CERTs.Announcement.Archive.2004

Reprinted from The International Society for Pharmacoepidemiology's Scribe, 3rd Quarter 2004, Volume 7, Number 3, www.pharmacoepi.org.

The Duke Center for Education and Research on Therapeutics (CERTs)
By Judith M. Kramer, MD, MS, and Richeille Ricketts, MPH

The Duke Center for Education and Research on Therapeutics (CERTs) is one of seven national centers created to improve the use of therapeutics through research and education. The mission of the Duke CERTs is to conduct research and provide education that will advance the optimal use of cardiovascular drugs, medical devices and biological products.

When the Duke CERTs began its work in late 1999, our research focused on 3 areas: 1) assessing "real world" use of life-saving, evidence-based medications for cardiovascular disease, 2) post-marketing surveillance of cardiovascular devices, and 3) risk management strategies for QT prolonging medications. Using the Duke Databank for Cardiovascular Disease (DDCD), a large clinical database with annual follow-up on patients with documented coronary heart disease (CHD), we found that long-term, outpatient use of evidence-based medications for CHD was suboptimal. These results prompted us to initiate a series of projects to further explore issues in translating research findings into clinical practice and improving long-term adherence to medications. In one project we developed and tested a multifaceted intervention in regional medical practices to increase beta-blocker use in appropriate heart failure patients.

In a related effort Duke CERTs investigators provided methodological and analytic support in an informal collaboration with the Council for Affordable Quality Healthcare (CAQH) , who measured use of beta-blockers over the first year after MI in patients with commercial health insurance and prescription drug coverage. The National Committee for Quality Assurance (NCQA) has recently adopted the CAQH methodology for a 2005 quality measure of 6-month adherence to beta-blockers after MI. This marks the first national quality effort to focus on long-term adherence to an evidence-based medication for cardiovascular disease.

Other projects that were initiated in the first few years of the Duke CERTs program included the following:

Today the Duke CERTs has over 20 ongoing research and education projects. The current focus of the Duke CERTs is centered on the following themes:

Several projects are underway to bridge the gap that exists between evidence-based research and clinical practice. The Duke CERTs and the ACC have initiated several studies to evaluate the processes by which clinical research findings are developed into clinical practice guidelines and guidelines are used to develop performance measures. In addition, the Duke CERTs continues its focus on improving long-term use of life-saving, evidence-based medications. These projects include continued use of the DDCD to expand our knowledge of current use of these evidence-based medications, predictors of medication use, and clinical consequences of non-use. We also continue to develop and test interventions aimed at improving long-term use of evidence-based medications for CHD, including interventions directed at patients as well as practitioners.

The second theme is improving patient safety. Although all of the Duke CERTs projects to improve use of evidence-based medications are also viewed as efforts to improve patient safety through preventing errors of omission, the Duke CERTs has also focused on patient safety issues related to QT prolonging medications. In a series of studies, we have found that health care practitioners generally lack a complete understanding of the QT interval and medications that prolong the QT interval. In a separate study, we found that a risk management program for a specific QT-prolonging antiarrhythmic drug improved adherence to dosing and monitoring recommendations, but overall use of the drug was extremely low in comparison to a similar drug without a risk management program. This discrepancy in prescribing of the two drugs may have been an unintended consequence of the risk management program.

Other Duke projects addressing patient safety include a study evaluating patient receipt and comprehension of medication guides and mandatory patient package inserts, a series of studies evaluating drug-eluting stents, and a collaborative project with the University of Alabama CERTs, United Healthcare, and the Center for Biologics Evaluation and Research at FDA on cardiovascular safety of TNF-inhibitors.

The third broad theme is education. After identifying the knowledge deficit of health care practitioners on issues related to the QT interval and QT prolonging medications, the Duke CERTs developed an Internet-based educational module on the QT interval. This interactive, case-based program is being disseminated through the Duke CERTs Web site and the American Heart Association (AHA) Web site. In addition, the Duke CERTs continues to work to develop educational materials on evidence-based medications for CHD, evaluate the impact of medication information provided to patients, and provide patient- and physician-friendly information on cardiovascular therapeutics.

As the Duke CERTs begins its 6th year, we continue to expand our efforts within the three broad themes discussed above and explore new ways to improve the use of cardiovascular drugs, devices and biologics through education and research.

* CAQH is a national, not-for profit organization of leading health plans and networks

Editor's Note: This is the second in a series of articles appearing in the Scribe newsletter each featuring a different CERTs center.

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