In 2020, the Chesapeake Regional Information System for our Patients (CRISP) and the American College of Cardiology (ACC) were awarded funding through ONC’s Leading Edge Acceleration Projects (LEAP) in Health IT program. The award aimed to address one of a few special areas of interest, Advancing Registry Infrastructure for a Modern API-based Health IT Ecosystem.

CRISP and ACC’s LEAP project, “Development and Testing of Data Sharing Functionality for Health System Participating in National Cardiovascular Disease Registries,” was designed to advance the health IT ecosystem through the accelerated adoption of modern standards — such as Health Level Seven International® (HL7®) Fast Healthcare Interoperability Resources® (FHIR®) — both in the acquisition of clinical data for registry submission as well as the subsequent use of clinical data to improve care decisions.

Clinical Registry Background

A clinical data registry form contains vital information about the health status of patients and the care they received. Clinical data registries tend to focus on patients with a common condition (e.g., heart disease) to allow clinicians to see what treatments are available, and how patients with different characteristics respond to various treatments. These registries assist hospitals and private practices measure and improve the quality of care they provide to patients. About 46% of non-federal acute care hospitals in the U.S. reported being actively engaged in a clinical data registry.

It’s not an easy process to gather all the data needed to complete a registry form. This data may be collected from multiple locations such as electronic health records (EHRs), emergency medical services systems, or a legacy system that is not connected to an EHR. Data may need to be collected from multiple facilities or care settings to create a longitudinal portrait of the patient.

Disconnected systems tend to make this process challenging and cumbersome because the person responsible for assembling the registry submission must manually extract data from each source. Discussions with the clinical team are often required to interpret or derive data that are not included with data entered during the treatment cycle. Once the registry form is complete and submitted to the registry, the registry accepts or rejects the form based on its unique data validation rules.

Leading Registry Health IT Forward Using FHIR

CRISP focused on the CathPCI Registry®, which contains treatments, treatment outcomes, demographics, patient history, and risk factors related to cardiac disease. The proprietary registry data elements were mapped to universal terminology standards like the Systematized Nomenclature of Medicine – Clinical Terms (SNOMED CT®) and the Logical Observation Identifiers Names and Codes (LOINC®) as comprehensively as possible. When mapping was not possible, the gaps were flagged.

CRISP further explored the theory that FHIR can be used to extract data and submit the registry form with the click of a button. During the January 2023 HL7 FHIR Connectathon, the team used a proof-of-concept application to successfully demonstrate the extraction of data from an EHR and submission to the CathPCI Registry.

Dr. James E. Tcheng, a cardiologist on the faculty of the Duke University School of Medicine and an advisor on informatics to ACC, led a team to normalize the National Cardiovascular Data Registry (NCDR) – a suite of cardiovascular data registries – to universal standards. Based on findings, Dr. Tcheng reported that, “more than 40% of clinical registry data would be extractable using FHIR; it’s not 100% yet, but we are moving in the right direction.” Registry data extraction and submission can be less manual and thus more seamless with the help of FHIR. Using FHIR to mitigate the pain points of registry completion can result in reduced processing times, less intervention for registry documentation, reduced submission delays, and improved data quality. As a result, the time required for clinicians to use the information to make clinical decisions and support patient care can be reduced.

CRISP and ACC developed the Protocols for Clinical Registry Extraction and Data Submission (CREDS) FHIR Implementation Guide (IG) that describes a scalable solution for hospitals, HIEs, and organizations contributing to NCDR and other registries. This IG will be published in fall 2023. You can find more information in the final report created by the CRISP team.