To achieve an EMR that truly integrates clinical care and clinical research, unique user roles, system workflows, and functional capabilities must be combined without impeding clinician productivity. Like other large academic centers, our integrated clinical care/clinical trials system needs to meet the needs of a variety of users: a broad array of clinical care generalists and specialists treating tertiary care patients, an active NIH-sponsored general clinical research center, a large regulatory clinical trials office, a multifacility IRB, and a substantial number of investigator-initiated clinical studies. As we worked on specifying EMR implementation requirements, we identified a set of clinical care and clinical trial roles and identified a set of issues—a mixture of institutional policy and regulatory requirements—that require explicit answers associated with these roles (). Many of the issues contained in appear in the clinical vignette (Appendix 1
); the vignette was designed to cast the generalized issues enumerated in into a tangible, real-world clinical scenario, making the nature of the questions and alternative answers more accessible to the responsible executives and clinicians.
Representative Clinical-Trial-Related Functional and Access-Restriction Questions that Affect Electronic Medical Record (EMR) Implementation Decisions
Reaching institutional consensus on what constitutes acceptable answers to the questions posed in the clinical vignette and in has been difficult and sometimes contentious. Clinical care and clinical trials both have complex workflows with substantial regulatory oversight.28
The EMR team has had to work closely with clinical, administrative, and regulatory leaders to develop creative approaches to resolving differences while satisfying regulatory demands, workflow requirements, and unique information-management approaches within the capabilities of the commercial EMR system.
As we explored alternative policies, the implementation team described or created test implementations to illustrate the resulting workflows using the functional capabilities in our commercial EMR product. For some alternatives, the current product did not have sufficient functionality to implement a proposed policy. In other instances, a policy could be implemented in the ambulatory care application, but not in the more complicated inpatient application, even though both products were created by the same vendor. In still other cases, a policy could be implemented for clinical laboratory results, but not for pathology results. In a number of examples where a test implementation could be created, the changes in workflow required to craft the solution within the product's existing functionality were clearly onerous and would not be acceptable in actual practice.
In addition to exploring the EMR's capabilities to support new or revised policies, we had to consider long-established policies in terms of the EMR as well. Traditional institutional practice had established that patient safety concerns for potential duplicative radiation exposure overrode strict clinical trial confidentiality policies. Thus, research-related radiology reports historically have been included in the paper medical record. Research-related clinical laboratory tests traditionally have not been part of the paper medical record, but these results are available in the laboratory information system under a unique subject identifier. Both of these historical practices will continue in the EMR. Traditionally, the remaining research-related diagnostic test results, such as cardiology, pulmonary, and pathology reports, have not been part of the paper medical record. Although the current EMR product allows these reports to be labeled as research results, it does not allow research diagnostic test results to be suppressed in electronic displays. Thus, although these reports were not available in our paper medical records, these research-related findings will appear in the EMR. In the past, research-related orders have been written and processed using study-specific order sheets that were not part of the medical record. The current version of computer-based physician order entry (CPOE) system does not support separating research-related orders from standard-care orders in order entry or order review screens. Until new functionality is available, research-related orders will remain paper-based, and standard-care orders will be entered using the CPOE system. In the ambulatory care setting, the EMR allows physicians to mark specific documents as research notes, and special access restrictions can be placed on them. Similarly, the EMR's inpatient system allows notes to be marked as research notes, but it does not provide a method for placing special access restrictions on any type of note except for mentalhealth-related notes.
Despite differences in what can or cannot be suppressed from clinical care EMR users in various settings, all orders, reports, and notes that are marked as research will be removed from the legal medical record when it is printed. References to research results or clinical actions based on research findings that appear in the standard-care documentation notes or dictations, however, will be included in the printed legal medical record. Physicians are encouraged to not make standard-care decisions on the basis of research findings, except for those care decisions related to potential study-related adverse events. However, the limited system functionality does not prevent all research results from being suppressed during standard-care encounters.
The EMR vendor has established a clinical research advisory council to provide input into future product developments to incorporate missing functionality. Over time, as new functionality is released, we will revisit our current approach and remove the current discrepancies so that the research policies and the EMR implementation are consistent across all practice environments.