Fast-Track proposals will be accepted. Direct-to-Phase II proposals will NOT be accepted. Number of anticipated awards: 3-5 Budget (total costs, per award): Phase I: up to $400,000 for up to 9 months Phase II: up to $2,000,000 for up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Summary This solicitation builds on work performed in response to previous solicitations that developed information technology to support financial hardship, patient navigation, informal caregiving and care coordination. These areas of research remain NCI priorities; small business researchers who want to conduct research in these areas are encouraged to apply to the omnibus SBIR solicitation: https://sbir.cancer.gov/funding/opportunities/SBIR-STTR-omnibus-solicitation. Social determinants of health (SDH) are the health-affecting circumstances in which people are born, grow up, live and work. Examples of SDH that adversely affect health include food insecurity, financial strain, housing instability, social isolation, and transportation-related barriers. Addressing SDH within healthcare improves access to preventive care and improves treatment adherence. Accountable care organizations and other hospital systems have saved over $4.5 million by addressing food insecurity, reduced healthcare costs by 40% after establishing housing partnerships, and reduced inpatient and outpatient spending by 53% and 23%, respectively. Several large organizations, including CMS, CDC, HRSA and Kaiser Permanente, have invested in programs to address SDH. These programs are aimed at addressing SDH in primary care, not in oncology practices. Cancer patients are more likely to worry about their standard of living and experience food insecurity compared to individuals without cancer; these patients are less likely to receive appropriate and timely cancer treatment and have poorer survival. Recently, the American Cancer Society published a blueprint to understand and address SDH in cancer patients. The first step in addressing SDH is to conduct a patient assessment. The National Academy of Medicine (NAM) has identified several domains and validated measures of SDH that can be used in electronic health records (EHRs). For example, for the domain of social connections and social isolation, NAM identified the NHANES III measure (consisting of four questions) and for the domain of financial resource strain, it identified the measure of overall financial resource strain (consisting of one question). Another relevant activity is the Protocol for Responding to and Assessing Patients’ Assets, Risks, and Experiences (PRAPARE) assessment tool that includes16 core measures and 4 optional measures; this tool can be used in EHRs. The next step after conducting a systematic patient assessment is to address the relevant SDH need(s) in a timely manner. Because most interventions to address SDH are delivered by community-based social service providers (e.g. food banks), a clinician’s role is typically limited to referral and appropriate follow-up. A recent market analysis by NORC showed high variability in the level of sophistication of SDH-related systems and their functionalities; this analysis identified several needs, including better patient engagement, better analytic tools, improved collaboration with behavioral health professionals, and scalability of approaches to share data among healthcare providers and community organizations. There is a need for well-designed IT that supports systematic SDH assessment, appropriate referral, and follow-up of cancer patients in oncology practices in a manner that reduces the burden on patients, clinicians, and practices. Project Goals The goal of this concept is to solicit proposals that develop and evaluate software to address SDH in oncology practices. The software will be cancer-specific and developed in close collaboration with oncology practices. The software should be designed to support and enhance existing clinical workflows and reduce the burden of SDH data collection and synthesis in care settings. It will support appropriate evidence-based clinical actions, including referral, to address identified patient needs. The software will meet current IT interoperability standards, using FHIR (Fast Healthcare Interoperability Resources) when feasible, and privacy standards. The activities that fall within the scope of this solicitation include assessment of the current landscape of electronic SDH screening instruments and clinical decision support (including referrals to community-based social service providers); collaboration with oncology practices to understand existing workflows and IT architecture (including existing strategies for collection and use of SDH data); develop software with at least 5 existing, valid SDH measures; conduct usability studies of end-users: clinicians, patients, and community-based service providers; conduct an impact evaluation of the software on clinical workflows, care delivery processes, use of community resources, user satisfaction, and patient outcomes; and, identify an approach to scale the software beyond the initial set of oncology practices and SDH measures. Activities not responsive to announcement: Developing software that only screens for SDH without supporting appropriate clinical actions triggered by the screening (including referral to relevant community resources); software that does not work with validated SDH screening instruments; software that is either not integrated into the workflow or the existing IT architecture; software that does not incorporate the current standards and requirements of interoperability, cybersecurity and patient privacy; not working in partnership with oncology practices to identify the most relevant SDH measures and related clinical tasks; software not designed to reduce the patient- and clinician-level burden of performing SDH-related tasks. Phase I Activities and Deliverables • Establish a project team with expertise in the areas of software development, cybersecurity, user-centered design, SDH screening and implementation, oncology, health services and disparities research, community-based social services, community engagement and/or patient advocacy, as appropriate for the proposed project. • Conduct a focused environmental scan of existing software to screen and address SDH, as well as a targeted literature review on the accuracy of screening instruments and effectiveness of interventions for identified patients. The new software should screen for at least 5 SDH measures and use FHIR standards. • Conduct key informant interviews with members of at least two oncology practices to understand what is currently being done to address SDH, how IT systems are currently configured, how SDH data are collected and analyzed, and how new software would help. • Develop a prototype of the software. The design requirements of the software should ensure it can be used in a variety of cancer care delivery sites, ranging from academic clinics to community oncology practices, which care for diverse patient populations, including under-served cancer patients. Further, the design requirements should include compatibility with diverse IT architectures and the ability to work across IT systems. • Conduct pilot usability testing of the prototype with at least 25 persons who represent the end-users including but not limited to: oncology care team members, patients and community-based service providers. • Propose an approach to modify the software based on user feedback prior to implementation in Phase II. • Present Phase I findings and demonstrate prototype to an NCI Evaluation Panel via webinar. Phase II Activities and Deliverables • Establish a project team with expertise in the areas of software development, cybersecurity, user-centered design, SDH screening and implementation, oncology, health services and disparities research, implementation science, and statistical methods for validation/evaluation, as appropriate for the proposed project. • Provide a report detailing the approach to integrate the software in existing workflows and IT systems, and to evaluate the software, while considering the requirements of inter-operability, cybersecurity and patient privacy protection. • Develop appropriate human subjects protection/IRB submission packages and document approval of research plan. • Develop final study design including aims, participant characteristics (e.g. end users), recruiting plans, inclusion and exclusion criteria, measures, primary and secondary endpoints, design and comparison conditions (if appropriate), power analyses and sample size, and data analysis plan. • Implement and evaluate the software in at least three oncology practices. The evaluation includes user satisfaction with software, impact of software on care delivery processes and patient outcomes, lessons learned, and recommended modifications to the software, as appropriate. • Provide a report documenting the results of the software evaluation. • Identify an approach to scale the software beyond the initial set of oncology practices and SDH measures. • Provide study progress reports quarterly, documenting recruitment and enrollment, retention, data quality assurance and control measures, and relevant study specific milestones. • Develop user support documentation to support all applicable potential users of the technology, including but not limited to clinicians, patients, and healthcare systems. • Prepare a tutorial session for presentation via webinars describing and illustrating the technology and intended use. • In the first year of the contract, provide the program and contract officers with a letter(s) of commercial interest. • In the second year of the contract, provide the program and contract officers with a letter(s) of commercial commitment. • Present Phase II findings and demonstrate the validated software to an NCI Evaluation Panel via webinar.