Afternoon Session - Transcript

And with that I’m going to turn it over to Dr. Clancy to make introductions.

So this topic also is in direct response to a suggestion from one of you. It might have been Jane. I guess this will be the Jane meeting. So we won’t be listening to her—

I’m gone for the entire term.

--Suggestions next time. But my recollection is that, if you were the one who suggested it initially, about three other people jumped in to say, “That’s right. All this hospital stuff is terrific but we would love to have a better sense of what you are doing in ambulatory care safety.” It turns out we’re actually doing a fair amount but it also turned out that the request was quite good for us because some of that we are doing falls into different portfolios. So it provided a great opportunity for us to pull together, at least a representative sampling of the whole.

So with that we briefly debated, since it touched a number of portfolios, having a multi person presentation and decided that no, our fearless leader of the Patient Safety Portfolio, Dr. Jeff Brady should and would do this by himself. And I have full confidence it will be great. Take it away, Jeff.

Thank you very much, Dr. Clancy. And although I’m by myself here at the table, I’m joined by several of the Patient Safety Team members in the audience here, both the core team members and the extended safety team that reaches into the whole agency. As Dr. Clancy described we make full use of the expertise that we have in different parts of the agency, primarily the Patient Safety Portfolio, which is situated in the Center for Quality Improvement and Patient Safety, which my boss, Dr. Bill Munier leads, here in the audience.

So with that I’m going to—my purpose, really today will be to T-up, I think, what will hopefully be an interesting discussion involving you all at the end. And the way I’m going to try to do that is just to provide some very general context for patient safety in this subset of health care overall that is ambulatory health care. Primarily I’ll spend time focusing on some ongoing projects, current research activity, available tools and resources that have come out of our work in patient safety (Can everybody hear me okay?)—and touch briefly on some future directions and then, again, move to the discussion involving your all.

So for the purposes of, I think, the Patient Safety Portfolio’s organization and distinction of ambulatory care and then this talk as well, what we are talking about is medical services that are provided in an outpatient environment. So it is a little bit easier in some cases to define ambulatory care by what it is not rather than what it is. It is not hospitalized care. It is also not long term care, at least for the purposes of this discussion.

Services sort of reached the full range of health care activities, diagnosis, treatment, surgery and rehabilitation. And then examples really make the best case of being specific of what we are talking about. The more readily apparent parts of ambulatory care--medical offices of various sizes; outpatient clinics and community health centers; also the Emergency Department, including urgent care centers; outpatient surgery centers, another sub segment, if you will of ambulatory care; renal dialysis; and home health care, sometimes not included but for the purposes here we are including it.

I think this is really the, probably the main theme of the talk, if I had to summarize it in one phrase. And it’s the reason that we are here today. I think most agree that there has been uneven progress in patient safety across health care settings. Much more of the activity has been focused in the hospital setting. And sort of one way to think about this, in terms of some significant milestones and bookends almost, generally speaking, to the last decade—way back in 2000 we sponsored a conference that was really focused on development of an agenda for research in the ambulatory patient safety.

Some of the major topic areas you might think about, sort of the focus on data and surveillance, epidemiology if you will. Also, though interventions and what could be done and essentially, again, laying out what the agenda could be over the next decade. Jump ahead 10 years and two, more recent analyses or activities that are focused on this area specifically. One was by the AMA published last year. And that was a 10-year retrospective review of research and ambulatory safety. Quite helpful—but I think what it documented was, relatively speaking, a persistence of lot of the challenges that were documented more than 10 years prior to that review.

I want to mention an ongoing project. And I’m joined also here in the room by a colleague from the Department, Office of the Assistant Secretary for Planning and evaluation. And they have funded a project that is essentially an environmental scan of patient safety in ambulatory care, primarily looking at estimates and methods for developing estimates of the various types of events that exist, patient safety events that exist in this setting.

Oh, so this is really an overall summary of what challenges primarily predominate this issue and a challenge for patient safety in the ambulatory setting. I think the first bullet really addresses resource and a lack of both human and financial resources to support the kind of robust safety and quality improvement operations that you see in other settings, the hospital in particular. Relatively speaking that’s not present in ambulatory settings, certainly with some exceptions.

The nature of ambulatory care itself, although less technologically complex often has many logistical challenges that are at the heart of most patient safety problems that exist in ambulatory care. As I think has been noted even today, some of those challenges related to information exchange, whether it is electronic or otherwise, those are one example of this logistical complexity and the challenges that it creates.

Furthermore, the diverse nature of outpatient care can often result in longer times to identify and document errors. These are very isolated episodes or essentially touches, if you will with the patient over time. If you think about the brevity of an outpatient appointment and several outpatient appointments even in comparison to hospitalization and that episode of care. It’s very difficult to just identify what’s happening in terms of care generally speaking but also errors as well.

And then finally, and by no means least, the reliance and the importance of the patient and that factor, in this whole sort of milieu that sets up an opportunity for even, for different types of errors or in some cases contribution to the same types of errors and situations that I’ve also described. So many challenges in ambulatory care.

So moving on to what we have available, I’ve sort of talked about the challenges and, I think, barriers that we need to overcome. In spite of those there has been some progress. And over the next few minutes I’m going to share some of those with you. Our portfolio is, very simply stated, focused on the risks and harms that are inherent in health care. We’ve increasingly tried to focus on implementation. But we’ve tried to also continually maintain a focus on sort of the more basic, fundamental research that is necessary.

And that’s definitely an issue that is operative in ambulatory patient safety where we are still challenged even just defining what the prevalence is of various events. And just to mention explicitly, we are—all settings of health care are within the scope of the portfolio. So first I just want to run down a couple of key funding opportunities and funded efforts over the past say, six to eight years. We have an ongoing research opportunity in simulation research that’s not limited to ambulatory care. However, as I’ll describe a little bit later, ambulatory care and in particular the Emergency Department has been well represented among that set of grants.

Diagnostic errors and the diagnostic process, both cognitive and more processing types of issues related to the diagnostic process has been frequently noted as common among patient safety events and ambulatory care. In 2007, we funded a Special Emphasis Notice expressing our interest in research in that area. As Dr. Clancy mentioned, by no means are the safety projects limited to the safety portfolio. And our colleagues in the Health Information Technology Portfolio have an ongoing program focused on ambulatory safety and quality. And that has yielded many important findings and contributions to the field.

And then, the last two things I would like to mention, just as an overview, are a focus on risk informed interventions and analysis that, again, focuses on where the risks are in health care and, in particular, the ambulatory environment. And finally, I think another notable milestone that merits inclusion on this list, is the availability of the Medical Office Survey on Patient Safety Culture. And I’ll describe a little bit more about that in a second.

So hopefully, most of these specific projects and resources and tools will be a reminder to you, and you are already familiar with some of them. AHRQ PSNET is really designed to be our one-stop savings for all things patient safety in terms of research findings, tools, other resources. It is not limited to only things that come out of the Agency but has a much broader scope. It’s operated by Dr. Robert Wachter at UCSF.

And I took this opportunity to just describe to you what’s in PSNET at a very broad level. Some—almost 8,000 resources across the whole collection. And you can see the subset of those that are tagged. These are catalogued and tagged across different dimensions. And approximately 10 percent of those, only 10 percent, have some association with ambulatory care or the ambulatory environment. So, just another representation of, relatively speaking, how much or how little has been done in this area.

Similarly, a sister site, AHRQ WebM&M—this is where individuals and the field practitioners can submit cases. And they get expert commentary on the patient safety learning aspects, if you will, from that incident. And of the 260 cases and commentaries that are available on WebM&M, a little over 50 of those are identified as having a focus on ambulatory care.

I mentioned the Medical Office Patient Safety Culture Survey. It’s one of a suite of tools that are intended to measure patient safety culture in different settings. Again, it became available at the end of 2008, early 2009 after we had published the hospital and nursing home survey. We expect to make available the Retail Pharmacy Patient Safety Culture Survey soon, if not already, actually. And clearly that’s focused on another important aspect of ambulatory care. And you can see the survey dimensions that really do span across different settings, although there are unique aspects of each of these. And that’s really where the adaptation is to the different types, different settings of care.

As are all of our tools and resources, heavily evidence based. This survey underwent testing in 200 offices. It is freely available and we also publish a comparative database where users of the survey can voluntarily submit their results. And those are available to other users so they can compare how they rate among the different dimensions of patient safety culture.

As I mentioned, in the Simulation Portfolio, the Emergency Department is well represented. And this is not a simulation product per se. But it’s focused—it’s an effort focused on the Emergency Department throughput, flow through Emergency Department, addressing specifically the issue of overcrowding, the unfortunate result of patients leaving in some cases. So the real focus of some projects was to make available some concrete strategies for implementation and ways to address the problem of ED throughput.

An example of kind of specialized care but still in the ambulatory environment, we have—the Patient Safety Portfolio funds, in part, or we contribute funding to the HIV Research Network that itself has a scope that is broader than just patient safety. However, there are—there have been specific patient safety, not only findings but actual implementation and changes in care that have resulted based on the availability of data in the HIV Research Network—reaches almost 28,000 patients that are in this network, some 19 sites throughout the network.

One of the, I think, more interesting challenges in patient safety overall and clearly the ambulatory environment is challenged in this way, too, is how to collect information from providers themselves and from the environment—and what’s actually happen that—and this project MEADRS, which stands for Medication Error and Adverse Drug Reporting System, was an example of an effort to address that challenge of data collection and provider reporting.

I think one of the main outcomes of this was, in addition to the experience, the taxonomy and sort of struggling with how to define medication errors in a way that makes it easier to report, was an intense focus on the usability of this system—and in particular, very specifically, the time necessary to report. I think when that time is measured in seconds rather than minutes, that’s often the difference, often means the difference between getting a report or reporting at all versus no report. So those are some of the output.

As we look ahead, the output of this project, I think we hope will inform. Another effort that is ongoing, and that is our common formats. You’ve heard about these in various updates that Dr. Clancy has provided over the course of your meetings. Essentially, these were established or we were authorized to promulgate common formats for patient safety event reporting as part of the Patient Safety Act back in 2005. We have these for the hospital setting. They are developed initially in consultation with our colleagues at various federal agencies.

There is a public input process that’s in place utilizing the NQF and an expert panel that advises us on reports or rather comments that receive. And I guess, the summary points on the common formats is we found in the hospital setting that these have been a very important contribution to the standardization of patient safety measurement. That simple point alone, I think, has been one of the, probably the biggest barriers in all settings. And it’s certainly—the ambulatory environment is no exception.

And what we are finding with the availability of the hospital common formats is they are increasingly gaining acceptance and sort of confirming this need that has existed for standardization. And that acceptance spread between both the government and private sectors and there are many examples of that. So as we look ahead and we’re beginning to work on development of ambulatory common format and a beta version of that—what we are finding is the structure and sort of the foundation of the common formats and definitions for patient safety events, much of that intellectual work that we’ve done will actually directly apply and translate into the ambulatory setting.

There is another, I guess, sort of set of issue, data elements, if you will, and circumstances where we will need to engage in some new conceptual work to sort of fully adapt and accommodate the common formats and that standardized structure into the ambulatory environment. And that’s underway as we speak.

Finally, I’ve already alluded to our simulation grants and simulation funding. We really began this work in earnest back in the 2007 – 2008 time period with a significant investment in this research. And what we have—what you see here is just a subset of the topics that are covered in this set of research projects. These are the ones that are most identifiable with the ambulatory environment.

I won’t go through all of these. But as I mentioned before, the Emergency Department, very well represented among these. But, as well, there are some more traditional clinic based kinds of issues, diagnosis of melanoma, for example, and other types of care scenarios that have a safety component were simulation has a role in helping to inform what’s really happening.

Finally, turning, as I sort of finish up here, to the patient. And I mentioned the importance of the patient in care overall and even more so in the ambulatory setting. We have some patient focused, patient oriented resources and tools. This is actually a campaign that includes different tools that—you’ve heard this discussed before as well. Basically this—the heart of this initiative really stressed the importance of clinicians and patient communications in ambulatory settings.

And a very specific way, focused on the need to establish common understanding or priorities between the patient and the provider. In many cases—in some cases there is not prioritization at all. In cases where there is a priority setting, you have disparate priorities. And so, ultimately, I think an agreed upon set of priorities and focus to help guide the activity both of the clinician and of the patients is something that is focused on here. And you can see just screen shots here of the different tools and resources to help support that.

And then, finally, the last resources that I want to talk about focus on medication, safety and in particular, these high risk medication, anticoagulants in this case. And the need to really engage the patient in their role in effectively achieving and staying within this narrow therapeutic range, outside of which, many bad things can happen. Again, the patient’s role in understanding why that is the case, number one. And then, number two, what they can do to help support that. These are resources that are developed based on a grant and our partnerships implementing patient safety projects.

And then, the success of this and the interest that we received pushed us to adapt a lot of that same information into a DVD that has been very well received by the field. And just to put a number to it, we received some, I think, 20,000 requests for this a month, measured by Web hits and downloads. So that, again, has really hit a sweet spot in terms of a need for specific guidance about what patients can do to help support their own safe care.

So with that, just to wrap up, I think despite some of the improvements that I’ve described and some of the, I think, progress and specific tools and resources, the ambulatory care setting really does still lag behind other settings, and the hospital in particular. There are many remaining opportunities for improvements in this setting. And hopefully it is clear to you that AHRQ is committed to sort of continuing to work to try to identify those and, you know, contribute what we can to help advance that.

So I think at this point, we are keenly interested in what you have to say about this in terms of reactions, general observations about what I’ve said or otherwise, thoughts about high priority topic areas within this field, some strategic opportunities for the Agency and collaborations and, as well, any other recommendations.

Thank you, Dr. Brady. Much appreciate your thoughtful comments And we will open it up for comments and questions. And I appreciate your posing some specific things to us.

I’ll start out with, I guess, two comments about this. And one is from our point of view of safety net hospitals. We do have very large ambulatory networks, unlike many other hospitals. And so I think we would be interested in having further discussions with you about how we can disseminate some of this in our networks and through our own platforms.

The second question I have—you know, we have watched, I think, or many of us have watched the rapid alignment of physician practices with hospital systems, and sometimes an affiliation, sometimes outright ownership. There is certainly a convergence that is happening very rapidly in some communities. And I’m curious in your thoughts about whether that will help you or hurt you in terms of your spread activities. Because it seems like many of these practices are not so dissociated from hospital anymore.

And I wonder if that will address the issue raised before about the lag in adoption in some of these practices?

I think it is a very important question. And I think, you know—in general, I think that’s actually a good trend in terms of safety. Again, one of the challenges that we pointed to earlier was lack of an infrastructure and resources, both human and financial, to focus on patient safety. And so I think that consolidation, if you will, establishes and opportunity for that and maybe, at least some central resources that could help support patient safety initiatives in individual practices.

Great. Thank you. What I’m going to do now is I’m going to go a different direction this time. So I’ll start with Dr. Pensen and go to the left.

I wasn’t prepared for that. So thank you for your presentation. It’s very interesting. And I’m struck, and again, I’ll put on my surgeon’s hat, but I think it is actually pretty appropriate, by the sort of minimal focus on outpatient surgery. I see that there is some but not very much. And I know that is not your fault. But I think that that is something that you absolutely, positively must make a high priority.

The majority of surgical procedures are performed in the outpatient setting. Ambulatory surgery centers right now are the Wild West. And the fact of the matter is that this is an incredible area to improve the health of Americans. The patient safety issues there are overwhelming. Providers have not guidance. There is minimal regulation there. And there is also the hand-in-hand with patient safety is the quality improvement piece. There is a tremendous need for quality measures there.

I appreciate that there has been some simulation work there but I think it has to go beyond simulation work because frankly, there is nothing there now and people are getting hurt.

Thank you for bringing it up. It is actually—it’s an issue we are fully aware of. I think some 15 million outpatient procedures per year. That’s the rough estimate. I think a transition of care to that setting. We do have some projects underway looking at sort of evaluating risk in a very specific way. What are the points, what are the key areas in ambulatory care? Another opportunity that I think we have is to, I guess, adapt some of the existing tools we have, for example, the culture survey and what are the unique issues that impact the culture of safety in that setting.

And I think we are starting to sort of do that very quickly in recognition of the shift in care that you talked about. Anything else? I might turn to my Patient Safety Team members. Jim anything that you would want to add about ambulatory surgery?

Well, we do have an Action-2 task order on the street to create what we are calling, let’s say, surgery for ambulatory care, which is in parallel with what we are doing with the inpatient. We’re not doing it but CMS is creating a CAPS for ambulatory surgery that is on the street. I don’t think that contract has been awarded. So, we fully recognize and we are trying to move as rapidly as we can.

I think you raised an important point, which is, you can graft what has been done in the inpatient setting to the outpatient setting. We’ve tried to do that in my institution. And it’s ironic and it is almost humorous until you think about what the consequences are. Surgeons, you’re trying to get them to do a check list in inpatient surgery. You had tremendous resistance. Now they do it. The outpatient setting, there is the same resistance if not more and yet, still you know that that is a culture change. And you need to make that happen. And you can basically use the same mechanism.

One thing I would suggest is, there are organizations out there. There are advocacy groups for ambulatory surgery centers. They are, again, funny groups that sort of—it’s not the same as going to, you know JCAHO or AHA. There are these organizations, which you have to partner with to make this work. And I can’t stress how critical this is, just because I think there is a lot of badness going on out there.

Bill, please.

I wanted to pick up that point. With the common formats we will probably—ambulatory surgery will be high on the list of where we will go next. And I wanted to mention—I’m not sure I’ve got the name right but quad A or 4-A. It is one of the ambulatory surgery organizations has a fairly sophisticated adverse event reporting system. And it’s voluntary. Although, if you join it you have to report. And I’ve seen presentations from their database and it is actually quite good. That’s one of the groups we will want to partner with.

Dr. Wyatt, I didn’t see you card initially.

Right. Thank you.

Start with you.

It was a great presentation. I just wanted to ask you about your work or coordination with the FDA’s Sentinel System, their Sentinel Initiative, which is big, distributed electronic system that is going to use hospital and payer information, particularly about drug and medical devices surveillance. It just launched a couple of years ago. It’s a relatively passive surveillance system at this point. But there is a goal within that system to engage consumers in a more active surveillance kind of process.

The whole concept pharmaco vigilance I think is something that really needs to be emphasized, particularly post market initiative. I would be interested in hearing more in the future, perhaps, about your work with or your coordination with the FDA in this initiative.

I think most of our really intense, direct coordination with the FDA has been through our common formats work, through the patient safety work group that I described, the federal partnership, the federal coordination that we have. And so I guess the simple point that I would make is that, in all cases we attempt to be harmonized and aligned with other, federal data collections. In fact, that is, I think one of the top, potential benefits of the common formats and standardized reporting.

If you think about it from the local level, sort of silo’ed reporting is really just almost a non-starter at the local level. If a local provider needs to sort of know which system to go to, based on their own decision about what type of event they are talking about—essentially the common format tries to standardize across all types of events, the need for data—and essentially is one place to go for reporting.

Bill, anything else to add about coordination with the Food and Drug Administration around medication errors?

Well, one thing that has been interesting about working with the FDA is, they have an adverse event reporting oriented around drugs and devices. And we’ve been working with their—in a three-way collaboration with the Office of the National Coordinator, who has been looking into IT adverse events. Which, of course, IT is a kind of device. And some devices are a combination of it and mechanical.

So we’ve been working with ONC, with FDA and with ourselves to try and come up with an adverse event reporting systems for devices, including IT, which would come in through the common formats and be reported—wherever they need to go, including the state reporting, or the hospital’s local event reporting but also into the MedSun system at FDA. And we’ve been harmonizing the AHRQ common formats with the MedSun system at FDA.

And while we were in the process of doing this, the FDA got a call from a bunch of hospitals in Michigan, which were very frustrated because they were entering data into their own system and to their local PSO. And they had to turn around and enter it into a different system, MedSun at the FDA. And they called up the FDA and said, “We just entered the same information twice. And it’s conflicting and it’s not the same.” And the FDA was able to say, “Yeah. We know about that. We’re working with AHRQ.

And our goal is to have one portal where you will enter it into your own system in the hospital, which will then export it wherever it needs to go, including to the state, to the PSO, to the FDA, to whomever. And it is our goal, actually, to eventually get to the point where the end users, hospitals, ambulatory surgery clinics or whatever, can report for their own quality improvement purposes into their own system. And then that system will electronically export it to whatever other external bodies need it.

Now, that sounds simple. It also sounds logical. It sounds desirable. It decreases data collection burden for the end user. It also increases the scientific value of what getting collected. That’s the goal. We are now actively working with CDC, FDA, ONC and CMS to arrive at that goal. But we need all of your support in getting there because it’s not only a technological and scientific issues, it’s a people issue. And people have a lot of investment in legacy systems and doing things the way they used to do them. But that’s where we want to go.

That’s wonderful, the common formats issue. I hope there is a way to engage patients in a more active way. I mean because patients are talking about their drug experiences and ambulatory care experiences in blogs all over the place, particularly in the Voluntary Health Associations, whether it’s cancer or arthritis or what have you. And the DOD has surveillance systems right now that are monitoring every email that we send to anybody for key words.

And so it would be interesting to see if there could be some sort of systems developed to engage the Voluntary Health Associations, who have active blogs about patients’ experience with medications. I mean in the arthritis experience there are over 128 adverse side effects or adverse events that could occur within the range of arthritis medications. And we need to teach patients about that. Thank you.

Thank you. Dr. Ng Oh, I’m sorry. Bill, do you have another follow-on?

I just had a direct follow-on that, in that we’re supporting the development of a consumer reporting system. And one of the tasks in that is to try to tie it in with PSO reporting. There is some—I don’t want to bog down the NAC with descriptions of the confidentiality and the provider protections and why it doesn’t work so well for consumers. But we’re very aware of the fact that the consumer has a piece that no one else had, especially with continuity of care. And, so, we are trying to make those ties.

Dr. Ng.

Yeah. I’ll try to make this brief because I think that there’s been some allusion to the point that I wanted to ask about. I also, like Dr. Siegel work at a safety net hospital. And working with diverse populations is very important for me and the community I serve. And especially as we think about 2050 and the face of America as it continues to change and the cultural, linguistic needs or Americans who seek health care and those who are not Americans but living here, who still need health care.

I’m curious to know, what are some of the safety improvements that are inclusive of culturally and linguistically appropriate services and other germane characteristics about a particular population or subpopulation of individuals and who all that fits in.

I guess I would just start generally by saying health literacy clearly is an issues that impacts patient safety. And so to varying degrees that’s reflected, depending on the project and the focus of the project, that is reflected in various projects. In some cases it is the absolute focus, where we are developing or adapting existing tools or developing tools anew to address the issue of health literacy. So that’s a short answer, in general. ‘

I guess one of the things I see some times, I work in the area of diversity, whether it is sexual orientation, gender, identity or race, ethnicity, language, etcetera. So I see things oftentimes get pigeon holed into one, particular area of resource or health service that—well, this is a class issues or this is a sexual orientation – race issue or whatnot—and when they are everyone’s issue.

So I’m hoping that there could be some collaborative opportunities between the Agency and other folks, whether we are talking about the Joint Commission or we are talking about other advocacy groups that we’ve talked about here, whether for patients or provider or health professionals—that could hopefully address this a little bit more of a multi-faceted way so it is not just presented as a, you know, uni-facet, this is a culture issue or this is a simple language issue.

No. This is all part of the context of creating a safe environment.

and if you look at Glenn Flores’ work in this area you’ll see what can go on in an ambulatory environment.

Absolutely.

Ms. Haskell.

I just wanted to ask what you are doing specifically to address care coordination in the ambulatory setting. That is really one of the biggest concerns if not the biggest concern that patients have. And they are more worried about the ambulatory setting in the hospital setting because that is where most of their experiences occur. And people are trying desperately to sort of juggle their own care themselves and coordinate it all themselves.

I also wanted to echo the safe surgery and the patient reporting and the medication adverse events. Those are all important things. But I also wanted to ask you about the care coordination.

So I think, just clearly, care coordination is an issue that spans the full range of not only the patient safety portfolio activities but I think, as evidenced by your conversation earlier today, you know, it’s just an ever present issue. I think specifically, in the Patient Safety Portfolio, sticking with this idea of, although not exclusively, just adapting what we have in the hospital setting to the outpatient setting, hopefully doing that in a thoughtful and complete way.

But our team steps sort of set of training tools, I think that is sort of, as I see it, foundational work to address issues of care coordinate. Certainly, I think there are some specialized focused, care coordination issues that require, you know, more focused resources. But in terms of a foundational, to establish some norms and basic work practices and easy wins, if you will, if there are such things in patient safety. For the ambulatory environment I think it is adaptation of very successful program team steps from the hospital environment to the ambulatory setting. And that’s underway right now.

Team steps is absolutely wonderful but I don’t think too many patients would say that their hospital care is very well coordinated either. I think what most patients would like to see would be somebody in charge in the way the primary care physician was, theoretically, once in charge, creating someone that they could go to with problems and concerns and who can give them some sort of authoritative advice on what to do.

So, recognizing that a lot of people have their cards up, can you just say a couple of things about what it is that you hear from patients that you interact with about—how does that translate? Do people talk about care coordination? Do they talk about specific types of experiences or—

Well, it’s the multiplicity of specialists and having to make all the arrangements, the fact that the providers are not talking to each other.

Got it.

That’s the biggest thing that people find very hard to wrap their minds around that that could really be the case.

Yeah. Thanks.

Dr. Selker.

This is actually kind of follow-on to the coordination. You were looking at the safety issues pertaining to hand-offs. And by that I’m thinking specifically of the hand-offs from the community to the hospital and to the setting, the ambulatory setting as well—and also, going out of the hospital back to the VNA care and so forth. And actually it kind of reminds us the difference between medical error and patient safety, it’s so chaotic. I mean it is not really—none of it is really medical error. It is just completely unsafe because the hand-offs are so random.

And one of the things is that the systems for collecting data upon which you must build understanding of safety don’t exist. If you have a vertically integrated health system, which has relationships up and down, from the offices to the hospital and then out to their own VNAs, then perhaps. But communities are terribly served by the circumstances that they are in now.

There are multiple hospitals, multiple VNAs, multiple all sorts of rehab and all kinds of facilities, none of which have a real, integrated, public hand-off systems or, also, coming in. I mean sometimes people that you would think would focus—well, door to balloon time for angioplasty. But even that is hard to get a whole city to work together. So it seems to me that this is one of those circumstances where—and I don’t think there is much research really being going on in that area, too, in that hand-off.

I just think it’s a completely missed opportunity to improve care at low cost. Because when bad things happen, people go out—you know all the stories when people go out—you know all the stories about people not having the right pills or coming in to the wrong hospital and not knowing that they already had information there. Those hand-offs I think, between the systems, it’s just terrible right now.

Absolutely. I think just a brief response to that would be, sort of your comments and—your comment sort of reminds me of Dr. Siegel’s comment and the potential benefit. I think it is, by no means that absolute solution. But I think situations where the outpatient setting is organizationally more associated with inpatient care in hospitals, at least offers the potential for some infrastructure and better coordination. Again, that won’t work in all places. I think that’s at least a potential basis.

In fact, I mean I think that until we have a universal health care system, single payer. And so I think we have to realize this is a pluralistic system. So, rather than kind of waiting for cartels to develop or ACOs that take over complete area, I think we really need to focus on the public’s need to address between facility, between entity hand-off.

Thank you. Dr. McElwee.

So given all the cards that are up, I just want to make a very quick comment. And if you want to follow-up off line, I would be happy to do that. But it has to do with communication. So, in the deck there’s, you know, some examples of physician nurse communication and communication from patients back to providers. But I really don’t see anything about the communication from providers to patients. I just wonder if you’ve thought about that as an important aspect of this.

I guess I would just as one prominent example point back to the Questions are the Answer Campaign. And that initiative is absolutely focused on the patient and provider communication. I’m not sure if that’s addressing your question. Maybe you could say a little bit more about—

When we’ve talked to providers about how they communicate with patients about drug therapy and about things like side effects and commitment to therapy and adherence—we find that a lot of them really don’t know how to have that conversation with patients. And so now there are—there are some various models out there like motivational interviewing. There’s an empowerment model that some of the diabetes treatment centers are using. There’s transtheoretical model.

And we don’t really have a lot of evidence, good evidence about which one is best and who they work and those kinds of things. But it seems like, you know, the common theme across all of them is that we need to move from this more paternalistic approach that we used to have to a more patient-driven approach.

Definitely. I think with that additional explanation, I think what you describe, actually, spans the entire Agency’s work in terms of some of the comparative effectiveness outreach that is happening as well. Dr. David Meyers, who is a prevention and care management, or that portfolio is in his area—I think a lot of the—one specific example, risk communication around, you know, patients’ decisions related to clinical, preventative services. So I think, clearly what you describe as an issue affects patient safety but it is actually much broader.

So I think that work exists in various pockets but maybe we could do better by pulling that together. I agree.

Dr. Spitzer.

It was a good lead in to what I wanted to say. Because I think one of the real deficiencies that I’ve personally experienced throughout my career in medicine has to do inability of the physician and the patient, especially from the physician’s side, to match up the patient’s understanding of what is being told to them. And I’ve had this in so many different ways. For example, I’ve had a highly educated family, a professor of law at the University of Pennsylvania, mother a sociology professor who fed their child milk for a year and a half as the only food that this child took, thinking that milk was the perfect food. The child came with a hemoglobin of 2.

I’ve had young mothers where I’ve spent huge amounts of time trying to explain to them the nature of their child’s illness in as simple a set of terms as I possibly can. And yet, understanding of anything biological and medical was so limited that there was no way that they were possibly going to be able to do the care that would be required of them afterward, leaving open a huge number of safety considerations—to the point where you wonder if that child can be sent home to that particular home environment because of the limitations of understanding of the family.

I’ve seen it in—going back to my father-in-law again—when we went to the cardiologist a few months ago, I thought the cardiologist, again, my father-in-law is very bright, I thought the cardiologist gave a beautiful explanation of what he thought my father-in-law’s problem was, what my father-in-law needed to do, the medication that he had to use, how much he should take, etcetera.

When we walked out—I was sitting there with him as the cardiologist explained this. When we walked out to the waiting room where my mother-in-law was waiting for us to come out, she asked my father-in-law, “Well, what did he say?” And my father-in-law said, “I don't know. He spoke too fast.” Well, my father-in-law forgot to put his hearing aid in that day so he didn’t hear anything that the cardiologist said.

And so this communication gap seems to exist between provider and patient, is a huge one that I think is probably one of the most fertile areas for errors and patient safety issues. And always needs to be, I think, at the forefront of these discussions.

Well said. Thank you. Ms. Darling

So I wasn’t going to say anything about that but what you said was so important, it seems to me. And one solution in the short term, at least is, to the extent we can figure out how to do it is written instruction. I know at different points when I’ve had a test or somebody has been in a hospital, usually it’s an old Xerox copy. I mean it’s just so, like something on a—what was that old machine you used to have in high school?

Mimeograph.

I mean literally it would be a copy of a mimeograph but, you know, if you were pregnant or something, you would walk out the door and they would hand you this stuff. And you’d go back to it many, many times because it is hard, even under the optimal circumstances to remember these things. So I think more work, to your point, on how do we do that? Is it possible—it’s just like the checklist idea.

So all the relatively common conditions for which there might be advice that you could ideally just make the changes in it, maybe handwriting, like four times a day instead of three times a day, stuff like that. So more work on that. But the point I was going to mention was, I love the safety tools, the guide to using them. I would say, this is, we talked—I don't know if you were here earlier when we talked about getting the patient engaged, not as a substitute for the physician behavior changes but as a supplement and a compliment.

 

The only way we are actually going to deal with these complex problems is everybody is trying to take whatever step he or she can have. So if we have more of these, here’s what could be unsafe if you do or don’t do certain things on every topic you could possibly have. And doing them always in collaboration with the relevant physician groups so nobody thinks, no matter what it is, it’s not the government tell you what to do. It’s the American Medical Association working with the American Board of this, that and the other, and your friendly Agency for Health care Research and Quality work together to give you these safety tool kits, essentially.

And if it’s done once, ideally, and translated in a few instances and then made available to everybody so you can download them at your office—or you can even tell the patients. You can say, you’ve got this. Now they won’t all have access to the Web but more and more will. And I’ll make one final point, which is that, at least in the employer world I’m living in, they are moving almost everything to an app of some sort. And while it may be true that lots of people over 75 aren’t into that world yet, more and more, every day the person who turns 65 is somebody who may have already been working with a computer for 20 years.

And we will have more and more people who will want to say, if their doctor tells them they have this, and there is an app for that, that has lots of good advice, that tells you, “If you’ve been diagnosed with this condition or your doctor has said that you have this problem, this is the app.” You go one central app, which tells you, you just click on that and basically it’s there. And you could even imagine for things like pregnancy or where somebody needs to take medication on a regular basis, you build into the app an alert system, to you, to remind you to do it or to take it.

So it seems to me that’s the direction that AHRQ can head with safety to develop tools—

And make it interactive.

And make it interactive. I’m sure there are many, many details, which I’m not touching on. But those directions, instead of thinking of the world as this kind of passive world, is a much more interactive world.

Yes. I just want to add something. I think that the app idea is a very good on. And it’s one that I think probably could be tailored more ideally to a variety of different patient need situations. The problem that I’ve had – in addition to my medical writing, I’ve done a lot of writing for parents directly. And one of the difficulties you have in trying to write instructions for parents to try to avoid errors is, what level do you direct it at?

We’ve sort of been taught that it should be at about a sixth grade level of writing, which is fine for a lot of people. But if I hand that to a highly educated family, they are often offended by it. So I very much like this idea of trying to produce some online system that could be expanded based on the educational background of the individuals using it. I think that just handing people pieces of paper, again is—you feel like you are doing something better. They have something permanent. But it doesn’t always work, ideally, for every situation. And, again, it tends to very often misjudge the educational level of the family.

I would say just very briefly, thank you for both your comments. I think I would refer you back to the Questions are the Answer. And that experience and sort of, I guess, consulting on that project, the credit really goes to our Office of Communications and Knowledge Transfer who played a really strong role in developing those resources.

And one of the most interesting components of that work is, I think, the story that come out from both providers and patients. And that’s definitely a key feature of that initiative is sort of equal time, if you will, and not only equal time but what’s the interface and what are the issues. And what we found in doing that work is that, really, no scripts were necessary. A lot of the key principals and components, and actually where I think the Agency tries to situate itself is very specific, practical guidelines about what can patients do what can providers do. That naturally came out in some of the discussions, things as simple as writing down questions ahead of time, in some cases ahead of time, before an appointment—a pretty novel thought to have homework before your doctor’s office, not necessarily a traditional way of thinking about medical care.

But that came through naturally again, both from providers and patients and very specific scenarios and characterizations of how that simple task has a strong role and specific role in changing the course of their treatment and avoiding errors. So it’s really an easy way to digest these kinds of concepts is through the mouths of patients and providers. So I’d refer you back with those because it’s interesting to see.

Dr. Thompson.

Well, this relates to medications and maybe a different definition for a medication error. So, number one is, if you are going to do the pharmacies, one area—you know, the NCPDP has standards for DUR edits and overrides. I’ve never actually seen the pharmacies being measured for the amount of overrides they do. In other words, if Viagra comes up and it’s a female, then they have to override a gender edit. Or a drug – drug interaction is actually an edit that is actually centralized across the United States. But what we find is there is huge differentiation between pharmacies that override those edits, and then just push the drugs out. And that’s an easy one because is it all automated. It is all centralized.

But another one that Carolyn knows that I’m interested in is too much, too many, too much, too old. You know, instead of a drug- drug interaction or a drug - gender interaction, you know, could we start establishing, how many physicians are prescribing two times the FDA dose of a narcotic. Or, you know your practice is two standard deviations in the prescribing of anti-psychotics to five year olds or less, you know, and those types of things.

So the FDA has those recommendations. And so it would be interesting to put both, not only age but dose standards and then, start feeding back. Because right now, Senator Grassley, HHS, and others are asking us to implement decision aids for prescribing of anti-psychotics to foster care. And so this is a nice interaction between what AHRQ does with decision aids. How do you inform the families before the prescription ever gets written and actually put out?

So it’s a huge issue with narcotics. I think it is the number one death issue now over and above age and motor vehicle. But handing out 10,000 mg of morphine equivalent in one script is not considered a red flag. That’s my highest in my state, 10,000 mg of morphine a day to one client. Well, yeah, but somebody said it’s fine. And somebody said it is fine for a one year old on anti-psychotics. So it’s something to think about. This happens routinely. It is not about a drug – drug interaction but some red flags on some, what everybody sort of grimaces.

But I’ll tell you, I’ve had to have the fight about where do you draw the line on age when it comes to antipsychotics.

Thank you. Very helpful.

Dr. Dembrey?

So in high priority topic areas, I’m sure you have already thought about this. It’s what’s near and dear to my heart, which is health care associated infections, which is a reminder to everybody that HAI doesn’t stand for hospital acquired infections, but health care associated infections. And I reiterate—I think—I don’t remember who said it across the table. I usually say, if you think things are bad in the hospital, it’s truly the Wild, Wild West out there.

And when I look at, go out to, well, the doctor’s offices that we’ve bought and infusion centers and all these places where there are a lot of procedures going on, it is again this mindset that it’s somehow the physical structure of the hospital that’s dangerous, it’s the care that we are providing, which doesn’t matter where you provide it. But that’s really what the risk is. So, when you are talking about ambulatory, there is very low risk, which I would argue is probably the doctor’s office, the general visit, etcetera. That is not a no-risk but it is a low risk.

All the way up to pretty high risk, like ambulatory surgery centers, renal dialysis and I would put home care as a medium risk, an area we’ve not addressed a lot. And as we are pushing more and more of this risky care outside the hospital and into the community, we really don’t know what’s going on. We have many groups of health care providers who don’t see the risk. I don't know if it’s just because they think they are outside the hospital or it’s too difficult to address. I think one of the barriers there is going to be this whole culture thing of, it’s not in hospital so it’s not risky.

I think for ambulatory surgery centers, it’s what’s kind of happening now, and you certainly know this, CMS is cracking down—but with regulation, you don’t necessarily always change practice. The way you will end up changing practice is changing the mindset and the culture and it gets back into med recon, communication, all those kinds of pieces. I think it poses some unique challenges. But at the same time, it’s kind of through the same process.

I think HAIs are really big in the non-hospital setting. I would certainly like to see that they get addressed. They provide, certainly, a big challenge and surveillance in not necessarily required to address that.

So, really quickly, in addition to the ambulatory surgery project that Jim Battles described, which is actually funded out of the HAI portion of the Patient Safety Portfolio, just a quick data point—more than one half the funding that we have in patient safety is now focused on health care associated infections, health care not hospital. Dr. Jim Kleeman (?) in the audience here leads that work. And so, in addition to ambulatory surgery, we have a handful of projects focused on renal dialysis in that specific setting.

Jim, is there anything else you would want to add about health care associated infections?

Just to say that the ambulatory arena is an important focus for our interest in eradicating health care associated infections. We have several grants in that area. We have announcements that evoke our interest in ambulatory care. So you message is being heard loud and clear. And we also regard the issue as not the physical setting but the culture and the approach to various procedures and the communication between patients and physicians.

As Jim Battles has mentioned, we have that program that is now going forward to adapt the comprehensive, unit based safety program, CUSP, for ambulatory surgery. And it tries to encompass all of the issues that have been raised, communication and team work and a checklist of interventions that are evidence based. So we think that we’re trying to cover those bases. But your message is a very important one and we are hearing it very loudly.

Thank you, Dr. Dembrey. Dr. O’Neal?

Yes. My point I think has been already made by a number of individuals, but it focuses in on cultural competencies. And something that was brought up earlier, that a heavy duty amount of attention has been focused in that particular area. And so it’s a point to re-emphasize but also be even a question. And that is, how much has been focused in the ambulatory care setting on cultural competency communications—because we talk about patient to provider communications and provider to provider communications. What is being done there more specifically, or should I say, I would suggest to be more specific with regard to those issues and be sensitive to who is doing the communication, who is receiving the communication as was talked about over here several times.

And the application therein may be utilizing some of the apps, as was brought up. But not everybody has an app. Not everybody has an particular understanding that is culturally sensitive with regard to an application. So I think you understand what I’m saying.

Absolutely. And I think I would say that what we find in the Patient Safety Portfolio and, in fact, Agency-wide I think—in addition to being cross-cutting issue, where every effort potentially has some component that is—for us it is more health literacy and what is the role of the patient’s understanding as it bears on patient safety issues. So I guess I would just simply say, it’s a cross-cutting issue and then we do have some specific efforts that are very targeted. And the effort is wholly focused on health literacy and addressing that specifically.

 

I don’t have a roll-up, if you will, or a specific list of projects. But that’s something we can work on. Since in many cases it’s an integral component of a project but it may not be apparent at the high level, you know, summary description of a project. It may take some work for us to sort of establish some definition in terms of, you know, is this a health literacy project or not or other culturally sensitive kinds of factors.

I think it is something we need to work on in terms of analysis and identifying and maybe bundling sets of projects, to identify then with that characteristic. I hope that makes sense.

Ms. Crowley.

Thank you for you report. I had a high priority topic area to suggest or become aware of. And that is, that either promulgating or developing the evidence for what procedures are safe in what environments. So it seems to me as a delivery system expert that it’s pretty casual. You know, we used to admit everybody for cardiac CAS (?) and then there was a lot of payer pressure. And eventually, now we admit almost nobody to do that work. It seems very case-by-case, community by community, something will drift into an interventional procedure, drifts into the outpatient setting without, to my knowledge, much of risk assessment or a way to make that decision.

It is often very, I think, very payment driven. And like others have said, very sophisticated, interventional procedures are being done outside of hospital settings, off hospital campuses even beyond AMB-SURG centers, biopsies, laser work, all kinds of, infusions, all kinds of settings with virtually no back-up. So it’s fine if it all goes all right. But if you hang chemotherapy in the home and have a problem—it’s done everywhere.

But what are you going to do? None of us could actually help if something went wrong. There is nothing else in the house to help you if something goes wrong. So, what are the—are there any decision making tools for what gets done to whom, where. And if that evidence exists, let’s get it out and promulgate it.

I would say really quickly to that, that I think where we are at is we have, based on prior—the field, I should say, the field—based on the experience of prior research we have methodologies that could be applied to answer those questions. One question I would have is whether the research could keep up with the shifts in care. But I think, just to specifically put some, probably too technical names to these-- probabilistic risk assessment, that was sort of a hallmark of a funding opportunity that we had not too long ago.

And really, what that simply does is looks at key points of risk throughout a full care scenario. So I think some might be familiar with failure mode effects analysis. So I think those kinds of methodologies and the experience in prior work is something that could be applied to the questions you are asking.

So, marry the two. If we could use and existing database to identify hospital admissions that were subsequent to an ambulatory event, that would tell us where the most confusion is or the most risk is in the ambulatory environment.

Definitely. No. Thank you for that.

Dr. Johnson.

Dr. Brady, thanks very much for the presentation. And, actually, the discussion here has been terrific. So I’m going to touch on a couple of the points that were made. And I was keyed up very well in the last two, regarding sort of care being pushed further and further away from the hospital. I’m in the home health setting. So we’re the last stop in many cases. And based on the news, you can easily suggest that home health is the Wild West.

I’d like to believe in our organization, we have 70 offices, Wyatt Earp’s in every office. We pay very, very close attention to patient safety. And, in fact, I think it’s—the risk and the worry that we have in home health, I worked in hospital settings, is even higher. Because not only do you have the issues with medication and all the other things, you’ve got throw rugs, you’ve got small dogs, you’ve got all these other risks that you don’t have in the hospital setting. And you are there on your own.

So a couple of recommendations—I was really excited to see home health included in your definition of ambulatory care. What I might suggest is, either we redefine ambulatory care or we call it patient safety in post-acute care. Because with the Accountable Care Act and everything, care is moving into the post-acute setting, if for no other reasons than it is less expensive. And particularly in the home because the patient I’m taking care of is covering room and board.

So I guess my point there is, from speaking on behalf of my organization, which, if we were a hospital today, we would be a 9,000 bed facility. That’s how many patients we are taking care of today. The average number of medications that that population is taking today, is almost nine meds. So we know a lot about our populations and we know the risks that we are under. But looking at how do we get better at that is something we think about all the time.

We have to report adverse events, wound care infections, urinary tract infections, falls, near falls—you know, we get our outcomes based quality monitoring, OBQM reports or adverse event reports. So CMS monitors it very, very closely. But it’s, I don’t want to say it’s an afterthought, but it feels that way. And I’m not sure that the industry has reached out to say, “We could use help.” But I’m saying as care is moving in the direction, as we are delivering care, I think very high level care in that area, every point that people have made are really good points—how do we continue to do it, the right care, and do it safely?

Because the other piece that I would add is, our organization, we have multiple lines of business. I’m in the Medicare certified home health, you know, nursing, PTOT, short-term, episodic. But our largest practice is high tech pediatrics in the home. I think we are the largest provider of high tech pediatrics. So it’s trachs. It’s vents. It’s very highly acute patients. And we do it well. I’m biased but we will be happy to share the data. I think we do it really, really well.

So I would be interested. What are the right places to deliver care? The hospital isn’t necessarily the best case, not the people we are suggesting that. And sometimes with hospital acquired infections it may be the worst place. But I guess the point that I would like to make is that if we know a lot about our clients and, I think, working with AHRQ and others, to pay the kind of attention that we’ve been paying to hospitals, to the post-acute setting where care is moving, I think would be a really good investment of time and energy. Not taking away from the hospitals but just beginning to move our learning into those other environments as quickly as we can.

Sure.

Thank you.

Really quick, a tool that is—a resource, rather, a report that is absolutely in line with what you are describing that was written a few months ago. We worked with the National Academy of Sciences on an review of home health , in particular, human factors issues—

I’m familiar with it.

You know that.

It’s a nice report.

For the rest of the group—and it also included the technology issues. We worked with our colleagues in health information technology to develop that. And so I think it’s at least a drop in the bucket towards addressing the issues that you describe.

In all fairness, I would say it is more than a drop in the bucket. And I didn’t thank you for it because it really was very helpful.

I’m sorry Dr. Kerm (?) Hendrickson, my colleague who was really the project officer on that is not here to hear that. So thank you. And one other quick, if I may Dr. Siegel, a quick point that I think many of the members touched on, and one of my colleagues was helpful in reminding me, we actually have an Agency Website focused on health literacy and cultural competency. I think that does some of what Newell was trying to describe that we need to maybe do a little more specifically for patient safety.

But that kind of cut, if you will, has been done for the Agency. And we can get that to you, I think through Jamie, get that site to you, that link.

Go ahead.

Just to add one additional point on a bit of conversation that we had regarding making sure the patient understands what we are asking them to do—what I didn’t hear in the conversation, but I know AHRQ, the whole concept of Teach Back. We spend time so much time on what are we teaching, how are saying it an on what level are we delivering it, without really saying, did they understand it. So I think our opportunity, we’ve known this is to focus on learning and, more importantly, adult learning, which means, you can’t just say it to them once.

In the Teach Back methodology we’ve hard-wired it into our processes particularly around disease management using zone tools. Because I would argue if the patient doesn’t know that if they’ve gained three to five pounds with heart failure, if they don’t recognize that as a problem, that’s a patient safety issue. But I don’t live at the house with them. So how do we make sure that they understand that? To me that’s a step in the direction of better patient safety. It is just food for thought.

Dr. [01:14:09]

Just a quick comment. I think HHRSA (?) just recently came out with a videotape on how to communicate to low literacy patients. That may be what you were referring to. But it’s actually a great video

I’m going to ask before we get to our last questions, is there anybody on the, members on the phone who have a question or comment? Hearing none, Dr. Hoven.

Yes, thank you very much. I just wanted to—by the way, this has been a fabulous presentation and discussion. I think I was one of the people in the initial queue who suggested this as a topic for discussion. But I want to just pose a reminder to everybody around this table because I think all of us are going to have to be engaged going forward. As we talk about this issues on outpatient safety, we’re talking. And the common themes I’ve been hearing are care coordination , appropriate transitions in care, the whole issue around home care and all the elements.

This requires manpower. It requires a workforce change. It’s going to require personnel because no one person can do this. And, in fact, this is going to cost money. I think it is probably going to be the result of some upfront expenditures in order to provide long-term benefits, cost savings, and quality outcomes. And so that we are going to have to put a little bit more money out there. The dollar needs to follow the patient.

You know, this care that we have been providing has been so silo'ed that we, from time-to-time lose track of that. But I think that this discussion today has really put its arms around some of the issues. But this is going to be a funding question. And in order to do this work, the funding streams are going to have to be there. But thank you, again. This has been very informative.

Ms. Crowley, did you have another question?

No. Just a slow learner.

All right. We are at the point of public comment. And we have no one signed up for public comment currently. Is there anyone who is here who wishes to make public comment? Okay. Seeing none—I should first, also—Dr. Brady, thank you very much. It was a great presentation. I appreciate it—and for an engaging in discussion with us.

So we are coming towards the end of the day. And it is now time for our wrap and for our final input. And I think at this point what we generally do is ask for your final commentary on the things you have heard today and also your suggestions for areas where you think we should, given what we have heard today and in the past be providing input to the Agency for, on—and also, along the same lines, topics for future meetings. So I would ask you to think about that over the next few minutes.

I’m going to key off with two comments about today’s proceedings. First, I want to thank Carolyn and her staff for posing a series of questions to us at the end of each presentation. I don’t think that has always been the practice before. And I think it does really help us to sharpen our input and hopefully give you feedback that is of use to you and the Agency, because that is what we are here for. So I think that was a very good strategy to employ.

The second thing I wanted to mention is a little longer. And this may or may not work. And so I leave that to you. You know, clearly all health care is local in America, either in a community or a state, perhaps too much so and we can debate that. And I think the structure of health reform is going to continue to do that in large part, to a great degree. When I listened to your report this morning, I was struck by the richness of work that you do, and work that is not top down, work that provides tools to people at a state level or at a community level to actually build that infrastructure for improvement that you references at the very beginning, an infrastructure that some communities seem to develop and some do not.

And I wonder is at some point it would be worthwhile for us to think, not so much in terms of different programs that AHRQ has but to take a community in America or a state in America and to actually look at how AHRQ is making a difference in building that infrastructure in that state—whether that is through CVEs, MONAHRQ, PSOs, the Medicaid Medical Directors Learning Network, the design of public reports, work that Judy Heberg (?) has done. Because I suspect that there are communities or states in America where you are impacting care in a multidimensional fashion. And it would be good to see how that is happening, to fully understand the richness, so perhaps how some of the infrastructure is integrating that.

(?) Fantastic.

So it is just something for you to think about. And it could be Cleveland. It could be Louisiana. I don't know. And I leave that to you; but just a thought for the future.

So with that said, I will turn to our members to see if they have any closing comments or thoughts for us. Dr. Johnson, please.

And I’ll be brief. I’m just going to echo your comment. This is only my second meeting so I have a sample size of two. Any statistician will tell you that the power is not terrific. [Laughter] But what I felt like I got out of this meeting versus the last meeting was an opportunity to contribute, much more so than the previous meeting—based on how the meeting was structured. It was noticeably different to me. And I’m walking away feeling like I got a better sense of the people that I’m on a team with but also a lot of additional knowledge. And hopefully, the discussion was helpful to AHRQ and the team there. But for me this was very fulfilling. So I appreciate that. So, thank you.

Ms. Darling.

So I have two things. One, and I’m building on your last point and I would add—the greater the geographic dispersion for the examples, the better. Every state, no matter how small or how unpopulated has two senators [Laughter] so geographic dispersion really works. But the point I would just make is to kind of remind everybody looking forward—first, most payers already believe strongly that they pay way too much for current health care. So they are not on a path. Maybe it’s justified. Maybe it’s even reasonable to incrementally spend more. In fact, they go in the opposite direction.

But at the same time, consumers, patients, taxpayers, others who are on the other paying side, paying the cost sharing or the contribution if it is employers or the taxes if it’s Medicare—will be paying much more when we are thinking about—if you just look at the percentage of the total spend every year now that consumers are paying, it’s increased. It’s actually doubled, just in the last three or four years.

So, as we are thinking about all of these things, there’s going to be an effect on behavior. Everybody’s behavior, consumers, patients, providers, institutions that are dealing with them because of that—so as we think about what we need to do, we need to fast forward some of those things that recognize that difference. And it means that for some people who don’t have the resources, they won’t do what they need to do.

So how can we figure out design that says, if you participate in the disease management program or the care management or you do what you are supposed to do, we will pay for all your cost sharing, things like that because that is the direction we are headed, whether you think that is a good idea or not. That is where we are going. So that is what I would leave you with.

Thank you. Thoughts? Dr. Selker.

Two things that come to mind for maybe next time. One is, as Ardis just mentioned, the manpower situation for all this assessment is really thin. And I wonder if maybe next time as a topic you might talk a little bit about that. I raised the question about training and development. But career development in this area, I don’t have a big picture of it and I think it would be worth having that as one of the presentations.

The other thing is, obviously, this is a small agency relative to many other entities out there. And maybe more about the partnering opportunities, to the extent it would be positive and it would be helpful for us to give any input, such as with the Innovation Center or CMS or Pecori (?), things where there’s real synergies and efforts and resources. Obviously there is a lot of that going on but maybe even focusing on some of those that would be kind of the lowest hanging fruit that maybe we could be of some use.

I’m going—Doctor. Actually, I’m going to go from left to right. Dr. O’Neal and then I will move to the right.

Yes. I was very, very impressed with this particular meeting, as I’ve been with a number of the others. I think I look to my right, this is my second to last meeting. So I’ve had a lot of time to absorb and learn from participating with colleagues around the table. The information that was shared with regard to cost up front, I think is monumental. Obviously, I think that’s an understatement given everything else that we are seeing going on right now politically as well as realistically.

The one thing I was talking with Dr. Hoven about relative to health information technology is that maybe one of the things that could be standardized in HIT systems would be identifying medication therapy management as a—or better said, compliance and adherence as a vital sign. We have vital signs for everything else—why can’t we put that in, make it mandatory? If you are going to have an HIT system or whatever you want to call it, claim system, whatever, that needs to be in that system or you don’t use it.

Some systems use it in other places such as in Kentucky where I trained and where Dr. Hoven is. But I can’t say that that’s true across the country. And the vendors therein may not necessarily look at it as an important issue but to begin to rein in some of these particular costs, identify, did the patient actually get a medication? How many times did they get it filled, at least have a checkmark so we can begin to identify, yes it might increase a little bit with regard to, quote – unquote cost. But we have to bring the ultimate cost down to get to—if we got adherence rates at no greater than 50 percent for treating high blood pressure, I think that is dismal. For schizophrenia and some mental disorders 20 percent, 30 percent, those are horrible.

But make it mandatory with regard to a way to help us bring down ultimate costs in the long run.

Dr. Thompson.

I just want to—Dr. Hoven’s thing around the workforce, I think that would be interesting to hear. And, in addition to, sort of what are we doing to understand how case management—I mean the answer to everything is case management but yet we don’t really measure case management or understand what the—or how to enhance it. I always quip that, you know, in Medicaid we’ve got 3.8 case managers for every Medicaid client. If you think of our children’s department, our juvenile department, our mental health department, you know, the managed care—you know, the hospital has got a case manager.

But yet we don’t sort of roll up and are all these case managers, like we are talking about with physicians talking to each other? Are they standardizing their treatment plans? Are they working with the physicians? Is the mental health and the substance abuse and medical case manager, you know, working together. So, in addition to, you know, sort of work force, what does it take because it always just—the standard answer is just more case management.

And quite frankly, when I’ve looked at the literature, it’s pretty wanting for effectiveness. And so it would be interesting to hear where is the literature wanting and who can we fill it out a little bit more.

Dr. Schneider?

So also with an N of eight, I want to echo—I think the format and the pace of today was great. And the amount of dialogue was really terrific. And I also wanted to just echo what Dr. Selker said. It kind of harkened back to the first time during my tenure that we really had a prolonged presentation with a lot of discourse around the rollout of the National Quality Strategy. And I’d like to see that come back maybe for kind of a follow-up visit.

I actually stole a lot of those slides and have been using them with a little inside joke on the slide says, “Proprietary and confidential for the client,” the client being the US of A. [Laughter] So I’d love to hear back at the appropriate time, a follow-up on that. And with a multi-agency, you know, really where there are synergies, I think that’s a great opportunity for us to be good advocates [simultaneous conversation] the resources.

I think the NQS goes through an annual revision, right? Is that correct? National Quality Strategy?

Well we do the strategy but they give us feedback all along the way. And then their recommendations are annual.

Annually updated. Okay. There is some cycle to this, I think. That makes a lot of sense. Anyone else? Oh, sorry. I must have a neurologic problem here.

I just want to also say a very heartfelt thanks for the session today and echo everyone’s value for it. One of the things that is continuing to be frustrating for me is figuring out ways to create some operational strategies to engage patients as partners, as full partners in care. And a couple of concept that in the rheumatoid arthritis community that we’ve really been struggling with is the definition of inadequate response or treatment failure.

And those two concepts in relation to switching patients to different biologic drugs, which are extremely expensive—the longitudinal care or the longitudinal period of time for most patients with a biologic drug is less than four years. And the reasons for switching are very vague. And it’s often engagement of a patient in a conversation about are they getting the same, you know, perhaps, initial big bang for their buck that they got years ago when they first started the biologic. And it’s a very subtle pattern of response after the initial benefit.

So often patients are switched to a different drug, potentially a more expensive drug, and the risk for returning to the original biologic is that they may risk losing the initial response, the benefit they got at the initial time of therapy. So I think the concept of treatment failure and in adequate response really involves a lot of patient determination and conversations with providers. The patients get upset with either the delivery method of the drug or the fact that they’re engaged in perhaps another comorbidity that seemingly effects that particular response—and so they bargain with the provider to switch and try something new.

And so, we just don’t have a good way of determining what inadequate response is and what treatment failure really is. And I’m not sure there is an answer to that. It’s definitely confounding rheumatology care.

All right. I think—oh, Dr. Atkins.

I also enjoyed all the discussion time. So one issue that I think we are struggling with, I think all research agencies struggle with is how to make are research more timely and partnered And I’m thinking that we could—there are a number of programs that deal with sort of trying to get closer connections with partners at upfront stage to speed implementation.

And I think it would be helpful to, since all the people around this table are sort of potential partners, to hear about what the Agency is doing and get input into other things. I think if we don’t solve the long delay it takes between an issue arising and getting research done and disseminated, if we can’t figure out how to shorten that time and get the research more aligned up front, we are always going to be chasing our tail in terms of show that we are relevant.

I think we have come to the end. Carolyn, do you want to make any closing comments for us?

I would simply say my hand is a little tired from writing down a lot of your very thoughtful comments. So thank you for that. I thought today’s discussion was terrific. And it is no small tribute, to be quite honest, to Jamie Zimmerman and Karen Brooks—we actually set an internal record, not that I share this very often, for when we were ready with everything for this particular meeting. There have been meetings in the past when Thursday night we were running around like crazy. And most of this was done early in the week. So that is really a salute to the magnificent efforts and also to Karen Migdale who helped polish the format on slides and so forth.

So please travel safe. To be continued. And I’m counting the days to the next time, which will, of course, be three days after the election. So, interesting times. We are looking into having the next meeting downtown. That’s always slightly dicey because of competing demand for that one room. But we will keep you posted.

Hopefully, it won’t be another Friday the 13^th.

No. We’ve already hit two this year. So I think we are done for now.

Everything will become clear by then. What’s that Helen?

I said, if it doesn’t have to be in a public—I mean it could be public in the sense.

Yes.

Our office has a conference room.

Well, we’ll consider that. Thank you very much, Helen.

Well, thank you, Carolyn. I also want to thank Dr. Meyers and Dr. Cohen for their presentations earlier. I didn’t get a chance to do that. But it was great and thanks to all the staff. And we will see you November 9^th.

Great