098 Testing and Validation of Technologies for Inclusion in the CART Demonstration Project for Collaborative Aging Research
Phase I only proposals will not be accepted.
Fast-Track proposals will be accepted.
Direct-to-Phase II proposals will be accepted.
Number of anticipated awards: 3
Budget (total costs):
Phase I: up to $150,000 for up to 6 months
Phase II: up to $1,000,000 for up to 24 months
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
New strategies are needed to develop an evidence-based healthcare system for the aging population, including those with chronic disabilities. Technologies that combine data from multiple sources, create meaningful presentations and visualizations and integrate information into a patient’s electronically accessible health record are needed. These technologies also need to be combined with systems that can interact with the health care team and respond with timely interventions. To date, evidence is lacking demonstrating that home-based healthcare technologies improve or stabilize health so that the aging population can remain at home longer and avoid unnecessary hospitalizations or admissions to a nursing home. This SBIR contract aims to develop research evidence to support the use of technologies in the home that address heart, lung, blood, or sleep diseases using the Collaborative Aging (in Place) Research Using Technology (CART) research infrastructure and provide evidence for scaling up after the demonstration project.
The purpose of the trans-NIH, inter-agency Collaborative Aging (in Place) Research Using Technology (CART) grant funding opportunity (RFA-AG-16-021) is to develop the infrastructure to improve the capacity of the research community to rapidly and effectively conduct research utilizing technology to facilitate aging in place, with a special emphasis on people from underrepresented groups. The underrepresented groups include those living in rural areas, section 202 housing, PACE Program and others. The CART grant funding opportunity focuses on the following: 1) Algorithmic and other data aspects of in-home technologies; 2) Validation of devices and sensed data; 3) Protecting privacy and security for in-home technologies; 4) Making sensed data actionable for home healthcare; and 5) Methods for successful engagement by patients, physicians, caregivers, and payers. This initiative grew out of a visioning workshop held by the National Heart Lung and Blood Institute, National Science Foundation, and the Computing Community Consortium on the technology needed to enable successful aging in place (http://www.cra.org/ccc/visioning/visioning-activities/aging-in-place). The workshop discussion centered on four main topics: designing for the population, sensing innovations required to enhance health, using technology to identify and support transitions in health and utilizing new non-health technologies to support health in smart homes. Workshop panelists highlighted the challenges of talking across disciplines and the need to develop standard metrics that allow better collaborations among diverse disciplines. More information is available in the White Paper. This announcement solicits proposals relevant to heart, lung, blood or sleep disorders. Technologies for cardiovascular diseases are of interest, for example, because cardiovascular diseases account for over 17% of total health care dollars spent nationwide. This work is needed before the potential benefits of these devices can be fully leveraged in a health care system.
This contract solicitation will support the testing and validation of existing technologies within the context of the CART Demonstration Project being developed under a separate grant award (RFA-AG-16-021). The trans-agency CART Demonstration Project seeks to develop and test the feasibility of a research infrastructure supporting in-home care utilizing innovative technology targeted to reduce hospitalizations, emergency room visits or admissions to a nursing home for older populations. After iterative testing of in-home cardiovascular, respiratory, hematological, or sleep technologies, the results will be compiled and study outcomes assessed with the potential for adoption in future phases of the CART Programs.
Phase I Activities and Expected Deliverables
All proposals submitted under this topic must provide evidence that significant development milestones (detailed below) for a specific remote/mobile/wireless or other technology or system have already been achieved to demonstrate readiness for Phase II SBIR contract. In addition, the proposed technologies must be compatible with
the CART platform requirements. These milestones will be evaluated in addition to standard review criteria for all submissions. The following milestones are expected to be completed during Phase I prior to the start of a Phase II award, or should be demonstrated prior to submission of a Direct to Phase II proposal.
• Provide evidence that a working prototype, including all major functional components of the technology, is ready for formal validation in a Phase II SBIR project with minimal further development other than that required to perform the validation or outcomes research.
• Provide the process for installing and monitoring the technology installed for CART homes (approximately 5-10 homes and possibly more).
• Provide documentation that the product to be evaluated has been developed based on theory and/or empirical evidence.
• Present evidence that appropriate focus groups, interviews, cognitive or user testing with potential end-users of the device/software tool, etc. have been conducted to demonstrate that the feasibility, acceptability, and usability of the product have been established.
Phase II Activities and Expected Deliverables
• Evaluate specific IT customization requirements specified by the CART grant funding opportunity (RFA-AG-16-021) to support hardware, software, or communications system integration of the technology into the target clinical setting, health system or service, or other relevant software environment in preparation for validation. Provide a report documenting the specific IT customization requirements and timelines for implementation. This will be done according to the CART specifications. The CART specifications will be developed within a year of the CART grant award and will require collaboration with the small business partner awarded a contract.
• Test the integration of the technology into the target clinical setting, health system or service, or other relevant software environment in preparation for validation. This may occur as an iterative process.
• Provide a report documenting the results of system testing, validation, and timelines for problem mitigation.
• Develop user support documentation to support all applicable potential users of the technology, including but not limited to patients/consumers, family/caregivers, and providers. Provide a report documenting user support resources including, but not limited to, links to online resources and copies of electronic or paper user support resources as appropriate.
Provide a report including the following at a minimum:
• Appropriate human subjects protection / IRB submission packages and documentation of approval for your research plan;
• Study design including aims, participant characteristics, 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. Publication plan in collaboration with the CART collaborators outlining potential research and whitepaper publications resulting from the research, including anticipated lead and co-author lists.
Provide study progress reports quarterly, documenting recruitment and enrollment, retention, data QA/QC measure, and relevant study-specific milestones for the technology used in the CART home.
This small-scale, path-building work requires significant economies of effort and the basic organizational operations and execution responsibilities for the entire project will need to be shared between the CART and small business collaborators. The small business contractor will contribute and participate in the CART committees and provide feedback to the committees based on the technologies proposed. In addition, the small business contractor will fully comply or negotiate the CART requirements for testing and validation of the technologies proposed.