Innovative Programs to Enhance Healthcare Quality: A Comprehensive Guide

I. Introduction: The Imperative for Quality Improvement in Healthcare

In today’s rapidly evolving healthcare landscape, the pursuit of safer, higher quality, and more equitable care is paramount. The Agency for Healthcare Research and Quality (AHRQ) stands at the forefront of this mission, dedicated to producing evidence that drives improvements across the healthcare spectrum. An innovative program to improve quality in health care is not just desirable, it’s essential for navigating the complexities of modern medical practice and ensuring optimal patient outcomes.

This Notice of Funding Opportunity (NOFO) underscores the critical need for innovative programs to improve quality in health care, specifically targeting digital healthcare interventions at the point of care. By leveraging the Phased Innovation Award (R21/R33) mechanism, AHRQ is empowering researchers to develop and rigorously test cutting-edge digital solutions that promise to revolutionize healthcare delivery. This initiative recognizes the transformative potential of technology to enhance efficiency, reduce errors, boost safety, and foster greater patient engagement.

II. The Digital Healthcare Revolution: Transforming Point of Care Services

The digital healthcare ecosystem is no longer a futuristic concept; it’s a present reality. The proliferation of digital innovations is fundamentally reshaping care delivery models across all healthcare settings – from hospitals and clinics to homes and long-term care facilities. This transformation presents both immense opportunities and critical challenges. To fully realize the benefits of digital healthcare, robust evidence is needed to guide effective and safe deployment at the point of care.

Point of care encompasses any location where patient care is delivered. The integration of evidence-based, technology-driven solutions at these critical junctures holds the key to unlocking unprecedented improvements in healthcare. These solutions offer the potential to:

Boost Productivity: Streamline workflows and optimize resource allocation.
Minimize Errors: Reduce human error through automated processes and alerts.
Enhance Safety: Implement safety protocols and real-time monitoring systems.
Increase Patient Engagement: Empower patients through accessible information and shared decision-making tools.

III. Focus Areas: Digital Healthcare Solutions for Quality Enhancement

This NOFO strategically focuses on three key research areas, all aligned with the overarching goal of fostering innovative programs to improve quality in health care. These areas highlight the most promising avenues for digital intervention and impact:

1. Advanced Analytics: Driving Quality and Equity with AI

Harnessing the power of advanced analytics, particularly Artificial Intelligence (AI), is central to creating innovative programs to improve quality in health care. AI technologies, including Natural Language Processing (NLP) and Machine Learning (ML), offer unprecedented capabilities to analyze vast datasets and extract actionable insights.

Research projects in this area should focus on:

AI Integration at Point of Care: Testing digital healthcare solutions that seamlessly integrate AI into healthcare service delivery.
AI Impact Assessment: Evaluating the real-world impact of AI applications on practice workflows and the quality of care provided.
Machine Learning for Improved Outcomes: Applying ML algorithms to large health datasets to identify patterns and drive improvements in care delivery, equity, and overall quality.

By leveraging AI, healthcare systems can move towards more predictive, personalized, and equitable care models, representing a significant step forward in innovative programs to improve quality in health care.

2. Patient-Centered Digital Health Technologies: Elevating Experiences and Delivery

Patient-Centered Digital Healthcare Technologies (PC-DHTs) are revolutionizing how patients interact with the healthcare system and are integral to innovative programs to improve quality in health care. Wearables, sensors, mobile health applications, and other PC-DHTs empower patients to actively participate in their care, generating valuable data and facilitating timely interventions.

Research in this area should explore:

PC-DHT Impact on Patient Outcomes: Investigating how PC-DHTs influence patient outcomes, including functional status, well-being, and overall experiences.
Technology Implementation Effects: Assessing the impact of PC-DHT implementation on practice workflows and the quality of care delivery.
Information Sharing and Shared Decision-Making: Specifically focusing on digital technologies that enhance communication and collaborative decision-making between patients and providers.
Digital Solutions for Chronic Conditions: Evaluating novel digital solutions tailored for patients managing multiple chronic conditions, a growing area of need in healthcare.

This focus area emphasizes the importance of innovative programs to improve quality in health care by placing the patient at the center of digital health solutions. It moves beyond simply adopting technology to strategically using it to enhance the patient experience and improve care delivery.

3. Clinical Decision Support Systems: Augmenting Knowledge at the Point of Care

Clinical Decision Support Systems (CDSS) are vital tools for clinicians, providing access to evidence-based knowledge and patient-specific data precisely when needed. Innovative programs to improve quality in health care heavily rely on CDSS to enhance clinical decision-making and ensure adherence to best practices.

Research projects should investigate:

Patient-Generated Data in CDSS: Testing innovative CDSS tools that incorporate patient-reported outcomes and patient-generated data to personalize recommendations.
NLP-Enhanced Decision Support: Evaluating digital solutions that combine NLP with CDSS to transform unstructured clinical data into actionable knowledge, bridging the gap between data and practice.
Standardized Biomedical Knowledge Integration: Exploring digital healthcare innovations that enable clinicians and health system leaders to efficiently utilize standardized, computable biomedical knowledge for informed decision-making and shared care planning.

By enhancing CDSS with patient data and advanced analytics, innovative programs to improve quality in health care can empower clinicians to make more informed decisions, leading to better patient outcomes and more efficient care processes.

4. Integrated Approaches: Combining Research Areas for Synergistic Impact

AHRQ encourages researchers to consider integrated approaches that span across the three research areas. For example, projects could explore innovations that combine AI with CDSS and patient-reported outcomes. Such integrated strategies can unlock synergistic effects, leading to more comprehensive and impactful innovative programs to improve quality in health care.

IV. The Phased Innovation Award (R21/R33): A Pathway to Impactful Research

This NOFO utilizes the Phased Innovation Award mechanism (R21/R33), a strategic approach designed to support both initial exploratory activities and subsequent expanded research. This phased approach is crucial for nurturing innovative programs to improve quality in health care from initial concept to impactful implementation.

R21 Phase (Exploratory): Provides up to 2 years of support for initial developmental activities and milestone-driven progress.
R33 Phase (Expanded): Offers up to an additional 3 years of funding to scale up successful R21 projects and further expand activities.

Key features of the R21/R33 mechanism:

Milestone-Driven Progression: Transition from R21 to R33 is contingent on achieving pre-defined milestones in the initial phase.
Not Guaranteed Transition: Continuation to the R33 phase is competitive and based on progress, program priorities, and funding availability.
Combined Application: Applicants must propose both R21 and R33 phases within a single application, ensuring a cohesive long-term research plan.
Preliminary Data Optional: While not required, preliminary data can strengthen the application.

This phased approach ensures that innovative programs to improve quality in health care are rigorously developed and evaluated, maximizing the potential for impactful and sustainable solutions.

V. Essential Project Requirements: Building Blocks for Success

All projects funded under this NOFO must adhere to specific requirements to ensure alignment with the goals of innovative programs to improve quality in health care. These requirements serve as guiding principles for project design and implementation:

Comprehensive Innovation Description:
- Clearly define the digital healthcare intervention being tested.
- Articulate the problem the intervention addresses and its readiness for research.
- Present a unifying, testable hypothesis that spans both R21 and R33 phases.
- Specify how performance will be measured (outcomes, baselines, indicators).
- Detail strategies to mitigate or avoid exacerbating health disparities.
- Evaluate the reliability, validity, and usability of the digital solution.
- Describe how the intervention will integrate into clinical workflows and impact care delivery.
Contextual Implementation Details:
- Define the healthcare practice setting(s) for the research.
- Describe the patient population(s) that will be impacted.
- Identify all users of the digital healthcare solution.
Innovation Adoption and Sustainability Strategy:
- Outline a clear innovation adoption strategy, detailing how the technology will be designed for easy adoption and scalability.
- Demonstrate the sustainability of the innovation and its potential for broader adoption in other settings.
- Develop a leading-edge dissemination strategy to be implemented during the R33 phase.
Comprehensive Evaluation and Reporting:
- Measure and report on improvements in care quality and reductions in adverse events.
- Evaluate enhancements in patient experience and the delivery of whole-person care.
- Assess reductions in burden on providers, patients, and caregivers.
- Report on any unintended patient safety events.
- Analyze the impact on health inequities – whether biases are mitigated, maintained, or exacerbated.
Detailed Project Timeline: Provide a clear timeline outlining major milestones for both the R21 and R33 phases.

By addressing these comprehensive requirements, researchers can develop robust and impactful innovative programs to improve quality in health care that are poised for real-world implementation and dissemination.

VI. Funding and Eligibility: Key Information for Applicants

1. Award Information:

Funding Instrument: Grant
Application Types: New, Resubmission
Clinical Trial: Optional
Funds Available: Contingent upon AHRQ appropriations.
Award Budget:
- R21 Phase: Up to $280,000 total costs for 2 years (max $140,000 per year).
- R33 Phase: Up to $720,000 total costs for 3 years (max $240,000 per year).
Project Period: Maximum 5 years (R21 phase max 2 years, R33 phase max 3 years).

2. Eligibility:

Eligible Organizations: Higher Education Institutions, Nonprofits, Local Governments, State Governments, Federal Governments, U.S. Territories, Independent School Districts, Public Housing Authorities, Native American Tribal Organizations, Faith-based/Community-based Organizations, Regional Organizations. For-profit organizations are not eligible to lead applications but can participate as consortia members or subcontractors. Foreign institutions can also participate in consortia or as subcontractors.
PD/PI Eligibility: Any individual with necessary skills, knowledge, and resources. Minimum 20% full-time effort required from PD/PI(s).
Cost Sharing: Not required, but institutional support is welcomed and indicates project sustainability.

3. Application and Submission:

Application Package: Available through ASSIST, Grants.gov Workspace, or institutional system-to-system solutions.
Page Limits: Research Strategy section limited to 12 pages.
Submission Dates and Times: Refer to Part I. Overview Information of the original NOFO.
Electronic Submission: Required via Grants.gov and eRA Commons.

VII. Review Process and Criteria: Ensuring Scientific Merit

Applications will undergo rigorous peer review based on established AHRQ procedures. Review criteria are designed to assess the scientific and technical merit of proposed innovative programs to improve quality in health care.

1. Merit Review Criteria:

Overall Impact: Potential for sustained and powerful influence on relevant research fields.
Significance: Importance of the problem addressed and potential impact on scientific knowledge, technical capability, and/or clinical practice.
Investigator(s): Suitability and expertise of PD/PI(s), collaborators, and researchers.
Innovation: Novelty of theoretical concepts, approaches, methodologies, instrumentation, or interventions.
Approach: Reasonableness and appropriateness of strategy, methodology, and analyses; feasibility and risk management; robustness and unbiased design; clear milestones for R21 and R33 phases; focus on improving quality and healthcare delivery at the point of care; evaluation of reliability, validity, and usability; measurement of care quality and patient experience improvements; sustainability and scalability considerations; dissemination plan; detailed project timeline.
Environment: Contribution of the scientific environment to project success; adequacy of institutional support and resources.

2. Additional Review Criteria:

Protection of Human Subjects: Adequacy of plans to protect human subjects and address inclusion/exclusion criteria.
Inclusion of Priority Populations: Adequacy of plans to address the needs of AHRQ priority populations (inner city; rural; low income; minority; women; children; elderly; and those with special health care needs, including those who have disabilities, need chronic care, or need end-of-life health care; and underserved communities as defined in Executive Order 13985).
Degree of Responsiveness: How well the application aligns with the NOFO’s purpose and objectives.
Budget and Period of Support: Reasonableness of the budget and appropriateness of the requested project period.

VIII. Award Administration and Reporting: Post-Award Requirements

1. Award Notices:

Notification of successful applications via Notice of Award (NoA) sent to the recipient organization.
Compliance with funding restrictions and AHRQ-specific terms and conditions outlined in the NoA.

2. Administrative and National Policy Requirements:

Adherence to HHS’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, and HHS Grants Policy Statement.
Compliance with whistleblower rights and protections, health IT standards, non-discrimination laws, and other applicable regulations.

3. Reporting Requirements:

Annual progress reports due 3 months before the start date of the next budget period.
Annual Federal Financial Report (FFR; SF 425).
Final Progress Report, final FFR, and Final Invention Statement within 120 days of project end date.
Reporting of subawards over the threshold to the Federal Subaward Reporting System (FSRS).
Disclosure of civil, criminal, and administrative proceedings in the System for Award Management (SAM).
Program planning and performance reporting based on reach, process, and impact measures.

IX. Agency Contacts: Your Resources for Application Support

AHRQ encourages inquiries and provides dedicated contacts for application assistance:

Application Submission Contacts: eRA Service Desk, Grants.gov Customer Support (contact information provided in original NOFO Section VII).
Scientific/Research Contact(s): Stephanie R. Pitts, Ph.D., Digital Healthcare Research Division (contact information provided in original NOFO Section VII).
Peer Review Contact(s): Boris Aponte, Ph.D., Division of Scientific Review (contact information provided in original NOFO Section VII).
Financial/Grants Management Contact(s): Brian Campbell, Office of Management Services Grants Management (contact information provided in original NOFO Section VII).

X. Conclusion: Advancing Healthcare Quality Through Innovation

This Notice of Funding Opportunity represents a significant investment in innovative programs to improve quality in health care. By supporting research on digital healthcare interventions at the point of care, AHRQ is fostering a future where technology empowers healthcare professionals, engages patients, and delivers safer, higher quality, and more equitable care for all. Researchers are encouraged to leverage this opportunity to contribute to the growing evidence base and drive meaningful advancements in healthcare delivery through innovative programs to improve quality in health care.

Learn more and apply to be a part of this transformative initiative.

References: (As provided in the original NOFO)

Alowais, S. A., Alghamdi, S. S., Alsuhebany, N., Alqahtani, T., Alshaya, A. I., Almohareb, S. N., … & Albekairy, A. M. (2023). Revolutionizing healthcare: the role of artificial intelligence in clinical practice. BMC medical education, 23(1), 689. doi: 10.1186/s12909-023-04698-z
Pinsky, M. R., Bedoya, A., Bihorac, A., Celi, L., Churpek, M., Economou-Zavlanos, N. J., … & Clermont, G. (2024). Use of artificial intelligence in critical care: opportunities and obstacles. Critical Care, 28(1), 113. doi: 10.1186/s13054-024-04860-z
Pyper, E., McKeown, S., Hartmann-Boyce, J., & Powell, J. (2023). Digital health technology for real-world clinical outcome measurement using patient-generated data: systematic scoping review. Journal of Medical Internet Research, 25, e46992. doi: 10.2196/46992