Enabling Patient-Centered Care Through Health IT

Ambulatory Safety and Quality

Technical Assistance Call

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This document summarizes the technical assistance call for the Ambulatory Safety and Quality: Enabling Patient-Centered Care Through Health IT funding opportunity announcement (FOA). Select to access the FOA.

The technical assistance teleconference was held at the Agency for Healthcare Research and Quality (AHRQ) conference center in Rockville, MD, on January 4, 2007. If after reading this document you have any questions or comments, contact ImprovingQuality@AHRQ.hhs.gov.

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Introductions

Good afternoon, everybody. This is David Meyers. I'm a medical officer in the Center for Primary Care, Prevention, and Clinical Partnerships here at the Agency for Healthcare Research and Quality.

At this time, we're going to begin the Ambulatory Safety and Quality (ASQ) program's Enabling Patient-Centered Care Through the Use of Health IT FOA technical assistance call.

If you're interested in any of the other FOAs, we have just finished one on measuring quality, and we will have one later this afternoon at 3 o'clock on Improving Quality Through Clinician Use of Health IT.

At this time, I'd like to have the other staff who are in the room with me today and part of the team here at AHRQ introduce themselves to you so that you'll have a voice to associate with the folks who will be helping you through this process.

• Michelle Burr—I'm Michelle Burr from Grants Management.
• Rebecca Roper—Rebecca Roper, Scientific Review Administrator.
• Kishena Wadhwani—Kishena Wadhwani from Division of Scientific Review.
• Yvette Davis—Yvette Davis, Scientific Review Administrator.
• James Battles—Jim Battles from the patient safety team here at AHRQ.

So again, what we have are people from the programmatic office who are your content advisers, staff from grants management and budgeting, as well as those who will be leading the grant review process. So at anytime during the call, we will have people to answer your different types of questions.

Before we begin, I'd like to make sure that everyone knows that this is the only formal technical assistance call or a service that we will be having for this FOA. At the end of this telephone call, we will begin writing summary notes of the answers to all questions that were asked and answered.

If we run out of time and there are questions that we have not had time to answer, we'll give you an E-mail address where you can mail them to today. Any questions that we receive today will also be included in the transcript and this transcript will be posted on the AHRQ Web site. Everybody who registered for today's call will be notified when those transcripts are available.

Slide Presentation

We'll be following a set of slides today that was provided electronically before the call began: (PowerPoint® file, 100 KB; Text Version). Slide presentations can be accessed using a free PowerPoint® Viewer.

So with that, I'd like you to turn to your slides that we will be using during this talk. If you didn't receive a copy, they will be available on the Web site and I will be saying most everything found in the slides.

Additionally, I'd like to point out that the slides come directly from the FOA itself. Everything we say today is a reflection of what is in the FOA. I'm sorry I will not be able to be more entertaining than that. We hope you have had a chance to review the FOA.

What we will be doing is providing a little bit of additional clarification and pointing out some of the highlights of the FOA that we hope you'll pay attention to as we move forward.

Additionally, once we're done with the formal presentation, we'll review some Frequently Asked Questions and then open up the floor for questions from the audience. Rather than answering each question after it's asked, we will ask folks to dial in if they have a question. We'll take a large group of questions and then as a group at AHRQ we will try to answer them.

Again, if we don't get to any questions, we'll be sure to answer them on the transcript.

So moving on to the third slide. I'm going to start a little out of order by reviewing what is an eligible institution for this FOA. This is a question many people have asked us and so I'd like to call your attention to the language in the FOA.

You are eligible to submit an application if your organization is one of the following three things:

• A public or nonprofit/not for profit institution. This includes nonprofit healthcare organizations, universities, and faith-based and community organizations.
• A unit of local or State government, which is eligible to apply for Federal funding.
• Indian or Native American tribal governments, or their designees, are eligible to apply.

For-profit organizations are not eligible to lead an application. However, they are able to come in as members of consortia or as subcontractors on an application led by an eligible institution.

For-profit organizations that produce Health IT systems are encouraged to apply in partnership with an eligible nonprofit organization.

Finally, foreign institutions are not eligible to apply. They again are eligible to come in as members of consortia or as subcontractors under an application.

So if you thought you could apply and you just found out you couldn't, you can now signoff the call. Hopefully, most of you already knew that and we can begin the review of the program.

Looking to the next slide, AHRQ's ambulatory safety and quality program is an outgrowth of two sets of work that AHRQ has been engaged in. One is our large patient safety and quality program and the second is our health information technology (Health IT) initiative.

And the overall goal of this large new initiative launched in 2007 is to improve the safety and the quality of ambulatory healthcare in the United States. AHRQ recognizes that much of our earlier work was focused on the inpatient setting, in both quality and patient safety, as well as HIT. This work is beginning to expand, not giving up our old focus but expanding into the ambulatory care setting, recognizing that ambulatory care is increasingly complex in its scope, its volume, and the issues that it's dealing with.

Additionally, this FOA as well as the large umbrella program that it is part of have an emphasis on harnessing the power of Health IT to move to a safer and higher quality healthcare system.

Flipping slides, the ASQ program has four components. This afternoon we're now discussing the third of them—Enabling Patient-Centered Care Through Health IT.

This is the one that focuses not so much on the healthcare system or the people who deliver care, but on the people who receive the care. That of course is done in the context and in partnership with healthcare providers and healthcare systems.

In the next slide, we describe what we are referring to as ambulatory care under this large initiative. Ambulatory care is all types of health services provided by healthcare professionals on an outpatient basis.

And in the FOA you will notice that we give examples, including healthcare clinician offices, clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers, which are clearly part of the ambulatory care system.

Additionally, for the purposes of this FOA, homecare entities are included under our definition of ambulatory care and are therefore eligible to apply and to study patient-centered care in the home.

The next slide reminds us that the overall goal is to explore the use of Health IT and related policies and practices to establish and enhance patient-centered care in the ambulatory setting.

If you go to the FOA, you'll see several goals and I pull them together here for you. I won't read through this but refer back to it as you're thinking about “is this what AHRQ is asking for?” It's in the slide as well as in the FOA.

In the next slide, we define for you patient-centered care for the purposes of this FOA. This is care that is responsive to the needs and preferences of individual patients, which provides patients with access to their medical information, and empowers patients to be active participants in care decisions and in the daily management of their health and illnesses.

Under this FOA, AHRQ recognizes that there are many different and important areas of patient-centered care that could be studied and while we're interested in all of them and will entertain applications that are responsive to this FOA, we specifically are interested in focusing on four areas:

• Shared decisionmaking and patient-clinician communication.
• The use of personal health records.
• The integration of patient information across transitions of care.
• And patient self management of chronic conditions.

These four areas are again noted in the FOA.

Skipping on to the next slide. As with most Federal funding opportunities, applicants are expected to describe an intervention, to place the intervention in a context, to discuss how the intervention will affect patient-centered care, to provide a detailed implementation plan along with your detailed methods, and then give us a robust analysis and evaluation plan with specific measures for assessing patient, office, and health system level outcomes. And finally, you are expected to include a dissemination plan in your application.

The next few slides highlight aspects of the FOA.

Before I go over this, I'd like to point out that in the FOA, there are several places where you will find that the “applicant must...” Whenever AHRQ uses the word “must,” there will be a first review process of your application, an administrative review, where we determine whether you met all of these requirements. Applications that do not meet these requirements can be, and often are, returned without further review.

We'll talk later about the peer review process, which I hope by participating on this call, all of you are going to make it to.

So going on to the next slide, highlights of the research design and method section.

Applicants should describe the Health IT component of the intervention. There are many ways the patient-centered care can be achieved but the focus of this FOA is the marriage of or the use of Health IT to empower healthcare systems to provide patient-centered care.

When possible, Health IT interventions should conform to interoperability standards and, when possible, we recommend and encourage the use of certified products. More information about those can be found in the FOA as well as the links where you can learn more about standards and certification.

Going on to the next slide. Because this application is looking at the patient's experience of care, applicants are strongly encouraged to use the newly released AHRQ-funded and developed CAHPS® Clinician and Group survey instrument. These instruments have several core domains as well as additional modules that can be used for assessing patient's experience of care. If you do use CAHPS®, we also encourage you to write about if and how you plan to participate in the national CAHPS® benchmarking database. More information about how you can do that is again in the FOA. This is an encouragement—a strong encouragement, but not a requirement.

There are however several required measurements in this FOA. The reason for this is that this FOA is part of a larger program that is part of a larger portfolio that is part of a larger Agency mission that itself is part of the HHS and its mission. And so to understand how all the different programs across the Agency work together, we encourage the collection of standard measures of outcomes across many different projects.

For the purposes of this FOA, applicants are required to measure and report the percent of eligible patients who have access to their personal health information.

This does not mean that this needs to be the focus of your application. It does not need to be the specific aim of your application and your project doesn't need to move this goal forward. Nonetheless, you are required to describe how you will measure and report back to AHRQ information regarding patient's access to their health information.

Additionally, under this FOA, when appropriate, we encourage applicants to measure and report patient's access to and utilization of quality measurement reports of their healthcare providers.

And finally, we also encourage applicants to measure and report the percent of ambulatory clinicians who you are working with under your study who routinely use measurements to evaluate their patients' experience.

All of these, again, do not need to be the focus of your grant but these measures are—the first one required and the second two strongly encouraged—things that you collect and report.

Going on in the slides, it is important that you discuss the sustainability of the intervention after grant funding has ended.

Additionally, it's required that you have a project dissemination plan by which you plan to share the results of your work. The plan itself must be incorporated not only into your description of the project but also incorporated into your proposed budget.

I'm proud and happy to announce that AHRQ is planning to have additional dissemination grants available for people who are funded under this FOA. However, you may not count on that funding in the planning of your application. Your dissemination plan and the budgeting for it need to stand alone.

The next slide deals with privacy and security and I strongly recommend that you read the FOA and the sections where we describe what we mean by privacy and security, what we expect to see from your application about the protection of patient's privacy and security, and also get resources and ideas for you to consider.

Specifically, all applications are required to describe how both in the development and the implementation of their project, privacy and security issues related to the exchange of sensitive health information will be identified and addressed. And on this slide, I just pulled out one of the good paragraphs that describe some of the methods that you might want to consider.

On the next slide, you'll see that AHRQ has identified three special funding preferences under this FOA. Before we describe what they are, I want to point out that we recognize that many of the applications may fit under more than one of these and that many of the funded applications will end up under more than one of these. So it's possible that the total amounts given to special preferences will not equal the sum that you see here for the three special emphases.

With that noted, we are looking for projects that are conducted in primary care practice based research networks. We are looking for projects focusing on practices that serve vulnerable populations. And, finally, we are looking for projects that have a significant focus on medication management and patient-centered care within medication management.

The details of what we mean and what you need to do to describe whether you should be considered by AHRQ for these funding preferences are in the FOA itself under Section 3.3. All of your answers should be included not in the application directly but in Appendix 1. All applications are required to have Appendix 1 whether or not you want special funding preference. If you do, this is the place you detail one, two, or three that you believe you qualified for or should be considered for. Or include the sentence, “No funding preference required.”

The funding preferences will not be a focus of the special emphasis panel who review your applications. This is for AHRQ to consider when selecting well-reviewed applications for funding.

Thinking about how we will take the applications and how they'll be funded, please flip to the next slide.

As you'll see here, there are many things that AHRQ considers when determining what applications will be funded. The first is the scientific merit of the proposed project as determined by peer review and this is the area you have most control over. The other factors are listed here so you understand what are some of the other factors AHRQ considers such as the relevance to AHRQ's overall priorities and the programmatic balance across both this FOA and the larger ASQ program.

If you flip to the next slide, you'll see the review criteria by which your specific application will be reviewed by a panel of your peers. It includes the significance and impact, the usefulness and generalizability—a category that folks may not have seen before and I encourage you to read what we mean by that—and, specifically, the questions the peer reviewers will be asked about your application. Additionally, they'll look at your approach, which includes your method, the investigators and their qualifications as well as the partnerships you bring to your projects and the settings in which it takes place, and finally the budget is included and your peers will review whether your budget is appropriate for the project that you are proposing.

Additionally, the peer reviewers will look at how responsive you were to the goals of this FOA, to privacy and security protections for patients which we just went over, protection of human subjects and research risk, and the inclusion of priority populations. We encourage you to make it very easy for your peers when they're reviewing your applications to understand how you were addressing these final three considerations:

• Privacy and security,
• Protection of human subjects,
• And inclusion of priority populations.

In our last few slides, we're going to review some of the nitty gritty of the application.

This FOA uses an R-18 mechanism, which is for research demonstration and dissemination projects. Its goal is to provide support designed to develop, test, and evaluate health service activity.

We should note that this is a one-time solicitation, while AHRQ may in the future choose to reissue this, we have no plans to do so at present.

We are projecting $6 million in total costs for the applications for fiscal years (FY) 2007, which would fund approximately 15 to 20 grants. Applications can come in for funding of up to 36 months duration with a total cost of up to $1.2 million with no more than $500,000 in any one year.

So, I'll say that again; $500,000 in any one year, but with a total that is only $1.2 million. If you do $500K and $500K and $500K, you're over $1.2 million.

Additionally, AHRQ grants request a total cost which is your direct plus your indirect. Your total cost may not exceed $1.2 million over the course of your grant or $500,000 in any one year.

On the next page, we note that AHRQ does not accept modular budgets. We only use detailed research and related budgets. If you try to use a PHS-398 modular budget, your application will be returned without review.

Fortunately, this shouldn't be so difficult, because you'll be using the new SF 424 (R&R) electronic submission process. All applications must be submitted using the 424 and be submitted electronically. The FOA gives instructions on how to obtain the electronic forms necessary as well as how to register your institution—the lead institution that is—and the principal investigator (PI). If the institution and the principal investigator are not registered, you are not able to submit your grant application for review. The registration process, for those who have not already completed it, can take up to 6 weeks to complete. Often, it takes less, but you should budget at least 6 weeks. If you don't calculate the timing well, you can be ready with your application to submit before the due date and find that you will not be able to submit it. If you have questions about this, one of the AHRQ experts on the electronic review and submission process is here with us today to answer questions. Additional information is in the FOA.

On the next slides, we reiterate what is an eligible institution. We know that these are public institutions or not-for-profit private institutions including healthcare organizations, colleges, universities, and community and faith-based organizations.

For-profit organizations cannot be lead, but may come in as members of consortia or subcontractors and the same goes for foreign institutions.

Information about the principal investigators is detailed in the FOA. The PI should devote a considerable portion of his or her time to the project, and this will be reviewed by the peer reviewers. If less than 20 percent of his or her time will be devoted, the application must include an explicit justification. This is an example of a “must” in the FOA.

On the next slide, you'll see the key dates as listed in the FOA. When we say opening date, that means the first date in which an electronic application can be accepted by the system.

We encourage you to send us a letter of intent. These are nonbinding. Information about what we request in the letter of intent is in the FOA. These letters are extremely helpful to the Agency to make sure we have the right number of peer reviewers with the right skill set to evaluate your application. So it is to your advantage as well as AHRQ's for you to submit an letter of intent if you're considering applying.

The application submission date is February 15, 2007. The peer review date we hope will be in April or May of 2007 but that is a projection. There are many other factors that may change that date.

In your planning, you can plan that your earliest anticipated start date under this FOA if you were given an award would be July 2007. That's very useful information as you consider your timeline, which is also required in your application.

Question and Answer Period

Before we turn to questions from the audience, I'm going to go through a few that we've been asked several times already since this announcement was released.

Question: Are hospitals allowed to apply?

Answer: If I could, I'd turn this over to the group and ask you to answer it. Since I can't, I'll just go over it again. Public and nonprofit healthcare or institutions, which includes hospitals, are eligible to apply. For-profit organizations including for-profit healthcare organizations and Health IT vendors may not lead applications. For-profit hospitals may be included as consortium members or subcontractors, but may not lead an application.

Question: Does AHRQ accept modular budgets?

Answer: No, and that's that.

Question: Are emergency rooms or emergency departments considered ambulatory care site?

Answer: For the purpose of this FOA, the answer is yes. Ambulatory settings for this FOA include healthcare clinician offices (both large and small practices), outpatient clinics, community health centers, emergency departments, urgent care centers, and ambulatory surgery centers. For the purpose of this program again, home care entities are included.

Question: What if we want to focus on the transition between settings?

Answer: As the FOA states, transitions, including patient-centered care during healthcare transitions, are a focus of this FOA. We define transition as the movement of patients between healthcare providers and settings as their conditions and care needs change during the course of the chronic or acute illness. Overall, the whole ASQ program includes a focus on transitions between ambulatory care settings and the inpatient setting. Non-ambulatory settings who have a strong interest in fostering safe, high-quality ambulatory care and transitions between inpatient and ambulatory care are encouraged to apply in conjunction or in partnership with an ambulatory care organization.

Question: Can there be co-principal investigators?

Answer: No. AHRQ requires that the lead institution designate one and only one individual as the project's principal investigator. You may then in describing the rest of your team, give titles, king, queen, duke, co-investigator or any other terms to the rest of your team, but officially, there is one and only one principal investigator on an AHRQ application.

That concludes the formal part of our presentation. And now, we'll get to the fun where you get to ask us your questions.

We do have a list of approximately 14 questions that were submitted electronically as people registered for the conference. If you've already asked, if you know you've done that, we have those and we'll be addressing them as we proceed. So right now, I'd like to turn it over to the group and to the operator for people to queue up to ask additional technical assistance questions.

What we're going to do is ask everybody to state your question, and then we will go to the next person and we'll take a list of at least 10, possibly a few more questions. Any questions that we don't have time to take on the air, we ask that you submit electronically. The E-mail address is at the end of the slide set and as well as in the FOA; it's patientcenteredcare@ahrq.hhs.gov. And if you submit those additional questions, by the end of the day, we'll include them in the transcript.

If you'd like to ask a question, please press star-1 on your phone. You will be prompted to record your name. To cancel your question, press star-2.

[A transcript of audience questions is not included. Questions and answers are included below.]

These are all very important and very good questions, and we'll try our best to get through these as well as many of the ones that were submitted in advance. In fact, I'm going to start with those while the rest of the staff scrambles for answers to the others.

Responses to Presubmitted Questions

Question:  Can we confirm whether there are any matching requirements for this FOA?

Answer:  I can confirm there is no matching requirement. You will find language in the FOA that additional investment and partnership especially with Health IT vendors is encouraged and looked favorably upon, but there are no requirements.

Question:  Is the objective as a grantee to utilize health information technologies that are new and under development or to use existing off the shelf technology as a way to enhance patient-centered care?

Answer:  The answer to that one is clearly yes, both of those. We recognize that there is a spectrum of development and that some applicants will come in describing that there is a lack in an area and describing how they will fill that with new materials. Other applications will come in describing things that are already in existence and the need for testing them in new ways or new settings or to improve patient-centered care. Either of those specific aims would be considered responsive to this FOA.

Question: the health information technologies proposed have to be Internet-based? 

Answer: The answer to that is absolutely not.

Question: Please clarify the application submission deadline?

Answer: Applications are due on February 15th. The closing date is the date the computer system has been programmed to shut off. That's not of interest to you. The application deadline date is the date you need to look at and for this FOA it is February 15.

Question: Can Federal dollars be used to purchase in-home electronics health monitoring devices? I'll broaden that question to say, can funding under this FOA be used for any form of Health IT hardware or software or licenses?

Answer: And the answer is yes. You should note however, that your budget is part of the review criteria. A group of your peers will be asked to determine how appropriate your use of funds is for the project and the value of the project that you're proposing.

Question: Can Federal dollars be used to compensate participating clinical providers in exchange, for example, for downtime caused by their participation in training activities under the intervention?

Answer: Yes, in general. There are some small Federal technical regulations, for example, that Federal employees can not be compensated in this way, and there may be local institutional rules as well, but in general that is possible.

Question: What do we do if we don't fit in to the funding preferences? Does that mean we're not competitive?

Answer: Funding preferences will not be used by the peer-reviewers but will be evaluated by AHRQ when considering how the money for this FOA is distributed. If you don't qualify for them, you are still encouraged to apply. And there is funding that will go to applications who meet none of the funding preferences.

Question: What if we meet more than one of the funding preferences, what should we do?

Answer: You may request consideration under 1, 2, or 3 of the funding preferences, and we understand that some of you have the potential to do that. This, too, is acceptable and again will not be used in the evaluation by your peers, for the scientific merit of your application. Funding preferences may be used when AHRQ is determining how to distribute and balance this funding.

Question: Can funds be used for implementation services and other operational costs or must they only be used for evaluation?

Answer: You will be evaluated on your specific aims and what you set out to do and your ability to do that. And that may include any of these things—implementation, operations, and evaluation.

Question: Are we allowed to leverage other Federal agency funded EMR infrastructure to this grants?

Answer: In general, the answer is yes. I'd also like to point out in the budget process or in the application's budget justification section, you are expected to justify all of your expenses and to provide why those are necessary and the details of how they will be used.

Question: Can the university partner with a network of free ambulatory clinic providers through an association?

Answer: The answer is yes.

Question: There are four areas of particular interest to AHRQ in this FOA. Do we need to demonstrate research on all of those areas, or can we choose just one area?

Answer: You are correct; there are four areas of interest. Applications most certainly do not need to address all four of them. You also may choose applications outside of the four of these. These are just ones that AHRQ put you on record that we have particular interest in and that the review panel will probably pay attention to in determining your responsiveness to the goals of this FOA.

Question: Since AHRQ recommended using CAHPS® as an outcome measure for patients' perceptions and care, could we incorporate that into our systems so patients could take it via Web portal?

Answer: That's a definite yes. You may do that. The CAHPS® survey instrument is in the public domain. More information about the CAHPS® program, the specific instruments, and how to access them is available on the AHRQ Web site and the direct link to be found in your FOA

Answers to Questions Taken on Today's Call

Question: When AHRQ states identify, promote, and disseminate, we are asking to what degree development of tools would be included in identify and promote?

Answer: Developing new things would be responsive to this FOA. If you find an area that there's a need for something and you are going to create that thing and test how it meets that need, that would be considered responsive to this FOA.

Question: Is the transferring of information onto a DVD for people in rural America considered a Health IT application?

Answer: While not necessarily what AHRQ would define as a priority or as our core idea of Health IT, an applicant could describe for us in an application that this intervention, using DVDs, is in fact using Health IT to improve patient-centered care. Clearly, if the DVD was being created through an interaction with a Health IT system, and the information being loaded on through it was from a Health IT system, this would be a very simple case to make. However, even without that, we believe that applicants could write an application that convinces the peer review panel that it is acceptable and responsive to the FOA.

Question: If an applicant is registered with the CCR, do they need to register again?

Answer: The answer is Yes and No. The No part of that answer is that the CCR, Central Contractor Registration, for an organization, is a one-time registration, and every organization applying under this FOA needs to have done that. However, there is this second required registration that both the organization and the principal investigator must complete, and that's with the NIH eRA Commons. Each applying organization will need to be sure that it's registered in both places. Registering with the CCR does not get you automatic registration in the NIH eRA Commons.

Additionally, someone asked, how do we know if our institution is already registered in the NIH Commons? If you go through the FOA, there is a link that gets you to the Web page that lets you search by institution to determine if it is registered. You'll find that under Section 4 under Application and Submission information.

Question: Are partnerships required?

Answer: There is nothing in the FOA that states they are required. However, the FOA does say that we encourage interdisciplinary teams and working across multiple settings.

Question: Can a non-ambulatory setting be the lead institution?

Answer: We've already told you the answer to that is yes. However, there is an expectation that among the team, that there will be an ambulatory organization participating. So, a non-ambulatory lead organization would need a partner with an ambulatory organization and an ambulatory organization could come in alone.

Question: Can you please clarify what is meant by dissemination?

Answer: We are not able to give additional guidance that is not in the FOA. So you do need to use the FOA. And on page 9, it describes what AHRQ is interested in terms of dissemination. It is rather general. The applicant must present a project dissemination plan including a proposal for widespread dissemination, should the project results be generalizable and meritorious. I believe that it would be safe to say that in the health services research community, journal articles and presentations are one form of dissemination, but there are clearly other methods that can be proposed and that we are interested in. To get more information, you should look at the review criteria. And on page 22, (on the version I'm looking at) under the review criteria, you'll see that there are specific questions under usefulness and generalizability. And reading through them you'll see that AHRQ is not going to ask your peers to review you on the ability to create commercial products or disseminate sales or work on the commercialization of a product. The dissemination plan has to do with the applicability and the generalizability of your work across multiple settings, and it would be expected that your dissemination plan would be related to the usefulness and generalizability of your work. Please remember, your dissemination plan needs to be included within the budget. The reasonableness of your plan will be taken into account; too small or too broad a plan would not be expected or favorably reviewed.

Finally, I'll point out again that AHRQ recognizes that dissemination often takes a lot of work. At the beginning of a project you don't know whether you have something that you are going to want to share with everybody. For that reason, AHRQ is planning to have additional supplemental limited competition grants for dissemination under this FOA for successful projects so they can do more dissemination work. Remember, however, that this potential additional funding may not be included in your application and you may not rely on getting that additional funding. Perhaps this helps you recognize we're not asking for you to do everything under this application.

Question: Does the dissemination plan mean that we must surrender intellectual property?
[Please note—this answer has been revised to reflect more accurate information]

Answer: With a grant mechanism, AHRQ does not require transfer of intellectual property rights that result from work done under this grant. The Federal Government, however, does retain the right to use and distribute products developed with Federal grant funding. The Federal Government does not receive rights to intellectual property that is developed previously and used during a grant. Additional information about intellectual property and Federal grants may be found at: http://www.ahrq.gov/fund/hhspolicy.htm.

Question: How do the Health IT requirements under this grant affect the real world situation of working with different ambulatory settings using different EHR systems?

Answer: AHRQ has no expectations that your project will try to get everybody on the same system. It would be appropriate to take certain variables or values and work for interoperability across the different systems. To do this in order to improve patient-centered care across transitions seems extremely responsive to the goals of this FOA.

Question: What format is AHRQ expecting for the letter of intent?

Answer: There are few things that I'd like to point out about the letter of intent. The letter of intent is described in Section 3.8.1. AHRQ requests this letter as a service to both us and to you. The letter of intent is non-binding, but it helps AHRQ in planning for the peer review process. So we're asking you to let us know, so we'll know how many applications we might expect, the types of projects (so that we have the right people to review them), and know who not to ask to be a peer reviewer because they are planning on submitting an application. That's why we want your key personnel listed. In terms of what format, we give you our E-mail, our fax, and our mailing address. Many people have found the E-mail system is working well at the moment and that clearly is acceptable, but fax and mail would also be wonderful as long as you tell us if you want to play.

Question: Isn't it possible for a project to be responsive to more than one FOA under the ASQ program? Can an institution submit more than one application?

Answer: One institution can submit multiple applications to either one FOA or to multiple FOAs. However, when an application is submitted under one FOA, the same application or basically the same application cannot be submitted under another FOA. However, two applications that dovetail to each other, that were separate interventions done though the same setting by the same institution, one focused on outcome measures related to patient-centered care and the other one focused on clinical decision support for the clinician and measuring those outcomes, could move forward under one institution through different applications under two different FOAs. AHRQ's review team would make the determination if they are too similar in their context.  We generally suspect that you should be able to say, is this the same project or different projects with different interventions, which is what AHRQ is expecting.

The Form 424 specifies that the Agency will not review the applications for the same project. So the justification for this answer comes from the SF 424 as well.

Question: If an organization is a nonprofit organization who has applied for 501 C3 status but has not yet been granted that status, are they allowed to apply?

Answer: The answer to that is yes. Before you were able to receive funds you would have to provide documentation of your not-for-profit or nonprofit status.

Question: Will AHRQ facilitate partnerships between organizations interested in applying, especially those without all of the necessary resources to apply?

Answer: While we wish we were large enough and had enough time to get everybody involved in this field together, we do not have that for this FOA. However, there are multiple opportunities that you can use by looking at AHRQ's Web site and our Health IT Web site to find other potential partners. Again, however, AHRQ will not be facilitating potential match ups between either vendors and healthcare providers or between healthcare providers and researchers. We are sorry we are not able to do this, but we are not.

Question: Is it acceptable if the principal investigator is not employed by the lead organization?

Answer: That is a very challenging question. Technically, that is a potentially acceptable application. AHRQ would expect that the applicant would clearly document the relationship between the PI and the organization, and most importantly, that the lead organization who is entering into a fiscal relationship with AHRQ has authority and accountability for the PI.  This will need to be very clearly documented and will need to be very clearly evaluated by AHRQ. Additionally, that question becomes even more acute when the PI is employed by a for-profit organization. The peer reviewers may have questions about an application in addition to those asked by AHRQ. However, with those caveats, it can be done. And if you'd like additional guidance, please see the technical assistance folks listed at the end of the FOA.

Question: Does the FOA have SBIR set asides?

Answer: SBIR stands for Small Business Innovation Research. There are none under this FOA.

Question: Are the review criteria weighted?
Answer: No, the review criteria are not weighted. If you look at Section 5.2, Review and Selection Process, the FOA states that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score.

Another issue with respect to review of an application is for applicants to pay careful attention to the SF 424 requirements for completing Section E. The Plan for Protection of Human Subjects, including addressing the inclusion plans for women and minorities and providing completed targeted enrollment table(s), as appropriate. Also, applicants should address the AHRQ Priority Populations.

Question: Is a person working on their home computer and communicating with their clinician considered ambulatory?

Answer: Yes. Under the whole ASQ program, a patient being at home is absolutely part of ambulatory, especially if they are communicating with their primary care team or with other non-hospital-based services. If the patient is at home, you're ambulatory, especially with the addition that home health care services, for this program, are also included under the definition of ambulatory.

Question: Are there any restrictions on the funding?

Answer: While there are multiple types of restrictions due to Federal regulation, specifically relating to the purchasing of technology, hardware, software, and licensing, there are no restrictions under this FOA. Again, though, a group of your peers will review your application for the reasonableness of its budget. Additional details about budget justification are listed in the FOA.

Question: Is telemedicine and the use of telemedicine for improving patient-centered care for those in the homecare setting?

Answer: Telemedicine involving Health IT and work in the ambulatory including home setting would be responsive to this FOA.

Question: Can AHRQ elaborate on what is meant by shared decisionmaking?

Answer: Shared decisionmaking appears as one of the four areas that AHRQ has specific interest in within this realm of patient-centered care and enabling it through HIT. By our regulations, we cannot elaborate more than what's in the FOA. However, I will point you to the section in the FOA, which on my copy appears on page 9, that says, in the background in significance section, the applicant must demonstrate an understanding of the nature of ambulatory care, the current challenges to the provision of patient-centered care, and how Health IT can enable better quality care. “The narrative of an application should include a brief review of the salient literature with respect to the focused area and the anticipated benefit limitations, …”. This is the language that your peers in the peer review committee will be given as it appears in the FOA. We won't be giving them any more definitions than we've given you, and so you get to set the stage of what this is and what literature supports that and describe what it is you're talking about within the definition of patient-centered care that we provided you.

With that, I think we've answered the questions that were asked to us today. I hope you have a better understanding of this funding opportunity. If your questions weren't answered or you need a further clarification, please feel free to submit those by the end of today to the E-mail on the last slide, and we'll be able to include them in the transcript.

The transcript as well as the slides will be sent to all of you who have registered for this call as soon as they are available. Does anybody at AHRQ have any final thoughts?

Please note that this FOA doesn't have SBIR set aside and that the agency does not have plans for any program in that area at this time.

We thank you all for joining. We hope this has been helpful. We look forward to receiving your letters of intent, and to working with many of you in the future. Best of luck.

Below are four additional questions received via E-mail during the technical assistance call. As stated during the call, answers to these questions are provided here.

Question: Regarding the requirement to measure the percent of patients “who have access to their personal health information,” should we measure the percent of patients for whom personal health information could be accessed (i.e., access is available through their providers) or the percent that have actually obtained their personal health information (i.e., access was utilized)?

Answer: AHRQ requests that grantees measure and report on the percent of patients who have direct access to their personal health information. This does not require a count of the number of patients that have accessed or used this information. Individuals who are required to ask the medical records office to provide them with a copy, print out, or CD with their records would not be counted. In summary, while access does not require use, it must be direct access.

Question: Can you please clarify what is meant by “when appropriate” in the second requirement to measure patients' access to and utilization of quality measurement reports of their providers?

Answer: The measurement requirements are specific to each FOA. For this FOA, all grantees are required to report on the percent of eligible patients within the practices that they partner with who have access to their personal health information…” Applicants are asked to determine for themselves if they have the ability to report on a second measure related to “patients' access to and utilization of quality measurement reports of their providers.”

Question: Can a single institution apply for the same grant (patient-centered care) under two different PI's with different innovative approaches?

Answer: Yes. AHRQ has not restricted the number of applications an institution may submit. In my experience, however, individual study sections have not favored this and have questioned institutional commitment.

Question: In the research study do we need to have a control group or can we use retrospective data to compare the outcomes from a specific intervention?

Answer: The FOA does not specify a specific type of research design and encourages applicants to propose the most appropriate methods for the aims of the study. The research plan, outcomes, and analysis plan will be reviewed by the peer-review committee.

Current as of February 2007