Active Aging, Supporting Individuals and Enhancing Community-Based Care through Health Information Technology

Technical Assistance Conference Call

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This document is a summary of a technical assistance teleconference call that took place on January 13, 2010, from the Agency for Healthcare Research and Quality (AHRQ), on the Agency's Funding Opportunity Announcement (FOA), Active Aging: Supporting Individuals and Enhancing Community-based Care through Health Information Technology (Health IT) (P50) (RFA-HS-10-016).

Select to access the slide presentation for this technical assistance teleconference call (PowerPoint® slides, 670 KB; Text Version). PowerPoint® files can be viewed with Microsoft® PowerPoint® or with a free PowerPoint® Viewer.

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Introductions | Highlights | Questions and Answers

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Introductions

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. If you'd like to ask a question please press star 1.

I will now turn today's meeting over to your host, Mr. Robert Mayes. You may begin.

Robert Mayes: Thank you very much. Welcome everyone and thanks for joining us here at AHRQ for the Technical Assistance call on the Active Aging, Supporting Individuals and Enhancing Community-Based Care through Health Information Technology Funding Opportunity Announcement.

In today's call I'm going to give a very brief overview of the FOA, and touch on a few points, since I'm assuming that all of you have had an opportunity to read it thoroughly. I'll talk to frequently asked questions. Then I'd like to reserve most of the time to answer the questions that you have; both those that were submitted prior to the call, as well as those you might have on the call. If we don't get to a question on today's call, you can submit the question to our E-mail box and we will post answers and questions of general interest on our Web site.

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Highlights

This was a relatively challenging Funding Opportunity Announcement to write. We here at AHRQ are very aware that it's going to be quite a challenge to respond to. So thank you for having the interest. But I do think it's an exciting topic. I think that it can really move the field forward. So I'm looking forward to seeing a lot of interesting applications.

This is a P50 grant mechanism, which is a Specialized Center grant. We're soliciting applications to carry out community based, participatory research on the use of communication and information focused technology for improving health status of, and health related services provided to older adults. We also wish to focus on applied research, with the objective of developing sustainable and reproducible strategies to translate this research into practice in an effective and efficient manner.

The overall objectives of the funding of the announcement and the project are

1. To provide a stable strategic mechanism for community based participatory research in this area of communication and information technologies in older adults.
2. To focus on implementation research, using scientific methods to promote the adoption of evidence based information focused on communication technologies, and practices that would improve health status and personal care—formal and informal—as well as integration of care provided by caregivers to older adults.

The FOA has three strategic themes.

1. Use of information in communication based technologies to extend the independence and functioning and reduce unnecessary health care utilization of older adults. This is often times referred to as Aging in Place. We're looking for the use of technologies in helping older adults maintain their independence and the highest level functioning they can.
2. Look at the use of information in communication technologies to place the individual, their family and extended informal care network at the center and expand it in a more efficient service delivery network. We're trying to achieve a more explicit integration between formal care networks, made up of various professional providers, and the informal care network. The informal care network is really much broader than the individual themselves, or just their spouse, child, or immediate family. Very little attention is paid to integrating that overall network with the formal care network.
3. Look at translational research as it applies to the first two themes. How can we take the findings that have developed through the projects that were carried out under the first two themes and evaluate good approaches to translating them into practice more broadly, beyond simply the groups that were a part of the intervention project?

Overall the research results of this effort are intended to enhance the independent functionality of older adults through applied research, through the development of tools, the conduct of demonstration projects, educational program development and implementation, and a broad dissemination of results.

I stress broad dissemination because I think it's more than just the formal dissemination that we think about; articles in peer review journals, that sort of thing. We really want to try and get the community in aging services to adopt the positive results that we get from this research.

Project requirements: The applicants are expected to develop an overarching comprehensive strategic plan that prioritizes a broad base of research needs across the three strategic themes that I just spoke about. It's expected that the applicants will develop a research center infrastructure with adequate facilities, institutional support, and appropriate expertise to support research dissemination and translation of research into practice.

The applicant should be able to propose specific projects that focus on strategies to achieve goals that fit within the framework of the overall initiative. They need to be able to propose projects that have distinct goals in implementation, but are also explicitly part of the larger strategic plan that I talked about as the first bullet that reflect the related nature of this initiative's three strategic themes.

The projects, while independent on one level, need to be synergistic and connected somatically within the framework of the initiative. What we would really like to see are projects that build upon each other and ultimately result in changes in the day-to-day practice of both formal and informal caregivers, and self-care, within a community based strategy for translation and dissemination.

Research settings: The research settings are very broad. I just want to mention this because they're almost anyplace that you find older adults. Research can be done in any ambulatory care setting, any of the formal ambulatory care settings that one might think about. That would be physician practices; could be a community based care centers, mental health, behavioral health, or substance abuse center. These are all appropriate. Patient's homes are appropriate settings as well as independent living centers and residential care communities.

In addition to these settings, projects and activities that looked at transitions of care between settings would be appropriate. That includes not only transitions of care between or among the settings I've just talked about, that are listed in the FOA, but transitions also between those settings and, for instance, in-patient hospital settings, which are not appropriate for a independent project.

The scope of settings is very broad. One of the things that is interesting about aging services as part of the overall health care sector is that there has been a realization and an explicit move towards understanding health more broadly, not merely in terms of services provided within a formal medical type of service provision setting. So we have this idea of community based intervention in aging services that I think holds promise more broadly than just for looking at health care of older adults.

Privacy and security: We are concerned about privacy and security particularly in projects and initiatives having to do with information technology. We explicitly require that you address that in your applications. So all applicants are required to describe how, in the development and implementation of interventions, privacy and security issues—particularly those related to the exchange of sensitive health information—will be identified and addressed.

You need to describe the resources and processes that you would use to protect privacy or to meet privacy and security concerns throughout the project period and throughout the initiative period. This is distinct from the emphasis on the protection of human subjects. So, if you're dealing with health sensitive personal information, with information systems, you need to be able to show that you have a plan to deal with that.

The application doesn't have to include a fully developed privacy and security plan. But it has to include enough detail so that when asked for that plan later, should you get the award, you can produce a plan.

There's a bit more information on this in the FOA. But it's not boilerplate; it's something that you really have to pay attention to. So I urge you to read this section.

Funding considerations: The funding considerations that we have for the initiative are similar to those that we apply to all of our grant funding opportunities. We look at the scientific merit of the proposed projects and initiatives. This is done through an external peer review process. Obviously the availability of funds plays an important role. The responses to the goals and objectives of the Funding Opportunity Announcement is something that's looked at closely.

We then, as an agency, look at the application in terms of its relevancy to our program priorities, in terms of its relevancy to a programmatic balance and between other projects that we have both in AHRQ as well as in the Department of Health and Human Services.

Review criteria: The review criteria are spelled out in the FOA. I should mention that what are listed in the FOA as Core Criteria are now being renamed Scored Criteria. So those criteria—and I'll talk to them just briefly under the heading of Core Criteria, are the ones that the review panel will be using to score the applications.

That's not to say that you shouldn't pay any attention to the additional criteria listed, because those certainly will speak to some of the other things that I just spoke about in terms of funding relevancy and that sort of thing. The core, or scored, review criteria are significant in impact approach, innovation, investigators and partnerships, and environment or setting of research.

Additional criteria that we are interested in and that we will look at through the lens of at your applications are:

• To what degree was the application responsive to the FOA?
• Does the budget seem to be appropriate to what's being proposed?
• Privacy and security protections.
• Protection of human subjects from research risk, a standard criterion.
• Inclusion of priority populations. This FOA is looking at a priority population, but older adults include every priority population except children that AHRQ is interested in. So within the context of older adults, there are other priority populations one could look at.
• Translation obviously is also a very key part because it's one of the three strategic themes of the FOA.

Those are the review criteria. Again, they're spelled out, and I'm sure you've all had a chance to look at them in the FOA itself.

Funds available: In terms of the mechanism and the funds available; this is a P50 grant mechanism, which is a P50 Specialized Center grant mechanism. As you've seen from the FOA, we want to establish an infrastructure that supports this research over a period of time, in this case 5 years.

We anticipate funding the initiative at $2 million a year for 5 years—$2 million being available in this first year, and then subsequent years after that—for a total of $10 million. However, we only allow $2 million per year. So when you put your budget together, you need to keep that clear. I'll talk a little bit more about the budget in just a second.

We're only anticipating one award. Now unlike most of our program announcements, or other RFAs where we have multiple awards for very different projects, this is a single award. That's to create, if you will, a system strategic depth around this area of research.

The length of time, the period of performance of the grant, the amount, and the fact that we're doing it as a single award, speak to our interest in creating a strategic, synergistic approach that allows us to leverage activity across a long enough period of time to see some potential impact type of results. Just as a reminder, any applications that request a budget that exceeds the amounts I just spoke about will not be reviewed. So you have to be paying attention.

Structure of application: One of the things that makes this a complex application is the way it's going to have to be structured, particularly in terms of budget. The application has to use a detailed budget format. By that I mean the budget has to be structured in such a way that allows the review of a discrete budget for center infrastructure, as well as each of the major project areas. Okay?

In addition, since it's a multi-year initiative, the budget has to speak to each of those four areas, broad areas, year by year. So we have to be able to look at what you're proposing and see whether or not the budget that you propose is appropriate and sufficient to carry out what it is that you're proposing. We need to see this across the 5 years of the initiative.

Submitting application: This is a little different than some of the grant funding announcements you may have responded to in the very recent past. As you may know, there's been a move, almost complete, to electronic submission of grant applications. However, the P50 mechanism has not made that move. So the P50 mechanism still uses a paper submission mechanism; it's the PHS 398 form.

Instructions are available. In the FOA, I believe there's a box right on the front page that has a link. I'll post the link in these slides when we publish these on the Web site as well. But the instructions are available at grants.nih.gov. The application form is paper, but all appendix materials have to be submitted on CD just so that we don't have applications that weigh 20 lbs.

If you just recently submitted a grant submission in to us or NIH, this is going to be a little different. It's a paper submission using PHS form 398, not an electronic submission.

Eligible institutions: This is a grant application. You may submit an application if your organization is a public or not-for-profit private institution, a unit of a local or State government or other eligible agency of the Federal government, Indian and American Native tribal government, or a tribally designated organization.

For profit organizations are not eligible to read the application. They can't be the Principal Investigator (PI) but they may participate as members of a consortia or subcontractors. So if you're for-profit, you can't be the PI, but you can certainly participate in the initiative with a not-for-profit or public partner. In fact, we encourage partner organizations that produce health IT systems to try and partner with some of these not-for-profit organizations.

Foreign institutions are also not eligible to be PIs. But there's no restriction on them participating within a consortia or partnering as subcontractors.

Principal Investigator: This is a fairly complex initiative in that it's actually setting up a center and then doing some research as well. The PI should be an experienced senior level individual with both scientific and managerial expertise.

Now, obviously not everybody is at the top of their game in both scientific research and managerial experience, so if in fact you—or whoever would be the PI—is more heavily focused on one or other of those two areas, that's okay. We would then be looking for another senior team member or co-investigator who can supply that expertise. In any event, the PI should be an experienced senior individual.

We think that expertise in evaluation is also a critical need. Again, that can be met through requisite experience of one or more of the team members of the initiative or project team. Because there is this managerial/organizational aspect to the FOA, it is required that the PI devotes at least 25 percent effort to the project. This is annual, so that's 3 person months a year that the PI would have to give to this initiative.

If for some reason you feel that the PI you would be putting forward cannot provide that much time, you would have to include a explicit written justification with your application as to both why they would not be able to provide 25 percent of their time, and what steps you would take to make sure that the work got done in an efficient and effective manner.

We do encourage individuals from under-served racial and ethnic groups and individuals with disabilities to serve as PI. So it's open to anybody with the requisite background. Certainly in the application you want to spend some time describing the background of the Principal Investigator.

Key dates: The FOA was released December 17. The letter of intent is not required, but we would ask you, if you are seriously thinking of applying, to send us a letter. It's an easy thing to do, there's not much required. You can do it by E-mail. It's in the FOA. We'd like to have those by February 25.

One of the reasons it's helpful for us is that it is very useful to help us figure out what size review panel we'll need to put together. So I would really just ask you as a big favor, if you are going to apply, to supply us with a letter of intent.

The application closing date is March 25. We've tried to give folks a reasonable amount of time to prepare a complex application that in fact may include more than one organization having to get their heads together to put the application together.

We anticipate a peer review panel in June. The start date is usually 3 months or so after that. So maybe we'll have the review in the middle of June and maybe September is the earliest time we can start. That gets a little tricky; we'll just have to see. But that gives you a rough idea of the time.

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Questions and Answers

First I'll answer two common questions, and then turn to the written questions. Once I've finished questions that were submitted prior to this call, I'll open it up for everyone on the call to ask further questions. As I said earlier, feel free to submit your questions. We try to get the slides and transcripts and answers to the questions up on the Web in 2 to 3 weeks. So if you get some questions to us in the next few days, we'll include those as well. Plus, we'll give you an answer directly to your question.

Frequent and Written Questions

Question 1: Can there be co-PIs?

Answer 1: No, AHRQ does not allow co-PIs. We require that the lead institution designate one, and only one, individual as the project's Principal Investigator. There can be co-investigators. Of course, this FOA has a Principal Investigator, but it would be assumed that there would be lead investigators for each of the projects that were pursued under the initiative. But only one official PI.

Question 2: What about the letter of intent?

Answer 2: We don't provide any feedback. Really all we want in it is an acknowledgement of interest. It would be great if you wanted to include a couple of comments on what you're thinking about and the background of key personnel and the nature and role of participating institutions. It's not required, it's not binding, it's not considered in the review; but it is helpful for us in putting that review together.

Question 3: Can we get a definition for Financial Conflict of Interest, percentage of ownership, et cetera. If a proposed steering committee chair has a history of successful aging services technology development, and commercialization, does this constitute a conflict of interest if one of the proposed projects involves a class of technologies that include a number of products similar to and including the one that the chair has pursued in the past? Can they propose to establish a governing structure that would include alternate leadership for scientific discussions, when there is a perceived conflict of interest?

Answer 3: I'm going to ask Michelle Burr, who's from our Grant Management office here, to respond briefly to that question.

Michelle Burr: We would refer you to the HHS Grant Policy Statement. You can find a link to that on the AHRQ Web site under Research Policies. specifically to the Financial Conflict of Interest section of that policy, which will in turn refer you to 42 CFR Part 50 for details about what your institution needs to do and what policies they need to have in place regarding conflict of interest.

Robert Mayes: I will mention this, because this comes up often in our general HIT grant. A project that deals with a class of technology that the applicant is involved in, isn't automatically disqualified as being inappropriate.

Why? Because obviously our interest is getting this stuff used, and frankly most people implement HIT through commercial products, and not through building their own. We understand that if we were to completely do away with all commercial products, we really wouldn't have much to show people.

Question 4: Given that the entire Active Aging Research Center, its governance, administration, scientific support, policies, procedures, as well as the individual projects and project methodologies must be presented in 25 pages, how will the reviewers be instructed in terms of their expectation for detail on specific methodologies in the individual projects?

Answer 4: This is a question every one of you who sent questions in early asked. We realize that 25 pages is pretty tough for a description of a 5-year, $10 million project that has these various pieces. Basically the 25 pages of description needs to be a clear picture of the strategic approach that you're planning on taking of the major thematic project that you're going to undertake. Remember, this is looked at in relationship or in conjunction with the budget as well. So there's a bit more information that actually can be gleaned from the budget.

The real challenge is to present an overview to the review committee that allows them to feel comfortable that what you're proposing is feasible, what you're proposing is measurable in terms of whether or not you succeed in what you're doing, and what you're proposing in fact does have both relevance and has some significance within the strategic themes of the FOA.

I realize that that's really skirting around your question. We understand that it's a limit. On the other hand, this is a 5-year project in a very, very dynamic sector. Information and communication technologies are literally changing month to month.

If we had given you 100 or 200 pages; first of all it would have been a lot of work; but secondly, giving that much detail, projecting out 5 years in a sector that's going to be changing 6 months from now or 12 months from now, would really limit the potential usability of some of the findings.

So it's a balance. It has to be enough detail because you have to budget it out, but it has to be developed or presented in a way that allows you to be flexible in how you reach the goals of the activity. That's all I'm going to say about that.

Question 5: Please confirm that the Principal Investigator and the steering committee chair can come from the same institution, if their credentials and experience are consistent with the guidelines in the RFA.

Answer 5: It is permitted within the FOA, within the language of the FOA. We don't explicitly say that they can't come from the same institution. The steering committee is there to provide guidance to the overall initiative. as it said in the FOA, we anticipate that it would be made up of a broad group of individuals with a broad perspective.

Question 6: The language in the FOA suggests that the government is interested in establishing a solid infrastructure for the Conduct of Aging Services Technology study. that there is a desire to use this infrastructure for studies that go beyond those initially proposed in the application. Can you provide some guidance on the desired allocation of resources—that is, should the bulk of resources be allocated to projects, or to building the infrastructure of the center with the expectation that a firm foundation will be needed for future studies?

Answer 6: You're absolutely right. One of the reasons we chose this P50 mechanism is that we think that there is value in creating an infrastructure that has a certain amount of robustness and permanence to it, because we feel that that having such a focus would be attractive potentially to other organizations that are interested in doing research in this area and that may wish to provide funds for research.

Having said that, the focus of this, and the focus of the AHRQ money is what's described in the FOA, which is research on the strategic theme areas as outlined in the Funding Opportunity Announcement. So, we explicitly say in the FOA that funds can be used to establish the center infrastructure.

Obviously, budget will have in it support for the steering committee, and support for meetings and that sort of thing. But we would anticipate that the bulk of funds in any particular year, and certainly over the life of the initiative would be spent on the research focus projects.

That said, setting up the infrastructure, if in fact other organizations have an interest, is one of the reasons to have it there, so that there's a mechanism, or there's something that can attract other funding. But the AHRQ funds, the funds in the FOA, are primarily there to do the research, not to build an edifice.

Question 7: The FOA indicates that the individual projects should entail community based participatory research in the selection of outcome measures, research instrument study designs, to take community preference, and address cultural sensitivity. This implies that projects will entail exploration feasibility, and it may not be possible to include power analysis in the 25 page submission. Can you explain how you envision evaluating this in submitted application?

Answer 7: Spoke to this briefly. The research agenda should be—it needs to be, because it has to be presented in the application—by the applicant of the institution, a PI. The community participation stems from the implementation of that agenda, certainly as it moves forward in the evaluation and translation of the results.

What you need to do as an applicant is to demonstrate the feasibility of the projects, demonstrate that the methodology proposed is sufficient to answer the question scientifically, that the analyses proposed are in fact appropriate. It's understood that given the limited amount of words that you have, we do not anticipate that you would put forward a detailed analytic plan for all of the different projects.

But you really have to show the review panel that you've thought through the scientific process, that you understand the components, that you have hypotheses, that you have appropriate methodology and a statistical or analytic plan even if you don't go into great detail.

Remember, the reviewers can raise questions as part of the review process. In fact, it is common, almost universal, that applicants that score competitively are asked a series of questions after the review, based on the questions from the review panel. So you have to paint a coherent picture.

Don't get drawn too far down into detail in one little piece of it because you don't have a lot of space. But be prepared should I come back, as a technical officer on this and say, "We have a question about what you're proposing as an analytic plan. Could you provide more detail on that." Okay?

It really has to be a coherent view with enough details so that someone could ask intelligent questions if they wanted more detail. So we will very likely ask further questions after the review, for those applications that score competitively.

Question 8: Will AHRQ further elaborate on the profile of proposed review committee members who will evaluate the application?

Answer 8: Obviously we can't tell you about any specific reviewer. This Funding Opportunity Announcement will be reviewed by a special emphasis panel—not by one of our standing panels.

The benefit of putting it in front of a special emphasis panel is that we can try and attract a review committee that has expertise that's closely aligned with the interests of the FOA. We've looked for reviewers that have expertise in health and health information and communication technologies, in aging services, and in community based practice methodologies. Obviously not every reviewer has experience in all three of those, but we do feel that as a group, we will get a nice rounded amount of experience that's relevant to this FOA.

The size of the review panel depends on the number of applications. But there is a minimum of seven reviewers. So, if we only get a few there'll be at least seven. But we have standing panels that have dozens of reviewers on them. So we'll see how that goes.

Question 9: Can we provide a list of attendees at the technical assistance call?

Answer 9: In other words, those that are on this call? Yes we can do that. We'll post that with the slides and the transcript.

Question 10: The FOA requires a focus on a specific chair setting. However, theme one is focused on the use of Aging in Place and extended independence and functioning of adults outside of care centers. Will AHRQ please clarify the degree to which theme one must focus on health care versus active and independent living.

Answer 10: There really is no requirement to focus on a single, specific care setting. The fact that it also includes the issue around transitions of care, further speaks to the fact that we're looking at health status or let's say independence and functionality, and use of health care—use of services for older adults in a holistic way, across settings. We realize that there is not one particular setting where health happens. In fact we include the home as a setting.

So I think that this is something of misreading. You can include more than one setting. The setting does not determine the projects—it's whether or not they link to each other through the themes.

Question 11: How self contained should projects be?

Answer 11: We need to clarify how broad or narrow they would be and how related to each other. I think I've spoken to that. They need to be self contained to the extent that you can provide a budget for them. However, they should explicitly be linked to the themes. We would anticipate that many of them would be linked at the project level so that this project might be looking at one aspect, and this project at another aspect. Or the projects might be looking at the same sort of thing in two or three different settings.

The more synergy that you can produce, the more cohesiveness that you can provide in your application around the major project areas that you're proposing, the stronger the application becomes.

Question 12: Does the center need to be an independent entity or could it be under the umbrella of our university recognized center on aging?

Answer 12: It does not have to be an independent entity. It can be under the umbrella of an existing center. It has to be relevant of course. In fact, if you can leverage existing infrastructure, so much the better. It gives you money to do other things.

Question 13: Do the projects all need to start early in the grant period or could they be partially sequential?

Answer 13: There is no requirement that they start at any particular point in the initiative. Let's remember, it's $2 million a year for 5 years. The budget has to reflect the $2 million. If you're going to do a project or series of projects sequentially, if it's going to start in year 3, it has to be in the year 3 budget or the year 3 part of the budget.

So just keep it connected that way. But there's nothing in the FOA, nor are we particularly requiring you to do a minimum number of projects per year. You have to have three major project areas, each reflecting one of the themes. There can be sub-activities under those projects.

Obviously an initial part or certainly significant or a portion of the first year would be setting up the infrastructure for the Active Aging Research Center. So you might not start some of the research projects till later. But that's up to you, and you just have to describe it in your application. make sure it matches what's in your budget as well.

Open Forum Questions and Answers

Coordinator: We will now begin the question and answer session with Robert Mayes. Our first question comes from Robin Stone. Your line is now open.

Question 1—Robin Stone: I have a question about the translation focus of this project. There's a strong emphasis on translational research and evidence base. My question really has to do with your interest in translation itself as a science and as an activity. Should we be thinking about translation as it runs across the projects? Are you thinking about translation as its own project, or as a device for going across the various themes? Related to that, how interested are you in the translational scientific method itself?

Answer 1: In terms of the translational focus, it's a little bit of both. Obviously we would like to see translational efforts around any successful projects that were undertaken that were focused specifically on theme one and two.

But we're also are interested in translation, particularly with the community that we're looking at. Regarding aging services, are there translational methodologies that could be more broadly applied? Not only to research that comes out of the specific projects of this initiative, but other types of research, or other similar kind of research that other folks might be doing.

So yes, there should be a translational component directly linked to the first two themes. But we would also be interested in exploring translational methodologies particularly in terms of this population segment, in terms of the kinds of service providers and the range of different types of service providers, and whether they're formal or informal. Are there translational methodologies that are particularly relevant or particularly effective with these groups?

Question 2—Tom Musculan: Our question was relevant to the breadth of the demographics. Is there any preference on the population size; whether it's a county, a State, or national? Are there any particular boundaries on that?

Answer 2: In terms of the breadth of demographics, you'll note that in the FOA we do talk a bit about community obviously because we're interested in a community based, participatory approach. We define community pretty broadly.

But what you see is that the definition of community is really more around shared interest than necessarily around geography. So it's really a community of interest versus a geographic community of location or residence.

Having said that, you obviously want to have enough broadness of community so that the results of your project, of your research, have a certain level of generalizability about them. That could be done by either making it geographically large—like you said, city, State or whatever—or a more community of practice that's spread out.

So perhaps you have a partnership doing a project with a continuing care retirement community and you're working with an organization that has several of these dispersed around the country.

You're doing the project with this organization in three, four, or five different settings. You could then say, "We've done this with this continuing care community and we did it in several settings. So we think that the results might be generalizable to other types of continuing care communities or retirement communities," et cetera.

So we don't have a specific county level or the State level or whatever. The community really just has to be well defined. Then you have to be able to speak to the generalizability of your findings. I'll leave it at that.

Again, if that's not exactly what you're asking, or if I was unclear, I think we probably have time to go farther into that.

Coordinator: Our next question comes from Helaine Resnick. Your line is now open.

Question 3—Helaine Resnick: I wanted to know if AHRQ has policies in place that govern the licensing issues and commercialization of products that are involved in the research that it supports.

Answer 3: In terms of licensing issues, these are grants, these aren't contracts. Unlike a contract where the government actually owns the products, that's not the case under a grant.

Now you know, we don't fund the development of commercial products either. What we would probably want to do, if there were a significant issue, for instance if within the research there was some tremendous breakthrough and a question arose, we would have to bring it to our General Counsel and get a full legal opinion. But in general, the grantee retains intellectual rights to things that were developed using the grant money.

But I'm not a lawyer and I don't represent the agency or the department as a lawyer so when it came down to it, if this were really something that needed an opinion, we would just get a legal opinion. But in general we're not interested in owning things. In general, our interest is in getting them out there.

Again it's somewhat similar to the licensing issue. We recognize that this is a field, particularly on the hit side, that has a lot of commercialization involved in it and that it's sometimes difficult to do a lot of work without getting involved with commercial activity. So we don't take a rigid position on this. We would have to do it on a case-by-case basis, in terms of any kind of conflict of interest.

Michelle Burr: Again, the HHS Grant Policy Statement does have a section devoted to intellectual property. So you'd want to go there to look for more detail.

Robert Mayes: Yes.

Coordinator: Our next question comes from Ge Wu. Your line is now open.

Question 4—Ge Wu: I have a question about the Active Aging Research Center that needs to be built throughout the funding period. Does that center have to be a new center? Or can it be a portion, a new segment, of an existing center on campus? For example, Center on Aging, and then we can create another initiative under this existing center to be called Active Aging Research Center.

Answer 4: In terms of whether the Active Aging Research Center needs to be a new independent entity, or part of an existing entity; it can be part of an existing entity. Again, we're not looking for a building with the name Active Aging Research Center on it and lots of offices. It's somewhat more than a virtual entity, but the main focus is not building this edifice called the Active Aging Research Center.

So if there is already an appropriate center that does this kind of work, or supports this type of activity, it can certainly be an initiative, although, it would have to be an explicit initiative. We'd have to have acknowledged that it was funded by AHRQ. But it could be part of an overall center.

In fact, that might be positive, because then potentially you could leverage some of the existing infrastructure—administrative and otherwise—that already exists for that center. That would leave more resources for the research.

Question 5—Majd Alwan: I just wanted to see if it's possible to include a link to the 42CFR50, to the latest section that defines the conflict of interest when the written responses are posted on the Web.

Answer 5: That link is in one of the slides. So when we publish the slides it'll have that link for you on the conflict of interest.

Question 6—Richelle Koopman: As the grant unfolds over 5 years, we would anticipate having some community representatives on our steering committee from the outset and certainly through the 5-year period. Do you have a sense of a balance of academic representatives on a steering committee, compared to say aging services representatives from the community on that same steering committee?

Answer 6: In terms of the balance on the steering committee; we would anticipate that the steering committee in fact be well balanced, not just between community representatives and academics, but also providers of community-based services. Let me back up.

To some extent, the composition of the steering committee will reflect—or should reflect—certainly in part, the kinds of projects that you're thinking of doing and that you're proposing. If you were working with long-term care or resident care facilities as a major part of your product activity, it would be appropriate to have someone on the steering committee who represented resident care type of providers.

The community-based participatory research is not tokenism as you all well know. So it's not a matter of simply having a token old person from the community on the steering committee. Most of us would already match that description anyway I guess, so it wouldn't be token.

But in any event the point of the steering committee is to really make sure that the research has some meaning in the community. Which gets back to an earlier question about the ability to translate that research into actual practice.

So by involving the community and that community at large, in this whole process, it just helps assure that it's going in the right direction in a meaningful way. That it's not simply winding up someone's pet academic project because it supports some thesis work, or some other thing.

The goal here is to really think about what are the issues facing older adults as they age in this society. It seems that research and other informal information sources all say the same thing: People want to stay in control of their lives as they age. That means they want to stay active in their communities, they want to stay active with their social networks.

How can we help people do that for the longest period of time in their lives? How can we help them stay an active participant in the broader society that they find themselves in? Some of these new communication and information technologies have the potential of greatly enhancing the ability of individuals to do that.

What we want is a research agenda and projects that do that. In order to do that we have to understand from their perspective what works, what doesn't work.

Question 7—Melanie Wasserman: Is the page limit for the application 25 pages including research plans for all the three proposed projects and description of the governance structure, et cetera? Second, could community-based participatory research be used, in theory to shape the research agenda, to select the innovations tested, to select from among the range of possible research methods, to implement the research and figure out how we're doing that, and to translate and disseminate the research?

From your answers I think I understand that you'd like community-based participatory research to be involved mainly in the implementation of the research part and translation and dissemination, and that the other parts need to be stated by the researchers in their application. Is that correct?

Answer 7: Obviously as a methodological approach, community-based participatory research ideally involves the community at the very beginning of the process. What questions do I want to look at? What are relevant questions for this community?

I was trying to suggest that, you can engage whatever community around aging services and older adults that you think that you're interested in, to the extent that you engage them, even at this point, even at the point of thinking about the application and how you would go forward, that's great. Just keep in mind that you've got to actually present an application that has specificity in terms of what it is you're planning on doing, and how much it's going to cost over a 5-year period.

So, in terms of ongoing community engagement, it probably is going to be more heavily weighted on the intervention and translation side because it's hard between now and March 25, unless you've already been working at it. Maybe, Loren in Hawaii, as part of your pilot you already have engaged the community.

But if you're starting off cold on this, you just may not have time to get a real effective community involvement in development of the research agenda. But it's not saying you couldn't. It's just that we want the community involved because that's how we know that the research is relevant and potentially translatable into actual practice.

Question 8—Loren Petty: We're calling from Hawaii. We have a pilot project already running. It's been approved by ethical review committee and all. It's starting out in a small number of patients. If we were to apply for this grant, and suppose there's a second phase, is it okay to build on an existing thing, although you didn't own the original design and the pilot study?

Answer 8: It's completely appropriate to build on existing or previously done work. In fact, that has benefit, even if its pilot findings, you can actually show that it's worked so far, kind of thing, or show here's what we've found. It's not just coming out of my head. We've actually started this and we think it's really going to change the face of aging services.

So hopefully I've answered those questions. Again, if I haven't, just come back on the phone and ask them again. Any more questions?

Question 9—Marilyn Rantz: If a person is going to be the PI on the center grant, can they also be a PI on one of the proposed projects within the center grant?

Answer 9: Okay, Marilyn. Yes, the PI could be the overall PI of the initiative as well as the PI on one of the major projects. It's just a matter of time. Remember, if you look at the duties of the PI, they're heavily, heavily weighted around the management of the Center. There is a 25 percent time requirement there.

If you are also going to be a PI on one of the major projects, or really any other project, you would have to address, explicitly is that part of the 25 percent, and if so, how much of that 25 percent? Or are you going to have 25 percent for the Center and another 10 percent or 15 percent of your effort for this particular project?

But there's no restriction in the FOA on a PI being the PI and a Lead Investigator. They're actually two different things, because the projects don't have a formal PI. There's only one PI, and it's the PI of the overall of initiative. Everybody else is a lead or coinvestigator or something. A bit of semantics, but semantics are important.

Question 10—Jay Ford: When I was reading the RFA, there seemed to be an implication that there should be a group set up within the center that would be reviewing pilot-type applications that may or may not be funded as part of this. Could you address that?

Answer 10: In terms of the review group, Jay that you spoke about, yes it is in there. Basically it speaks to the fact that one of the reasons that we took the P50 Specialized Center mechanism is that we're hoping that this would attract other research, other funds for doing related research. One of the things we would like to see as part of the infrastructure—again, it's virtual—is a formal process by which the center could attract funding other than the funding provided by AHRQ.

So the steering committee and with this review panel, or your review committee, would potentially alert other organizations that fund this type of research that you're there and available and you've pulled together a great team and have support, ongoing support, from an operational level.

But should other folks come and say, "We would like to do this research, would you like to be involved," it can be looked at vis-à-vis the responsibilities that you have to effectively carry out the AHRQ funded grant.

Again if I didn't answer any of these questions clearly enough please restate them and I'll try again. Any more questions?

Question 11—Helaine Resnick: Hi, it's Helaine again. Just a point of clarification about the Publication and Proposals Review committee and the Public Private Partnership subcommittee. My understanding was that the primary charge of the Review committee was to provide a mechanism for scientific review and vetting. The Public Private Partnership committee was more aimed toward identifying opportunities and bringing new parties together into the Center. Is that correct?

Answer 11: Yeah, Helaine you're right. I was a little unclear which one Jay was referring to, but there are the two. Your description is in fact exactly what we thought.

So yes, there's one committee that really is just there to help provide a scientific review type of function. Then another committee, the Public Private Partnership committee is to help bring in, potentially, other partners. Any further questions?

Question 12—Robin Pilus: I just wanted you to address the idea and the principles associated with evidence based research and how that in fact plays out in this project.

Answer 12: The question on evidence base is a pretty broad question. AHRQ is in the business of generating evidence through research, through quality research. It's in the business of generating evidence around what works, what's effective, what's safe—in terms of health care, in terms of safety.

One of the things that we look at in all of our activity, whether it be grants or contracts, is whether, after we've funded an activity, we can say with a certain amount of scientific certainty or rigor that the findings, whether they be positive, negative, or reflect reality, have a certain level of generalizability, That's also part of it.

One of the things we want to look for here is activity around the fact that we want to try things, particularly new approaches using relatively new technologies, that support changing the way we do things around providing services for older adults.

The projects that we undertake need to ask specific questions. They can't just say, "Well we think this is a great way to do things." They should actually be a bit more focused than that, and say, "We think that this is our hypothesis."

They should also be undertaken in settings that have characteristics that are not completely unique to that setting, or that don't have one or more characteristics that make things that happen there unlikely to be applicable in other settings in the United States.

An example of that might be a setting with a particular payment model, or a setting that relies on facilities or services that are not generally available broadly, or whatever. So when we talk about evidence based, we want to know that it's credible that the technologically based approach is going to work elsewhere.

Now, it can be based on prior evidence. There's evidence that we generate through the work that we're doing here and maybe this might be part of what you're asking as well. We also want to know, have you looked to see whether there is existing evidence that would indicate that the approach that you're taking is going to be successful?

Now in research you learn something even if you don't succeed. I mean you can have a failure that actually provides a great deal of information. But generally speaking we try to make our hypothesis positive.

So it's part of our culture at AHRQ that we don't provide health care, we don't pay for health care, we don't regulate health care. What we do is study health care. We do that so that we can generate information, evidence if you will, so that others know what works and what doesn't work.

It can be forward looking in terms of evidence base. We would also expect that as part of the application, you would be able to provide some kind of either theoretical framework or, for instance in the situation in Hawaii, actual experiential evidence to say, "Based on this, we think going forward that we can actually prove or disprove the utility of the approach we're taking."

Question 13—Robin Stone: I want a little bit of a clarification. You talked about the potential for these projects to be linked across themes, but also that there's the potential for more sequential projects that were thematic—one, two and three—over the time period.

Do you have preference for one or the other, or do you have very discrete projects within each of these themes, and you inter-relate them at the very highest theoretical level. Another way of thinking about it is that you actually have sequential projects with the same set of settings across the 5 years and you really related to them in the real world. I'm just wondering whether there is any preference that AHRQ has or you're letting us think about how we would lay it out.

Answer 13: In terms of the project, you're luring me onto thin ice here. The challenge in writing this Funding Opportunity Announcement is that we often have a hard time when we put together a research agenda in creating what I'll call strategic depth.

Most of the time when you see grant funding announcements, the announcement concerns a broad area of interests. Then it's open to any idea that relates to that interest. Now obviously it's evaluated and we evaluate them. But you might announce, 10 grants, and they could be on 10 different things.

Yes, over time you accumulate a certain amount of evidence and other things, but it's difficult to say. We want to give enough time, and we want to give enough resources focused on a specific idea that we can build on things in a coherent way. So one of the things we were trying to find was a way to do that, a way to provide enough time and enough resources so that we can learn from things as we go on.

On the other hand, a grant requires that we can describe what we're giving the money to you for. We have to be able to describe it for someone on the outside who says, "Well, how did you give these people $10 million? We can't give it out."

So it requires certain of level of specificity, for when an external evaluating body—office management and budget, or GAO, or somebody like that—comes in and says, "Why did you give these people this money? We've looked at the application and we can't—we don't see anything."

Now, a grant is nowhere nearly as pre-scripted as a contract, where we actually list out all the deliverables and we pay you by the deliverable. But nonetheless, there is a structure to it. We have to be able to abide by that structure.

It is a tightrope. It's a very difficult position to walk into saying, "We want you to learn over the 5 years, and to modify your approach during the 5 years based on what you're learning, while at the same time keeping to the relatively detailed budget and plan that you proposed, which is why we gave you the money, because that's what was reviewed."

We could have said we're going to a new application every year, and we're on a renew-review panel. But then we're right back where we normally are, which is, we can't guarantee you'll get funded again the next time. So it's not a good answer for your question.

I can't really answer your question—legally I can't say one way or the other. You've got to give us a project plan that has enough details so that it matches your budget, and so that we know what we're giving you $2 million a year for over 5 years.

On the other hand, we're interested in successful implementations. We would ideally want projects that have an implementation at the end because they have to move towards this translational aspect. We understand that things shift. That's why there is this requirement to do a project at least under each of the themes.

That could be a pretty big project. A 5-year project under the theme of information and communication technologies to support independence, that's a pretty broad scope. So you could potentially develop a project that met those requirements, and yet build into it a recognition that things grow over time.

It's like handing in your deliverables. I do a draft or I hold a series of meetings, and then based on the input of meetings, I modify the paper. You know, they're all approaches that you can go with. I know that this is not an extraordinarily helpful answer, particularly since we're confining you to such a short application. But it's the best I can do at this point without running afoul of folks.

It's really up to you all to structure in a way that best supports your process. So we're not dictating a particular structure, a mix of projects. We're just saying, hopefully you have a vision. We had a vision when we wrote this. We've tried to get it across.

I would hope that your applications contain a vision, because you're in this because you think this is interesting. So you've got this vision, and you ask, if I had this kind of resource for 5 years, where could we move this whole thing? You need to think through what kind of structure you would put in place over the next 5 years and what kind of activities you would engage in to actually realize that vision.

I can't dictate to you; AHRQ can't dictate to you; we're just giving you an opportunity. But there are constraints on how we have to present the opportunity.

So I apologize I can't be any more clear. But that's just the way the world works.

Question 14—Marilyn Rantz: I had a follow up question about scoring for the review process. You mentioned at the beginning in the overview, that the Core Criteria are actual going to be the Score Criteria. Will you be using some sort of scoring mechanism that is parallel to NIH, or do you have another scoring rubric in mind?

Answer 14: The criteria are the criteria listed in the FOA. We actually use the same scoring methodology as NIH. As you rightly mentioned this has changed recently. So it's 0 to 10 and each criterion is scored. But, it's the same as NIH's scoring methodology. But the criteria, and as they're stated, that's what's going to be scored. That's not changed.

Question 15—Ge Wu: I'd like to confirm that the submission of the grant is in paper form, not online because right now NIH submission is all pretty much done online. Also are we going to use the new format, or the old format, or simple pitch limits for file sketch, and other things?

Answer 15: Dr. Wu, this is a paper submission. NIH and AHRQ, because we use the same infrastructure, have moved almost all of our grant applications to electronic format. But this particular mechanism, the P50 mechanism, has not been moved to the new format.

So it is a paper submission. Right at the very front page of the funding announcements there's a box. In that box it actually notes, use the paper PHS 398 application. There is a link that goes to the instructions.

None of the complex mechanisms and the P50 is understood as a complex mechanism, have yet been moved over to the electronic system. So this, unlike probably most other things you've been applying to recently, is a paper submission.

Question 16—Dr. Pang: I work with Jayme Tamaki from Hawaii. I have a comment rather than a question. First of all, we are the ones with a pilot study already running for the last 9 months. We are quite intimidated about applying for this.

We are, I think, right on the money. We are exactly what you want. We have shown initiative already. But we are intimidated because according to the rules, there's only one winner of $2 million. To tell you the truth, we could use $2 million—we're not that big a county. We could use $2 million, but in our pilot project already, we have so many partners and I'd like to see some commitment money-wise, besides finance, on their part.

So what I'm trying to say is, our project might use $2 million, but I think 80 percent should come from on-the-ground partners. We are intimidated. If we were to apply for $200,000 that would be more reasonable. But to us it seems all or nothing.

Answer 16: Dr. Pang, I really appreciate your comment and I understand your position. What you described is business-as-usual, and how we normally do things in AHRQ. Again it gets back to that rather lengthy monologue that I just delivered about it. With this particular one we're trying to do things a little bit differently.

It is difficult for smaller groups. To be honest, I've received a lot more inquiries than usual on this call, particularly between the Notice of Intent and the publication of the FOA. I think a lot of people read the Notice of Intent as our standard type of process where we give out multiple awards of a smaller amount that add up to the total.

Once people saw that this required a pretty significant investment in terms of energy, and that this was pretty big project—it's not $2 million, it's actually $10 million because this is a 5-year project—fewer people were engaged.

Now, having said that, most of these complex larger initiatives wind up being partnerships, consortia, that sort of thing. So it's very likely that most applications will involve more than a single organization. Simply, we'd be hard pressed to find a single organization that could bring to bear all of the variety of things that we would like to have included in these applications.

So, it sounds like your group in Hawaii has already developed strong partnerships and wide ranging partnerships. You're both fortunate and unfortunate in being fairly isolated. Unfortunate in that you're often hard to connect to outside, but fortunate in that it's easy generate local partnerships because you're all there together working constantly every day. I would encourage you to leverage those partnerships when you think about this application.

Coordinator: At this time we show no further questions.

Robert Mayes: Let me mention that should you come up with questions as you've had time to digest this call and read the FOA over again, please feel free to submit them to agingfoa@ahrq.hhs.gov.

I thank all of you for joining me, and the rest of us here at AHRQ today. We look forward to some really exciting, interesting applications. The best of luck, and I really do encourage you and hope that a lot of you apply.

I think that this could be a very, very exciting opportunity. I think it speaks to a really relevant and large issue in our society today. So I hope we do get some top flight applications out of it. I think it'll be an exciting way to spend the next 5 years.

Thank you all, and have a good day. Sherry, thank you for being such a good coordinator.

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