(Circulation. 2006;113:767-770.)
© 2006 American Heart Association, Inc.
Editorial |
From Kaiser Permanente, Oakland, Calif (R.G.B.), and Scott & White Clinic, Texas A&M College of Medicine, Temple (G.J.D.).
Correspondence to Ralph G. Brindis, MD, MPH, Northern California Kaiser Permanente, Oakland Kaiser Medical Center, 280 W MacArthur Blvd, Oakland, CA 94611. E-mail Ralph.Brindis{at}kp.org
Key Words: Editorials cardiovascular diseases catheterization registries outcomes
| Introduction |
|---|
|
|
|---|
Article p 814
CQI efforts in cardiovascular care have shown benefits such as attaining a high level of adherence to evidence-based performance and process measures in the management of acute coronary syndromes. More importantly, CQI, through an improvement in patient care processes, has an association with better clinical outcomes with emerging data demonstrating decreased mortality.6,7 However, large confirmatory randomized clinical trials are still lacking. An important question is whether large-scale randomized trials are really necessary in this circumstance. Is it necessary to have direct evidence that you have saved lives, or is it enough to show that you have improved processes that have a strong link with outcomes? That will be a very important question in the future as there is a greater emphasis on improving the quality of medical care.
The core of most CQI programs includes the following: (1) the collection of data containing clinically relevant patient variables that allow assessment of clinical processes, performance, and outcomes; (2) feedback of this performance and outcomes data to the clinicians, ideally with risk adjustment and benchmarking of the data; and (3) implementation of appropriate interventions to promote reduction in wasteful and inefficient variation in care while simultaneously improving performance. These interventions might include the development of evidenced-based clinical guidelines and then dissemination of this information through grand rounds, "pocket guides" of critical pathways, and other reminder tools such as preprinted order sheets. The actual "key ingredients" from the smorgasbord of potential tools to best ensure successful CQI programs are still not fully understood. We also have much to learn regarding the context of how these "key ingredients" are applied. We do know that there are several known predictors of success for CQI programs, invariably focusing on the presence or absence of local physician champions in conjunction with an administrative and financial commitment from the parent organization.8,9
In this issue, Moscucci and colleagues10 describe a substantial effort to implement a statewide CQI initiative in Michigan, specifically devised for the cardiac catheterization laboratory. Their program, designed to examine and reduce outcome variation in the performance of percutaneous coronary intervention (PCI), documents the positive effects of a CQI program. This topic is both relevant and important as
1 million PCI procedures are now performed annually in the United States. The potential for improvements in PCI outcomes attained through a CQI program could have a major impact, as measured by lives saved and a decrease in hospital costs through a reduction in prolonged hospitalizations that are associated with procedural complications, such as contrast nephropathy, vascular injury, bleeding, stroke, and myocardial infarction. The authors, recognized leaders in the cardiovascular outcomes and quality community, are to be congratulated for their vision and effort in developing this program and, more importantly, in evaluating the impact of this CQI program. Through this documentation, the quality and outcomes community can better understand the importance of CQI implementation in the cardiac catheterization laboratory and its potential for improving care.
The Michigan PCI CQI program used a wide range of concurrent and reinforcing strategies directed throughout the system of care. A key element was the quarterly feedback to clinicians on their adherence to process and performance measures along with crude and risk-adjusted outcomes. Grand rounds presentations, site visits, work group meetings, and newsletters were also used to provide information to clinicians. Various bedside clinical tools to assess the risk of in-hospital mortality after PCI and aids for the prediction and prevention of contrast nephropathy requiring dialysis and reduced blood transfusions were distributed. Other examples of interventions instituted in participating hospitals included uniform preprocedure order sets to ensure the administration of critical medications, standard nursing protocols for assessing preprocedure medications, delay of cases if necessary medications were neglected, routine preprocedure hydration plus efforts to limit contrast administration in high-risk patients with renal insufficiency, and modification and standardization of emergency department protocols for patients with acute coronary syndromes.
As a result of these interventions, there was a demonstrable decrease in bleeding, transfusion requirements, vascular complications, and contrast utilization and a trend for the reduction in the occurrence of contrast nephropathy. Increased adherence to these process measures further translated into temporal improvements in major clinical outcomes. Compared with the period before the CQI program, there were lower crude and risk-adjusted rates of in-hospital death, emergency coronary artery bypass graft surgery, contrast nephropathy requiring dialysis, myocardial infarction, and stroke. With the exception of contrast nephropathy, many of these other improvements could be ascribed to temporal advances in PCI care that occurred between 1998 and 2002. However, their study results support the benefits of CQI implementation, even when these temporal trends are considered. The differences in catheterization laboratory performance measures and associated clinical outcomes documented in their control versus intervention cohort studies from 2002 further support the value of a PCI CQI program. When comparing 2002 data from the CQI intervention hospitals with data from the control hospitals, the authors described statistically significant better clinical outcomes defined by a quadruple end point of death/emergency coronary artery bypass graft surgery/stroke/repeated PCI. Of interest, the control hospitals reported a trend toward a lower rate of periprocedural myocardial infarction than the CQI-utilizing hospitals. This observation most likely reflects an incorrect assessment of the frequency of periprocedural myocardial infarction, a finding typical in PCI registries, where it is related to the lack of a consistent measurement of cardiac biomarkers after the procedure compared with studies in which the measurement of cardiac biomarkers is mandatory after the procedure.
Unfortunately, this was not a randomized study, a major weakness that undermines support for the hypothesis that a CQI program is beneficial. Therefore, it is not possible to definitively determine whether it was the CQI program that caused the improved outcomes or whether these improvements would have occurred in any case for reasons related to temporal changes in PCI practice. Moreover, although these data were risk adjusted, there were important variations in the clinical characteristics of the patients treated between the intervention and control arms. The authors freely acknowledge this shortcoming in their discussion and analysis. Temporal practice patterns, such as higher use of glycoprotein IIb/IIIa inhibitors, increased use of PCI <48 hours after a myocardial infarction, better stent technology, and the increased use of stents in PCI all contribute to improved PCI outcomes. However, the markedly increased in-hospital mortality associated with contrast nephropathy requiring dialysis is well known. This studys unequivocal demonstration that achieving a decrease in contrast use led to a decreased incidence of contrast nephropathy, as well as a trend in decreased contrast nephropathy requiring dialysis when postintervention hospitals are compared with both themselves temporally and with the control hospitals in 2002, validates the use of these CQI initiatives. Indeed, the Michigan CQI program of Moscucci et al most likely contributed substantially to the positive changes in performance observed, although the strength of this evidence is not as strong as it might be with a randomized controlled trial. Particularly commendable was their building into their project an evaluation component that should serve as a model for future programs. Such an effort can also help us to determine whether such programs might paradoxically reduce quality or have an adverse, unintended, and unexpected effect.
| Barriers to CQI Program Implementation |
|---|
|
|
|---|
| External Driving Forces in CQI |
|---|
|
|
|---|
Working together, the ACC and SCAI have created a cardiac catheterization laboratory quality improvement tool called ACC-CathKIT. ACC-CathKIT is an up-to-date Web-based cardiac catheterization and PCI tool kit to aid clinicians and hospitals in developing their own CQI initiatives in the cardiac catheterization laboratory.16 Included in CathKIT are lessons in CQI methodology, examples of relevant CQI projects, such as management and avoidance of groin complications, and downloadable templates for catheterization laboratory protocols and PCI pathways. Individual NCDR hospital presentations given at ACC-NCDR user group meetings have confirmed the effectiveness of adopting CathKIT CQI projects with the demonstration of positive changes in aspects of cardiac catheterization care along with cost savings to their institution.
| Pay for Performance and CQI |
|---|
|
|
|---|
Perhaps through direct financial support by the payers, hospitals and clinicians will be more motivated to embrace the quality initiatives already demonstrated to be of significant value in the management of acute coronary syndromes and now being highlighted in the cardiac catheterization laboratory.
| Acknowledgments |
|---|
None.
| Footnotes |
|---|
| References |
|---|
|
|
|---|
2. Juran JM. Juran on Quality by Design: The New Steps for Planning Quality Into Goods and Services. New York, NY: The Free Press; 1992.
3. Donabedian A. Specialization in clinical performance monitoring: what it is and how to achieve it. Qual Assur Util Rev. 1990; 5: 114120.[Medline] [Order article via Infotrieve]
4. Berwick DM, James B, Coye MJ. Connections between quality measurement and improvement. Med Care. 2003; 41 (suppl 1): I30I8.[Medline] [Order article via Infotrieve]
5. Jencks SF, Wilensky GR. The health care quality improvement initiative: a new approach to quality assurance in Medicare. JAMA. 1992; 268: 900903.
6. Eagle KA, Montoye CK, Riba AL, DeFranco AC, Parrish R, Skorcz S, Baker PL, Faul J, Jani SM, Chen B, Roychoudhury C, Elma MA, Mitchell KR, Mehta RH, for the American College of Cardiologys Guidelines Applied in Practice (GAP) Projects in Michigan; American College of Cardiology Foundation Guidelines Applied in Practice Steering Committee. Guideline-based standardized care is associated with substantially lower mortality in Medicare patients with acute myocardial infarction. J Am Coll Cardiol. 2005; 46: 12421248.
7. Brindis RG, Sennett C. Physician adherence to clinical practice guidelines: does it really matter? Am Heart J. 2003; 145: 1315.[CrossRef][Medline] [Order article via Infotrieve]
8. Ohman EM, Roe MT, Smith SC, Brindis RG, Christenson RH, Harrington RA, Gibler WB, Peterson ED, for the CRUSADE Investigators. Care of non-ST-segment elevation patients: insights from the CRUSADE national quality improvement initiative. Am Heart J. 2004; 148: S34S39.[CrossRef][Medline] [Order article via Infotrieve]
9. Bradley EH, Holmboe ES, Mattera JA, Roumanis SA, Radford MJ, Krumholz HM. A qualitative study of increasing ß-blocker use after myocardial infarction: why do some hospitals succeed? JAMA. 2001; 285: 26042611.
10. Moscucci M, Rogers EK, Montoye C, Smith DE, Share D, ODonnell M, Maxwell-Eward A, Meengs WL, De Franco AC, Patel K, McNamara R, McGinnity JG, Jani SM, Khanal S, Eagle KA, for the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2). Association of a continuous quality improvement initiative with practice and outcomes variations of contemporary percutaneous coronary interventions. Circulation. 2006; 113: 814822.
11. Brindis RG, Fitzgerald S, Anderson HV, Shaw RE, Weintraub WS, Williams JF. The American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR): building a national clinical data repository. J Am Coll Cardiol. 2001; 37: 22402245.
12. Anderson HV, Shaw RE, Brindis RG, Hewitt K, Krone RJ, Block PC, McKay CR, Weintraub WS. A contemporary overview of percutaneous coronary interventions: the American College of Cardiology-National Cardiovascular Registry (ACC-NCDR). J Am Coll Cardiol. 2002; 39: 10961103.
13. Shaw RE, Anderson HV, Brindis RG, Krone RJ, Klein LW, McKay CR, Block PC, Shaw LJ, Hewitt K, Weintraub WS. Development of a risk adjustment mortality model using the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR) experience: 19982000. J Am Coll Cardiol. 2002; 39: 11041112.
14. Anderson HV, Shaw RE, Brindis RG, Klein LW, McKay CR, Kutcher MA, Krone RJ, Wolk MJ, Smith SC, Weintraub WS. Relationship between procedure indications and outcomes of percutaneous coronary interventions by American College of Cardiology/American Heart Association Task Force guidelines. Circulation. 2005; 112: 27862791.
15. Califf RM, Peterson ED, Gibbons RJ, Garson A, Brindis RG, Beller GA, Smith SC. Integrating quality into the cycle of therapeutic development. J Am Coll Cardiol. 2002; 40: 18951901.
16. Dehmer GJ, Hirshfeld JW, Oetgen WJ, Mitchell K, Simon AW, Elma ME, Kellett MA, Brindis RG. CathKIT: improving quality in the cardiac catheterization laboratory. J Am Coll Cardiol. 2004; 43: 893899.
This article has been cited by other articles:
![]() |
V. Bahl and D. A. Campbell Jr Medicare's New Hospital Payment Rule: Limitations and Unintended Consequences American Journal of Medical Quality, July 1, 2009; 24(4): 347 - 351. [PDF] |
||||
![]() |
L. W. Klein, P. Kolm, X. Xu, R. J. Krone, H. V. Anderson, J. S. Rumsfeld, R. G. Brindis, and W. S. Weintraub A Longitudinal Assessment of Coronary Interventional Program Quality: A Report From the American College of Cardiology-National Cardiovascular Data Registry J. Am. Coll. Cardiol. Intv., February 1, 2009; 2(2): 136 - 143. [Abstract] [Full Text] [PDF] |
||||
![]() |
B. Bridgewater, A. D Grayson, N. Brooks, G. Grotte, B. M Fabri, J. Au, T. Hooper, M. Jones, B. Keogh, and on behalf of the North West Quality Improvement Pr Has the publication of cardiac surgery outcome data been associated with changes in practice in northwest England: an analysis of 25 730 patients undergoing CABG surgery under 30 surgeons over eight years Heart, June 1, 2007; 93(6): 744 - 748. [Abstract] [Full Text] [PDF] |
||||
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Circulation Home | Subscriptions | Archives | Feedback | Authors | Help | AHA Journals Home | Search Copyright © 2006 American Heart Association, Inc. All rights reserved. Unauthorized use prohibited. |