It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide, follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/foaguidance/index.html, and follow any program-specific instructions noted in Section IV of the FOA. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This Funding Opportunity Announcement (FOA) invites R18 grant applications for research that demonstrates how health information technology (IT) can improve patient-centered health outcomes and quality of care in primary care and other ambulatory settings through the scale and spread of successful, existing health IT-enabled practice models that use Patient-Reported Outcome (PRO) measures to achieve these objectives

For the purposes of this FOA, successful models are defined as models that demonstrate measurable impact on factors such as patient and clinician adoption, patient health outcomes, or quality of care.

The patient’s perspective is central to healthcare decisions affecting prevention, diagnosis, treatment and long-term care. PROs offer an essential perspective that complements clinician assessments, and may provide greater insights into health status, function, symptom burden, adherence, health behaviors, and quality of life. For the purposes of this FOA, PROs are data provided by patients regarding their health and functional status, including quality of life, symptoms, and activities of daily living. PROs can inform the clinical management of individuals, shared decision-making, patient self-management support, care planning, and goal setting in addition to supporting goal attainment. Furthermore, PROs provide important data for research and quality improvement efforts.

Several validated PRO measures are publically available and used to gather PRO data. For example, specialty practices can utilize condition-specific PRO measures such as the Knee injury and Osteoarthritis Outcome Score (KOOS)1 and the Hip disability and Osteoarthritis Outcome Score (HOOS)2 to systematically monitor an individual’s progress following knee and hip interventions, respectively. The Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement (FORCE-TJR)3 registry effort is a successful health IT-enabled model for collecting KOOS and HOOS measure data. The FORCE-TJR system collects and shares with participating surgeons real-time patient-reported outcomes to improve patient care following joint replacement surgery.

Examples of successful health IT-enabled approaches for PRO measure implementations exist for other conditions as well. The Distributed Ambulatory Research in Therapeutics Network (DARTNet), a collaboration of practice-based research networks, completed a comparative effectiveness research project on major depression4 that built an informatics infrastructure to collect patient-reported data on a large scale via the PHQ-95. Also, the Comparative Effectiveness Research Translation Network (CERTAIN), a network of healthcare provider organizations in Washington State, works in collaboration with the Surgical Care and Outcomes Assessment Program (Spine SCOAP)6, to conduct a program focused on spine surgery performance. Spine SCOAP provides data collected from patients undergoing lumbar or cervical spine surgery utilizing measures such as the Numeric Pain Rating Scale7, a general measure of pain, and spine-specific measures of function, including the Oswestry Disability Index8, and the Neck Disability Index9 (Hartzler, Chaudhuri, Fey, Flum, & Lavallee, 2015).

AHRQ is interested in understanding how heath IT can further extend ( scale and spread ) successful PRO measure implementations beyond the initial clinical setting or institution in which the health IT-enabled PRO implementation was originally developed and applied, thereby increasing the impact on practice. There is a need to scale and spread the successful use of PROs in a manner that is efficient, actionable by the physician, supports patients' engagement with their health and care, and improves clinical processes and outcomes.

The overarching objective of this FOA is to demonstrate how health IT can improve patient-centered health outcomes and quality of care in primary care and other ambulatory settings through the scale and spread of successful, health IT-enabled practice models that use PRO measures to achieve these objectives. Since health IT is a demonstrated enabler of the use of PROs in certain care settings with certain populations and disease types, AHRQ is interested in further studying the use of health IT for the scale and spread of existing, successful PRO measure implementations in primary care and other ambulatory settings.

This FOA intends to support projects that scale and spread existing, successful PRO implementation approaches to additional sites, new settings, or new populations.

Examples of research projects responsive to AHRQ Health IT Priorities under this FOA include but are not limited to, the following:

• Implementation and evaluation of the use of health IT to facilitate the scale and spread of an existing PRO measure implementation to a larger or different population compared to the population involved in the original implementation (e.g., scale a local implementation to a regional, state, or national level).
• Implementation and evaluation of the use of health IT to facilitate the scale and spread of an existing PRO measure implementation into settings (e.g., primary care vs sub-specialty care) or disease conditions different from those in the original implementation.
• Implementation and evaluation of an innovative and scalable interface design to provide enhanced features to scale and spread the use of PRO measures by clinical providers, patients, health center staff, and other populations in ambulatory care settings.
• Adaptation, implementation, and evaluation of the effectiveness of a health IT implementation strategy to scale and spread PRO measures into rural, minority, low literacy and numeracy, and other underserved populations to reduce health disparities and improve quality of care.

All projects must:

• Describe the target population of the scaling effort;
• Describe a quantifiable impact of the scaling effort (e.g., number of additional patients and or clinicians affected);
• Describe the scaling effort, including the scaling methodology and the plan to evaluate the actual impact on patient health outcomes and quality of care due to the effort. Effects on the quality of care may include effects on patient and provider satisfaction, impacts on clinical workflow or other relevant indicators;
• Contain a discussion about the original PRO implementation, including the PRO measure(s) used, the setting and populations involved as well as the patient health and quality of care outcomes achieved; and
• Incorporate the use of existing PRO measures. Development of new PRO measures is beyond the scope of this effort.

Applications that propose to develop new PRO measures will not be accepted for peer review. Applicants proposing to develop new PRO measures in their initial application will not be allowed to revise or send in additional information after submission.

In addition, applicants are strongly encouraged to address, in their evaluation plans, how they will identify implementation facilitators and barriers and note strategies that will be used to overcome any encountered barriers.

Successful scale and spread efforts must deal with many challenges beyond the actual technology innovation (Mittman, 2014) and AHRQ is interested in understanding best practices for dealing with these challenges.

Applicants interested in learning more about conceptualizing a scale and spread project are encouraged to refer to two white papers published by the Institute for Healthcare Improvement (IHI) on the Framework for Spread (Massoud, Nielsen, Nolan, Schall, & Sevin, 2006) and a guide for designing large-scale improvement initiatives (McCannon, Schall, & Perla, 2008).

References:

Hartzler, A. L., Chaudhuri, S., Fey, B. C., Flum, D. R., & Lavallee, D. (2015). Integrating Patient-Reported Outcomes into Spine Surgical Care through Visual Dashboards: Lessons Learned from Human-Centered Design. eGEMs, 3(2), 1133. doi:10.13063/2327-9214.1133.

Mittman, B. (2014). Factors That Influence the Scale Up and Spread of Innovations. AHRQ Health Care Innovations Exchange. [Accessed: October 12, 2016]. Available from: https://innovations.ahrq.gov/perspectives/factors-influence-scale-and-spread-innovations.

Massoud MR, Nielsen GA, Nolan K, Schall MW, Sevin C. (2006). A Framework for Spread: From Local Improvements to System-Wide Change. IHI Innovation Series white paper. Cambridge, MA: Institute for Healthcare Improvement; [Accessed: September 28, 2016]. Available from: http://www.ihi.org/resources/Pages/IHIWhitePapers/AFrameworkforSpreadWhitePaper.aspx.

McCannon CJ, Schall MW, Perla RJ. (2008). Planning for Scale: A Guide for Designing Large-Scale Improvement Initiatives. IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; [Accessed: September 28, 2016]. Available from: http://www.ihi.org/resources/Pages/IHIWhitePapers/PlanningforScaleWhitePaper.aspx.

Citations:

¹ The Knee injury and Osteoarthritis Outcome Score (KOOS); 2003. [Accessed: October 12, 2016]. Available from: http://www.koos.nu/koos-english.pdf.

² The Hip disability and Osteoarthritis Outcome Score (HOOS); 2003. [Accessed: October 12, 2016]. Available from: http://www.koos.nu/HOOSEng.pdf.

³ University of Massachusetts Medical School. FORCE-TJR Overview; 2016 [Accessed: September 26, 2016]. Available from: http://www.force-tjr.org/overview.html.

⁴ The DARTNet Institute. Comparative Effectiveness Study on Major Depression; 2012 [Accessed: September 26, 2016]. Available from: http://www.dartnet.info/ComparativeEffectivenessMajorDepression.htm.

⁵ The Patient Health Questionnaire-9 (PHQ-9); 2001. [Accessed: October 12, 2016]. Available from: http://www.phqscreeners.com/sites/g/files/g10016261/f/201412/PHQ-9_English.pdf.

⁶ Foundation of Healthcare Quality. Spine SCOAP; 2016 [Accessed: October 11, 2016]. Available from: http://www.becertain.org/projects/spine/spine_scoap.

⁷ Numeric Pain Rating Scale; 1989 [Accessed: October 12, 2016]. Available from: http://www.va.gov/PAINMANAGEMENT/docs/Pain_Numberic_Rating_Scale.pdf.

⁸ Oswestry Disability Index; 2000 [Accessed: October 12, 2016]. Available from: http://drbrassie.com/files/Oswestry_Disability_Index_12_07.pdf.

⁹ The Neck Disability Index; 1991 [Accessed: October 12, 2016]. Available from: http://www.aaos.org/uploadedFiles/NDI.pdf.

See Section VIII. Other Information for award authorities and regulations.

These projects are authorized by 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 services.

All applications submitted and AHRQ grants made in response to this FOA are subject to 45 CFR Part 75 (Uniform Administrative Requirements, Cost Principles and Audit Requirements for HHS Awards; http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75) , the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

You may submit an application(s) if your institution/organization is a (an):

• Public or non-profit private institution, such as a university, college, or a faith-based or community-based organization;
• Unit of local or State government;
• Eligible agency of the Federal government.
• Indian/Native American Tribal Government (Federally recognized)
• Indian/Native American Tribal Government (Other than Federally recognized);
• Indian/Native American Tribally Designated Organization.

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Non-Profit 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 Institutions (AANAPISIs)

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 grantee 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 Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) may participate in projects as members of consortia or as subcontractors only.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which 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.
• NATO 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program 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.

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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

Each PD/PI is required to devote a minimum of 20% annual full-time effort (i.e., at least 8 hours per week) in each year of the project.

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 SF424 (R&R) Application Guide. Applicants are also encouraged to refer to AHRQ's recent update on multiple PIs noted in NOT-HS-16-018.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, 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.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. 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 (A1) application.
• 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-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. 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 in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Specific Aims section is limited to 1 page,
• Research Strategy section is limited to 12 pages, and
• Evaluation Plan section is limited to 2 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

AHRQ is not using the Modular Grant Application and Award Process. Applicants 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.

Budget Component: Special Instructions for AHRQ applications

Software, Hardware, and/or Equipment Purchases: Combined purchases for software, hardware, or any other equipment needed to conduct the project are expected to be less than 20% of the total costs of the project over the duration of the project. These purchases may include modest incremental software development to enable implementation of existing health IT in a new setting or to improve health IT functionality. If funds for such purchases are in excess of 20% of overall total costs budgeted for the duration of the project, an explicit justification must be included

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Applicants should describe their approach to utilize health IT to scale and spread successful PRO implementations to additional sites, new settings, or new populations.

In describing this approach, applicants must address the following elements:

• How the proposed design, methods, and analyses will adequately address the specific aim(s).
• How this scaling effort builds on the original PRO implementation but has a quantifiable impact (e.g., number of additional patients or clinicians affected) and a target population that significantly differ from the original implementation.
• How the project will be completed within the project period of 3 years, including development, testing, validation, evaluation, and additional phases where necessary.
• How the approach considers the following design factors: current information needs and related processes; user needs, goals, and motivations; the environments and context in which the health IT application or system will be used; the need for training and testing; and impact on workflow and workload, efficiency, economic, and health or clinical outcomes.
• How the approach is sustainable beyond the project period.

Evaluation

Applicants are to describe their plan to evaluate the scale and spread effort in the Evaluation Plan section. In describing this plan, applicants must address the following element:

• How the project will measure the actual impact of the scale and spread effort on patient health outcomes and quality of care. Effects on the quality of care may include effects on patient and provider satisfaction, impacts on clinical workflow or other relevant indicators.

Applicants should also address how they will identify implementation facilitators and barriers, and note strategies to overcome any encountered barriers.

Project Administration:

• Grant applications must fully address the administration of the project. This is especially crucial for teams necessitating the coordination of multiple team members efforts across disciplines, institutions, and geographic regions.
• Grant applications must include a detailed project timeline.

Letters of Support:

Applicants should include letters of support from stakeholder organizations (e.g., professional medical societies, patient/family representative organizations, provider organizations) who have agreed to participate in and collaborate as part of the proposed project.

Letters of support, recommendation, or endorsement should NOT be included from any entity or individual who is not directly participating in the proposed project. These types of letters may impede the review and/or selection process.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study: All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

For efficient grant administration, AHRQ grant administration procedures will be used and conducted in accordance with the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The Grants Policy Statement can be found at http://www.ahrq.gov/funding/grants/policies/hhspolicy.html.

Pre-award costs are allowable. A grantee may, at its own risk and without AHRQ prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new award if such costs are necessary to conduct the project and would be allowable under the grant, if awarded, without AHRQ prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain AHRQ approval before incurring the cost. AHRQ prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on AHRQ either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. AHRQ expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

The applicant should pay particular attention to the SF424 (R&R) application guide instructions concerning letters of support. Letters of support, recommendation, or affirmation from any entity or individual not directly participating in the project should not be included.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH and for responsiveness by AHRQ. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email Gerald.Calderone@ahrq.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

AHRQ supports research, evaluations, and demonstration projects concerning the delivery of health care in inner-city and rural areas (including frontier areas), and health care for priority populations. Priority populations include low income groups; minority groups; women; children; the elderly; and individuals with special health care needs, including individuals with disabilities and individuals who need chronic care or end-of-life health care. 42 USC 299(c). Women and members of minority groups are included in all AHRQ-supported research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate, e.g. because of the lack of connection between the study and the health of women or particular minorities. Investigators should review the document entitled, AHRQ Policy on the Inclusion of Priority Populations, which is available http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html. Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data may wish to describe briefly the expected schedule for data sharing; the format of the final dataset; the documentation to be provided; whether or not any analytic tools also will be provided; whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use); and the mode of data sharing (e.g., under its own auspices by mailing a disk or posting data on its institutional or personal website or through a data archive or enclave). Investigators choosing to share under their own auspices may wish to enter into a data-sharing agreement. References to data sharing may also be appropriate in other sections of the application.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Investigators should review the document titled AHRQ Announces new Policy for Public Access to AHRQ-Funded Scientific Publications which is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-008.html). For all research arising from AHRQ support, this policy requires that AHRQ-funded authors submit an electronic version of the author’s final peer-reviewed accepted manuscript to the National Library of Medicine's PubMed Central (PMC) to be made publicly available within 12 months of the publisher s date of publication.

The AHRQ confidentiality statute, 42 USC 299c-3(c), requires that information that is obtained in the course of AHRQ supported activities and that identifies individuals or establishments be used only for the purpose for which it was supplied. Information that is obtained in the course of AHRQ-supported activities and that identifies an individual may be published or released only with the consent of the individual who supplied the information or is described in it. There are civil monetary penalties for violation of the confidentiality provision of the AHRQ statute. 42 USC 299c-3(d). In the Human Subjects section of the application, applicants must describe procedures for ensuring the confidentiality of the identifying information to be collected. The description of the procedures should include a discussion of who will be permitted access to this information, both raw data and machine readable files, and how personal identifiers and other identifying or identifiable data will be restricted and safeguarded. Identifiable patient health information collected by grantees under this FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164.

The grantee should ensure that computer systems containing confidential data have a level and scope of security that equals or exceeds that established by the HIPAA Security Rules, if applicable, and that established by the Office of Management and Budget (OMB) in OMB Circular No. A-130, Appendix III - Security of Federal Automated Information Systems. The applicability and intended means of applying these confidentiality and security standards to subcontractors and vendors, if any, should be addressed in the application.

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products.

AHRQ requests that grantees notify the Office of Communications (OC) when an AHRQ-funded research article has been accepted for publication in a peer-reviewed journal. Researchers should submit manuscripts that have been accepted for publication in a peer-reviewed journal to JournalPublishing@ahrq.hhs.gov at least four to six weeks in advance of the journal’s expected publication date.

Regulations applicable to AHRQ grantees concerning intangible rights and copyright can be found at 45 CFR 75.322.

Applicants should anticipate that some dissemination activities will be conducted in cooperation with the AHRQ PO responsible for monitoring project progress and/or updating content on the Health IT Web site, http://healthit.ahrq.gov. AHRQ requests that awardees cooperate fully with the PO in promoting their work and findings. Activities that the awardee may be asked to engage in over the course of the grant may include:

• Reviewing a project description or profile for publication on the Health IT Web site and providing timely feedback;
• Providing brief, high-level quarterly updates on the progress of the grant;
• Sharing information on any grant outputs (e.g., publications, survey instruments) for inclusion in AHRQ output repositories, as appropriate, and so that the PO can update the project profile on an annual basis; and
• Assisting in disseminating project-specific findings and/or authoring lessons; informing the stakeholder engagement process; and/or supplying other relevant and reasonable content as requested to aid in the dissemination of findings.

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

The mission of AHRQ is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work with the U.S. Department of Health and Human Services (HHS) and other partners to make sure that the evidence is understood and used.

AHRQ's priority areas of focus are:

• Improve health care quality by accelerating implementation of patient-centered outcomes research (PCOR).
• Make health care safer.
• Increase accessibility.
• Improve health care affordability, efficiency, and cost transparency.

As part of this mission, applications submitted to AHRQ to support health services research are evaluated for scientific and technical merit through the AHRQ peer review system.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate peer review group convened in accordance with standard AHRQ peer review procedures that are described in 42 CFR Part 67, Subpart A. Incomplete and/or non-responsive applications or applications not following instructions given in this FOA will not be reviewed. Only the review criteria described below will be considered in the review process.

Administrative Criteria: Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH, and for responsiveness by AHRQ.

Merit Review Criteria: Merit Review Criteria, as described below, will be considered in the review process.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Will extending the original health-IT enabled PRO implementation to the newly proposed site(s), setting(s) or population(s) have a significant, quantifiable impact on the number or type of patients and clinicians now using PRO measures to improve the quality of care? Does this project address an important problem or a critical barrier preventing the scale and spread of existing PRO measures in ambulatory care settings through health IT? If the aims of the project are achieved, will scientific knowledge, technical capability, and/or clinical practice be significantly improved?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Is the work proposed appropriate to the experience level of the PD/PI and other researchers? Do the PD(s)/PI(s) and investigative team bring complementary and integrated expertise to the project? Are the leadership approach, governance, and organizational structure appropriate for the project? Is each PD/PI devoting a minimum of 20% annual full-time effort in each year of this project (i.e., at least 8 hours per week)? Are letters of support included for collaborating stakeholder organizations?

Is the project original and innovative? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area? Are unique partnerships presented that could serve as a model for scaling and spreading the use of successful health IT-enabled PRO implementations?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are the plans to scale and spread the original PRO measure implementation to additional settings, sites, or systems likely to be successful? Are they realistic? Can they be completed within the proposed timeframe? Are the plans for data collection/analysis, system refinement, testing, and evaluation scientifically sound? Are the proposed metrics for evaluating impact appropriate? Does the approach adequately discuss sustainability beyond the proposed timeline? Is the project management plan adequately developed? Are potential problems and alternative strategies presented? Is a section entitled Evaluation Plan included in the grant application? Has the applicant adequately described the evaluation plan for the proposed study? Does the applicant sufficiently specify how the team will collect and analyze measures of the actual impact of this effort on patient health outcomes and quality of care? Does the applicant address how the team will identify implementation facilitators and barriers, and note strategies to overcome any encountered barriers?

Will the scientific environment in which the work will be done contribute to the probability of success? If the application indicates partnering organizations, is there a history of successfully working together? Is there evidence of institutional commitment and support from all proposed organizations? Is the scientific and organizational environment strong enough to support completion of the project as described and according to the timeline? Are the institutional support, equipment, and other resources available to the investigators adequate for the project proposed?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Reviewers will assess how well the application addresses the purpose and objectives of this FOA. How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

• Does the approach focus on extending a successful, health IT-enabled PRO implementation beyond the initial site, setting, or target population?
• Does the approach clearly specify the impacts of the scaling effort, including proposed impacts on patient health outcomes and quality of care?

Reviewers will assess the adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups). Reviewers will assess the adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements ).

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Not Applicable.

Not Applicable.

Not applicable.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by AHRQ, in accordance with AHRQ review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Applications will be assigned on the basis of established AHRQ referral guidelines to the appropriate AHRQ Office or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ research priorities, as well as overall programmatic and geographic balance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Generally, applicants should anticipate eight months between the application submission date and the earliest possible start date.

If the application is under consideration for funding, AHRQ will request "Just-In-Time" information from the applicant. Just-In-Time information generally consists of information on other support, any additional information necessary to address administrative and budgetary issues, and certification of IRB approval of the project's proposed use of human subjects. For details regarding IRB approval, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html).

If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NOA are at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5., Funding Restrictions.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/funding/grant-mgmt/index.html.

All AHRQ grant and cooperative agreement awards are subject to OMB's Uniform Grant Guidance, HHS’s Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards, (http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75), and the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

A standard term and condition of award will be included in the Notice of Award (NOA) that states: in any grant-related activity in which family, marital, or household consideration are, by statute or regulation, relevant for purposes of determining beneficiary eligibility or participation, grantees must treat same-sex spouses, marriages, and households on the same terms as opposite-sex spouses, marriages, and households, respectively. By same-sex spouses, HHS means individuals of the same sex who have entered into marriages that are valid in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By same-sex marriages, HHS means marriages between two individuals validly entered into in the jurisdiction where performed, including any of the 50 states, the District of Columbia, or a U.S. territory or in a foreign country, regardless of whether or not the couple resides in a jurisdiction that recognizes same-sex marriage. By marriage, HHS does not mean registered domestic partnerships, civil unions or similar formal relationships recognized under the law of the jurisdiction of celebration as something other than a marriage.

All applicants will be subject to a term and condition that applies the terms of 48 CFR section 3.908 to the award, and requires that grantees inform their employees in writing of employee whistleblower rights and protections under 41U.S.C. 4712 in the predominant native language of the workforce.

As necessary, additional Terms and Conditions will be incorporated into the NoA.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually unless specified otherwise in the terms of the award. Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Progress reports are due 3 months before the anniversary of the award. In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. If applicable, detailed instructions on additional reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2016, the annual FFR is due 9/30/2016 (90 days after the end of the calendar quarter of 6/30/2016).

A final Progress Report, final Federal Financial Report, and Final Invention Statement are required when an award ends. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable AHRQ grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm) for additional information on this reporting requirement.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Janey Hsiao, Health Scientist Administrator
Agency for Healthcare Research and Quality
Center for Evidence and Practice Improvement
Division of Health Information Technology
Telephone: (301) 427-1335
E-mail: janey.hsiao@ahrq.hhs.gov

Direct your questions about peer review issues of grant application made in response to this FOA to:

Boris Aponte, MPH, Ph.D.
Agency for Healthcare Research and Quality
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: (301) 427-1396
E-mail: boris.aponte@ahrq.hhs.gov

Anna Caponiti
Grants Management Specialist
Office of Management Services, Division of Grants Management
Agency for Healthcare Research and Quality
Telephone: 301-427-1402
Email: anna.caponiti@ahrq.hhs.gov

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq., and in accordance with 45 CFR Part 75 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.