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This document summarizes the technical assistance call for AHRQ-sponsored Research Centers for Excellence in Clinical Preventive Services request for applications (RFA). Select to access the RFAs.
The technical assistance teleconference was held at the Agency for Healthcare Research and Quality (AHRQ) conference center in Rockville, MD, on April 14, 2011. If after reading this document you have any questions or comments, contact Gloria Washington.
Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen-only mode. We will conduct a question and answer session during the conference. To request to ask a question, please press star 1. Today's conference is being recorded. If you have any objection, you may disconnect at this time. Ma'am, you may begin.
Mary Barton: Thank you so much. This is Mary Barton at the Agency for Healthcare Research and Quality. I'm going to start off here by asking the folks in the room here at AHRQ to introduce themselves briefly, and then we will go into describing the Funding Opportunity Announcement that you have called about.
So just to start, I am Mary Barton. I am the—mostly here at AHRQ—the Scientific Director for the U.S. Preventive Services Task Force Program, and I am joined to my left by Tess Miller.
Tess Miller: Hi. I'm Tess Miller. I lead the Prevention Care Management Portfolio here at AHRQ.
Mitra Ahadpour: Hi. I'm Mitra Ahadpour. I'm the Scientific Review Officer for this project.
George Gardner: I'm George Gardner, Grants Management.
Michelle Burr: I'm Michelle Burr. I'm also in Grants Management.
Debbie Rothstein: I'm Debbie Rothstein. I work in Extramural Research here at AHRQ.
Gloria Washington: Gloria Washington, (I) coordinate the call.
Mary Barton: Thank you very much. So you have all been—if you've been sent a phone number, you've also been sent the slides. And so what we're going to do to start is to go through this small set of slides, just to cover some of the really key points from the Funding Opportunity Announcement.
Then we will stop that and talk about a few—we've had the chance to answer some questions already. They are not necessarily frequently asked, but there are some questions that we've heard of already. So we will go through some of those, and then we will open the phone lines—and the operator has told you how to get a question in here—so that you all can ask your questions on the phone.
So to start with, we are talking about RFA-HS-11-005, in case anybody is finding they are on the wrong plane or the wrong call. We have—our second slide says that the agenda (is) as I just said. We will do an overview and then questions that we have to answer, and then questions from you all.
The third slide gives you a very high-level summary of what this Funding Opportunity Announcement is about. We are soliciting Research Program Project Grant applications, P01s, that have a general area of clinical preventive services and that specifically have a focus area in either patient safety, health equity, or health care system implementation. And we will later on, in the next 10 minutes, tell you in more detail what we mean by those three topic areas.
The next slide, which is 4, covers sort of the ground that we expect this effort to take up. So we realize that there are other federal investments in prevention and public health, specifically the CDC funds centers of excellence in community prevention. And what AHRQ is doing (in) this program project FOA is to focus on the role of the formal health care system, and primary care in particular, with the goal of improving health care for all Americans and improving patient experience through the implementation of evidence-based clinical preventive services.
Ultimately, we are hoping here to support high-quality multidisciplinary research programs that are innovative and that will in particular impel forward the nation's emerging strategies in prevention and quality, which of course are two things that were required in the Affordable Care Act and are being implemented or rolled out, you know, as we speak.
On Slide 5 we separate the points of two main elements of the grant program. Each center will have a core infrastructure and between two and four integrated research projects. The projects should contribute to the overarching center goals to create a whole greater than the sum of the individual parts. And in particular, the project will be—you know, the best case for your proposals in the review committee is if the projects are not highly idiosyncratic or unitary investigations that would be really better supported by a different mechanism and not as part of a program project.
The sixth slide—I'm going to talk a little about it here—about the first, patient safety—the first programmatic area, which is patient safety. So the reason why this is so important is that there are in fact potential harms associated with clinical preventive services. While there may be a public estimation that preventive services are like apple pie, in fact, like any medical intervention, there is a plus side and a downside.
So in this case, we know of issues like false-positive testing, anxiety, labeling, physical harms or risk, and opportunity costs such as time that has to be taken away from other activities to pursue them. These harms can be linked very closely with a clinical preventive service or they can be kind of downstream harms or risks that come from additional followup tests or even from treatments of a condition.
This has been—as is true probably across medicine, and it is true for clinical preventive services—that this has been a relatively understudied area of this sector of the health care system, and so AHRQ is very committed to funding this work to learn as much as possible about specific tradeoffs between potential benefits and potential harms of clinical preventive services.
Additionally, AHRQ sees a very high level of importance in not only the existence of the risk or the harm or the burden, but really the patient experience of those risks or downsides. And so, you know, getting a better understanding of how patients perceive these harms and how to communicate with patients so that they get a full appreciation of the harms or downsides to clinical preventive services before they jump in.
The second programmatic area of interest is health equity. So this center's purpose is to study how to improve access, delivery, and outcomes of clinical preventive services in priority populations. AHRQ has a list of priority populations, that can be seen at the Web site, that's mentioned there. They include children, women, the elderly, racial and ethnic minorities, and rural residents. The aim of this center area is to generate evidence that will help increase health equity in both access to and use of clinical preventive services.
So some example areas that a center applying in this programmatic area might pursue: a center could focus on constructing new datasets and/or cataloguing existing datasets to study causes of disproportional morbidity and mortality in priority populations. They could develop new methods or enhance existing methods to study priority populations. It could conduct original research on the provision of clinical preventive services in groups of people with different risk factors. And finally, it could also conduct research on strategies to decrease disparities in priority populations. Strategies could include communitywide approaches as well as very specific clinical setting interventions.
Moving on to Slide 8, the third programmatic area of interest is the implementation of clinical preventive services, and this center will support basic or applied implementation research to address how primary care practices within the larger health care system can improve the delivery of evidence-based clinical preventive services, as laid out or based on the U.S. Preventive Services Task Force and the CDC's Advisory Committee on Immunization Practices.
The kinds of research that this center could pursue could include how to redesign primary care to improve the delivery of clinical preventive services. The center might study how primary care practices can partner with community-based organizations and resources and the public health system to enhance the delivery and quality of clinical preventive services.
The next, Slide 9, we have some definitions. So clinical preventive services are considered to include screening tests such as blood tests, colonoscopy, mammography, or blood pressure measurement. The second category of clinical preventive services is counseling endeavors, such as counseling to prevent tobacco use. The third category is preventive medication, such as aspirin to reduce the likelihood of heart attack or stroke, and the fourth is immunizations to prevent illnesses in infants, children, and adults, including pneumonia, flu, polio, and others.
The next slide continues with this same definition. Some preventive services are meant to catch diseases early while others are meant to prevent diseases entirely. For the purposes of the FOA, clinical preventive services do not include or would not include screenings for services targeted to individuals who already have established medical conditions as part of the management and treatment of those conditions.
For example, this Funding Opportunity Announcement is not intended to address research gaps in the provision of screening for retinopathy in patients with diabetes.
So moving on now to Slide 11, we now start to lay out the elements of the program project. So first the program project core. The core personnel should include administrative positions, most specifically the principle investigator and the collaborative lead, and also the core should address certain functions. And this is not an exhaustive list, but at a minimum should address training, evaluation, administration, and dissemination.
On the next, Slide 12, I've listed a few other possible functions of the core that would be acceptable, (such as) shared research resources such as statistics communication or data programming expertise. And lastly, the important core function of coordinating with the other centers and with the Technical Assistance Center.
So alongside the funding of the three centers, we anticipate a contract mechanism to fund a Technical Assistance Center. They will be responsible for a certain amount of communication with centers, and the center is responsible for participating in that as well. So there would be regular teleconferences and once or twice a year in-person meetings.
These coordinated activities are expected to include support for common elements in evaluation and dissemination where, for example, there might be important audiences who need to hear about the program project in all three centers as a whole in order to get across the message about the work that's being done there.
So that's a very brief discussion of the core, and I know some of the questions that have come in already are—will—help us talk a little bit more about the core. But I'm going to move on now to Slide 13, which starts us with the research projects.
So there must be between two and four research projects in the application. The proposed projects may be independent, linked, sequential, or conducted in parallel as long as each one affords good independent feasibility and probability of success. All projects should relate to the chosen programmatic area of the center, so that's either health equity, patient safety, or implementation.
Individual projects are not required to begin at the very beginning nor to last the entire duration of the project period, but the proposed start and end for each project must be clearly stated and must be budgeted appropriately. And overall, the series of projects must span the entire project period.
On Slide 14 we go over—and this is all, of course, exactly in the Funding Opportunity Announcement itself—the sections that must be included for each project, including background, the rationale, specific aims, research design, and analytic plan. A separate detailed budget must be provided for each research project as part of the application budget section.
Applications must also identify the specific research team that will conduct each study. Each specific research project should have an identified project leader. Individual project leaders must be listed as key grant personnel, but they are not considered to be co-PIs or the center as a whole.
Slide 15 describes the budget and project period. The total cost for the grants awarded under this FOA will not exceed $1.5 million annually for each year of the project period. An application with a budget that exceeds that amount in any year or a project that exceeds 3 years will not be reviewed.
Funding beyond the first year and in all subsequent years will be contingent upon the review and acceptance by agency staff of an annual progress report. There is a plan for a renewal that the center has established under this Funding Opportunity Announcement. (It) will be eligible for a single 2-year renewal that will follow the initial 3-year period.
The next, Slide 16, reminds you of some key dates. When this was released in March, the letters of intent that we have asked of you—which are not required but which will help us in the review—are due April 29, the application receipt date of May 23. (The) Peer review date is still not clearly set, but will be in the range of 7 to 8 weeks after the applications are received. And the earliest anticipated start dates that you can put into your proposals will be approximately 2 months after the peer review date. So I think realistically, dates in September would not be a bad idea.
So we've got some example questions and answers, and so I want to go over these quickly because I know some of you might have similar questions, or maybe you didn't even know you had these questions, but these are in the areas of training, dissemination, and project research topics.
So first on training, questions have come in. Can the P01 support a small grant research fund to be administered by the core? That's a good question. And can the P01 support doctoral positions?
Well, so what AHRQ Grants Management has told us and what we understand is that the individual projects may include named personnel—persons who are doing postdoctoral research. So they can be included as specific, you know, contributors to one of the projects, but the P01 is not meant to be used as a T32, and so it can't be used generically to fund postdoctoral investigators. And also, it may not have funds for research that are not—there can be no set-aside funds for future research ideas. All the research projects have to be clearly delineated in the application—the proposal.
So the next slide, Slide 19, is about dissemination. Someone had asked us whether activities that are described as being undertaken by the Agency for Healthcare Research and Quality's Office of Communication and Knowledge Transfer are meant to take the place of dissemination activities in the center.
And we wanted to make sure that you understood that the answer is no. The requirement is, I think, pretty well set out in the FOA that the grantees must maintain contact with AHRQ's OCKT or Office of Communications, and that there are some specific pieces of information that grantees are expected to share with that office, but that is meant to supplement the plans of the core that are described in the application about dissemination efforts from the core.
Next, on Slide 20, we have some questions about project topics. Should the projects be grouped into a single clinical topic? Well this is a little bit—you know, obviously this is an area that's not totally specifically laid out in the FOA. But in terms of our being able to give the best feedback to folks like you who have questions about the proposals, we are going to, in addition to this call, make sure that we post these responses on the Web site under the FAQs so that everybody will have access to this.
AHRQ wants to see that these centers advance generalizable knowledge about clinical preventive services. So, I think, the easiest and clearest way to do that would be to focus research on more than one clinical topic, because then that would be the best way, I think, for a center to make the case that it is poised to provide that kind of generalizable knowledge. However, I think it is possible that a proposal that focuses multiple projects on one service could make clear the general applicability of their findings to other services.
For example, if a, you know, patient safety themed center came in saying, you know, "We're going to understand how to communicate with patients about the harms of services. As an exemplar service, we are choosing colorectal screening for maybe two of our projects." But in both cases, that's just an example of a more general question that we're answering, about how do you communicate with patients about the risks.
And so that's our response, that it's conceivable to focus more than one of the projects on the same topic, but it is—it would have to be done in a way that made clear what the generalizable knowledge that was being gained was.
Slide 21—we have some quick questions. Does AHRQ accept modular budgets? No. Does AHRQ recognize multiple PIs? Well no, AHRQ does not do that. Must a P01 be prepared on paper? Yes, looking back to the last millennium, the P01 application must be submitted on paper and appendix material submitted on CDs. This application does need a table of contents, and I would also make sure to mention the specific information about the way the budget needs to be prepared, because that is clearly laid out in the Funding Opportunity Announcement.
So on Slide 22 we've got some information about the link. It's really going to be very short. These applications must set out the overall strategy for the program projects—I think there's like one page for that—and in addition, include two distinct sections describing the core center functions and structure and a separate research strategy for each proposed project. And all of that together may not exceed 30 pages, including tables, graphs, figures, diagrams, and charts, but that does not include reference lists.
The next, Slide 23. AHRQ anticipates committing $4.5 million in FY2011 to fund three centers. AHRQ anticipates awarding one application under each programmatic interest area, assuming high-quality competitive applications are received for each area.
The Slide 24—this is the guidance and ground rules for the open forum that we plan to follow (in a) moment. The conference call operator is going to put you in a queue based on, I think, the order in which you indicate that you have a question by using your keypad. We're going to ask you to keep your questions brief and we will in turn try to keep our responses brief.
If there are questions that are very specific to a particular institution or a situation you know that's quite idiosyncratic, these can be discussed individually with a Project Officer from AHRQ at a later time. And if you do not get an opportunity to ask a question, please E-mail the question to Gloria Washington at the E-mail listed there, because we will be adding to the FAQ document when we get additional questions in from potential grantees.
So at that point, I'm going to go to these other slides. So I think we have a couple of slides that we will talk about at the very end—Slide 27, which has our contact information—but since I'm reminded of it now, Slide 27. If you (will) skip 25 and 26, they are duplicates, unfortunately. I apologize for that. But 27 has contact information for myself, Mary Barton, and Tess Miller and Mitra Ahadpour. And listed there is one individual within the Grants Management Group.
So, with that—operator, thank you for helping us. Would you be able to open up the questions?Coordinator: Of course. At this time, if you would like to ask a question, please press star 1 and record your name when prompted. If you decide to refuse your request, you can press star 2 to withdraw your request. Again, press star 1 to ask your question. One moment for our first question.
Our first question comes from Julie Wong. Your line is now open.
Julie Wong: Hi. Our question is related to Slide Number 9, the definitions of clinical preventive services. Clinical preventive services includes (unintelligible). Then on the next page, there's also a definition of some preventive services. I was wondering are the—is the list on Slide Number 9 (exhaustive)?
Mary Barton: Well, I think between the list that we give there and then the reference to the U.S. Preventive Services Task Force and the Advisory Committee on Immunization Practices, it is pretty exhaustive. And, you know, counseling can be a lot of different shapes and variations, but in that, I imagine this covers all the services that we intend. And yes, I'm reminded (that) in the Funding Opportunity Announcement, there's a little more description of that, but I think mostly that's reproduced exactly on the slide.
Julie Wong: So for example, if we want to look at tobacco control and prediabetes, are those included? You know, we read the Request for Proposals and we also looked at the (slides), but still we are not very clear about (these).
Mary Barton: Well, if you look at the recommendations of the U.S. Preventive Services Task Force, you will see that counseling for tobacco cessation is clearly a recommended clinical preventive service from the Task Force. So I think (it's) easy to say "yes," that that's an intended area to be covered.
In terms of prediabetes, if you are talking about identifying people at risk for bad health outcomes, like heart attacks as a result of their cardiac risk factors, including potentially problems with glucose handling and, you know, glucose management—that is—you know, that's not exactly entirely in the realm of the clinical preventive service.
And I do want to, you know, emphasize that here, you know, clinicians' offices are small little places and people only spend a small amount of time in them, and a lot of the time that people spend in their lives and their homes are relatively not influenced by what happens in the clinical arena. You know, the CDC does convene the Community Task Force on Preventive Services that covers, you know, the issues of what schools can do, what workplaces do, what should communities do to improve health—but those are not necessarily AHRQ's aims in this program project FOA.
Julie Wong: Can we ask another followup question on our side?
Mary Barton: One more brief question.
Man: Sure. In looking at the multidisciplinary nature of a center like this, would a resource such as agricultural extension, especially focused on health and wellness—would you consider that as an interdisciplinary component?
Mary Barton: I'm not sure what you mean by literally "agriculture extension service." So you mean you would talk to farmers about their health or...
Man: No, let me give you a very specific example. We've got 95 counties in Tennessee. (We've) got 65 health education centers that are related to extension that focus on wellness care, immunizations, tobacco use, smoking cessation, a whole variety of diseases. And we've worked very closely with them in developing community-based health initiatives, and so they are—these are people usually with master's degrees in nutrition and/or health education. So it's not dealing just with farmers, but it is reaching into rural areas of the state.
Mary Barton: Well, it is—you know, it seems plausible that, you know, a regional health center that is focused on improving—you know, that uses paraprofessionals within the health, you know, clinical realm, would be part of the sort of intent of the health system, but I'm going to defer to my colleague here.
Tess Miller: I think—this is Tess. I think the important point would be that they are linked into the clinical setting, so that you wouldn't be looking at an intervention that is completely conducted outside of the clinical setting that has no relationship back to it. So I think we'd actually encourage you to look at AHECs, as long as there's that strong link back to the clinical setting.
Man: It's not an AHEC.
Tess Miller: Okay, an Ag extension center office. Sorry. But personnel who are working there—there has to be some relationship back to the clinical setting.
Mary Barton: Thank you. Are there other questions?
Julie Wong: No, thank you.
Coordinator: Our next question comes from Gotham Raul. Your line is now open.
Gotham Raul: Thank you. I just had a question from Slide 11. It describes the need for core personnel to include a principal investigator and a collaborative lead. Could you describe the role of the collaborative lead in a bit more detail?
Mary Barton: Sure. So as it is stated in the FOA, the collaborative lead is responsible for participating in the efforts that are convened by the Technical Assistance Center, which bring all three centers together. And in specifying that we want someone to devote a significant chunk of time—I think 20% is specified—for the collaborative lead, to me, this is the area for your imagination to run free.
I think that—I'm hopeful that we would see collaborative leads creating new proposals that cross—you know, combined all three centers. Or they might come up with ways to leverage what was done in one center and work out how it can be built upon at their center.
So I think—you know, our hope is that this will be a linchpin for engagement with the other centers and will also be a—you know, it could be someone who is a counselor and a mentor to the project leads. And in particular, the core functions of training, you know, could be something that someone—you know, if there's (similar) strengths in, you know, whether it's postgraduate training or even professional training that they could bring that strength. So I think this is where we want to see exciting ideas from you all about what kind of work could be accomplished by an individual with those qualifications.
Coordinator: Our next question comes from Ann Jackman. Your line is now open.
Ann Jackman: Yes, thank you. Just as a followup to the collaborative lead, one of the questions I did have about that is that it states we're not supposed to have funds in the administrative core that aren't allocated for specific projects. So how does, you know, the idea of coming up with collaborative leads along that way who have great ideas across sites (work)? Is that funding that still comes within the center or is that simply sort of future research?
Mary Barton: I'm sorry. I'm not sure if I understood or agree with the first thing you said.
Ann Jackman: Okay.
Mary Barton: The core is expected to have a budget.
Ann Jackman: Right.
Mary Barton: And the kinds of activities that we expect to see in the core budget are the salary of the PI, the salary of the collaborative lead, and any efforts that are associated with the things that we've mentioned about training elevation, administration dissemination, as well as potentially core research tools. So there is a budget for that section. I thought I heard you say that nothing could be in that core if it wasn't for one of the projects?
Ann Jackman: No. I'm sorry, you didn't understand. I was not clear. What I was saying is, is that I understand that both things fall in there, but when we were talking about ideas generated across centers, it was my understanding that things in the core, if they were project-related, needed to be specified in advance. So would that be...
Mary Barton: Look, I would say that the 20% salary of the collaborative scientific lead is the one place in the $4.5 million that we're looking for you to propose something new and draw on the strengths of the person you've got.
Ann Jackman: That sounds great, okay. And then my second question was just sort of a technical budget question. Which is, do you have any strong preference for whether or not we start the project more late September, early October, or first of the year in 2012?
George Gardner: The latest is September 30. But not, definitely not October.
Ann Jackman: Okay. I got you. Thank you.
Coordinator: Our next question comes from Dr. Jim Mold. Your line is now open.
Dr. Jim Mold: Not sure that I—it may already have been answered—but we're not, in private care, we're not used to having administrative support for projects. So this core idea, the idea of the center, is wonderful, but (we have) very little experience with it. Can you speak a little bit more about what you envision with regard to training, since you won't pay for stipends, I guess, but who are you thinking we're going to train? Practitioners, students, faculty, researchers...
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