN

Robert C. Hendel, MD, FACC

Midwest Heart SpecialistsWinfield, IL

Chairman, ACCF/UHC SPECT-MPI Pilot Study

Late Breaking Clinical TrialsAmerican College of Cardiology Scientific Sessions 2009

March 29, 2009

Page 2: Late Breaking Clinical Trial Presentation at ACC 2009

Presenter Disclosure Information

Robert C. Hendel, MD

The following relationships exist related to this presentation:

Consulting PGx Health ModestAstellas Pharma ModestGE Healthcare Modest

Research support Astellas ModestGE Healthcare Modest

Organizational ACC (Appropriate Use Criteria Task Force)

Page 3: Late Breaking Clinical Trial Presentation at ACC 2009

BACKGROUND

• Growth and cost of CV imaging has placed renewed attention on proper/optimal test ordering

• True nature of utilization unknown–Overuse/underuse/appropriate use

• Development and publication of SPECT-MPI appropriate use criteria (AUC) in 2005–Subsequent AUC for echo, CT, CMR–SPECT MPI revision 2009

• Criteria widely available and increasingly being adopted, but evaluation in community practice settings required

Page 4: Late Breaking Clinical Trial Presentation at ACC 2009

GOALS OF STUDY

•Assess feasibility of tracking AUC–Point-of-service data collection–Computer derived indication assignment

•Determine patterns of use for SPECT MPI in clinical practice

•Evaluate the impact of referral source

•Identify selected areas (indications) for quality improvement

Page 5: Late Breaking Clinical Trial Presentation at ACC 2009

METHODS

• Sites selected by ACC from potential locations provided by UHC

• Data collection instrument and web-based entry system developed

• Automated algorithm created

• On-demand reports

• Periodic overall and site-specific summaries provided

• Audit of automated indication assignments

Page 6: Late Breaking Clinical Trial Presentation at ACC 2009

DATA COLLECTION FORM

• Front page– Patient Demographics– History & Risk

Factors,– Prior procedures &

Tests

• Back page– Current Study– Reference section

• Designed to be completed in one minute or less

Page 7: Late Breaking Clinical Trial Presentation at ACC 2009
Page 8: Late Breaking Clinical Trial Presentation at ACC 2009

METHODSSites of Pilot

State Locale # MD’s#

patients enrolled

Site 1 FL Urban 17 635

Site 2 FL Urban 7 1293

Site 3 WI Rural 15 1597

Site 4 FL Urban 20 1570

Site 5 OR Suburban 17 328

Site 6 AZ Suburban 9 938

Page 9: Late Breaking Clinical Trial Presentation at ACC 2009

METHODSEnrollment Periods

3/1/08 8/15/08 2/28/0910/15/08

Period 1 Period 2 Period 3

On-demandReport

PaperReport

SITE 123456

1 SITE 23456

Page 10: Late Breaking Clinical Trial Presentation at ACC 2009

RESULTSPatient Characteristics (n =

6,351)

Age, years 65.7±11.8

Gender, male 3,729 58.7%

Diabetes 1,446 22.3%

Smoker 743 11.7%

Hypertension 4,856 76.7%

Hyperlipidemia 4,616 72.9%

Prior PCI 1,806 36.1%

Prior CABG 945 19.7%

Asymptomatic 2,414 38.0%

Page 11: Late Breaking Clinical Trial Presentation at ACC 2009

RISK ASSESSMENTAutomated Calculation and Indication

Assignment

5%

40%

49%

6%

Very LowLowModerateHigh

66%9%

25%

LowModerateHigh

SYMPTOMATIC PATIENTS(Diamond & Forrester)

ASYMPTOMATIC PATIENTS(Framingham; CHD Risk)

Page 12: Late Breaking Clinical Trial Presentation at ACC 2009

APPROPRIATENESS CLASSIFICATION(n = 6,351)

Appropriate66%

Uncertain14%

Inappropriate13%

Unclassifed7%

Page 13: Late Breaking Clinical Trial Presentation at ACC 2009

APPROPRIATENESS CLASSIFICATION Elimination of Unclassified (n =

5,928)

Appropriate71%

Uncertain15%

Inappropriate14%

Page 14: Late Breaking Clinical Trial Presentation at ACC 2009

APPROPRIATENESS CLASSIFICATION Based on Site

0%

20%

40%

60%

80%

100%

Site 1 Site 2 Site 3 Site 4 Site 5 Site 6

InappropriateUncertainAppropriate

n = 578 1200 1448 1448 322 932

InappropriateRange: 4-22%

Page 15: Late Breaking Clinical Trial Presentation at ACC 2009

APPROPRIATENESS CATEGORYBased on Patient Factors

0%

20%

40%

60%

80%

100%

Age >65 Age ≤65 Men Women

InappropriateUncertainAppropriate

p < 0.0001 p = 0.039n = 3,046 2,882 3,468 2,460

9.8% 19.3% 13.6% 15.5%

Page 16: Late Breaking Clinical Trial Presentation at ACC 2009

MOST COMMON “INAPPROPRIATE” INDICATIONS

INDICATION % INAPPRO INDICATIONS

% TOTAL STUDIES

Detection of CADAsymptomatic, low CHD risk 44.5% 6.0%

Asymptomatic, post-revascularization< 2 years after PCI, symptoms before PCI

23.8% 3.2%

Evaluation of chest pain, low probability ptInterpretable ECG and able to exercise

16.1% 2.2%

Asymptomatic or stable symptoms, known CAD< 1 year after cath or abnormal prior SPECT

3.9% 0.5%

Pre-operative assessmentLow risk surgery 3.8% 0.5 %

TOTAL 92.1% 12.4 %

Page 17: Late Breaking Clinical Trial Presentation at ACC 2009

APPROPRIATENESS CATEGORY Based on Referral

0%

20%

40%

60%

80%

100%

Cardiologist Non-Cardiologist

InappropriateUncertainAppropriate

n = 4,792 n = 1,136

p < 0.0001

13.2%

16.1%

19.5%

70.7% 70.7%

9.9%

Page 18: Late Breaking Clinical Trial Presentation at ACC 2009

APPROPRIATENESS CATEGORY Based on Referral

0%

20%

40%

60%

80%

100%

Within Practice Outside Practice

InappropriateUncertainAppropriate

n = 4,881 n = 1,047

p < 0.0001

13.2% 20.1%

16.0%

70.9%

10.1%

69.8%

Page 19: Late Breaking Clinical Trial Presentation at ACC 2009

FEEDBACK TO SITES

Page 20: Late Breaking Clinical Trial Presentation at ACC 2009

INAPPROPRIATE SPECT-MPITemporal Changes Based on Site

0

5

10

15

20

25

30

Period 1 Period 2 Period 3

% Inappropriate

Site 1Site 2 Site 3Site 4

Page 21: Late Breaking Clinical Trial Presentation at ACC 2009

LIMITATIONS

• Non-evaluable data–Missing information–Conflicting indications

• Rolling recruitment with inconsistent time periods

• Lack of validation of computer-assigned indications–Multiple indications–Audits reveal variance

• Educational initiatives inconsistently applied

• Non-adjudicated SPECT interpretations

Page 22: Late Breaking Clinical Trial Presentation at ACC 2009

CONCLUSIONS

• Data collection and analysis regarding appropriate use of SPECT imaging is feasible in busy community practice environment–Easy to use, point-of-ordering tool with web-based data entry–Automated determination of appropriateness–On-demand, benchmarked reports

• Variable rates of test appropriateness

• Consistent inappropriate indications–Asymptomatic, low risk patient are most frequent

• Feedback/education may influence on practice habits

• Less inappropriate testing from cardiologists than non-cardiologists

Page 23: Late Breaking Clinical Trial Presentation at ACC 2009

IMPLICATIONS

• Physicians and other health care professionals, working with medical societies, recognize the current healthcare environment and are taking active measures to optimize performance and cost-effectiveness, while preserving patient access to evaluation and treatment procedures

• The development and implementation of AUC may offer an alternative to prior authorization/pre-certification approaches–Transparency –Expanded information regarding practice habits–Facilitation of on-going quality improvement–Movement toward point-of-order application–Potential for wide-scale utilization

• Establishment of partnership between ACC, imaging subspeciality society, and health plan regarding responsible approach to medical imaging and continuing emphasis on improving the quality of care

Page 24: Late Breaking Clinical Trial Presentation at ACC 2009

ACKNOWLEDGMENTS

• American Society of Nuclear Cardiology (ASNC)

• Support from UnitedHealthcare

• Leadership of ACC–Especially Douglas Weaver, Ralph Brindis, Michael Wolk, Pamela Douglas, Jack Lewin, and Janet Wright

• Staff from ACC, NCDR, and DCRI–Notably Joseph Allen, Karen Caruth, Wenqin Pan, and Nichole Kallas