Enhancing trial enrollment for advanced heart disease

Principal Investigators: Mitesh Patel, MD, MBA, MS and Tom Cappola, MD

Cardiovascular disease remains the leading killer in the U.S., and advanced forms of heart disease carry a prognosis similar to cancer. However, unlike clinical oncology, the practice culture of cardiovascular medicine, even in academic settings, does not regard investigational therapeutics as a routine option; such investigation is viewed as an extra activity. We hypothesize that current cardiovascular practice models built on relative value unit-based incentives and high clinical volumes guide physician behavior in a way that negatively impacts trial enrollment. Discussing investigational options is slow, complex, uncompensated, and is in effect disincentivized.

Our project is developing and testing a meaningful, ethically sound, and compliant approach to compensate cardiovascular physicians for time spent discussing and referring patients for clinical trials. In Aim 1, we will expand the efforts of the University of Pennsylvania Department of Medicine and Cardiovascular Division working group to include expertise in behavioral economics targeted to physician behavior, establish a formal oversight committee to assure compliance, and implement tools to track physician-patient conversations about trials in the PennChart electronic health record. In Aim 2, we will test the efficacy of our compensation model in a pilot randomized clinical trial deployed in the context of recruitment efforts for 40 therapeutic trials managed by the Cardiovascular Clinical Research Unit.