Integrating EHRs to Clinical Research EDC Systems

It has been a longstanding challenge to integrate patient data from EMRs (Electronic Medical Record systems) with EDC (Electronic Data Capture) systems for clinical studies and trials.

The challenges include:

• Low adoption rates of EMRs in physician practices
• Lack of interoperability tools provided by vendors to extract data from EMRs
• Lack of standardized payload (content) and method of delivering (transport) from different EMRs to the EDC systems
• All subjects of clinical studies not being part of the same health system and therefore same EMR
• Lack of automated methods for identifying the same patient between EMRs and EDC systems
• Inability to map and translate the EMR data into CRFs (case report forms) of the EDC systems

These hurdles have been so high that the task has rarely been attempted in earnest, let alone accomplished in any significant way.  That is until recently.  How are these challenges being overcome today?  What changes have allowed this integration to be to considered and implement today? The answer is: lots!

EMR Adoption Rates

EMR adoption rates in physician practices rose slowly but steadily in the early 2000s. Although aware of EMR’s advantages, the high startup and software costs, unavoidable upheaval in their practices, and the costly conversion of historic paper records, conspired to keep EMR adoption low.  Then came Obama’s HITECH that paid physicians to achieve “meaningful use” of EMR, which gave explosive growth to the market. Adoption rates soared from single digits to over 60%.  HITECH also incentivized hospitals to achieve meaningful use of their EMRs, and required certification of the systems’ capabilities, which caused a rush for vendors to improve their systems, and hospitals to upgrade to newer versions. In the past few years both physician practices and hospitals have been rapidly adding or upgrading their EMR systems to be compliant with HITECH rules.

One certification requirement of ‘meaningful use’ is interoperability which requires both the physician practice and hospital EMRs to be able to export and import patient medical records using a common, standardized format. The EMR industry first converged on using CCD, or the Continuity of Care Document, which provided a ‘snapshot in time summary’ of a patient’s health record.  However, the C-CDA (Consolidated Clinical Document Architecture) emerged as a bigger container, using CCD as just one section, or embedded document, of clinically relevant information.  Other sections include Discharge Summary and Consultation Note. The C-CDA specifies what information is mandatory for which use cases, and specifies the structure, format and content of the data, including use of the appropriate coding dictionaries for each kind of data. All recently certified EMRs against Stage II of Meaningful Use rules must be able to import and export patient records in this format.

Another part of HITECH incentivized the exchange of these records through safe and secure use of technologies. This was created by establishing funds for creating statewide Health Information Exchanges (HIEs), as well as interstate exchange through protocols for the Nationwide Health Information Network (NHIN).  Although HIEs existed prior to that, they were generally just local or regional, and worked differently.  Most used HL7 as the standard for both payload and transport, but the implementation of the HL7 interfaces varied widely. With HITECH, the explosion of HIE deployments caused the coalescing of standards for querying and delivering of patient medical record data.

Unfortunately, it is very time consuming for HIEs to establish and gain traction. The government was in favor of interoperability of EMRs but was unable to wait for all HIEs to begin functioning.  Moreover, not all data transport was limited to state borders, so interstate exchange was necessary.  This fomented the creation of the Direct Project, a simple subset of HIE functionality that enabled point to point delivery of medical records over the existing standard internet using the equivalent of secure email technology for transport. Using Direct, with the patient’s permission, a physician could “email” his/her record to another registered physician without breaking HIPAA regulations.  Additional use cases emerged, such as laboratories using Direct to send diagnostic results into an ordering physician’s EMR. Many vendors have come to offer solutions for Direct, including the certification process for registering the physicians, the physician directories of registered users, and the secure messaging software tools. It is an inexpensive solution and enables physicians to collect their meaningful use incentive payments, and adoption rates are beginning to climb rapidly.

What about the EDC systems?

Some EDC system vendors have been making their products more standards-based and interoperable despite the lack of similar government incentives that the EMR vendors had.  For example, data dictionaries are now being used to ensure fields inputted in CRFs are uniform and reusable. This enables mapping and translation of data being imported to, and exported from, the CRFs. Additionally, the use of standards has increased.  IHE, the overseer of the C-CDA standards, also include formats for Clinical Research Data Capture (CRD) using both CCD standards as well as CDASH (the latter being more common in the EDC world today). EDC systems that support CDASH and reusable CRF libraries are well positioned to accept or exchange patient data with EMRs.

What does this all mean?

Let’s imagine a clinical study where there are 5 sites in the U.S.  At each site there are about 30 patients enrolled, each not necessarily associated with the same hospitals or the same physician practices. Their varied insurance plans ensure that multiple laboratories will be involved for the required blood and other sample diagnostic work at each site. Up until recently, it would have been impossible to succeed in integrating this with an EDC system; and any attempt to do so would have been costly, time consuming, and complex. Yes, it may have been possible for a custom interface between one of the EMRs and the EDC system, but likely that would have only helped with a subset of the enrolled subjects.

Fast forward to 2014. It is possible that all 5 sites will be in areas where robust HIEs exist. If so, many of the physician practices and hospitals will have their EMRs integrated to the HIE, and will be able to exchange data in standardized formats. Connecting additional systems to the HIE is straightforward. For those practices not participating in the HIE, their certified EMRs can deliver data via Direct Project protocols to other physicians and systems. This means that it is likely that most, or all, of the patient’s enrolled can have their existing and future medical records part of the study.

The study is using a modern EDC system. The CRFs are CDASH compliant, and so data being captured in EMRs can easily be inherited into the study, speeding the process of data capture and reducing errors. Electronic transaction logs make it straightforward to audit the source data and data received into the CRFs is already coded (medications, immunizations, allergies, problems, procedures, diagnostic results, etc.) in standard formats so that it can be understood by the systems and actionable.

Today, it has become more cost effective to integrate data from HIEs or EMRs. The costs of duplicate entry and the associated errors are higher than the costs of establishing the interfaces to the external systems. There are many use cases for EMR data integration with EDC, and one size does not fit all. We at Clinovo are interested in the use cases you have, or foresee similar, to this integration, and welcome any dialogue or feedback.