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

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)

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

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

METHODS

• Sites selected by ACC from potential locations provided by UHC

• Data collection instrument and web-based entry system developed

• Automated algorithm created

• Audit of automated indication assignments

• On-demand reports

• Periodic overall and site-specific summaries provided

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

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

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

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%

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)

APPROPRIATENESS CLASSIFICATION(n = 6,351)

Appropriate66%

Uncertain14%

Inappropriate13%

Unclassifed7%

APPROPRIATENESS CLASSIFICATION Elimination of Unclassified (n = 5,928)

Appropriate71%

Uncertain15%

Inappropriate14%

APPROPRIATENESS CLASSIFICATION Based on Site

0%

20%

40%

60%

80%

100%

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

Inappropriate

Uncertain

Appropriate

n = 578 1200 1448 1448 322 932

InappropriateRange: 4-22%

APPROPRIATENESS CATEGORYBased on Patient Factors

0%

20%

40%

60%

80%

100%

Age >65 Age ≤65 Men Women

Inappropriate

Uncertain

Appropriate

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

9.8% 19.3% 13.6% 15.5%

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 %

APPROPRIATENESS CATEGORY Based on Referral

0%

20%

40%

60%

80%

100%

Cardiologist Non-Cardiologist

Inappropriate

Uncertain

Appropriate

n = 4,792 n = 1,136

p < 0.0001

13.2%

16.1%

19.5%

70.7% 70.7%

9.9%

APPROPRIATENESS CATEGORY Based on Referral

0%

20%

40%

60%

80%

100%

Within Practice Outside Practice

Inappropriate

Uncertain

Appropriate

n = 4,881 n = 1,047

p < 0.0001

13.2% 20.1%

16.0%

70.9%

10.1%

69.8%

FEEDBACK TO SITES

INAPPROPRIATE SPECT-MPITemporal Changes Based on Site

0

5

10

15

20

25

30

Period 1 Period 2 Period 3

% I

napp

ropr

iate

Site 1 Site2Site 3Site 4

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

IMPLICATIONS

• Physicians and other health care professionals, working with medical societies, recognize the current healthcare environment

–Active measures to optimize performance and cost-effectiveness –Preserve patient access to evaluation and treatment

• The development and implementation of appropriate use criteria 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, subspeciality societies, and health plans regarding responsible approach to medical imaging and continued emphasis on improving the quality of care

ACKNOWLEDGMENTS

• American Society of Nuclear Cardiology (ASNC)

• 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

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

AUDIT OF COMPUTER-ASSIGNED INDICATIONS VERSUS INDEPENDENT PHYSICIAN REVIEW

71%

15%

14%

AgreePartial agreeDisagree

SPECT RESULTSBased on Appropriateness Category

40.3%

59.7%

NormalAbnormal

43.6%

56.4%

NormalAbnormal

34.3%

65.7%

NormalAbnormal

APPROPRIATE

UNCERTAIN

INAPPROPRIATE

p < 0.0003

INDICATION AND SPECT FINDINGSMost Common “Inappropriate” Indications

INDICATION

% Abnormal SPECT

Detection of CADAsymptomatic, low CHD risk 27.7%

Asymptomatic, post-revascularization< 2 years after PCI, symptoms before PCI 54.7%

Evaluation of chest pain, low probability ptInterpretable ECG and able to exercise 19.7%

Asymptomatic or stable symptoms, known CAD< 1 year after cath or abnormal prior SPECT 63.6%

Pre-operative assessmentLow risk surgery 25.0%

PROBABILITY OF CORONARY ARTERY DISEASE BASED ON AGE, GENDER AND SYMPTOMS

(Diamond & Forrester)

Very LowLowModerateHigh

Very LowLowModerateHigh

ESTIMATEDn = 5,567

CALCULATEDn = 6,332

CORONARY HEART DISEASE RISKBASED ON FRAMINGHAM CRITERIA

66%9%

25%

LowModerateHigh

32%

32%

36%

LowModerateHigh

ESTIMATEDn = 5,649

CALCULATEDn = 6,082

REASON FOR TESTBased on Appropriateness Category

Overall % A % U % I %Detection of CAD/Risk stratification-Symptomatic

47.4 60.7 19.4 25.8

Detection of CAD/Risk stratification-Asymptomatic

9.9 3.8 17.5 24.4

Risk assessment- Post-revascularization

16.4 11.7 36.3 15.7

Assessment of viability/function 3.4 4.3 1.7 2.0

Risk assessment- Prior test results

12.1 8.0 16.6 24.2

Risk assessment- Pre-operative evaluation

8.0 9.5 2.9 7.8

Risk assessment- Post-ACS

2.9 2.1 5.5 4.3

ACC METHODOLOGY FOR DEVELOPMENT OF APPROPRIATE USE CRITERIA

(Rand/Modified Delphi Method)

Outside Review of Indications and Additional Modification Prior to Rating

1st Round – No interaction

Face-to-Face Meeting

2nd Round – Panel interaction

Literature Review and Synthesis of the Evidence List of indications and definitions

Appropriateness Score

(7-9) Appropriate

(4-6) Uncertain

(1-3) Inappropriate

Retrospective comparison with clinical records Prospective clinical decision aids

Va

lid

ati

on

Ap

pro

pri

ate

ne

ss

De

term

ina

tio

n

% Use that is Appropriate, Uncertain, Inappropriate Increase Appropriateness

Adapted from Fitch K, et al. The RAND/UCLA Appropriateness Method User’s Manual, 2001, 4

Balanced panel comprised of different types of experts rates the indications in two roundsBalanced panel comprised of different types of experts rates the indications in two rounds

Writing Group

Technical Panel

External Reviewers

Implementation Working Group