Tutorials, B. Hieb, M.D. Research Note 6 November 2003 Clinical Decision Support: Core Capability of Evolving CPR More-sophisticated computer-based patient record systems can offer increasing value to caregivers. CDS systems represent a key component of that value equation. They will become standard as CPR products mature. Core Topic Healthcare: Critical Healthcare Applications for Business Efficiency and Improvement Key Issue How will healthcare organizations successfully justify, evaluate, select, deploy and support vendor application and sourcing services? Healthcare automation systems are struggling to provide effective support (and hence real value) to clinical caregivers. A significant aspect of that struggle involves the complexity needed to offer effective support to clinicians at the time when they are making decisions about the delivery of clinical care. Clinical decision support (CDS) systems represent the core computerbased patient record (CPR) system capability attempting to address this need. In the most-general case, a CDS system can be applied to assist in nearly any clinical decision involving the management of a patient. In the practical world, the actual deployment of these systems has been much more limited and their value to clinicians has been correspondingly small. Here, we define the level of CDS system capability required for the five CPR generations defined by Gartner. A CDS system is a core capability of the Gartner CPR model. The other eight core capabilities are: Clinical documentation and data capture (see "Clinical Documentation in the Enterprise CPR") Clinical display including the clinical dashboard (see "The Clinical Dashboard Is Another Key CPR System Element") Clinical workflow (WF; see "Workflow Evolution Within the CPR Generations") Order management including physician order entry (see "Order Management Is a Core Capability of a CPR System") Clinical data repository (CDR; see "The Clinical Data Repository Provides CPR's Foundation") Support for privacy Interoperation (see "The Gartner 2004 Criteria for the Enterprise CPR") Gartner Reproduction of this publication in any form without prior written permission is forbidden. The information contained herein has been obtained from sources believed to be reliable. Gartner disclaims all warranties as to the accuracy, completeness or adequacy of such information. Gartner shall have no liability for errors, omissions or inadequacies in the information contained herein or for interpretations thereof. The reader assumes sole responsibility for the selection of these materials to achieve its intended results. The opinions expressed herein are subject to change without notice.
Controlled medical vocabulary (CMV; "Controlled Medical Vocabulary in the CPR Generations") Currently, most CPR systems are at Generation 2, but several Generation 3 systems are expected to be available by year-end 2004. For advanced CPR generations (Generation 3 and above) the combination of CMV, CDS and WF become key to the CPR system's ability to implement knowledge management capabilities (see "Knowledge Management and the CPR System"). A major challenge in CPR software development is to design a CDS system in such a way that the end result is to help humans make better decisions. Specifically, in the context of the CPR system, the challenge is to identify which decisions the computer could help the caregiver make, collect the necessary information to help make the decision, present that information at the time the human is actually making that decision, record the decision that was made and, to the extent possible, help carry it out. It is evident that the construction of an effective CDS system involves far more than just executing a set of rules. It must also incorporate capabilities such as effective user interfaces, mechanisms to notify mobile users, event monitoring, other data collection activities and adjusting decisions to the unique context represented by a specific patient. The CDS system should be able to incorporate rules content from accepted industry sources. All of these elements must be effectively managed to achieve useful CDS; yet, the primary focus must be the rules that constitute the set of decisions the CDS system can process. The CDS system plays a crucial role in a CPR system because it carries out the decisions established by the institution to support the provision of optimum patient care. These rules can cover a wide variety of clinical (and nonclinical) situations, depending on the sophistication and maturity of the CDS system and its associated CPR system. In an advanced CPR system, the CDS system interacts extensively with other CPR components, such as: The CMV, for definitions of terms and their relationships The WF controller, to embed decisions in the processes in which they participate The communications systems, to provide notification of events Through these interactions, a mature CDS system can participate in nearly any automated activity where it is needed. The Evolution of CDS Functions as CPR Systems Mature 6 November 2003 2
Here is a description of the CDS functionality needed to achieve each level of capability according to Gartner's generations of CPR systems: Generation 1, The Collector: No formal CDS capabilities are required. A Generation 1 CPR system is essentially a CDR with the ability to collect information from a variety of departmental systems and enable results viewing. Generation 2, The Documentor: The CPR system and its environment must encompass basic rule capability for at least a limited set of data items, such as drug allergies and laboratory values. CDS functions in this generation often are implemented in systems separate from the CPR system. For example, the pharmacy system may have a set of rules to evaluate drug/drug and drug/allergy interactions. The laboratory may have rules determining what constitutes a critically low or high laboratory result. Each of these systems typically is an independent system with its own mechanisms for creating and maintaining the rules that drive these activities. These CDS systems tend to monitor a very narrow set of input conditions and use separate databases. Generation 3, The Helper: At this level, the core CPR system must have at least basic CDS capability that is integrated with functions, such as order entry and clinical documentation. There may still be departmental CDS functions, such as a pharmacy system, but there must be a single CPR system that functions as the primary CDS system. Over time, all decision support activities should migrate toward this primary CDS system. That system must support basic rules editing and management functions (such as "find all rules that deal with hip fractures") and must be linked to a CMV/vocabulary server (Voser) to standardize the concepts and relationships being manipulated. The CMV/Voser must interact with the CDS system to allow rules to be based on semantic concepts (for example, "all antibiotics," without having to specify each individual antibiotic in the rule). The system must be designed so that clients, should they choose to do so, are able to fully support the CDS system once it is installed without requiring further reliance on the system's vendor. CDS functions must be made available to caregivers at the point of care, and the applications that use the CDS system should provide feedback to the user at the earliest time possible. (For example, a potential drug-drug conflict should be displayed to the user while the order for that drug is being constructed, not after the drug has been finalized and submitted.) The CDS system's rule engine must support full Boolean logic rule expressions and permit the output of one rule to trigger the evaluation of a subsequent 6 November 2003 3
set of rules. A variety of notification options should include creating an entry in the CDR, sending an e-mail message and creating an item to be viewed by any person who reviews that patient's clinical results display. The CDS system must be capable of supporting at least minimal interaction with other CPR components such as CMV, order management and WF. Generation 4, The Colleague: For this generation CPR system there must be a separate CDS system rule engine that is capable of dealing with a variety of rule types, including Boolean logic, set theory and fuzzy logic algorithms. This will support decisions that cannot be answered by a "yes" or "no," such as "Is this patient at risk of having a stroke?" The CDS system must be able to fully participate in clinical care protocols, including actively monitoring relevant data input streams (for example, orders, clinical documentation, patient results) as well as providing real-time outputs to users logged on to the system and to those not actively using the system (via pagers or mobile phones). All data in rules and messages must be normalized by interaction with a Voser. It must be feasible to embed CDS capabilities in WFs that are managed by a WF controller that is dedicated to the management of processes. The CDS system must support rule-management capabilities for the creation, indexing, testing and maintenance of rules. It must support rules applying to patient populations as well as rules regarding a single patient. The CDS system should have at least basic capabilities to support importing new rules from external sources. It must be possible to embed CDS functions in WFs managed by the WF controller. The CDS system must provide basic integrity-checking capabilities to ensure that a given version of the institution's rule set is logically consistent. Rules tailoring should take into account all of the patient's active diagnoses and problems, the primary practitioner caring for the patient, and all treatment protocols currently active for the patient. All actions taken by the CDS system must be logged and available for analysis to support clinical quality assurance, continuous process improvement and the development of new rules. Generation 5, The Mentor: At this level the CDS system must be fully integrated with the other components of the CPR system and operate from a unified database schema (some vendors describe this as an "integrated data architecture") used for the CDR. CDS system capabilities must be available in real time for use by any application in the CPR environment. Advanced decision techniques, such as artificial intelligence, must be available for applications that require them. Virtually all automated activities in the care delivery organization's (CDO's) environment should be 6 November 2003 4
monitored by the CDS system, and this information should be available as input, when needed, for decision making. The CDS system must support customization of clinical rules based on relevant clinical parameters, including information on the capabilities and limitations of the particular CDO where the patient is being treated. Importing rules from an external authority should be an automated process with the only manual step being the evaluation of the rule by whatever group is designated to approve changes in clinical practice. The CDS system fully participates in the implementation of evidence-based medicine throughout the CDO and is incorporated into defined WFs at any and all points where a nontrivial clinical decision needs to be made. The system is equipped with robust facilities to manage the current rule set and ensure the logical integrity of the operating set of rules. The system supports full versioning, logging and security capabilities. Key Facts: CDS represents one of the key capabilities for a CPR system to offer value to caregivers. A CDS system is essential for CDOs to achieve their error reduction goals. A CDS system must interact extensively with other CPR systems such as CMV, physician order entry and WF. A CDS system must permit each CDO to create and maintain its own rules. Knowledge of the full evolution of CDS is needed to avoid implementing dead-end systems that must later be replaced. Acronym Key CDO care delivery organization CDR clinical data repository CDS clinical decision support CMV controlled medical vocabulary CPR computer-based patient record Voser vocabulary server WF workflow Bottom Line: Clinical decision support capabilities constitute a component that is rapidly growing in importance as computerbased patient record systems mature to meet the demands for reducing medical errors and improving the quality of care. With the imminent emergence of Generation 3 CPR systems, a CDS system will transition from a "nice to have" component to one that is essential. Clients that have, or are considering acquiring, a CPR system must ensure that they understand the product's current and future capabilities with respect to CDS. Implementation of an inadequate CDS system will severely restrict the value that a CPR can offer to its users and may constitute a substantial competitive disadvantage for a care delivery organization. 6 November 2003 5