Implementing and Evaluating Patient-Centered Clinical Decision Support Strategies in Real-World Settings(U18)

To advance the field of patient-centered clinical decision support through research that tests tools and resources in real-world settings. The mission of the Agency for Healthcare Research and Quality (AHRQ) is to produce evidence to make healthcare safer, higher quality, and 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 the evidence is understood and used. The purpose of this Notice of Funding Opportunity (NOFO) is to conduct research on patient-centered clinical decision support (PC CDS), a nascent area within the larger field of CDS. Through the AHRQ-funded Patient Centered Outcomes Research (PCOR) CDS Initiative and the CDS Innovation Collaborative specifically, PC CDS resources are now publicly available for interested researchers to further build upon, develop, and test, in real-world settings. Innovative research is needed to understand how to make traditional, clinician-facing CDS more patient-centered, while also engaging patients, families, and caregivers in a co-design process to design and implement these tools. BACKGROUND Clinical decision support refers to digital tools that are used to help inform patient care. Patient-centered clinical decision support (PC CDS), in contrast to traditional clinician-facing CDS, is CDS that focuses on the patient, or their caregiver, and facilitates their active involvement in healthcare decision-making with their clinicians. PC CDS uses information from patient-centered outcomes research findings and/or patient-specific information and has the potential to be transformative by enabling higher-quality care delivery and improved outcomes. PC CDS can also support shared decision making (SDM), which AHRQ defines as a collaborative process in which patients and clinicians work together to make healthcare decisions informed by evidence, the care team's knowledge and experience, and the patient's values, goals, preferences, and circumstances. PC CDS can also support shared care planning enabling patients, caregivers, and clinicians to work together to tailor a clinical plan to align with a given patients priorities and goals. PC CDS is a developing field and has the potential to increase the quality and experience of patient care. AHRQ’s CDS Initiative is supported by the Patient Centered Outcomes Research Trust Fund (PCOR TF) and is guided by AHRQ’s PCOR TF strategic framework (https://www.ahrq.gov/pcor/strategic-framework/index.html). Since 2016, AHRQ’s PCOR CDS Initiative has been building tools, concepts, frameworks, and conducting pilot projects. Much of AHRQ’s recent effort has focused on patient-centered CDS, and several past projects have generated resources that could be highly useful to the developing PC CDS field. Examples of these projects include AHRQ’s PC CDS Learning Network and CDS Connect, as well as a project that assessed the current state and future directions with PC CDS. Additional information for CDS projects is available on the PCOR CDS Initiative webpage. AHRQ’s most recent PC CDS project, the CDS Innovation Collaborative, or CDSiC, is a multi-component stakeholder-driven initiative that produced a rich set of resources and tested concepts around different aspects of PC CDS. As part of the CDSiC, four workgroups were formed, each around a specific area of PC CDS, with the charge to create products (e.g., frameworks, guides, checklists) that could be used in the clinical field to establish or measure use of PC CDS. These products could address clinical workflows or the development of CDS technologies, among other areas related to PC CDS. During the first two years of the CDSiC, these workgroups created numerous products that addressed PC CDS in different areas. These areas included CDS outcomes, trust and patient-centeredness, and scaling and dissemination. One workgroup also focused on the existing standards and regulatory frameworks that could impact the future uptake and use of PC CDS. Applicants can examine, using these products and tools, how PC CDS can support shared decision making and care planning among individuals with complex needs including older adults, people living with multiple chronic conditions, frailty, disabilities, and/or socioeconomic disadvantage and how this may foster the delivery of person-centered care. They may also study strategies to scale and spread effective tools including use in lower resourced and safety net instituions. Applicants responding to this NOFO must propose to use the resources developed by AHRQ's PCOR CDS Initiative, or any of the many products developed by the ongoing CDSiC, to further explore their usefulness, impact, and practical application in real-world settings. For example, CDSiC products that could be used may include the Taxonomy of Patient Preferences, Integration of Patient-Centered CDS into Shared Decision Making, Approaches to Measuring Patient-Centered CDS Workflow and Lifeflow Impacts, or the PC CDS Performance Measurement Inventory User Guide. Links to and descriptions of the products are available on the CDSiC Stakeholder Center webpage (https://cdsic.ahrq.gov/cdsic/cdsic-stakeholder-community-outreach-center ) The CDSiC's Innovation Center (https://cdsic.ahrq.gov/cdsic/innovation-center) developed a comprehensive report around measurement of PC CDS and created two pilot dashboards that can help clinicians understand and use Patient Generated Health Data. Additional information on other PCOR CDS projects is available at https://cds.ahrq.gov/about. Examples of Highly Responsive Projects include: A community hospital with a large priority population, selects from the CDSiC portfolio of projects generated by the Trust and Patient-Centeredness workgroup. The recipient selects the source credibility product from the Trust and Patient Centeredness workgroup and conducts a study to understand how their population perceives the information they receive from within their existing electronic health record (EHR) system. Patients provide input, and the approach is assessed against existing CDS tools, as well as the definition of PC CDS as defined by the CDSiC, to assess their level of patient-centeredness. A small startup company is developing applications (apps) to help patients improve their healthcare. The startup leverages two products from the CDSiC standards and regulatory frameworks workgroup: Advancing Standardized Representations for Patient Preferences to Support Patient-Centered Clinical Decision Support and an Environmental Scan that reveals opportunities to evolve standards and regulatory frameworks to advance PC CDS. The company works with a patient advocacy organization to co-design the patient-facing PC CDS app, uses standards to leverage existing patient generated health data (PGHD), and incorporates a final assessment as to the level of patient-centeredness of their technology. A primary care physician group is working to reduce clinician burnout with the goal of improving patient outcomes. The group looks at the CDSiC’s Taxonomy of Patient Preferences and assesses how they can incorporate these concepts into restructured workflows. The group then also uses CDSiC’s product called Approaches to Patient-Centered CDS Workflow and Lifeflow Impact, which provides a framework to help identify the optimal point for a patient-centered CDS tool’s deployment in a patient’s lifeflow. Their study will also assess how increased patient-centeredness in their CDS tools do not inadvertently have a negative impact on clinician workflows or experience. All projects are encouraged to: Incorporate Clinical Quality Language (CQL) and other HL7 standards into their project design, if appropriate for developing, integrating, (or modifying) their CDS with their EHR system or other health information technology (Health IT) components to become more patient-centered. OBJECTIVES AND SCOPE This NOFO aims to support innovative collaborative research to understand how clinical decision support tools in real-world settings can be improved to become more patient centered. Recipients will become part of an existing community of researchers who have an interest in PC CDS including AHRQ, the CDSiC, and other researchers. Interested applicants may include health information technology experts, patient advocates and representatives, clinicians, electronic health record developers, policymakers, payors, as well as leaders from research and academic medical institutions. All projects must: Utilize one or more of the products from the CDSiC or the PCOR CDS Initiative, which are available on the project website: cdsic.ahrq.gov, or another resource available from the PCOR CDS Initiative (cds.ahrq.gov), which includes the PC CDS Learning Network, CDS Connect, or AHRQ's Evaluation project that assessed the current state and future directions with PC CDS; If CDSiC products are used specifically, applicants must identify if any other frameworks are being used to evaluate the performance of their PC CDS (e.g., RE-AIM or other); Apply the definition of patient-centered CDS (available here: https://cdsic.ahrq.gov/cdsic/patient-centered-clinical-cds-infographic) and describe the degree to which each of the 4 elements are incorporated into the patient-centered CDS tool: knowledge, patient data, delivery, and use. Apply an equity lens, consistent with AHRQ's PCOR Strategic Framework. Apply at least 1 of the 4 priorities from AHRQ's PCOR Strategic Framework. Include meaningful and substantial participation from patients and/or patient representatives in the co-design, implementation, and evaluation of their research, to also be reflected in the proposed budget. Fully describe their research ecosystem. If developing or extending a digital tool, be mobile friendly to be more accessible to a broader population (for example, a patient-facing portal, website, etc.). If the research or tool will be incorporated into an EHR system, the facility must have a mature, functioning EHR system (e.g., the facility is not planning any significant system upgrade or migration). Otherwise, an alternative means to test and evaluate the selected CDS product can be described. If the research strategy intends to modify an existing clinical workflow that is currently clinician-focused, to become a patient-centric or patient-facing approach, then the strategy must include an evaluation component to characterize the performance of the PC CDS tool versus the previous clinician-facing workflow. If the proposed project plans to promote implementation of SDM, it should align with AHRQ’s definition of SDM (available here: https://www.ahrq.gov/sdm/about/index.html) and include at least one validated measure of SDM in its evaluation.