Fast track proposals will be accepted. Direct-to-Phase II proposals will not be accepted. Number of anticipated awards: 2-4 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 Cancer care delivery systems are complex and difficult to navigate. Patient navigators (PNs) help patients navigate these systems. PNs facilitate timely cancer screening, diagnosis and treatment by decreasing barriers to care. Navigation programs have successfully reduced time from detection to diagnosis, and from diagnosis to start of treatment, in cervical, breast, and colorectal cancers, and have reduced disparities in cancer outcomes due to differences in income or employment. Page 83 Nurses, social workers, and lay persons may serve as PNs. PNs work with patients to overcome health system barriers, provide health education, and psychosocial support. Common tasks of PNs include patient education and communication, scheduling and coordinating appointments, communication with clinicians, connecting patients and caregivers with community resources, and assistance with medical paperwork. Patient navigation services are mandated by the Commission on Cancer. There is an increasing demand for expanding the use of PNs in all phases of the cancer care continuum. A National Academy of Medicine (NAM) report has identified several challenges faced by PNs, including: care coordination, tracking patients through their trajectory of care with different clinicians and facilities, supporting patients throughout the cancer care continuum, and addressing communication, transportation, and financial barriers. It takes significant time for PNs to collate information across different information systems, from patients and their caregivers, and from the relevant clinicians. It can be cognitively burdensome for navigators to synthesize this information, triage key tasks, and address patient needs in a timely manner. Projected increases in cancer survivors will further strain the capacity of the existing professional PN workforce, accelerating the need for new approaches to support and extend the work of both professional and lay PNs. Information technology (IT) has the potential to increase the reach and effectiveness of patient navigation programs by supporting the day-to-day work of PNs. IT-based tools can provide education, support communication and coordination, curate information, assist decision-making, reduce cognitive burden by improving information synthesis or decision support, and adaptively meet patients’ needs. However, the lack of user-centered design and sub-optimal integration of navigation related IT tools into existing IT systems are significant barriers. User-friendly IT tools are needed to reduce the cognitive and time burden of performing navigation tasks. User-friendly IT tools that are integrated in the workflow of PNs can improve cancer care delivery and patient outcomes. Project Goals The long-term goal is to provide timely cancer care and improve patient outcomes by developing new software tools that support patient navigation. The short-term goals are to develop, deploy and evaluate IT tools that: 1) reduce the cognitive or time burden (or both) of navigation-related tasks performed by either PNs or patients; 2) are well-integrated in the work flow of PNs and existing IT architecture; 3) securely transmit information across a variety of IT systems. The technical scope includes the development, deployment and evaluation of IT tools that support patient navigation. The tool design approach must account for integration within existing IT systems, interoperability, cyber-security and protecting patient’s privacy. Activities outside the scope of this Topic: Not using a human-centered design process to understand and meet the users’ needs; development of tools that do not use current best practices for inter-operability, cybersecurity and patient privacy; development of tools that are either not integrated in the work flow or in the existing IT architecture; merely increasing access to patient data (e.g. increasing access to data within a patient portal) without synthesis and presentation of data in a manner that reduces the user’s cognitive burden. Phase I Activities and Deliverables • Project team: Establish a project team with expertise in: cancer patient navigation; software development and evaluation; user-centered design; health services research; and the design, deployment and use of health IT in a healthcare delivery organization. Knowledge and design of systems architecture, health IT interoperability, cybersecurity, and HIPAA and other laws and regulations to protect privacy and confidentiality of patient information will be required. • Perform a targeted literature review to inform the needs assessment of PNs and the approach to be used to design, develop and evaluate the IT tool(s). • Conduct a needs assessment of PNs and cancer patients in at least one cancer care delivery site. • Develop prototype software tool(s) to support two or more patient navigation tasks. Tasks include, but are not limited to, providing education to patients, scheduling or coordinating appointments, communicating with clinicians, coordination care planning, referring patients to appropriate resources to meet their financial or transportation needs. • Conduct at least one usability study of the IT tool(s) with the participation of a minimum of 25 users. • Submit a report specifying approach taken to design and evaluate the IT tool(s), usability study findings and the plans and approach to be taken to improve the tool(s) usability. • Submit a report detailing plans for implementation of IT tool(s), including technical assistance and a review of technical specifications for systems interoperability, within existing EHR and other health IT systems, cybersecurity and patient privacy. • Present Phase I findings and demonstrate the functional prototype system to an NCI evaluation panel via webinar. Phase II Activities and Deliverables Phase II activities should support the commercialization of the proposed technology, including but not limited by the following activities: • Deploy the IT tool(s) in at least one cancer care delivery site. • Conduct a study to evaluate the usability and effectiveness of the deployed IT tool(s) in supporting two or more patient navigation tasks. The specific aims, approach, outcomes and analysis plan of the evaluation study should be explicitly stated. A minimum of 100 users should participate in this evaluation study, and the human subjects protection plan (including IRB review and patient consent) should be in place before the start of the study. • Refine the IT tool(s) based on the evaluation of the usability and effectiveness. • Evaluate the interoperability of the IT tool(s), the effectiveness of the cybersecurity design and the protection of patient privacy. • Submit a report that details the aims, approach, data analysis, and conclusions of the evaluation of usability, effectiveness, interoperability, cybersecurity and protection of patient privacy. • Submit a report that details the future approach to modify the tool(s) to support additional PN tasks and to support patients across the cancer care continuum. This report should include a plan to commercialize the IT tool(s). • Present Phase II findings and demonstrate the system via a webinar at a time convenient to the contractor and NCI Program and Contracting staff. • 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.