It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV, and follow the AHRQ Grants Policy and Guidance found on the AHRQ website at http://www.ahrq.gov/funding/policies/foaguidance/index.html. 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

A. Background: Overview of CAHPS

The purpose of this RFA for CAHPS V is to continue the work of the Consumer Assessment of Healthcare Providers and Systems (CAHPS ) program which AHRQ began in 1995. The CAHPS program is a public-private initiative to develop and maintain standardized surveys of patients' experiences with ambulatory and facility-level care. CAHPS surveys ask consumers and patients to report on and evaluate their experiences with health care services. These surveys cover topics that are important to consumers and focus on aspects of quality that consumers are best qualified to assess, such as the communication skills of providers and ease of access to health care services. The acronym "CAHPS" is a registered trademark of the Agency for Healthcare Research and Quality (AHRQ).

For the past 21 years, the CAHPS program has advanced the science of patient experience, particularly through the development of CAHPS surveys and related materials that allow consumers to assess their quality-related experiences with their health plans, from providers, and in health care facility settings (see https://www.ahrq.gov/cahps/about-cahps/cahps-program/index.html).The CAHPS surveys are now broadly used by governmental agencies and organizations such as the Centers for Medicare and Medicaid Services (CMS), other health care purchasers, and the National Committee for Quality Assurance for a variety of different purposes such as value-based purchasing, public reporting, and accreditation (see https://www.ahrq.gov/cahps/surveys-guidance/index.html ).

Throughout this expansion of CAHPS, AHRQ has maintained its unique role as the agency sponsoring independent research to ensure that the surveys and related materials are current, responsive to the user community and changing health service delivery needs, enhance patient-centeredness, and use the best survey science in questionnaire development and survey administration. To promote those goals, the CAHPS team has developed surveys and supplemental item sets; survey administration guidelines; survey mode and length, and guidance for reporting CAHPS data to consumers, providers and other audiences. Recently, the CAHPS program has also conducted research on the use of patient narratives to strengthen the value of close-ended survey questions. (Detailed information about CAHPS products and history can be found at http://www.ahrq.gov/cahps.)

B. Research Objectives

This RFA solicits research to be performed within five broad areas: a) Advancing the science of consumer assessment of patient experience; b) Continued innovation to ensure relevance to health services delivery and survey best practices; c) Reporting patient experience data; d) Quality improvement studies; and e) Developing internal and external program communication strategies.

Each of these areas is described in detail in this section.

This RFA lists approaches as examples of the kind of work that could be performed in support of a particular effort. Applicants should not be constrained by these suggestions or regard them as inclusive of all the aims that may need to be performed in a given area, and are encouraged to propose different and new approaches that fulfill programmatic and agency goals.

A note on terminology used in this RFA: The CAHPS Consortium includes CAHPS cooperative agreement recipients (Grantees), AHRQ CAHPS staff and staff from the CAHPS User Network contract. Grantee teams are work teams organized to conduct research, develop a particular survey, reporting resource, quality improvement guide or other product. Grantee teams are led by representatives from grantee organizations, and are supported by the CAHPS User Network. Grantees will need to designate an individual from their staff to serve on each of the teams and participate in team meetings. Teams cover the following areas: Survey instruments, Quality Improvement, Reporting, Analysis, and Communications.

The successful adoption and implementation of CAHPS products are based on collaboration among potential users, stakeholders, health professional organizations, health advocacy groups and many other people and organizations. Also, development and promotion of maximally useful CAHPS products depends on cooperation, trust and open sharing of information and participation within the CAHPS team structure. In describing their ability to perform the research in response to this RFA, applicants must highlight their experience with and ability to work as part of collaborative teams in addition to their technical skills and research-related experience.

At the beginning of each project year, the Program Director/Principal Investigators (PD/PI) will meet with the AHRQ CAHPS Program Official (PO) by phone to discuss with AHRQ technical support for survey development, research, or other needs as appropriate, from the CAHPS User Network Contract in the coming year.

A source that might be helpful in developing an application in response to this RFA is The National Health Care Quality Strategy and its annual updates (http://www.ahrq.gov/research/findings/nhqrdr/nhqdr15/priorities.html).

Applicants should feel free to propose research that overlaps the five areas of work identified below and should indicate how a research project might fulfill the requirements and aims of more than one of these areas. The budget percentage allocation estimates for the following areas of work are to be used as general guidance in preparing an application but are not absolute amounts.

1. Advancing the Science and Practice of Patient Experience Assessment (approximately 30% of the project budget)

The CAHPS program has been the lead innovator in consumer assessment of a patient’s experience in health care. As CAHPS enters into its third decade, the understanding and importance of patient experience, and the methodological approaches and considerations in assessing and reporting what happens in a healthcare encounter, have matured significantly from the original health plan CAHPS survey. The AHRQ CAHPS program has been at the lead in developing methodology for assessment, incorporating patients and stakeholders in a collaborative process to develop meaningful and relevant measurement tools and approaches, reporting patient experience, and in data-driven quality improvement research from the perspective of what’s important to patients. The CAHPS surveys have become the primary tool for measuring patient experience to enhance patient-centered medical care. AHRQ intends for this funding opportunity to serve as a mechanism to further the knowledge of patient experience, assessment methodologies, and to further integrate patient experience measurement and perspectives into health service delivery.

a. Research to further patient experience understanding.

A desired outcome of this RFA is to further the understanding of patient experience with foundational work that can then be applied to survey or supplemental item set development. In particular, the focus should be on enhancing patient-centered approaches from the patients' perspective in: i) shared decision-making; ii) patient engagement; iii) care coordination; and iv) patient safety. Applicants must identify at least one of these areas in which to pursue advances in understanding patient experience. The research could involve partnership with clinical entities, health plans or other providers. The research must be patient focused; that is, patient feedback must be incorporated in a significant way into the research and testing process. Please note, the research identified here could also be instrumental in the approaches for the other components of this RFA, including: 1b), Research to further patient experience assessment and data collection; 2) Continuing innovation to ensure relevance to health service delivery and survey best practices; 3) Reporting patient experience data, and 4) Quality improvement studies. Applicants can propose: one study addressing all of these areas, different studies for each area, or a combination. The goal is to address all of these areas within the application.

While findings from this foundational research might not lead to a new survey or supplemental item set development, applicants should also consider the possibility that a new survey or supplemental item set in these areas could be developed. Applicants should discuss the research challenges in defining and measuring these concepts.

An important role of this cooperative agreement is to develop CAHPS surveys or supplemental item sets. Applicants must propose to develop at least one CAHPS survey or supplemental item set, complete with instructions for its implementation, drawn from field test and implementation research. The survey or supplemental item set could be part of the foundational research just described, or could pertain to another topic entirely. Survey and supplemental item set development must follow guidance set forth in the CAHPS Survey Developer's Guide (applicants interested in viewing the CAHPS Survey Developer's Guide should request the document directly from [email protected]). The research must also establish CAHPS composite measures and develop the composite measure labels. The labels for these composites must make logical sense and appeal to users of CAHPS reports. Methods used in this research include factor analysis to see which items cluster together, development of draft labels, and iterative testing of proposed labels with target audience members until they identify ones that work. Applicants must describe their ability to and experience in performing research for measure development and for producing accurate and understandable composite labels. AHRQ requires that those wishing to use the CAHPS trademark on their surveys to develop and report survey composites exactly as specified in the Survey Developer's guide and administration instructions for that survey.

Finally, as part of the survey development process, grantees applicants must provide information relevant to administration and reporting, such as inclusions and exclusions to the sampling frame, number of surveys necessary for reporting purposes, reporting labels, and other critical factors related to survey implementation. The CAHPS recipients will provide this information to the CAHPS User Network contractor, who will take the lead in writing, assembling and publishing these implementation materials and guidance. Some user products, such as programs for analysis of CAHPS data, must be developed by the grantees.

Applicants must identify an area of survey or supplemental item set development or refinement. They must propose the foundational work that is necessary to develop measurement in this area, the principles that would guide their survey or supplemental item development process and testing methods, how a survey or supplemental item set might be used, and considerations in developing implementation materials, including the description and formation of a sample frame. Applicants must describe how their choice of area for survey or supplemental item set development would contribute to knowledge of patient experience of care, why measurement is needed in this area to further understanding of the patient's experience. Applicants must describe their capability for developing or collaborating in the development of these products, their partnership arrangements, and how they might work with the CAHPS Consortium. Applicants must describe their experience to date in patient experience research and survey development, particularly as it is relevant to CAHPS measurement.

b. Research to further patient experience assessment and data collection

Patient Elicitation: AHRQ has embarked on patient elicitation research to collect patient narrative descriptions about their care. Research has produced a supplemental item set of open ended questions to be used with the Clinician and Group CAHPS survey (see: https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html). Applicants must propose the next phase of research in at least one of the following areas: 1) developing narrative data collection to be used independently of the CAHPS surveys; 2) broadening the approach for use with other CAHPS surveys; and/or 3) developing protocols for administering the narrative questions for fast-turnaround to facilities to address specific concerns. Applicants must identify work to date in this area, the central research question(s) driving the choice of topic(s), research methodology, and anticipated products. CAHPS grantees should expect to work collaboratively with others, such as published subject matter experts in this area.

Survey administration: For most settings of care, the CAHPS team recommends the following modes of survey administration: telephone, mail, or a mixed mode combining both methods. In some instances, electronic survey administration could be used for data collection. Electronic survey administration methods have the potential to reduce the cost of data collection if they yield valid and reliable data. As new settings for CAHPS surveys are explored, the CAHPS Team will need to develop reliable methods for obtaining data from vulnerable populations who might not be reached by standard methodology. Implementation of electronic administration and other methodologies needs careful assessment to determine their utility for the respondent population. For example, novel research and innovation might be needed for survey administration methods to keep pace with an aging population who may have increasing human factors challenges in responding to an electronic, paper or phone instrument. Another example is that surveys at the point of care might be more viable for hard to reach populations who might not be accessible by phone or have a regular address.

Applicants must identify at least one method of survey administration that could be used for collecting experience of care data, and describe the challenges in using that methodology for data collection in a specific population. Electronic methodologies could include, for example, Web-based data collection using email addresses to reach patients, patient portals, or point-of-care tablet administration. Applicants must discuss the concerns with their selected administration methodology, and appropriateness for data collection in specific populations. Applicants must pose at least one test of survey administration to determine its appropriateness for data collection in a specific population. Applicants should consider whether testing such administration methodology could be incorporated into other research proposed in response to this RFA.

Applicants must summarize their work to date in these areas: a) Research to further patient experience understanding and b) Research to further patient experience assessment. They must identify the next steps in research development in these topics, as well as the goals of such research. Specific aims involved in this work may include developing products, testing strategies, conducting field tests, analyzing data and modifying methods. Applicants must demonstrate an understanding of the central questions to further our understanding and assessment of patient experience, and experience in conducting research to develop and scientifically test patient narrative question development and analysis. Applicants must describe their strategies for obtaining information about new avenues for patient experience data, developing or assessing new methodological techniques for survey administration, survey or supplemental item set development, and preparing them for adoption by CAHPS users. Cooperative relationships between the grantees must be developed to enable collaboration and discussion of the work in order to avoid duplication of effort.

2. Continued Innovation to ensure relevance to health service delivery and survey best practices (~20% of budget)

The CAHPS team is known for its ability to develop surveys and supplemental item sets to address new areas of patient experience using standardized processes and methodology. The goals of such survey development are to ensure that the measures are comparable and consistent, and that the measures remain meaningful. The hallmark of these surveys is their careful incorporation of potential respondents in survey development and testing. Further, as health care quality measurement is a dynamic field, the Consortium must routinely consider and implement changes to the surveys, supplemental item sets, administration strategies, and modes of data collection. The surveys must remain responsive to the surveyed population and changes in health care delivery arrangements. CAHPS survey users and stakeholder organizations look to the CAHPS Team to keep CAHPS core survey items current while also ensuring comparability in the core measures. Applicants must identify at least one existing CAHPS survey or supplemental item set, discuss its relevance and need for additional research to maintain its applicability to the current health care delivery landscape (see https://www.ahrq.gov/cahps/surveys-guidance/index.html for CAHPS surveys and supplemental item sets). Applicants must describe emerging challenges for users and how they plan to approach and prioritize research and testing to assess CAHPS products for their continued relevance to and challenges of a changing health care service delivery environment. Applicants also should describe how they will partner with stakeholders in such research to determine need, constraints and field test opportunities. Such research should be reflected and incorporated into administration guidance of CAHPS surveys and related analytic tools. Cooperative relationships should be developed to enable collaboration and discussion of the work with the other awardee in order to avoid duplication of effort.

3. Reporting patient experience data (approximately 20% of budget)

Applicants to this RFA must describe at least one research study they wish to conduct in CAHPS V regarding reporting patient experience data. Research topics can address either a) Research to further the science of reporting; or b) research to further report usability and accessibility. Applicants must describe their capability for developing or collaborating in the development of a reporting tool in this area, including work to date, with specific emphasis on their experience producing them as part of a collaborative team.

a. Research to further the science of reporting

In the past CAHPS grantees have developed and conducted research projects to advance the science of reporting healthcare quality information to consumers and other audiences. This RFA calls for research that examines the effect of the application of different ways to report health quality data to consumers (for choice of health care services) and providers and their organizations (for quality improvement purposes). For example, the CAHPS IV grantees conducted research to identify patient narrative questions that could be used to complement CAHPS Clinician and Group Survey questions. Part of this research involved testing how consumers used this information to select providers. Applicants must demonstrate their research experience in this area and propose an approach to further advance reporting CAHPS data for consumer choice or quality improvement. Applicants can consider developing on-line tools or other systems for quality reporting purposes.

b. Research to further report usability and accessibility

AHRQ is interested in research to further the accessibility and usability of reports and CAHPS products for users, and in particular recognize any specific concerns of vulnerable populations. Suggested topics could include: developing CAHPS products recognizing a culturally diverse audience; developing products for those with low literacy or developmental disabilities; or understanding how consumers use CAHPS data to select health plans and providers. Should applicants be interested in this research, they must describe a research question and approach for addressing that research. The applicant should describe any products or tools that might be developed to further report usability and accessibility.

In addition to the above-described aims, applicants must describe their experience with and demonstrate their capability for developing or collaborating in the development of these products, including work to date, with specific emphasis on their experience producing them as part of a collaborative team.

4. Quality improvement studies based on CAHPS data (approximately 20% of budget)

CAHPS began with a primary goal of providing high-quality information to consumers and purchasers which they could use to guide their health plan selection decisions. As CAHPS has evolved, there has been growing interest in exploring the usefulness of CAHPS data for identifying opportunities and designing strategies to improve the quality of health care from the consumer or patient perspective.

Each applicant must conduct up to two quality improvement studies during the course of the project period. Proposed studies must be based on existing or new CAHPS data. Applicants must include at least one site at which the studies will be conducted. Description of these study designs must show that the applicant’s team has the skills and expertise necessary for designing, conducting, implementing, and evaluating quality improvement studies based on CAHPS data.

Applicants may choose any CAHPS survey to use as pre- and post- measures of change. Applicants are free to propose any QI study they like. An area of interest for potential QI collaborations is pay-for-performance projects. These projects provide incentives to health plans, provider groups and other health care delivery systems to improve their performance by offering increased financial reimbursement or special bonuses to those who meet certain goals. CAHPS or similar consumer assessment data are often included as one of the performance measures in these types of studies. Applicants should consider proposing studies that employ interventions and measurement strategies that can be used relatively easily and at low cost to other settings. Another area of interest is the use of CAHPS to reflect changes in experience with enhanced care coordination, patient engagement, shared decision-making or patient safety. Projects in these areas should build on existing work in defining and measuring these concepts and provide a clear model for how interventions in this area would improve patient experience in these areas and how that might be reflected in CAHPS scores.

Applicants may need to develop different and new CAHPS products to implement a QI study. For example, CAHPS data can identify areas in which a provider or an organization is performing poorly (e.g., in provider communication skills) but these data do not specify where and what the particular communication problems are. Thus, grantees may need to develop qualitative or quantitative tools to pinpoint specific behaviors that need to be changed.

5. Developing program communication strategies (approximately 10% of budget)

The CAHPS team provides frequent communications, technical assistance, and learning programs to users and staff. The CAHPS program communicates about new research, product launches and product training in many ways as determined by audience analysis and user feedback. The CAHPS program uses a variety of communication strategies to deliver this information including online methods, research publications, and presentations. Many of the aims relating to communications are intertwined in the development work. Some additional aims are described below.

a. Annual CAHPS Working Meeting

Organizations who receive CAHPS V awards must collaborate with each other and the CAHPS User Network contractor to plan and conduct a working meeting every year of the cooperative agreement. AHRQ will host an annual invitation-only, day-long, working meeting of not more than 75 people to discuss a research topic of interest to CAHPS researchers and users. The meeting will be held in Rockville, Maryland. Topics can include research on conceptual approaches to patient experience related to such topics as care coordination, patient engagement, shared decision-making, patient safety or another topic; a survey methods focus; quality improvement; or policy-relevant findings from CAHPS data. The goal of these meetings is to announce research to date, collect feedback, and develop next steps. Grantees activities (in consultation with AHRQ PO) will include, but not be limited to: identification of topics, planning the theme of the meeting, developing an agenda, developing content for the sessions and proposing speakers; serving as speakers, moderators or facilitators at the meeting; developing a strategy for soliciting and reviewing proposed sessions for the meeting; and working with the CAHPS User Network contractor on all other elements of meeting planning, presentation and evaluation. As part of the response to this RFA, applicants should identify a topic of interest for this meeting and meeting outcome or product.

b. Annual CAHPS Planning Meeting

Grantees will attend a one day annual CAHPS planning meeting at AHRQ headquarters to discuss ongoing topics of concern and develop a plan to address them. Grantees will collaborate with the AHRQ CAHPS program staff and the CAHPS User Network Contract to develop the agenda and will be prepared to present information to speak to specific issues.

c. Supporting dissemination and promotion activities.

Applicants to this RFA must collaborate with the CAHPS User Network contractor as necessary on the development and delivery of materials related to new patient experience of care research, product announcements and training. Such promotion and dissemination could consist, for example, of participating in a WebEx presentation on current research, developing content as necessary for the CAHPS website, or authoring blogs about current work. Topics for these communications will be determined in collaboration with AHRQ staff and the CAHPS User Network Contractor. Applicants to this RFA may wish to suggest successful strategies for reaching CAHPS users with new information about CAHPS research, products, and services.

The CAHPS program maintains a database of voluntarily submitted Clinician and Group CAHPS and Health Plan surveys. Clinician and group practices and health plans voluntarily submit data for benchmarking purposes. In addition, researchers can request de-identified data for research purposes. Applicants will discuss with the CAHPS User Network managers any decisions related to the CAHPS Databases, as necessary, particularly concerning changes to the surveys, production of the annual report of findings, and the development of analytic tools and techniques for data analysis (e.g., the CAHPS "macro"; https://www.ahrq.gov/cahps/news-and-events/events/ahrq-conference-2015/walsh-slides.html). Grantee team members, usually the Principal Investigators, attend a meeting with the managers of these databases to consult with them on technical questions or questions related to the use of the data. Sometimes these meetings are by conference call; sometimes they are in-person, usually in connection with other scheduled CAHPS meetings. As such, applicants to this RFA must include travel to these annual meetings as part of their budget (e.g., travel and airfare). The total length of the database management meetings are not expected to exceed a half a day.

Applicants to this RFA are encouraged to present information about CAHPS research and products at professional meetings; publish articles (including monographs and special journal supplements, if appropriate) about CAHPS in professional journals; and meet with groups who play a critical role in the adoption of CAHPS products, such as National Committee for Quality Assurance (NCQA) or National Quality Forum (NQF).

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

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

These projects are authorized by 42 U.S.C. 299a, which provides that AHRQ shall conduct and support research, support demonstration projects, and disseminate information on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness, and value of health care services.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for AHRQ support as Public or Private Institutions of Higher Education:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

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

Nonprofits Other Than Institutions of Higher Education

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

For-profit private institutions

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations
• Non-domestic (non-U.S.) Entities (Foreign Institutions)

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement via https://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf may participate in projects as member of consortia or as subcontractors only

Applicant Organizations

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

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

Program Directors/Principal Investigators (PD(s)/PI(s))

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for AHRQ support.

Multiple Program Director/Principal Investigators (MPD/PI)

Not applicable.

This RFA does not require cost sharing.

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

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

AHRQ will not accept duplicate or highly overlapping applications under review at the same time. This means that the AHRQ will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this RFA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

The letter of intent is to be sent to:

Caren Ginsberg, PhD
Telephone: 301-427-1894
Fax: 301-427-1341
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed:

• Introduction is limited to 1 page.
• Specific Aims is limited to 1 page.
• Research Strategy, including tables, graphs, figures, diagrams, and charts, is limited to 25 pages.

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

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

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

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

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

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

Budget Component: Special Instructions for AHRQ applications

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

All instructions in the 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:

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

• Generally, Resource Sharing Plans are expected, but they are not applicable for this RFA.

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. See NIH/NIOSH/AHRQ New Policy Appendix Guide located at NOT-OD-16-129 via https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-129.html

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

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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement (http://www.hhs.gov/sites/default/files/grants/grants/policies-regulations/hhsgps107.pdf) may participate in projects as member of consortia or as subcontractors only.

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

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

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

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to AHRQ. See Section III of this RFA 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 and compliance with application instructions by the Center for Scientific Review, NIH and responsiveness by AHRQ. Applications that are incomplete or non-compliant will not be reviewed.

In order to expedite the review, applicants are requested to notify the AHRQ Referral Office by email [email protected] when the application has been submitted. Please include the RFA 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 https://grants.nih.gov/grants/guide/notice-files/NOT-HS-00-003.html). However, initiation of IRB review, if necessary or applicable, is strongly encouraged to assure timely commencement of research.

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

Priority Populations

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

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants who are planning to share data 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.

Public Access to AHRQ-Funded Scientific Publications

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

Data Confidentiality

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

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

Sharing Research Resources: Rights in Data

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

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

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

Applicants should demonstrate specific experience in collaborating with other research and support organizations to realize larger programmatic goals.

Applicants should use the following percentages as guidelines, though not strict limits, for allocation of resources by project area:

• 30% Advancing the science and practice of patient experience assessment;
• 20% Innovation to ensure relevance to health service delivery and survey best practices;
• 20% Reporting patient experience data;
• 20% Quality improvement studies; and
• 10% Developing program communication strategies.

PD/PIs and grantee team members will be required to attend the following meetings:

• Twice monthly conference calls with PD/PIs, their alternates and AHRQ Program Official throughout the project (other designated team members may attend depending on topic);
• Scheduled conference calls of the instrument (weekly), reports (weekly), quality improvement (monthly) and communications teams (weekly) and others, throughout the project (at least one designated individual per cooperative agreement);
• One annual planning meeting (in-person) in Rockville, MD (up to 5 individuals per cooperative agreement)
• One annual research meeting (in-person) in Rockville, MD (up to 8 individuals per cooperative agreement)
• Annual in-person grantee team meetings, as necessary, located in Rockville, Maryland or Pittsburgh, Pennsylvania (plan for 2 quality improvement team meetings and 2 reports team meetings; up to 6 individuals per meeting);
• Up to five Technical Expert Panel meetings over the life of the cooperative agreement (in-person or by phone); one meeting per year; one person in Rockville, Maryland; up to four people (by phone) per cooperative agreement in person;
• Quarterly webcasts for CAHPS users.

Applicants should budget for

• 1 new CAHPS survey or new supplemental item set during the life of the project ( see Section I. Funding Opportunity Description, B.1.a. for details)

Each grant application must propose a PD/PI, as well as a co-investigator and describe a plan for decision making throughout the project period. Multiple PDs/PIs are not applicable for this program.

Applicants should propose cross-grantee teams in these areas: Instruments, Reports, Quality Improvement, Analysis, and Communications. Grantee teams are composed of members from each cooperative agreement organized to perform defined aims. These teams provide oversight, coordination to the research and other activities overseen by the teams. For example, the instrument team communicates information from their research and work with CAHPS survey development and implementation to maintain consistency among CAHPS surveys, recommend survey administration best practices, and ensure that the surveys and supplemental item sets reflect current health service delivery arrangements. The Reports team collaborates on the patient narrative elicitation developmental and implementation research and develops recommendations for use and analysis of information. For each team, applicants must propose a lead staff person and an alternate. During the course of the project, other teams may be created. The length of time teams are needed is dependent upon the work being performed by the team.

Applicants for this RFA must describe Technical Expert Panels (TEPs) required in order to complete proposed work. These committees advise the CAHPS Team about the needs and concerns of the organizations that use CAHPS products. They also provide valuable advice on dissemination and implementation of CAHPS products. TEPS usually include organizations representing consumers/patients; health care providers, purchasers; health plans; accrediting organizations and others. The grantees will select the members of these groups, set meeting agendas, and convene the group (in person or by phone) as often as necessary.

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

Applicants are required to follow the instructions for post-submission materials, as described in the policy (NOT-OD-16-130).

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 insurance 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 RFA 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 RFA 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.

For this particular announcement, note the following:

The U18 cooperative agreement supports activities which generally provide collaboration between participating PD/PIs, institutions and AHRQ. A cooperative agreement is an "assistance" mechanism (rather than an "acquisition mechanism), in which substantial AHRQ programmatic involvement with the grantees is anticipated during the performance of the activities as applicable in the terms and conditions of the award. Under the cooperative agreement, the AHRQ purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the PD/PI for the project as a whole, though specific tasks and activities may be shared between a grantee and AHRQ as described in the FOA. Cooperative activities are intended to strengthen the individual grantee activities through the facilitation of data/information sharing, data access, and cross cutting communications. Applicants must demonstrate flexibility in meeting emerging needs. Applicants must also demonstrate ongoing research in the areas specified in this RFA. Reviewers should evaluate the ongoing experience of applicants in the research specified above, and ability to work cooperatively on teams to complete research in progress.

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.

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Does the applicant understand the use and importance of patient experience understanding and measurement to CAHPS survey users? Does the applicant understand the history of the CAHPS program, challenges it faces moving forward, and areas in which patient experience work can grow within healthcare delivery? Does the applicant understand the significance of survey methods research to patient experience of care assessment?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or co-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Does the PI/PD have experience in:

• Designing patient-based experience of care surveys, field testing them, developing measures for public reporting using appropriate methodological and statistical techniques;
• Identifying and working productively with stakeholders from different organizations (e.g., accreditation organizations, health plans, consumer advocacy organizations, purchasers of health care services, etc.) and different health care service delivery settings (i.e., hospitals, community- based clinics, patient centered medical homes (PCMH), nursing homes, assisted living facilities, Accountable Care Organizations;
• Understanding the needs and various audiences who use health care information (e.g., consumers, patients, purchasers, plans, providers, payers, State and local-level health care organizations, etc.) and the ways in which they might use this information (selection of plans and providers; rewarding performance; comparing plan/provider performance; comparing plan/provider performance identifying local or multi-site quality problems; etc.);
• Identifying and recruiting appropriate sites, audiences for survey instrument testing, report template testing, QI studies and evaluation studies;
• Recruiting members of populations (e.g., people with poor cognitive skills or limited English proficiency; people with poor reading skills; people from diverse ethnic and cultural backgrounds; people with diminished visual capacity) to include in testing;
• Survey development methodology; survey research design; sampling; and psychometric analysis?
• Designing and implementing studies that examine mode of survey administration; development, testing, and analysis of patient narrative questions; and patient experience of care survey development and data analysis, particularly as they related to either patient safety, care coordination, patient engagement or shared decision-making;
• Collaborating with, providing technical assistance or training to, and/or monitoring the progress of test sites, community-based organizations, data supplying organizations and site representatives;
• Designing and implementing methodologically sound quality improvement programs based on patient experience data;
• Designing and implementing process and outcome evaluations, including: specification of evaluation questions and outcome measures; data analysis; development of data-based recommendations and use of the recommendations to improve products and procedures;
• Developing measurement tools for use in QI and evaluation studies?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed? Does the proposed team have experience in developing and testing new ways to deliver health quality information to a wide range of audiences (patients, consumers, providers, health plans, national, state, and local policy makers, government agencies, etc.)? Does the proposed team have experience designing and implementing methodologically sound studies for laboratory and real world testing of health quality reports for consumers and other audiences? Does the proposed team have experience developing and testing novel ways to administer national surveys of patient experience?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

Does the team have experience with all aspects of fielding a large scale, multi-site survey including but not limited to: formulation of a methodologically sound design; use of appropriate psychometric and other statistical and analytical techniques (e.g., imputation methods, case mix adjustment methods,) performance of validity and reliability studies on large-scale survey instruments; identification and resolution of methodological issues associated with sample selection and sample size; administration of surveys to the subpopulation of interest and within a variety of health care delivery settings; identification and resolution of methodological issues associated with mode of administration? Does the proposed team have experience in developing patient experience of care surveys and supplemental item sets using standardized CAHPS methodology (please see CAHPS survey developer guidelines)? Does the PD/PI have strong working knowledge of the methodology for developing patient experience of care surveys using the standardized survey development guidelines established by the CAHPS program? Does the team have experience producing detailed guidelines for survey data submissions for the CAHPS databases or other similar databases? Does the proposed team have experience writing clear, concise reports, summaries, and other documents? Does the team have experience in testing and translating surveys and related materials into Spanish with an approved CAHPS methodology? Does the proposed team have experience managing and collaborating productively with geographically distant team members who represent different disciplines, fields of study, and points of view? Does the proposed team have knowledge of health care quality issues (especially those important to consumers and other purchasers) as they pertain to long-term services and support, hospital care, care for those with poor cognitive skills, visual skills or other disability, and care received in ambulatory settings?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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

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

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

Degree of Responsiveness

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

Inclusion of Priority Populations

Reviewers will assess the adequacy of plans to address the needs of 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 ).

Not applicable.

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

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

As part of the scientific peer review, all applications:

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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

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

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

If all administrative and programmatic issues are resolved, a formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the AHRQ grants management officer is the authorizing document and will be sent via email to the 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 RFA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the AHRQ web site at http://www.ahrq.gov/funding/grant-mgmt/index.html. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to AHRQ grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this RFA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Terms and Conditions of Cooperative Agreement Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines: DHHS grant administration regulations at 45 CFR Parts 75 via http://www.ecfr.gov/cgi-bin/text-idx?node=pt45.1.75),, and other DHHS, PHS, and AHRQ grant administration policy statements (see http://www.ahrq.gov/funding/policies/hhspolicy/index.html). AHRQ will use these procedures in evaluating and administering the cooperative agreements under this RFA.

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

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

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

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

The grant recipient PD(s)/PI(s) (and Co-PD/PI) will be responsible for:

• Survey instrument development and appropriate testing;
• Feasibility studies as necessary to support the development of new CAHPS products;
• Formation of any Technical Expert Panels, including selection of members, convening meetings, planning meeting agendas and documenting activities;
• Report development and testing;
• Translation of instruments and report templates into other languages;
• Evaluation of the cultural comparability of questionnaires;
• Design, implementation, and analysis of quality improvements studies, including evaluation of the impact of intervention(s);
• Design, implementation, and analysis of survey and other methodological studies;
• Design, implementation, and analysis of other studies conducted under this cooperative agreement funding;
• Development of relationships with testing sites, QI study sites, and evaluation sites;
• Provision of AHRQ access to all data generated under this award as it is collected; and
• Cooperation with other key parties in these cooperative agreements, including but not limited to the CAHPS User Network contractor; other CAHPS grantees; and AHRQ Program Officers and other AHRQ staff.

AHRQ Responsibilities

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

Under the cooperative agreement, AHRQ’s purpose is to support and stimulate the recipient's activity by involvement in and otherwise working jointly with the grantee in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity.

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

The AHRQ program official is responsible for meeting yearly with the grantee to discuss and prioritize the research activities focusing on AHRQ's priority to improve health care quality, thereby determining assistance from the CAHPS User Network contract in fulfilling those goals.

AHRQ program officials will participate in all conference calls and planning meetings and providing input as needed; participate in the planning of and present at the annual working research and planning meeting; serve as liaison between the grantee and government organizations (such as the Office of Management and Budget (OMB)) and non-governmental organizations; report on the progress of the grantees towards project goals to OMB and to Congress; and perform other activities as required.

AHRQ program officials may also provide expertise/technical assistance to the grantee and assist with project activities or help coordinate activities with the CAHPS v grantee (e.g., author or co-author articles on issues related to consumer assessment and reporting or quality improvement studies).

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

Collaborative Responsibilities

When appropriate and feasible, AHRQ expects the grantee to work with the other CAHPS V grantees under this RFA to identify collaborative opportunities that can contribute to the overall success of these projects. These collaborative relationships may be facilitated by AHRQ program officials or contractors, instigated by the awardees through self-identified opportunities, or developed via other mechanisms during the life of the project.

The grantee is expected to work closely with the other CAHPS V grantee on collaborative projects including the patient narrative research and other research as defined.

The grantee is required to work with the CAHPS User Network contractor for the following:

• Developing, testing, and revising instructions for users of all CAHPS products;
• Updating other CAHPS products as necessary;
• Answering technical questions from CAHPS users, if necessary
• Providing all meeting materials, reports, and other items to the CAHPS User Network contractor in a timely manner;
• Providing guidance on the CAHPS Database as necessary;
• Participating in webinars and podcasts as required.

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

For details regarding progress report submission, refer to http://www.ahrq.gov/fund/noncomp.htm. If instructions on the AHRQ website are different from the RPPR Instructions, follow the instructions on the AHRQ website. Progress reports are due 3 months before the anniversary of the award.

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

Expenditure data is to be reported on the Federal Financial Report (FFR; SF 425). AHRQ requires annual financial expenditure reports for ALL grant programs as described in the HHS Grants Policy Statement (http://www.ahrq.gov/fund/hhspolicy.htm). AHRQ implementation of the FFR retains a financial reporting period that coincides with the budget period of a particular project. However, the due date for annual FFRs is 90 days after the end of the calendar quarter in which the budget period ends. For example, if the budget period ends 4/30/2018, the annual FFR is due 9/30/2018 (90 days after the end of the calendar quarter of 6/30/2018).

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

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

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

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

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

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Caren Ginsberg, Ph.D.
Center for Quality Improvement and Patient Safety (CQuips)
Agency for Healthcare Research and Quality (AHRQ)
Telephone: 301-427-1894
Fax: 301-427-1341
E-mail: [email protected]

Nghia Vo, M.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
Telephone: (301) 427-1191
Fax: (301) 427-1562
E-mail address: [email protected]

Brian Campbell
Office of Management Services
Division of Grants Manangement)
Telephone: 301-427-1266
Email: [email protected]

Recently issued AHRQ policy notices may affect your application submission. A full list of policy notices published by AHRQ is provided in the NIH Guide for Grants and Contracts. Notices can also be found at AHRQ Grants Policy Notices.

AHRQ Grants Policy and guidance to applicants regarding Funding Opportunity Announcement procedures can be found at Funding Opportunity Announcement Guidance.

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 U.S.C. 299 et seq., and in accordance with 45 CFR Part 75, and other referenced applicable statutes and regulations. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement. The HHS Grants Policy Statement can be found at http://www.ahrq.gov/fund/hhspolicy.htm.