Performing Department
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Non Technical Summary
Pediatric respiratory diseases disproportionately affect children in rural and tribal communities, where access to specialized care is limited. The lack of timely, accurate information about a child's respiratory symptoms makes it challenging for healthcare providers to diagnose and manage these conditions effectively, leading to poorer health outcomes and higher healthcare costs. The MamaBear Health project aims to address this critical issue by developing an innovative, user-friendly smartphone app that empowers parents to track their child's respiratory health and share this information with their healthcare providers in real-time. The project will involve a collaborative effort between app developers, a premier pediatric academic center, and HIPAA and EHR integration specialists. The team will conduct extensive usability testing with parents and providers to ensure the app is easy to use and meets their needs. The app will be designed to securely collect and transmit data, complying with all necessary HIPAA privacy regulations. It will also be integrated with most healthcare provider's electronic health record systems, allowing seamless data sharing and improved care coordination. The MamaBear Health project is not just about developing an app. It's about providing parents and healthcare providers with a powerful tool for monitoring and managing pediatric respiratory health. This tool has the potential to not only improve health outcomes and reduce healthcare costs but also enhance the quality of life for children and families affected by respiratory conditions. The app canbridge the gap in access to specialized care for underserved rural and tribal communities, promoting health equity and reducing disparities. Moreover, by reducing the need for in-person visits and hospitalizations, the project could have a positive environmental impact by decreasing travel-related emissions. If successful, the MamaBear Health app could serve as a model for other patient-centered, data-driven approaches to managing chronic pediatric conditions, revolutionizing how we deliver care to vulnerable populations.
Animal Health Component
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Research Effort Categories
Basic
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Applied
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Developmental
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Goals / Objectives
This Phase II SBIR project is poised to revolutionize pediatric respiratory health management by developing MamaBear Health (MBH), a truly innovative smartphone application. Built on the success of our Phase 1 SBIR grant, MBH combines cutting-edge technology with user-centered design principles. Our Phase 2 grant directly responds to user and clinician feedback, taking MBH to the next level. It will provide a secure, intuitive, and HIPAA-compliant platform that empowers parents to participate actively in their child's respiratory care. The app seamlessly integrates with the Epic Electronic Health Record (EHR) system, harnessing the power of real-time, patient-generated data to bridge the gap between home and clinical settings. This enables healthcare providers to make informed decisions and deliver personalized, evidence-based care. The MBH app will feature a user-friendly interface that guides parents through tracking their child's symptoms, medication use, and environmental triggers. Advanced data visualization tools will allow parents to quickly identify patterns and trends in their child's respiratory health, promoting early intervention and self-management. Simultaneously, healthcare providers will have access to a wealth of actionable data through the Epic EHR integration, facilitating timely and targeted interventions that can prevent exacerbations and improve long-term outcomes. The successful completion of this project will demonstrate the immense potential of patient-centered, data-driven care delivery as a milestone in the digital transformation of pediatric healthcare. MBH will set a new patient engagement and care coordination standard, fostering collaboration between families and healthcare teams to optimize respiratory health management. By reducing the burden of chronic respiratory conditions on children, families, and the healthcare system, MBH has the potential to generate significant societal and economic benefits, ultimately improving the quality of life for countless children and their families.Objectives:One of our key objectives is to conduct a rigorous, two-part usability study of the MBH app prototype at the University of Minnesota within the first nine months of the project. This study will involve a diverse sample of at least ten parents and six clinicians, employing a mixed-methods approach. We will combine quantitative metrics (e.g., task completion time and error rates) with qualitative feedback to identify usability issues and inform iterative improvements. The LoonMD team will measure the success of this study by developing a comprehensive plan to address at least 80% of the most critical issues identified by participants. This study will ensure that the final app is intuitive, efficient, and satisfactory for parents and clinicians, enhancing its credibility and user acceptance. Achieve robust HIPAA compliance (minimum 90%) for the MBH app, cloud-based server, and data web links by the end of the Phase II grant period. LoonMD will accomplish HIPAA compliance by implementing state-of-the-art encryption techniques, granular access controls, and secure data transmission protocols. The LoonMD team and an external HIPAA compliance firm will conduct a comprehensive risk analysis to identify potential vulnerabilities and develop stringent policies and procedures to mitigate risks. LoonMD will demonstrate success by producing detailed documentation, including a risk analysis report, policy and procedure manuals, and a successful audit report by a third-party HIPAA compliance expert.Develop a comprehensive integration plan with an external integration firm for seamlessly incorporating the MBH app into the Epic EHR system by September 2025. The plan will adhere to the technical standards and implementation specifications outlined in the Interoperability Standards Advisory (ISA) by the Office of the National Coordinator for Health Information Technology (ONC), ensuring full compatibility and data exchange capability. The integration plan will encompass technical requirements, data mapping strategies, API specifications, and a phased development, testing, and deployment timeline. LoonMD will measure success by the timely delivery of a complete integration plan validated by Epic technical experts that meets all relevant interoperability standards.Submit the fully functional MBH app to the App Store, Google Play Store, and Epic Connection Hub for review by the end of the project, incorporating insights and enhancements derived from the usability study, HIPAA compliance plan, and EHR integration plan. The app development process will adhere to agile software development principles, emphasizing iterative refinement, modular architecture, and continuous quality assurance. The final app will boast a modern, responsive user interface, robust security features, and seamless EHR integration. LoonMD will measure success by ensuring the app is free of critical bugs and security vulnerabilities, verified through extensive testing and third-party code audits. LoonMD will validate user acceptance through positive feedback from at least 80% of beta testers representing parents and healthcare providers. These objectives are ambitious yet achievable within the 24-month project timeline, leveraging the expertise of our multidisciplinary team, which includes 2.0 FTE Scientists, 1.3 FTE Professionals, 0.5 FTE Technical staff, 0.3 FTE Administrative staff, and 0.5 FTE Students (0.4 Graduate and 0.1 Post-Doctorate). The project will also benefit from strategic partnerships with three renowned outside firms specializing in usability testing, HIPAA compliance, and EHR integration, ensuring a comprehensive and holistic approach to app development. By successfully executing these objectives, MamaBear Health will emerge as a transformative force in pediatric respiratory care, empowering families, enabling providers, and, ultimately, improving the lives of children affected by respiratory conditions.
Project Methods
Efforts:Usability Testing: The project will commence with a comprehensive two-part usability study, engaging parents and healthcare providers to thoroughly assess the ease of use, functionality, and user satisfaction of the MBH app prototype. The study will employ a meticulous mixed-methods approach, combining quantitative metrics (e.g., task completion time, error rates) with qualitative feedback (e.g., user interviews, observations) to identify areas for improvement. The results will be analyzed using descriptive statistics and thematic analysis, informing iterative design refinements to enhance the app's usability and user experience.HIPAA Compliance: A cornerstone of our project is ensuring the security and privacy of patient-generated health data. The project will prioritize HIPAA compliance throughout the app development process to achieve this. This commitment involves conducting a comprehensive risk analysis, implementing encryption techniques, access controls, and secure data transmission protocols, and developing detailed policies and procedures. The effectiveness of these measures will be evaluated through third-party audits and vulnerability assessments, with findings used to strengthen the app's security posture continuously.EHR Integration: A pivotal part of our project is developing a comprehensive plan for integrating the MBH app with the Epic EHR system. Following the technical standards and specifications outlined in the Interoperability Standards Advisory (ISA), this effort will involve close collaboration with Epic technical experts and outside firms specializing in EHR integration. The aim is to ensure seamless data exchange and workflow integration. The success of the integration will be evaluated through extensivetesting, user feedback, and data quality and completeness assessment.App Development: The MBH app will be developed using an agile methodology, emphasizing iterative development, continuous testing, and user feedback. The development process will incorporate insights from the usability study, HIPAA compliance plan, and EHR integration plan to create a user-friendly, secure, and interoperable mobile health application. The app's performance and stability will be evaluated through comprehensive testing, including unit testing, integration testing, and user acceptance testing, focusing on identifying and resolving critical bugs and vulnerabilities.Beta Testing: Before the public launch, the MBH app will undergo extensive beta testing with a diverse group of parents and healthcare providers to validate its usability, functionality, and impact. Participants will be asked to use the app in real-world settings and provide feedback through surveys, interviews, and usage data. The results will be analyzed to identify any remaining issues and inform final refinements before the app's official release.Evaluation: The success of the MamaBear Health project will be evaluated using a comprehensive, mixed-methods approach that assesses both the app's technical performance and its impact on pediatric respiratory care management. Key milestones and quantitative indicators of success will include:Usability: Feedback from at least 80% of parent and healthcare provider participants in the usability study is incorporated.HIPAA Compliance: The MBH app, server, and web links are at least 90% compliant with HIPAA regulations.EHR Integration: The MBH app integrates with the Epic EHR system, enabling seamless data exchange and workflow integration, as validated through extensive testing and user feedback.App Performance: The MBH app, verified through comprehensive testing, is free of critical bugs and security vulnerabilities.