Clinical Research Requires EHR Optimization, Data Interoperability

EHR optimization to support data interoperability could improve the value of pragmatic clinical research, according to a study published in JAMIA.

Pragmatic clinical trials (PCTs) leverage existing data streams in EHR systems and usually involve multiple clinical sites with wide eligibility criteria to generate real-world evidence.

The Healthcare Systems Research Collaboratory team collected survey responses from 20 PCT projects and found challenges in six main categories:

• Inadequate collection of patient-reported outcome data
• Lack of structured data collection
• Data standardization
• Resources to support customization of EHRs
• Difficulties aggregating data across sites
• Accessing EHR data

Based on these findings, the researchers created six prerequisites for the successful conduction of PCT trials.

PCTs should be able to:

• Integrate the collection of patient-reported outcomes data into EHRs
• Facilitate structured data collection by leveraging standard EHR functions and workflows
• Support high-quality research through data standards
• Ensure adequate IT staff for embedded research support
• Create aggregate type resources for multisite trials
• Create re-usable and automated queries.

The researchers explained that the use of EHR system data takes effort and detracts from other health system priorities. This fact seems “fundamentally unchangeable,” they noted, so the alternative is to change the argument for customizable EHR systems.

“The story needs to not be about promoting research per se but rather about finding and implementing the best and most effective treatments, and continuously learning within and across health systems,” the study authors wrote.

However, building the infrastructure for reusable EHR data collection in support of continual learning is not without costs, they emphasized.

“It is the joint responsibility of funders, researchers, healthcare systems leaders, EHR vendors, and policymakers to work together to accomplish these goals,” the researchers argued.

A recent article by Collaboratory leadership suggests reimbursing healthcare systems for research-related costs and supporting reuseable infrastructure in highly engaged systems could encourage health system participation.

The study authors called for research stakeholders to promote the collection of high-quality data not just for clinical trials, but for other use cases such as population health, ongoing quality improvement, pharmacovigilance, and comparative effectiveness research, as well.

“These programs can be conducted more cheaply and effectively with high-quality data,” they wrote. “Standards-based EHR systems can empower customers to adopt new practices, which can lead to improvement and implementation in health systems.”

However, EHR systems are usually not standardized. Of the 21 trials studied, 16 used different data sources, which creates an ongoing challenge for investigators conducting PCTs.

The study authors suggested that research stakeholders promote standards-based EHR systems to health system leaders as a necessary enabler for integrating real-world evidence-based practices to improve healthcare quality and outcomes.

The researcher team also reported the need for configurable EHR systems. Key stakeholders, such as policymakers, are not fully aware of or incentivized to facilitate the EHR customizations needed for multisite trials as informaticists often control the EHR system in an organization.

EHR optimizations can allow organizations to respond nimbly to public health issues, deliver evidence-based treatments, and address patient-specific care, the authors wrote.

“Driving change for routine PCTs will require meaningful partnerships between healthcare systems, individual clinics, informatics teams, EHR vendors, and researchers, as well as federally driven standards and policies to ensure that EHR systems can support research,” the researchers explained.

Clinical and health services researchers should spearhead efforts to develop and promote standards for data interoperability in support of clinical research, the authors noted.

“These researchers can also leverage new regulations for quality measures, and weigh in and advocate for the importance of patient reported outcomes,” they wrote.

“Embedded PCTs are integral to a learning health system and will enable faster changes in practice and improved patient outcomes,” the authors continued. “In time, the case for standards will grow in clarity and support as the learning cycles get faster and the benefits become more visible and established.”