Project Summary
Despite widespread recognition of pervasive patient safety problems in the U.S. health care system, research
to develop feasible, scalable solutions has lagged, particularly in the ambulatory setting. The need for new
approaches to improve safety is especially pressing in the care of ambulatory patients using high-risk
immunosuppressive medications, as use of this category of medications has grown precipitously and reports of
preventable adverse events have increased. In the last AHRQ funding period, our research team generated
new epidemiological evidence of patient safety risks and adverse events and used this information to develop
electronic health record-based quality measures (eMeasures) for the Centers for Medicare and Medicaid
Services Quality Payment Program. In addition, we implemented these eMeasures nationally in the American
College of Rheumatology's RISE registry, which includes electronic health record data from over one-third of
U.S. practicing rheumatologists. In this proposal, we aim to build on this work to improve ambulatory patient
safety for individuals using high-risk immunosuppressive drugs. In Aim 1, we will use data from the RISE
registry linked to Medicare claims to identify emerging patient safety errors for newly approved
immunosuppressive drugs and analyze these errors across race/ethnicity, socioeconomic status, medical
complexity, access to care and practice characteristics. In Aim 2, we will perform a comprehensive evaluation
of current national patient safety eMeasures related to immunosuppressive drugs, assessing feasibility,
reliability, and validity across diverse practice settings, electronic health record systems, and visit types
(telemedicine versus face-to-face). In Aim 3, we will use mixed-methods grounded in implementation science
theory to determine key drivers of performance on ambulatory patient safety eMeasures. Data from this
research will be used to develop and disseminate the first implementation toolkit designed to improve patient
safety for high-risk immunosuppressive drugs. The proposed research will contribute significantly to the
national infrastructure to improve ambulatory patient safety for the millions of Americans with immune-
mediated diseases.