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CDS Connect Contract Year 2 Final Report

Contract Year 2: CDS Connect released an enhanced CDS Authoring Tool that allows the community at large to create content without needing deep CQL coding expertise. The project demonstrated a repeatable CDS development process by creating and posting the “Pain Management Summary” artifact to the Repository.

Executive Summary

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. AHRQ’s priority areas of focus are: investing in research to make healthcare safer and improve quality, creating materials to train healthcare systems and professionals to put research results into practice, and generating measures and data used by providers and policymakers. AHRQ’s evidencebased tools and resources can be used to propel stakeholders toward improved quality, safety, effectiveness, and efficiency of health care.

The Patient Protection and Affordable Care Act (ACA) of 2010 directs AHRQ to disseminate and build capacity in patient-centered outcomes research (PCOR). Working with clinical organizations, AHRQ is assisting health information technology (IT) users with incorporating patient-centered research findings expressed as clinical decision support (CDS) into clinical practice. CDS provides patient-specific information and evidence-based knowledge via health IT to clinicians, patients, or other individuals. CDS includes processes and mechanisms that aim to deliver the right information, to the right person, using the right format, in the right channel, and at the right time during workflow (often referred to as the “5 Rights” framework). Well-implemented CDS can improve health care decisions and the quality and efficiency of the care provided to patients.

CDS provides patient-specific information and knowledge, enabled by health IT, to clinicians, patients, or other individuals to enhance health and health care. CDS includes processes and mechanisms that aim to deliver the right information, to the right person, using the right format, in the right channel, and at the right time during workflow (often referred to as the “5 Rights” framework). Well-implemented CDS can improve health care processes. AHRQ has launched an initiative that fulfills its ACA requirements related to PCOR and CDS.

The goals of AHRQ’s overall CDS initiative are to advance evidence into practice through CDS, and to make CDS more shareable, health IT standards-based, and publicly available. This effort includes the following components:

  1. Engaging stakeholders to catalyze the development and use of PCOR-based CDS throughout the health care system and provide CDS developers and stakeholders with constructive advice and feedback.
  2. Developing prototype infrastructure to create and share CDS, including coded clinical knowledge, implementation guides, and a publicly accessible repository of CDS resources or “artifacts.”
  3. Advancing CDS research through demonstration and dissemination grant funding opportunities.
  4. Evaluating the overall initiative, including lessons learned and future recommendations.

To realize the second component of this initiative, AHRQ sponsored the CDS Connect project, a contract with CMS Alliance to Modernize Healthcare, a federally funded research and development center operated by the MITRE Corporation. The CDS Connect team developed a production-level “CDS Connect” repository to host and share standards-based, interoperable CDS artifacts (knowledge expressions implemented in EHR systems to inform care) via a web-based, publicly available system. Through the Repository, CDS contributors and CDS consumers have equal access to knowledge generated from cutting-edge CDS research, as well as clinical and regulatory standards. Additionally, organizations that work to balance limited resources can leverage advanced technical resources and secure information critical to the CDS implementation process. Contributions to the Repository grow every day, expanding the breadth of resources available to stakeholders across the Nation.

The CDS Connect project also developed a production-level CDS Authoring Tool that leverages interoperable standards so that CDS can be written to common specifications. This capability was designed to be intuitive and easy to use, with the intention of reducing the development burden that health care organizations undertake. By making it easier to compose and express CDS artifacts, this software improves the quality of CDS design, accelerates the velocity of CDS development, ensures open access to supporting CDS resources, and enables integrated software systems for interoperable CDS. Furthermore, the code for this system is open-source, enabling greater access, adoption, and community involvement.

To demonstrate a repeatable CDS development process and the Repository’s capability to host and share CDS in this second year of the project, the CDS Connect team developed, tested, and implemented a CDS artifact that generated a summary view of patient data relevant to pain management. The “Pain Management Summary” markedly reduced clinician burden by compiling clinical data that normally needs to be searched for across several sections of an EHR. Documentation and sharing of the development and implementation processes promotes transparency and increased awareness to future developers and implementers—furthering efficiency and effectiveness.

Key to all streams of work, CDS Connect leaders hosted a monthly Work Group meeting attended by a broad array of CDS stakeholders (subject matter experts from across government, industry, academia, clinical settings, and nonprofits) and conducted outreach via conference presentations, demonstrations, webinars, and strategic discussions to inform and maximize work efforts and increase adoption of the CDS Connect systems.

This second year of the CDS Connect project enabled the two central systems (the Repository and Authoring Tool) to be developed into robust, valuable assets to the health care and CDS communities. This work provides the framework for improving health care outcomes via CDS creation, discovery, integration, and implementation using evidence-based interoperable CDS artifacts.

CDS Connect Contract Year 1 Final Report

Contract Year 1: CDS Connect developed a publicly available, web-based Repository, and a prototype CDS Authoring Tool. It also published several cholesterol management artifacts, one of which was piloted in a clinical setting. The project convened two advisory Work Groups to guide development efforts for these artifacts and the Repository.

Executive Summary

The mission of the Agency for Healthcare Research and Quality (AHRQ) is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable. AHRQ works within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used. AHRQ’s priority areas of focus are for improving health care quality by accelerating implementation of patient-centered outcomes research (PCOR). Further, AHRQ is focused on making health care safer, increasing accessibility to health care, and improving health care affordability, efficiency, and cost transparency.

The Patient Protection and Affordable Care Act (ACA) of 2010 directs AHRQ to disseminate and to build capacity in PCOR. Working with relevant medical and clinical associations, AHRQ is assisting users of health information technology (IT) focused on clinical decision support (CDS) to incorporate findings into clinical practice and to promote the ease of use of such incorporation. AHRQ supports processes for receiving feedback from stakeholders, including physicians, providers, patients, and commercial vendors of health IT focused on CDS about the value of the information and the assistance provided.

CDS provides patient-specific information and knowledge, enabled by health IT, to clinicians, patients, or other individuals to enhance health and health care. CDS includes processes and mechanisms that aim to deliver the right information, to the right person, using the right format, in the right channel, and at the right time during workflow (often referred to as the “5 Rights” framework). Well-implemented CDS can improve health care processes. AHRQ has launched an initiative that fulfills its ACA requirements related to PCOR and CDS.

The goals of the initiative are to advance evidence into practice through CDS and to make CDS more shareable, health IT standards-based, and publicly available. This effort includes the following components:

  1. Engaging stakeholders to catalyze the development and use of PCOR-based CDS throughout the health care system and provide CDS developers and stakeholders with constructive advice and feedback.
  2. Developing prototype infrastructure to develop and share CDS, including coded clinical knowledge, implementation guides, and a publicly accessible repository of CDS resources or “artifacts.”
  3. Advancing CDS research through demonstration and dissemination grant funding opportunities.
  4. Evaluating the overall initiative.

Through this project, named “CDS Connect,” the CMS Alliance to Modernize Healthcare v (CAMH) is piloting a process that accounts for the agile nature of CDS development. CAMH is a Federally Funded Research and Development Center (FFRDC) operated by the MITRE Corporation. As part of this work, this CDS Connect project has included clinical and technical translation of guidelines into computable CDS, testing and monitoring, implementation protocols, and feedback loops. Initial work is grounded in the domain of cholesterol management and designed to promote the transformation of findings into actionable, relevant, and interoperable clinical capabilities.

The CDS Repository is a web-based software service that offers structured data, aggregated resources, and the ability to leverage the international standard Clinical Quality Language (CQL). Through the CDS Repository, CDS contributors and CDS consumers have equal access to knowledge driven by cutting-edge research in CDS, as well as clinical and regulatory standards. Additionally, organizations that work to balance limited resources are able leverage advanced technical resources and secure information critical to the CDS implementation process.

The CDS Connect Project has convened two advisory Work Groups (Cholesterol Management and CDS Repository) consisting of CDS subject matter experts from across government, industry, academia, clinical settings, and non-profits. These Work Groups guide the development, implementation, and inclusion of cholesterol management CDS artifacts while providing ongoing collaboration in support of AHRQ’s commitment to developing a repository with the features and functions critical to the CDS community.

The CDS Connect project also supported the design and development of a prototype CDS Authoring Tool that leverages interoperable standards so that CDS can be written to common specifications. This capability was designed to be intuitive and easy to use, with the purposes of reducing provider burden. By making it easier to compose and express CDS artifacts, this software improves the quality of CDS design, accelerates the velocity of CDS development, ensures open access to supporting CDS resources, and enables integrated software systems for interoperable CDS.

This CDS Connect project has resulted in a proof-of-concept that will lead to the increased use of findings in clinical healthcare practice. This work is providing the foundation for improved healthcare outcomes via CDS creation, discovery, integration, and implementation using interoperable data standards to express the logic of the CDS for use by health IT software systems.

Environmental Scan of Opioid and Pain Management CDS

CDS Connect conducted an environmental scan of chronic, non-cancer pain management. The findings informed future CDS Connect activities.

Executive Summary

Chronic pain is among the most common, costly, and disabling chronic medical conditions in the U.S. [1-3, 66]. Approximately 100 million adults in the U.S. experience chronic pain [4-6], and approximately one in five patients with non-cancer pain or pain-related diagnoses is prescribed opioids in office-based settings [5]. Given these staggering statistics, the U.S. Department of Health and Human Services (HHS) released a National Pain Strategy in March 2016 to improve the prevention and management of pain, and increase awareness of treatment options and risks to facilitate informed decisions [7]. Most recently, the President declared a public health emergency to mobilize Federal efforts to address drug addiction and opioid use disorder [8].. This action will provide standards-based, shareable CDS resources that are free and publicly available to healthcare providers across the Nation to support decision making and high-quality care, and mitigate the risk of opioid misuse and related deaths.

During the first 6 weeks of the CDS Connect effort, the MITRE team conducted an environmental scan of the chronic, non-cancer pain management landscape to gain foundational awareness of the standards of care in this clinical domain and identify evidence-based recommendations and tools that could contribute to the development of new patient-centered CDS artifacts. The scan identified several findings that will inform CDS Connect efforts over the coming year. Some of the high-level findings include:

Limited availability of opioid CDS artifacts: Due (in part) to the shift of evidence-based recommendations in the past several years, which encourage self-management, nonpharmacologic, and non-opioid medications as the first line of treatment [9,10], presently CDS that supports the new standards of care is still evolving and is minimally shared. Reduced access to published CDS efforts and artifacts reduces the opportunity to leverage lessons learned regarding specification and implementation challenges.

Significant legal restrictions abound: The organizations responsible for many clinical practice guidelines, pain assessments, and opioid risk assessments hold copyrights that restrict their use. Obtaining legal approval to represent the copyrighted work in an electronic CDS format and disseminate publicly can be time- and labor-intensive. Intellectual property status is a prominent factor in the decision of what to develop, likely leading to strong consideration of governmentauthored resources for which permissions may be easier to attain.

Data characteristics and availability are critical: A 2014 study uncovered barriers to implementing electronic clinical quality measures (eCQMs) in the addiction domain due to a lack of standard terminologies to represent care concepts (e.g., psychosocial treatments) and the structured capture of these concepts [11]. The availability of structured data that accurately and interoperably reflects clinical care across various vendor electronic health record (EHR) systems and clinical workflows is vital to effective eCQMs and CDS. Careful consideration of feasibility constraints related to the specification of a standard of care as CDS is imperative.

Minimal amount of published specifications: At present, there are no publicly available eCQMs and only one published opioid CDS specification [12]. In addition, there are only a handful of nonmalignant pain and opioid value sets available in the Value Set Authority Center (VSAC). This maybe due, in part, to the data characteristics discussed above. As a result, CDS development will likely be more labor intensive and require significant subject matter expert (SME) input to ensure proper translation of the evidence-based recommendations.

Prevention of inappropriate prescribing and opioid misuse: National efforts reflected in the most recent round of evidence-based recommendation statements advocate prevention of inappropriate prescribing and opioid misuse through patient education, provider training, risk evaluation, proper prescribing practices, and shared decision making between patients and providers based on the benefits and risks of potential treatments [9,10]. Well-positioned CDS artifacts in clinical workflow can contribute valuable support of patient and provider decisions, thus reinforcing the recommended standards of care.

Change management challenges: Recent shifts in pain management protocols and prescribing practices urge self-management and non-pharmacologic treatments as the first line of treatment [9,10]. When medications are indicated, providers are encouraged to prescribe non-opioid medications as opposed to opioids. In addition, under recent guidelines, the goal for pain management does not primarily focus on pain elimination but instead a reduction in pain to enable an individual to meet their functional goals [9,13]. This transformational change can be facilitated by CDS, but requires significant patient education, provider training, and organizational policy and process changes to realize maximum success.

External factors influencing treatment: Self-management techniques require patient buy in and adherence. Further, non-pharmacologic treatments can be costlier than opioids for patients due to gaps in insurance coverage of these treatments [14]. Furthermore, asking providers to consider a prescription of “alternative treatments” is impractical in the absence of supporting incentive structures [14]. As a result, first-line treatment approaches that are offered and encouraged via CDS may be refused by the patient or rejected by the provider, thus lessening the desired outcomes.

This document serves as a foundational resource for the CDS Connect team. MITRE researchers will continue investigation and outreach beyond the delivery of this paper to further inform project efforts.

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