Part I Overview Information


Department of Health and Human Services

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

Components of Participating Organizations
Center for Quality Improvement and Patient Safety
Center for Primary Care, Prevention, and Clinical Partnerships

Title: Ambulatory Safety and Quality: Enabling Patient-Centered Care through Health IT (R18)

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-07-007 

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release/Posted Date: December 5, 2006                                
Opening Date:   January 15, 2007
Letters of Intent Receipt Date:   January 19, 2007
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 Submission/Receipt Dates:   February 15, 2007
Peer Review Date:   April/May, 2007
Earliest Anticipated Start Date:   July, 2007
Technical Assistance Teleconference:   January 4, 2007
Expiration Date:   February 16, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

This funding opportunity announcement (FOA) solicits Research Demonstration (R18) grant applications from applicant organizations that propose to explore the use of health information technology (IT) and related policies and practices to establish and enhance patient-centered care in ambulatory settings.   Patient-centered care is responsive to the needs and preferences of individual patients, provides patients with access to their medical information, and empowers patients to be active participants in care decisions and in the daily management of their health and illnesses.

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 weeks prior to the grant submission date. See Section IV.6.

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(s) 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. Submission, Review and Anticipated Start Dates
      1. Letter of Intent
    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
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
  3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
  1. Award Notices
  2. Administrative and National Policy Requirements
  3. Reporting

Section VII. Agency Contact(s)
  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

General Purpose of the Ambulatory Safety and Quality (ASQ) Program

The purpose of the Agency for Healthcare Research and Quality’s (AHRQ) Ambulatory Safety and Quality (ASQ) program is to improve the safety and quality of ambulatory health care in the United States.  The program’s components, with the exception of the announcement on risk assessment, have an emphasis on the role of health information technology (health IT).  Emerging information about ambulatory care suggests that the patient safety crisis in hospitals is only the “tip of the iceberg.” The scope of ambulatory care has increased over the past decade, as the volume and complexity of interventions has burgeoned.  Safe, high quality ambulatory care requires complex information management and coordination across multiple settings, especially for patients with chronic illnesses.  The opportunity to turn the potential of health IT towards improving safety and quality in the ambulatory care setting, especially within care transitions, will form the cornerstone of this proposed Ambulatory Safety and Quality (ASQ) Program.

Specific Purpose of this FOA

The purpose of this FOA, ASQ: Enabling Patient-Centered Care through Health IT, is to investigate novel methods or evaluate existing strategies for using health IT to create or enhance patient-centered models of care in the ambulatory setting. Applicants are expected to demonstrate how patient-centered care can improve health outcomes, patient safety, and patients' reported experience with care. Applicants are encouraged to consider projects that focus on shared decision-making and patient-clinician communication, personal health records, integration of patient information across transitions in care, or patient self-management of chronic conditions.  The long term goal of this effort is to improve the delivery of patient-centered care in ambulatory settings, with a particular focus on transitions of care, personal health records, and improved patient-clinician communication and decision making.

Overview: Ambulatory Safety and Quality Program

The Ambulatory Safety and Quality (ASQ) Program offers an integrated approach to improving ambulatory safety and quality of care.  While there are strategies that could improve the quality and safety of ambulatory care, there are unknown risks in ambulatory care and across transitions that need to be better understood and described before appropriate interventions can be developed.  Where effective strategies exist to drive ambulatory safety and quality, such as health IT, there is a need for research to demonstrate value, as well as best approaches to broader diffusion, implementation, and effective use. In particular, the high risk associated with medication use in ambulatory care and across transitions in care provides some urgency for targeted risk assessment and health services interventions related to medication management.  Finally, effective strategies to improve ambulatory care will be limited by the capacity of current electronic health systems to measure and report on ambulatory safety and quality. 

To achieve measurable improvements, the 4 funding opportunity announcements (FOAs) that comprise the Ambulatory Safety and Quality (ASQ) Program address research needs that share a common focus on ambulatory care clinicians, patients, and information technology. This funding opportunity is 1 of the 4 in the ASQ program, as described below:

I.   ASQ: Risk Assessment in Ambulatory Care:  This announcement has a broad view on ambulatory care that includes the ambulatory care clinician, as well as the patient cared for in ambulatory settings and across high risk transitions in care.  Research will focus on assessing the risks associated with ambulatory care that have not yet been fully elucidated.  Unlike the rest of the ASQ program, this announcement does not include a primary focus on health information technology.

II.   ASQ: Improving Quality through Clinician Use of Health IT: This announcement has a primary focus on the ambulatory care clinician.  Research will focus on strategies to improve medication management and the delivery of evidence to the point-of-care resulting in improved clinical decision-making and clinical quality for priority conditions.  Issues to be addressed include the relationship between health IT and workflow redesign, systemic barriers to health IT adoption, care for patients with multiple chronic conditions, enhanced patient-centered models of care delivery, and improved use of effective alert strategies for decision support.

III.   ASQ: Enabling Patient-Centered Care through Health IT: This announcement has a primary focus on patients and their interaction with the ambulatory health care system.  Research will focus on strategies to improve the patient experience of care through the use of health IT.  It will include work to improve the delivery of patient-centered health information to ensure patients and clinicians have the information they need to make better health care decisions.  Specific topics to be addressed include shared decision-making and patient-clinician communication, personal health records, integration of patient information across transitions in care, and patient self-management of chronic conditions.

IV.   ASQ: Enabling Patient Safety and Quality Measurement through Health IT: This announcement has a primary focus on integrating patient safety and quality measurement with information technology.  Research will focus on strategies to improve transparency for patients in ambulatory care through the development, deployment and export of quality measures from electronic health record systems.  Issues to be addressed include measure development across episodes of care, clinical data needs for quality measurement export and reporting, and the reporting of quality data for improvement.

The research themes within these announcements were developed through expert consultation, new and emerging areas of federal and State focus, including the breakthroughs of the American Health Information Community and the work of federal partners, such as the Centers for Medicare and Medicaid Services, Indian Health Service, and the Health Resources and Services Administration.  The July 2006 release of the Institute of Medicine (IOM) report entitled “Preventing Medication Errors: Quality Chasm Series” offered important insights into risks of medication use in the ambulatory setting and across transitions in care, as well as potential strategies for improvement in need of demonstration projects.  The recent series of three IOM reports on the status of emergency services in the United States also confirmed the importance of emergency departments as high risk ambulatory care sites.  Finally, the IOM report entitled “Priority Areas for National Action: Transforming Health Care Quality (2003)” provided focus for the ASQ program on the ambulatory care priority areas identified for the nation, including care coordination, asthma, cancer screening, diabetes, children with special health care needs, hypertension, immunizations, ischemic heart disease, and frailty associated with old age. 

Definition of Ambulatory Care

For the purpose of the ASQ program, ambulatory care refers to all types of health services provided by health care professionals on an outpatient basis, in contrast to services provided in the home or to persons who are inpatients. While many inpatients may be ambulatory, the term ambulatory care usually implies that the patient must travel to a location to receive services which do not require an overnight stay. This program will specifically focus on the following ambulatory settings: health care clinician offices; large and small practices, outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers.  Though not usually considered an ambulatory setting, home care entities are also encouraged to apply. 

For the purpose of the ASQ program, health care transitions will refer to the movement of patients between health care providers and settings as their conditions and care needs change during the course of a chronic or acute illness (Coleman and Berenson, 2004; see also http://www.caretransitions.org/definitions.asp).  Non-ambulatory settings with a strong interest in fostering safe, high quality ambulatory care and transitions are welcome to apply in partnership with an ambulatory organization.  In particular, a focus on transitions between ambulatory care settings and hospitals, home care, assisted living centers, and nursing homes are critical to the success of ambulatory care for many elderly and chronically ill populations.

Program Purpose and Evaluation

The goal of the ASQ program is to improve the quality and safety of health care. AHRQ will measure progress toward that goal by evaluating whether patients are receiving the appropriate care for prevention, treatment and management of the IOM's priority areas; whether patients are able to access reports of ambulatory care quality and safety for their providers; whether patients report satisfaction with their care.

Each project in the ASQ program will be required to have a robust evaluation plan that addresses one or more of these goals. In order to facilitate comparisons across ASQ projects, AHRQ suggests evaluation measures and instruments in these FOAs. We encourage the use of these measures whenever possible and scientifically appropriate.

Researchers are encouraged to propose projects in low resourced rural and urban safety net settings where health IT diffusion is likely low, as well as projects that seek to improve the care provided to priority populations.  AHRQ is strongly committed to supporting research in priority populations, which include women, children, elderly, minority, rural, urban, and low-income populations, as well as patients with special health care needs and disabilities. AHRQ encourages the development of strong public and private partnerships that may include the health IT vendor community.

Background:  Patient-Centered Care

Patient-centered care integrates the perspectives, understanding, and preferences of patients and their families into the delivery of health care.  Patient-centeredness is a characteristic of the relationship between clinicians and patients and of the larger health care systems in which these relationships exist.  In “Crossing the Quality Chasm” (IOM 2001), the IOM included patient-centeredness as an essential component of quality care.  In this context, patient-centeredness includes both the patient’s experience of care and the presence of an effective partnership between clinician and patient (and the patient’s family and friends, when appropriate).  In addition to being a key domain of quality, patient-centeredness is important to ensuring patient safety.

Patient-centered care is based on an effective clinician-patient partnership that is the product of a relationship in which the clinician’s recommendations are informed by an understanding of the individual patient’s needs and the context in which he or she lives (e.g., home life, job, family relationships) to enhance the patient’s ability to act on the information provided.  Additional features of an effective clinician-patient partnership include informed, shared decision making and development of patient knowledge and skills needed for self-management of chronic conditions (Davis et al., 2005).  In contrast to care that is clinician- or disease-centered, patient-centered care customizes treatment recommendations and decision making in response to an individual patient’s preferences, knowledge and beliefs. 

Multiple studies have demonstrated that patients who are involved with their care decisions and management have better outcomes than those who are not (Wagner, Grothaus, et al., 2001; Wagner, Glasgow, et al., 2001; Greenfield et al., 1985; Greenfield et al., 1988).  Patient self-management, particularly for chronic conditions, has been shown to be associated with improvements in health status and decreased utilization of services (Loring et al., 1999). Nonetheless, approaches to engage patients in their care, in particular patients with one or more chronic illnesses, have not yet become a routine part of clinical care (Wagner, 1998).  A recent international Commonwealth Fund study of sicker patients found that patients across many countries including the U.S. report lack of care coordination and inadequate understanding of their care (Schoen et al, 2005).  Health care delivery organizations are engaged in system improvements to improve chronic illness care, incorporating self-management support, clinical information systems, and decision support.  (Wagner et al, 2001) Organizations can assess the patient’s experience of chronic illness care as health care delivery organizations change, gaining insight into progress toward meeting a patient-centered goal (Glasgow et al., 2005).

The IOM issued ten design rules for redesigning health care for the 21st century.  These included:  care based on continuous healing relationships, customization based on patient needs and values, the patient as the source of control, shared knowledge and the free flow of information.  Applications of health IT can help build a patient-centered health care system in which patients share information and control with professionals.

Preventing, detecting and reducing the burden of chronic disease and disability is an important goal for both patients and health care providers. These are also core activities and indicators in demonstrating improvements in the quality of care. The advice of health care providers to change high risk behaviors, such as tobacco use, has been shown to be important in motivating people to change. Changing personal health behaviors, whether to prevent illness or manage chronic illnesses, is difficult. Clinical practices alone are unlikely to be of sufficient intensity or frequency to improve these health behavior outcomes. Patients need support not only through their health care provider but also where they live, work, go to school, and play.  Success is more likely, and wasteful duplication of efforts less likely, if health care providers and community-based programs work together to support patients in self-management activities and in health behavior change efforts. These types of support can be facilitated through linkages between clinical practice and public health/community programs, linkages which can benefit from the use of health information technology.  Examples of the use of health information technology in these ways include the sharing of clinical information through personal health records, and the development and implementation of electronic resources for use by patients, clinical providers, and community programs. Resources such as these have the potential to make evidence available to support decisions by health care providers and patients at the point of care and in day-to-day self-management. Evidence to support decision-making can also be combined with information about local, community based and public health programs to support patients and families where they live, which is integral to patient-centered care.

Early experience confirms that when patients are given the chance to bridge the information gap between themselves, their health data, and their health care providers, many people enthusiastically take a more active role (Working Group on Policies for Electronic Information Sharing between Doctors and Patients, July 2004).

AHRQ’s Health IT portfolio

Health IT has the potential to deliver evidence-based information to the point-of-care; expand the range and ease of potential electronic health record (EHR)-based quality measures; and improve the value and quality of health care. AHRQ has funded over 30 years of research in the use of health IT to improve quality (Fitzmaurice et al., 2002). The projects span the research and development spectrum, from innovations in health IT, planning for adoption, implementation, evaluation of outcomes, and taking the systems to scale through participation in regional and statewide health information exchange. AHRQ’s projects have historically addressed issues of knowledge representation, delivery of tailored evidence, quality feedback, workflow and systems changes, and new approaches to care, including delivery in non-traditional settings.

One major component of AHRQ’s health IT portfolio is the National Resource Center (NRC) for Health IT. The NRC captures the lessons learned in health IT adoption, and documents the progress of the portfolio grants. Collective learning from the health IT portfolio pointed to some major lessons:

More information about AHRQ’s health IT portfolio can be found at http://healthit.ahrq.gov.

Objectives of this FOA

The goal of this FOA is to identify, promote, and disseminate models of patient-centered care that include the use of personal health data and evidence-based information to support patients in managing their health and illnesses and improve health outcomes in ambulatory care and across health care transitions. AHRQ expects this initiative will inform health care professionals, payers, policy makers, and the public about the value of patient-centered care, including the ability of health IT to improve ambulatory health care quality and safety by providing patient-centered care.  There are many ways health IT may be used to provide patient-centered ambulatory care.  While attentive to the full spectrum of ideas, AHRQ has identified the following four areas of particular interest:

Illustrative questions include:

Shared decision-making and patient-clinician communication

Personal health records (PHRs):

 Integration of patient information across transitions in care

Patient self-management of chronic conditions

From its earliest investments in health IT research initiatives, AHRQ has emphasized the importance of the privacy and security of personal health information – whether in electronic or other media – to individual trust in health information exchange.  Without this trust and faith in an information system, patients and other users will not use it fully, and system data will be inaccurate or incomplete.  As a result, the potential for quality and safety improvement from investments in health IT will be lost.  More importantly, assuring privacy and security are values patients should expect and receive from the health care system.  For these reasons, AHRQ is interested in efforts to enhance the privacy and security of electronic health information in proposed projects.

Project requirements:

Applicants are expected to: describe an intervention to be studied, place the intervention in context and discuss how it is expected or known to affect patient-centered care,  provide a detailed implementation plan with appropriate methods, describe a robust analysis and evaluation plan with measures for assessing patient-, office-, and health system-level outcomes, and include a dissemination plan.

The applicant must address the following project requirements in the Research Plan portion of the application.

In the Specific Aims section:

1. The applicant must specify an intervention, the type of ambulatory settings in which it will be applied, the health professional groups involved (note that interdisciplinary teams are encouraged whenever possible), and the patient populations included in the intervention.  It is expected that some aspect of the intervention will include the use of some form of health IT.

In the Background and Significance section:

2. The applicant must demonstrate an understanding of the nature of the ambulatory care, the current challenges to the provision of patient centered care, and how HIT can enable better quality of care.   The narrative should include a brief review of the salient literature with respect to the focus area and the anticipated benefits, limitations, and scientific, clinical or performance-based significance of the proposed research, the purpose and expected impact of the intervention, objectives or hypotheses to be evaluated, the supporting theoretical or conceptual framework, underlying assumptions, and scope or boundary conditions of the proposed research.

In the Research Design and Methods section:

3. Given the project objectives, and taking into account practical constraints, the applicant must describe the research design or methodology that will best enable the research objectives to be realized.  The applicant should describe the health IT component of the intervention.  When possible, the health IT intervention should conform to interoperability standards and use certified products (see http://www.cchit.org).  The design must include a timeline with specific milestones, covering all major phases of the project.

4. Applicants must specify the project’s primary and secondary outcome measures.  These may include health outcome, patient satisfaction, process measures, costs, and measures of patient safety.   (Please refer to the next two sections below for AHRQ’s recommendations for outcome measures.)  The narrative should also include data collection plans, instruments and tools to be used, and a well-developed analysis plan. Applicants are encouraged to incorporate into the project  a strategy for monitoring and assessing salient reportable financial and organizational dimensions of implementing health IT under the initiative and to develop strategies to report estimates of the rate of return on investments required for implementation under the initiative. To the extent possible, applicants should discuss any anticipated limitations or cautions needing to be exercised in generalizing results.

5. The applicant should describe how the intervention could be integrated into the delivery of ambulatory care throughout the applicant organization and potentially into sites across the nation. The applicant should discuss the future sustainability of the intervention by their organization after the grant funded period has ended. The applicant must also present a project dissemination plan, including a proposal for widespread dissemination should the project results be generalizable and meritorious.  While AHRQ plans to offer additional funding through limited competition to further the dissemination of important findings and activities that result from these projects, these dissemination supplements will only be considered should future funds become available.  Applicants must include a project dissemination plan within the project plan and budget. The dissemination plan may include activities in cooperation with AHRQ's National Resource Center on Health IT, http://healthit.ahrq.gov.

6. The applicant must describe how, in the development and implementation of the intervention, privacy and security issues related to the exchange of sensitive health information will be identified and addressed.  Keeping health information in electronic format introduces new risks, real and perceived, to the privacy and security of health information.  New concerns arise, such as who has access to and use of electronic data, disclosure to patients regarding the collection and use of the data, patient consent requirements, the ability of patients to decline participation in electronic data collection, patient access to audit records, what happens to data after research is completed, and informing patients of any security breaches. 

Developers of electronic health information systems have promulgated policies for consideration with participating consumers and patients in order to assure patient awareness of, comfort with, and participation in electronic data collection and use.  While privacy and security solutions are not intended to be the focus of projects under this announcement, interventions should be designed to incorporate emerging privacy and security principles that may be applicable (see http://healthit.ahrq.gov/hiepolicyissues). Applicants should describe the resources and processes they will use to assure that these privacy and security concerns are being met throughout the project period.  These could include the inclusion of participating patients in periodic reviews in order to solicit their input and consultation with knowledgeable professionals over the course of the project, as well as a description of any existing privacy or security practices and technology consistent with those policies that will be incorporated into the project and reviewed for compliance on a regular basis.

Assessing Patient Experience with Care

Applicants are encouraged to use the new AHRQ- funded CAHPS® Clinician & Group Survey as an outcome measure.  The survey is designed to assess patients’ perceptions of care at both the individual clinician level and the group practice level.  The survey has been developed with an emphasis on the actual experience of the patient and the use of the best science.  The survey instruments are in the public domain. 

The CAHPS Clinician & Group Surveys cover several domains including: access (getting needed care and getting care quickly), clinician communication, office staff courtesy, helpfulness and respect, and an overall rating.  The surveys also may be used with optional supplemental modules focusing on the domains of shared decision making and cost of care.  AHRQ continues to develop additional items in the domains of coordination/integration and health promotion and education. 

Users are encouraged to share their data with the National CAHPS Benchmarking Database (NCBD).  The primary purpose of the NCBD is to facilitate comparisons of CAHPS survey results by survey sponsors.  Participating sponsors can receive reports that compare survey results to benchmarks derived from the database, access data from individual surveys, and order customized analyses and reports on a fee-for-service basis.

To access the CAHPS Clinician and Group Survey and to learn more about the CAHPS program, please visit:  www.cahps.ahrq.gov

Other outcome measures

AHRQ requires applicants to measure and report on the percent of eligible patients within the practices that they partner with who have access to their personal health information, including medication therapy, and/or customized decision support.  When appropriate, AHRQ requires applicants to measure patients’ access to and utilization of quality measurement reports of their providers.

AHRQ also strongly encourages applicants to consider measuring and reporting the percent of ambulatory clinicians within the practices that they partner with who routinely use measurement tools to evaluate their patient’s experience.

See Section VIII, Other Information - Required Federal Citations.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the R18 research demonstration award mechanism.

The individual researcher sponsored by each organizational awardee will be solely responsible for planning, directing, and executing his or her proposed projects.

AHRQ is not using the Modular Grant Application and Award Process.  Applications submitted in modular format will be returned without review.

2. Funds Available

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.  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 $6 million dollars in FY 2007 to fund 15-20 applications.  Should additional funds become available, AHRQ may fund additional meritorious applications.

The total project period for an application submitted in response to this funding opportunity may not exceed 3 years. Although the size of award may vary with the scope of research proposed, it is expected that applications will range from $200,000 to $400,000 of total costs per year. Total costs are limited to $1.2 million over a three-year period, with no more than $500,000 in total costs allowed in any single year. Facilities and administrative (F&A) costs requested by applicants are included in the total cost limitation.  

AHRQ intends to award at least $2 million to projects that include a focus on medication management.  AHRQ also intends to award at least $1.5 million to projects conducted by primary care Practice-Based Research Networks and $1.5 million to projects focusing on vulnerable populations.  AHRQ expects that many funded projects will be included in more than one of these priority categories.

Applications requesting more than $500,000 in total costs in any one year, more that $1.2 million over 3 years, or longer than 36 months of support will be returned to the applicant without review.

AHRQ plans to offer additional funding through limited competition to further the dissemination of important findings and activities that result from these projects.  Dissemination supplements will only be considered should future funds become available.

AHRQ grants policies as described in the PHS Grants Policy Statement (see http://grants.nih.gov/grants/policy/gps/index.html) will apply to the applications submitted and awards made in response to this FOA.

At this time, it is not known if this FOA will be reissued.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

AHRQ’s authorizing legislation does not allow for-profit organizations to be eligible to lead applications under this research mechanism, thus, for the purpose of this FOA, AHRQ will make grants only to non-profit organizations.  For-profit organizations may participate in projects as members of consortia or as subcontractors only.  For-profit organizations that produce health IT systems are encouraged to apply in partnership with a non-profit organization.  Because this FOA is principally intended to increase the quality of delivery of patient-centered care in the U.S., foreign institutions are not eligible to apply.  Foreign institutions may participate in projects as members of consortia or as subcontractors only.  Applications submitted by for-profit organizations and foreign institutions will be returned without review.  Organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his or 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 programs.

The Project Director/Principal Investigator should devote at least 20% time to the project over the course of the award. If the Project Director/Principal Investigator devotes less than 20% time to the project, an explicit justification must be provided.

Because of the nature of the project, expertise in evaluation is also a critical need that can be met through the requisite experience of the PD/PI or another member of the project team.

2. Cost Sharing or Matching

AHRQ 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 their collaborators indicates a greater potential of success and sustainability of the project. Examples of institutional support would include: donated equipment and space, institutional funded staff time and effort, or other resource investments. Applicant institutions should indicate institutional support by outlining the specific contributions to the project and providing assurances that their organization and any collaborators are committed to providing these funds and resources to the project.  

3. Other-Special Eligibility Criteria

Funding preferences:

This FOA has three funding priorities associated with set aside funding.  The first is related to the focus of the project; AHRQ intends to award at least $2 million to projects that include a focus on medication management.  The second relates to the applicant organization; AHRQ intends to award $1.5 million to projects conducted by primary care Practice-Based Research Networks (PBRNs).  The third funding priority relates to the populations served by the project sites; AHRQ intends to award $1.5 million to projects that focus on vulnerable populations and practices that serve them.  AHRQ expects that many funded projects will be included in more than one of these priority categories.

Applicants may request to be considered for funding preference in one, two, three, or none of these areas.  All applicants must declare which if any funding preferences for which they desire to be considered in Appendix 1.  Appendix 1 should be titled “Qualifications for funding preferences.”  The first line of Appendix 1 should explicitly state which if any of the three funding preferences (medication management, PBRN, vulnerable populations) the applicant requests consideration. If no funding preferences are requested, Appendix 1 should state “No funding preferences requested.” The remainder of the appendix should be used to justify these considerations as follows.

1.      Medication Management

Medication management has been identified as one of the primary areas for prevention of medical errors. Health IT applications have the potential to improve medication management through use of both clinician and patient focused applications including, but not limited to: electronic prescribing, decision support, alerts and reminders, medication reconciliation, and patient education. To qualify for this funding preference, the proposed project must have medication management as a primary focus area, though it does not need to be the entirety of the project. In the Appendix, highlight aspects of your project that are relevant, and estimate the proportion of the project that affects the management of medications. For example, in studying a personal health record application, one might estimate that 30% of the modules assist the patient in understanding their medication needs, or in studying a clinical decision support system, one might estimate that 25% of the rules in the system relate to medication administration or interactions.

2.      Practice-Based Research Networks

AHRQ defines a  primary care Practice-Based Research Network (PBRN) as a group of ambulatory practices devoted principally to the primary care of patients, affiliated with each other (and often with an academic or professional organization) in order to investigate questions related to community-based practice and to improve the quality of primary care. This definition includes a sense of ongoing commitment to network activities and an organizational structure that transcends a single project.

A major goal of primary care PBRNs, some of which have existed in the U.S. for over twenty years, has been to involve busy community-based clinicians and their staffs in activities directed by investigators experienced in clinical and health services research. The best of PBRN investigative efforts have linked relevant clinical questions with rigorous research methods in community settings and have produced scientific information that not only is externally valid, but, in theory, easily assimilated into everyday practice (Nutting, 1999). Leaders of PBRNs in the U.S. and other countries have also recognized the potential of primary care networks to expand their purposes beyond traditional research to the nurturing of an evidence-based culture in primary care practice (Thomas, 2001). Many PBRNs have begun to envision their networks as places of learning, where clinicians are continually engaged in reflective inquiries about practice, and clinicians and their patients in the community are united with science to search for answers that can provide a basis for improved delivery of primary care (Lindbloom, 2004).

Applicants wishing to be considered for funding preference as primary care PBRNs should include the following information in Appendix 1:

A)  Description of the PBRN. Describe the practices included in the network, including geographical distribution of practices and types of clinicians. The applicant should provide reliable information, if available, about the characteristics of the patient population currently served by network clinicians. A complete listing of network clinicians and practice addresses should be included as a separate appendix to the application. The description must document that the PBRN meets, at minimum, the following qualifications:

      o The PBRN organizational structure includes a core of at least 15 ambulatory primary care practices and/or 15 clinicians devoted to the primary care of patients. The majority of the practices must be located in the U.S. Applicants should refer to the Institute of Medicine report on primary care (Donaldson, 1996) for definitions of primary care and primary care clinician.

      o The network has an accepted statement of its purpose and a mission that includes an ongoing commitment to the research endeavor.

      o A director has been identified who is responsible for most administrative, financial and planning functions.

      o The director is, or will be, supported by a staff of at least one person.

      o A mechanism (such as a community advisory board) is in place to solicit advice/feedback from the communities of patients served by the PBRN clinicians.

      o An organizational structure exists that transcends a single study, including multiple systems of communication with and among participating practices in the form of regularly produced newsletters, e-mail or list-serves, conference calls, and/or face-to-face meetings of various combinations of network members.

B) Current institutional and other resources available to the PBRN. This discussion (which may also be included in the Resources section of the application) should describe the relationships between the network and any affiliated academic department or other organizational unit. A list of the consultants, co-investigators and other resources available to the network as a result of the affiliation should be included. Senior officials in any PBRN-affiliated organization(s) should provide a letter documenting support for the network's activities. These and other letters of support should be included as an appendix and referenced in this section of the application

C) Network director and staff. The PBRN director and any network support staff should be identified, and their network roles and qualifications briefly described.

D) Mechanism for community feedback.  This section should also include a description of the mechanism used for obtaining advice and feedback from the patient communities served by the network practices.

3.      Vulnerable populations

AHRQ defines ambulatory health care sites that serve vulnerable populations as those ambulatory health care entities that meet the IOM definition of safety net providers: those providers that organize and deliver a significant level of health care and other related services to the uninsured, Medicaid, and other vulnerable patients.  Core safety net providers have an additional distinguishing characteristic in that they, either by legal mandate or explicitly adopted mission, maintain an “open door”, offering access to services for patients regardless of their ability to pay (IOM 2002).  Examples of these ambulatory health care organizations include: Public Hospital systems (outpatient/ambulatory care depts.), federal/state/locally funded community health centers/clinics, Federally Qualified Health Centers, local health departments, family planning clinics, school based health programs, Ryan White Care Act AIDS programs, and free clinics.  In some situations teaching or community based hospitals (outpatient departments), private physicians, and other ambulatory care sites also serve as safety net providers.

Vulnerable patients, as defined by the IOM in 2002, are those populations served by health care entities that fall outside the medical and economic mainstream, with little or no access to stable health care coverage.  These include the uninsured, low-income underinsured, Medicaid beneficiaries, patients with special health care needs, minority populations, immigrant populations and geographically or economically disadvantaged communities.  AHRQ recognizes that many rural and inner city communities are medically vulnerable and encourages applications that target these communities.

Applicants wishing to be considered for funding preference for project sites serving vulnerable populations should include the following information in Appendix 1:

A)   Detailed description of the vulnerable populations served.  Demographics to include: race/ethnicity, insurance coverage, geographic or economic disadvantaged conditions, immigrant status, and special health care needs. 

B)   Detailed description of mission orientation to patients regardless of their ability to pay for health services provided by the ambulatory care entity.

C)   Proportion of the total user populations that are vulnerable populations (as defined above) served by the project sites and/or applicant institution. 

D)   For each of the project sites for the intervention, provide evidence if the practice has documentation of designation as a Medically Underserved Area (MUA), Medically Underserved Population (MUP), or Health Professional Shortage Area (HPSA).  For more information, visit: http://bhpr.hrsa.gov/shortage/

Applicants may submit more than one application, provided each application is scientifically distinct.  However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

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, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

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

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

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.

Note that if a PD/PI is also an AHRQ peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

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 in both Grants.gov and the Commons.  AHRQ will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and 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 301-435-0714, 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 and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to AHRQ. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (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 “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include 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
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

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

Detailed Budgets:

Note:  AHRQ uses ONLY the detailed Research & Related Budget.  Do not use the PHS 398 Modular Budget.  Applications submitted in modular budget format will be returned without review.

Technical Assistance

AHRQ encourages applicants to take advantage of a technical assistance conference call sponsored by AHRQ program staff. The purpose of the conference call is to provide potential applicants with background information and respond to questions about the preparation of an application in response to this FOA. The conference call will take place on January 4th at 1:30 pm EDT. To register to participate in the conference call, please send an e-mail request to Ms. Angela Lavanderos (PatientCenteredCare@ahrq.hhs.gov) by January 2nd.  All registrants will be sent an e-mail reply which will contain information on the call, including call-in information, by COB January 3rd. Potential applicants are encouraged to contact AHRQ staff with any questions (see WHERE TO SEND INQUIRIES, below).

The conference call is open to any individual or organization intending to apply. Participation is not a prerequisite to applying.  Participants are encouraged to submit questions via email prior to the conference call.  Please submit up to five questions with your name and the name of your institution to Ms. Lavanderos by January 2nd.  Questions of a similar topic and nature may be grouped at the sole discretion of AHRQ staff.  Notes from the conference call will be sent to all participants via e-mail by January 17th.  If interested applicants are not able to participate in the call, please send requests for a copy of the notes to PatientCenteredCare@ahrq.hhs.gov.

3. Submission Dates and Times

See (Section IV.3.A) for details.

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

Opening Date: January 15, 2007
Letter of Intent Receipt Date(s): January 19, 2007
Application Submission Date(s): February 15, 2007
Peer Review Date(s): April/May, 2007
Earliest Anticipated Start Date(s): July, 2007
Technical Assistance Teleconference: January 4, 2007

3.A.1. Letter of Intent

To allow AHRQ staff to estimate the potential peer review workload and plan the review (e.g., anticipate the nature of reviewer expertise to be required), prospective applicants are asked 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), a few comments on the subject of the proposed research, background expertise of key personnel, and the nature and role of participating institutions.  Please include the name and email address of the 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 to this document.

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

Angela Lavanderos
Center
for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850

Telephone: (301) 427-1505
FAX: (301)-427-1597
Email: PatientCenteredCare@ahrq.hhs.gov

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/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Upon receipt, applications will be evaluated for completeness and responsiveness by the Center for Scientific Review and AHRQ.
Incomplete or non-responsive applications will be returned without review.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons.  Information related to the assignment of an application to a Scientific Review Group is also in the Commons

AHRQ will not accept any application in response to this FOA 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.  

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. In consultation with CMS, AHRQ will use this information to develop a cost estimate for obtaining the data. 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, Principal Investigators 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 AHRQ's confidentiality statute, 42 USC 299c-3(c), the Privacy rules at 45 CFR Parts 160 and 164, if applicable, and standards set out in OMB Circular A-130, Appendix III–Security of Federal Automated Information Systems. The use of the data will be restricted to the purposes and time period specified in the DUA. At the end of this time period, the grantee will be required to return the data to CMS or certify that the data have been destroyed.

Unless AHRQ is able to negotiate exceptional arrangements included in the DUA is the requirement that the User agrees to submit to CMS, a copy of all findings within 30 days of making such findings, for the sole purpose of assuring CMS that data confidentiality is maintained.  The user further agrees not to submit these findings to any third party (including but not limited to any manuscript to be submitted for publication) until receiving CMS's approval to do so.

In developing research plans, applicants should allow time for refining, obtaining approval, and processing of their CMS data requests. Requests may take 6 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 Section VII (Agency Contacts).

To avoid double counting, applicants should not include the cost of the 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 principals, 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.

6. Other Submission Requirements

The Principal Investigator/Project Director and at least one key program staff member from the project are required to attend at least three days of an annual AHRQ grantee meeting.   Travel to the annual meeting must be included in the project’s budget.

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. 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 “Registration FAQs-Important Tips” - “Electronic Submission of Grant Applications.”

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.”

Research Plan Component Sections

While each section of the Research Plan needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits.  All attachments must be provided to AHRQ in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used. 

Use of Standards

Use of ANSI HITSP standards, where they exist, are required (see http://www.hitsp.org).  Applications that do not provide appropriate documentation of inclusion of existing ANSI HITSP standards will be returned without review.  Partnership with a vendor of CCHIT-certified health IT is encouraged (see http://www.cchit.org). In applications that employ existing measures of quality, use of AHRQ-developed, AQA- or HQA-approved standards is encouraged (see http://www.aqaalliance.org and http://www.aha.org/aha_app/issues/HQA).

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts and with the following requirements for applications:

Appendix Material

Appendix 1 should be titled “Qualifications for Funding Preferences” and follow the format outlined in Section III.3

Additional appendices may be used for:

a)   Listing of PBRN practices and/or application project sites.

b)   Preliminary data referred to in Preliminary Study section of Research Plan.

c)    Surveys, questionnaires, data collection instruments, clinical protocols, informed consent documents, and product snapshots.

d)   Up to five publications, manuscripts, abstracts, or other materials directly relevant to the proposed project.

e)   Letters of support.

Applicants are cautioned not to use the Appendix to circumvent the page limitations of the Research Plan.

Application Characteristics

Budget:

Applications in response to this FOA will use the Research & Related budget components, with a maximum allowable request of up to $1.2 million in total costs over three years and a maximum of $500,000 in any one year.  Provide a narrative justification for each proposed personnel position, including role and proposed level of effort.  All other budgeted costs should also be justified. 

The budget must include funding to allow at least two members of the project team to attend at least three days of an annual AHRQ grantee meeting in the Washington DC area. 

Specific 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 be returned without review.

Priority Populations

The Healthcare Research and Quality Act of 1999, in amending the PHS 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, which 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 also found at 42 USC 299.  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, the 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 are to 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 inpatient 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 databases include:  the Nationwide Inpatient Sample (NIS) with inpatient data from a national sample of approximately 1,000 hospitals, the Kids’ Inpatient Database (KID) with a nationwide sample of pediatric inpatient discharges, the State Inpatient Databases (SID) with the universe of inpatient discharge abstracts from participating states, the State Ambulatory Surgery Databases (SASD) with data from ambulatory care encounters from hospital-affiliated and sometimes freestanding ambulatory surgery sites from participating states, and the State Emergency Department Databases (SEDD) with data from emergency department encounters from hospital-affiliated emergency departments from participating states.  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, noninstitutionalized population.  MEPS comprises 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.

This does not preclude the use of secondary data sources or primary data collection.

Plan for Sharing Research Data

Not Applicable

Sharing Research Resources

Not Applicable

Section V. Application Review Information


1. Criteria

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

Merit Review Criteria are described in Section V.2 below. Only the review criteria 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 be returned to the applicant without further consideration. 

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

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:

In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance and Impact: Does this study identify, promote, and/or disseminate an important aspect or model of patient-centered care?  Does this project effectively utilize health IT to support patients in managing their health and illnesses?  If the aims of the application are achieved, how will patient-centered clinical practice be advanced?  Will the project, if successful, result in meaningful improvements in patient safety, health outcomes, and/or satisfaction for its target population?

Usefulness and generalizability:  Does the study demonstrate the application of an intervention across multiple settings or institutions?   Will it be feasible for other ambulatory practices, clinicians and patients to implement this intervention?  Will the lessons learned in this study be applicable to other types of ambulatory settings, patient populations, and/or clinical conditions? Does the study advance our ability to achieve widespread implementation of positive gains?  If successful, will the intervention be sustainable after the study period ends?  Are the core aspects of the intervention dependent on study resources that can not reasonably be expected to exist in health care settings outside of the study?

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 study measure outcomes of interest, including appropriate clinical outcomes? Where possible, does the applicant make maximum use of existing standards and measures? Is the evaluation plan sufficient to illuminate the effects of the intervention?

Investigators and partnerships: Are the investigators appropriately trained and well suited to carry out this work? Is the investigative team cross disciplinary? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Is there evidence of institutional support?

Study setting(s): Is the project being conducted in an ambulatory setting, with ambulatory clinicians and staff, and ambulatory patients?  Will the proposed study benefit from the unique features of the selected ambulatory sites and patient populations?  Have the ambulatory practices involved in the project demonstrated their interest in participating in this study?   Does the intervention foster interdisciplinary ambulatory care teams?

Budget: Is the proposed budget reasonable and is the requested period of support appropriate in relation to the proposed research? Is the budget allocated toward health IT hardware, software, and support appropriate? 

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

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?

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.  See section 6 under Project Requirements.

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 item 7 of the Research Plan, component of the SF 424 (R&R)).

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

2.B. Additional Review Considerations

Not Applicable

2.C. Sharing Research Data

Data Confidentiality

Pursuant to 934 (c) of the PHS Act 42 USC 299c-3(c), information obtained in the course of any AHRQ supported-study that identifies an individual or entity must be treated as confidential in accordance with any explicit or implicit promises made regarding the possible uses and disclosures of such data. There are now civil monetary penalties for violation of this confidentiality statute [42 U.S.C.299c-3(d)). In the Human Subjects section of the application, there must be a description of 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 42 CFR Parts 160 and 164, the Federal Privacy Rule developed by the Department of Health and Human Services (DHHS) pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  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 of 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.aspe.hhs.gov/admnsimp/ or http://www.hhs.gov/ocr/hipaa/

The PI 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 websites 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.

2.D. Sharing Research Resources

Rights in Data

AHRQ grantees may copyright, unless otherwise provided in grant awards, or seek patents, as appropriate, for final and interim products and materials including, but not limited to, methodological tools, measures, software with documentation, literature searches, and analyses, which are developed in whole or in part with AHRQ funds. Such copyrights and patents are subject to a worldwide irrevocable AHRQ license to use and permit others to use these products and materials for government purposes.  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; and 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 the AHRQ's grants regulation at 42 CFR Part 67, Subpart A (Available in libraries and from the GPO's web site http://www.gpoaccess.gov/cfr/index.html).

3. Anticipated Announcement and Award Dates

Generally, applicants should anticipate 7 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 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). 

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

Selection of an application for award is not an authorization to begin performance.  Any costs incurred before receipt of the NGA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See 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 to you based on your recipient type and the purpose of this award (see http://www.ahrq.gov/fund/hhspolicy.htm).

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

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Grant Progress Report (PHS 2590) annually and financial statements as required in the Public Health Service (PHS) Grants Policy Statement, found at http://grants.nih.gov/grants/policy/gps/index.html.

The Progress Report must include Sections a through f as described on pages 10-14 in the general PHS form 2590 instructions, as well as sections g through j as described in Section IV of the 2590 instructions. 

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.

Financial Status Reports (FSRs; SF 269) are required annually by AHRQ for ALL grant programs.  This report must be submitted for each budget period no later than 90 days after the close of the budget period.  A hard copy of the report should be submitted to the assigned grants management specialist.

A final progress report and Financial Status Report are required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.

Projects funded under this announcement are considered part of the AHRQ’s Patient Safety and Health IT Initiatives. AHRQ has established a Patient Safety Research Coordination Center (PSRCC) and the National Resource Center (NRC) for Health IT to support activities of the AHRQ Patient Safety and Health IT Initiatives. When appropriate and feasible, AHRQ expects awardees to work with each other in collaborative opportunities that can contribute to the success of their projects and AHRQ’s portfolio initiatives. These collaborative relationships may be facilitated by the AHRQ resource centers, and awardees will be expected to cooperate with AHRQ’s Centers.

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Direct your questions about general FOA issues, including information on the Inclusion of Women, Minorities and Children, and other priority populations to:

David Meyers, MD
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road, 6127a
Rockville, MD 20850
Telephone: (301) 427-1634
Email: PatientCenteredCare@ahrq.hhs.gov

or

Ronda Hughes, PhD, RN
Center for Primary Care, Prevention and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road, 6052
Rockville, MD 20850
Telephone: (301) 427-1578
Email: PatientCenteredCare@ahrq.hhs.gov

2. Peer Review Contacts:

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

Kishena Wadhwani, PhD, MPH
Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
540 Gaither Road, 2032
Rockville, MD 20850
Telephone: (301) 427-1556
FAX: (301) 427-1562
Email: Kishena.Wadhwani@ahrq.hhs.gov

3. Financial or Grants Management Contacts:

Direct your questions about financial or grant management matters to:

Michelle Burr
Grants Management
Office of Performance, Accountability, Resources and Technology
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD  20850
Telephone: (301) 427-1451
FAX: (301) 427-1462
Email: Michelle.Burr@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 conducted and 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 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 45 CFR 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 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:

The OMB Circular A-110 has been revised to provide access to research data developed with Federal support through the Freedom of Information Act (FOIA) 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) 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 under FOIA, 5 USC 552(b), disclosure of confidential identifiable data from such study, statutorily protected under 42 U.S.C. Section 299c-3(c), is exempted from disclosure under "the (b)(3) exemption” in FOIA.  It is important for applicants to understand the scope of this requirement and its limited potential impact on data collected with AHRQ support.  Proprietary data might also be exempted from FOIA disclosure requirements under "the (b)(4) exemption", for example, if they constitute trade secrets or commercial information.  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 the confidentiality statute applicable to AHRQ supported projects, 42 U.S.C. 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 2010:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," 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 2010" 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 authorization of 42 USC 299 et seq, and under Federal Regulations 42 CFR 67 and 45 CFR Parts 74 and 92 and applicable authorizing statutes and regulationsAll 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 PHS mission to protect and advance the physical and mental health of the American people.

REFERENCES

Referring to Section I under “1.”(Research Objectives):

Coleman EA, Berenson RA. "Lost in transition: challenges and opportunities for improving the quality of transitional care." Ann Intern Med. 2004 Oct 5;141(7):533-6.

Davis K, Schoenbaum C, Audet A.  A 2020 Vision of Patient-Centered Primary Care.  J Gen Intern Med, 2005; 20:953-7.

Fitzmaurice JM, Adams K, Eisenberg JM. "Three decades of research on computer applications in health care: medical informatics support at the Agency for Healthcare Research and Quality." J Am Med Inform Assoc. 2002 Mar-Apr;9(2):144-60.

Glasgow RE, Wagner EH, Shaefer J, Mahoney LD. Development and validation of the Patient Assessment of Chronic Illness Care; Med Care, 2005, 43(5):436-44.

Greenfield S, Kaplan S, & Ware, JE. Expanding patient involvement in care. Effects on patient outcomes. Ann Intern Med, 1985; 102(4):520-8. 

Greenfield S, Kaplan SH, Ware, JE, Yano EM, & Frank HJ. Patients' participation in medical care: effects on blood sugar control and quality of life in diabetes. J Gen Intern Med, 1988; 3(5):448-57.

Institute of Medicine (IOM). Crossing the quality chasm: A new health system for the 21st century.  National Academy Press: Institute of Medicine. 2001. 

Lorig KR, Sobel DS, Stewart AL, Brown BW, Bandura A, Ritter P, Gonzalez VM, Laurent DD, & Holman HR. Evidence suggesting that a chronic disease self-management program can improve health status while reducing hospitalization: a randomized trial. Medical Care, 1999; 37(1):5-14.

Schoen C, Osborn R, Huynh PT, Doty M, Zapert K, Peugh J, Davis K.  Taking The Pulse Of Health Care Systems: Experiences Of Patients With Health Problems In Six Countries.  Health Aff (Millwood). 2005; W5:509-25.

Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Effective Clinical Practice, 1998; 1(1):2-4. 

Wagner EH, Glasgow RE, Davis C, Bonomi AE, Provost L, McCulloch D, Carver P, & Sixta C. Quality improvement in chronic illness care: a collaborative approach. Joint Committee Journal of Quality Improvement, 2001; 27(2):63-80.

Wagner EH., Grothaus LC, Sandhu N, Galvin MS, McGregor M, Artz K, & Coleman EA. Chronic care clinics for diabetes in primary care: a system-wide randomized trial. Diabetes Care, 2001; 24(4):695-700.

Wagner EH, Austin, BT, Davis C. Hindmarsh M, Shaefer J< Bonomi A.  Improving chronic illness care: translating evidence into action. Health Aff (Millwood) 2001, 20(6): 64-78

Working Group on Policies for Electronic Information Sharing Between Doctors and Patients.  Connecting Americans to their Healthcare.  Final Report.  Markle Foundation - Connecting for Health.  July 2004.  Accessed on 9/12/2006 at: http://www.connectingforhealth.org/resources.

Referring to Section III, 3. (Other-Special Eligibility Criteria), under No. 2.,  B):

Lindbloom EJ, Ewigman BG, Hickner JM. Practice-based research networks: the laboratories of primary care research. Med Care. 2004 Apr;42(4 Suppl):III-45-9.

Nutting PA, Beasley JW, Werner JJ. Practice-based research networks answer primary care questions. JAMA 1999;37:1092-1104.

Thomas P, Griffiths F, Kai J, O'Dwyer A. Networks of research in primary health care. BMJ 2001;322:588-90.


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