Part I Overview Information

Department of Health and Human Services

Issuing Organization
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Quality Improvement and Patient Safety

Title:  Limited Competition: Continuation of Consumer Assessment of Healthcare Providers and Systems (CAHPS IV) (U18)

Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type

New

Request for Applications (RFA) Number: RFA-HS-12-003

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: February 10, 2012
Opening Date:  February 29, 2012
Letters of Intent Receipt Date(s): March 2, 2012
NOTE: On-time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization).
Application Due Date(s): March 29, 2012
Peer Review Date(s): Approximately two months after receipt date
Earliest Anticipated Start Date(s): September, 2012
Additional Information to Be Available Date (Activation Date): Not Applicable
Expiration Date: March 30, 2012

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content

Executive Summary

The purpose of this FOA for CAHPS IV is to continue the work of the Consumer Assessment of Healthcare Providers and Systems project (or CAHPS) which AHRQ began in 1995. The current FOA is a limited competition opportunity, which builds upon and extends the work of current grantee organizations that were funded under CAHPS III (see http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-07-001.html).  Thus only these grantee organizations are eligible to apply to this FOA.

While grant awards are made to institutions rather than individuals, this announcement and its instructions are written to inform individual researchers of this funding opportunity and facilitate the submission of grant applications by their organizations.

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants
    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other-Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Receipt, Review, and Anticipated Start Dates
          1. Letter of Intent
          2. Technical Assistance
    B. Submitting an Application Electronically to AHRQ
  C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
     A. Cooperative Agreement Terms and Conditions of Award
       1. Principal Investigator Rights and Responsibilities
       2. AHRQ Responsibilities
       3. Collaborative Responsibilities
3. Reporting

Section VII. Agency Contacts
1. Scientific/Research Contact(s)
2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

A.  Background: Overview of CAHPS

The purpose of this FOA for CAHPS IV is to continue the work of the Consumer Assessment of Healthcare Providers and Systems project (or CAHPS) which AHRQ began in 1995.  For the past 17 years, the CAHPS team -- CAHPS grantees, the CAHPS/SOPS Survey User Network, and AHRQ CAHPS staff -- has developed and tested surveys through which consumers can assess the quality of care they receive through their health plans, from providers, and in hospitals, nursing homes, in-center hemodialysis facilities, and other settings. The CAHPS team has also conducted research and developed guidance for reporting these data to consumers, providers and other audiences.  (Detailed information about CAHPS products and history can be found at http://www.cahps.ahrq.gov/.)  In 2011, over 143,000,000 Americans were enrolled in health plans or visited health facilities through which CAHPS data were collected. 

B.  Research Objectives

This FOA solicits research to be performed within five broad areas: a) developing and testing CAHPS survey products, b) maintaining existing CAHPS surveys and all materials related to survey administration; c) developing and maintaining materials related to reporting CAHPS survey results; d) designing and implementing quality improvement studies based on CAHPS data; and e) promoting CAHPS products. Each of these areas is described in detail in this section.

This FOA lists approaches to aims as examples of the kind of work that could be performed in support of a particular effort.  Applicants should not feel 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.

A note on terminology used in this FOA: The CAHPS Team includes the two CAHPS grantees, AHRQ CAHPS staff and staff from the CAHPS/SOPS User Network contract. The CAHPS Consortium (or The Consortium ) includes all these groups plus any funder (apart from AHRQ) of a CAHPS product. The Steering Committee refers to selected representatives of each group composing the CAHPS Consortium. Grantee teams are team organized to develop a particular survey, reporting resource, quality improvement guide or other product. Grantee teams include members from both grantee organizations as well as a support person from the CAHPS/SOPS User Network Contract and an AHRQ representative.

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 within the CAHPS team. In describing their ability to perform the research in response to this FOA, applicants should highlight their 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 Steering Committee will meet in person to assess progress towards goals and activities for the coming year. The Steering Committee will also determine what types of support will be needed from the User Network Contract in the coming 12 to 24 months. After this meeting, the Director of the User Network Contract will prepare a budget based on the list of the proposed support activities. The Steering Committee will then meet by phone to discuss and refine the number and types of support activities, as well as timelines, specific aims, and budget.

For the purpose of application preparation, applicants should expect that the maximum annual total costs of $1.5M is to be budgeted approximately as follows:

25% Developing and testing CAHPS survey products

10% Maintaining existing CAHPS surveys and all materials related to survey administration

25% Reporting CAHPS data,

25% Performance of quality improvement studies based on CAHPS data, and

15% Disseminating and promoting CAHPS products.

Sources that may be helpful in developing content for this FOA include: The National Health Care Quality Strategy (http://www.ahrq.gov/workingforquality/nqs/) and its annual updates, and the Affordable Care Act, especially Part D, Title IX, Subpart II, relating to consumer assessment of health care services.

Applications that respond only to individual objectives of this FOA rather than the entire range of objectives will not undergo review.

1.  Developing and testing survey products (~25% of budget)

The CAHPS IV grantees will need to work with the AHRQ Project Officers (POs) to 1) develop OMB clearance packages to cover the collection of data for survey testing and other purposes and 2) develop packages to submit to the National Quality Forum for endorsement.

a. Developing new surveys

From the beginning of CAHPS to the present, the CAHPS Team has had more ideas (and requests) for new surveys than the budget could support. In their applications, applicants should identify the most important areas within which new surveys should be developed and explain why survey development in these areas is critical. Applicants should also describe the principles that guide their survey development process and testing methods.

b. Developing materials to support the implementation of CAHPS products

Every CAHPS survey comes with complete instructions for its implementation, from how to draw a sample or hire a contractor to responding to questions from the news media about survey data. Though the CAHPS/SOPS User Network contractor takes the lead in writing, assembling and publishing these implementation materials, these documents are based on written or verbal input from the CAHPS grantees. Some user products, such as programs for analysis of CAHPS data, must be developed by the grantees. Applicants must describe their capability for developing or collaborating in the development of these products, with specific emphasis on their experience producing them as part of a collaborative team.

c. Advancing the science and practice of consumer assessment

Developing new strategies for collecting CAHPS data. Since the beginning of CAHPS, the CAHPS Team has developed both telephone and self-administered versions of each survey. In addition to those formats, applicants should consider identifying and testing nonstandard methods for survey data collection, such as Web-based data collection or interactive voice response.  If they yield valid and reliable data, these methods have the potential to reduce the cost of data collection, thus making them more attractive to potential users.  As new settings for CAHPS surveys are explored, the CAHPS Team will need to develop reliable methods for obtaining data from (and reporting data to) people with cognitive impairments and people with visual or mobility impairments.  Specific aims involved in this work may include developing testing strategies, conducting field tests, analyzing data and modifying methods. Applicants must describe their strategies for obtaining information about and developing new methodological techniques, as well as testing these techniques and preparing them for adoption by CAHPS users.

d. Advising the CAHPS/SOPS User Network managers on decisions related to the CAHPS Databases.

The User Network Contract develops and maintains two CAHPS Databases, one containing data from the CAHPS Survey for Health Plans and a second containing data from the CAHPS Survey for Clinician and Group Practices. Grantee team members, usually the Principal Investigators, attend an annual meeting with the managers of these databases to advise 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 a CAHPS/SOPS User Meeting. Applicants to this FOA must account for their participation in these annual meetings as part of their budgets.

2. Maintenance of Existing CAHPS Surveys and Administration Materials (~10% of budget)

To accommodate the needs of CAHPS survey users and stakeholder organizations, the CAHPS Team strives to keep CAHPS core survey items stable from year to year.  Health care quality measurement is a dynamic field, and from time to time, the Consortium considers and implements changes to the surveys, administration strategies, modes of data collection, as well as development and testing of new sets of supplemental items. Applicants must describe how they plan to maintain existing surveys and the types of testing that may be required to support changes to the surveys. They should also describe plans for updating and maintaining all materials related to administration of CAHPS Surveys, including but not limited to: programs for data analysis; sampling strategies; sample letters and postcards to request respondent participation; instructions for administering the surveys via mail, telephone or other media; and instructions for administering surveys to Spanish-speaking as well as English-speaking people.

3.  Reporting CAHPS Data (~25% of budget)

a. Development of Reporting Resources.

In CAHPS I, the CAHPS Team developed a turn-key template for users of CAHPS surveys so they could report results to consumers and other audiences. But the CAHPS team found that no survey sponsor used the template in its entirety, though many used chunks of the text or the data displays in reports they designed themselves. In view of this, the CAHPS Team realized that we could best serve report developers by publishing reporting resources rather than turn-key templates.  The CAHPS II Team developed two products for this purpose, the TalkingQuality Web site and the Report Card Compendium, which are briefly described below.

TalkingQuality.gov. To assist developers of quality reports for consumers, the CAHPS II Team developed a Web site, http://www.talkingquality.gov/, which organizes existing expertise and research about principles of effective reporting.  The TalkingQuality Web site describes the entire process of developing a quality report, from Getting Started to Evaluating the Project, and offers, when available, evidence-based advice on strategies that contribute to a successful report. 

Report Card Compendium.  In addition to advice about effective reporting, sponsors often want to see how other organizations similar to theirs respond to the demand from consumers for easily understandable health quality information.  In response, the CAHPS Team developed the Report Card Compendium, a directory of over 200 reports of comparative information on the quality of health plans and providers.  Its purposes are to inform and support the people and organizations that develop report cards and to provide easy access to examples of different approaches to content and presentation. 

In CAHPS III, the CAHPS grantee teams worked collaboratively with the CAHPS/SOPS User Network contractor to completely update both these resources. CAHPS IV applicants may wish to consider updating them as part of their work.

Applicants are free to propose development of additional reporting resources. If additional resources are proposed, the applicant should explain why this resource is necessary and how it will be useful to report developers.

b. Composite labels development and testing

CAHPS Survey data are traditionally reported in composites. Composites roll up scores related to a cluster of similarly-themed items and makes it possible for the user to review five or six composite scores rather than responses to 30 or 40 individual items. (Most report developers, however, choose to include individual item scores along with composites for those users who want a more complete picture of the quality of services offered by a provider or institution.) AHRQ requires organizations that wish to use the CAHPS trademark on their surveys to develop and report survey composites exactly as specified in the administration instructions for that survey.

The labels for these composites must make sense and appeal to users of CAHPS reports. To ensure that this is the case, the CAHPS Team has traditionally begun the process of composite label development by conducting a factor analysis to see which items cluster together. The analysis team then meets with the reports team to develop draft labels for these item clusters. The reports team then iteratively tests proposed labels with target audience members until they identify ones that work. Applicants must describe their ability to perform such research or describe a different and better way to produce accurate and understandable composite labels.

c. Conduct of research related to the science of reporting

In addition to the aims listed above, past CAHPS grantees have developed and performed research projects to advance the science of reporting healthcare quality information to consumers and other audiences. For example, the CAHPS III grantees performed a study where members of the target audience visited a Web site that gives users different types of information about physicians, including clinical data, patient assessment data and anecdotal data. Participants in this study were asked to review the data and select a physician who would be best for them and their families. The design of this experiment will enable us to see which type of information users consult first or most often, as well as their reasons for choosing these sources of information.

AHRQ is interested in research that examines the effect 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). Applicants to this FOA must describe report research studies they wish to conduct in CAHPS IV. Applicants may choose to devote funds to a single large report research study as the CAHPS III grantees did. In either case, the study description must explain why testing the proposed hypothesis is important and how the results will benefit the report development community.

d. Additional reporting research

In addition to the above-described aims, applicants must describe their experience with and demonstrate their ability to:

4.  Quality Improvement (~25% 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 designing strategies to improve the quality of health care from the consumer or patient perspective. 

a. Quality Improvement (QI) Studies Based on CAHPS Data

For the purpose of application preparation, each applicant should assume that they will conduct one quality improvement study within the first half of the project, and one additional study in the last half of the project.  Both studies should be based on CAHPS data.  For the first study, the applicant should recruit a site at which the studies will be conducted and include letters from the organization indicating its willingness to collaborate, should the application be successful.  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.  For the QI study proposed for the latter half of the project, applicants are not required to have already recruited a site(s) but should describe these studies in their applications in a way that will allow reviewers to assess that applicant’s ability to perform the work.  Before beginning work with a second site, the grantee must submit a research plan and obtain approval for this plan from the Project Officer.  

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, but AHRQ is interested in studies that incorporate multiple interventions in different settings.  Another 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 one or more QI studies that employ interventions and measurement strategies that will transplant relatively easily and at low cost to other settings.

Applicants may need to develop different and new CAHPS products to implement a QI study.  For example, CAHPS data can identify areas where 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.  Like all CAHPS products, all interview protocols, focus group discussion guides and other such materials developed for QI studies will be published on the Web site and available to users free of charge.

b. The CAHPS Improvement Guide

The CAHPS Team, in collaboration with the Center for Medicare and Medicaid Services (CMS), developed The CAHPS Improvement Guide: Practical Strategies for Improving the Patient Care Experience in CAHPS II. This document, which was updated during CAHPS III, is available on the CAHPS Web site and contains a wealth of information about the value of patient experience data, assessment of an organization’s readiness to change; and steps to implementing quality improvement strategies. It also identifies strategies that can be used for quality improvement. Applicants to this FOA may consider updating this resource as part of CAHPS IV as well as developing additional resources to assist CAHPS Survey users in implementing quality improvement strategies.

5.  Disseminating and promoting adoption of CAHPS products and providing technical assistance (~15% of the budget)

Though dissemination and promotion is described in this separate category, many of the aims relating to these areas are intertwined in the development work.  Some additional aims are described below.

a. CAHPS/SOPS User Network Meetings

Since the beginning of CAHPS, national User Network meetings have been an important and positively evaluated means of communicating with CAHPS product users. These meetings allow users to discuss problems or issues with survey implementation, report preparation, sampling procedures or any other issue related to CAHPS products. It also allows users to meet each other and share strategies to overcome obstacles or success stories related to use of CAHPS products. User Network meetings have also allowed the CAHPS Consortium to hear about problems that need to be fixed, information that needs to be expanded or explained differently, or requests for new products.

Since 2007, the contract that supports CAHPS and promotes its products also performs these services for AHRQ-funded Surveys of Patient Safety Culture (SOPS) for Hospitals, Medical Offices and Nursing Homes. It is anticipated that a SOPS Survey for Pharmacy will be completed by the time these cooperative agreements are awarded. The past two User Network meetings have included sessions on CAHPS, sessions on SOPS, and sessions that address the use of data from each of these surveys identifying areas where providers and health care organizations could improve service. Though developing SOPS Surveys is not part of this FOA, grantees need to be familiar with SOPS surveys and contribute to planning CAHPS/SOPS sessions at User Group meetings. (See http://www.ahrq.gov/qual/patientsafetyculture/ for more information about SOPS Surveys.)

Organizations who receive CAHPS IV awards must collaborate with each other and the User Network contractor to plan and present one national CAHPS/SOPS meeting during the five year span of this cooperative agreement. This collaboration will involve but is not limited to: identifying a location appropriate for the meeting; planning the theme of the meeting, 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; working with the User Network contractor on all other elements of meeting planning, presentation and evaluation.

In addition to User Network meetings, applicants may wish to propose planning and delivery of smaller scale meetings on narrower topics, such as best practices for reporting CAHPS data to consumers, purchasers of health care services or policy-makers.

b. Participation in the AHRQ Annual Meeting

Every September, AHRQ sponsors a meeting to showcase AHRQ-funded research and present information and discussion on issues related to AHRQ’s mission. In the past, the CAHPS Team has found that this forum offers a relatively low-cost way to communicate new information to CAHPS users.

For budget preparation, applicants should assume that the CAHPS Team will present three CAHPS sessions and one CAHPS pre-session at the AHRQ Annual Meeting for four years of the five year span of this project. The Team will not present CAHPS sessions at the AHRQ Annual Meeting during the year in which the CAHPS/SOPS User Meeting will take place.

c. Additional meetings.

Applicants are free to propose additional meetings for the purpose of disseminating information about CAHPS products. For example, the CAHPS II grantees developed and presented a meeting to present and discuss CAHPS research conducted both within and outside of the cooperative agreements.

d.Webinars, podcasts, use of social media, and in-person presentations to CAHPS Users

Applicants to this FOA must collaborate with the CAHPS/SOPS User Network contractor on the development and delivery of webinars and podcasts related to CAHPS surveys, data reporting and quality improvement strategies. Topics for these webinars and podcasts will be determined in collaboration with AHRQ staff and the User Network Contractor. Applicants to this FOA may wish to suggest other strategies in addition to webcasts and podcasts for reaching CAHPS users with new information about CAHPS products and services.

e. Other dissemination and promotion activities

Applicants to this FOA will also: assist the User Network contractor when necessary with responding to requests for information from users; present information about CAHPS products at professional meetings; publish articles (including monographs and special journal supplements, if appropriate) about CAHPS in professional journals; meet with groups who play a critical role in the adoption of CAHPS products, such as NCQA, NQF or the Hospital Quality Alliance; and perform other activities, if necessary.

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

Section II. Award Information

1. Mechanism of Support

This funding opportunity will use the cooperative agreement award mechanism. In the cooperative agreement mechanism, the PD/PI retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with AHRQ staff being substantially involved as a partner with the PD/PI, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

Although the financial plans of AHRQ provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

AHRQ intends to commit approximately $3 million dollars in FY 2012 to fund two applications.  Each application must be five years in duration with a budget not to exceed $1.5 million annually in total costs to the government. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation. Applications with project periods that exceed five years or budgets that exceed $1.5 million total costs in any given year will not be reviewed. Funding beyond the first year will be contingent upon a review by Agency staff of the non-competing continuation report.

Section III. Eligibility Information

Since 1995, AHRQ has funded CAHPS grantees to develop and test patient experience surveys, to conduct research on reporting survey results to consumers and other audiences, and to develop and implement quality improvement programs based on CAHPS data.

Asking health care organizations to change long-held practices, such as the use of a new survey for collecting patient assessments of care, is often met with resistance.  Most organizations that collect these data have invested a considerable amount of time and money in development of systems to sample patients, collect the data, analyze the data and interpret the results.  To these decision-makers, changing existing surveys and associated systems, even when a new survey has significant advantages over the existing one, often looks like spending scarce resources to fix something that isn t broken.

Over the past 17 years, AHRQ has learned that the most important factor leading to adoption of CAHPS surveys is a strong and consistent working relationship between the CAHPS team and potential users.  This includes involving potential users, as well as organizations that represent them, in all phases of product development, from identifying survey topics and items to brainstorming about potential obstacles to survey adoption. In CAHPS III, the CAHPS team spent three years establishing an excellent working partnership with stakeholder organizations to develop the CAHPS Survey for the Patient-Centered Medical Home (PCMH).  Though a first draft of this survey has been produced, there is still work to be done in this area, such as a field test to examine implementation issues including the effect of survey distribution methods on validity, reliability and other variables, and testing new strategies for lower cost data collection.  It would take months for new grantees to develop a similar working relationship with all the stakeholders in this process, and it would extremely difficult to accurately communicate the history of decisions that lead to this product. For these reasons, AHRQ has decided to limit the competition for CAHPS IV to the two existing grantees.

1. Eligible Applicants

Number of Applications. Each applicant may only submit a single application.

Resubmissions. Applicants are not permitted to submit a resubmission application in response to this FOA.

1.A. Eligible Institutions

The competition for this FOA is limited to the two current CAHPS III grantees.

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.

1.B. Eligible Individuals

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

2. Cost Sharing or Matching

This program does not require cost sharing for applications in response to this FOA.

While there is no cost sharing requirement included in this FOA, AHRQ welcomes applicant institutions, including any collaborating institutions, to devote resources to this effort. An indication of institutional support from the applicant and its collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions that plan to provide support 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 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.

3. Other-Special Eligibility Criteria

None.

Section IV. Application and Submission Information

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, use the Apply for Grant Electronically button in this FOA or link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

Registration:

Appropriate registrations with Grants.gov and eRA Commons must be completed on or before the due date in order to successfully submit an application. Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered with both Grants.gov and the Commons. All registrations must be complete by the submission deadline for the application to be considered on-time (see 3.C.1 for more information about on-time submission).

A one-time registration is required for institutions/organizations at both:

PD(s)/PI(s) should work with their institutions/organizations to make sure they are registered in the NIH eRA Commons.

Several additional separate actions are required before an applicant can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Registered

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note: The registration process is not sequential. Applicants should begin the registration processes for both Grants.gov and eRA Commons as soon as their organization has obtained a DUNS number. Only one DUNS number is required and the same DUNS number must be referenced when completing Grants.gov registration, eRA Commons registration and the SF424 (R&R) forms.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and the SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo -- Telephone 301-710-0267; Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms for this FOA through Grants.gov/Apply and in accordance with the SF424 (R&R) Application Guide (http://grants.nih.gov/grants/funding/424/index.htm).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. Some fields within the SF424 (R&R) application components, although not marked as mandatory, are required by AHRQ (e.g., the Credential log-in field of the Research & Related Senior/Key Person Profile component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

The SF424 (R&R) application has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in the following components:

Required Components:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Research & Related Budget

(See Section IV.6., Special Instructions, regarding appropriate required budget component.)

Optional Components:

PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

SPECIAL INSTRUCTIONS

Applications Involving a Single Institution

When a single institution is involved, follow the instructions contained in the SF424 (R&R) Application Guide.

Applications Involving Multiple Institutions 

When multiple institutions are involved, one institution must be designated as the prime institution and funding for the other institution(s) must be requested via a subcontract to be administered by the prime institution. When submitting a detailed budget, the prime institution should submit its budget using the Research & Related Budget component.  All other institutions should have their individual budgets attached separately to the Research & Related Subaward Budget Attachment(s) Form.  See Section 4.8 of the SF424 (R&R) Application Guide for further instruction regarding the use of the subaward budget form. 

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review, and Anticipated Start Dates

Opening Date: February 29, 2012 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): March 2, 2012
Application Due Date(s): March 29, 2012
Peer Review Date(s): Approximately two months after receipt date
Earliest Anticipated Start Date(s): September, 2012

3.A.1. Letter of Intent

AHRQ requests the prospective applicants to submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (please refer to the number and title of this funding opportunity). Please include the name and email address of the PD/PI.

This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application.  However, these letters are administratively very helpful, as indicated above. To be most useful, the letter of intent is to be sent by the date listed above and at the beginning of this document.

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

Christine Crofton, Ph.D.
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Christine.Crofton@ahrq.hhs.gov
Telephone: (301) 427-1323
FAX: (301) 427-1341

The letter of intent is to be sent by the date listed in Section IV.3.A

3.A.2. Technical Assistance

Section 3.A.2 Technical Assistance

Not applicable to this FOA.

3.B. Submitting an Application Electronically to AHRQ

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/applicants/apply_for_grants.jsp and follow Steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

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

3.C. Application Processing

Applications must be received on or before the application receipt date described above (Section IV.3.A.). If an application is received after that date, the application may be delayed in the review process or not reviewed.

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

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial merit review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PD/PI receive Commons acknowledgments. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on the application status in the Commons.

AHRQ will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

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

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

o Use of CMS Data

Purchase of Centers for Medicare and Medicaid Services (CMS) public-use data, if required, should be discussed in the application narrative and included in the budget. Projects will ordinarily not use CMS (Medicare or Medicaid) data involving individual identifiers. However, for applications that propose to use Medicare or Medicaid data that are individually identifiable, applicants should state explicitly in the Research Design and Methods section of the Research Plan (form 398) the specific files, time periods, and cohorts proposed for the research.  The applicant should obtain an estimate for the cost of the requested data, if possible. This estimate will be included in the estimated total cost of the grant at the time funding decisions are made.

Applicants should be aware that for individually identifiable Medicare and Medicaid data, PD/PI(s) and their grantee institutions will be required to enter into a Data Use Agreement (DUA) with CMS to protect the confidentiality of data in accordance with the terms of the DUA and applicable law.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take six months from the time they are submitted to complete. Applications proposing to contact beneficiaries or their providers require the approval of the CMS Director and may require meeting(s) with CMS staff.

CMS data are provided on IBM mainframe tapes using the record and data formats commonly employed on these computers. Applicants should either have the capability to process these tapes and formats or plan to make arrangements to securely convert them to other media and formats.

Questions regarding CMS data should be directed to the AHRQ program official listed under Agency Contacts (see Section VII).

To avoid double counting, applicants should not include the cost of identifiable CMS data in the budget.  In the event the total costs of the project plus the cost of CMS data is greater than the total cost cap of this FOA, the budget for the project will be adjusted so that the total costs awarded to the recipient plus the CMS data costs do not exceed the cost cap. 

4. Intergovernmental Review

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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/fund/hhspolicy.htm

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

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

6. Other Submission Requirements

Grantees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.2.A "Award Administration Information". Also, grantees must work collaboratively with each other, with staff from the CAHPS/SOPS User Network Contract, with other governmental agencies who may provide financial or intellectual contributions, and with the AHRQ Project Officer and other AHRQ staff.

Appendix Material

The following materials may be included in the Appendix:

Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. 

Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan. No images may be included in the Appendix that are not also represented within the Research Plan.

Applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan. An application that does not observe the relevant policies and procedures may be delayed in the review process.

Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

Application Characteristics

Budget

To simplify budget preparation, applicants should follow the assumptions listed below:

Number of awards. AHRQ intends to commit approximately $3 million dollars in FY 2012 to fund two applications.  For budgeting purposes, each applicant may submit a total cost annual budget that does not exceed $1.5 million dollars. 

Resource allocation by project area. Applicants should use the following percentages as guides for allocation of resources by project area:

25% Developing and testing CAHPS survey products

10% Maintaining existing CAHPS surveys and all materials related to survey administration

25% Reporting CAHPS data,

25% Performance of quality improvement studies based on CAHPS data, and

15% Disseminating and promoting CAHPS products.

Meetings. PD/PIs and grantee team members will be required to attend or help plan the following meetings:

The grantees will participate in an annual site visit conducted by the AHRQ project officer (PO); the purpose of the site visit is to review project progress and to assess the level of institutional support and commitment. 

Project organization and management. Each grant application must propose a PD/PI, as well as a co-investigator who will be available to make decisions regarding the CAHPS program in the PD/PI s absence. The PD/PI has ultimate fiscal and intellectual responsibility for the project but the co-investigator, a senior investigator on the team, will be responsible for all aspects of project management when the PD/PI is unavailable.  The PD/PI and the co-investigator should coordinate their schedules so that one or the other is always available.

The PD/PI serves as the official voice of that grantee team.  Communication from the grantee team to the AHRQ Project Officer should come from the PD/PI rather than from multiple members of that team.

Applicants should propose staff with a range of experience and skill levels.  Our goal is to avoid the situation where extremely qualified or senior level staff are performing aims that a person with less experience could perform just as well.

Applicants should propose cross-grantee teams in these areas: instruments, reports, quality improvement, and analysis. Cross-grantee teams are composed of members from each grantee team organized to perform defined aims. For each cross-grantee team, applicants must propose a lead staff person and alternate. During the course of the project, other cross-grantee teams may be created. The length of time cross-grantee teams are needed is dependent upon the work being performed by the team.  During CAHPS IV, one staff person from the CAHPS/SOPS User Network contract will participate in each cross-grantee team to prepare and publish call notes for that team and sometimes to participate in the content of the work. 

For critical periods during CAHPS I through III, the PD/PIs met weekly by phone and sometimes in person with the AHRQ project officers, representatives from the UN contractor, team conveners, and other people as required.  CAHPS IV may begin with weekly phone calls to set the initial agenda and determine how to best organize the work, and then move to monthly calls once major decisions have been made. 

The Steering Committee (described above) will set the overall direction of the CAHPS project and decide on project priorities from year to year. The grantees will determine whether and what types of Technical Expert Panels (TEPs) are necessary.  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.  One representative from each organization on the Steering Committee is an ex officio member of each TEP.

PD/PI Credential (e.g., Agency Login)

AHRQ requires the PD/PI to fill in his/her Commons User ID in the PROFILE Project Director/Principal Investigator section, Credential log-in field of the Research & Related Senior/Key Person Profile component.

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

PHS398 Research Plan Component Sections

All application instructions outlined in the SF424 (R&R) Application Guide that are not otherwise specified within this Funding Opportunity Announcement are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

Budget Component

Special Instructions for Modular Grant applications

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

Warning: Please be sure to observe the total cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the Public Health Service Act, directed AHRQ, in carrying out its mission, to conduct and support research and evaluations, and to support demonstration projects, with respect to 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.  This authority is found at 42 USC 299(c).  To implement this statutory mandate, AHRQ published a Notice in the NIH Guide on February 28, 2003, establishing a new Agency policy on the Inclusion of Priority Populations in health services research (see http://grants.nih.gov/grants/guide/notice-files/NOT-HS-03-010.html).  Applicants under this FOA should consider and discuss including priority populations in the research design as specified in this Notice.

To facilitate generalizability of CAHPS products to a variety of populations and settings, applicants to this FOA should indicate their strategies for inclusion of representatives of these populations in their testing studies: people with poor cognitive skills and/or reading ability; people for whom English is not the primary language; people with visual impairments; people with mobility impairments. 

Publication Transmittal: General AHRQ Requirements

In keeping with the Agency's efforts to translate the results of AHRQ-funded research into practice and policy, grantees are to inform the AHRQ Office of Communications and Knowledge Transfer (OCKT) when articles from their AHRQ-supported activities are accepted for publication in the professional literature.  Grantees should also discuss any ideas about other dissemination and marketing efforts with OCKT staff.  The goal is to ensure that efforts to disseminate research findings are coordinated with other Agency activities to maximize awareness and application of the research by potential users, including clinicians, patients, health care systems and purchasers and policymakers.  This is critical when outreach to the general and trade press is involved.  Accordingly, contact with the media will take place with close coordination between OCKT and the press offices of the grantee's institutions.  In cases when products are created (such as annual or final reports, Web-based tools, CD-ROMs), grantees will be asked to submit to OCKT a brief plan describing how the product will be publicized.  An OCKT staff person will be assigned to each product and will coordinate the implementation of the plan, especially issues related to printing and electronic dissemination, and outreach to the media.

Assessment of AHRQ Grant Programs

In carrying out its stewardship of research programs, AHRQ may request information essential to an assessment of the effectiveness of Agency research programs.  Accordingly, grant recipients are hereby notified that they may be contacted after the completion of awards for periodic updates on publications resulting from AHRQ grant awards, and other information helpful in evaluating the impact of AHRQ-sponsored research.

AHRQ expects grant recipients to keep the Agency informed of publications, as well as the known uses and impact of their Agency-sponsored research. Applicants must agree to notify AHRQ immediately when a manuscript based on research supported by the grant is accepted for publication, and to provide the expected date of publication as soon as it is known, regardless of whether or not the grant award is still active.

HCUP & MEPS

Applicants are encouraged to make use of AHRQ’s Healthcare Cost and Utilization Project (HCUP) or the Medical Expenditure Panel Survey (MEPS).  HCUP is a family of health care databases and related software tools and products developed through a Federal-State-Industry partnership.  HCUP databases bring together the data collection efforts of State data organizations, hospital associations, private data organizations, and the Federal government to create a national information resource of patient-level health care data.  HCUP databases provide data beginning in 1988 and contain encounter-level information for all payers compiled in a uniform format with privacy protections in place.  HCUP includes three nationwide databases, the Nationwide Inpatient Sample (NIS) and the Kids Inpatient Database (KID), and the Nationwide Emergency Department Sample (NEDS), and three types of State databases, the State Inpatient Databases (SID), the State Ambulatory Surgery Databases (SASD), and the State Emergency Department Databases (SEDD).  More information on HCUP can be found at http://www.hcup-us.ahrq.gov/home.jsp.

The MEPS is conducted to provide nationally representative estimates of health care use, expenditures, sources of payment, and insurance coverage for the U.S. civilian, non-institutionalized population.  MEPS is composed of three component surveys: the Household Component (HC), the Medical Provider Component (MPC), and the Insurance Component (IC).  The Household Component is the core survey, and it forms the basis for the MPC sample and part of the IC sample.  The MEPS IC collects data on health insurance plans obtained through employers and unions, including the number and types of private insurance plans offered, employer characteristics, premiums, and contributions by employers and employees.  More information on the MEPS is available at http://www.meps.ahrq.gov.

Applicants use of HCUP and/or MEPS data does not preclude the use of secondary data sources or primary data collection.

Health Literacy

AHRQ encourages applicants to write Informed Consent (IC) and HIPAA Authorization documents for research to be understandable to all potential research participants, including those with low levels of literacy and limited English proficiency.   AHRQ recommends that IC and Authorization documents be written in accordance with health literacy principles, and that IC and Authorization documents be available in multiple languages if potential research participants include individuals with limited English proficiency. AHRQ also recommends adopting a process to verify potential research participants understanding.

IC documents must provide information in language understandable to potential participants (45 CFR 46.116). For covered entities under the Privacy Rule, authorization documents must include core elements and required statements in 45 CFR 164.508(c) and must be written in plain language. The AHRQ Informed Consent and Authorization Toolkit for Minimal Risk Research (http://www.ahrq.gov/fund/informedconsent/) provides sample forms and guidance on adapting them, and also describes an appropriate process for obtaining informed consent and authorization.

Consumer Products

All consumer products produced under an AHRQ-funded grant should be appropriate for the target audience. This includes individuals from diverse cultural, language, and literacy backgrounds.  Audience testing should be part of the development process. AHRQ’s Talking Quality website (http://www.talkingquality.gov/) and AHRQ’s guide and checklist for developers and purchasers of health information (IT) that is designed to be accessed and used by consumers (http://healthit.ahrq.gov and select Health IT Tools) are resources applicants can use to ensure appropriateness of consumer products.

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.

Section V. Application Review Information

1. Criteria 

Administrative Criteria: Upon receipt, applications will be reviewed by AHRQ for completeness and responsiveness.

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

2. Review and Selection Process

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

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

The mission of AHRQ is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. 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. 

Overall Impact

Reviewers will provide an overall impact/priority 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 five scored review criteria, and additional review criteria (as applicable for the project proposed). 

Scored Review Criteria  

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

Significance. Do the studies proposed address important problems? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? 

Does the proposed team have experience 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?

Does the team have experience 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?

Investigators. Are the PD/PI and other key personnel appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level(s) of the principal investigator and other researchers? Does the PD/PI and investigative team bring complementary and integrated expertise to the project (if applicable)?

Does the PD/PI have experience in 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 (e.g., hospitals, community-based clinics, patient-centered medical homes (PCMH), nursing homes, assisted living facilities, HCBS providers, and new entities or programs created by health reform or other legislation/regulation/innovative demonstrations such as Accountable Care Organizations, Chartered Value Exchanges (CVEs), and the Children’s Health Insurance Program Reauthorization Act (CHIPRA) etc.)

Does the PD/PI understand the needs of 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 may use this information (selection of plans and providers; rewarding of performance; comparison of plan/provider performance; identification of local or multi-site quality problems; etc.).

Does the PD/PI have experience identifying and recruiting appropriate sites/ audiences for survey instrument testing, report template testing, QI studies, and evaluation studies.  Does the PD/PI have experience recruiting members of populations (e.g.; people with poor cognitive skills; people with poor reading skills; people from diverse ethnic and cultural backgrounds; people with diminished visual capacity) to include in testing?

Innovation. Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches or methodologies, tools, or technologies for this area?

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?

Approach. Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well-integrated, well-reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? 

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, and with administration of surveys to the subpopulations of interest and within a variety of health care delivery settings; identification and resolution of methodological issues associated with mode of administration?

Does the team have experience with producing detailed survey operations materials (print or electronic) suitable for use by groups with minimal as well as extensive experience in fielding large-scale, multi-site surveys? Does the team have experience conducting cultural comparability and health literacy studies on questionnaires and other materials?

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 conducting qualitative research and analyzing the resulting data, including cognitive testing, focus groups and usability testing?

Does the proposed team have experience writing clear, concise reports, summaries and other documents? Does the team have experience translating surveys and related materials into Spanish?

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?

Environment. Do(es) the scientific environment(s) in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment(s), or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? 

Does the proposed team have knowledge of quality issues (especially those important to consumers and other purchasers) as they pertain to long-term services and support, hospital care, care to those with poor cognitive skills, visual skills or other disability, and care received in ambulatory settings?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will be addressed and considered in the determination of scientific merit and the rating.

Degree of Responsiveness:  How well does the application address the purpose and objectives of this FOA?  How responsive is the application to the special eligibility criteria, including the project requirements, noted in the FOA?

Budget and Period of Support: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research?

Inclusion: Adequacy of plans to address the needs of both genders, racial and ethnic minorities (and subgroups).  Adequacy of attention to AHRQ priority populations (see above discussion on Priority Populations in section IV.6 Other Submission Requirements, and inclusion criteria included in section VIII of Required Federal Citations, below.)

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. See the Human Subjects Sections of the PHS398 Research Plan component of the SF424 (R&R).

Privacy and Security Protections for Patients:  The resources and processes to be used to address privacy and security issues in the development and implementation of the intervention will be assessed.

Selection Process

Applications submitted in response to this funding opportunity will compete for available funds with all other recommended applications. The following will be considered in making funding decisions:

2.B. Additional Review Considerations

Not applicable.

2.C. Resource Sharing Plan(s)

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 FOA will also be obtained and managed in accordance with the HIPAA Privacy Rule, 45 CFR Parts 160 and 164. These regulations serve to limit the disclosure of personally identifiable patient information by covered entities and define when and how such information can be disclosed e.g., to researchers.  Thus, health care plans ordinarily will require either patient authorization for disclosures of identifiable information to be made to researchers or waivers of such authorizations obtained from an IRB or Privacy Board (defined in the regulations), which will involve review to ensure that identifiable health information will be appropriately safeguarded by the investigators.  The DHHS Office of Civil Rights is the enforcement body for this regulation. Additional information about the regulations, their implementation, and alternative methods of permissible disclosures to researchers (limited data sets with data use agreements, de-identified data sets, data about deceased persons, and data use to develop protocols) can be obtained from: http://www.hhs.gov/ocr/hipaa/

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 (see HIPAA website in prior paragraph) 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 National Institute of Standards and Technology (NIST) has published several implementation guides for this circular. They are: An Introduction to Computer Security: The NIST Handbook; Generally Accepted Principals and Practices for Securing Information Technology Systems; and Guide for Developing Security Plans for Information Technology Systems. The circular and guides are available on the web at http://csrc.nist.gov/publications/nistpubs/800-12/. 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's Office of Communications and Knowledge Transfer (OCKT) wishes to be consulted in advance of publication in order to coordinate announcements of new AHRQ-supported research results with other AHRQ dissemination activities.  Important legal rights and requirements applicable to AHRQ grantees are set out or referenced in AHRQ's grants regulation at 42 CFR Part 67, Subpart A (available in libraries and from the GPO's website at http://www.gpoaccess.gov/cfr/index.html), which incorporates additional applicable provisions on Rights in Data, including 45 CFR Part 74 and 37 CFR Part 401.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

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 NIH eRA Commons. 

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 issues, and certification of IRB approval of the project's proposed use of human subjects.  For details, applicants may refer to the "AHRQ Revised Policy for Institutional Review Board (IRB) Review of Human Subjects Protocols in Grant Applications" (http://grants.nih.gov/grants/guide/notice-files/not-hs-00-003.html). 

Once all administrative and programmatic issues have been resolved, a formal notification in the form of the Notice of Award (NOA) will be generated via email notification from the awarding component to the grantee business official at the applicant organization. The NOA signed by the AHRQ grants management officer is the authorizing document.

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.

2. Administrative and National Policy Requirements

All AHRQ grant and cooperative agreement awards are subject to AHRQ s grants regulations at 42 CFR Part 67, Subpart A, and are subject to the requirements of the HHS Grants Policy Statement that are applicable based on the recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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

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, are currently required by HHS to be cleared by OMB under the Paperwork Reduction Act (PRA) (44 USC 3501-3521). Submissions for clearance under PRA are through AHRQ and HHS. Therefore, affected grantees should include the time in their proposed timelines to develop materials and receive necessary clearances. It typically takes at least six months from date of initial submission to AHRQ to receive clearances ,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 grantees receive written notification via e-mail from AHRQ that clearance has been obtained. Detailed information on the PRA can be found at http://www.hhs.gov/ocio/policy/collection/.

The following Terms and Conditions will be incorporated into the award statement and will be provided to the Principal Investigator as well as to the appropriate institutional official, at the time of award.

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to otherwise applicable OMB administrative guidelines: DHHS grant administration regulations at 45 CFR Parts 74 or 92 (Part 92 is applicable for State and local Governments), and other DHHS, Public Health Service, and AHRQ grant administration policy statements.  AHRQ will use these procedures in evaluating and administering the cooperative agreements under this FOA.

The administrative and funding instrument used for this program is the cooperative agreement U18, 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 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, although specific aims and activities may be shared between a grantee and AHRQ as described below. 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 staff.

2. A.1. Principal Investigator Rights and Responsibilities

The PD/PI will have primary and lead responsibilities for the project as a whole including:

2. A.2. AHRQ Responsibilities

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

For this cooperative agreement, the AHRQ program official is responsible for participating in regular conference calls, reviewing progress reports and providing input as needed. The program official will also conduct annual site visits if the Agency budget permits.  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 grantees 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 projects.  Specific cooperative aims and activities in carrying out individual projects may be shared among the awardees and the AHRQ program officials. 

AHRQ program officials will participate in all conference calls and planning meetings; participate in the planning of and present at the CAHPS/SOPS User Network Meeting and the AHRQ Annual Meeting; serve as liaison between the grantees and government organizations (such as the Office of Management and Budget) and non-governmental organizations (such as the National Committee for Quality Assurance and the National Quality Forum); 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 awardees and assist them with their project activities or in coordinating the activities of other grantees (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.

2.A.3. Collaborative Responsibilities

When appropriate and feasible, AHRQ expects awardees to work with each other to identify collaborative opportunities that can contribute to the overall success of their 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.  It is expected that the projects will be conducted in a dynamic environment with AHRQ reviewing the results on an ongoing basis.

Each grantee is expected to work closely with the other CAHPS grantee, as detailed in RFA-HS-12-003).  The grantee is required to work with the CAHPS/SOPS User Network contractor for the following:

3. Reporting

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

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

The Progress Report is to include descriptive and evaluative comments on both completed activities and plans for the remainder of that year, including any changes foreseen in the future.  At a minimum, the reports will include descriptive comments on:  progress to date measured against project aims; methodological changes implemented; key preliminary findings; significant problems and resolutions; inclusion of priority populations; and project related publications, presentations, and dissemination activities.  AHRQ will provide the timetable for these progress reports.

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

A final Progress Report, Invention Statement, and Federal Financial Report are required when an award ends. For further details regarding grant closeout requirements, refer to http://www.ahrq.gov/fund/closeout.htm.

Section VII. Agency Contacts

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may be written or by telephone, and fall into three areas: scientific/research (program), peer review, and financial or grants management issues.

1. Scientific/Research Contact(s):

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

Christine Crofton, Ph.D.
Center for Quality Improvement and Patient Safety
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1323
Fax: (301) 427-1341
E-mail address: Christine.Crofton@ahrq.hhs.gov

2. Peer Review Contact(s):

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

Nghia Vo, M.D.
Office of Extramural Research, Education and Priority Populations
Division of Scientific Review
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1191
Fax: (301) 427-1562
E-mail address:  Nghia.Vo@ahrq.hhs.gov

3. Financial/Grants Management Contact(s):

Direct inquiries regarding fiscal matters to:

Brian Campbell
Office of Performance Accountability, Resources and Technology
Division of Grants Management
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1266
Fax: (301) 427-1462
E-mail address: Brian.Campbell@ahrq.hhs.gov

Section VIII. Other Information

Required Federal Citations

Inclusion of Women and Minorities in Research Study Populations:

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 are provided that inclusion is inappropriate, e.g., because of the lack of connection between the study and the health of women or particular minorities.

All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/not-od-00-048.html). A complete copy of the updated Guidelines is available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm. To the extent possible, AHRQ requires adherence to these NIH Guidelines.

Investigators may obtain copies from the above sources or from the NIH Guide Web site at http://grants.nih.gov/grants/guide/index.html.  AHRQ Program staff may also provide additional information concerning these policies (see Section VII, Agency Contacts).

Human Subjects Protection:

Federal regulations at 45 CFR Part 46 require that applications and proposals involving human subjects research must be evaluated in accordance with those regulations, with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).
 
Standards for Privacy of Individually Identifiable Health Information:

The Department of Health and Human Services (DHHS) "Standards for Privacy of Individually Identifiable Health Information", regulation was mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 which governs the protection of individually identifiable health information.  It is administered and enforced by the DHHS Office for Civil Rights (OCR). The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools that may be used to determine whether a researcher is a staff member of a covered entity. Compliance with the Privacy Rule for those classified under the Rule as "covered entities" is mandatory.  Decisions about applicability and implementation of the Privacy Rule reside with covered entities.  Project Officers will assist grantees in resolving questions about the applicability of HIPAA requirements.

Access to Research Data through the Freedom of Information Act:

OMB Circular A-110 provides access to certain research data developed with Federal support through the Freedom of Information Act (FOIA), 5 U.S.C. 552, in certain circumstances.   Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation or administrative order) may be accessed through FOIA. If no Federal action is taken having the force and effect of law in reliance upon an AHRQ-supported research project, the underlying data are not subject to this disclosure requirement.  Furthermore, even if a Federal regulatory action is taken in reliance on AHRQ-supported research data, disclosure of such data is limited in accordance with the AHRQ confidentiality statute, 42 USC 299c-3(c). NIH has provided general related guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm which does not include discussion of the exception applicable to confidential identifiable data collected under AHRQ's authorities.

Should applicants wish to place data collected under this FOA in a public archive, which can provide protections for the data (e.g., as required by confidentiality provisions of the statute applicable to AHRQ-supported projects, 42 USC 299c-3(c) and manage the distribution of non-identifiable data for an indefinite period of time, they may. The application should include a description of any archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should consider how to structure informed consent statements or other human subject protection procedures to permit or restrict disclosures of identifiable data, as warranted.

Healthy People 2020:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting health improvement priorities for the United States. AHRQ encourages applicants to submit grant applications with relevance to the specific objectives of this initiative. Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.

Authority and Regulations:

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

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the Public Health Service mission to protect and advance the physical and mental health of the American people.

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