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Technical Assistance Call for Applications to AHRQ's Health IT Announcements

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Transcript (continued)

Question: Will AHRQ accept unsolicited additional materials during the initial peer review phase?

Answer: AHRQ's policy is to review applications as received by the application receipt date; so in essence, no. You have the Web site [to which] you can link and read AHRQ's notice with respect to submission and under what circumstances post-peer review that additional information may be solicited by AHRQ. [go to http://grants.nih.gov/grants/guide/notice- files/NOT-HS-08-012.html]

The person in charge of that type of gateway of information is Gerald Calderone, and he is mentioned in the notice that you have a reference to.

Question: Who will review the health IT applications?

Answer: You may remember when we went around the room we started off with some gentlemen—they just happen to be gentlemen today—from the Division of Scientific Review. They are part of OEREP. They, under the leadership of Dr. Kish Wadhwani, have the joy and the burden of engaging reviewers and conducting peer review meetings.

Rebecca Roper: As appropriate, OEREP will assign an application to an AHRQ standing review group or special emphasis panel. I provided some links to Web sites [Descriptions of the SRGs' research foci are available at: http://www.ahrq.gov/fund/peerrev/peerdesc.htm] and [Rosters of the SRGs are available at: http://www.ahrq.gov/fund/peerrev/hctdsrst.htm]

We anticipate that the Healthcare Technology and Dissemination Science Standing Review Group will review many of these applications.

With respect to the career awards and the research dissertation, there will be a separate review group that's in charge of the career review—the review of the career award projects. Dr. Azadegan is involved in that review. Dr. Aponte is involved in Healthcare Technology and Dissemination Sciences. But at Dr. Wadhwani's discretion, I'm sure he will involve other members of the Division of Scientific Review.

Question: Are nonprofit entities eligible to apply if they do not have a 501(c)3 status?

Answer: Nonprofit organizations are eligible. You do not have to be 501(c)3 status, but you cannot be 501(c)4 status. Organizations described in section 501(c)4 of the Internal Revenue Code that engage in lobbying are not eligible for Federal funding.

You'll notice at the end of each of the [Health IT FOAs] announcements that there is a member of the grants management staff who is identified for contact. Today, we are joined by Michelle Burr from Grants Management. The person listed on our health IT FOAs is Sherry Cochran. Would you care to add any more from Grant's Management, Michelle?

Michelle Burr: Sometimes in relation to this question people will ask if they have to be a [nonprofit, e.g., (501(c)3)] organization at the time of application. You do not have to have that [nonprofit] status at the time of application but if you are selected for funding you will have to demonstrate that you have nonprofit status.

Rebecca Roper: Thank you. Now, we are [discussing] some example questions with respect to the allowable healthcare settings.

Question: "If a study was going to occur that features a mobile van," I'll let you read the actual text provided [Slide 41].

Answer:  A health IT study for which ambulatory care is being provided in a mobile van would be considered responsive to these FOAs. [Mobile Van: A health IT study for which ambulatory care is being provided in a mobile van would be considered responsive to these FOAs.]

An ambulance that would be considered allowable [responsive to these FOAs] would be as follows [Slide 41]: A health IT study for which the patient is being transported between ambulatory settings or [where the patient is being transported] from a hospital to an ambulatory setting * * *[when] the level of care provided [in the ambulance] is commensurate with the level of care provided in ambulatory settings, as specified in these FOAs.

[The following is an example] when an ambulance would not be an allowable [health care setting]: A health IT study for which the patient is being transported to the Emergency Department to receive acute care would not be considered responsive to these FOAs because the ambulance is in essence an extension of the acute care provided in the hospital.

We anticipate that there will be many different variants of allowable ambulatory settings and/or transitions in care and have not chosen to select an exhaustive or present an exhaustive list; we just encourage you to articulate and demonstrate why the care provided [in your proposed healthcare setting] is commensurate [with the level of care provided] in an ambulatory setting.

Rebecca Roper: To this end, we also received questions with respect to allowable overnight care settings [Slide 42, 43 and post-Technical Assistance Call Question C].

Question: Describe the type of care provided to patients so that it is clear that it is commensurate with the level of care that would be provided in the ambulatory settings specified for these FOAs.

Answer: In general, an assisted-living setting where there is low-level or intermittent care provided COULD be responsive to the FOAs, if the low level of care is clearly demonstrated.

[Clarification provided to match verbatim guidance from PowerPoint® Presentation] We had not intended for the care setting to be a subsection of nonskilled nursing beds within a skilled nursing facility. Such a care setting would NOT be considered responsive to these  health IT FOAs because it is not seeking to understand health IT implementation and use in an ambulatory setting.

As you recall we explicitly stated that health IT studies that are solely occurring in a skilled nursing facility would not be considered responsive.

We have another example with respect to when dementia care facilities may be allowable. And it really speaks to the extent of the type of care provided in that particular facility. So I ask for you to look at that in detail in the PowerPoint® presentation. [Example provided from PowerPoint® presentation: Given the continuum of types of care (and facilities) that could be provided for a patient with dementia, it is possible that an overnight facility treating dementia patients might meet the spirit of the "ambulatory setting." For example, an assisted-living facility providing patients with low level or intermittent care would be considered responsive to the FOAs. However, an overnight facility providing a high level of care (such as a skilled nursing facility) for the monitoring or treatment of patients with dementia would not be considered responsive.]

Rebecca Roper: In addition to the PowerPoint® presentation we have, the transcript that will be promoted and provided to you a week from Friday [January 23]. We also strongly encourage you to visit our AHRQ National Resource Center (NRC) for Health IT Web site [http://healthit.ahrq.gov], where you can get lots of information with respect to ongoing activities, knowledge libraries, funding opportunities in general, frequently asked questions about health IT and access to the different types of publications that have already been realized through cooperative agreements or grantees.

Just take a look at it [AHRQ NRC for Health IT: http://healthit.ahrq.gov]; it is a cornucopia of health IT information. It may inspire you; it may cause you to think the information [you seek] is already available to the public; it [is a resource] that really should inform your research project depending on how you proceed.

Before we get to the open forum, we had talked earlier about the fact that AHRQ has just reissued some other funding opportunity announcements. Questions have risen about the recently published, AHRQ-sponsored new AHRQ-wide funding opportunity announcements, the (PA-09-070), so that's the R18 and the (PA-09-071), that's the R01 FOAs.  I'll translate into English.

We're now talking about AHRQ's republication of the R01 [PA-09-070], the general AHRQ health services research projects and the R18 [PA-09-071], the AHRQ health services research demonstration and dissemination grant. Each of these funding opportunity announcements articulates the current portfolios for AHRQ, of which health IT is one.

You'll notice within them [PA-09-070 and PA-09-071], they do say that if you're going to [apply for one of these] that deal with health IT, that you must address one of the three [health IT research] areas. But the AHRQ-wide FOAs do not provide information or a framework in the sense of articulating the areas of interest that are particularly of interest to AHRQ, right now, with respect to the health IT.

So let me restate that: The most information and the intended vehicle for our high-priority areas of interest for health IT research right now, are articulated in the three FOAs we've been discussing, the R03 [PA-08-268], the R21 [PA-08-269], and the R18 [PA-08-270]. You may have an area of interest with respect to health IT that would not fit well within these particular funding opportunity announcements [PA-08-269; PA-08-269; PA-08-270] that you may wish to pursue through either the AHRQ-wide R01 [PA-09-070] or R18 [PA-09-071].

Jon White: I would add that there may even be people on the phone who may not only be health IT investigators but also general health services research investigators. And I'd really strongly encourage you to look at those program announcements too. They provide nice opportunities for work that overlaps between portfolios and we just encourage you to look at them. We're looking forward to getting applications in for them.

Rebecca Roper: For those FOAs [PA-09-070; PA-09-071], they have the first-time due date of March 9.

Jon White: Yes.

Rebecca Roper: So that due date is coming up. And, once that date passes, then those FOAs [PA-09-070 and PA-09-071] will follow the regular due dates as posted [http://grants1.nih.gov/grants/funding/submissionschedule.htm].

Jon White: Yes. And for that I would also reemphasize what Debbie Rothstein said earlier that that is the due date for which we will be able to consider an application for funding out of our FY 2009 budget. If it [an application] comes in after that due date then it would be considered for funding in a later year. The only [grants]  that we're going to be able to consider for funding out of our 2009 budget are going to be the ones we get by March 9 for the Agency-wide program announcements just described.

Rebecca Roper: Just to reemphasize that the additional specifications in the three health IT-oriented FOAs [PA-08-268; PA-08-269; PA-08-270] we've been talking about, such as healthcare settings, articulate issues that are of particular interest to AHRQ in the context of health IT-oriented research at this time, which is really centered on ambulatory care and transitions in care.

Jon White: Right.

Rebecca Roper: Just one moment please.

So now we're going to take a few moments to go through the questions and answers based on the early-bird questions that we received. And thank you very much for letting us know what you're thinking about.

Again, this transcript will be available by January 23. Some of the details may be easier to follow in the transcript. We have about 20 questions and then we'll go to the open forum.

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Questions and Answers

This section features AHRQ's responses to questions submitted in advance of the Technical Assistance Call followed by general questions submitted after the technical assistance call.

Question: I would appreciate if the speakers would provide further information on the types of projects that would typically be or have been funded under each of these FOAs.

Answer: The FOA-specific requirements in each of these FOAs, such as health IT research areas and allowable healthcare settings, provide the framework for applicants to construct their research proposals. So hopefully we've addressed this issue.

Because these are brand new FOAs there is no history with respect to who has been funded through them.

And, as we mentioned before, as far as the types of grants that have been funded in the past, AHRQ's National Resource Center for Health IT [http://healthit.ahrq.gov] and other references such as AHRQ's Grants Online Database GOLD [http://www.gold.ahrq.gov/] or CRISP [Computer Retrieval Information on Scientific Projects [http://crisp.cit.nih.gov/] can provide you the ability to search for other previously funded health IT grants and get an idea about what's happened [the types of grants we have funded] in general.

Also, I'll put a plug in for the AHRQ funding site [http://www.ahrq.gov/fund/grantix.htm]. You'll notice if you go to the main AHRQ Web site [www.ahrq.gov] that there is a list of funding opportunity announcements. And if you go there, you can [be put] on the LISTSERV and receive weekly notices when AHRQ posts any new special emphasis notice or revisions to funding opportunity announcements. You would receive them [through Sign Up for Grant Announcements E-mail Updates].

At this time, we do not plan to issue such documents [related to health IT FOAs]. But [we recommend that you should signup], just so you're ready to go in case we do.

Question: I'd like to hear your advice to nonacademic not-for-profit applicants who would like to apply for one of these FOAs. In particular, we are not a research hospital that generally fits this category, but rather we are a rural, Midwestern, federally qualified health center system of medical dental clinics with a lab, radiology, ambulatory surgical center, and nursing home. Are you particularly concerned that we have any type of collaborator(s) and what might this be?

Answer: AHRQ recognizes that multidisciplinary research teams and collaborations among and between on-the-ground implementers of health IT and traditional research entities may be quite appropriate for some research projects.  Each FOA has specific application and submission information and review criteria with respect to the adequacy of the investigators and environment.

Question: Will funding be granted to facilities or organizations already committed to health IT solutions for health records? In other words, will there be available funding to expand and complete convergence to electronic medical records? My main question is whether or not we can use the funds to assist us in implementing electronic medical records or other forms of health IT. My secondary question is if we can use the funds to supplement the technology we have for implementing a backup system for our data or to use for other applications like replacement of phone systems, updating our network infrastructure technology, and replacing an antivirus perimeter security system.

Answer: These FOAs support the conduct of research grants involving health IT implementation and use and require an evaluation of that implementation and use. These research grants cannot be used to fund the purchase of new or updated or enhanced health IT for its own sake. If an appropriate research evaluation is not an integral part of this proposal then it would not be responsive to these FOAs. Within each of the FOAs, as we talked about, we have guidance with respect to expected levels, up to 20 percent, to be spent on software, hardware, and/or equipment purchases.

At this time AHRQ does not have any additional guidance regarding if and how it would be involved in providing additional financial support for the conversion of paper medical records to an electronic system at large.

Question: I'm specifically interested in R36 funding mechanisms and the dates we can expect to hear back about our proposal.

Answer: As specified in that particular mechanism, the PAR-06-118, the earliest anticipated start date of a dissertation grant would be within 5 months of submission. There are many factors that determine the turnaround time between submission and funding. For general information regarding R36 grants, please contact Brenda Harding. Her address is provided at the end of the PowerPoint® presentation [Brenda.Harding@ahrq.hhs.gov]. All applications in response to AHRQ's grants for health services research dissertation R36 FOA are reviewed in the same fashion, pursuant to the same timeline whether they are directed toward health IT or other areas of interest.

Question: We are a nonprofit private diabetes research institute in Europe that is interested in pursuing being an applicant to the R18 mechanism.

Answer:  Since you are a foreign institution you are not eligible to apply. The purpose of this program is to improve healthcare in the United States. However, foreign institutions may participate in projects as members of consortia or subcontractors only. And you should look at the eligibility information is provided in each of the FOAs.

[Another issue to] highlight is AHRQ's authorizing legislation does not allow for-profit organizations to be eligible to lead an application, thus for the purposes of these FOAs will make only grants to nonprofit organizations. When we say lead applications we mean the recipient institution.

Thus, for the purpose of these FOAs, AHRQ will make grants only to nonprofit domestic organizations.

Question: Is it possible to include a foreign study site in a proposal?

Answer: As stated in the FOAs, our intent is to understand how health care can be improved in the United States. A research project may include a foreign study site component, if it is very well justified.  Also stated throughout all three FOAs, funding decisions are made based on several factors and considerations.

Question: Will patient safety technology such as medication bar coding initiatives or telemedicine be covered in some of the grant opportunities?

Answer: Applicants are welcome to submit applications with respect to bar code and medication administration and telemedicine. They would be allowable health IT applications.

Question:  Will clinical decision support technology software qualify?

Answer: Indeed that's one of our research areas. And we anticipate that some of the applications will be set forth for that type of technology.

Question: What fiscal year will grant funding cover?

Answer:  As we stated before, the FOAs are active for 3 years. The first round of grants to be funded through these FOAs will be the FY 2009 fund. Each grant period of award will depend on that date of funding and receipt of notice of award, duration of project, and availability of funds to AHRQ. As such, depending on your start date and your duration of your research period, some multiyear grants will continue to be funded beyond the 3-year active period, as identified for receipt of these proposals.

Question: What expectations does AHRQ have regarding institutional review board (IRB) approval?

Answer: Prior to making a funding award, research involving human subjects and their data must have approval from the IRB. However, such approval is not required at the time of submission of a proposal. So just check out our specified language in each of the funding opportunity announcements.

Question: What happens if the due date falls on a weekend or holiday?

Answer: As I said earlier, you are given an extension into the next business day. It just so happens for the first cycle of the R18 you are due on January 25, which is a Sunday. So you have until January 26, 5:00 p.m. local time to submit your application.

Question: What are the due dates?

Answer: Check the link within each of the FOAs with respect to the National Institutes of Health (NIH) funding submission schedule. We adhere to that submission schedule, unless we have a publication specifying otherwise [http://grants1.nih.gov/grants/funding/submissionschedule.htm].

Debbie Rothstein: Just to augment what Rebecca was saying, we were talking about due dates. But actually in the e-grants world there's actually a submission period. And there's an open period which is a month prior to up to including the due date.  So the due date should be thought of as like the last day to submit. But you can and are encouraged to submit earlier than this due date. But it's actually an open period as to when you should do that.

Question: Is there any way we can receive an extension on the due date?

Answer: No. All applicants are expected to meet the due date. Very rarely, in acute extenuating circumstances, you may wish to contact our receipt and referral officer to request an extension.  Examples of extenuating circumstances are [the loss of a close relative] or a hurricane [or other natural disaster] or other very acute situations.

Question: Can I submit additional information for purposes of peer review after the initial proposal was submitted?

Answer: As we discussed earlier in the presentation, no you cannot [submit additional information for purposes of peer review after the initial proposal is submitted]. AHRQ has a notice with respect to our policy on that. [AHRQ's policy is to review applications as received by the application receipt date. [http://grants.nih.gov/grants/guide/notice- files/NOT-HS-08-012.html]

Question: Is a comprehensive cancer center considered an ambulatory care setting?

Answer: Most comprehensive care centers are not overnight facilities and act as an outpatient facility where folks go to get care and then go home. If a comprehensive care center is an outpatient facility it is an appropriate health care setting for these FOAs. If they are overnight facilities they are not eligible. Additional discussion on allowable ambulatory care settings is found on Slides 41-43 in the accompanying PowerPoint® presentation. That guidance refers back to the narrative found in the funding opportunity announcement.

Question: What are the minimum and maximum numbers of grants that will be awarded?

Answer: Unlike the request for applications (RFAs) that you may be used to funding previous AHRQ-supported health IT grants, through the health IT FOAs, we do not specify a targeted number of grants that may be funded to each of the FOAs. But as we state, we are really enthusiastic about these mechanisms. And we encourage you to send in those submissions. And we are looking forward to funding competitive applications that are submitted.

Question: I would like to revise a grant proposal that I submitted in response to one of the previous AHRQ ambulatory safety and quality ASQ RFAs that were published in 2007. Do I have a three-page allotment to address the concerns raised in the previous application?

Answer: So this is maybe quite pertinent to many of you on the call. No. What's important here is that these [PA-08-268; PA-08-269; and PA-08-270] are new funding opportunity announcements. And new applications are submitted in response to them. Since your earlier proposal was submitted in response to a different FOA [ASQ RFA], you do not have an additional page allotment to address concerns previously raised in a related grant proposal. Rather you would be responding to one of the three new health IT FOAs; each first-time application MUST be prepared as a new submission.

Now to the extent that you can meet those expectations it will be very helpful. Just make sure [the new submission] is distinct from your predecessor proposal. [The new submission may in fact] be a version of the grant idea that has been refined over time. Yet, you are putting forth a new proposal in response to these new health IT FOAs.

Also remember that these health IT FOAs have distinct requirements that were not part of the predecessor [ASQ RFAs]. Really take time to look at what we're asking for, what are the research methods required, what are the review criteria, [and so on].

Question: It is possible that our group would submit up to four applications—one to each of the funding opportunity announcements and maybe two to the R03. Each application would have a different research development thrust. The language of the FOAs does not appear to disparage this type of submission. But in doing so,would we in any way jeopardize our chances of being awarded a grant?

Answer: AHRQ anticipates that many research implementation groups will have several research ideas that they will wish to pursue over time and perhaps in a given funding cycle. So you're welcome to submit more than one application in response to a given funding opportunity announcement and/or [submit multiple proposals] across funding opportunity announcements. But with respect to funding decisions, AHRQ does take into consideration the extent to which would-be applicants' time and resources may already be oversubscribed as part of determining the appropriateness to fund an application. So that [administrative issue] shouldn't affect your priority score, but it could be taken into account with respect to deciding what AHRQ is going to fund.

Question: What are the minimum requirements for the skills, knowledge, and resources designated to be an eligible project director [PD] or PI?

Answer: You should check the description of what is expected with respect to a PD or PI as articulated at the SF-424 guidance. Also additional information with our expectations for the project director (PD) or principal investigator (PI) for these specific FOAs is articulated within each FOA. And just for point of information, the terms project director (PD) and principal investigator (PI) are used interchangeably.

Question: What are the chances that a facility with a 25-bed doctor's clinic, two satellite clinics, and a 75-bed health and rehabilitation long-term facility can receive a health IT grant?

Answer: Well, when it comes to these health IT FOAs, given the expectation that these are requirements that research proposals feature health IT implementation in ambulatory care settings or in transitions between settings, this would not be considered responsive as written. However, I remind you that two of AHRQ's recently published FOAs, the AHRQ health services research demonstration grants, the R18, and the AHRQ health services research projects, the R01, report other research endeavors that may feature a health IT research component. Those FOAs do not require that research be conducted in an ambulatory setting [PAR-09-070; PAR-09-071].

Question: Will projects using health IT to improve quality and care for patients that speak languages other than English be considered?

Answer: Yes. The appropriateness for a patient-centered care health IT intervention that uses language other than English must be demonstrated in the proposal. But indeed, AHRQ has funded grants which feature some interventions that are specifically designed to meet the needs of non-English speaking participants.

Question: The third research area—so we're talking about the requirement [for an application to address one of three] research areas of health IT— [specifically,] health IT to improve health care decisionmaking. And it's described as including the development, implementation, and integration of health information tools, products, or systems to the use of integrated data and knowledge management. Could you please tell us if the term knowledge management is used in the program announcement as it has been historically applied in a business sense? In other words, how knowledge is found, shared, and developed at an organizational level. Another intuitive interpretation of knowledge management might be management of clinical knowledge as applied at the individual practitioner or patient level, which is a candid clinical decision support.

Answer: The third research area, health IT to improve healthcare decisionmaking, includes several aspects of healthcare decisionmaking. This information comes directly from the FOA. "Given the breadth of each research area and the limitation on time and financial resources of a single grant, one grant is not expected to singlehandedly address all elements of a health IT research area. Rather an applicant must articulate the extent to which a specific grant would generate knowledge regarding elements of that research area and how that knowledge would advance the field of health IT and be transferable to other real world settings." Both of the definitions posited by the person raising the question regarding knowledge management would be consistent with this research area.

Question: Would a proposal that evaluates the implementation of a health IT content database, for example, repository of health information linked to a personal healthcare record be eligible for these FOAs?

Answer: Yes. The type of health IT application to be evaluated as articulated would be responsive to these health IT FOAs.

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