Pre-Application Technical Assistance Conference Call for RFA-HS-15-002

Moderator: Kamila Mistry
April 3, 2015, 11 a.m. ET

For more information, please visit http://grants.nih.gov/grants/guide/notice-files/NOT-HS-15-008.html.

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Coordinator: Welcome and thank you for standing by. At this time, all participants are on a listen-only mode until the Q&A session. At that time, you may press star 1 on your touchtone phone if you would like to ask a question. Today's conference is being recorded. If you have any objections, you may disconnect at this time. I would now like to turn the call over to Ms. Kamila Mistry from AHRQ. You may begin.

Kamila Mistry: Thank you. Thank you again for joining us. This is a technical assistance call for RFA-HS-15-002, which is AHRQ's health services research project, "Making Health Safer in Ambulatory Care Settings and Long-term Care Facilities."

I'm just going to briefly go over a high-level agenda so you sort of know how we're going to structure the call, and then we'll get started. First, we're just going to walk through some quick introductions so we can let you know who's in the room to answer questions. After that, we'll review the general goal of the call. And after that, we'll provide a quick overview of the objectives of the RFA.

And then we'll go into some questions that have been sent to us via Email in advance of the call. And then we'll open the lines up for the operator-assisted question-and-answer session, and then we'll just wrap up.

So with that, I think I'll start with introductions.

Michelle Burr: I'm Michelle Burr from AHRQ Grants Management.

Nicole Williams: I'm Nicole Williams from Grants Management.

Barbara Bartman: I'm Barbara Bartman from the Center for Quality Improvement and Patient Safety.

Erin Grace: This is Erin Grace, also in the Center for Quality Improvement and Patient Safety.

Debbie Rothstein: I'm Debbie Rothstein from the Office of Extramural Research, Education, and Priority Populations.

Francis Chesley: I'm Francis Chesley with Extramural Grants.

Kamila Mistry: This is Kamila Mistry, also from the Office of Extramural Research, Education, and Priority Populations.

((Crosstalk))

Kamila Mistry: Wonderful. Okay. So I'll just review very quickly. The goal of the call is to provide a brief overview of the RFA. And then actually the main goal is to answer questions. So with that, I'm going to turn it over to Barbara, who's going to provide an overview.

Barbara Bartman: Thank you all for joining. For those of you who I've spoken to over the last couple of weeks, you know that I'm suffering from some laryngitis. So I will do my best. Thank you for joining the call. And as many of you know, for the last 15 years at least, AHRQ has funded research and programs to improve patient safety.

The most significant investments have been made in the inpatient, or hospital, setting. As there is considerably less known about safety in other health care settings, AHRQ is launching an initiative this fiscal year to expand opportunities for research in two general areas. This RFA focuses on those areas: the ambulatory care and long-term care settings.

In addition, AHRQ has an interest in ambulatory and long-term care settings that serve vulnerable populations and disparities in patient safety in these settings. The project scope and the specific areas of interest are outlined in the RFA, which you should all have available to you. I will turn it back to Kamila.

Kamila Mistry: Great. So I think at this point we're just going to jump into a set of questions that were sent via Email in advance. I'll start off and Barbara and I will take turns going through these.

One of the questions was around including a cost analysis as part of a larger study as long as it was consistent with the goals of the funding opportunity. So we would answer that by saying yes; this is within the scope, but we're primarily interested in safety outcomes.

A related question is the announcement mentions development of evidence-based tools. How much emphasis is expected to be placed on tool development? So we would say this is an R01, so the research is expected to be largely development in nature.

And then I'm going to continue on to another set of questions. This set of questions really is around development of comprehensive epidemiologic study focused on ambulatory pediatric safety and if that would be responsive. And we'd say yes; the intent of the RFA is to look at ambulatory settings outside the hospital.

And there was another—and that question relates to emergency care and if that was part of the scope of this RFA. We would also advise [you] to look at PA-14-290 and PA-14-291, in addition to this announcement.

And I think we would say that actually we would like to focus here only on the ambulatory setting and those other PA announcements would probably be better in terms of fit—and, sorry, ambulatory care and long-term care for this particular announcement.

And the last question in this set: Is pediatrics considered a priority population for this RFA? And the answer is yes, it is considered a priority population for AHRQ. Okay. I'm going to hand it over to Barbara.

Barbara Bartman: I have two sets of questions here. One asks if the safety of self-management at home, including following clinician instructions, can be considered within the scope of this RFA or more focused on safety in the ambulatory clinic.

And the response is yes, we are interested in self-management at home, or what we call nonvisit care, as it is a component of ambulatory patient safety. So that is an area of interest to us.

The second question, in considering the population of study for epidemiologic studies and trying to be programmatically responsive, is it best to cast a wide net for different patient ages and conditions or be more narrow?

And the answer to this is that it really depends on what data and resources are available to produce a methodologically rigorous or sound study. There are many gaps in our knowledge about safety in these settings.

So there are a number of studies that could be done that could be narrowly focused or broadly focused. It really depends upon what the investigator can do with the resources available, particularly the amount of funding.

Can I ask one more? (Unintelligible). Another potential applicant asked Is home health care considered to be part of ambulatory care for this call? And the answer to that is no. We define home health care according to the Centers for Medicare & Medicaid [Services], CMS, and it is not considered within the scope of this particular RFA.

The second question: What sorts of safety issues does AHRQ want to study—health care acquired infections in the ambulatory setting, medication errors, diagnosis errors, any of these?

And the answer is we're interested in all of these for this particular RFA. But we are asking that you examine the special areas of interest in the RFA in regards to HAIs, medication errors, and diagnostic errors.

We're not necessarily interested in a specific disease or drug, but rather in how to improve behavior, interaction, coordination, continuity in transitions—this is stated in the RFA—so as to reduce errors. And we are also interested in the epidemiology of such errors, as well as disparities—issues related to disparities. And I think that's—those are all the questions that we did receive. Did you? one more, two more, okay.

Kamila Mistry: So this question asks do you know which study section this will be assigned to for grant review? Since this is an RFA, the application will be reviewed by a special emphasis panel.

And then the final question that we received in advance is a set of questions actually: To what extent does the project need to address the three areas—epidemiology, evidence-based strategies, and toolkit—which are three main components that were highlighted in the RFA.

So we would say it's not important to address all three, but likely it's best to probably focus on one of these three and that's what was intended. The second question was Does the generation of evidence, through clinical trials for example, of specific risk-reduction strategies fit with the RFA? And then we would just answer simply yes; this is a fit with the RFA.

I think those are all the advance questions. So at this time we can open the phone lines.

Coordinator: Thank you so much. We will now begin the question-and-answer session. If you would like to ask a question, please press star 1. Please unmute your phone and record your name clearly when prompted. Your name is required to introduce your question.

To withdraw your question, press star 2. There may be a moment of silence as speakers verify the answers to your question. One moment, please, for the first question. Once again, if you would like to ask a question, please press star 1. Our first question comes from, I believe, (Participant 1). Your line is now open.

(Participant 1): Thank you. I noted in the RFA, particularly in the ambulatory care section, that the langue specifically says medical error and subsequent adverse events. My question is would medication adherence in the ambulatory setting fall under this perhaps broader definition of medical errors?

Barbara Bartman: This is Barbara Bartman. Yes, it falls under the scope of this particular RFA.

(Participant 1): Thank you.

Barbara Bartman: Don't be shy. You have all of us in the room here.

(Participant 1): Is my line still open?

Barbara Bartman: Yes.

(Participant 1): Great. I have another question then. Am I the only one on the phone? In terms of care transitions, one of the—are we speaking specifically or certainly—would care transitions from inpatient to outpatient, outpatient to inpatient again, be what you're referring to, or care transitions limited to the ambulatory care setting?

Barbara Bartman: Any kind of transition is—the ones that you mentioned, we would be interested in as well.

(Participant 1): Very good. Thank you.

Barbara Bartman: Yes.

Coordinator: Our next question comes from (Participant 2). Your line is now open.

(Participant 2): Thank you. Hi. I didn't think you'd gotten it. So I'm interested in the definition of medication error and how that might relate to the use of medications off label or the use of medications that are known to cause significant reactions, whether or not it was the intention of the physician to use it.

Barbara Bartman: Yes, hi. This is Barbara Bartman again. We're interested in medication errors as they relate to how a practitioner or provider provides care, or a pharmacist provides care or administers the medication. We're not interested, necessarily, in the inherent error or harm that might come from the drug itself.

(Participant 2): Okay. But if someone uses two drugs that have synergistic harms and it's recommended that that's not, that would be within the definition of medication error?

Barbara Bartman: Yes.

(Participant 2): Okay. Thank you.

Barbara Bartman: Yes.

Coordinator: And for our next question—next question comes from (Participant 3). Your line is now open.

(Participant 3): Hi. Thank you very much. I was wondering if this RFA is expected to just be offered in this April due date, or is there anticipated that it may be offered again in the fall?

Barbara Bartman: Discussions about a program announcement are currently ongoing. As we mentioned in the RFA, there is an intent to produce a program announcement and those discussions are underway.

(Participant 3): Thank you.

Barbara Bartman: Sure.

Coordinator: Our next question comes from (Participant 4). Your line is now open.

(Participant 4): Yes. Our question is, while you indicated emergency care is not within the scope of this grant, is care provided by EMS? Would that be considered an appropriate scope for this grant? Specifically related to mobile integrated health care between EMS and care in the home?

Barbara Bartman: (Participant 4)?

(Participant 4): Yes?

Barbara Bartman: Yes. Hi. This is Barbara Bartman. The type of care that you're describing is possibly considered under this scope. I think it would be best if you could Email me and we could discuss it further offline.

(Participant 4): Okay. That's great. Thank you.

Barbara Bartman: Okay.

Coordinator: Our next question comes from, I believe, (Participant 5). Your line is now open.

(Participant 5): Hi. I have two questions. My first question is I believe in the RFA HAIs are only listed under the long-term care facility portion of the RFA. And I'm wondering if you would also consider that as far as infections or HAIs or resistant infections in ambulatory care?

Barbara Bartman: For this particular RFA, yes, we are considering them now.

(Participant 5): Okay. So you're considering resistant infections, HAIs, under ambulatory care as well...

Barbara Bartman: Right. Yes.

(Participant 5): ...as an outcome. And then my second question is I'm wondering if dental practices would be included under the ambulatory care setting?

Barbara Bartman: Yes. Yes.

(Participant 5): Great. Thank you so much.

Coordinator: Our next comes from, I believe it's (Participant 6). Your line is now open.

(Participant 6): Hi. Actually, my question was previously answered already.

Coordinator: Okay. Thank you. Our next question comes from (Participant 7). Your line is now open.

(Participant 7): Hi. Thanks for taking my question. My question—so we're planning sort of a body of research around ambulatory medication errors. And the first, we have a few aims. One is looking at just sort of describing these errors. Two is sort of predictors of these errors.

And we have a third, which I'm considering, and I wanted to see if this was of interest to AHRQ, because I was told perhaps that it might not be. But looking at sort of a comparative safety, sort of an association between errors for certain medication prescribing patterns compared to others. So I'm just curious if comparative safety is of interest within this RFA.

Barbara Bartman: This is Barbara Bartman again. For this particular question, comparative safety, I would like to speak offline or if you can Email me, we can have a discussion about it so I can get some more details about your project. And then I can determine if it falls within scope.

(Participant 7): That sounds great. Thank you.

Barbara Bartman: Okay. Thanks.

Coordinator: Our next question comes from (Participant 8). Your line is now open.

(Participant 8): Hi. I'm following—this is sort of following up a little bit on (Participant 2) question, having to do with medication use in circumstances where a medication—where there are alternatives, strategies that might be available to a clinician and a particular medication might be a risky choice.

So it's not a medication error in the sense that the prescriber didn't intend to prescribe that medication, but the choice was a risky choice and particularly for an off-label use. So strategies that try to encourage more judicious prescribing of medications that might be inherently risky or less than the safest choice, would you say that's within scope?

Barbara Bartman: Yes.

(Participant 8): Okay. Thank you.

Coordinator: Our next question comes from (Participant 9). Your line is now open.

(Participant 9): Okay. Good morning. Well, my question's really related around I was told that the study focus that I'm looking at, which is developing transitional care management bringing work from inpatient to outpatient looking at building the community agreements and handoff, would fall within the scope.

But what my question is, is kind of related to the research data. Because of the fact that we have a large county with multiple different providers and some patients come to our organization, but others don't have primary care providers, what I'm trying to figure out is baseline data.

If we gather baseline data on perceptions of the adequacy of care coordination and monitored what our current readmission rates were, and then after the project or through the project measured throughout the whole community each setting's readmission rates and perceptions of improved care coordination—I've never done a grant before. So I'm kind of new at this.

So that's kind of my general question. Would that meet the framework of the data gathering needed? I hope that makes sense.

Kamila Mistry: So if you could just elaborate a little bit and just let us know where does this fit in with regard to safety or errors?

(Participant 9): Right. So currently when patients are discharged, we all know that there is a breakdown in the communication regarding when they receive their discharge instructions. So typically the meds that they're discharged with, when they leave they may or may not actually take their medication, i.e., they have a stroke and they're not taking their Coumadin.

So what we would be focusing on are most of the discharge instructions and handoffs, the communication from the point of being discharged up until their next care setting.

So that current framework of doing transitional calls postdischarge and basically ensuring that there's a phone call immediately within the first 48–72 hours after that patient's discharged, and then a followup with the next care setting to make sure that that've actually seen their next provider, who's assuming responsibility for their care.

And then there are patients that do not have primary care providers, so we would continue to follow them to help facilitate that they've established care with someone else and that they're following their directions as they should postdischarge.

…Nobody is really doing transitional care management right now in our region, and that's the gap that we see. So it's self-care, medication, what's the perception of having this extra assistance?, and What are the community providers' perceptions of that assistance in their outcomes with their patients.

Barbara Bartman: This is Barbara Bartman. Yes, this is something that's clearly within the scope of ambulatory care. What we're recommending, however, is that you look at other work that AHRQ has funded, because we have funded a number of researchers to look at readmissions and hospital discharge, just to make sure that your work is not duplicative or hasn't already been done.

(Participant 9): Got it. Thank you.

Coordinator: A moment for our next questions. Our next question comes from (Participant 10). Your line is now open.

(Participant 10): Yes, hi. Can you hear me?

Kamila Mistry: Yes, we can hear you.

(Participant 10): Okay. Great. My question is for this specific RFA: Are you requiring a significant amount of preliminary data that we gather?

Kamila Mistry: I think it just depends on the project. You could either send us an Email and we could give you some more detailed feedback, or you could, you know, elaborate here if you'd like.

(Participant 10): Okay. Thanks.

Barbara Bartman: It is an R-01. So in that sense, we anticipate a number of projects that are somewhat developmental.

Kamila Mistry: And exploratory...

Barbara Bartman: And exploratory.

Kamila Mistry: ...in nature.

Barbara Bartman: But should have some pilot data with it. You know, that would be—one would typically consider that a part of a tool development.

(Participant 10): Okay. Thank you.

Barbara Bartman: But like as Dr. Mistry said, though, please Email us with a little bit more information about your particular study.

(Participant 10): Okay. Will do. Thank you so much.

Coordinator: Our next question comes from (Participant 11). Your line is now open.

(Participant 11): Hi. Thank you. In thinking about the epidemiologic studies and talking with colleagues, you know, we think typically of epidemiologic studies as sort of large database type studies, but many studies of errors include ethnographic techniques, such as direct observation.

I'm sort of wondering if techniques that combine or include that ethnographic work would generally be considered part of your epidemiologic studies, or if you can give some examples of what you mean in terms of epidemiologic safety studies. Thanks.

Kamila Mistry: So this is Kamila. I think use of qualitative methods or mixed method approaches are fine and within the scope of the RFA.

(Participant 11): Okay. Thanks.

Coordinator: Our next question comes from (Participant 12). Your line is now open.

(Participant 12): Hi. Thank you. This is a question regarding the focus on ambulatory care settings. Is there a preference for outpatient primary care clinic settings versus outpatient subspecialty clinic settings?

Barbara Bartman: No. The setting, obviously, should be appropriate for your study or research question.

(Participant 12): Okay.

Barbara Bartman: But both, I could clearly see questions, research questions, relating to our areas of interest and to the RFA that could be done in either or both settings.

(Participant 12): Great. Thank you.

Coordinator: Our next question comes from (Participant 13). Your line is now open.

(Participant 13): Good morning, everyone. My question has to do with ambulatory care. We're looking at disruptive patient behavior and risk reduction for patients and staff, as far as ambulatory care is concerned.

And I see that we have listed under ambulatory care, the role of the patient and caregiver behaviors in improving patient safety. And I was wondering if that would actually fit for this particular project.

Barbara Bartman: You know, this issue has come up in a few other reviews that I've been involved in, and I know it's an issue that is increasingly faced by employers. But I wonder if, again, we could take this one offline and if you could Email me some more information specifically about your study and I can give you a more definitive answer?

(Participant 13): Okay. Thank you.

Coordinator: Our next question comes from (Participant 14). Your line is now open.

(Participant 14): Hi. Thank you for the question. I don't have a copy of the RFA. First question is how I can get that.

Barbara Bartman: You can go to AHRQ's Web site, www.ahrq.gov.

Kamila Mistry: It was also part of the TA announcement as part of the Federal Register notice, and so there is—it's in parenthesis right after we named the RFA. And you can just click on that.

(Participant 14): Okay. And I will find also Barbara's phone number over there?

Kamila Mistry: Yes, correct.

(Participant 14): Okay. Okay. And my other question is since I don't have a copy in my—it sounds silly, but I'd like to know the requirements for the type of organization and the size of the organization that could apply for this grant.

Barbara Bartman: It's actually detailed in the RFA.

(Participant 14): Okay.

Barbara Bartman: So you can find that information...

(Participant 14): Okay. Thank you.

Barbara Bartman: ...and Email me any other questions that you might have.

(Participant 14): Okay. Thank you so much.

Barbara Bartman: Sure.

Coordinator: Our next question comes from (Participant 15). Your line is now open.

(Participant 15): Hi. I have two questions this morning. One is on the previous question, you mentioned that there will be—there may be a program announcement coming out on the same topic. Will proposals that are reviewed and not funded on this one be accepted on the program announcement as, you know, a resubmission?

Barbara Bartman: This would have to be submitted as a new application, if we do issue a new program announcement.

(Participant 15): Okay. Thank you. And the second question is, is it acceptable to have pilot data or a demonstration of the method based on studies in acute care, then, you know, applied to discovering what a similar safety issue is in long-term care?

(Bill Spector): Hi. This is (Bill Spector). That would be fine.

Kamila Mistry: So if there aren't any additional questions, then we'll go ahead and end the call.

Coordinator: Actually, there are some additional questions. I thought you were still trying to find the answers to (Participant 15) question.

Kamila Mistry: Sorry. Okay. Thank you.

Coordinator: It's okay. Our next question comes from (Participant 16). Your line is now open.

(Participant 16): Hello?

Kamila Mistry: Hi.

(Participant 16): My question has to do with whether fall prevention is considered in the scope of medical error?

(Bill Spector): Absolutely.

(Participant 16): Perfect.

Coordinator: Our next question comes from (Participant 17). Your line is now open.

(Participant 17): Hi. Thank you very much. Good morning, everyone. Just a quick question about the RFA background. There's a statement referring to interest in vulnerable populations. I'm just curious if there's any particular interest in either urban or rural populations, or if they're of equal interest?

And a related question to that is, is there any interest in facilitating or incorporating engagement within the proposals with PCMHs, Patient Centered Medical Homes, and Accountable Care Organizations? Thank you.

Kamila Mistry: So the answer to both questions is yes. And, (Participant 17), remind me of the first question again so I can be more specific.

(Participant 17): Sure.

Kamila Mistry: Urban versus rural, I think?

(Participant 17): Correct. Yes.

Kamila Mistry: So I think both of those would be of interest with regard to the disparities or vulnerable populations' piece. And then either of the ACOs and the other-PCMH, I think, also we'd be interested in both.

(Participant 17): Okay. Great. Thank you very much.

Coordinator: The next question comes from (Participant 18). Your line is now open.

(Participant 18): Thank you. In relation to eligibility criteria, would it be acceptable to have associate investigators from private facilities so that a larger population can be inclusive of regional data? That way we can acquire what they're reporting versus what just a nonprofit or public institution would.

(Bill Spector): So in answering your question, the applicant institution has to be a nonprofit organization for this announcement. The PI could be from a private institution. The applicant organization would have to have a substantial role in the work proposed in your application.

(Participant 18): Okay. Thank you.

Coordinator: Our next question comes from (Participant 19). Your line is now open.

(Participant 19): Hello. Thank you for taking my question. If proposing epidemiologic studies, frequently in AHRQ proposals there's an interest in seeing either proto interventions or complete interventions. Is that required for this or is a deep look at epidemiologic data sufficient?

Barbara Bartman: Hi. Can you say that again and maybe clarify (croto)?

(Participant 19): What? Clarify what?

Barbara Bartman: Can you say it again? There was a term you used that we weren't familiar with.

(Participant 19): Proto interventions like, you know, sort of the scoping of potential interventions that aren't necessarily tested or the complete testing of an intervention that responds to high-risk aspects of care that are returned from epidemiologic studies. So...

Kamila Mistry: (Participant 19), do you mean like prototype? Is that what you're saying?

(Participant 19): Yes.

Barbara Bartman: Okay.

(Participant 19): So if you're doing it—so I'll be clear. I'm interested in pediatrics. There are very, very few epidemiologic studies on pediatrics, in terms of the epidemiology. We have some initial information that suggests there are certain areas. Some are more prevalent, some are more risky.

But to really dig down and to understand better what the nature of the risk is, but then do you need to have an intervention that you're going to propose, or is that deep dive enough?

Barbara Bartman: Yes. Studies such as those would fit very well under this R-01.

(Participant 19): And you don't need the intervention.

Barbara Bartman: Yes, you don't need—right, don't need the intervention.

Kamila Mistry: The epidemiologic focus is, I think, sufficient, (Participant 19). That's what they're saying.

Erin Grace: And it may set you up for, you know, a second—a follow on study, an R-18 or something like that.

Barbara Bartman: Yes.

Erin Grace: Also in the way the R-01s work.

(Participant 19): Terrific. The timeframe was challenging to think about if you need it to be more. Thank you.

Coordinator: I believe our next question comes from (Participant 20). Your line is now open.

(Participant 20): Yes. I just need to ask about data. How much data are you exactly asking for, for pretool implementation and posttool implementation? So is there a specific timeframe you're looking for?

Barbara Bartman: No. It's really dependent upon your study.

(Participant 20): Okay. I just have one more question. Specific tool infrastructure that will be—that's already in place, is that something that could be expanded and shown, or we have to show that there's going to be a new infrastructure that is going to be put in place?

Barbara Bartman: No, expansion would be fine.

(Participant 20): I'm sorry, I'm going to take my time. I waited for long, so last question hopefully. We have a smaller long-term care facility and a bigger long-term care facility. One is urban, one is rural. We are trying to figure out whether should we apply for both, or should we apply for only one? Was I supposed to ask only two?

(Bill Spector): The project would have to make the case if you're trying to study an intervention that you have the power to study it.

Kamila Mistry: In both.

(Bill Spector): That you can show an effect. So that'll determine the time, followup time, et cetera. It will depend on what you're trying to do. It can't be just a case study in one facility.

(Participant 20): Okay.

Coordinator: Our next question comes from (Participant 3). Your line is now open.

(Participant 3): Hi. Just a followup question. It sounds like you guys have answered this similarly, but again the pressure part is only mentioned in long-term care, but just to confirm that you guys are interested in that across all ambulatory care areas?

Barbara Bartman: Yes.

(Participant 3): Thank you.

Coordinator: And at this time I'm showing no further questions in queue. Once again, at this time, I'm showing no further questions in queue.

Kamila Mistry: So with that, we will close the call. Thank you again for joining us. We'll just reiterate that the final date of submission is April 27. And you're welcome to followup with additional questions. You can send Emails to barbarabartman@ahrq.hhs.gov, and that's also included in the technical assistance call announcement that was published in the Federal Register.

(Bill Spector): So that's April 27 as the due date for applications.

Kamila Mistry: April 27th, yes.

Kamila Mistry: Thank you. We'll close the call. Thank you.

Barbara Bartman: Thank you all very much.

Coordinator: Thank you for joining. This concludes today's conference call. All participants may disconnect at this time.