Centralized Coordination and Standardization of Electronic Health Record (EHR) Pilot

EHR treatment plans are essential components of NCI-supported clinical trials, but their configuration is complex, inefficient, and can be a barrier to trial activation and participation. NCI is working to standardize and improve the implementation of EHRs in clinical trials.

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Background
Methods
Objectives

Background

Multi-institutional clinical trials, like those performed by NCI’s National Clinical Trials networks (NCTN), Experimental Therapeutics Clinical Trial Networks (ETCTN), and NCI Community Oncology Research Program (NCORP), use EHRs to support the delivery of both standard-of-care and investigational care and treatments.

EHR-based Treatment Plans Can Be Highly Variable

• EHR-based care plans may vary considerably for routine therapies between organizations due to differences in EHR systems or in local implementation of the same EHR system.
• Treatment plans for investigational therapies can change from study to study, site to site, or even among different commercial insurers.

Treatment Plans Are Required but May Never Be Used

• Although it is possible that an EHR will not be used, individual plans must be developed for each trial in preparation to provide support should it be needed.
• Estimates suggest that 20-30% of clinical trials and 40-50% of treatment plans built in EHRs are never used. This occurs because not all trials activate, or only a few or no patients enroll on a trial.
• A recent NCTN survey estimated a minimum of 26.5 hours of effort are required to build the treatment plan for a single study arm with a major EHR vendor.

Inefficiencies Can Lead to Roadblocks

• The EHR study build must be complete to activate the study at a site and enroll patients and must be modified with each study amendment.
• The repetitive efforts to develop and modify instances of EHR systems across potentially hundreds of institutions are inefficient, costly, and hinder study participation.
• The lack of standardization across different EHRs increases the local administrative burden associated with data collection and reporting to an Electronic Data Capture system.

Methods

In the summer of 2020, NCI approved administrative supplements to 11 P30 Cancer Center grants and established two consortia comprising the grantees. The consortia collaborated to perform exploratory work to facilitate the development of standardized EHR treatment plans for NCI-supported clinical trials applicable across a broad range of clinical research sites. The two consortia and their lead sites were:

Clinical Trials Rapid Activation Consortium (CTRAC); Lead Site: MD Anderson

Electronic Health Record Consortia (Big Ten EHRC); Lead Site: Indiana University

In the spring of 2023, NCI assembled a single consortium and changed the support mechanism to fund a contract with Leidos Biomedical Research, Inc. Subcontracts were issued to:

MD Anderson Cancer Center (Lead Site)

Objectives

The scope of this project encompasses the earlier work of the P30 Cancer Center consortia and the current NCI-supported consortium’s expansion on the original efforts.

The project goals are to:

• Retrospectively identify the tasks across the sites to analyze and identify the similarities and difference between the SOPs, policies, and workflows associated with EHR treatment plans at each site
• Identify opportunities for standardization across sites
• Streamline the work process to develop and maintain study-specific content for clinicians to complete the EHR-mediated tasks at multiple sites
• Develop standard representations of protocol-specified pharmacotherapy and other required therapeutic and assessment procedures
• Develop an approach to “packaging” the standardized requirements in a form that can either be imported directly into a site’s EHR or at least will facilitate local customization
• Build a library of modules that can be reusable across trials
• Pilot the central EHR study build and distribute to participating sites with three or four NCI studies and expand to additional studies and sites following evaluation at the completion of the pilot