Technical Assistance Call
This document is a transcript of a technical assistance teleconference call that took place on January 10, 2008, from the Agency for Healthcare Research and Quality (AHRQ) on the Agency's funding opportunity announcement (FOA), "Improving Management of Individuals with Complex Healthcare Needs through Health IT
Technical Assistance Call."
Introduction / Slide Presentation / Written Questions
Introduction
Coordinator: Welcome and thank you for standing by. At this time, all participants are in a listen-only mode. During the question and answer session, please press *1 on your touchtone phone. Today's call is being recorded. If you have any objections, you may disconnect at this time.
I would now like to turn the meeting over to Mr. Robert Mayes. Sir, you may begin.
Robert Mayes: Thank you very much. And thanks everyone for joining us on today's technical assistance call where we will be discussing the funding opportunity announcement (FOA), "Improving management of individuals with complex healthcare needs through health IT."
I'll be the host of the call today. I'm Bob Mayes. I'm a senior advisor in the AHRQ Center for Primary Care, Prevention, and Clinical Partnerships on the Health Information Technology [Health IT] team.
There are several other AHRQ staff with me today who will be able to answer any of the questions that you might have. I'll let them introduce themselves.
Kishna Wodwani: Good afternoon. My name's Kishna Wodwani. And I'm a division director of the scientific review. I will be here to respond to any questions related to peer review.
Michelle Burr: I'm Michelle Burr. I'm from AHRQ grants management and I'm here to address financial or grants matters.
Jerry Calderon: I'm Jerry Calderon. I'm the AHRQ referral officer.
Robert Mayes: Okay, great. I think that between the four of us, we've got expertise on all aspects of the FOA so I think we'll be able to answer your questions.
I will now go through the slide deck that was sent out out. If any of you didn't get the slides, I'll try to cover the content of each slide.
Both the slides as well as the questions and answers will be posted on the AHRQ Web site. A transcript of the call will also be posted that will be available for your review in the future. And if any of your colleagues weren't able to make the call, they'll also be able to look at both the slides as well as the transcript of the call.
When I have finished the slide deck, I think the most efficient way to handle the questions will be that if you have a question, you'll press *1 on your telephone.
That will bring up who you are on the operator's screen and she will then call on you by name. You can state your question. We'll take all of the questions first. We'll then take a short break, put you on mute, and each of us here in AHRQ will decide who's the best respondent to the questions. We'll then answer the questions.
If we get finished with all of the questions, fantastic. If in fact we have more questions than we have time, what we'll do is get the answers for those questions, post the questions and the answers along with the call transcript and slides, so all of the questions will get answered. We hope to get everybody's questions answered today on the call, but if not, you will get an answer within the next few days. With that, I will start going through the slides. I'll simply indicate each slide as I finish talking about it. We'll skip the title slide. And the next slide, Slide number 2, is the agenda for this call.
This FOA is part of a larger set of FOAs that have been announced and published for AHRQ's Ambulatory Safety and Quality Program (ASQ). I'll talk about that program to give you a little broader programmatic context for this particular FOA. We'll then review the FOA in more detail. I should say at this point that although this is a technical assistance call, fundamentally I'll simply be going over what's already written in the FOA.
We're not bringing up new information here. It's really to review the FOA and to give you the opportunity to clarify points within the FOA.
We'll do a quick review of the highlights or the important parts of the FOA followed by some frequently asked questions, just a few that we get commonly on these calls. I'll dispose of those before we get into your specific questions.
Slide Presentation
Select to access the Slide Presentation (PowerPoint® file, 660 KB; Text Version).
Robert Mayes: The Ambulatory Safety and Quality Program is a broad program in AHRQ whose primary focus is to improve the safety and quality of ambulatory healthcare in the United States.
It became obvious that some of the safety and quality issues that we had begun to see in the hospital setting really were only the tip of the iceberg and that with the increasing complexity of interventions provided in the ambulatory care setting, safety and quality were very important issues.
The ASQ program was developed to look specifically at safety and quality in the ambulatory setting. A major emphasis of the ASQ program is the role of health information technology, or health IT, and how it might support improving quality of care and outcomes the ambulatory setting.
The next slide looks at the five major components of the ASQ program. Each of these components was supported through an FOA.
The first four FOAs have been published and the grants awarded. The fifth, which is the FOA we're talking about today, is focused on the management of individuals with complex healthcare needs and the role of health IT. Previously AHRQ funded research that looked at the risk assessment in ambulatory care, improving quality through clinicians' use of health IT, enabling patient-centered care through health IT, and enabling patient safety and quality measurement through health IT.
I should note that the issues that we're looking at in the current FOA were derived from these earlier FOAs as well. We felt that it was an important enough area that we would develop out a FOA that focused specifically on the management of individuals with complex healthcare needs and on high-risk transitions of care.
Let me go over a couple of definitions for you that are fairly key to the FOA. The first is the definition of ambulatory care. For the purposes of this FOA, ambulatory care is defined or refers to all of the types of health services provided by healthcare professionals on an outpatient basis in contrast to those that individuals receive in inpatient settings.
This usually implies that an individual has to travel to a location to receive services and that those services don't require an overnight stay. There are a wide variety of ambulatory settings that we include in our definition and that we're interested in—healthcare clinician offices, both large and small practices, outpatient clinics, community health centers, emergency departments, urgent care centers, ambulatory surgery centers.
For the purposes of the ASQ program, we also include home care entities, so although you may not have to travel from your home to receive home care, we do include that as an important setting for ambulatory care.
The definition of complex healthcare needs is not as well articulated in the FOA. And I wanted to just give you a very brief idea of what we're thinking about when we talk about complex healthcare needs.
Basically an individual with complex healthcare needs can be thought of as one who requires ongoing services from a variety of providers over a significant period of time. A common example and one which would come to mind most readily are individuals with multiple chronic diseases.
However, that's not the only kind of patient who has complex needs. Another example, for instance, would be an individual that has AIDS who over the course of their life experiences potentially a variety of comorbidities that may arise and be treated.
These might or might not be chronic in nature, but as a whole they result in an individual that is going to be seeking healthcare services on a routine basis of a very specialized nature, oftentimes across multiple providers.
So complex healthcare needs do not refer solely to multiple chronic diseases, although that is an area of interest.
The other term that's used in the title of the FOA is transitions. For the purposes of this FOA, we're looking at healthcare transitions as the movement of patients between healthcare providers and settings as their condition and care needs change through the course of their life or their chronic or acute illness.
The focus of this FOA is on transitions between ambulatory care settings and hospitals, between ambulatory settings and home care, assisted living centers, nursing homes.
So again, what we're seeing is that, increasingly, care in the ambulatory world is becoming more and more complex and that individuals are receiving services in ever larger numbers of settings.
I'd like to point out that non-ambulatory settings, such as hospitals, that have a strong interest in fostering safe and high-quality ambulatory care and transitions can in fact participate in partnership with an ambulatory organization as part of this FOA.
I'd like now to turn to the slide titled "FOA HS-08-002" and begin to talk specifically about the context of this FOA and the highlights that we think you need to be aware of.
AHRQ in this FOA is interested in supporting research that investigates novel methods for evaluating existing strategies for both clinician and patient family use of health IT in ambulatory settings to improve outcomes through more effective decision support or care delivery for those patients with complex healthcare needs and those in high-risk care transitions.
There are several aims that are listed. Health IT can, in fact, have a positive impact on healthcare safety and quality. This has been demonstrated over time in several large healthcare delivery systems. But the rate of health IT adoption in the ambulatory setting has remained relatively low.
We do think that once health IT becomes a more routine tool in the ambulatory setting it will have the potential to facilitate new models of care that include the management of patients by populations, encouraging—engaging patients in a variety of ways more directly in their healthcare, as well as helping to link resources in community settings.
AHRQ is looking to advance knowledge in several areas through this FOA. One area is provision of high quality, appropriate care through the use of health IT. Another area of interest is shared decision making and patient/clinician communications.
We'd like to know more about the integration of patient information across transitions of care, strategies for successful adoption of health IT in ambulatory settings, as well as the impact ultimately of health IT on outcomes related to these types of patients and related to transitions.
Grants that we fund through this FOA will really span the spectrum from discovery through translation through measurement and widespread dissemination. So this is a fairly broad canvas that we present you with in terms of being able to propose innovative projects.
I've gone over the objectives in terms of the areas of knowledge that we're hoping to advance. Let me now talk briefly about the grant requirements.
As part of the grant, applicants are expected to describe the specific application intervention to be studied, as well as to be able to articulate the expected effect on safety and other domains of quality.
A well-developed project design and methodology plan is required that should include the research design, the outcome measures and evaluation plan, as well as project milestones and timelines.
The applicants would be expected to assess primary and secondary outcomes, such as clinical outcomes, system-level processes, and/or efficiency outcomes.
It is also required that you use the measures suggested in this FOA where appropriate. I'll talk a bit more about that further down in the slides.
An evaluation and data analysis plan, including how the data will be collected, both at baseline and after the interventions is also required.
Dissemination is of great interest to AHRQ, so we would like to see a well developed plan for dissemination of results and adoption by other sites, hopefully including a proposal for widespread dissemination should your results merit that.
The focus in health IT dissemination is beyond simply articles published in peer-review journals. We are actually interested in supporting further adoptions of these solutions by other organizations besides the ones who are doing the research.
To go to the next slide, just to touch upon some of the highlights of research design and methods, when describing the health IT intervention, you should also describe the development of the intervention and the methodology for implementation of that intervention.
We'd like to point out that, increasingly, there is an interest in and a focus on the development and adoption of standards and there are several national activities looking at interoperability standards and certification of health IT products.To the extent possible, we would like interventions to conform to those standards and to use certified products. There's more information in the FOA about where one can go to find out more about this.
You should be able to describe how the intervention could be integrated into the delivery of ambulatory care, both throughout your organization and potentially beyond your organization into other sites across the country.
Again, the focus is on expanding the actual use of these technologies in the Nation and not merely describing a successful experiment. Part of your design and methods should be a discussion of the future sustainability of the intervention by yourselves, by your organization after the grant has ended. We hope that your results would be positive enough so that the intervention would be continued on by your organization and other resources could be identified by you to support that.
The dissemination plan has to be incorporated in the proposed budget. I should note that we are always hopeful that, should we find projects whose results are particularly promising, that we may be able to provide further resources and support for broader dissemination. However, that would completely depend on availability of funds. So your initial proposal needs to both define the dissemination plan as well as budget for it right up front.
Let me move to outcome measures, the next slide. You must specify in the proposal both the project's primary and secondary outcome measures and how you will evaluate these.
AHRQ has several outcome measures that it is using to do comparative analysis across many of its projects in health IT. And if appropriate, we would require that you use one or more of these standard outcome measures. I've listed the five on the slide. Obviously we don't expect you to incorporate all five in your project. They have to be appropriate to your proposed intervention. But where they are, we would require that you use them.
I'd like to touch a moment upon the issue of privacy and security because this is one that, particularly in health IT, is quite important. All applicants are required to describe how, both in the development and in the implementation of the intervention, the privacy and security issues related to sensitive health information will be identified and addressed. You need to describe the resources and processes that you'll use to assure the appropriate levels of confidentiality and how you're going to address security concerns.
There are a variety of ways you could approach that, including the inclusion of participating patients in periodic reviews in order to solicit their input, consultation with knowledgeable professionals in the field of privacy and security, as well as a description of any existing practices and technologies that'll be incorporated into the project. There is more detail in the FOA about this.
I do want to make one extra comment on this slide, and that is if the subjects of the intervention are healthcare providers, privacy, confidentiality, and security concerns still apply. Oftentimes applicants focus on privacy and security of patients and ignore potential privacy concerns of participating providers. So just make a note to yourself that if you do have providers of any ilk participating and they are providing sensitive information, the same concerns have to be met for them as well.
Let me move now to some of the funding considerations. As you know, these are competitive grants. Applications will be reviewed by both an independent review panel as well as AHRQ staff. The funding considerations outlined on this slide are those used by AHRQ after the applications have been reviewed by the panel. In the next slide, I will talk about the review criteria used by the panel.
As far as funding considerations, there are five or six that are key. One, AHRQ will assess the scientific merit of the proposed project. Is this project of significance scientifically?
Second, we'll keep in mind the availability of funds, as we always do. So there is a focus on your budget and whether or not it's appropriate for what you're proposing.
Third, does your application respond to the goals and objectives that have been listed?
We'll also look to see whether or not the application is relevant to our programmatic priorities. I covered a few of those when I talked more broadly about the ASQ Program.
Finally, we look for programmatic balance among our various initiatives and projects as well as a balance within both AHRQ and broader Department of Health and Human Services patient safety and health IT activities.
As I move to the next slide, this is actually the review criteria that the technical peer review panel will be using when they examine your application.
Again, the significance and impact of the proposal.
They'll also take a look at the approach. Is the methodology that you're proposing, the approach that you're taking in the project, appropriate for the subject matter that you're studying? Is it one that is likely to support your findings or to be able to describe your findings appropriately?
The review panel will be looking at how innovative your proposal is. There is an interest in who the investigators and what partnerships you've pulled together to look at this.
Study settings are always of interest to us. Remember, these are all focused in the ambulatory setting, but as I noted earlier, that provides a wide variety of potential settings that you can do research in.
Then there are several other additional considerations—how responsive was the application to the FOA, your budget as I mentioned earlier, the privacy and security protections, human subjects and research risk, and inclusion of priority populations. And again, if you go to the FOA, these are listed on Page 19 and there's a bit more detail provided for each of those.
Just some general information in the next slide on the mechanism and the funding available.
The mechanism for this FOA is R18 research and demonstration grants. The purpose of R18 grants is to provide support to develop, test, and evaluate health services activities.
We anticipate up to approximately $3 million to be made available in FY 2008 for these projects.
The projects can be proposed for up to three years and up to $1.2 million total cost with no more than $500,000 allowed in any single year. We anticipate awarding about five to seven awards under this FOA.
I should point out that if your application exceeds any of these limits, so either three years or the $1.2 million or the $500,000 in any single year, it will not be reviewed and it will be returned to you. I should also point out that AHRQ does not accept modular budgets.
Applications are to be submitted electronically. There are instructions in the FOA on how to obtain the forms and register.
You are eligible to submit an application if you're a public or not-for-profit private institution, if you're a unit of a local or a State government or an eligible Federal agency, an Indian or a Native American tribal government or tribally designed organization.
For-profit organizations are not eligible to lead applications however, they may participate in projects as members of consortia or subcontractors. If you're a for-profit organization that produces healthcare IT systems focused in ambulatory settings, you are encouraged to apply in partnership with not-for-profit organizations.
Foreign institutions are also not eligible to apply. However, as with the for-profit organizations, they may participate in the project as members of consortia or subcontractors.
Just a word on the next slide about the principal investigator [PI], we anticipate and expect that the PI should be an experienced, senior-level individual. Because of the nature of these projects and our interest in evaluation, expertise in evaluation is a critical need that can either be met through the requisite experience of the PI or through another member of the team. But we want to see that experience explicitly talked about.
It is anticipated by AHRQ that the PI would devote a considerable portion of time to this project. If it's going to be less than 20 percents, then you have to include an explicit justification for that. The application should include a detailed description of PI responsibilities as well as their background.
Individuals from underserved racial ethnic groups, as well as individuals with disabilities, are encouraged to serve as PIs.
Finally in my overview, let me talk just briefly about a couple of important key dates.
The opening date for submissions is January 21, 2008, a couple of weeks, 11 days from now. Letters of intent receipt date is January 18. The closing date for submissions is February 21, 2008. We must receive your application by February 21.
Generally speaking, peer review takes place about 4 or 5 months after the applications close and the start date is usually a couple of months after that. These last two dates are not firm at all. They're estimates. They're only there so that you would know potentially, if you were successful, when you might start receiving some funding so that you can do planning. So you can keep in the back of your mind that should you be a successful applicant, you're probably looking at a project start date towards the end of the summer of this year.
As I mentioned at the beginning, there are a few questions that very routinely come up in these calls. Let me just cover those very briefly before we open it up to questions from all of you.
We always get a question about modular budgets. While other agencies may accept those, AHRQ does not. We only use the detailed research and related budgets. So if you submit a modular budget, your application will be returned to you without review.
In the earlier ASQ FOAs, we were asked about whether or not emergency rooms counted as ambulatory care sites. As I mentioned earlier, they do.
Oftentimes, there's a question whether or not there can be co-PIs, co-principal investigators. AHRQ does not allow co-PIs. We require that the lead institute designate one, and only one, individual as the project's principal investigator.
There is often a question of how much detail to include in the Letter of Intent. The Letter of Intent allows the AHRQ staff to estimate the potential peer review workload and plan the review. We don't provide any feedback on it. It's not for you to send a little concept paper and have us come back to you. The content should include acknowledgement of your interest, a few comments on the proposed subject of the study, some background, again brief, of the expertise of key personnel, and the nature and role of participating institutions. It's not required. It's not binding. And it's not considered in the review of subsequent applications.
However, we do encourage you to submit it because it does really help us put together an appropriate review panel and allows us to give your application adequate review time. So we would encourage you to submit the letter.
The final slide that I have lists the contacts here at AHRQ if you have specific questions after this call that don't get answered. You can certainly contact us and if possible we'll provide you with answers.
For scientific or content issues, the contact would be myself, Bob Mayes. I can be reached at complexpatients@ahrq.hhs.gov. And my contact information is also listed in the FOA.
For review issues, Kish Wodwani—and his E-mail is listed here—is available.
And for financial grant management issues, Michelle Burr, who also introduced herself earlier in the call, is available and her contact information is also listed.
That wraps up the presentation on the slides. By my clock, we have a quarter til 2:00 Eastern Time, so we have about an hour and 15 minutes to cover any questions that you might have.
As I stated at the beginning of the call, the way we will handle this is I would ask any of you that have questions to press *1 on your phones. The Operator will then recognize you by name. You can state your question. We'll simply collect everyone's questions. We'll then mute the call for 5 minutes or so while we go over those questions. We'll come back on and we'll answer them in the order that we've taken them. Hopefully we'll get to everybody's questions today. If not, we will include the answers with the call transcript that you will receive in a few days. [Editor's note: Transcript has been edited to include answers directly after each question.]
So with that, Barbara, are you available?
Coordinator: Yes. If you'd like to ask a question, please press *1.
And our first question comes from George Mishan.
George Mashan: Yes, this is George Mashan from the Maine (network health). I was wondering whether there was any inherent preference of projects focused on implementation of novel IT solutions versus implementation of existing IT solutions in, say, a novel setting?
Robert Mayes: There's no inherent preference.
We're really looking not so much at the technology, but at how the technology supports the outcomes. In other words, how does technology support better safety and quality in the ambulatory setting?
Coordinator: And our next question comes from Denise Babalon.
Denise Babalon: Hi. I was interested in knowing if the pre-hospital care provided by EMS services is considered ambulatory care under this FOA?
Robert Mayes: Are pre-hospital emergency medical services considered ambulatory care? Yes, they are for this FOA.
Coordinator: ...from Lisa Webber.
Lisa Webber: Hi. Are there any specific qualifications necessary to be the PI? For example, could it be a nurse rather than a physician?
Robert Mayes: I would refer to you to Pages 11 and 21 in the FOA where it talks specifically about what we're expecting to see as far as a PI. Generally speaking, though, the answer is we expect the PI to have sufficient experience and skills to successfully manage the project being proposed.
Now you sort of tacked on a specific question as did it matter what kind of professional training or degree the PI had, was there a preference for an MD. No, definitely not. The nurses are encouraged to apply as PIs.
Coordinator: And the next question comes from Amanda Wong.
Amanda Wong: Yes, my question is whether or not the PI needs to be an employee of the applicant organization or if the PI could simply be under contract with the organization specifically for this project?
Robert Mayes: No, they do not. We do allow third-party setups. But let me let Michelle talk a bit more about that because you want to be careful there.
Michelle Burr: It's true that it's not required that a PI be an employee of the applicant organization. However, there does need to be an agreement in place that will ensure the PI's accountability to the applicant organization.
The application should describe the logistics of the arrangement of not having an onsite PI. And a letter from the PI's organization acknowledging this individual's availability for involvement in the project would be most helpful.
Coordinator: And the next question comes from Frank Denassi.
Frank Denassi: Yes, hi. The question specifically was because the dissemination plan must be incorporated into the budget the way I'm reading that is that the project—the initial proposal—must include all of the dollars from within this first proposal that would cover a dissemination plan. Is that correct?
Robert Mayes: The question asked was about including the dissemination plan in the budget and whether or not all of the funding for the dissemination plan had to be included in the application project budget.
Yes, it does. However if the project results are sufficiently exciting and generalizable that a large-scale dissemination effort would be justified, that effort would be funded separately from this FOA.
So we would expect that all of the projects proposed would articulate a dissemination plan but that a dissemination plan would be appropriately sized to go with the project at this point, particularly since we don't know what the outcome necessarily of your project will be.
So, yes, you have to have it. It has to be in there. But we don't expect you to put 2/3 of your budget towards dissemination.
Coordinator: And our next question comes from Lori Santree.
Lori Santree: Yes, I have actually three questions.
One, what is meant by the term "machine actionable" in the RFP? My other question is just some—I would like some more examples of system-level process outcomes.
And then I also wondered, you talk a lot about security and what happens to data after research is completed. I presume that goes into the human rights section, but I was wondering if you also wanted it in another main section... Thank you.
Robert Mayes: The term "machine-readable" (or "computer-readable") refers to information encoded in a form which can be read (i.e., scanned/sensed) by a machine/computer and interpreted by the machine's hardware and/or software. Theoretically, anything that can be read, can be read by machines, but not necessarily comprehended by machines. Common machine-readable data storage and data transmission technologies include optical character recognition (OCR) and barcodes. Any information retrievable by any form of energy can be machine-readable. System outputs refer to information retrieved from a functional unit or from a network, usually after some processing. Source: Federal Standard 1037C.
The third question is about what section does the security plan go into. I'll let one of my colleagues will give you more detail on that.
Teresa Zayas-Caban: I just want to clarify for all potential applicants that there is a distinction between the human subjects protection of research participants that has to do with any data collected as part of the study and the security plan.
Human subjects protection is part of the additional review criteria outlined on Page 22 of the FOA. The privacy and security requirements that are to be part of your research design and methods section are explained on Page 10 of the FOA, which refers specifically to the privacy and security of the health IT intervention that you're either testing, developing, or implementing as a part of the study. And that again is part of your research and design plan.
Coordinator: And the next question comes from Mark Stevens.
Mark Stevens: Hey, my question is, can a lead organization or a member of a collaborative application process be a 501(c)(3) pending organization, so it hasn't received formal okay from the IRS?
Michelle Burr: Yes. However, if the application is selected for funding, an award will/can not be made unless evidence of the organization's non-profit status approval (i.e., letter/documentation from the IRS [Internal Revenue Service]) is provided to AHRQ.
Coordinator: And the next question comes from Greg Alexander.
Woman: We had a few questions. The first is when you talk about health IT, are you generally referring to the electronic record or are other sort of novel technologies of interest?
Man: Such as a sensor network. We also had a question about the letter of intent. Is that submitted via the NIH [National Institutes of Health] Commons Web site or directly to your staff and who would that be?
And then also, the last question, the third one, would be—since we are using a novel sensor network, if that's acceptable—about sample size. Our sample size would be fairly small, between 15 and 20 individuals. Is that acceptable under this call given the nature that's in an intervention study?
Robert Mayes: When we talk about health IT, are we talking about only electronic health records or would other more novel technologies such as sensor networks be included?
The answer is yes, we are looking at health IT broadly. So interventions that might utilize something like a sensor network would be appropriate for an application.
In terms of how the letter of intent is to be submitted, that is detailed on Page 15 of the FOA. There is actually a little section that lists the name of the individual, the address, and 3(a)(1) is the section. Thank you very much.
The third question was how big of a sample would be necessary. There's no pre-defined sample size. You simply have to justify that in your application how the sample that you're proposing would provide the appropriate analytic power, and then the peer review panel will take a look at that and if there's further questions, they'll ask them.
Coordinator: And our next question comes from Ibukan Ogumbikum. Your line is open.
Ibukan Ogumbikum: Does the hospital...[unintelligible]... this grant and is there an upper limit on the (personal) budget that will be allocated to IT ...[unintelligible]... and so forth.
Robert Mayes: You're breaking up just a little bit. I'm sorry, could you repeat the two questions again?
Ibukan Ogumbikum: Does the hospital or health systems provide ...[unintelligible]... to patients with complex disease qualify as ...[unintelligible]... for the purpose of this grant? And is there an upper limit on the proportion of ...[unintelligible]... that can be allocated to IT?
David Meyers: We understood the second question to be, Is there an upper limit on the budget that can be given to purchasing hardware and software. Is that correct?
Ibukan Ogumbikum: I'm sorry, that's correct.
David Meyers: Okay. We still were having trouble on the first question. What I'd like to suggest for you and for the other person who we got cut off from earlier, if you would E-mail your questions to Bob after the call or right now, we will make sure to get you and everyone else an answer to the first half of this question and any missed questions.
Ibukan Ogumbikum: Thank you.
Robert Mayes: As to the question on whether there were budgetary limits in terms of hardware and software, there are no specific limits in the budget in terms of how much can be spent on hardware and software.
However, I would point out that we are interested in what you do, not what you buy. So again, as part of your application, if you are expecting to spend a large portion of money on buying hardware or software, you certainly want to include a good justification as to why.
Coordinator: Jennifer Kimball
Jennifer Kimball: Hi. I have two questions. First is, I downloaded the e-application and some of the forms on it have expiration dates that have passed, so just wondering if that's a concern?
The second question is in the FOA; it says the research plan must include specific aims, background of significance. Is a preliminary study section not required? Thank you.
Robert Mayes: The forms on the electronic submission site are current.
Is a preliminary study section required? Yes. With the online application process, fundamentally when you go onto that site, it will tell you what's required. We choose to highlight in this presentation a couple of sections, but we didn't go through the entire application form in detail.
So when you go onto the site to make the application, you need to fill out everything that it tells you you need to fill out. So it's all required.
Coordinator: Okay. We have a question from Christina Crevasco.
Christina Crevasco: Greetings. You mentioned that transitions from ambulatory settings to hospitals is something that you're interested in. I wanted to specifically ask if transitions from hospital to ambulatory or hospital to home was an area of interest in this FOA?
Robert Mayes: Yes, the transition from a hospital to an ambulatory setting is okay, but if it's going to be the home or another ambulatory setting, it has to be a transition from the hospital to some other clinical or care provision setting.
So in other words, it can't just be a hospital discharge to home. It would have to be a discharge to home care or to the primary care provider for that individual.
Coordinator: Kathleen Murphy, your line is open.
Kathleen Murphy: Good afternoon. I wanted to ask how would a cash match be evaluated in this FOA and how have cash matches been evaluated in past FOAs?
Robert Mayes: Matching funding, is that what you're referring to?
Kathleen Murphy: Yes.
Michelle Burr: There is a section on Page 11 of the FOA that mentions cost sharing. It is not required. But AHRQ does welcome applicant institutions to devote resources to this effort. Refer to the FOA for the complete text.
Coordinator: Okay, next question is Cheryl LaCoursier.
Cheryl LaCoursier: Hi. I have a two-part question.
One is just general as to how many applications are you expecting to receive based on your other—the other four FOAs that you had for health IT? And the second part of the question is, if you have an existing program that you're trying to ramp up—so like in other words you're already in the middle of intervening—is this appropriate if you want to maybe change a couple of items about it, could you apply through this grant?
Robert Mayes: In terms of how many applications are expected, one, we don't have any idea, and two, we couldn't tell you if we did. We're not allowed to actually make public how many applications were received. But at this point, we haven't received any because it's not been open yet.
David Meyers: And it's for this reason that we've strongly encouraged you to submit letters of intent. It not only helps us plan for the review of you, it also lets us know whether the areas of expertise exist in that review pool so that your application is reviewed by somebody who knows what you're talking about. So it's really to your benefit as well as ours to submit your letter of intent.
Robert Mayes: The second part of the question was they have an existing program and they wanted to know would it be appropriate to use this grant funding to make changes in this program.
It's fine. The issue is the application has to reflect a research question; it's not an implementation grant. We wouldn't give you money simply to implement something because you want to do it. There has to be a research question as relevant to what's been laid out in the FOA within the application. But the project can certainly be looking at an existing system in terms of the context of that research question.
Coordinator: Your next question comes from Sharon Pollack.
Sharon Pollack: Hello. I have one question.
Do you have identified measures for appropriateness of care? Or is it expected that these measures will be identified and selected by the local projects? Thank you.
Robert Mayes: It is expected that measures for appropriateness of care will be defined and selected by the applicant in the context of the project being proposed.
Although they are not appropriate care measures, there are the outcome measures that we list on Page 10 and 11 that if appropriate we would want you to use.
Coordinator: And we have Ulis Velise. You're line's open.
Mary Kratz: Oh, hi This is Mary Kratz for Ulis Velise.
We have a question about the dissemination plan related to technology transfer. And I'm going to let my colleague, Krista McPhere, actually articulate this question.
Krista McPhere: We were just wondering if there's a preference for open source versus proprietary solutions, and how you would envision that to be incorporated for technology transfer overall in an ideal scenario for the dissemination?
Is part of the dissemination plan looking at the IT aspects for technology transfer and what would be the ideal balance for free and open source software versus a for-profit approach?
Robert Mayes: AHRQ does not take any particular position on the question of open source versus proprietary systems. However, if as part of your dissemination plan you feel that a case could be made why, for instance, an open source solution might in fact reach more people or be more broadly disseminated, you would certainly want to make that case in your application.
Coordinator: And the next question comes from Victoria Chuck.
Victoria Chuck: Okay. Two questions. One, there's an emphasis on the PI's ability to do evaluations. Is that an evaluation of the efficacy of the project overall? And is that something that could or should appropriately be given to an external reviewer or evaluator? And the second question is, What kind of expertise at evaluation are you looking for in the PI if not?
And then are indirect costs allowable in these project budgets? And if so, is the negotiated indirect cost rate acceptable?
David Meyers: A couple of issues to clarify in answering this question, First of all, I call your attention to Page 6 where we define some of what we mean by evaluation and how because these—we expect that many of the proposed projects will involve implementation—we use the term evaluation to talk about that this is a research project that gives information about what happened during that implementation.
In thinking about who needs to do that evaluation, we don't expect that projects will have external evaluators as if you were looking at an ongoing program for evaluation of it. Instead we want—we're using the word evaluation here in the context of research and that the team must have the necessary skills.
We recommend that this is a skill that the PI may have, but we specifically in the FOA explain that if the PI doesn't have these skills and the skills can be documented by other members of the team, that's completely acceptable.
Robert Mayes: Thanks. Second question: Are indirect costs allowed and is a negotiated rate allowed?
Michelle Burr: I'd refer you to Pages 10 and 18, which focus on budget information and budget limits. Yes, indirect costs are allowed. This is a total cost award, so the dollar limit stated must include all indirect costs.
You must use the negotiated indirect cost rate. And if you are an organization that does not happen to have a negotiated cost rate, I'd ask you to contact me directly to discuss that.
And I think we just wanted to reemphasize that the budget limit is $1.2 million total costs over three years with a maximum of $500,000 total costs in any one year.
Coordinator: Lawrence Friedman, your line is open.
Lawrence Friedman: Are meetings required during each budget year? And should we budget for that as well?
Michelle Burr: Yes, on Page 18 it indicates that the budget must include funding to allow at least two members of the project team to attend at least three days of an annual AHRQ grantee meeting in the Washington, DC area.
Coordinator: Mary Frankel.
Mary Frankel: Hello. I have two questions concerning definitions of phrases in the FOA. The first has to do with high risk care transitions. And the second is, Could you please clarify what you mean by priority conditions?
Robert Mayes: I would suggest that a high risk transition is one in which, if the appropriate information did not move along with the individual, would result in reduced quality of outcomes and non-appropriate or insufficient care.
In terms of the list of priority conditions, those are the conditions indicated as priority conditions by the IOM. It is referenced in the FOA. According to the most recent survey data, the top 15 priority conditions are cancer, diabetes, emphysema, high cholesterol, HIV/AIDS, hypertension, ischemic heart disease, stroke, arthritis, asthma, gall bladder disease, stomach ulcers, back problems, Alzheimer's disease and other dementias, and depression and anxiety disorders.
Coordinator: Alicia Fields Buchanan.
Alicia Fields Buchanan: Hello. I was wondering whether a nonprofit regional medical center providing both ambulatory and inpatient services—will they qualify as a lead organization under this FOA?
Robert Mayes: A not-for-profit regional medical center with both inpatient and ambulatory programs would be eligible for the grant. However, remember that the focus of the project has to be in the ambulatory setting. So we would look to see if the primary focus is focused your ambulatory clinics and the issues in the ambulatory settings.
Coordinator: Okay, and as a reminder, press *1 to ask a question. The next question comes from Lynn Nelson.
Lynn Nelson: Hi. I was wondering if you would comment on whether this grant is using preferences, urban versus rural, for example, or vulnerable populations, and whether you'd say a little bit about that?
Robert Mayes: The question asks are there preferences for a certain priority populations or settings. This FOA, unlike the previous ones does not have any funding set aside.
However, if you look on Pages 6 and 18, we do talk about inclusion as being one of the criteria that we use to review the applications. So obviously we are interested in projects that include priority populations, but it is—there's no funding set aside in this FOA for specific populations.
Coordinator: And the next question comes from Elizabeth Wilburn.
Elizabeth Wilburn: Yes, I know that you talked quite a bit about the dissemination plan. And I wondered if you have any kind of materials that, or any way that, you can elaborate about the dissemination plan?
Robert Mayes: No, we do not have an example or examples of dissemination plans. To extend that answer a bit, the dissemination plan is really going to be contextual to your project and to your intervention.
So there's not a set format. When the research is complete, when you've done your intervention and your evaluation, we would expect you would disseminate those findings.
Depending on what the intervention is and depending on what your findings were, the dissemination plan might include articles, it might be presentations at professional meetings, or it might be a toolkit. So we don't really have any apriori structure or format that we have for dissemination plans.
David Meyers: I think it's perfect to say that scientific research often is disseminated through journal publication, presentations locally or nationally, and professional meetings, the development of users guides for materials.
However, the purpose is that as research, if your results are kept only to yourself, there's no value in that to the rest of the country. And AHRQ is saying to you here that not only do we want you to think about how you improve healthcare.
We need you to explain to us how your work is going to contribute to the benefit of others outside of your system. And so some beginning thinking about that should come in now as you develop your projects, which would be reflected in your project plan and budget.
Robert Mayes: And again, as we mentioned earlier, if your findings turn out to be things that are extremely relevant, exciting, and need to be broadly disseminated, then we'll deal with that at that point through further funding for dissemination explicitly.
David Meyers: Since we're on the topic, I'm sorry, I can't resist. Please remember that negative findings also have value. And so at this point in your research, we are very interested in you having a plan not only if you're successful, but if not successful. How are you going to share what you learned with others so that they can learn from what you did as well?
Coordinator: And the next question comes from Robert DeBust.
Robert DeBust: This is a two-part question. The first regards the home care as point of intervention or the home as a point of intervention where the intervention is advice regarding what the patient should do in the event of particular symptoms.
And the second concerns the single disease state. Is a single disease state, especially one that's complex and expensive, allowable under this project?
Robert Mayes: Any medical care as we mentioned before, any care delivered in the home falls within the context of this FOA. Therefore the home would be a point of intervention. And is a single disease state allowable? We recognize that in fact there are individuals that have a single disease state that nonetheless have complex healthcare needs. So it's certainly allowable.
Coordinator: And Debra Bowers, your line is open.
Debra Bowers: Hi. I was wondering if you could give me some examples of where it would be appropriate for the PI not to put forth 20 percents effort?
Robert Mayes: AHRQ feels that it is appropriate and in most cases necessary for the PI to be significantly engaged in the project and so we feel that anything less than 20 percents of time spent on the project really needs to be justified by the organization making the proposal.
That said, of course, if there may be specific circumstances that would lead you to think the PI could participate for less than that time and still add value and be able to manage the project appropriately—if so, make that explicit justification as part of your package and it will be evaluated.
Coordinator: And next is Kevin Wang.
Kevin Wang: Hi. Given that dissemination of the intervention is a major priority, are there preferences for study designs that would confirm efficacy of the intervention before dissemination should begin; i.e., Is a randomized controlled trial necessary?
Robert Mayes: Are random control studies necessary? No. There's no preference in the design of the study.
Again, I go back to the idea that the study design needs to be appropriate to the proposed intervention and needs to be such that it needs to be robust enough so that appropriate analysis and evaluation of the findings can be made and that those evaluations are statistically relevant and would be accepted by the field.
Coordinator: Mimke Dosa, your line is open.
Mimke Dosa: Would a project that's focused primarily on transition from one ambulatory care setting to another ambulatory care setting be applicable for this RFP? And I'm speaking of pediatric to adult healthcare.
Robert Mayes: Let me clarify that. That would be you would look at as an individual grows older and then goes out of pediatric care into adult care?
Mimke Dosa: That's correct.
Robert Mayes: Transitions from one ambulatory setting to another ambulatory setting, and in this case specifically from pediatric to adult ambulatory settings, would be appropriate for this FOA and of interest to us.
Coordinator: And I'm showing no further questions.
Robert Mayes: Okay. Did anybody come up with one last question? We have about 15 minutes left, so if there are, I'll give a chance for one or two others if there's anybody that's been too shy or just came up with something.
And then let me just do mention while you're thinking about that last question, the transcripts and the slides will be posted on the AHRQ Web site, which is www.ahrq.gov. And it will be under the funding opportunities page. The link to that is on the home page when you first get there on the left-hand side of the screen, left center; it'll be under the link to the full FOA. So you'd go under funding opportunities, go to the link for the full FOA, and under that, you will see some verbiage saying here's the transcript to the technical assistance call and there'll be a link for it there. And we expect that we'll be able to post these within the next two weeks.
Debbie Rothstein: I just wanted to make one quick point that if anyone is not familiar with electronic submissions of grant applications, these electronic submissions require registration in two different places. And registration can take two to four weeks.
So it's not a good idea to assume that you can just type everything, go through at the very last minute, right at the submission date. You need to actually be thinking that through right now, especially in terms of registration if you've not already done so.
David Meyers: If you register, you're not necessarily committing to anything. Is that correct? So the message, the take-home message here, is if you have any thought at all of submitting, you probably ought to go in and register as soon as possible so that you give yourself plenty of time before the submission closing date and don't find yourself stuck not being able to submit because you're not registered.
There's more information on the electronic grants process in the FOA and a link in the FOA to that. I'd like add additionally that there are not only two registrations required, but both the institutions and the PIs must be registered.
And so it ends up being three separate registration processes that must take place. It sounds like four, but it's actually three—two for the institution and one for the PI—to be able to successfully submit a grant when you want to.
And I'd recommend at least four to six weeks of planning if you haven't already started, if you're not already registered.
Robert Mayes: So that means, given the submission close date of February 21, once you hang up the phone, you ought to get onto the Internet and start looking at the site.
Are there any last issues or questions that we might be able to help you with today?
Coordinator: And again, press *1. You have a question.
Woman: Hi, yes. I wanted to clarify my question from before, which was on previous applications. What I was asking about was you had said that there were FOAs on previous health IT grants. And it was my impression that those types of things are usually publicly available, like I know NIH posts how many people have applied to for what types of grants. And does AHRQ not do the same thing?
Robert Mayes: For the grant that were awarded, both the FOAs and the funded grants are in fact available. What's not available are how many applications we got in the first place.
David Meyers: And to clarify that, it's not the full application that is simply available, but information about those projects can be found at healthit.ahrq.gov. However, the actual applications are not readily available. And additionally, we are not legally allowed to release any information about the total number of applications that were submitted to AHRQ. NIH is the same way and can't—won't after this FOA—be able to tell you how many other people applied. That protects the privacy of those who weren't and didn't receive funding.
Robert Mayes: Any other comments from the AHRQ staff? No? Well, if that's the case, then I would like to thank all of the participants to the call. I thank you so much for your interest in what I think is going to be a very interesting FOA. It's certainly an area that's going to become of increasing importance and interest to the health-care system in the United States.
We look forward to many good, high quality applications. So thanks again. And as I said, a transcript of this conversation with some additions on the questions that we couldn't answer immediately will be available on the AHRQ Web site within the next two weeks.
Thank you all and have a good afternoon.
Coordinator: And that concludes today's call. Please disconnect your line at this time.
Written Questions
The following questions were submitted by E-mail and were not answered on the technical assistance call. Note that if a similar question was asked during the call, it is not repeated here.
Bentson McFarland:
1. It sounds like your focus is on applicants who will adopt new health info tech interventions during the course of the project. Would you also consider evaluation of existing health info tech interventions (perhaps versus a paper-based comparison site)?
2. Are community mental health centers eligible?
3. Are outpatient substance abuse treatment agencies eligible?
Answer:
1. Evaluation of existing health IT interventions would be acceptable.
2. Yes, community mental health centers would be eligible.
3. Outpatient substance abuse treatment agencies are eligible.
Gail Bellamy:
1. Is $3 million per year available or $3 million total to fund up to 7 projects?
2. Can the PI be a subcontractor with a primary organization? This project will involve 3 organizations (State agency, college of medicine, and federally recognized HMO).
Answer:
1. Approximately $3 million total will be available in FY2008. The number of projects funded will depend on the amount awarded to each successful applicant.
2. The PI may be a subcontractor; however, the applicant must clearly demonstrate the relationship between the PI and the applicant institution and lines of accountability (for more detail refer to a similar question submitted by Amanda Wong in the transcript).
Dean Wantland: Would transitions between clinics be within the scope of the FOA?
Answer: Yes.
Donald Evans: Issues of patient satisfaction and safety in a culturally sensitive setting would be efficiently researched using qualitative research techniques (in-depth interviews, observation, etc.). Is a qualitative research paradigm, either in full or in part, acceptable in this program? In some circles, quantitative research is the ONLY scientific paradigm.
Answer: Both quantitative and qualitative methods are acceptable as long as they are appropriate for the research questions being asked and have the statistical power to enable appropriate evaluation.
Katherine Wilson: I have three questions. First, under the term "Health IT" would telemedicine fall under this category? Second, regarding "Complex Healthcare Needs" would trauma injury or the need to improve trauma care fall under this category? Finally, is the transition from pre-hospital care to emergency room care of interest?
Answer:
1. Telemedicine would be an appropriate technology area for this FOA.
2. Trauma care would be acceptable.
3. Yes, pre-hospital to hospital transition would be included.
Kelli Radican: In getting ambulatory practices to use Health Information Technology, could we test a unique payment system as part of an overall study to focus on key functions of Health Information Technology.
Answer: Yes, that would be within the scope of the FOA.
Kevin Hwang: Does dissemination refer to dissemination of research findings (articles, presentations, toolkits, users guides) or dissemination of the actual intervention (recruiting other sites to participate in the intervention)?
Answer: Both of these sorts of activities could be included in a dissemination plan. It would be acceptable to only propose a dissemination plan for the research findings.
Ibukun Ogunbekun:
1. How large should the study be (in terms of participating healthcare providers) to be considered appropriate for this level of funding?
2. Is there conflict of interest where staff of a collaborating for-profit entity serves as one of the principal investigators?
3. Are there benchmarks or upper limits on the portion of the total budget that can be allocated to IT (hardware, software and support)?
4. Is there demerit in limiting the scope of the study to just one or two thematic areas?
Answer:
1. It is up to the applicant to determine whether or not the research questions they are interested in can be addressed within the limits of this FOA. The application must justify both the relevancy of the research and the resources requested.
2. AHRQ does not allow co-PIs and the Lead organization must be non-profit.
3. Answered in transcript above.
4. Answered in transcript above.
Current as of January 2008
Internet Citation:
Improving Management of Individuals With Complex Healthcare Needs Through Health IT. Transcript of a Technical Assistance Call held on January 10, 2008. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/fund/trans011008.htm
540 Gaither Road Rockville, MD 20850