With the pervasive use of electronic health record (EHR) data comes the opportunity to organize, aggregate, analyze, and even predictive use for care coordination and optimal patient intervention, not to mention comprehensive support research via tapping into real-world data. Recently, Kaiser Permanente leveraged their internal EHR system (Epic) to develop a patient registry for patients over-using to excessively using alcohol. This new EHR registry will help Kaiser researchers better understand alcohol use and more efficiently target high-risk patients for intervention and care coordination. This is purportedly the first fully-integrated EHR registry available to address a major problem in the United States: alcoholism.
Kaiser Permanente Northern California (KPNC) researchers developed the EHR-based registry to better identify alcohol screening information from the health system’s over 5 million patients. As KPNC offers a range of care coordination services with specialist providers, such as addiction medicine and associated treatment to beneficiaries of the system, the new registry opens up and socializes data for external health systems and investigators seeking to improve the health of those patients addicted to alcohol. The recent KPNC registry study was published in the Journal of Medical Internet Research. The registry was built on top of the market-leading EHR platform known as Epic EHR System, from Epic Systems in Verona, WI. In Kaiser, the EHR platform is known as “HealthConnect.”
But What about HIPAA & 42 Part 2?
Of course, health data in the United States continues to be highly regulated with laws such as HIPAA and 42 Part 2 in place. However, patients evidence a growing openness to consenting for their data and biospecimens to be shared to contribute to research endeavors.
For example, a UC San Diego-led study in 2019 showcased that based on a sample of patient participants, most are willing to share their data and biospecimens for research. Patients, at least in the United States, do appreciate flexibility and choice. And by offering that option for patients may impact research involving secondary use of EHR and biospecimens for research.
In the case of the KPNC registry, the team took ten months to develop. It involved implementing a data dictionary for information architecture and a flexible approach keeping the data open to others moving forward. The development effort also involved the enablement of reporting tools to depict and display alcohol patient trends, and the team had a set of functional requirements that included queries for quality control and other factors such as data storage requirements.
Post-development of the registry, the KPNC team could analyze data from 2013 to 2019, including those patients with unhealthy alcohol dependence and those with an alcohol disorder diagnosis. A powerful data suite, KPNC can now rapidly identify most alcohol abuse issues such as the best treatment regimens for long-term outcomes. The team identified that of the approximately 5 million in the registry, 13% were using alcohol in an unhealthy way while 3% had an actual alcohol use disorder diagnosis. The U.S. average is 13.9%—far higher.
Power of Registry
Comprehensive EHR-based registries lead to powerful, real-world evidence-based research opportunities. With the advent of EHR registries heretofore not feasible real-world data generation opportunity can support and augment clinical research, including randomized controlled trials for an even more accurate and holistic understanding of the outcomes associated with a specific drug. The FDA has established guidance for the use of Real-world Evidence.
Vanessa A Palzes, MPH, Corresponding Author, Division of Research, KPNC
Call to Action: To connect with Palzes and the other authors, see the link.