Challenge

Clinical Decision Support (CDS) is the user facing representation of clinical guidance. Effective CDS interventions require availability of computable biomedical knowledge, person-specific data, and a reasoning or inference mechanism that combines these elements to generate and present helpful and actionable information to clinicians, individuals, or caregivers in the right way – at the right time. In order to optimize these benefits, CDS interventions must be made more easily shareable and implementable so that any organization can easily acquire and deploy CDS interventions. To this end, standards must be advanced to enable either the routine or regular consumption of CDS interventions through a Web service or the repeated import and update of CDS artifacts into CDS systems.

Scope Statement

To identify, define and harmonize standards that facilitate the emergence of systems and services whereby shareable CDS interventions can be implemented via:

• Standards to structure medical knowledge in a shareable and executable format for use in CDS, and
• Standards that define how a system can interact with and utilize an electronic interface that provides helpful, actionable clinical guidance

In order to facilitate integration of a system with CDS interventions, the scope includes standards to refer to data in electronic health records and standards to map recommendations to locally implementable actions.

Value Statement

Health information technologies designed to improve clinical decision making are particularly attractive for their ability to address the growing information overload clinicians face and to provide a platform for rapidly incorporating knowledge into care delivery.
Standardized expressions of Clinical Decision Support have a number of important benefits including:

• Increased quality of care and enhanced health outcomes for individuals and populations
• Improvement in workflow
• Avoidance of errors and adverse events
• Improved efficiency, cost benefit, and provider and patient satisfaction
• Reduced latency for incorporating new clinical knowledge and evidence-based guidelines into clinical practice

Focusing the S&I Framework community on Clinical Decision Support through the Health eDecisions Initiative will enable the translation of interventions into implementable components, increasing the speed and ease of adoption by the provider community.

Target Outcomes

• Alignment with Meaningful Use
  • The product of this initiative will help providers achieve meaningful use of HIT and their quality improvement goals through addressing a known barrier to CDS development, adoption, and implementation
• Repositories or catalogues can emerge, supplied by a range of content creators such as societies or content vendors, whereby CDS artifacts can be selected and imported into HIT systems
  • Each intervention will represent a standardized expression of a guideline that can be accessed by EHR system developers and users to simplify the process of incorporating guidelines into EHRs
• Clinical Decision Support Services can interact with EHRs and/or other Health Information Technology implementations
• Alignment with other S&I Initiatives, e.g., Query Health (HQMF)
• Close the gap between standard availability and widespread use/value
• Perform outreach to medical professional societies and guidance authors to promote their development of CDS interventions in addition to traditional guideline publications
  
  

Timeline

Updated version of the deliverables and timeline can be found on the Health eDecisions Homepage

Pre-Discovery: Complete Call for Participation Discovery (Phase I): In Progress Finalize Project Charter Construct Use Cases & Functional Requirements Analyze Standards Gaps Engage Appropriate SDOs Implementation (Phase II): Summer / Fall 2012 Create Harmonized Specifications Conduct Technology Evaluations Generate Reference Implementations Design Pilot Plan Pilot (Phase III): Winter / Spring 2013 Create Pilot Technology Validate / Revise Specifications and Implementations Evaluation (Phase IV): Spring 2013 Assess Outcomes Present Final Recommendations

Expected Deliverables

Updated version of the deliverables and timeline can be found on the Health eDecisions Homepage

• Agreement on the Project Charter
  • Now
• Use Case and Functional Requirements
  • End of August 2012
• List of Relevant Standards
  • End of October
• Standards Support and Coordination Plan
  • December 2012
• Implementation Guidance
  • January/February 2013
• Pilot applications, Plans, and Lessons Learned
  • March/June 2013

Relevant Standards and Stakeholders

Relevant Standards, Schemas, Formats, Terminologies, and Value Sets

• ArdenML
• Arden Syntax
• AHRQ eRecommendations Format
• CDSC L3 [hyperlink will be provided]
• CREF [hyperlink will be provided]
• GELLO
• GEM (Guideline Elements Model)
• HITSP C32
• HL7 Care Record
• HL7 CCDA (Consolidated Clinical Documentation Architecture)
• HL7 Decision Support Service (DSS) Specifications
• HL7 Context Aware Information Retrieval (InfoButton)
• HL7 Model Interchange Format
• HL7 QRDA (Quality Reporting Documentation Architecture)
• HL7 Virtual Medical Record (vMR) data model
• HQMF
• IHE Care Management Profile
• IHE Retrieve Clinical Knowledge Profile (Profile for InfoButton)
• IHE RFD (Retrieve Clinical Format for Data Capture)
• IHE RPE (Request for Procedure Execution)
• IHE Request for Clinical Guidance Profile (an implementation of HL7 DSS)
• IHE Sharing Value Sets
• NQF Value Sets

Relevant Stakeholders

• Content and Guideline Creators (such as but not limited to):
  • Content Publishers
  • HIT Vendors
  • Academic and Community Provider Organizations
  • Medical Societies
  • Public Health Agencies and other Government Agencies (CDC, NIH, NLM, FDA, etc.)
  • Standard Terminology Suppliers
  • Pharmaceutical and Medical Device Companies
  • Medical Research Organizations

• Content Integrators (such as but not limited to):
  • Providers implementing clinical content in an HIT system
  • OpenCDS
  • Clinical Decision Support Consortium
  • Content Publishers who offer CDS services
  • Content Implementers (i.e. consulting firms)
  • HIT Vendors
  • HIEs

• Content Users (such as but not limited to):
  • Practitioners
  • Case Managers
  • Patients
  • Provider Organizations (including VA and DoD)
  • Payers and their agents involved in revenue cycle
  • Public Health Agencies
  • Compliance, regulatory, and legal entities
  • Pharmacies and MTM Services

• Standards and Schema Development Agencies (such as but not limited to):
  • GLIDES (GuideLines Into DEcision Support)
  • CDSC (Clinical Decision Support Consortium)
  • HL7 (Health Level Seven International)
  • IHE (Integrating the Healthcare Enterprise)
  • NQF (National Quality Forum)
  • HITSP (Health Information Technology Standards Panel)
  • OMG (Object Management Group)

• Quality Measurement Entities (such as but not limited to):
  • NQF (National Quality Forum)
  • NCQA (National Committee for Quality Assurance)
  • CMS/PQRS (Center for Medicare and Medicaid Services, Physician Quality Reporting System)
  • JCAHO (Joint Commission)
  • BTE (Bridges to Excellence)
  • QOPI (Quality Oncology Practice Initiative)
  • ACIP (Advisory Committee on Immunization Practice)

Potential Risks

• Risk 1: Including implementation of clinical/treatment guidelines may increase scope.
  • Mitigation/Response: Identify and manage scope by aligning to Meaningful Use Stage 3 target timelines.
• Risk 2: Insufficient “end-user” input (e.g. physicians, clinicians, technology vendors).
  • Mitigation/Response: Evaluate role and type of initiative participants; invite additional participants early in the initiative process to balance representation.
• Risk 3: Data reconciliation process may be negatively impacted due to a lack of value sets and terminology standards.
  • Mitigation/Response: Keep abreast and adopt developments and alignment strategies from the HIT Standards Committee and from the HIT Policy Committee. Such information may be part of an implementation guide.
• Risk 4: Services integration may be negatively impacted due to a lack of standards.
  • Mitigation/Response: Identify gaps and partner with appropriate organizations to close them.
• Risk 5: EHR vendors may resist opening their architectures to services integration.
  • Mitigation/Response: Identify and communicate the benefits early in the process; ensure EHR vendors are represented in the initiative participants (see Risk 2). As this initiative matures with deliverables, incorporation into MU3 would likely be an incentive for vendors to come aboard.
• Risk 6: Standards and solutions may not scale to small vendors and small practices.
  • Mitigation/Response: Ensure that proposed standards and solutions are modular/scalable.
• Risk 7: Proposed project timeline does not reflect actual deadlines in relevant SDO Balloting.
  • Mitigation/Response: Identify support to help mitigate this issue including inviting SDO members to participate in our work group and working with SDOs on out-of-cycle balloting. Change expectations in the HeD timeline. Begin working with the SDOs ASAP.
• Risk 8: Proposed project timeline is significantly faster than what has traditionally been possible through participant effort alone.
  • Mitigation/Response: Monitor and communicate timeline, deliverables and progress frequently to all stakeholders; identify and request increased or reallocated resources (as needed).