An important observational registry evaluating processes of care and one-year outcomes of over 4300 heart attack patients, is now being completed. Researchers at the Saint Luke’s Mid America Heart Institute in Kansas City, MO have led this observational research study in collaboration with 23 other hospitals throughout the U.S. A vast knowledge store, produced from the significant size and diversity of this cohort, is expected to generate numerous publishable studies in the years ahead. The complex information repository was populated with help from the Velos eResearch Clinical Research Management System to ensure the quality and validity of data that will be available for all studies.
“This venture fits within our overall vision of improving the quality of care in heart attack patients – and it represents a significant evolutionary step in our increasingly complex studies. Velos eResearch provided the foundation for our data collection from this very large, diverse cohort,” said principal investigator, John A. Spertus, M.D., medical director of cardiovascular education and outcomes research at Saint Luke’s Mid America Heart Institute in Kansas City, Missouri; professor of cardiology at the University of Missouri, Kansas City; and adjunct professor of medicine at Washington University School of Medicine.
Referred to as TRIUMPH (Translational Research Investigating Underlying Disparities in Myocardial Infarction Patients’ Health Status), this registry is unique in the breadth and depth of the sociodemographic and clinical characterization of heart attack patients and their clinical and health status outcomes over time. Health status is often overlooked, yet acknowledged as the best approach for measuring outcomes that are most relevant to patients.
The NIH (National Institutes of Health) funding of TRIUMPH has made possible the rigorous, complex and labor-intensive effort to collect these data, which included hospital chart abstraction, lab data, extensive interviews, in-home assessments on many patients, and adjudicated repeat hospitalizations. An estimated 2500 pieces of information have been collected on each patient as to their post-hospitalization functional status. Data from all interviews forms are captured by Velos eResearch. One-month, six-month and 12-month interviews, coordinated through a centralized call center at Yale University, were conducted. Data from one-year follow-up will be complete by first quarter 2010.
“We were able to leverage numerous features of the Velos system to create numerous data logic checks to ensure the quality of data entered,” continued Spertus. “For example, if a patient is male, the system will not allow a ‘post-menopausal’ field to be checked. Similarly, insulin could not be registered as a medication without a diagnosis of diabetes. This has helped us a great deal to know that we have valid data upon which we can conduct our planned analyses.”
A network of researchers will use the opportunity of having access to this large repository for a variety of studies. Some might want to look at patients’ physical functioning after heart attack and some might be interested in depression. Some will study the types of treatments received and the efficacy of medications prescribed upon discharge. The linking of the data to genetic samples also enables numerous genomic and pharmacogenomic analyses to be conducted. A team of statisticians will work full time over the next several years to support this undertaking.
The analytic phase of this study begins this October with a gathering of research scientists to explore the many studies possible with this registry.