Using Innovative Digital Healthcare Solutions to Improve Quality at Point of Care (R21/R33) is sponsored by National Institutes of Health (NIH). This funding opportunity supports exploratory (R21) and developmental (R33) research projects that test digital healthcare interventions.

PA-24-266: Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional) Health and Human Services Part 1. Overview Information Participating Organization(s) Agency for Healthcare Research and Quality ( AHRQ ) NOTE: The policies, guidelines, terms, and conditions stated in this Notice of Funding Opportunity (NOFO) may differ from those used by the NIH.

Where this NOFO provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this NOFO.

of Participating Organizations Funding Opportunity Title Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial March 10, 2026 - Notice of Early Expiration PA-24-266 -- Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional).

See Notice NOT-HS-26-008 March 31, 2025 - This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 04, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025.

See Notice NOT-OD-24-084 August 27, 2024 - Notice of Change to Research Opportunity: Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional). See 13, 2024 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Improve Care Delivery, Access, Quality, Equity, and Health Outcomes for Older Adults. See NOT-HS-24-013.

8, 2024 - Notice of Intent to Publish a Funding Opportunity Announcement for Using Innovative Digital Healthcare Solutions to Improve Quality at the Point of Care (R21/R33 - Clinical Trial Optional). See 12, 2024 - AH Guidance on Salary Limitation for Grants and Cooperative Agreements FY 2024. See NOT-HS-24-007.

21, 2023 - Reminder of eRA Commons ID Requirement for All Personnel on the R&R Senior/Key Person Profile Form. See NOT-HS-24-042 . 16, 2023 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Improve Healthcare for Persons Living with Disabilities.

See Notice NOT-HS-24-004 8, 2023 - Special Emphasis Notice: AHRQ Announces Interest in Health Services Research to Advance Health and Healthcare Equity. See NOT-HS-23-013. 11, 2023 - AHRQ Announces Interest in Research on Climate Change and Healthcare.

See Notice NOT-HS-23-006 11, 2022 - Competitive Revision Supplements to Existing AHRQ Grants and Cooperative Agreements to Enhance Workforce Diversity in Health Services Research. See PA-22-175 26, 2020 -The Agency for Healthcare Research and Quality Data Management Plan Policy. See NOT-HS-20-011.

5, 2016 - AHRQ Policy Guidance Regarding Inflationary Increases (aka, cost-of-living adjustments, or COLAs) beginning in Fiscal Year 2017. See NOT-HS-17-001 . Funding Opportunity Number (FON) Companion Notice of F unding Additional Information on Eligibility .

Assistance Listing Number(s) F unding Opportunity Purpose This NOFO invites applications that propose research projects that test promising digital healthcare interventions used at the point of care and aimed at improving the quality of healthcare services delivery.

This NOFO will use the Phased Innovation Award (R21/R33) mechanism to provide up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities. Open Date (Earliest Submission Date) Letter of Intent Due Date (s) dates apply.

The first application due date is October 16, 2024 All applications are due by 5:00 PM local time of the Applicants are encouraged to apply early to allow adequate time to for them to make, by the due date, corrections to any errors found in the application during the submission process.

AIDS Application Due Date(s) Generally, four months after receipt date Generally, four months after the peer review date New Date March 10, 2026 per issuance of NOT-HS-26-008 .

(Original Expiration Date: August 1, 2026) It is critical that applicants follow the Research (R) Instructions in How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both to Apply - Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www. ahrq. gov/funding/policies/nofoguidance/index.

html . the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. do not comply with these instructions may be delayed or not accepted for There are several options available to submit your application through Grants.

gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity. Use the NIH ASSIST system to prepare, submit and track your application online.

Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

Workspace to prepare and submit your application and eRA Commons to track your application. Part 1. Overview Information Part 2.

Full Text of the Announcement I. Notice of Funding Opportunity Description Section II. Award Information Section III.

Eligibility Information Section IV. Application and Submission Section V. Application Review Information Section VI.

Award Administration Information Section VII. Agency Contacts Section VIII. Other Information Part 2.

Full Text of Announcement Section I.

Notice of Funding The mission of the Agency for Healthcare Research and Quality (AHRQ) is to produce evidence to make healthcare safer, higher quality, and more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure the evidence is understood and used ( AHRQ Research Priorities and Compliance Guidance | Agency for Healthcare Research This Notice of Funding Opportunity (NOFO) invites applications for research projects that test promising digital healthcare interventions used at the point of care and aimed at improving the quality of healthcare services delivery.

This NOFO will use the Phased Innovation Award (R21/R33) mechanism to provide up to 2 years of R21 support for initial developmental activities, and up to 3 years of R33 support for expanded activities. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO.

Continuation from the R21 phase to the R33 phase will be determined by AHRQ staff based on progress achieved in the R21 phase and factors such as program priorities and availability of funds.

The digital healthcare ecosystem is rapidly evolving, and there is a need to build the evidence base on how digital healthcare innovations can be effectively, efficiently, and safely deployed at the point of care, which is considered any location where patient care is provided (e.g., hospital, primary and ambulatory care facilities, the bedside, home, long term care facilities, rehabilitation facilities or ambulance).

The prolific emergence of new technological innovations used by multiple members of the healthcare team as well as caregivers in healthcare settings is transforming care delivery models and impacting care delivery and patient care experiences. The use of evidence-based, technology-driven, point of care process solutions has the potential to revolutionize the way care is delivered.

The use of these solutions can improve productivity, reduce errors, enhance safety, and increase opportunities for patient engagement and shared Artificial Intelligence (AI), Patient-Centered Digital Healthcare Technologies (PC-DHT), and Clinical Decision Support Systems (CDSS) are among the digital healthcare solutions that are being used to support efficient healthcare delivery, enhance patient engagement, advance the quality of care, and mitigate safety risks.

For example, health-related AI applications are used to improve care processes and provide AI-based diagnostic and treatment recommendations (Alowais et al. , 2023). PC-DHT such as mobile health applications, wearables, invisibles, and sensors are being used to improve care and patient experiences (Pyper, McKeown, Hartmann-Boyce, & Powell, 2023).

PC-DHT is used to capture patient-generated data, provide timely health information to inform decisions, facilitate shared decision-making, and promote self-care activities. Digital CDSS tools are used to link clinicians with health knowledge to assist with clinical decision making at the point of care (Pinsky, 2024).

Research is needed to understand how these technologies impact health outcomes and health equity, the delivery and quality of care, patient experiences, and healthcare disparities.

Health services research that explores the use of innovative patient-centric digital healthcare solutions to improve services at the point of care aligns with AHRQ's research priority to support healthcare professionals in providing whole-person care through healthcare system use of digital healthcare data (clinical, contextual, and patient-generated), knowledge (training, guidelines, decision support, and advanced analytics), and tools to support clinicians in The objective of this NOFO is to improve the quality of healthcare services delivery at the point of care through integration of digital healthcare solutions.

This NOFO aims to support phased exploratory and developmental research projects that test promising digital healthcare interventions used at the point of care and intended to improve the quality of healthcare Research should be designed to test promising digital healthcare solutions that enable or facilitate technology-driven, point of care process solutions that use advanced analytics, patient-centered clinician and patient facing digital healthcare technologies, or clinical decision support systems to improve quality and health outcomes at the point of care.

A theoretical framework should inform the research study and incorporate the use of care models when appropriate. The proposed digital healthcare solution should be accessed by a patient, provider, or other person providing healthcare Accordingly, this NOFO is focused on three research areas of interest.

Examples of research projects responsive to this NOFO include but are Use advanced analytics to improve quality and equity at Projects that will test innovative digital healthcare solutions that integrate the use of artificial intelligence (AI) (e.g., Natural Language Processing, Machine Learning) during the provision of healthcare services at the point of care.

Such applications should assess and evaluate AI’s impact on practice workflow and quality of care. Projects that apply machine learning against large health data sets to improve care delivery, equity, and quality at the point of care.

Use innovative, patient-centered, clinician and patient facing digital healthcare technologies to improve patient experiences and healthcare services delivery at the point of care Projects that explore understanding how the use of patient-centered digital healthcare technologies (e.g., wearables, sensors, and mhealth solutions) impacts patient outcomes including functional status and well-being, experiences, and healthcare services delivery at the point of care.

Such applications should assess and evaluate the technology implementation s impact on practice workflow and quality of care. Of particular interest is (1) testing innovative digital healthcare technologies that facilitate information sharing and shared decision-making between patients and providers, and (2) evaluating the use of novel digital solutions for patients with multiple chronic conditions.

This area of interest is intended to initiate research into how existing PC-DHTs can be integrated into care. Development of novel PC-DHTs, such as new sensors or wearables, is not allowed under this NOFO. Use evidence-based knowledge and patient-data to augment support for clinical decision-making at the point of care.

Projects that will test innovative digital clinical decision-making tools that incorporate the use of patient-generated data and patient-reported outcomes at the point of care. Projects that evaluate a digital point of care solution that combines the use of natural language processing (NLP) with a decision support tool to turn unstructured clinical data into knowledge and facilitate the advancement of the knowledge into practice.

Enabling clinicians and health system decision makers to effectively and efficiently use standardized computable biomedical knowledge to support clinical decision making and shared care planning is also an interest area. Applications that explore digital healthcare innovations in support of this interest area are welcome.

It is acceptable for applicants to propose research that crosses the research categories of interest mentioned above.

For example, an applicant may propose to study an innovation that integrates AI with a clinical decision support solution that incorporates patient-reported outcomes at the This NOFO will use the Phased Innovation Award Mechanism (R21/R33) to provide up to 2 years of R21 support for initial developmental activities and up to an additional 3 years of R33 support for expanded Proposed projects must include both an R21 phase, with milestone-driven developmental activities, and an R33 phase with expanded activities that will build on the initial developmental phase to achieve the aims of the entire award.

Applications proposing only R21 or R33 activities alone will Preliminary data are not required for this mechanism but may be included if available. Three months prior to the end of the R21 phase, awardees will submit a package, endorsed by an authorized institutional official, that requests transition to the R33 phase.

This package will include a progress report that describes progress made toward each of the initial applicant-defined milestones, and a clear description of whether the original R33 proposed aims will remain intact or be modified based on the results of the R21 phase.

Materials will be reviewed by AHRQ program staff and then, if selected to continue into the R33 phase, the R21 grant will be transitioned to an R33 Decisions on transitioning to the R33 phase will be based on successful completion of the original applicant-defined milestones, program priorities, and availability of funds. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO.

Fully describe the digital healthcare innovation and its Describe the digital healthcare intervention; Describe the problem which the digital healthcare intervention is intended to address and its readiness for an exploratory/developmental research Describe a unifying and testable hypothesis that transcends both Describe how performance will be measured (expected standards, outcomes, baselines, indicators, etc); Describe how the solution should be expected to reduce (or at least not exacerbate) disparities; Evaluate the reliability, validity, and usability of the digital healthcare solution used at the point of care; Describe how the digital healthcare intervention will be incorporated into the clinical workflow and will impact healthcare delivery; Fully describe the context in which the innovation will be Describe the healthcare practice setting(s) for the research; Describe the patient population(s) impacted by the research; Describe all users of the digital healthcare solution or system; Describe an innovation adoption strategy, including: Describe how technology modifications, systems, or tools will be designed from the outset to be easily adopted by other providers and teams in the organization and how the project will be designed to scale across the organization and beyond to other, similar organizations; Clearly demonstrate how the resulting innovation can be sustained and adopted by other settings; Develop an innovative and leading-edge dissemination strategy that will be implemented during the second phase of the grant; Evaluate and report (as applicable): Improvement in the quality of care and reduction in adverse Improvement in patient experience and delivery of whole Reduction in provider, patient, and caregiver burden; Unintended patient safety events; Impact on health inequities whether biases in care delivery and outcomes are exacerbated, maintained, or mitigated; and Provide a detailed project timeline that shows major milestones.

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 Resources, if applicable: Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care https://jamanetwork.

com/journals/jamanetworkopen/fullarticle/2812958 Chronic Conditions Electronic Care Plan project to improve interoperability of data for people living with MCCs; Include SMART on FHIR care planning applications, FHIR data standards, and value sets from common clinical Available on the Agency for Healthcare Research and Quality's (AHRQ) eCare Plan webpage. https://ecareplan. ahrq.

gov/ See Section VIII. Other Information for award authorities and regulations. Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or Application Types Allowed Apply - Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon AHRQ appropriations and the submission of a sufficient number of meritorious Future year amounts will depend on annual appropriations.

In the R21 phase, the combined budget for total costs (direct and indirect) for the two-year period may not exceed $280,000. No more than $140,000 total costs may be budgeted in either year of the R21 In the R33 phase, the combined budget for total costs (direct and indirect) for the three-year period may not exceed $720,000. No more than $240,000 total costs may be budgeted in any given year.

Applications that exceed the total costs caps described above and applications that do not include budgets for both the R21 and R33 phases will not be reviewed.

Funds may be used only for those expenses that are directly related and necessary to the project and must be expended in compliance with applicable OMB Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards (45 CFR Part 75) and Grants Policy Statement . The duration of the entire R21/R33 award may not exceed 5 years. The R21 phase may not exceed 2 years of support.

The R33 phase may not exceed 3 years of support. Transition to the R33 phase is not guaranteed for all grants awarded under this NOFO. Continuation from the R21 phase to the R33 phase will be determined by AHRQ staff based on progress achieved in the R21 phase and factors such as program priorities and availability of funds.

These projects are being funded pursuant to 42 U.S.C.

299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care All applications submitted and AHRQ grants made in response to this NOFO are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; https://www.

ecfr. gov/cgi-bin/text-idx? node=pt45.

1. 75) , the HHS Grants Policy Statement (see https://www. ahrq.

gov/funding/policies/hhspolicy/index. html ), and the terms and conditions set forth in the Notice of Award.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism.

For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed.

Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible. HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties.

If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the recipient and what substantive role the applicant organization will play.

Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Award Management (SAM) Applicants must complete and maintain an active requires renewal at least annually . The renewal process may require as much time as the initial registration.

SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Entity Identifier (UEI) - A UEI is issued as part of the SAM.

gov registration process. The same UEI must be used for all registrations, as well as on the grant application. Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.

gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Applicants must have an active SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Pro gram Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide . The AHRQ multiple PDs/PIs policy can be found at https://grants. nih.

gov/grants/guide/notice-files/NOT-HS-16-018. html . A single PD/PI, or the multiple PD(s)/PI(s) combined, must devote at least 20% minimum full-time effort (i.e., at least 8 hours per week) in each given year of the project.

This NOFO does not require cost sharing. While there is no cost sharing requirement included in this NOFO, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project.

Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.

This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request. Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The AHRQ will not accept duplicate or highly overlapping applications.

This means that the AHRQ will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-18-197). IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. It is critical that applicants follow the Research (R) Instructions to Apply - Application Guide , except where instructed in this notice of funding opportunity to do otherwise.

Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted For this specific NOFO, the Research Strategy section is All page limitations described in the How to Apply Application Guide of Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in to Apply - Application Guide and should be used for preparing an application to this NOFO. All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed.

Budget Component: Special Instructions for AHRQ applications AHRQ is not using the Modular Grant Application and Award Process. Applicants applying for funding from AHRQ are to ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R).

Applications submitted in the Modular format will not be reviewed. All instructions in the How to Apply - Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional Applicants should describe their approach to test promising digital healthcare interventions used at the point of care and aimed at improving quality of care and care delivery using advanced analytics, innovative patient-centered digital health technologies, or clinician decision The Research Strategy must include details of both the R21 and R33 phases in the single Research Strategy attachment.

In describing this approach, applicants must address the Describe the healthcare practice setting(s) and the point of care Describe the patient population(s) impacted by the research; Describe all users of the digital healthcare solution or system; Describe how the solution should be expected to reduce (or at least not exacerbate) disparities; Describe the digital healthcare intervention and the problem indicating its readiness for an exploratory/developmental research project; and Describe how the digital healthcare intervention will be incorporated into the clinical workflow to meet the needs of and be adopted by Applicants are to describe their approach to test the innovative intervention(s) within the research strategy.

Applicants should consider a wide range of scientific methods, including quantitative, qualitative, and other novel methods. The study design and analytical plan should be well-justified and consistent with the specific aims and study type.

In describing this plan, applicants must also address the following elements: Applicants must evaluate the reliability, validity, and usability of the digital healthcare solution used at the point of care. Applicants must describe how the research will measure the Improvement in the quality of care and reduction in adverse Evaluate and report on unintended patient safety events.

Applicants are to describe how technology modifications, systems, or tools will be designed from the outset to be sustainable and easily adopted by other providers and teams in the organization and how the project will be designed to scale across the organization and beyond to other, similar Grant applications must include a detailed project timeline that shows major milestones.

Include a specific section labeled "Milestones" within the research strategy. Milestones are intermediate goals which support the completion of specific aims. Applicants should convey milestones using a format of their choice, such as a Gantt chart, timeline, or table.

Milestones should be clearly-described, feasible, well-developed, quantifiable, and scientifically justified to transition to the R33 phase. R21 and R33 milestones should be clearly differentiated as two separate projects. A discussion of the milestones relative to the progress of the R21 phase and the implications of successful completion of the milestones for the R33 phase should be included.

Applicants are to describe their approach to disseminate research findings for both the R21 and R33 phases of the research grant within the research strategy in a specific section labeled "Dissemination." Applicants should consider applying innovative and leading edge dissemination strategies and methods that enhance the broader applicability, reproducibility, and scalability of the research findings.

Applicants must submit a dissemination plan that describes how the team will effectively communicate and disseminate research evidence and findings to diverse audiences. Applicants