Infrastructure for Maintaining Primary Care Transformation (IMPaCT): Support for Models of Multi-Sector, State-Level Excellence

Funding Opportunity Announcement (FOA) HS-11-002

Technical Assistance Conference Call

December 2, 2010

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This document summarizes the technical assistance call for the Infrastructure for Maintaining Primary Care Transformation (IMPaCT): Support for Models of Multi-Sector, State-Level Excellence (U18) funding opportunity announcement (FOA). The FOA is available at http://grants.nih.gov/grants/guide/rfa-files/RFA-HS-11-002.html.

The technical assistance teleconference was held at the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD, on December 2, 2010. If after reading this document you have any questions or comments, please contact Leilani Liggins at leilani.liggins@AHRQ.hhs.gov.

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Introductions

David Meyers: Welcome to AHRQ's technical assistance call for RFA-HS-11-002, Infrastructure for Maintaining Primary Care Transformation (IMPaCT): Support for Models of Multi-Sector, State-Level Excellence (U18). During this call we will be providing an overview of the FOA, providing answers to frequently asked questions, and conducting an open forum to respond to additional questions.

The following introductions were made:

• David Meyers, Director, Center for Primary Care, Prevention, and Clinical Partnerships, AHRQ.
• Debbie Rothstein, Advisor for Extramural Research, Office of Extramural Research, Education, and Priority Populations, AHRQ.
• Nghia Vo, Scientific Review Officer, Office of Extramural Research, Education, and Priority Populations, AHRQ.
• George Gardner, Chief, Grants Management Office, AHRQ.
• Leilani Liggins, Program Contact for the FOA, Center for Primary Care, Prevention, and Clinical Partnerships, AHRQ.

Funding Opportunity Announcement (FOA) Information

David Meyers: This FOA solicits applications to expand current State-level, multi-sector efforts to transform primary care practices and develop sustainable infrastructure for quality improvement in small- and medium-sized primary care practices.

The goal of the FOA is to foster the advancement and evaluation of leading State-level primary care practice support efforts that may become models for a potential national primary care extension service. Successful applicants must demonstrate both their existing successful collaborative efforts and significant existing infrastructure and activities.

This initiative has three major aims: to support and expand existing programs that assist primary care practices with general quality improvement and practice change; to encourage program synthesis, evaluation, and sustainability among existing exemplar programs; and to package and actively disseminate lessons learned about primary care practice support to other developing multi-sector efforts around the country.

Let's begin by reviewing some of this FOA's basics:

• AHRQ is utilizing a cooperative agreement mechanism (I will talk more about this later and we will have time for questions at the end).
• We intend to make three awards, and if Congress were to direct additional funds to AHRQ, I would be thrilled to award more.
• Grants are limited to $500,000 per year, total costs, for each of 2 years. Total costs include direct and indirect costs and do not include in-kind contributors.
• The Research Strategy section of the application is limited to 25 pages.
• Grants are made to organizations, not to individuals. Eligible institutions for this FOA include not-for-profit, for-profit, and tribal organizations, as well as agents of the State or Federal government.
• AHRQ requires there be one, and only one, principal investigator/project director (PI/PD) per application. The PI/PD should spend at least 20% of their time on the project (if less, the application must include a justification for this decision). If you were considering having co-PIs, you can give folks any titles you want—Research Queen, Implementation Czar—but your application must identify one, and only one, PI/PD.

While there are likely many possible ways of organizing quality improvement infrastructure for primary care, this initiative focuses on one specific way—one we at AHRQ believe has great potential and the type that is outlined in the Affordable Care Act—and that is multi-sector collaboration. Therefore, application under this FOA must demonstrate the active involvement of:

• State Department of Health.
• State entity responsible for administering the State Medicaid program within the State, if other than the State health department.
• Primary care department or departments of one or more health profession schools in the State that train primary care professionals.

All of these must be included in the application and show active involvement.

Additionally, AHRQ strongly encourages projects to demonstrate a variety of other stakeholders, such as:

• Primary care professional societies.
• State Medicare Quality Improvement Organizations.
• Area Health Education Centers.
• Consumer groups.
• State Primary Care Associations.

It is important to note that while State government involvement is required, it does not need to be the lead agency for an application.

So who can submit an application? As stated in Section III.1.A, eligible institutions include:

• Public or nonprofit private institutions.
• For-profit private institutions.
• Units of local or State government.
• Eligible agencies of the Federal government.
• Indian/Native American Tribal governments (Federally Recognized).
• Tribally Designated Organizations.

Please note that for-profit organizations described in section 501(c) 4 of the Internal Revenue Code that engage in lobbying are not eligible.

Eligible Institutions

Tribal-focused initiatives, programs that are working with tribes, are most certainly encouraged to respond to this FOA. In responding, tribes must demonstrate collaboration with organizations that are responsible for tribal public health, Medicaid, and a tribal or nontribal academic department of primary care. Finally, foreign institutions may not submit applications. Foreign institutions may participate in projects as members of consortia or as subcontractors only.

Now let's dive into the specifics.

The Research Strategy section of each application must include the following components:

• Description of the existing program.
• Demonstration component, which includes a plan for any program enhancements.
• Evaluation plan.
• Sustainability plan.
• Dissemination component.

Existing State-Level Program

This section must demonstrate multi-sector involvement required under this FOA, in addition to any other groups that are participating. The section should describe the theoretical and organizational models that underlie the program, along with the goals of the program. If the program helps primary care practices adopt a specific model of care, such as the patient-centered medical home or chronic care model, this should also be described in the mechanisms of the program. AHRQ is particularly interested in the use of practice facilitators or coaches, although this is not absolutely required. The application should, however, describe how the program works directly with individual practices across the entire State or how the program has been designed to be scalable so that all practices within the State can be reached.

It is important to remember that this section must include a brief discussion of current or planned efforts to ensure support is provided to minority clinicians and practices serving minority communities. Applications should discuss how program goals are established and how stakeholder feedback, including the experiences of primary care professionals and consumers, is incorporated.

Finally, applications should include evidence of the success to date of the program in achieving its goals.

Demonstration Component

The Demonstration component of the application is one of the main sections. This section itself has two subsections: one on program enhancements and a second on evaluation and sustainability plans.

Program Enhancements

Recognizing that even successful established programs are likely to have identified areas for enhancement and gaps that require filling, applicants may request funds as part of this grant to refine their program. The application should describe what, if any, specific enhancement activities will be conducted and funded as part of this grant, how they were identified, and how they are expected to contribute to the larger program and its goals.

Evaluation and Sustainability Plans

All applications must describe how the program will be evaluated during the performance period. Applications will be evaluated on the creativity, sophistication, rigor, and value of their proposed evaluations. This said, applications may request, but are not required, to use grant funding to support the proposed evaluation.

If an evaluation is not part of the current program, this is an opportunity to use funds to conduct it. However, if funds are already in place to conduct an evaluation, the applicant should describe the evaluation, but does not have to use grant funding to conduct it.

Additionally, all applications must either describe an existing plan for program sustainability or describe a plan for developing one during the grant period. Funds may be requested to support sustainability planning.

Dissemination Component

Finally, all applications should include a section on its Dissemination component.

Applicants must describe a plan for "packaging" their efforts and lessons learned. They must describe an outreach effort that will result in a minimum of three other States or State coalitions receiving training about the applicant's program and about how to develop their own programs.

Outreach efforts may include, but are not limited to, developing ongoing mentoring relationships, building a regional learning collaborative, arranging in-person site visits, and developing online resources.

In developing this FOA, AHRQ recognized that many successful local programs do not have the staff, time, or resources to share their stories and lessons learned with others. For this reason, we are requiring that these new resources made possible by this grant initiative be used for this purpose. Therefore, a minimum of 25% of requested funds over the 2-year grant period must be devoted to dissemination activities. It is not required that 25% of funds in each year be devoted to dissemination, as long as the proposed total expenditure over the course of the full grant period is equal to or greater than 25%.

Application Process

The Research Strategy section is limited to 25 pages. The following sections are required (and the page lengths are suggestions only):

• Introduction and Background (2-3 pages).
• Existing State-Level Program (4-7 pages).
• Demonstration Plan (which includes proposed program enhancements and proposed evaluation and sustainability planning) (7-12 pages).
• Dissemination Plan (6-10 pages).

Applicants may wish to consider using these specific section titles as headers and subheaders in their applications.

Let's review a few additional details:

• Applicants should describe how they will incorporate Federal program officials in demonstration and dissemination activity planning, execution, and evaluation, consistent with the nature of a cooperative agreement.
  • Cooperative Agreement. The administrative and funding instrument used for this program is the cooperative agreement U18, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial AHRQ programmatic involvement with the grantee is anticipated during the performance of the activities. Under the cooperative agreement, AHRQ's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.
  • Applicants should plan to include a Federal program official as a member of their project leadership team and to conduct at least quarterly teleconferences with the program official. I recommend you see section VI.2 for additional details about the cooperative agreement mechanism.
• It is expected that the PI/PD will devote a minimum of 20% effort to this project. If an applicant proposes the PI/PD will spend less than 20% effort on this project, a specific justification that addresses project leadership, management, and coordination must be included.
• Applications should include, as an Appendix, a specific budget breakdown related to the dissemination plan that demonstrates that a minimum of 25% of the total requested funds will be directed toward dissemination activity.
• Additionally, applications should also include a separate Appendix that details the central budget for the ongoing program. This budget helps establish that there is an existing program. This ongoing program budget is not part of the grant budget request, although program enhancements, evaluations, and sustainability planning may be covered by the grant.
• Applicants are encouraged to include letters of support demonstrating all of the required and any additional coalition partnerships. These may be included as a third Appendix.
• Applicants should budget for at least two senior team members to attend at least one 3-day AHRQ conference in the Washington, DC, area during the course of the grant.
• AHRQ will use several funding considerations when selecting applications for awards. As stated in the FOA, these include:
  • Scientific and technical merit of the proposed project, as determined by peer review.
  • Availability of funds.
  • Responsiveness of the proposed project to goals and objectives of the FOA.
  • Relevance of the proposed project to program priorities.
  • Overall programmatic balance.
  • Programmatic needs of AHRQ and the U.S. Department of Health and Human Services.

AHRQ intends to award no more than one award per State in response to this FOA, and reserves the right to fund proposals that represent a diversity of approaches from among applications rated as meritorious.

In preparing your applications, I recommend you pay particular attention to the Review Criteria that will be utilized by peer reviewers in determining the merit of your proposal (please see section lV.2 for the full details). The review criteria include:

• Significance.
• Investigators.
• Innovation.
• Approach.
• Environment.

Additionally, reviewers will consider:

• Degree of responsiveness.
• Budget appropriateness.
• Inclusion of the full range of primary care practices and professionals in the State and the needs of the public in the State.
• Protection of human subjects from research risk.
• Privacy and security protections for research subjects.

As you prepare your application, please remember that AHRQ does not accept modular budgets. AHRQ uses ONLY the detailed Research & Related Budget. We do not use the PHS 398 Modular Budget. Applications submitted in modular budget format will be returned without review.

SF424 (R&R)

All applications must be submitted electronically using the electronic SF424 (R&R form) created for this FOA. Please see the FOA for instructions on how to obtain electronic forms and to register your institution and PI/PD. Please remember that if you have not done this before, the process of registering the institution and the PI/PD in both eRA Commons and Grants.gov—two separate processes that must be done—can take several weeks. Please prepare early.

Please note that specific instructions in the FOA supercede  general  instructions that may be found in the SF424 or on the National Institutes of Health (NIH) Web site. For example, as stated earlier, applications under this FOA are limited to 25 pages for the Research Strategy section. That is the correct answer.

As the transition period will have ended, there will not be a 2-day correction period following submission. All applications must be submitted before the announced deadline.

Here are a few key dates highlighted in the FOA:

• Earliest that someone can submit a letter electronically: January 15, 2011.
• Letter of intent receipt date: January 7, 2011.
• Opening date for application submission: January 15, 2011.
• Application due date: February 15, 2011.
• Peer review date: expected to take place approximately May/June 2011.
• Earliest anticipated start date for any award: approximately August 2011.

Prospective applicants are asked to submit a letter of intent that includes the following information:

• A short descriptive title of your proposed application.
• The name, address, and telephone number of the PI/PD.
• Names of other planned key personnel.
• A list of participating institutions.

It is extremely helpful if the number and title of this funding opportunity is included in the letter. The letter of intent can be sent by postal mail or E-mail to:

Leilani Liggins
Center for Primary Care, Prevention, and Clinical Partnerships
Agency for Healthcare Research and Quality
540 Gaither Road
Rockville, MD 20850
Telephone: (301) 427-1500
Email: Leilani.Liggins@ahrq.hhs.gov

For additional technical assistance, please contact any of the following AHRQ staff, who will be glad to provide technical assistance:

Scientific/Research Issues:
Leilani Liggins: Leilani.Liggins@ahrq.hhs.gov

Peer Review Issues:
Nghia Vo: Nghia.Vo@ahrq.hhs.gov

Financial/Grant Management Issues:
Nicole Williams: Nicole.Williams@ahrq.hhs.gov

Frequently Asked Questions

Question: Can this FOA be used to support the launch of new initiatives?

Answer: AHRQ is interested in well-established programs that may serve as models to others. Applicants must demonstrate existing successful collaborations and existing activities. Applications may, however, propose expansions and enhancements to their existing efforts.

Question: Is the primary intent of this grant to assist established programs to further develop and create dissemination tools or is the intent to assist States with less infrastructure to develop a statewide primary care transformation and/or quality improvement program?

Answer: The purpose of this FOA is to support the further development of already existing State-level initiatives, thus catalyzing primary care transformation and quality improvement that may serve as models for Federal and State initiatives, and to support the active dissemination of these exemplar models.

Question: We have a State-level initiative to link care coordinators with small primary care practices. Would this program be of interest to AHRQ?

Answer: While primary care practices and the communities they serve may benefit greatly from shared community-based practice resources, such as care coordinators, patient educators, social workers, and mental and oral health professionals, the development of these types of practice resources is not the focus of this FOA. Applications that focus on State-level initiatives to provide practice support other than for practice transformation and quality improvement would not be responsive to the goal of this FOA.

Question: Can we propose a multi-State initiative?

Answer: No. While in the future the Federal government may explore creating a national primary care extension service based on multi-State or regional hubs, this FOA targets single, whole State-level initiatives.

Question: We have a strong and established program, but it does not yet reach every primary care practice in the State. Are we eligible to apply?

Answer: Maybe. It is not required that a program already have the capacity to reach every primary care practice in the State. In fact, expanding capacity is an allowable use of grant funds. Applications must, however, demonstrate State-level multi-sector collaboration through an existing program. A program that does not have multi-sector collaboration would not be eligible for this FOA unless it is arranged as part of preparing your application.

Question: Would a fully formed and integrated State telehealth system, which uses videoconference technology to bring physicians and patients together, be considered the existing infrastructure that you are looking for from grant applicants?

Answer: It depends on how the system is being used. A system for providing care, while valuable, would not be relevant to this initiative. A system that is used to connect practice facilitators with practice staff to conduct quality improvement training would be. To a large extent, however, the infrastructure AHRQ is looking for is organizational infrastructure, programmatic infrastructure, and people-based resources to conduct this type of program.

Question: Would a successful applicant need to first identify and agree to partner with other States prior to submission of the grant application?

Answer: There is no requirement that applicants identify the recipients of their planned dissemination efforts. In their outreach plans, however, or the Dissemination section, applicants may propose specific recipients for mentoring. If so, a letter of support would be expected in the third Appendix. All outreach plans, however, must be designed and funded to reach a minimum of three additional States or State-level multi-sector collaboratives.

Question: Does AHRQ accept modular budgets?

Answer: No. As stated earlier, AHRQ uses only the detailed Research & Related Budget. We do not use a modular budget. Applications submitted in modular budget format will be returned without review.

Question: Will the letters of intent, which are due on January 7, 2011, be available for public review?

Answer: No. The intent of the letters is to assist AHRQ in preparing for peer review.

Open Forum Questions

Question: How do you define a small- or medium-sized independent primary care practice? Are you working off a particular definition or is there flexibility?

Answer: We do not have a very specific definition of size of a practice. On page 5 of the printed FOA, we define primary care, primary clinician, and primary care practice related to size. In general, I would say small and medium are practices with five or fewer lead primary care clinicians; however, I think definitions of slightly larger moderate size, such as 10 and under, would be responsive. In this FOA, we are not as interested in reaching out to large, well-integrated systems with hundreds of clinicians, as we are in understanding that they already have the infrastructure for quality improvement, where smaller practices often do not.

Question: We have had a well-established, multi-party collaboration for several years, and the project itself will begins its implementation stage in April. Would such a project be considered established or not?

Answer: Tough question. I would say it is up to you in your application to make the best possible case as to why you think, even though you haven't started by the time you applied, that your project is good enough for the government to say you are an exemplar and a model. So, AHRQ would not presuppose that if you have been working for multiple years that you can show the development of your work as part of meeting your goal. However, the ability to show that you can reach practices and help them change clearly strengthens your case for being a model for other States to emulate.

Question: You talk about there being no requirement that applicants identify the recipient of their planned dissemination efforts, regarding the number of States, but then you suggest reaching an additional three States. Do we need to name those States?

Answer: You do not need to say who they are, but an application that came in and stated, "we are going to do all of this work with one other State," would not be responsive. An application that came in and stated, "we are budgeting for five teams to come and visit us in 2013 and we are going to spend 7 days with them, and this is what the curriculum is going to be, and we don't know who those five States are but we will have a national call and we will work with our PI to select States," would be responsive. A third application that came in and said, "we propose to work with three States—such and such, such and such, and such and such—and we will go and visit them, and here is the plan for dissemination," would also be considered responsive. You do not need to identify who the other States are, but you need to show that your plan would reach three or more other State-level initiatives.

Question: My question is also regarding the dissemination element. How do you define dissemination? Is it sharing lessons learned, sharing tools and resources, or is it actually pilot testing in a different environment?

Answer: The first would be responsive; the second would also be, and sounds much more robust. If you can do that, that's great, but I think the expectation here is training the staff, and teaching them what it is and consulting with them, but not testing there and being there as they do in their module—but sharing the "how to" knowledge.

Question: I would like to know whether one proposal can include assistance with enhancement evaluation and dissemination for more than one single State-level initiative? In other words, not multiple State-level initiatives, but a single, whole State initiative in more than one State.

Answer: In general, you are proposing that, if you have everything in place, there could be two completely separate grants because these are multi-sector collaboratives in more than one State doing all the pieces, and that each of them could come in independently, but for some reason you want them to come in one application. You would not get additional funding, such as from NIH, to have these two grants be linked and get double the money. We cannot let you do that, but if you wanted to do everything for two States separately, and you show that you have both State Departments, both Medicaid programs, and both primary care departments, you still would only have one PI and technically it would be possible. Again, if that is not clear (this is an unusual case), you can follow up with us afterward.

Question: What is the definition of QI?

Answer: On page 5, we try to define QI. For the record, I will read it: "quality improvement is a systematic form of ongoing effort to make performance better. In medical practice it often focuses on improving health outcomes, improving efficiency, and improving patient and staff experience."

Question: If you have community health workers installed in a practice to enhance the quality of care for a particular disease, it is sort of different from a traditional QI practice, but the end result is still the same: trying to improve the quality of care and outcome. Would that fit in here?

Answer: It depends. If the program function is to put community health workers in clinics all around the State, then I would say no, that it wouldn't be responsive, because it would be providing support to the practices. The theory that is guiding this initiative is that in addition to needing resources and the right people and support to do primary care, practices need an infrastructure to help them with general QI, and specifically "whole system, whole practice" transformation toward new models of primary care. That is the piece of QI and practice transformation this initiative is most targeted toward. We recognize, however, that some folks may be doing this plus more, or other things that could include this, and they will move into this systemwide approach. While AHRQ will not be paying for community health workers, helping practices learn how to best use community health workers could be one component of practice QI work.

Question: Is there any possibility of ongoing support from funding sources?

Answer: There are no definitive, ongoing plans at the Agency that I could announce today. However, as I mentioned earlier in this presentation, AHRQ is embarking on this FOA to inform a new authority given to the Agency under the Affordable Healthcare Act, which has authorized a very large national support for local primary care support, which is very similar and outlined in this grant. Whether that program has appropriate funds in the future is unclear at this point, but we are certainly hopeful that it would and the work done under this program would enhance our ability to be successful in meeting that authorization in the future. Additionally, the reason we are interested in the dissemination component and bringing other States along might be interpreted by some to mean that we would like to be able to help those groups in the future take their next steps as well; that is one interpretation, and certainly has not been confirmed.

Question: Should the evaluation include evaluation of the effectiveness and impact of the dissemination efforts?

Answer: In general that is not necessary. It is not the target. To the degree that it would be useful to the team, and they would like to do it—and certainly in general it is part of the QI paradigm—we would be very receptive to it, but specifically, the FOA requires an evaluation of the ongoing program and its ability to help practices, and does not explicitly require an evaluation of the dissemination component.

Question: Can you respond to whether this funding opportunity will help support existing small- or medium-sized practices to expand their programmatic elements by helping practices to transform and also to expand their evaluation, as opposed to expanding the number of practices involved in their effort?

Answer: The program enhancement component does not require reaching out to more practices. A program enhancement that would help an existing program do more with the practices it already has would absolutely be responsive to this grant. All that said, it is important to note that all programs that apply need to describe in the initial section how the program at large is designed and has the ability to be scalable to reach all practices in the State. A program applicant that says, "we will never go beyond Johnson County, Tennessee," would not be responsive to this FOA. A program applicant in Johnson County, Tennessee, that says, "we are the pilot county for the State to take this larger" could be responsive.

Question: Can you respond to whether the program to be enhanced and disseminated could be applicable to a subgroup of primary care providers (i.e., pediatric primary care providers)?

Answer: I think a program that specifically targeted one large section of primary care could be responsive to the application. Clearly the ability to show how it had relevance and the potential for expansion to other sectors of primary care would very much strengthen the application. But the fact that at one point in time the program was a little bit more targeted would not disqualify an application.

Question: Are you looking for specific credentials for the PI/PD?

Answer: On the second page of the application, the official language states that the PI/PD is an  individual with the skills, knowledge, and resources to carry out the proposed research. We are not requiring that the PI/PD have an MD, PhD, MPH, or any other specific degree.

Current as of December 2010