Participating Organization(s)	Agency for Healthcare Research and Quality (AHRQ) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. Also note that AHRQ may have different page limits than NIH for the application Research Strategy, which can be found within each individual FOA (see Section IV below). AHRQ Grants Policy and Information to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.
Components of Participating Organizations	Agency for Healthcare Research and Quality (AHRQ)
Funding Opportunity Title	Accelerating the Dissemination and Implementation of PCOR Findings into Primary Care Practice (R18)
Activity Code	R18 Research Demonstration and Disseminations Projects
Announcement Type	New RFA
Related Notices	None
Funding Opportunity Announcement (FOA) Number	RFA-HS-14-008
Companion Funding Opportunity	RFA-HS-14-009: Evaluating AHRQ's Initiative to Accelerate the Dissemination and Implementation of PCOR Findings in Primary Care (R01)
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.226
Funding Opportunity Purpose	The Agency for Healthcare Research and Quality (AHRQ) seeks applications to disseminate Patient-Centered Outcomes Research (PCOR) findings directly to primary care practices and to support them in implementing PCOR clinical and organizational findings. Applicants must propose a comprehensive approach that uses evidence-based quality improvement strategies, such as practice facilitation, designed to improve the capacity of primary care practices to implement new PCOR evidence into the delivery of care. Applicants must work with primary care practices to utilize PCOR findings to improve the percentage of patients successfully managing blood pressure and high blood cholesterol, and who are receiving advice and support from health care professionals about taking aspirin to prevent heart disease and to quit smoking. Applications must also rigorously evaluate their initiatives and contribute to an overarching evaluation.

Posted Date	March 11, 2014
Open Date (Earliest Submission Date)	June 3, 2014
Letter of Intent Due Date(s)	May 23, 2014
Application Due Date(s)	July 3, 2014, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Estimated to be September, 2014
Advisory Council Review	Not Applicable
Earliest Start Date	Estimated to be February, 2015
Expiration Date	July 4, 2014
Due Dates for E.O. 12372	Not Applicable

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

This initiative will fund cooperatives to provide quality improvement support to small and medium primary care practices within a defined geographic service area to:

Disseminate and implement Patient-Centered Outcomes Research (PCOR) clinical and organizational findings into primary care practice to improve healthcare quality, with an initial focus on cardiovascular care, and

Build primary care practices capacity to receive and incorporate other PCOR clinical and organizational findings in the future.

AHRQ is interested in understanding if and how externally provided quality improvement support can accelerate the dissemination and implementation of PCOR findings in primary care practice so that future initiatives might understand if and how to use a similar approach.

Definitions of Key Terms

For the purposes of this FOA, the following definitions apply:

Service Area: Applicants must define a discrete and contiguous geographical region for their work. It is expected although not required that the area will include a population of approximately 2 million to 5 million people and 500 to 1000 or more primary care practices. AHRQ encourages applications that propose regions that are made up of whole states, combinations of whole contiguous states, or logical contiguous portions of large states.

Cooperatives:

While applications must be submitted by single, eligible organizations, AHRQ recognizes that the scope and breadth of this project is likely best carried out through partnerships of multiple entities. AHRQ strongly encourages applications that bring together the skills, experiences, and resources of local organizations such as, but not limited to:

• Local, state, and/or regional primary care organizations (such as but not limited to academic primary care departments of one or more health professionals schools from within the region, 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), Chartered Value Exchanges (CVEs), and Regional Extension Centers for Health IT (RECs));
• Public health agencies and Community-Based Organizations;
• Private and public payers in the region, in particular entities responsible for administering the state Medicaid program for any states within the cooperative s ’s defined service region; and
• 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 ) to engage consumers in the region).

Any eligible organization willing and able to be responsible for the conduct of the project may submit the application on behalf of the Cooperative.

Primary Care: AHRQ defines primary care as the provision of integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, including prevention and health promotion, developing a sustained partnership with patients, and practicing in the context of family and community.

Primary Care Practices: Primary care practices are health care organizations that are dedicated to the provision of primary care utilizing lead clinicians such as family medicine physicians, general internal medicine physicians, general practice physicians, general pediatric physicians, geriatrician physicians, nurse practitioners, and physician assistants.

Small and Medium Primary Care Practices: Recognizing that large health care organizations usually have internal capacity for quality improvement and change management, the intent of this initiative is to provide dissemination and implementation support and capacity building to small and medium primary care practices that typically do not have internal resources for quality improvement and change management. While these practices may have administrative relationships with other practices or organizations for purposes such as billing or purchasing, the practices sought for this initiative are independent in their clinical and administrative governance, clinical protocols, and quality improvement efforts. For the purposes of this initiative, AHRQ defines small and medium practices as organizations or offices that consist of ten or fewer lead clinicians (e.g. physicians, physician assistants, and nurse practitioners). Community Health Centers with ten or fewer lead clinicians may be included. Multi-specialty practices that provide primary care and which have ten or fewer total lead clinicians may also be included. Applicants may propose to serve small and medium-sized primary care offices of larger organizations, including out-patient primary care offices of hospital systems or academic health centers, larger community health center networks, multi-office groups, or other organizations, if the applicant demonstrates that the offices do not receive significant quality improvement support. While delivering quality improvement support within larger organizations (i.e. those with more than ten lead clinicians) is not the intended focus of this FOA, if applicants propose including larger organizations within their work they must justify their inclusion.

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. This definition is based on the definition used in section 6301(a) of the Patient Protection and Affordable Care Act (ACA) of 2010 (http://housedocs.house.gov/energycommerce/ppacacon.pdf). PCOR produces not only clinical findings (e.g. diuretics are superior to ACE inhibitors and calcium channel blockers in treating high blood pressure and preventing cardiovascular events), but also evidence about the effectiveness of how health care is delivered, referred to in this FOA as organizational practices (e.g. patients control of blood pressure improves when their care is provided by a team of health professionals, rather than by a single physician). There are multiple sources of PCOR findings including the three 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/)

America s Heart Health

Over the past several decades, the United States has made great strides in lowering both the incidence and morbidity and mortality associated with cardiovascular disease through a combination of primary and secondary prevention efforts. Despite these improvements, cardiovascular disease continues to be a significant national health burden and the leading cause of death, involved in almost one of every three deaths.

Modifiable risk factors for cardiovascular disease, such as hypertension, hypercholesterolemia, and smoking, remain poorly controlled. One-third of U.S. adults have hypertension, yet only half of those individuals have their blood pressure controlled; one-third of adults have hypercholesterolemia, among them two-thirds are inadequately treated. Approximately 20% of American adults continue to smoke. Many people at highest risk for cardiovascular disease events do not take aspirin, despite the evidence demonstrating strong benefit. For all of these risk factors, control is even less among many racial, ethnic, and low socioeconomic populations. The current gaps in the management of risk factors present opportunities to substantially reduce the rates of cardiovascular disease and to reduce health care disparities.

In September 2011, in partnership with a range of public health and provider organizations, the U.S. Department of Health and Human Services launched Million Hearts (http://millionhearts.hhs.gov/index.html ) with an explicit goal of preventing one million heart attacks and strokes by 2017. To achieve that goal, the initiative is focusing on the ABCS Aspirin in high risk individuals, Blood pressure control, Cholesterol management, and Smoking cessation. This effort has the potential to reduce racial and ethnic health disparities and Million Hearts is aligned with the HHS Action Plan to Reduce Racial and Ethnic Health Disparities. Million Hearts instituted an aggressive and broad approach targeting both public health and clinical interventions. The Agency for Healthcare Research and Quality strongly supports this effort and through this new AHRQ initiative will assist primary care practices in implementing PCOR findings and improving the ABCS.

Patient-Centered Outcomes Research and AHRQ

AHRQ has been a leader in fostering comparative effectiveness research--developing methods, training researchers, conducting systematic evidence reviews, building national registries, funding comparative research studies, and disseminating the results. In recognition of these efforts, in 2010, with the establishment of the Patient-Centered Outcomes Research Trust Fund, Congress charged AHRQ with disseminating the results of PCOR findings.

This initiative is designed to accelerate the dissemination and implementation of PCOR findings into clinical practice. It recognizes the critical need to develop, test, and spread effective strategies of dissemination and implementation to ensure that Americans are getting high-quality, evidence based care.

Complex and Changing Practice Environments

AHRQ recognizes that applications in some cases will not represent the only initiative within a region working to improve health care outcomes and heart health in primary care practice. Approaches proposed through this initiative will thus be embedded within an external context and layered within or on top of existing, often broader, initiatives using a variety of supporting strategies. Supporting strategies are defined, for the purpose of this solicitation, as those by stakeholders outside of primary care practices, such as payers, health plans, or public reporting collaboratives, that seek to influence the quality of primary care in general or in specific. Such strategies typically have a measurement component and include (but are not limited to): pay for performance initiatives, public reports for consumers, and private physician or practice feedback reports. Proper attention and evaluation will allow a greater understanding of how approaches to disseminate and implement PCOR findings in primary care in combination with supporting strategies are effective in improving the delivery of primary care.

The Centers for Medicare & Medicaid Services includes four ABCS measures (see page 8 of this FOA) in its Physician Quality Reporting System (PQRS). Section 3007 of the Affordable Care Act mandated that, by 2015, CMS begin applying a value modifier under the Medicare Physician Fee Schedule (MPFS). While physicians in large practices (groups of 100 or more eligible professionals who submit claims to Medicare under a single tax identification number) will be subject to the value modifier in 2015, based on their performance in calendar year 2013, physicians in small and medium-sized practices who participate in Fee-For-Service Medicare will be affected by the value modifier by 2017.

In 2014, the Center for Medicare & Medicaid Services will award new contracts under the 11th scope of work to create Quality Innovation Networks (QINs). These organizations will replace the current Quality Improvement Organizations (QIOs) that worked under the 10th scope of work. It is expected that the QINs will operate in every state with each covering 3 to 6 whole states. QINs will provide quality improvement support to primary care practices serving Medicare beneficiaries. There may also be other concurrent initiatives within a region providing technical assistance and capacity building support to primary care practices. The work of this initiative will take place in a changing quality improvement landscape with which applicants should be familiar and which will offer both challenges and opportunities for grantees. Applications must explicitly discuss the broader context within which their work will be delivered and how the evaluation will capture and report on these contextual factors.

The U.S. health care system is rapidly adopting health information technologies. Given that in the future the vast majority of U.S. primary care practices are expected to be using electronic health records, it is important that approaches being evaluated through this initiative be tested in primary care practices that have adopted EHRs. AHRQ recognizes, however, that adoption of EHRs by primary care practices has not been uniform. The type of quality improvement support envisioned under this FOA may have particular benefit to small, rural, and/or under-resourced primary care practices that may be the least likely to have adopted and/or meaningfully use EHRs.

Applicants should:

Convene a team, likely drawing from multiple organizations, with the expertise and experience to achieve the goals of this FOA.

• Given the ambitious scope of this initiative and its required timeframe, AHRQ strongly encourages applications that include organizations with substantial experience in providing support to primary care practices and organizations with existing strong relationships with the primary care practices within their region.

Define a geographic region and develop a plan for recruiting and working with a minimum of 250 primary care practice sites that serve adult patients in that region such that:

• A diversity of primary care practices within the region are engaged, including practices that serve underserved communities. The plan must include working with practices other than exemplar, early-adopter practices.
• At least 60% of practices have adopted an EHR. If the applicant intends to work with fewer HER-enabled practices, the application must provide a justification for this decision.

Develop a process and criteria for identifying PCOR findings and determining what findings will be disseminated to primary care practices.

• In addition to clinical findings related to the ABCS and findings regarding organizational practices related to implementation, applicants may want to consider identifying and supporting implementation of findings on how primary care practices can partner with patients. The implementation of PCOR findings in practices may increase opportunities for shared decision-making as patients select among options based on their own values, preferences, and goals.

Define a comprehensive, multi-component, evidence-based approach to provide quality improvement support to small and medium-sized primary care practices. 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.

• AHRQ strongly encourages applications that use practice facilitation as a central and unifying strategy within the comprehensive approach. To learn more about practice facilitation, please visit: http://pcmh.ahrq.gov/page/practice-facilitation.
• The comprehensive approach 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/pcmhqi2.html.

Plan a rigorous evaluation that includes:

• An appropriate form of control for secular trends and other factors unrelated to the approach used. While cluster randomization is acceptable, it is not required. Alternative strategies such as interrupted time study, step-wedge designs, regression discontinuity design, and other delayed intervention groups and matched cohort control are fully acceptable and may be preferred.
• Measurement at baseline and every three months during the initial intervention and at least 6 months afterwards at the individual practice level of the six ABCS measures listed in Table 1. Additional measures of ABCS implementation may also be included.

Table 1: Required ABCS Measures

A: Aspirin	Percentage of patients aged 18 years and older with Ischemic Vascular Disease (IVD) with documented use of aspirin or other antithrombotic. PQRS 204/NQF 0068
B1: Blood pressure management 1	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. PQRS 236/NQF 0018
B2: Blood pressure management 2	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 (age 18-59 and/or people with diabetes or chronic kidney disease <140/90; age 60-85 <150/90) during the measurement year.
C1: Cholesterol management 1	Percentage of patients aged 20 through 79 years of age who had a fasting LDL test performed and whose risk-stratified fasting LDL is at or below the recommended LDL goal. PQRS 316
C2: Cholesterol management 2	Percentage of patients aged 20 through 79 years of age who had a fasting LDL test performed and who are prescribed a recommended dose of statin based on risk status if indicated.
S: Smoking cessation support	Percentage of patients aged 18 years or older who were screened about tobacco use one or more times within 24 months AND who received cessation counseling intervention if identified as a tobacco user. PQRS 226/NQF 0028

Applicants are encouraged to consider developing plans that allow flexibility to refine data collection efforts around the ABCS over time as the national measurement field evolves and responds to emerging evidence, recommendations, and guidelines around measures B2 and C2.

• Measurement of practice capacity for quality improvement at a minimum at baseline, at the end of the intervention, and at least 6 months afterwards at the individual practice level. The applicant should propose a measurement plan. 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 assessment. The measurement plan must include the two measures listed in Table 2.

Table 2: Required Measures of Practice Capacity

Change Process Capacity Questionnaire The 32-item questionnaire based on the work of Solberg and colleagues can be found in AHRQ’s Practice Facilitation Handbook, Module 6 Appendix at http://www.ahrq.gov/professionals/prevention-chronic-care/improve/system/pfhandbook/mod6appendix.html Measurement of Adaptive Reserve The 23-item adaptive reserve scale described by Nutting and colleagues in the article "Effect of Facilitation on Practice Outcomes in the National Demonstration Project Model of the Patient-Centered Medical Home" is available here. The full questionnaire developed by Jaen and colleagues from which the 23-items are derived may be found in the Clinician Staff Questionnaire available here.

• Measurement of the implementation of the comprehensive approach to quality improvement 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 on tracking what quality improvement techniques were used with individual practices.
• Ongoing data collection and analysis of results 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 must include an assessment of the degree of EHR adoption of each practice and the ability of the practice to report quality measures. At minimum, applicants must use the 2010 National Ambulatory Medical Care Survey Electronic Medical Records questionnaire (http://www.cdc.gov/nchs/data/ahcd/2010EMRSurveyfinal.pdf) and collect data from practices at baseline and annually throughout the intervention period. The external context includes concurrent initiatives such as the work of QIOs/QINS and supporting strategies such as pay for performance and public reporting initiatives.
• Applicants are encouraged to incorporate both quantitative and qualitative measurement and analysis methods as appropriate. Methods should be rigorous.
• Applicants are encouraged, but are not required, to consider examining the impact of their intervention on:
  • Racial, ethnic and other health and health care disparities.
  • Health outcomes.

Applicants may consider providing quality improvement support to primary care practices to assist them in collecting and recording patient self-reported demographic information including but not limited to race, ethnicity, and language preference. If collected, this information may be incorporated into the evaluation to understand the effect of the intervention on health and health care disparities and incorporated into more sophisticated analysis of heterogeneity of effects.

Applicants are not required or expected to propose measuring patient-level health outcomes. However, since improving health outcomes is an important ultimate goal of PCOR, applicants that are able to efficiently and effectively measure one or more health outcomes are encouraged.

Potential measures of health outcomes of interest include but are not limited to rates of heart attacks and strokes, all-cause and cardiovascular disease-specific mortality rates, and patient reported outcomes such as quality of life and functional status.

• Describe a data collection and detailed analysis plan for all aspects of the evaluation. The plan should include quality assurance procedures. Applicants are encouraged to use existing data collection efforts within the region and/or existing registries.
• While applicants should not plan on providing compensation to primary care practices for participating in the 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 actively in a separate overarching evaluation of all grantees to be conducted by an external organization selected by AHRQ. In order to fully participate in this overarching initiative, applicants must:
  • Dedicate at least 20% FTE of a senior evaluator from the team and 40% FTE of a research assistant in each year of the project to support collaboration with the external evaluation team.
  • Agree to coordinate data element standardization and quality assurance and to share de-identified evaluation data with the external evaluator. Applicants must plan to share required data, including measurement of six ABCS measures, two capacity measures, assessment of implementation, and assessments of internal and external context at least quarterly.
  • Not rely in their applications on receiving support for data collection from the external evaluator. They should also not anticipate receiving regular benchmarking or feedback from the external evaluator.
• Plan to complete all work within 36 months of the project period start date. Applicants' plans should not anticipate no-cost extensions. Applicants should develop a plan that provides for direct work with primary care practices to begin within 6 months of award. Project plans must assure complete provision of quality improvement support with a minimum of 250 primary care practices within 30 months in order to allow a full 6 months of post-intervention evaluation. AHRQ encourages designs that complete quality improvement support with most or all practices by 24 months, allowing for longer post-intervention evaluation. After completing initial work with 250 practices, applicants may plan on disseminating and supporting implementation of other PCOR evidence to these practices and/or disseminating and implementing ABCS-related PCOR findings to other primary care practices in the region that were not part of the initial cohort.

Plan and budget for three team members (the PD/PI, an implementation leader, and an evaluation leader) to travel to the Washington, DC area once a year for each year of the grant to participate in a two-day grantee meeting. The first meeting is expected to be held in the fall of 2014.

Plan not to receive additional funding from AHRQ after 36 months. If this initiative is successful, however, AHRQ may consider the release of a subsequent funding opportunity announcement limited to those award recipients under this initiative. The new FOA could potentially provide funding for an additional 24 to 36 months of PCOR dissemination and implementation support.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	AHRQ anticipates investing up to $40 million in the first year of this initiative and up to $120 million over three years to support up to 8 awards. Awards issued under this FOA are contingent upon the submission of a sufficient number of meritorious applications. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. The total amount awarded and the number of awards will depend upon the number, quality, duration, and costs of the applications received.
Award Budget	Applications may be up to 36 months in duration with a budget supported by AHRQ not to exceed $5,000,000 total costs in any given year. An application with a budget that exceeds $5,000,000 total costs in any given year or exceeds 36 months in duration will not undergo peer review. Funding beyond the first year will be contingent upon a review and acceptance by Agency staff of an annual progress report.
Award Project Period	The project period may not exceed 36 months.

Title 42 USC, section 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 AHRQ's grant regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://dhhs.gov/asfr/ogapa/aboutog/grantsnet.html and http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), and the terms and conditions set forth in the Notice of Award.

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

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

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism. For-profit organizations may participate in projects as members of consortia or as subcontractors only. Because the purpose of this program is to improve healthcare in the United States, foreign institutions may participate in projects as members of consortia or as subcontractors only. Applications submitted by for-profit organizations or foreign institutions will not be reviewed. Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

HHS grants policy requires that the grant recipient perform a substantive role in the conduct of the planned project or program activity and not merely serve as a conduit of funds to another party or parties. If consortium/contractual activities represent a significant portion of the overall project, the applicant must justify why the applicant organization, rather than the party(s) performing this portion of the overall project, should be the grantee and what substantive role the applicant organization will play. Justification can be provided in the Specific Aims or Research Strategy section of the PHS398 Research Plan Component sections of the SF424 (R&R) application. There is no budget allocation guideline for determining substantial involvement; determination of substantial involvement is based on a review of the primary project activities for which grant support is provided and the organization(s) that will be performing those activities.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD/PI)

The PD/PI must have an eRA Commons account. The PD/PI should work with his/her 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, he/she 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/Principal Investigator (PD/PI) 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.

An individual may not be the PD/PI for both an application submitted to this FOA and the related FOA RFA-HS-14-009.

Only one PD/PI may be designated on the application.

This FOA does not require cost sharing.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project. This information can be included at the end of the budget justification section of the application, but institutional support dollars are not to be shown/included in the detailed budget request.

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

Applicant organizations may submit applications to both this FOA and the related FOA RFA-HS-14-009. As noted above, however, an individual may not be the PD/PI on applications submitted to both FOAs.

AHRQ will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months, except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the 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 AHRQ staff to estimate the potential review workload and plan the review.

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/PI
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent can be sent electronically, and it should be sent to:

Phillip Jordan
Email: Phillip.Jordan@ahrq.hhs.gov

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 provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on April 24, 2014 at 2:00 p.m. Eastern time. To register to participate in the conference call, please send an e-mail request to Phillip.Jordan@ahrq.hhs.gov by April 21, 2014. All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB April 20, 2014. Potential applicants are encouraged to contact AHRQ staff with any questions (see Section VII, Agency Contacts, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying. 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 Phillip Jordan by April 21, 2014. Please include the phrase DISSEMINATION AND IMPLEMENTATION QUESTIONS in the subject line. Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff. Notes from the conference call will be posted on the AHRQ web site.

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 35 pages.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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, with the following additional instructions:

Budget Component: Special Instructions for AHRQ applications

AHRQ is not using the Modular Grant Application and Award Process. Applicants for funding from AHRQ should ignore application instructions concerning the Modular Grant Application and Award Process, and prepare applications using instructions for the Research and Related Budget Components of the SF 424 (R&R). Applications submitted in the Modular format will not be reviewed.

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

All instructions in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement must be followed, with the following additional instructions:

Research Strategy:

The research plan section of the application is limited to 35 total pages. Applications that exceed 35 pages will not undergo peer review. Below are 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 five sections:

1. The Cooperative and the Region (no longer than 5 pages)

2. Approach to Disseminating and Implementing PCOR Evidence through Quality Improvement Support (no longer than 15 pages)

3. Evaluation (no longer than 15 pages)

4. Project Timeline (no longer than 2 pages)

5. Dissemination (no longer than 3 pages)

This section should be no longer than 5 pages and should accomplish the following:

Describe the cooperative overall and each partnering organization’s capacities, including:

The cooperative’s 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 project’s organizational structure, including team leaders and membership as well as plans for staff hiring and training

Any history of working together and previous successful implementation of joint projects

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 environment of primary care practices
• Providing quality improvement support to primary care practices
• Electronic clinical decision support and the use of electronic health records for quality improvement and research data collection
• Complex, patient- and practice-level data collection, quality assurance, and management
• Comprehensive evaluation of complex, multi-site interventions
• Project management
• Any other available resources that will support the goals of this initiative
• Information and communication infrastructure

Applicants are encouraged to leverage and build upon existing and evolving administrative and clinical data aggregation infrastructure within the region, such as health information exchanges.

Define the geographic region to be served, including:

• The population and its health status, with attention to heart health
• The health care environment, including the state of primary care practice
• The total number of primary care practices and primary care professionals in the region
• Other supporting strategies (e.g., pay for performance, public reporting, practice transformation, and quality improvement activities) occurring in the region and how the proposed project is aligned with them. If not aligned, discuss how competition and confusion will be avoided or minimized

This section should be no longer than 15 pages and should accomplish the following:

Describe plans for practice recruitment, including:

How small- and medium-size primary care practices within the region will be identified

How primary care practices will be recruited and engaged, including primary care practices that serve underserved communities and/or are resource-limited

An estimate of the percent of primary practices that will agree to participate and the percent participating that will drop out

Potential barriers to engaging a minimum of 250 primary care practice sites and proposed mitigation strategies

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.

Describe in detail an evidence-based, comprehensive approach to quality improvement support to: 1) accelerate incorporation of PCOR clinical and organizational findings into practice with an initial 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.

If the comprehensive approach includes quality improvement support strategies not listed in Section 2 Part 1 (practice facilitation, practice assessment, the use of data for feedback and benchmarking, electronic clinical decision support, expert consultation, and peer-to-peer learning), applicants must discuss the evidence base supporting these additional strategies.

The application should include a general timeline of the approach for working with an individual primary care practice.

Provide the theoretical basis, conceptual model, and/or logic model for the overall comprehensive approach with an explanation of how individual strategies and techniques fit within the theory or model and are expected to contribute to its success.

Discuss potential challenges and barriers to implementing the comprehensive approach and proposed mitigation strategies.

This section should be no more than 15 pages and should accomplish the following:

Describe a multi-level evaluation plan that determines the effectiveness of the chosen approach and its component strategies in providing quality improvement support to disseminate and implement PCOR findings in primary care practices and to increase practices capacity to implement future PCOR findings. The plan should also be designed to develop new evidence about issues such as the contribution of various components of the approach, the effect of the intensity of the approach on outcomes, and the internal and external contextual factors that influence the effectiveness of the intervention, in order to understand prerequisites to successful replication.

The evaluation plan should include:

Evaluation of the project on at least the following five domains:

• Primary care practice delivery of the ABCS of heart health
• Primary care capacity to implement PCOR findings and improve quality
• Implementation of the planned comprehensive approach in the aggregate and individual practice level (e.g. feasibility, fidelity, implementation costs)
• External health care context (e.g. pay for performance, public reporting initiatives)
• Internal primary care context (e.g. practice staffing and organization, degree of EHR adoption, patient population served)

Articulation of clear evaluation questions, data collection, quality assurance, and management plans, and analytic methods and the relationship between them. Attention should be given to understanding heterogeneity of effects. The evaluation strategy and analytic plan should be designed to capture short-term improvements and longer term maintenance of initial changes.

A description of measures, data sources, and data collection strategies, including:

Collection and analysis of data from measures and measurement instruments required in Section 2 Part I, at the prescribed intervals.

Collection and analysis of additional quantitative and qualitative data.

Proposed measurement tools in addition to those that are required should be described.

Methods for assessing and assuring data quality and validity across practice sites and over time

Use of an appropriate form of control for secular trends and other factors unrelated to the approach used. While cluster randomization is acceptable, it is not required. Alternative strategies such as interrupted time study, step-wedge designs, regression discontinuity design, and other delayed intervention groups and matched cohort control are also fully acceptable and may be preferred.

A commitment to working with AHRQ’s external evaluator on an overarching, cross-grantee evaluation.

As described in Section 2 Part I, applicants are required at a minimum to devote 20% effort of a senior evaluator and 40% effort of a research assistant in each year of the project for cooperation with the overarching evaluation.

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.

This section should be no longer than 2 pages and 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 should be included as an appendix.

The timeline should document how all aspects of the proposed work described in the proceeding and following sections will be accomplished within 36 months.

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

• Start-up phase: including needed staff recruitment and training and practice recruitment
• Baseline data collection: for intervention and comparison practices
• Implementation of ABCS-focused quality improvement support intervention
• Post-intervention data collection
• Final data analysis, dissemination, and additional work with primary care practices

Applications must include a plan and budget for three team members (the PD/PI, an implementation leader, and an evaluation leader), to travel to the Washington, DC area once a year for each year of the grant to participate in a two-day meeting with other grantees. The first meeting is expected to be held in the spring, 2015.

This section should be no more than 3 pages in length.

In order to accomplish the major goals of this initiative it is important the results and team insights be clearly communicated with multiple stakeholders, including health care decision makers, health care systems, primary care professionals, and the public. It is equally important that these results and insights be shared in a timely manner.

While it is not the main focus of this initiative at this phase to ensure sustainability of the cooperatives, providing information about the structure and resources required for implementation of successful approaches is very important.

This section should accomplish the following:

Describe plans for making information publically available about the cooperative, 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 six months of the project and be updated regularly.

Describe plans for sharing results of the intervention with the range of stakeholders noted above. 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 insights into the implementation of the intervention with the range of stakeholders noted above. It is expected that findings 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. Activities may include:

Reviewing project descriptions that AHRQ or a contractor develop for dissemination on AHRQ websites and providing timely feedback;

Providing brief, high-level quarterly updates on the progress of the grant to AHRQ and AHRQ contractors; and

Sharing information on any grant outputs (e.g., results, publications, tools) for inclusion in AHRQ initiative descriptions.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. One section of the Appendix should include a detailed Gantt Chart.

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

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

Part I. Overview Information contains information about Key Dates. 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.

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
The PD/PI must include his/her eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH/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.

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

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

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

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

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

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

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

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

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

Unless otherwise provided in grant awards, AHRQ grantees may copyright, or seek patents for, as appropriate, final and interim products and materials developed in whole or in part with AHRQ support, including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses. Such copyrights and patents are subject to a royalty-free, non-exclusive, and irrevocable AHRQ license to reproduce, publish, use or disseminate for any purpose consistent with AHRQ’s statutory responsibilities and to authorize others to do so for any purpose consistent with AHRQ’s statutory responsibilities. In accordance with its legislative dissemination mandate, AHRQ purposes may include, subject to statutory confidentiality protections, making project materials, databases, results, and algorithms available for verification or replication by other researchers. In addition, subject to AHRQ budget constraints, final products may be made available to the health care community and the public by AHRQ or its agents if such distribution would significantly increase access to a product and thereby produce substantial or valuable public health benefits. Ordinarily, to accomplish distribution, AHRQ publicizes research findings but relies on grantees to publish research results in peer-reviewed journals and to market grant-supported products. AHRQ's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities. Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR) which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

AHRQ's priority areas of focus are:

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

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

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

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

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

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

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

Significance

As described above, this FOA seeks to disseminate Patient-Centered Outcomes Research (PCOR) findings directly to primary care practices and provide support for implementing clinical and organizational findings in practice, and to build the capacity of primary care practices to implement new PCOR findings into the delivery of care, for the purpose of understanding if and how externally provided quality improvement support can accelerate the dissemination and implementation of PCOR findings into primary care practice.

How likely is it that the proposed project will improve implementation of ABCS in primary care practices?

How likely is it that the proposed project will increase the QI capacity of the primary care practices targeted in the application to implement new PCOR findings into the delivery of care?

How likely is it that the evaluation will produce information useful to others who disseminate PCOR evidence and support its implementation, researchers studying effective methods to spread evidence-based findings, and implementers who seek to enhance practices QI capacity?

Does the evaluation include use of an appropriate control or comparison group as required by the FOA so that the results of the evaluation will be meaningful?

Does the evaluation include a meaningful assessment of internal and external contextual factors, including the degree of EHR implementation of each practice and a plan for incorporating this information into planned analysis?

Does the evaluation include a well-defined and feasible plan for assessing the implementation of the project that will provide information relating to implementation of the QI strategy to enable others to implement successful components elsewhere?

Investigator(s)

Are the PD/PI and team members (including individuals from organizations who are members of the applicant s Cooperative) appropriately trained and well suited to carry out this work?

Does the team have substantial experience with the proposed approach and relations with primary care practices that ensure that the project can start quickly, engage primary care practices, and deliver the proposed approach within the proposed timeline?

Are plans for staff hiring and training sound?

Do investigators and other team members have appropriate skills and experience for their roles in the project?

Are the total hours described for all key personnel appropriate to the level of effort required for the performance of their responsibilities?

Has the applicant proposed to dedicate at least 20% FTE of a senior evaluator from the team and 40% FTE of a research assistant in each year of the project to support collaboration with the external evaluation team?

Does the PD/PI and project team bring complementary and integrated expertise to the project, including, but not limited to, expertise in:

• managing complex, collaborative research projects involving coordination across multiple, diverse sites and actors;
• engaging with primary practices and delivering quality improvement support;
• identifying PCOR findings;
• conducting complex multi-level evaluations;
• statistical analysis including methods for analyzing heterogeneity of effects
• utilizing EHRs for clinical quality improvement and research data collection;
• rapidly disseminating evaluation findings

Innovation

The goals of this FOA do not require novel approaches or methods, but rather the application of evidence-based strategies to assist primary care practices in implementing PCOR findings to improve the delivery of the ABCS of heart health and the development of capacity within practices to implement future PCOR findings into on-going primary care delivery. The FOA also requires a robust multi-level evaluation, but does not specifically require innovation.

Does the application demonstrate the utilization of evidence-based techniques to support primary care practices in implementing PCOR findings?

Does the application bring together resources from across various organizations and stakeholders to improve the chances of project success?

Does the application include a robust, multi-level evaluation that is likely to produce results that are meaningful and valid?

Approach

When considering the scientific merit of the applicant's approach, reviewers may consider three aspects of the application: The approach to PCOR dissemination and implementation, to evaluation, and to dissemination.

The Approach to PCOR Dissemination and Implementation Through Quality Improvement Support

The FOA seeks the delivery of comprehensive, multi-component, evidence-based approaches to deliver PCOR findings directly to primary care practices and to support them in implementing clinical and organizational evidence, and in so doing improve the capacity of primary care practices to implement new PCOR evidence into the delivery of care.

How likely is it that the proposed approach to QI support will be successfully implemented?

How likely is it that the proposed approach will improve implementation of ABCS in practices?

How likely is it that the proposed approach will increase QI capacity of the practices targeted in the application?

Is the theory, conceptual model, and/or logic model (i.e., the links between the approach, its implementation, and expected outcomes) supporting the approach to QI support compelling? Are the proposed QI strategies within the approach sufficiently evidence-based?

Is the practice recruitment plan realistic and how likely is the applicant to succeed in recruiting at least 250 small- and medium-sized primary care practices?

Will the project reach primary care practices that serve underserved communities?

If the applicant proposes that fewer than 60% of practices will have not implemented an EHR, how well did the applicant justify its selection, demonstrate the feasibility of these practices collecting data for QI, and provide assurances that future EHR adoption would not derail practices participation in the study?

Does the approach include an appropriate plan for identifying and selecting PCOR findings for dissemination?

Is the plan to deploy the approach to QI support, including the proposed timeline and mitigation strategies, likely to lead to achievement of the project’s stated aims?

In assessing the likelihood for plan success, consider the adequacy of the following: Capacity, commitment, and readiness of the project team and all participating organizations to undertake the specified approach and strategies, as evidenced by past experience and performance in managing efforts of a similar nature and/or fostering implementation of evidence in primary care settings; Project management structure and plan including coordination among intervention and evaluation teams; Timelines, including whether the applicant has sufficiently addressed how particularly risky aspects will be managed and unanticipated challenges will be handled to ensure on-time completion of the project; Budget and other needed resources, including but not limited to funds, information and data, information processing capabilities, staff time, and expertise.

The Approach to Evaluation

This FOA seeks to evaluate the ability of direct, evidence-based quality improvement support to improve implementation of PCOR findings in primary care practices and to build the capacity of practices to implement future PCOR findings, with attention to internal and external factors and the process of implementation.

Does the application clearly articulate evaluation questions, and are the measurement, data collection and management, and analytic plans adequate to answer those questions?

Does the evaluation include use of an appropriate control or comparison group so that the results of the evaluation will be meaningful?

How likely is it that the evaluations will be able to produce findings on changes in implementation of the ABCS and on practices capacity for future implementation of PCOR findings?

Will the evaluation be able to capture short-term improvements and longer term maintenance of initial changes?

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?

Does the evaluation include a well-defined and feasible plan for assessing the implementation of the project that will provide information relating to implementation of the approach to QI support to enable others to implement successful components elsewhere?

Does the evaluation plan include a well-defined, feasible, and sound data collection plan that is likely to produce needed data, including the measures and frequency of data collection required in this FOA?

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?

Is the choice of measures and measurement instruments well justified?

Has the applicant adequately acknowledged the advantages and challenges of deriving data from electronic health records and addressed how the latter will be overcome?

Are appropriate plans for data validity and data quality assurance in place, including plans for assuring the quality and validity of quantitative and qualitative data across practice sites and over time?

Is a feasible plan in place for obtaining necessary OHRP-recognized IRB approvals within the proposed project timeline?

Has the applicant identified potential challenges to the evaluation plan and made appropriate contingency plans?

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?

The Approach to Dissemination

Has the applicant identified key topics for dissemination products, including descriptive information about the cooperative, region, and planned approach, quantitative results, and lessons learned about the process of implementation and the internal and external context in which it was delivered?

Has the applicant identified dissemination alternatives to peer-reviewed publications and presentations?

How likely is it that the dissemination proposed will provide results and findings 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?

Additionally, reviewers should consider the overall project timeline:

How likely is the applicant to be able to immediately launch the project, engage with primary practices within 6 months, and complete all aspects of the intervention, evaluation, and dissemination plan within the proposed project time frame?

Environment

How extensive are the capacities, experience, expertise and other resources of the applicant institution and participating organizations, institutions, and other entities? How well-aligned are they with the needs and aims of the project? How likely are they to contribute to the project’s success?

Does the application effectively leverage regional and local expertise?

Is there sufficient evidence of suitable arrangements and agreements for collaboration among all Cooperative members and between the Cooperative and other partners?

Do partnering organizations have a history of successfully working together?

Is there a clear governance structure with role delineation and a strong management plan?

Is there evidence of institutional commitment and support from all proposed organizations?

Is the region clearly defined and logical?

Is the region of appropriate size to allow successful engagement with 250 diverse primary care practices without being overly large?

Does the proposed project benefit from features of the region such as recent or on-going health and health care initiatives, health information exchanges, clinical environments, political environments, community settings, and patient populations?

Have potential environmental obstacles (e.g., political/interest group opposition; regulations) and the means for avoiding or mitigating their effects been identified?

For expansions of an existing QI support effort, have problems with coordination or other any potential challenges (e.g. technical constraints, resource limitations, other) and learning from prior experience on this or related initiatives been acknowledged/ properly anticipated, and are possible resolutions proposed?

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

Protections for Human Subjects

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

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

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?

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.6 Other Submission Requirements ).

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.

Not Applicable

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

As part of the initial merit review, all applications will:

• Undergo a selection process in which only those applications deemed to have the highest scientific merit will be discussed and assigned a priority score
• Receive a written critique

As part of the scientific peer review, all applications:

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

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

• Scientific and technical merit of the proposed project as determined by peer review.
• Availability of funds.
• Responsiveness to goals and objectives of the FOA.
• Relevance and fit within AHRQ portfolio priorities, as well as overall programmatic balance, including balance across funded studies to achieve geographic diversity, adequate inclusion of safety net providers and AHRQ priority populations, and uniformity of evaluation.
• Independence of grantee teams under this FOA and the related evaluation FOA RFA-HS-009.

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.

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

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

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

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

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

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/fund/postawrd.htm#terms.

All AHRQ grant and cooperative agreement awards are subject to AHRQ’s grants regulations at 42 CFR Part 67, Subpart A, the HHS Grants Policy Statement (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html), and the terms and conditions set forth in the Notice of Award.

A standard term and condition of award will be included in the notice of award; 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.

Quarterly progress reports may be required, and if required, these will be submitted through the AHRQ electronic reporting system ARRS.

When multiple years are involved, grantees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually.

The annual progress reports must include Sections 2.2.6 A through F as described in the general PHS form 2590 instructions. For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the PHS form 2590 instructions, follow the instructions on the AHRQ website.

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future. At a minimum, the reports will include descriptive comments on: progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities. AHRQ does not currently limit the length of the progress report to 2 pages. AHRQ will provide the due date for submitting annual progress reports.

In addition to the annual progress report, recipients may be required to submit quarterly progress reports to AHRQ. Detailed instructions on reporting requirements will be provided with the grant award.

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (see http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs will be 90 days after the end of the calendar quarter in which the budget period ends. Note that this is a change in due dates of annual FFRs and may provide up to 60 additional days to report, depending upon when the budget period end date falls within a calendar quarter. For example, if the budget period ends 4/30/2013, the annual FFR is due 9/30/2013 (90 days after the end of the calendar quarter of 6/30/2013).

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Finding Help Online: http://grants.nih.gov/support/index.html

TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Direct your questions about general FOA issues, including information on the inclusion of priority populations to:

Phillip E. Jordan, M.A.
Agency for Healthcare Research and Quality (AHRQ)
Center for Primary Care, Prevention, and Clinical Partnerships
Telephone: 301-427-1035
E-mail address: Phillip.Jordan@ahrq.hhs.gov

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

Kishena Wadhwani, Ph.D., M.P.H.
Agency for Healthcare Research and Quality (AHRQ)
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Telephone: 301-427-1556
E-mail address: Kishena.Wadhwani@ahrq.hhs.gov

Direct your questions regarding fiscal matters to:

Galen Gregor
Office of Management Services
Grants Management
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1457
Fax: 301-427-1462
E-mail address: Galen.Gregor@ahrq.hhs.gov

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

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authority of 42 USC 299 et seq. and, 42 CFR Part 67 and in accordance with 45 CFR Parts 74 or 92 and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.