RIDGEFIELD, Conn. and INDIANAPOLIS, Dec. 13, 2018 /PRNewswire/ -- The Duke Clinical Research Institute is leading a new clinical study to optimize care for people with type 2 diabetes and cardiovascular disease through evaluation of a multidisciplinary approach at cardiology clinics across the U.S. The research program, COORDINATE-Diabetes (COOrdinating CaRDIology CliNics RAndomized Trial of Interventions to Improve OutcomEs), will be funded by Ridgefield-based Boehringer Ingelheim and Eli Lilly and Company.
"The public health impact of type 2 diabetes and cardiovascular disease in the U.S. is immense," said Christopher Granger, M.D., professor of medicine in the Division of Cardiology at Duke University and lead researcher for COORDINATE-Diabetes. "While highly effective evidence-based treatments have been developed, these treatments are not consistently used, and thus preventable death and disability are occurring. Our goal with COORDINATE-Diabetes is to better understand the effectiveness of specific interventions at cardiology clinics to achieve best practices for improving patient health."
People with diabetes are up to four times more likely to develop cardiovascular disease than those without diabetes, and cardiovascular disease ranks as their leading cause of death and disability despite available treatments. To help improve these striking statistics, COORDINATE-Diabetes will examine the impact of multifaceted interventions involving guideline-based therapies among cardiologists, endocrinologists, primary care providers and patients, including the recommendations outlined in the American Diabetes Association (ADA) 2018 Standards of Medical Care in Diabetes and the American College of Cardiology (ACC) Expert Consensus Decision Pathway on novel therapies for cardiovascular risk reduction in adults with type 2 diabetes and atherosclerotic cardiovascular disease.
The trial will include 46 cardiology clinics in the U.S. and aims to enroll 30 patients at each site. The clinics will be randomized to a basic education arm (in which patients will be treated by clinicians who receive only basic information about guideline-based therapy) or an intensive intervention arm (that focuses on coordinating care between cardiologists and endocrinologists to develop and implement an integrated, multidisciplinary care pathway). The care teams at the intervention sites will be encouraged to communicate with patients' primary care physicians to facilitate a well-rounded, multidisciplinary approach to patient care. The trial will measure the impact of the intervention on the sites' use of guideline-recommended therapies after 12 months.
"We are pleased to support evidence-based research to understand how to best manage risks and optimize care for patients with type 2 diabetes and cardiovascular disease in a real-world, clinical setting," said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Although there are treatments with proven cardiovascular benefits recommended by the ADA and other organizations, many healthcare providers are not prescribing them to all their patients who may benefit. We look forward to learning more about how healthcare providers can work together to improve adherence to these treatment guidelines in the quest to reduce patients' cardiovascular risk."
The trial will also leverage the power of electronic health record data from a consortium of health systems across the U.S. that have curated their data to support research and improve outcomes. Researchers will begin enrolling clinics and patients for the study in 2019 with the goal of sharing the main results by 2021.
"Few rigorous studies have tested the effectiveness of a multidisciplinary approach to improving care among this vulnerable patient population," noted Sherry Martin, M.D., vice president, Medical Affairs, Lilly. "Given the serious cardiovascular complications associated with type 2 diabetes, it is important for cardiologists and endocrinologists to work collaboratively to help improve care for people with type 2 diabetes and cardiovascular disease."