Table 1.

Key barriers, facilitators, and needed actions for enabling effective PCCDS for pain management

Category	Barriers	Facilitators	Needed Actions
Regulatory environment	• There are state-specific regulations on controlled substances, but many states prohibit incorporating the actual PDMP source data into the EHR and CDS. • State-by-state regulations for prescribing limits and/or regulations restrict the ability to prescribe opioid antagonists and there may be limits orincentives for those that can be written electronically which subsequently limits associated CDS. • Federal regulations and recommendations may notalign with mechanisms to facilitate CDS implementation.	• Initiatives that link resources up help, e.g., PMP InterConnect, a product from the National Association of Board of Pharmacy that connects PDMPs from 44 states. • In some states there is mandated e-prescribingof controlled substances, e.g., New York. • The Promoting Interoperability program includes 2 opioid e-prescribing measures: queryof PDMP (optional in CY 2019 and required inCY 2020) and verification of an opioid treatment agreement (optional for CY 2019 and CY 2020).	• Federal and state law makers can: o support the development of unified national-level regulations and encourage voluntary coordination among state medical boards. NOTE: In general, there is a relative lack of evidence underlying regulations and policy. o enable the sharing of source data, and mandate or encourage e-prescribing for controlled substances to further enable point-of-care CDS o create policies and regulations based on evidence and support collection of evidence where lacking
Data integration	• It is difficult to access all relevant data across multiple health systems, and health IT systems overtime (e.g., medications, supplements, lab tests,imaging, referrals, care plan/controlled substance agreements, functional status, diagnoses and side effects). • Source data may have poor data quality, are temporally limited, and are difficult to both patientlevel match and to de-duplicate and may not be in a structured, standard form that facilitates matching,reconciliation, and de-duplication • Existing data structures were created without semantic interoperability as the goal, bi-directional information exchange may not be well supported,e.g., no clear way for controlled substanceagreements to be pushed out by a prescriber to other prescribers in a state. • A lack of consensus on a ‘data interoperability architecture’ for universal use inhibits achieving greater overall interoperability. • Visualizations to support interpretation are often limited and scales are subjective, e.g., pain scale. • SMART and other interoperable apps/services maybe important in this ecosystem for opioid use management, but they have limited abilities to contribute data back in/write due to API limitations.	• opioid use and pain management, a national focus, may serve as a catalyst for CDS. • There is a need to collect well-defined data for aggregation and summarization. The Open Notes movement could be leveraged fordata cleaning and reconciliation. Some patients and health systems are already engaged in open Notes and it could be used for patients to review and clean data. Natural Language Processingcan also be used to mine free text, e.g., for after-the-fact conversion to structured data or forfacilitating real-time data entry. • A dashboard for relevant data, e.g., pulling upfirst-line treatments that have already been tried. • There are some semantic interoperability standards available and adopted for relevant data that could facilitate data integration and summarization: • There are some semantic interoperability approaches/efforts that could be applied to help(e.g., Argonaut project, efforts at HIT Advisory Committee (HITAC) efforts to define priority healthcare uses and needed standards). • Population health management tools	• Concrete interoperability requirements need to be defined for this space. Need to identify achievable goals with associated clinical needs. This applies equally to CDS/knowledge interoperability (see alsoScalability). • Federal government could fund the development of a consolidated requirements specification for interoperability. • Data quality and de-duplication issues are still persistent. Need to enable patients to help in this de-duplication and data reconciliation process. Patient involvement will help ensure this is a patient-centered and patient-engaged process. • Probably the missing link here is the available data instructured, semantically interoperable form. once available, SMART should be useable for data summarization. There appears to be sufficient momentum through federal funding sources such asNIH, AHRQ, CDC in this area, as well as other non-grant resources. • Architecture and standards for semantically interoperable data are still not available, adopted, or verifiable to the extent needed. • Terminology standards and resources are needed for relevant concepts.
Establishing a clear business case and providing incentives	• The current system as it exists is generally a reflection of the current business incentives. In otherwords, the system we have now is optimized for the incentives we have now. • Cost of implementing desired solutions can be an important barrier. There needs to be a financial ROI case for the needed CDS and other HIT solutions, but such ROI information may not be clear or even available.	• Change is happening in terms of overall incentives to incorporate CDS and improve quality: o Value-based care should result in an incentive shift toward care that is better for opioid use and desired actions for opioid management. o Pharma incentives to be seen as helping with this issue o Providers are motivated to avoid regulation-related, penalties, lawsuits, maintain licensure, etc. o Many state medical boards are starting to put in opioid related requirements	• Incentives are still limited/do not support improving pain management and opioid management. CMS is important, but private payors are also getting actively engaged in this area. We need quality measures around what is desired. • one potentially promising approach would be coming up with best practice recommendations that can beadopted by state medical boards and supported by technology. • Need payments for desired outcomes and potentially use of appropriate CDS tools (processes), including extra time required by clinicians for optimized patient care.
Effective and Useful CDS	• What makes CDS effective is still not adequately defined and CDS interventions still often fail to achieve the desired outcomes. • The effectiveness of the vast majority of CDS interventions is never actually measured and it is unclear whether CDS interventions that are effective in one setting or clinical area would be useful in another setting or clinical area. Effectiveness of CDS may not be seen unless or until it exists at scale. • CDS platforms, whether standards-based or EHRvendor-based, may have many limitations to effectiveness.	• There are a number of CDS best practice approaches published already. • There are also guides on IT usability thataddress issues such as access, uptake,adherence, and effectiveness, e.g., the oNCEHR usability change package. • Behavioral nudges have been shown to be important and may be fairly easy to scale for impact, e.g., the default number of opioid prescriptions dispensed. • There are a number of guidelines available to serve as the basis for CDS.	• There is a need to continue to advance research to identify factors that contribute to CDS effectiveness and improve reporting of CDS intervention results. • Users of CDS platforms could help definedesired/needed enhancements and join together in asking for those enhancements to be made. Incentives to develop more effective CDS are needed. • Sharing of CDS and good examples of effective CDS could allow for higher-quality CDS. • There is a lack of agreement on documentation templates/expectations in this space, an authoritative body should step forward to develop consensus on this.
Scaling CDS	• Scalable clinical decision support and knowledge sharing, whether via shared knowledge artifacts, or applications, or as services, is currently in its infancy.Common interoperability architecture also needs tobe defined and adopted, e.g., SMART on FHIR, CDSHooks. • There are local factors that need to be accounted for such as: business needs, practice settings, cliniciantypes, patient populations, workflow approaches,documentation templates, and local resources.	• There are a few computer-interpretable guideline repositories. • There is a white paper on how to establish trust in this ecosystem.8 • Some hybrid approaches exist where the “hardpart” of guideline development is shared inter-institutionally, and each organization can adaptit to the local environment. • Standard value sets, such as those from the National Library of Medicine’s Value Set Authority Center.	• Trust requirements are needed, especially for centrally managed CDS. • It may be useful to prioritize across domains to help ensure content quality e.g. the overall medication list,to consolidate guidelines whenever possible, and to better engage patients.
Care Planning and Coordination	• There is a need for strong communication and shared mental models of care plans across organizations and providers, as well as between patients and their caregivers. Communication and information sharing among these providers can be sub optimal.	• opioid use, a big enough, well recognized problem, may incentivize competing organizations to agree on common approaches to treatment and better coordination and cooperation.	• There is a need for demonstration projects funded by government, payors, to investigate how pay-for-value-incented providers can improve intra- and inter-institutional care planning. • There is a need for more research around creating
	• Care plans are rarely synchronized while they evolve over time and are touched or updated by various stakeholders across organizational boundaries.	• There is some ongoing HIE, TEFCA, etc. work on care planning and coordination, e.g., IHE models on dynamic care plans, with somewhat limited implementation.	understandable and technically portable care plans for patients, and for more dynamic care planning.