It is critical that applicants follow the Research (R) 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 as well as any program-specific instructions noted in Section IV and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/foaguidance/index.html.

Applicants who propose the use of identifiable CMS data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data.

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

Purpose

This initiative will fund the dissemination and implementation of PCOR clinical and organizational findings into primary care practices to improve healthcare quality with a focus on cardiovascular care. AHRQ is particularly interested in applications from States with the highest cardiovascular disease (CVD) burden. The initiative will accomplish this goal by catalyzing the development of a sustainable, State-based external primary care quality improvement (QI) support infrastructure to expand the State s current and future capacity to disseminate and implement PCOR evidence into primary care practice.

AHRQ is interested in increasing understanding of how public and private organizations within a State can work together to develop a State s capacity to provide external QI support to primary care practices in order to accelerate the dissemination and implementation of PCOR findings. AHRQ strongly encourages applications from States that currently have limited capacity to provide QI support to primary care practices and that, with funding and support from AHRQ, could overcome existing barriers.

Definitions of Key Terms

For purposes of this FOA, the following definitions apply:

Cooperatives

Cooperatives are State-level entities, established by the applicant, which will provide a variety of QI support services to primary care practices to help build their capacity to engage in improvement activities and implement the best evidence to deliver high-quality care, with an initial focus on improving heart health.

Effective Cooperatives will bring together the skills, experiences, and resources of State and local organizations such as, but not limited to:

• Primary care organizations [such as, but not limited to, academic primary care departments of one or more health professionals schools from within the State, primary care specialty societies, primary care Practice-based Research Networks (PBRNs), Area Health Education Centers (AHECs), and primary care associations and organizations]
• Local, State, and/or regional organizations dedicated to improving care [such as, but not limited to, Quality Improvement Organizations (QIOs), practice transformation organizations, and Regional Extension Centers for Health IT (RECs)]
• Large health systems
• State and local public health agencies
• Community-based organizations
• Private payers
• The State agency responsible for administering the State Medicaid program
• Consumer/patient advisory and/or advocacy groups (these may include, but are not limited to, organizations working as partners with Million Hearts (http://millionhearts.hhs.gov/index.html)).

External QI Support Infrastructure

An external QI support infrastructure is primarily the human infrastructure essential to helping primary care practices develop improvement capacity. It provides the staff, resources, and supports needed to help practices identify improvement needs, develop skills, and engage in continuous quality improvement. It provides tailored practice support, including assessment, training, problem-solving, networking, and coaching to help primary care practices achieve their improvement goals. This support is intended to foster, to the extent possible, the development of internal capabilities that practices can apply to new challenges over time.

States with High CVD Burden

For the purposes of this FOA, a State with high CVD burden is defined as a State with a rate of CVD events in the highest quartile according to Million Hearts (https://www.cdc.gov/vitalsigns/million-hearts/infographic.html#map).

AHRQ strongly encourages applications from States with the highest rates of CVD in the U.S. Applicants must clearly identify their rate of CVD events and provide strong justification for how they will be addressing significant CVD burden across their own State.

Primary Care

AHRQ defines primary care as the provision of integrated, accessible healthcare services by clinicians who are accountable for addressing a large majority of personal healthcare needs, including prevention and health promotion; for developing a sustained partnership with patients; and for practicing in the context of family and community. For the purposes of this initiative, AHRQ is using a more expansive definition that includes non-traditional sources of primary care services such as public health clinics, rural hospitals, work-based clinics, and migrant clinics.

Patient-Centered Outcomes Research

Patient-Centered Outcomes Research (PCOR) is comparative clinical effectiveness research of the impact on health outcomes of two or more preventive, diagnostic, treatment, or healthcare delivery approaches.

PCOR produces not only clinical findings (e.g., thiazide diuretics are an effective first-line therapy for hypertension), but also evidence about the effectiveness of how healthcare is delivered, referred to in this FOA as organizational practices (e.g., patients control of blood pressure improves when their care is provided through a structured team-based approach, rather than by a single clinician). There are multiple sources of PCOR findings, including but not limited to those listed below:

• AHRQ Effective Health Care Program (http://www.effectivehealthcare.ahrq.gov/)
• Patient-Centered Outcomes Research Institute (http://www.pcori.org/)
• U.S. Preventive Services Task Force (http://www.uspreventiveservicestaskforce.org/)
• Community Preventive Services Task Force (https://www.thecommunityguide.org/)

Background

Addressing Cardiovascular Disease Burden

Over the past several decades, the United States has made great strides in lowering the incidence, morbidity, and mortality associated with CVD through a combination of primary prevention, risk factor management, and effective treatments. Despite these improvements, CVD continues to be a significant national health burden and the leading cause of death, involved in nearly one of every three deaths. Additionally, there are sizable disparities in CVD outcomes associated with socioeconomic status, race/ethnicity, sex, and geography. (Heart Disease and Stroke. Healthy People 2020. https://www.healthypeople.gov/2020/topics-objectives/topic/heart-disease-and-stroke).

Modifiable risk factors for CVD, such as high blood pressure, high cholesterol, and smoking, remain poorly controlled. One-third of U.S. adults have high blood pressure, yet only half of those individuals have their blood pressure controlled; one-third of adults have high cholesterol, but only one-third of these adults are adequately treated. Approximately 17 percent of American adults continue to smoke. Many people at highest risk for CVD disease events do not take aspirin, despite the evidence demonstrating strong benefit. For all of these risk factors, rates of control are lower among many racial/ethnic minorities, low income populations and those with lower levels of educational attainment. (Risks for Heart Disease and Stroke. Million Hearts: https://millionhearts.hhs.gov/learn-prevent/risks.html). The current gaps in the management of risk factors present opportunities to reduce the rates of CVD disease substantially and to reduce healthcare disparities. (The Evidence Behind EvidenceNOW: Improving Heart Health. Agency for Healthcare Research and Quality, Rockville, MD. https://www.ahrq.gov/evidencenow/heart-health/index.html).

In order to address these gaps, the United States Department of Health and Human Services, in partnership with a range of public health and healthcare organizations, launched Million Hearts (http://millionhearts.hhs.gov/index.html) with a goal of preventing 1 million heart attacks and strokes between 2017 and 2022. One of the means to achieve that goal is to increase the delivery of the ABCS of heart health Aspirin in high-risk individuals, Blood pressure control, Cholesterol management, and Smoking cessation. AHRQ strongly supports this effort and, through this new grant initiative, AHRQ will: assist primary care practices and professionals in implementing findings from PCOR to increase the delivery of ABCS (with a focus on blood pressure control and smoking cessation); and build State-based capacity to continue to provide QI support to primary care practices. This new initiative builds upon a several previous AHRQ initiatives, including EvidenceNOW (https://www.ahrq.gov/evidencenow/index.html).

Improving the Uptake of PCOR Findings: EvidenceNOW

AHRQ is engaged in training the next generation of PCOR researchers and with disseminating and implementing PCOR findings. AHRQ recognizes that changing clinical practice can be difficult, and primary care practices often need assistance in establishing processes to routinely implement new evidence. Recognizing that small- and medium-sized practices have fewer resources to keep up with the pace of new healthcare evidence and to engage in quality improvement (QI), AHRQ launched EvidenceNOW to support primary care practices in increasing their capacity to find and use the latest evidence to improve patient care. The goals of EvidenceNOW were to:

Help practices implement evidence to improve healthcare with a focus on CVD

Build practice capacity to receive and incorporate evidence in the future

Learn how external QI support helps primary care practices improve the way they work and improve the health of their patients

Build and spread the EvidenceNOW Model of how to improve primary care with external supports.

In 2015, AHRQ awarded seven implementation grants to build regional Cooperatives to deliver external QI support to 1,500 small- and medium-sized practices, and an eighth grant to conduct an independent evaluation of the efforts of the implementation grantees. With the current Request for Applications, AHRQ is building on what was learned in EvidenceNOW and from other federal initiatives in order to continue disseminating and implementing PCOR evidence and to expand the number of states capable of providing external QI support to primary care practices.

Developing State-level Capacity to Support Primary Care Practice Improvement

The last decade has seen a number of initiatives to transform the delivery of primary care. The introduction of new payment models from Federal and other payers are emphasizing the role that primary care practices play in coordinating and providing comprehensive care to patients. Additionally, the focus on patient-centered evidence-based care, adoption of EHRs and health IT systems, and the emphasis on shared decision making and data-driven care have required primary care practices to implement changes at an unprecedented rate. Programs such as AHRQ’s EvidenceNOW and others have shown the potential that providing primary care practices with QI support can have in helping them adapt to these changes and improve the quality of care that they deliver.

The landscape of primary care QI initiatives continues to evolve. There are currently other large-scale initiatives underway to promote primary care QI and transformation. CMS launched the Comprehensive Primary Care (CPC) Initiative in 2012 followed by CPC Plus in 2017 to strengthen primary care. In 2016, CMS launched the Transforming Clinical Practice Initiative (TCPI) to help practices develop and adopt comprehensive improvement strategies with support from regional peer-based support networks. A wide variety of other State and Federal organizations work directly with primary care practices to foster innovation and improve the quality of care delivered to Medicare, Medicaid and other insured beneficiaries. Other Federal agencies and organizations have initiated programs with an emphasis on primary care practice support, such as the Center for Disease Control and Prevention’s (CDC s) State Program Grants to improve prevention and management of diabetes and heart disease (https://www.cdc.gov/chronicdisease/about/foa/1815/index.htm). Aligning and linking with CMS s, CDC s, and other state-level initiatives, is critical to maximizing the potential impact of this initiative. Furthermore, aligning clinical, public health, and community interventions can increase their impact on reducing cardiovascular risk and improving health outcomes. Development of a State-level external QI support infrastructure can help ensure broad and equitable practice participation, align incentives, and reduce the potential for duplicative efforts. Partnering with a wide range of stakeholders can facilitate collaboration and coordination of primary care improvement activities. AHRQ is interested in supporting innovative approaches to identifying and aligning public health and community-based initiatives in the State to maximize the benefits of practice improvement efforts for primary care practices and the patients they serve.

This FOA will fund State-based projects to develop new or expand limited existing infrastructure for primary care QI support in order to increase the dissemination and implementation of PCOR evidence to improve heart health, with a focus on States with a high burden of CVD.

A goal of this FOA is to learn how developing a State s overall capacity to support QI programs can lead to sustainable gains in the overall quality of the State’s primary care, improvement of heart health, and reduction of health disparities in the State. Another goal is to learn what models and approaches are effective in improving the uptake of PCOR evidence in primary care, and in building a sustainable, external QI support infrastructure that brings together stakeholders, coordinates QI activities across initiatives, and establishes a statewide network of engaged primary care practices.

Objectives

The ultimate goal of this FOA is to improve heart health and help reduce CVD disparities by engaging with primary care practices, and disseminating and implementing PCOR findings to improve care delivery. The following six objectives describe the major activities applicants must propose in order to accomplish this goal.

Applicants must:

1. Establish a Cooperative that brings together existing State and local resources to support the development of an external QI support infrastructure that increases the State’s capacity to disseminate and implement PCOR evidence to primary care practices. Develop an external QI support infrastructure for delivering comprehensive external QI support services to primary care practices and professionals across the State.

• AHRQ recognizes that the process of establishing trust, alignment, cooperation, and shared goals requires time and resources. Applicants should anticipate dedicating 6-12 months at the start of this project to fostering working relationships within the Cooperative and between the Cooperative and other State and local stakeholder groups.

2. Build a network of primary care practices and related stakeholders across the State that can utilize the Cooperative as a resource for QI support.

• Applicants are encouraged to propose innovative approaches to aligning clinical, public health, and community interventions at the state and local levels to increase the potential impact of the intervention.

3. Develop a comprehensive, multicomponent, evidence-based approach for a heart health improvement project to improve delivery of ABCS and build internal improvement capacity. Develop a plan for recruiting and working with a minimum of 50 primary care practices that serve adult patients across the State. The goal of the support is to disseminate and implement PCOR findings in primary care practices and improve practices capacity to receive and implement other PCOR findings in the future.

• In addition to ABCS PCOR findings, applicants should also consider implementing PCOR findings related to team-based care, shared decision making and patient engagement, and use of technology to support implementation, as well as other relevant topics that will help practices increase their improvement capacity.
• AHRQ strongly encourages applicants to use practice facilitation as a central and unifying strategy for the implementation approach for the heart health improvement project. To learn more about practice facilitation, please visit: http://pcmh.ahrq.gov/page/practice-facilitation.
• The approach for the heart health improvement project may also include other evidence-based strategies such as practice assessment; the use of data feedback and benchmarking; the incorporation of electronic clinical decision support; peer-to-peer local learning; and expert consultation. To learn more, visit: http://www.ahrq.gov/professionals/prevention-chronic-care/improve/capacity-building/pcmhPI2.html.
• Applicants are encouraged to propose approaches to implementation that allow innovative adaptations at the practice level to address the specific needs of the practice, the clinicians and the patient populations served.
• Applicants are encouraged to partner with practices using innovative approaches to performance improvement including co-production of the intervention design and evaluation, evidence generation from practice-based data, rapid cycle evaluation and adaptive designs.
• Applicants are encouraged to pilot test their approach with a small number of practices prior to rolling out the larger implementation approach.
• To ensure that applicants are able to deliver a meaningful intervention and conduct an evaluation during the course of the 3-year grant, applicants should plan to begin working with practices other than pilot practices no later than 18 months after the start of the project.

4. Conduct a comprehensive robust evaluation of all phases of the project, including the establishment of the Cooperative, the development of the network, and the heart health improvement project.

• Applicants are encouraged to collect a mix of qualitative and quantitative process and outcome measures throughout all phases of the 3-year grant.

Applicants must plan to collect and evaluate the following data as part of their evaluation of the heart health improvement project:

• Measurement of practice capacity for improvement, at a minimum at baseline and again at the end of the intervention. Applicants are encouraged to consider also assessing outcomes 3-6 months after the intervention at the individual practice level. Concepts such as practice adaptive reserve and readiness for change, leadership and organizational style, quality improvement structures and processes, team-ness , staff satisfaction, and burnout may be incorporated into this evaluation.

The measurement plan must include the use of the 14 questions from the Change Process Capacity Questionnaire at baseline and at the end of the heart health improvement project. (See

https://www.ahrq.gov/funding/policies/measuring_capacity.html).

• Measurement of hypertension and smoking cessation measures (See Table below), at baseline and again at the end of the intervention as a minimum. Measurement 3-6 months after the intervention is strongly encouraged, but not required. Applicants are encouraged to propose the collection of other clinical and health outcome measures to assess the effectiveness of the implementation approach.

Table: Hypertension and Smoking Cessation Measures

1. Blood Pressure Control (NQF 008, CMS eMeasure 165)	Percentage of patients aged 18 through 85 years of age who had a diagnosis of hypertension (HTN) and whose blood pressure (BP) was adequately controlled (<140/90) during the measurement year.
2. Tobacco Use: Screening and Cessation Intervention (NQF 0028, CMS eMeasure ID 138)	Percentage of patients aged 18 years and older who were screened for tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user.

• Measurement of the implementation of the comprehensive approach to QI support at the aggregate and individual practice level. This evaluation may include aspects of the intervention such as acceptability, adoption, appropriateness, feasibility, fidelity, implementation costs, and sustainability. Applicants must plan to track what QI techniques were used with individual practices.
• Assessment of the internal and external practice context in which the approach is implemented. The internal context should include information about the practice organization, staffing, and patient population. The internal context evaluation should include an assessment of the degree of EHR adoption of each practice and the ability of the practice to report quality measures. The external context includes concurrent initiatives such as the work of QIN-QIOs and supporting strategies such as pay-for-performance and public reporting initiatives, and effectiveness of linkages with related public health and community interventions.
• While applicants should not plan to provide compensation to primary care practices for participating in the heart health improvement project or other PCOR dissemination and implementation activities, they may include compensation to practices for their efforts related to data collection and measurement activities. If applicants propose to reimburse individual practices for these efforts, the application budget justification must include a clear explanation of how the amount proposed per practice was calculated.
• Plan to participate in a separate, overarching program evaluation to be conducted by an external contractor selected by AHRQ. In order to fully participate in this overarching initiative, applicants must:
• Agree to share de-identified evaluation data and project documentation with the external evaluator.
• Identify an evaluation liaison with expertise across the project to serve as a chief informant and coordinator with the external evaluator. This team member must have a minimum of 10% full-time effort (i.e. at least 4 hours per week) in each given year of the project dedicated to evaluation liaison activities.
• Participate in qualitative data collection activities with the external evaluator. Applicants may be compensated for data collection efforts on behalf of the external evaluator and do not need to budget significant resources towards supporting the overarching evaluation other than the time of the evaluation liaison.
• Applicants should not plan on receiving support for data collection from the external evaluator for their own internal evaluation.

5. Propose a dissemination plan. The plan should consider dissemination of interim findings to State and local stakeholders while the project is still in progress.

• Applicants should also plan to coordinate broader dissemination activities with AHRQ’s Office of Communications and AHRQ's contractors for this initiative by the end of the project period.

6. Integrate sustainability planning into all aspects of the project and develop a plan to maintain the Cooperative and its network of practices and professionals beyond the conclusion of the project.

• Throughout all phases of this project, applicants should assess how the Cooperative can bring together and build on the existing support services in the State with the goal of forming partnerships and collaborations that will continue after the grant.
• Cooperatives are strongly encouraged to consider engaging in other primary care QI activities not specifically addressed in this FOA during the grant period, such as a disseminating and implementing other PCOR evidence of priority within the state, conducting grant or contract work through State, Federal, or private funding, or engaging additional primary care practices.

Applicants should plan to complete all efforts related to the preceding six objectives within 36 months of the project start date. Applicants plans should not anticipate a no-cost extension.

Applications must budget for at least three team members (the PD/PIs, an implementation leader, and an evaluation leader) to travel to the Washington, D.C. area once a year for each year of the grant to participate in a two-day meeting with AHRQ and other grantees. The first meeting is expected to be held in late 2020 or early 2021.

42 U.S.C. 299b-37(a) - (c) authorizes AHRQ to make these awards to support the agency's dissemination of comparative clinical effectiveness research findings.

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.

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as consortia or as subcontractors only. Applications submitted by 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.

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.

• 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) 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.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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.
• 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.

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. See also AHRQ's NOT-HS-16-018 related to Multiple PD/PI via https://grants.nih.gov/grants/guide/notice-files/NOT-HS-16-018.html.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this RFA, 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-18-197).

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 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, 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows staff to estimate the potential review workload and plan the review and ensure each application has the best chance of having appropriate peer-reviewers.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be emailed to [email protected].

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to summarize the purpose of this RFA and respond to questions about the preparation of an application in response to this FOA. The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying.

The conference call will take place on March 17, 2020 at 3:00 pm Eastern time. To register to participate in the conference call, please send an e-mail request to the Scientific/Research Contacts listed in Section VIII. Agency Contacts by March 10, 2020. Please include the phrase Supporting Primary Care to Advance Cardiovascular Health in States with High Prevalence of Preventable CVD Events FOA TA Call in the subject line. All registrants will receive an email with the call-in information at least one business day before the conference call.

Participants are encouraged to submit questions via email prior to the conference call. Please submit up to five questions with your name and the name of your institution to [email protected] by March 10, 2020. Please include the phrase Supporting Primary Care to Advance Cardiovascular Health in States with High Prevalence of Preventable CVD Events FOA Questions in the subject line. Questions of a similar topic and nature may be grouped together at the sole discretion of AHRQ staff. Notes from the conference call will be posted on the AHRQ website.

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:

• NOTE: For this specific FOA, the Research Strategy section is limited to 28 pages. See details in Research Plan section below.

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.

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.

Applicants who propose the use of identifiable Centers for Medicare and Medicaid Services (CMS) data are advised to review NOT-HS-19-007 (https://grants.nih.gov/grants/guide/notice-files/NOT-HS-19-007.html) for important changes to how applicants are to budget for the cost of this data.

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:

The research plan section of the application is limited to 28 total pages. Applications that exceed 28 pages will not undergo peer review. Below are suggested maximum page limits for each component of the research plan, which are intended to allow flexibility in developing the research plan.

The research plan section must include the following seven sections:

1. The State, the Cooperative, and the Project Team (recommended no longer than 6 pages)

2. Engagement with Primary Care Practices and Stakeholders (recommended no longer than 3 pages)

3. Approach to PCOR D&I and QI support (recommended no longer than 6 pages)

4. Evaluation Plan (recommended no longer than 6 pages)

5. Dissemination Plan (recommended no longer than 2 pages)

6. Sustainability (recommended no longer than 3 pages)

7. Project Timeline (recommended no longer than 2 pages).

Section 1: The State, the Cooperative, and the Project Team

This section should briefly provide the information about the healthcare environment of the State such as:

• The State’s population, demographics, health status, and disparities
• The burden of CVD within the State
• The state of primary care, including estimates of the total number of primary care practices and primary care professionals in the State and their organization
• The existing capacity of the State to deliver QI support to primary care practices, including other primary care support initiatives.

This section should also describe the proposed plan to establish the Cooperative and each partnering organization’s capacities, including:

• The Cooperative’s proposed leadership and governance structure, the roles and responsibilities of each organization, and how cooperation and coordination of all participating organizations, institutions, or other entities will be ensured. Identify potential challenges associated with the need for close cooperation and coordination among different stakeholder groups and ways to address these challenges.
• The Cooperative’s proposed organizational structure, including team leaders and membership, as well as plans for staff hiring and training (whether by the Cooperative or by participating organizations).
• Whether the Cooperative will be incorporated as an independent entity and how finances will be organized. In-kind support is highly encouraged and should be described.
• Any history of working together and previous successful implementation of joint projects, including public-private partnerships.
• The resources and expertise that each organization and key personnel brings to the project in the following areas:
• Identifying and evaluating PCOR findings
• Understanding the internal and external context of primary care delivery in the State
• Building relationships with primary care practices and professionals across the State
• Providing QI support to primary care practices
• Evaluation of complex programs and interventions
• Project management
• Sustainability planning
• Dissemination and communications.
• The proposed set of external QI support services the Cooperative plans to deliver. AHRQ encourages a focus on practice facilitation and the use of a range of quality improvement services, which may include such services as health IT support, local learning opportunities, expert consultation, quality measurement standardization and support, financial management guidance, community resource identification, tele-mentoring, and workforce development.

This section should also describe how the Cooperative will coordinate and integrate itself with any existing infrastructure of external QI support services within the State, including how the Cooperative will align with and leverage other potential supporting activities occurring in the State (e.g., pay-for-performance, public reporting, practice transformation, and improvement activities).

• Applicants should propose building or expanding partnerships among local and State organizations that are already engaging in quality improvement activities to efficiently share and align limited resources and avoid unproductive duplication of effort. Applicants should strive to build on and integrate the work of organizations that are already operating in this space in the State.

Section 2: Engagement with Primary Care Practices, Professionals, and Stakeholders

This section should accomplish the following:

Describe the primary care practice outreach and engagement strategy that the Cooperative will use to establish a network of primary care practices across the State, including:

• How practices in the State will be identified and targeted for outreach (with the goal of reaching as many practices in the State as possible).
• How the Cooperative will establish and maintain relationships with practices in the State, including practices in underserved communities and practices that may have limited experience engaging in QI activities.
• How the Cooperative will engage with non-traditional sources of primary care services such as pharmacists and pharmacies, public health clinics, rural hospitals, work-based clinics, and migrant clinics.
• How the Cooperative will engage and partner with other stakeholder organizations to disseminate information about the Cooperative.

Section 3: Approach to the Heart Health Improvement Project

This section should provide a detailed discussion of all aspects of the required heart health improvement project, including the following:

• Explain how PCOR findings will be identified and the criteria to be used for determining which findings will be disseminated to primary care practices. Applications should include a preliminary list of important PCOR evidence relevant to implementing the ABCS in Appendix A.
• Describe proposed strategies for recruiting and retaining a minimum of 50 primary care practices in need of QI support, including primary care practices in underserved communities and/or that are resource-limited. Applicants are expected to plan over-recruitment and describe expected rates of attrition.
• Provide the conceptual model and/or logic model for the overall approach, with an explanation of how individual strategies and techniques fit within the model and are expected to contribute to its success.
• Describe in detail an evidence-based, comprehensive approach to external QI support to: 1) disseminate and implement PCOR clinical and organizational findings into practice with a focus on cardiovascular health and the ABCS; and 2) increase the capacity of primary care practices to integrate new PCOR findings on an on-going basis. The application should include a timeline for implementing the approach with an individual primary care practice.
• Discuss potential challenges and barriers to implementing the heart health improvement project and proposed mitigation strategies.
• Applicants are encouraged to discuss how the project will address health disparities in CVD care, barriers to accessing health services, health literacy, and connections with community-based programs.

Applicants should discuss how they will tailor the intervention to increase effectiveness and impact in specific high risk populations and communities indicating what groups will be targeted.

Section 4: Evaluation Plan

This section should describe the evaluation approach, data sources, data collection, and analysis plan for the applicant’s internal evaluation.

The evaluation plan should include study of the process of Cooperative formation and evolution, the development of the network, process and outcomes of the heart health improvement project, and sustainability planning and execution.

The evaluation plan must indicate a commitment to work with AHRQ’s evaluation contractor on the cross-grant evaluation.

Section 5: Dissemination Plan

In order to accomplish the objectives of this initiative, it is important that the results and lessons learned be clearly communicated to organizations participating in the Cooperative, the primary care community, State and local policy makers, healthcare organizations, and the public. It is equally important that these results and lessons learned be shared in a timely manner.

This section should accomplish the following:

• Describe plans for making a description of the Cooperative publicly available, including its planned approach to working with primary care practices to disseminate and implement PCOR findings, and the external context in which the approach is being implemented. It is expected that this will be done within the first 6 months of the project and be updated regularly.
• Describe plans for sharing results of the heart health improvement project with relevant stakeholders, including AHRQ. It is expected that results will be shared in a timely manner and not only through peer-reviewed publications and presentations.
• Describe plans for sharing findings, tools, and lessons learned, including materials that would aid other States to form Cooperatives, develop networks of primary care practices, and implement external QI support at the State level. It is expected that these will be shared in an on-going manner throughout the project period and not only through peer-reviewed publications and presentations.
• Document a commitment to cooperating with AHRQ and its contractors in promoting the applicant’s work and findings.

Section 6: Sustainability Planning

This section should describe how this cooperative agreement s investment to develop the Cooperative and establish a network of primary care practices participating in QI activities will be maintained beyond the conclusion of this project, including how the Cooperative infrastructure will be sustained after funding ends.

• Describe the Cooperative’s sustainability plan for identifying other State, Federal, local, and private primary care QI support initiatives in which it can participate. Describe how the partnerships with other organizations and the network of providers developed during this project will be leveraged throughout and beyond this grant.
• Describe other practice improvement and related activities that the Cooperative may participate in beyond the activities specifically mentioned in this project that may help promote the sustainability of the Cooperative and continue the Cooperative’s efforts to provide QI support to primary care practices.

Section 7: Project Timeline

This section should accomplish the following:

• Provide a project timeline showing the major scheduled milestones (events, activities, data gathering, analysis, and reporting) for the project. A more detailed Gantt chart may be included as Appendix B.
• The timeline should document how all aspects of the proposed work will be accomplished within 36 months.

At a minimum, the timeline is expected to document the timing of:

• Establishing the Cooperative: activities may include initial startup and planning activities, meeting with stakeholder groups, forming partnerships, training staff, and forming QI support teams
• Primary care practice network outreach and engagement: start dates of outreach activities and communications, timeline for reaching primary care practices with a goal of reaching as many practices and professionals as possible across the State
• Implementation of the heart health improvement project: pilot activities, recruitment dates, start of external QI support activities, data collection schedule
• Evaluation and major dissemination activities

Resource Sharing Plan: Applicants are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Not applicable.

Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-18-126.

Special instructions for this FOA:

• Applications should include a preliminary list of important PCOR evidence relevant to implementing the ABCS in Appendix A.
• Provide a project timeline showing the major scheduled milestones (events, activities, data gathering, analysis, and reporting) for the project. A more detailed Gantt chart may be included as Appendix B.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) 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 Delayed Onset Study record.

Note: AHRQ’s public webpage on the protection of human subjects. This page is now published and publicly available at https://www.ahrq.gov/funding/policies/human-subjects/index.html.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). A Delayed Onset study is one in which human subjects research is anticipated within the period of award but definite plans are not yet known and cannot be described in the application.

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

In addition, include a description of the applicant's plan for obtaining Institutional Review Board (IRB) approval of the project. AHRQ encourages applicants to consider approaches that increase the chance that data collection will not be delayed.

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

Not applicable.

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. AHRQ 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 HHS Grants Policy Statement can be found at http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf.

These awards will not be made under expanded authorities, therefore pre-award costs are not allowable without prior approval from AHRQ.

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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 AHRQ. 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 by the Center for Scientific Review, NIH and for responsiveness by AHRQ. Applications that are incomplete will not be reviewed.

Institutional Review Board (IRB) approval of human subjects is not required prior to peer review of an application (see https://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.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-18-197. Any instructions provided here are in addition to the instructions in the policy.

Priority Populations

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 at https://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.

Public Access to AHRQ-Funded Scientific Publications

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.

Plan for Sharing Research Data

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 should 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.

Data Confidentiality

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. (see NOT-HS-18-012: Confidentiality in AHRQ-Supported Research). 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 RFA 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.

Sharing Research Resources: Rights in Data

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 Federal purposes, and to authorize others to do so. In accordance with AHRQ's research dissemination mandate, such products and materials will be made available to the public and the health care community. AHRQ purposes may include but are not limited to making project materials, databases, results, and algorithms available for verification or replication by other researchers. 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 [email protected] 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.

Grantees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information".

Section V. Application Review Information

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 available at https://www.ahrq.gov/funding/policies/foaguidance/index.html. 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, National Institutes of Health, 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.

The goal of this FOA is to disseminate and implement PCOR findings in primary care practices and to build the capacity of practices to implement future PCOR findings. This initiative is intended to effect meaningful and sustainable improvements in both the delivery of primary care through the adoption of PCOR findings and building sustainable capacity of States to provide ongoing primary care QI support.

AHRQ is particularly interested in funding applications in States with high CVD burden that currently lack capacity to support primary care practices. AHRQ recognizes that these States may have substantial underserved populations, their primary care practices may have had limited access to external QI support services, and there may be limited State-level resources and coordination for supporting primary care practices. AHRQ therefore does not expect applications to demonstrate substantial existing infrastructure or strong track records of collaborative success.

• Did the applicant clearly identify their state's rate of preventable CVD events and provide strong justification for how they will be addressing significant CVD burden across their own state?
• How well does the application respond to the RFA's goal of creating external primary care QI support capacity in a State with high CVD burden?
• How likely is it that implementing the proposed improvements to a State’s primary care practice support infrastructure will result in the increased dissemination and implementation of PCOR findings into primary care practices?
• How likely is it that the proposed work will result in new, sustainable capacity for the State to deliver primary care QI support services?
• Does the applicant demonstrate a clear understanding of the context of primary care delivery in the State, including the State’s CVD burden?
• How likely is it that the project and its evaluation will produce information and tools useful to others that are interested in improving a State s capacity to provide external QI support to primary care practices and to disseminate and implement PCOR findings in primary care practice?

• Do the PD(s)/PI(s), proposed members of the Cooperative, and the project team bring complementary and integrated expertise to the project, including, but not limited to, expertise in:
• managing complex, collaborative projects involving coordination across multiple, diverse sites and organizations
• engaging with primary practices and other community partners and delivering QI support
• identifying PCOR findings
• conducting complex multi-level program evaluations
• rapidly disseminating evaluation findings
• dissemination and implementation of evidence into practice.
• Are the PD(s)/PI(s) and identified team members appropriately trained and well-suited to carry out their roles as described in the application?
• Are plans for additional staff hiring and training sound? Does the application demonstrate that the applicants will be able to establish QI support teams that will be able to work effectively with practices?
• Is the level of effort allocated for key personnel appropriate to the level of effort required for the performance of their responsibilities?
• Has the applicant proposed adequate time in each year of the project to support collaboration with the external evaluation team?
• Has the applicant identified an evaluation liaison with a minimum of 10% full-time effort (i.e. at least 4 hours per week) in each given year of the project dedicated to evaluation liaison activities?

• The goals of this FOA do not require novel approaches or methods, but rather the development of new State-level QI capacity. Does the applicant propose to create State-level capacity to deliver QI primary care practice support in a State where this represents an innovation?
• Does the applicant propose the development of new partnerships in the State to deliver QI primary care practice support?
• Does the applicant identify opportunities for alignment with public health initiatives and community-based resources in the State?
• Does the applicant propose approaches to dissemination and implementation that will allow for innovative adaptation at the practice level?

Overall Approach

• How likely is the applicant to be able to immediately launch the project, establish a Cooperative, engage with primary practices to build the network, and complete all aspects of the heart health improvement project, evaluation, and dissemination plan within the proposed project time frame?
• Is the applicant’s proposed project likely to achieve the goal of expanding within the State the capacity to provide external QI support to primary care practices, and is the expanded capacity likely to continue beyond the project period?
• Is the proposed approach likely to result in dissemination and implementation of PCOR findings to primary care practices?

Approach to Establishing the Cooperative

• How strong is the plan for bringing together and aligning diverse organizations and resources to form a Cooperative that includes a clear governance structure with role delineation and robust plans for decision-making, project management, engagement, financial management, and sustainability?
• Is there sufficient evidence of suitable arrangements and agreements for collaboration among proposed Cooperative members or credible plans for obtaining them?
• How extensive are the capacities, experience, expertise, and other resources of the applicant institution and participating organizations? How well aligned are they with the needs and aims of the project? How likely are they to contribute to the project’s success?
• How likely is it that the proposed approach to develop a Cooperative in the State will be successfully implemented? How likely is it that the proposed approach will create sustainable infrastructure for supporting primary care practices across the State?
• Does the applicant have a plan for integrating the work of the Cooperative with other State organizations and ongoing QI improvement initiatives?

Approach to Establishing a Network of Primary Care Practices

• How likely is that the applicant’s approach to engaging with primary care practices across the State will be successful?
• Does the applicant have a reasonable communications, outreach, and recruitment plan aimed at developing a network of primary care practices across the State that will potentially participate in the Cooperative’s QI activities?
• Does the applicant propose a thoughtful approach for reaching practices in underserved areas and practices with limited internal improvement capacity?
• Does the applicant propose engaging with non-traditional sources of primary care?

Approach to Heart Health Improvement Project

• How likely is it that the proposed approach to QI support will be successfully implemented?
• Is the practice recruitment plan realistic and how likely is the applicant to succeed in recruiting and maintaining a minimum of 50 primary care practices?
• How likely is it that the proposed approach will improve implementation of ABCS in practices?
• Does the conceptual model and/or logic model (i.e., the links between the approach, its implementation, and expected outcomes) support the approach to deliver QI support?
• Are the proposed QI strategies within the approach sufficiently evidence-based?
• How likely is it that the proposed approach will increase improvement capacity of the practices targeted in the application?
• Is the proposed heart health improvement project likely to result in the dissemination and implementation of PCOR findings in primary care practices?
• How likely is it that the heart health improvement project will identify and address challenges to improving heart health experienced by at risk populations and communities?

Approach to Evaluation

• Does the application clearly articulate evaluation questions?
• Are the measurement, data collection and management, and analytic plans adequate to answer proposed evaluation questions? Do the plans include measures required by this FOA?
• Are data collection methods and analytic plans appropriate to assess change in required heart health and practice capacity metrics?
• Does the evaluation include a well-defined and feasible plan for assessing the creation of the Cooperative, the building of the network, the implementation of the heart health improvement, and the effort’s sustainability work that will provide useful information to stakeholders?
• Does the evaluation include a well-defined and feasible plan for describing internal and external contextual factors that may have influenced the effectiveness of the approach to Cooperative formation, network development, and implementation of the heart health improvement project?
• Is the evaluation plan strengthened through the collection at appropriate intervals of additional measures, including internal and external contextual information, and the use of both quantitative and qualitative methods?
• Has the applicant demonstrated a strong commitment to actively cooperate with the external evaluator in the conduct of the overarching initiative evaluation and allocated required resources to this activity?

Approach to Dissemination

• How likely is it that the dissemination proposed will provide findings and lessons learned in a timely manner to a variety of stakeholders throughout the course of the project?
• Has the applicant demonstrated a commitment to cooperate with AHRQ and its contractors on dissemination activities?

• Does the application effectively leverage State and local expertise, infrastructure, and resources?
• Does the proposed project benefit from alignment with current or planned health and healthcare initiatives, health information exchanges, clinical environments, political environments, community settings, and patient population needs?
• Have problems with coordination or any other potential challenges (e.g., technical constraints, resource limitations) and learning from prior experience on this or related initiatives been acknowledged/properly anticipated, and are possible resolutions proposed?
• Have potential obstacles (e.g., competing demands on primary care practices, shifts in payment policies, public health crisis, regulations) and the means for avoiding or mitigating their effects been identified?

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.

How well does the proposed research plan align with AHRQ s mission and research priorities?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the 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 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.

Degree of Responsiveness

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?

Budget and Period of Support

The committee will evaluate whether the proposed budget is reasonable, and whether the requested period of support is appropriate in relation to the proposed research.

Inclusion of Priority Populations

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.7 Other Submission Requirements ).

Resubmissions

Not applicable

Renewals

Not applicable

Revisions

Not applicable

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable.

Applications that are complete and responsive to the FOA will be evaluated for scientific and technical merit by an appropriate Scientific 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.

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.

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.
• Burden of CVD in the applicant's State.

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.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement (see https://www.ahrq.gov/funding/policies/hhspolicy/index.html).

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" (https://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 e-mail address designated by the recipient organization during the eRA Commons registration process.

Awardees must comply with any funding restrictions described in Section IV.6. 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.

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Post-Award Grants Management portion of the AHRQ website: https://www.ahrq.gov/funding/grant-mgmt/index.html#terms. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), AHRQ awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all AHRQ grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following Terms and Conditions will be incorporated into the award notice and will be provided to the grant recipient at the time of award.

Terms and Conditions of Cooperative Agreement Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines, DHHS grant administration regulations at 45 CFR Parts 75, and other DHHS, PHS, and AHRQ grant administration policy statements. AHRQ will use these procedures in evaluating and administering this cooperative agreement.

The administrative and funding instrument used for this program is the cooperative agreement. A cooperative agreement is an "assistance" mechanism (rather than an "acquisition mechanism), in which substantial AHRQ programmatic involvement with the grantee is anticipated during the performance of the activities. Under a cooperative agreement, the AHRQ purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the grant recipient and the PD/PI for the project as a whole, although specific tasks and activities may be shared between the grantee and AHRQ as described in the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data sharing, data access and communications.

All cooperative activities that include significant government involvement will require prior approval by AHRQ.

Activities conducted under this award that involve the collection of information e.g. conducting surveys or requesting responses to uniform questions from nine or more persons, establishments or other entities, with certain exceptions, are currently required to be cleared by OMB under the Paperwork Reduction Act (PRA). (44 USC 3501-3521). PRA review and approval is required in cooperative agreements if AHRQ has significant input or control over the data collection activity. Submissions for clearance under the PRA are through AHRQ and HHS. Therefore, impacted awardees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least 6 months from date of initial submission to AHRQ and sometimes much longer if submissions are incomplete or the justification for the proposed data collection plans are questioned during the clearance process. Information collection that requires PRA clearance may not begin until awardees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found here http://www.hhs.gov/ocio/infocollect/

Program Director/Principal Investigator (PD/PI) Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for conducting research in accordance with the terms and conditions of the Notice of Award, and cooperating with other key parties, including the AHRQ Program Official and other awardees.

The PD(s)/PI(s) will participate in monthly teleconferences with the program official and/or other AHRQ personnel as appropriate. The PD(s)/PI(s) will attend an annual two-day meeting with AHRQ and other grantees, which is held in the Washington, D.C. area.

A learning community will be created to bring together grantees, contract staff and AHRQ staff to discuss progress on the initiative, identify common challenges and engage in problem solving. Each PD/PI and any key personnel for implementation and evaluation are expected to participate in the learning community meetings.

In addition to the annual progress report, the grantee is required to submit quarterly progress reports to AHRQ. Instructions on reporting requirements will be provided at the time of grant award.

AHRQ Responsibilities

AHRQ program staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Cooperative activities are intended to strengthen individual projects and at the same time generate collaboration across the projects. Specific cooperative aims and activities in carrying out individual projects may be shared among the awardees and the AHRQ program officials.

AHRQ staff will provide advice and support to the awardee, and will assist in the cooperative work of the project beyond the usual program stewardship for grants.

The Program Official will maintain regular contact with the PD(s)/PI(s) to consult on key project decisions, help to trouble-shoot implementation barriers/challenges, and confirm that projects are proceeding according to project timelines and plans. The Program Official, in coordination with the grantee, will also disseminate project findings to research and policy audiences. Progress will be reviewed quarterly.

AHRQ will:

• Review the development of project timelines and project plans and assess progress.
• Work closely with grantees and AHRQ contractors to ensure harmonization of cross-grantee metrics for evaluation.
• Coordinate and facilitate collaboration and engagement with stakeholders.
• Facilitate the development of common frameworks, tool kits, and other products for implementation and evaluation activities.
• Facilitate conference calls with grantees and annual in-person meetings.
• Work closely with grantees and other federal partners to ensure dissemination of products.

Additionally, AHRQ program staff will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

Collaborative Responsibilities

Awardees will be required to work collaboratively with each other and with AHRQ to share information and develop common resources as noted above. Awardees and AHRQ will also participate in periodic meetings including monthly teleconferences and annual in-person meetings.

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.

For details regarding annual progress report submission, refer to https://www.ahrq.gov/funding/grant-mgmt/noncomp.html. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Annual 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 interim progress reports to AHRQ. If applicable, detailed instructions on additional reporting requirements will be provided with the grant award.

Grantees are required to submit expenditure data on the Federal Financial Report (FFR; SF 425) annually.

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 (https://www.ahrq.gov/funding/policies/hhspolicy/index.html). 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 4/30/2018, the annual FFR is due 9/30/2018 (90 days after the end of the calendar quarter of 6/30/2018).

Once an award ends, a final Progress Report, final Federal Financial Report, and Final Invention Statement are required. All final reports are due within 90 days of the project period end date. For further details regarding grant closeout requirements, refer https://www.ahrq.gov/funding/grant-mgmt/closeout.html.

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 (https://www.ahrq.gov/funding/policies/hhspolicy/index.html) for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matter.

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, application errors and warnings, documenting system problems that threaten submission by the due date, and 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 Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Robert McNellis, MPH, PA
Agency for Healthcare Research and Quality
Center for Evidence and Practice Improvement
Telephone: 301-427-1888
Email: [email protected]

Nghia M. Vo, MD
Agency of Healthcare Research & Quality
Division of Scientific Review
Telephone: 301-427-1191
[email protected]

Steven Young
Division of Grants Management
Agency for Healthcare Research and Quality (AHRQ)
Email address: [email protected]

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. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.

This program is described in the Assistance Listings (formerly called Catalog of Federal Domestic Assistance, or CFDA ) at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review.

This award is made pursuant to AHRQ's authority to support the dissemination of comparative clinical effectiveness research findings, 42 U.S.C. 299b-37(a) - (c), in accordance with the statutory requirements generally applicable to research supported under Title IX of the Public Health Service Act. 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 https://www.ahrq.gov/funding/policies/hhspolicy/index.html.