New Grant Will Leverage Health Data Interoperability Standards to Integrate Clinical, Research Systems

Thursday, October 20, 2016

The U.S. Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology (ONC) has awarded Keith Marsolo, PhD, Associate Professor in the Division of Biomedical Informatics at Cincinnati Children’s, a Standards Exploration Grant to study the cost efficiencies of integrating clinical research systems within a medical center’s electronic health record (EHR).

The one-year, $378,000 project will employ emerging health data interoperability standards to allow patient data to be used for both research and patient care more efficiently. The ONC grant totals $87,888. Cincinnati Children’s, strongly supportive of this type of innovation, is also contributing more than $290,000 in internal funding. 

Many clinical research trials already collect data from the EHR, but current processes to populate electronic case report forms (eCRFs) with EHR data are time-consuming and cumbersome, particularly when scaled to dozens or hundreds of centers. Marsolo and his team intend to develop new, standards-based methods to more closely integrate that data, which would result in streamlined workflows and significant time savings for research personnel. 

“Addressing these interoperability needs will increase the sharing of health information among stakeholders while also increasing the quality of, and trust in, that information,” says Marsolo. “We also expect these efforts to decrease costs by reducing the time spent completing eCRFs, which will lower costs for sponsors and allow research personnel to reallocate their effort to other tasks.”

The project aims to help achieve one of the main promises of interoperability: The transformation of traditional healthcare systems into Learning Health Systems, where new knowledge is quickly translated into clinical practice and clinical practice serves as the engine to generate new evidence and knowledge. 

Now, research personnel at study sites must either manually abstract data from patient charts and re-enter them into web-based forms, or spend dozens to hundreds of hours on procedures to generate extracts that can be used to pre-populate certain fields in the eCRF. For multi-site studies, this process must be repeated at each center, with few economies of scale.

In addition, delays in data entry limit the ability to use the registry as a point-of-care decision aid or to provide patients with an up-to-date summary of their care status on various clinical benchmarks.

To streamline those processes, Marsolo’s team will be developing systems to allow users to click on a hyperlink from within their EHR system in order to launch externally-hosted eCRFs. The system will automatically pre-populate certain fields with standard elements that have been previously collected, eliminating the need for manual re-entry. Research staff will be able to complete the remaining fields and send the responses to an external data repository.

Data standards to be leveraged in the project include Retrieve Form for Data Capture, an integration profile, and Fast Healthcare Interoperability Resources (FHIR), the latest data integration standard to be developed under the HL7 organization. Use of such standards will allow the system to work across various EHR platforms such as those developed by Epic, Cerner, and GE Healthcare. 

Marsolo and his team will partner on the project with ImproveCareNow, a 92-center quality improvement and research network (learning network). The proposed workflow will be implemented for an ongoing pragmatic clinical trial funded by the Patient-Centered Outcomes Research Institute (PCORI) comparing the effectiveness of two alternative medication regimens. 

Marsolo estimates that the ImproveCareNow network could save as many as 8,750 hours per year in time spent on data collection by using these improved methods.

Time and cost savings would be broadly applicable to any network or project that seeks to collect standardized information across multiple centers, Marsolo notes. He anticipates that the new, automated approach will be generalizable far beyond ImproveCareNow to a broad range of research studies. 

Marsolo’s coinvestigators on the project include Jareen Meinzen-Derr, PhD, Associate Professor in Cincinnati Children’s Division of Biostatistics and Epidemiology, and staff from the Division of Biomedical Informatics and Department of Information Services.