9UNP0169SD_Mike_Grasmick_WordPress

- Hi, welcome everybody. My name is Tom Zinnen. I work at the Biotechnology Center at the UW-Madison. And I also work for UW Extension Cooperative Extension. Welcome to the Plato Frontiers and Life Sciences Series, which is organized by PLATO, the Participatory Learning and Teaching Organization at UW-Madison. Today, I'm delighted to introduce to you Mike Grasmick, who's been a friend of mine since 1982 when we were both in graduate school. He's now working for the School of Medicine and Public Health, the Department of Family Medicine, which some of you may know was recently ranked the third best department of family medicine in the country by U.S. News and World Report. So Wisconsin is a very good place to have a department of family medicine that ranks that high. He's going to be talking about translational research, and how you speed discoveries from the lab, to the clinic, and to the home. 

It's going to be a pretty interesting thing. I've got a personal story. My dad has an abscess the size of California on his right arm right now. And I was home this weekend. The nurse said, well, what we should do is actually have a jelly covering on it, instead of a gauze covering, but the doctors that work with my dad are used to having-- This is what they were taught, to have the gauze. The jelly is new. So, right there for me, was an example of the kind of work that Mike and his colleagues are working on. How do you get people to speed up the application of stuff that's already out there. And so for me, I'm looking forward to hearing what Mike has to say. Please join me in welcoming Mike Grasmick to PLATO. 
(applause)

- Thank you. And thank you, Tom, for a nice introduction. As Tom said, I'm with the Department of Family Medicine. And Tom gave me a title, which was great. That was like 50% of my total effort was taken care of by Tom. But I put a question mark by this, because we don't have data that we're speeding things up. But through what's called practice-based research networks, that's a connection between bench top and bedside with the patient. We've been funded to do just that. 

So the jury is still out. But I hope to convince you through some stories that we're making progress on how to do that. So, I'd like to start out today with the discussion of what I call the old research model, and then move into what's called the NIH, National Institutes of Health's, road map. The University of Wisconsin-- and I apologize for all these acronyms. I get crazy with acronyms. I apologize, there's going to be several acronyms today. But ICTR stands for the Institute of Clinical Translational Research. That's a real big deal right now in the School of Medicine and Public Health. And then I'd like to talk about WREN as a PBRN, again that's Practice Based Research Network, and how that kind of fits into the new model. I'd like to end with a couple, three current projects, some are more research focused, some are more quality improvement focused. 

But, before I go to the next slide, I'm reminded that I want to keep this really informal. So if I say something, you don't understand, or if you have a question about anything, please stop me. I think I've said, Wisconsin Research and Education Network, so-called WREN is a practice based research network. And essentially, what we are all trying to do in the field of medical research is to look at new interventions or discoveries and direct those to the improvement or extension of life or improved quality of life. It's paramount that in this direction, we need to have safe and tested methods. That it be economical, effective, and that we get this launched and out as quickly as possible. So I mentioned the old research model. The old research model, you can think of as, I know you've all heard this before, as silos. And, essentially, what that is, is using an NIH model, back in the day, they had cardiovascular, diabetes, cancer, and most recently genomics, all headed up by, not the entire group headed up, but the important part about this is that for any one division there might be multiple, what's called, principal investigators that lead the project. As discoveries and diseases get more and more complicated in interacting with one another, this model just wasn't working. 

Basically, the way information or dissemination flowed out of this model, is that depending on what specific discipline you're in, you might present at professional meetings, or write a journal article. Things might happen in the popular press, and guidelines might be developed. Over time, a primary care practice might adapt what was found, maybe two, maybe three and, so on. This really depends on the type of research. Some things, like human papilloma virus, that whole development and dissemination went rather fast. There are other, more simple things that get real slowed down. But essentially, this passes or propagates to other clinics by word of mouth, professional associations, publications, etc., before it's widespread adopted. This whole process-- This again, there's no hard data around this, but people in the field estimate that this process to widespread adoption of the interventions takes 17 years. A long time. 

So, "What?" 17 years, like I said. All these silos, and people doing stuff, and this, that, and the other. That's really complicated. It's just taking way too long. The Institute of Medicine in 2002 said this, that I find interesting. "While NIH's success is to be celebrated, success alone does not answer fully the question of whether there is a better way to proceed particularly as one faces a future where the world of biomedical sciences is being rapidly transformed in all of its dimensions." So the NIH reviewed this situation. They, too, said this is too long, too complicated. There are gaps in biomedical research. 

It's complex. The dissemination rate stinks. Then came the NIH road map. I know Tom like dates, so I had to dig for some of these dates. Because tonight, I'll forget these, but I know Tom will remember them. So these dates are mostly for Tom. This was in 2002. It was NIH directors and other groups that got together that kind of reevaluated the entire system. And they decided that there had to be new pathways to discovery, new research teams, or teams of the future, and a re-engineering of the clinical research enterprise. And it's really this last one that we, in practice-based research networks, and we at Wisconsin are about. 

So that's what I'm going to talk about. Subdividing that out, there was a communicated need to develop new partnerships, both multi- and interdisciplinary partnerships. We, for example, have two projects going on with industrial engineering. We have people from industrial engineering looking at the patient safety side of things. And it's really fun, because new language is developed when you get a biostatistician an engineer, several doctors, all thrown into one room. We kind of develop our own language, and that's fun. So there is a need communicated to better integrate networks of academic centers, such as UW, to community-based healthcare providers. And Mark Dressner, Assistant Dean of Medical School has communicated the need to have the Wisconsin Idea be a two-way street. And one of our partners in the ICTR realm is a group that looks after that. They follow a model very similar to County Extension, that people in various regions of the state, that are actively engaged with their local communities, and feeding back what the needs are to our group, here at Wisconsin. 

We're kind of new at this. And we're just going through how to formulate research questions and how to develop protocols to address community problems. 

- What group did you say that was? 

- Health education. Or I'm sorry, Health Extension Program. 

- Extension? 

- It's set up by... 

- County Extension? 

- No, but the person that heads that group up is Dr. Fry, who's the ex-Chair of the Department of Family Medicine. 

So Tom mentioned, in the beginning, the word translation, translational research. I just want to make sure we're all square with what that means. It's actually the continuance of basic research, the so-called bench top research, generally focused on looking at efficacy, all the way to the bedside, where you can think of research in that area being done more in the lines of effectiveness. So I think I'll bring those terms up later. Think of the bench as efficacy, and bedside as effectiveness. Generally, the effectiveness part has been lacking in the delivery of, or the dissemination of findings. 

- Is there a standard for what bedside implementation percentages have to be? I mean, how many people have to be using it? 

- No. 

- Can you repeat the question? 

- Is there a standard for what the bedside, number of people, doctors, patients, for their implementation of bedside effectiveness? The answer is no, not that I know of. 

- Because of the 17 years that it took to get an idea out there and practiced, my thinking is that it might be ten of those years is that they're just not picking it up. It was disseminated, but they're hanging on to old practices. 

- Right. It's disseminated without any data on effectiveness. I think it's what's gone on. Doctors are incredibly busy, as we all know. We're, one of the things is trying to figure out how to crack that code. Most of them answer to a clinic. 

The clinic has their business plan. Doctors typically have 15-minute time slots. So when you have a new intervention that you want to get disseminated, how do you crack the code? And we're working on that. I've got an idea in an upcoming slide that I think is how to do that. So NIH launched what's called the Clinical and Translational Sciences Award in '06. And the UW was the recipient of this award in '07. And when this is fully implemented in 2012, there will be about 60 institutions linked together. I'm not going to spend any time on this slide. So the objective, the aim of the CTSA program is to grow and nurture well-trained multi- and interdisciplinary investigators and research teams. 

Create an incubator for any innovative research tools and information technologies. Again, stimulate the translation of your knowledge and techniques to clinical practice. This is just a list of the 2006 and 2007 recipients of CTSA awards. And on Wisconsin! There we are. This, in the next slide, but it was a $41 million grant across five years. This is one of the biggest awards ever given to the School of Medicine in Public Health. And you needn't read all this. The point is this was reported in March of '07. Just a quote from ICTR director, Mark Dressner, down at the bottom. 

"These working relationships will stimulate teamwork across Wisconsin, it extends from basic science investigators to research in clinics and communities." This is, of course, a map. The state of Wisconsin. This is a distribution of the WREN clinics, the Wisconsin Research and Education Network. We're pretty much spread all over the state. And we encompass over 87 individual clinicians in 35 towns, 21 different healthcare organizations. And of those, 13 are different UW Clinics. Back to ICTR. This is about creating an environment to transform delivery. I think I've said enough about that. 

The various groups at UW that benefit by this grant are the School of Medicine, as I mentioned, the WREN network under that, the School of Nursing, Pharmacy, Veterinary Medicine, and the College of Engineering. We've talked about WREN being a Practice-Based Research Network, or PBRN. WREN has been around for a number of years. But it was recognized by Mark Dressner and others at the School of Medicine that we just didn't have the infrastructure to deliver what was required of us. Can you read that? I just want to make the point that a PBRN is a network that uses patients and practices as a laboratory, so that's what this is all about. And this network brings together, of course, clinicians, academics, communities, to really look at the problems that most people have most of the time. We're not alone in this PBRN world. There are about 100 out there. This is a map. 

Can you see that? A map of PBRN networks across the United States. Notice that Wisconsin has three. We're the one, of course, in Madison. Just a brief history on WREN. We were founded in 1987 by Dr. John Beasley. There was absolutely no infrastructure at all. There was basically John for about 20 years. At that time, physicians were really the focus rather than clinics. 

And we saw a lot of value to get additional horse power by getting clinic buy-in to what we wanted to do, so we've really taken off. We still have our individual physicians, but we've found clinics that want to be long-term players with us. We had funding that was basically small grants, so nothing very sustainable, and no policies and procedures about how we were organized. So this was our structure as of January last year. Our director is Dr. Paul Smith, a practicing physician. He works in Belleville, at a UW clinic. And me, and I work with all the WREN clinicians. With some money, in a little over a year, we've been able to add a bunch of positions. I want to explain what a REPSS is. 

This is a Research and Practice Support Specialist. These folks are really in the trenches, getting to know clinic managers, nurses, reception people, whether they prefer doughnuts or bagels for a midday break. And essentially, develop a long-term relationship so that they're welcomed into the clinic at any time. So we've put a lot of emphasis on relationship building ahead of science, because we want to be able to use the same clinic over and over. Unlike some other PBRNs, when they have a new project, they'll roll to another set of clinics to participate. Project 3 comes on, there will be a new array of clinic participants. So we have Peggy O'Halloran, who's based in Eau Claire. Lisa Kietzer is based here in Madison. Katie Pronchinski is based in Milwaukee. And in Milwaukee, we really realized that as a group, we were really missing the demographic of under-served populations, so that's basically the rationale for the development of that position. 

These three people all answer to what we call full support clinics. Through ICTR CTSA, we have funds that we can buy out some of the people's times in those clinics. So it tends to be a better marriage when you have people in the clinics with skin in the game. And with our reps interacting with them, as opposed to relying on volunteerism. We receive quarterly invoices from these full support clinics, so we can buy out some of these people's times. And as I mentioned, when WREN was first started, it was pretty much individual clinicians, individual doctors. We don't want to say Sayonara to them. We have Cindy Columbo on staff here in Madison, looking after the individual clinicians. And most recently, we've hired a project coordinator, Kelly Kwiatkowski. She's going to be helping with manuscripts, technical writing, grant development, etc. 

I don't think we've seen this one. This is the WREN mission statement, which is basically to improve health outcomes for the people of Wisconsin through education, and through promoting and conducting primary care research in partnership with primary care clinicians in the communities they serve. Is everybody familiar with the term primary care? Okay, I won't spend any time on this then. I'm not going to dwell on this one either. This is, I mentioned, our full support clinics. We are also involved with a $13.5 million across five years WIPHL study. I'm not going to talk about that at all. But just to let you know that we currently have four full support practices. Milwaukee's going to come with between two and four additional full support practices. 

Again, the idea with these full support practices is to build relationships before we slap them with a bunch of stuff to do, and they're already busy clinics. So it's getting to know how a clinic works. It's trying to understand the timing of project roll outs so we're not hitting them when they're moving into a new building, or learning how to do electronic health records, which all clinics eventually are rolling to that. It eats up a lot of time. We don't want to be a burden. So we're really sensitive about how to time the rollout of projects to them. Now I'd like to talk through three of our current projects. We have more than this, but I think this illustrates-- These three illustrate the diversity of what we do. The first is called AZMATICS, another acronym. No it's not misspelled. 

There's an intentional Z there. I'll explain what that acronym is. Health literacy, and complexity. And complexity is really the complexity of providing primary care as it relates to the same patients that have a multitude of problems. And we are interested in essentially understanding the practice of the practice. So we do research type things. And we also do studies where we're looking at the practice of the practice. And that complexity falls under this. So AZMATICS. This is an acronym invented by the principal investigator, Dr. 

David Hahn, who's a practicing physician at Dean on the east side. This stands for AZithroMYcin, Asthma Trial in Community Settings. And azithromycin is an antibiotic, it's a specific antibiotic called a macro--. And it is effective against an organism called Chlamydia pneumoniae. And that's been found in the bronchial tracts, and in the throats of some people with adult onset of asthma. So David has really rocked the academic world, because there's not a whole lot of people believe that asthma is infectious. His claim is that a lot of researchers are tightly connected maybe to Pharma. And Pharma likes selling Advair, Singulair and all of these things that knockout symptoms, but they don't get at the root cause. That's a big, big dollar industry. So I think his theory there is probably valid. 

He's gone on the lecture circuit a number of times telling this story. The word is starting to get out about asthma being caused by a bacterium. A lot like ulcers caused by H. pylori. What's the genus Tom, do you remember? There's also been an association of Chlamydia in arterial plaques. So this is really interesting. I think we're going to hear a lot more in upcoming years about infectious bacteria being a component of certain diseases that we thought were due, in the case of asthma, to inflammation, perhaps COPD. Some doctors, when they see adult-onset asthma just call it COPD, because they don't really know. But anyway, I'm rambling. 

I'll get back to this. The theory behind this is that azithromycin can reduce asthma symptoms and improve quality of life. We do have some preliminary data from the Cook County Hospital in Chicago on this. I'll present the data in a few slides. If you're interested in asthma, or know of anybody that is, I would highly encourage you to look at a site called asthmastory.com and there are testimonials at that site. There are also links to Dr. Hahn's research. But, testimonials from marathon runners to dentists, to a guy that was wanting to walk the Appalachian Trail. And people had these barriers due to their asthma. For the most part, the story at this site is that they took the azithromycin, the trade name on this is called Z-Pak, for a period of time. 

And some people are cured of their asthma. Many are symptom-free for like 12-18 months, and have to take azithromycin again. But they've completely given up their bronchial dilators, their inhaled steroids. So it's a remarkable story. These are the data from the pilot study at Cook County Hospital. Let me get over here and explain this. On the Y axis is overall asthma symptoms, going from zero to three. And this is the azithromycin. So lower is better, reduced symptoms. And this is placebo. 

So these data were significant, even though they don't look like they're that far apart. They're really important in the life of someone who has asthma. We found kind of a sweet spot here at about five months after taking the antibiotics, where you see it starts to go down. We've heard people say this. And I mention it earlier, that after taking the antibiotic, they'll be fine for a while. Then their symptoms will start sliding south again. So we designed a study that's ongoing now, where we have a longer time course of antibiotic intervention at the beginning. People that are in the study take antibiotic for 12 weeks. I think it's a 600-milligram dose. Don't quote me on that, but it's a pretty high dose. 

So we're currently testing that. Again, back to this Cook County data, an additional piece of information or data is that there was clinical improvement, I won't go into the details. There was asthma symptom improvement. There was also clinical improvement. And this led to research questions and hypothesis. The primary question was, as I mentioned, does three months of taking this antibiotic reduce asthma symptoms; does it reduce asthma medication; exacerbations; does it improve quality of life, etc.? I've got another bullet that comes up here. The secondary question we have, and if you study the asthma literature again, with maybe a little bit of bias about what's going on with the Pharma industry, is that does treatment respond; do people that smoke or have COPD respond in the same way that people that have never smoked respond? If you look at the asthma literature, if you're a smoker, you're excluded. If you have COPD, you're excluded. 

The only reason we exclude people is if they're pregnant. These generally tend to be women. And otherwise if you smoke, you can be in the study. Again, we're going after a bacterium causation to the disease, not a kind of a restructuring of the lung in a negative way due to smoking. Okay, Chlamydia pneumoniae. Does everyone know what an obligate intracellular organism is? This is an organism, in this case a bacterium, that needs to live in cells. In other words, you can't culture it, work with it on a petri plate. It's got to be in cells. This is found all around the world. 

Just a side bar on the infectious nature of it is that sometimes it's thought that asthma can be passed on from family member to family member So if the environment is such that one person that's harboring this Chlamydia is in close proximity to children, often they will come down with childhood asthma, which we're not studying. But it's an interesting note. So the Chlamydia pneumoniae is found in somewhat loose association with people, 5% that have acute bronchitis and pneumonia. Again, Dr. Hahn's suggestion is that this is really under recognized. In the cases with adult, certain onset asthma cases, there's a fairly tight correlation between finding the organism in the lungs and the bronchial tubes by using a technique called PCR, too many acronyms again. You can also serologically, detect the immune response, if the bacterium is there, with specific antibodies to that antigen. Again, the asthmastory.com is a good site to look at. So I mentioned the preliminary data, or the pilot study. We really wanted to ramp this up. 

And the design is very similar to the pilot study. I didn't mention the design, but it's a double blind placebo controlled study. What's new about this, is that once a patient has enrolled with their doc, their doc doesn't need to see them again unless they have a problem. What they do, or what we do, is we send them a survey link by email link every week that's set up through our commercial survey platform. People have been really good about self-reporting. So we ask them in the course of the 12 weeks that they take study medication that they report whether they've taken their study medication and if not, why? Have they lost it? Do we need to replace it, etc. And they also report side effects. Then every six weeks thereafter, we ask them questions about their quality of life and their asthma symptoms. 

The compliance after one year in the study is upwards of 70%. So this to me is just amazing, because neither patients or doctors are incented in this study. People are all volunteer. People want to find a solution to this disease. And they're very giving of their time. So the other thing that's different in this study compared to the pilot study is that we are using five practice-based research networks. And I have a map of that I'll show you. Ours of course, is WREN. There's one in Oklahoma. ANSR in central Illinois. 

And the American Academy of Family Physicians, AAFP, National Research Network. This is essentially a research network that members, all across the United States, belong to. I don't know if you can see it, but that's the dotted line up to North Dakota. Is that North Carolina, Tom? 

- It is. 

- Thank you! You asked the question before about how to measure dissemination to the bed side. This has been referred to as Research to Practice Pipeline. There are a number of steps to this, both on the providers' side and the patients' side. First of all, the doctor or provider has to be aware, and have to accept this new information, have to apply it, be able to apply it, and act on it repeatedly over time. 

Then you have to have patients that agree and adhere. Notice the diminishing curve here. So, you might have a fairly big new research input into this pipeline. But at the end of the day, you have a very little trickle flow coming out of this pipe, because of all the possible steps for reduction. What we're trying to establish with the AZMATICS project is to make doctors aware, at the time this study was started, what we're trying to do. So essentially, once they agree to be in the study, we've got their buy-in for all their steps in this pipeline. They're aware of it, and they're all ready to act on it. So we've opened up the pipeline thus far. And with them knowing what the project is, enable to enroll patients, patients sign an informed consent, so they mostly agree to the intervention. And they adhere to this as we've evidenced by looking at compliance data. 

So people are taking their medication, and they are onboard for answering questions about their quality of life and their asthma symptoms for one year. So compared to that earlier pipeline model, we hope to have opened up the provider and the patient end of this pipeline to get better output of the pipeline. We think this is a valid model for any new intervention. Essentially, clinicians that have an interest in research involved early on, get them kind of turned on with the idea. Have them enlist or enroll patients. And once we have the data on whether this works, or whether the antibiotics work or not, we think it will be easy to propagate, or easy to disseminate further, because real doctors in real clinics with real patients have tested it. Yeah? 

- You know, that's kind of interesting from the standpoint, I used to work in the Center for Tobacco Research and Intervention. And we have two programs that are kind of involved in this kind of process. One is a research program that involves enlisting clinics, or it was, it's now in the writing up phase. 

Enlisting clinics, or clinics in testing tobacco cessation medications and counseling, etc. And that follows the model you've just been talking about, right? They enlist the clinics. They actually do a little different thing, because it's more involved, so they actually have people there who work with the patients. The docs just do the initial enlisting. But that's far different than actual dissemination in a larger scale. And they have an outreach program that's been working in the state of Wisconsin for, I think seven years, to take what's known about tobacco cessation, and try to get doctors to use what's already known. And that's a whole lot harder, because that's not a research project. That's getting them to change practice based on what's already been found out. So, I think that's a nice model for research. 

But you know, what they've discovered, and they had six outreach workers working in the state for seven years now. And they're making inroads, but it's very hard to change practice. And what they've discovered is that you really have to work down in that systems improvement area. You have to get the HMOs, and whatever, to buy into some of these changes. Because it does go in the medical records. It does involve reimbursement. And it does involve feedback to individual providers, etc. So their take away is that if you don't fix that systems part, your dissemination of new practice just doesn't happen very fast. So I don't know, if you've found that out. Is that something you're going to work on, or if there's a way to make this model stronger for non-research dissemination. 

- You know, that's a very good suggestion. And I've not thought of it that way before. We do have a group we're working with that I mentioned at the beginning of the talk that I said I wouldn't spend any time with. But I think it might be note worthy to mention the WIPHL group, which stands for Wisconsin Initiative for the Promotion of Healthy Lifestyles. Another acronym. That's headed up by Dr. Rich Brown. And it's a $13.5 million NIH grant across five years. And what it's looking at is not research at all, but implementation. Complete implementation centered around alcohol and substance abuse. 

And this has, I want to make two points with this. The first is that when a patient checks into a clinic, they can fill out a questionnaire and be worked in, as can be, to see a health educator. The health educator can then, depending on how severe substance abuser they are, can do a soft immediate intervention or maybe suggest that they attend AA, so there's kind of a whole gradation. So that's one point I wanted to make about it, is that there's health educators in a whole bunch of clinics across Wisconsin doing this. The second thing that I wanted to add is that the vision that Rich has is that these visits with a health educator will be a billable item over time, so that in the big scheme of things, the intervention will reduce healthcare costs, so therefore there's justification for billing for it up front. And I said there's two things, there's actually a third. So if this model starts working, or it is working, but going all the way to the end of the project, it's thought that health educators could handle things like obesity, smoking, or negative type of behaviors and actually bill for it. So there's been discussion with HMOs and various insurance companies on how to do this. And it looks bright, as far as they're going to be able to actually bill for it at that time. 

- I think currently though, in terms of smoking, is part of it is that you do need the physician intervention, because usually there's medications prescribed. 

But then to go and finish up with a health educator, if they could make that billable, that would certainly help. 

- Yeah and I oversimplified the WIHPL story. There is, or can be, physician involvement with this. I just introduced new players in the clinic called the Health Educator that have not been there before. But yes, the physicians can get involved and prescribe drugs for alcohol or substance abuse to help with that. Yes? 

- Is there a way that individual patients who might be interested in participating in research can get involved in this, or does it have to come from the physician or clinic to patient? 

- Very interesting question. Yes, there is a way you can get involved. I'll show you our department Web site. 

But that's my last slide. I have our Web address. At the beginning of the AZMATICS project, we had a lot of physician enrollment of patients, of study subjects. And over time, our proposal is listed on our Web site as well as linked through this asthmastory.com. Asthma patients were finding us, asking, "I want to be in this study, what do I do?" And the big hurdle there is getting them aligned with a physician that has an IRB, and get an IRB approval to do all this. It gets to be very complicated. But in terms of top down recruiting, that's kind of waned over time. And over time, we've had a whole lot of patients contact us. We have a patient that is actually part of the study from Australia. 

So they've come from California, the east coast. It's very interesting. People are willing to be involved. But unless they do their own research, or unless they're hit with a lot of promotional information, they don't know. And the best thing I could suggest would be just to take a look at our Web site. A lot of projects don't have the money to do advertising, in like Isthmus or even put up billboard, or little signs in community areas. Actually, that's pretty affordable, but there's all these IRB issues again. So just to summarize the AZMATICS work, we have approximately 15 practices involved across the U.S., and one in Canada. We have 57 subjects enrolled to date. As I mentioned, the compliance or follow up has been real good after a year. 

It's been around 70%. We're doing some things to try to increase that. And the demographics are broadly represented. So now I'd like to talk about health literacy. Health literacy is a passion of my boss, Dr. Paul Smith. I think he gave somewhere around 40 presentations last year across the state. He's been invited to conferences, giving workshops, etc., on health literacy. So a lot of these slides are stolen from him. 

But 20% of Americans read at or below the fifth grade level. And believe it or not, most healthcare materials are written above the tenth grade level. So you can start to see the disparity there. The Institute of Medicine, in 2004, said that they defined health literacy as the ability to understand basic information needed to make appropriate decisions regarding healthcare. And you've probably all heard of self-advocacy with medical treatment and plans. You absolutely have to understand what's being told to you before you can be a really good self-advocate. People with low health literacy have generally poorer health status. This was a look at about 3,000 new Medicare enrollees. And it was found that there was a correlation between reduced literacy and increased frequency of diabetes, high blood pressure, heart problems and arthritis. This little bar chart shows-- Inadequate health literacy is the red bar. 

And adequate health literacy is the blue bar. The Y axis is percent. And down below, it says Diabetics with Retinopathy, which is an eye disease. And look at the red bar. And in white up above it, there's 36% of people with inadequate literacy have retinopathy. And 19% of those that are health literate. So very alarming disparities across all diseases. The other big thing, of course, is cost. And these are 1998 data. I think it's probably only gone up. 

But the total cost of reduced health literacy is $73 billion. This is in 1998 dollars. That's just huge. It's costing all of us a big chunk of change. I'm really interested in this graph. This is percent of low literate adults, low health literacy adults, that have not told people like children, co-workers. Most have told children, or half have told children. But generally healthcare providers are in the dark. And physicians I talk with say that people have really good skills on how to hide this. They "forgot their glasses," or they've got another appointment. 

They don't want to take the time. Yeah, "Just give me that consent form. I know what this is all about." "I trust you guys. I'll sign here." So, they generally aren't in-the-know. There aren't good screening tools to discover it. Yes? 

- Is this in regard to the retinopathy? 

- No. 

- What is it that haven't told? 

- They haven't told their healthcare provider that they can't read or understand spoken English very well. It's generally the reading. So we went about trying to understand what some of the issues are with low health literacy adults last year. We did a focus group, six focus groups. Two in Madison, two in Racine, and two in Oshkosh. Basically, the themes came out that there's difficulty in communicating. Doctors usually, like we've talked about before, are in a harried schedule. They don't have time to spend, so there's this tension about, "Am I taking too much of the doctor's time to ask questions?" And they spend some time, for the most part try, but then they often just give up. 

Words are too long. Written materials are too long. Words are too big. Also, a lot of medication errors. Particularly with liquids. Tablespoon, no liters. You know, how to do that. So that came up over and over again. One woman said that her husband was Hispanic, and she went to the doctor with him, he had a back problem. He was prescribed a pain killer. 

The doctor wrote the prescription, and told her verbally that he could take two tablets a day. And then when she got the prescription filled, it was something different. She called the nurse, and got yet a third answer. So this is all confusing. It's confusing to me. And I can understand at least simple directions. They also don't know how to navigate. They don't know where to start. I think this is difficult for anyone, but especially difficult for them. If they know they have, say they're from another country, and they know they have a need for a dermatologist. 

How do you begin to do that? You've got to understand the whole insurance thing, and whether or not your doctor needs to refer you. So difficulty in accessing healthcare. The problem with reading forms. And then, this makes sense, but I certainly wasn't aware of it. There's this cycle of trying to communicate with your doctor, to feeling shamed about it, and getting anxious. So there's a lot of anxiety with this group as a whole. They're very embarrassed about their inability to understand written or spoken English. So these are some quotes that support some of these themes. This first one is probably with forms and consents. 

This one says, if you just look at the middle, "I'm not exactly, but I can read it, I think I'm reading it anyway, and I'm still not understanding exactly what they're saying." So, "The words are too big, and I can't pronounce them." And it's all too confusing. 

- I think that's true for everybody. 

- Yes, absolutely. And then there are embarrassment situations. A woman said, "I think it just makes it harder for somebody when you have to respond... before you can understand it. You know, it's embarrassing to sit there and think God, am I really that stupid, you know?" This is a resounding theme, different quotes, but essentially this idea. 

Again on embarrassment. "It's very stressful. It scares the daylights out of me." "I'm afraid to ask." "You feel dumb." "You don't understand what's being said." I mentioned the liquid medications earlier. A woman said, "I don't know what it consists of, as far as how many teaspoons." "They're supposed to have the grams and stuff on it, but I don't understand it if I look at it, what exactly it means because to me, it's foreign." And this came up again. 

Medication in general, but frequently with liquids. So another study that WREN did was kind of looking at the physician. This was a national study. We did Wisconsin docs, and also did docs across the United States. We wanted to get a good feel for opinions and attitudes of low literacy. We wanted to understand whether physicians have screenings in place to detect low literacy, whether they try to communicate better and whether the reading materials in their office are kind of geared to, hopefully this fifth grade level, and not tenth grade and above. This is just a graph showing the estimated percent of low literate adults. And this was a study done, I think, maybe in the late '90s. But anyway the average estimate on the part of the physicians was that 17.4% in their retrospective account of who they've seen, 17.4% are low literate. I mentioned a study that was actually in 2003. 

Their estimate is 36-52%. So you can see already that physicians have a tendency to really under-estimate low literacy. Again, people are really good putting up a front about it. This actually should have been in with the retinopathy slide. This just shows that there's increased risk of death. The red bar is low literacy, blue bar is higher literacy. And this has almost a two-fold hazard ratio. In other words, you have a greater chance of dying due to disease or complication if you are low literate. So back to the study that looked at physician attitudes. We looked at docs practicing in inner city, suburban, and rural, and asked them what the impact of quality care is due to low literacy. 

And what we found is that, no real big surprise, but those that saw this being a moderate or major impact were more urban or inner city. So we're seeing those that think moderate impact or major impact, the inner city doc sees it as being a real big thing. And what about the question, does being low literate impact health outcomes. 53% said that the impact on health outcomes is moderate to major. There's no significance difference, I said we looked at Wisconsin docs and national docs. No difference between these groups. But there was a gender and location difference. This is a very similar graph, just looking at impact of health outcomes as time-- again, the same trend. Inner city docs think that there's greater impact on health outcomes than do rural. The question was asked, you know, people generally recognize this as a problem, but what is your office doing about screening? 

Is there anything being done out there that's routine that we are weren't knowing about? And 84% said no. We do absolutely nothing in our office to screen. And the national estimate of what's done was greater than Wisconsin. So there are some tool kits out there. There's no consensus yet, as to what to use is the best upon admitting a patient or rooming a patient. But we did find that the national average for doing some type of screening is about two-fold greater than what Wisconsin is doing. And what about those educational materials? Again, these should be written at about a fifth grade level. And just a cross cut look at it, it seems that they're about a grade ten or above level. 

So the question was, do you or your clinic assess reading level of educational materials? 41% said no, and 41% said yes, 18% didn't know. What's interesting with this is that Wisconsin seems to be doing better with the assessment of reading materials than does the national average. This was statistically significant. And what do docs do, even though they might not be doing any screening, they often, if they recognize someone is low literate, they often will attempt to slow down, etc. So the question was, do you take steps to improve communication? 71% said yes. And there were, again, Wisconsin versus national differences. Wisconsin almost double that of national, where 72% of our docs try to communicate better compared to 43% of national docs. Differences on, again, rural, suburban, urban. 

I won't dwell on that. The question was asked, does a patient's literacy level have an impact on their health status? And there were other questions that I haven't shown that have these same results. Females are more sensitive at understanding and appreciating whole literacy situation than males. I've left a number of questions out that just illustrate that one. The blue bars are female, red bars are male. And this was statistically significant. No regional. This wasn't sorted out or teased out by location, or groups. I misspoke. 

It was looked at by location and groups. No difference. The only difference was the female/male difference across the U.S. Again, a different question, impact on satisfaction. Females say that this is more important than males do. And this again, was statistically significant. So to wrap up health literacy, basically no screening is done. Women get it more than men. My wife very much understands this. Clinicians, even though they don't identify people very well as being low literate, they do, when those people are identified, at least by guessing, they do try to communicate better. There's really a need for a universal tool kit. 

I mentioned the national look at screening versus Wisconsin. That's statistically different. But we really don't know what's out there that's being used with any success. We submitted a grant to look at this and we were rejected. But we're going to bring it up again, because this has opened a lot of doors that we need answers on. Yes? 

- Is literacy really the best word to use for this? Maybe comprehension, or some other? Because saying "literate" has certain other implications with regard to reading, primarily, as opposed to comprehension? 

- Would you repeat the question? 

- Is comprehension perhaps a better word than low literacy? And I don't know. I like the word comprehension. I don't know what other. 

- Literacy means whether you read at a Dick and Jane level, or you're reading a classic or something, as opposed to understanding what you're being told and understanding what you're reading. I see a distinction. 

- Yes? 

- I sort of have a question related to that. Because I'm wondering, as I watch this, are you referring to strictly printed materials. Because sometimes you use literacy, which to me implies reading ability. 

And then in other ways, you talk about communication, so it's not clear to me, what you're studying, whether you're studying reading ability and reading fifth grade or tenth grade level reading ability, or communication, whether they understand what the doctor says when he says MI. You know, I went with my father for an exam years ago. And the doctor's going on with his jargon and says, and by the way, you've had a slight MI. And he goes on and on and, later I asked my dad, do you know what an MI is? "No." He had no comprehension at all that this doctor was telling him that he had a heart attack. So it isn't clear to me what they're studying here. 

- Very good question. I didn't explain that very well. We've done two studies. 

The one was looking at a focus group approach to what they see the barriers are to getting optimal healthcare. I talked about communication that way, which was mostly spoken. Strategies that doctors use to try to understand them better. And I didn't even mention the translator piece of that, or family members. But most of that, the outcome of that, was related to spoken communication. Whereas, the last study I talked about was looking at physicians' attitudes and opinions. That was asking them, have you done anything to assess the grade level of the reading material you have in your office, that might be directed at MI, so when people hear that term, do you know what is it? And there just wasn't a whole lot done. Wisconsin does a little better than the national average. Does that answer your question? 

- Yes, it does. Kind of follow up question is, or observation, I guess, is that this seems to focus on the patients in terms of literacy and understanding. I'm an RN, and so in relation to the communication that comes from the clinician to the patient in terms of technical language, and jargon, and speed of presentation. And a patient who wants them to repeat or explain, and wondered if those components are looked at. 

- We have not looked at all the components other than kind of a proxy to that through our focus group. But I've been interested in that very thing, because I mentioned we partner with industrial engineering. The principal investigator on a couple of projects we have is Bentzi Karsh. And he has grad students that are trained in being a little mouse in the corner of the room and watching when the doctor flinches, and when the nurse does him a double look or gives him the hairy eyeball. And what that means is, we've got the right people to do what you're getting at, I think, is actually be in the room and look for hazards or risks associated with communication and define that better. So the next thing, speaking of Bentzi Karsh. 

This is an industrial engineering term, and someone raised it earlier. Doesn't it make sense to make things more readable for all of us, because it's all so confusing. The term is universal design. And that is kind of getting at what you were mentioning about comprehension. Throw literacy out the door, and just make things more understandable. I don't know if any of you have been at the new UW Children's Hospital. The signage there is horrible. They've got small signs. They're hard to read. I can read fairly well, and the first time I was in that area, I was very confused. 

If you go to UW Hospital and try to navigate through all the pods, H-2, G-3, and the floors are different numbers, it's terrible. So I think there's something to be said about making everything more understandable. Shorten the words, and you'll help everybody out. So, another proposal we've been working on is the use of low literacy people as consultants, to actually go into hospitals and look at their consent forms, looking at how they get around in hospitals and clinics, and try to get change made at hospitals with this group of consultants' input. So the next thing I'd like to talk about, I mentioned this term earlier, is studying the practice of the practice. We've done and completed a body mass index, BMI. I'm not going to talk about that, nor will I talk doctors opinions of Pharma reps and whether they get anything useful out of them. We're currently midway in proactive risk assessment. That's a project designed to look at, again this is Bentzi Karsh's group, looking at hazards in the delivery of healthcare to the elderly. And we're defining elderly as greater than 70 years old. 

So there are little mice there watching things, like whether a doctor spends a lot of time on the electronic medical record, looking for tests that he thought were done, but, you know, it's here somewhere, maybe fumbling back and forth with paper charts and electronic records. So like I said, that's about midway through. The project I want to talk about and end on is the complexity of addressing multiple patient problems, generally in this 15-minute time slot. The principal investigator on this is an ex-director of WREN. His name is Dr. John Temte And he practices, I don't have my directions here very good, but right across the street, at the Wingra Clinic. He has a PhD in zoology, and really enjoys epidemiology and numbers. He serves on boards with the CDC and American Academy of Family Physicians. So he's a great researcher to have on board WREN, because he's extremely bright about numbers. These are John's data. 

I got this from him yesterday. We're about ready to wrap this project up. This is a graph looking at number of problems a patient presents with per encounter. So if you see a patient, if you're a doctor and see a patient, and say go, 30 minutes or maybe 15 minutes, the encounter is whatever it is. It's the number of problems that the patient has. And on average, patients have about 3.23 problems. And you can see how it's distributed. There's some that have all the way up to 12. So for the typical 15 minute time slot, that probably induces a little bit of anxiety. And we wanted to measure that. 

How anxious does that make docs and what happens when they get real anxious, when they have to do an admission or having a patient ask a lot of questions, that, you know, they've got to move on. And we're using an instrument to look at what's called mental workload, abbreviated MWL. This is a validated instrument that was developed by NASA, as in space. NASA wants to know what the mental workload is of astronauts that have to be on their toes, looking at a lot of gauges and flying their shuttle, as well as fighter pilots. This tool has been used to look at fighter pilot mental workload and astronauts. And we're using it to look at doctors and their workload. So this is a graph of what's called the NASA TLX composite score. Higher score, higher mental workload. And the Y axis is frequency. So regardless of what the patient is presenting with, such as the number of problems per that encounter, the mental workload that a doctor sees or experiences during a day is fairly high. 

John tells me, I said John, if I were a doctor, wouldn't I want to be down here? He says, no. You've got to have some kind of stress going on to be a good doctor. So it's kind of a normal distributive curve, with it looks like, I don't know if this is on there, but it looks like an average of somewhere around maybe 55-60 is this mental workload score. And I show you that just to go to this slide where we're looking at, on the Y axis, mental workload versus the number of problems per encounter. Viola, this is as we expected, if a doctor sees more patients per encounter, the mental workload goes up. In fact, John has derived an equation for this slope that he wants to further develop into being able to better predict, based on a patient's health history, whether they have diabetes or not, how much workload there's going to be. And maybe a way to expand that time through a team approach and meeting with the patient up front, or identifying problems before the visit, so they can get a leg up in identifying the problems. So that's just a real brief look at that. Essentially, what we're concluding is the more problems, the greater the mental workload. 

And the greater the mental workload, the greater the chance of making errors. I didn't show you that data, but this is actually a proxy to making errors by asking the doctors, okay, how do you think you did? Rate yourself. We're seeing a good correlation to more mental workload, yeah, I might have made a mistake. Definitely there's more time needed. And as I mentioned, perhaps a team approach. We've talked through this with Bentzi Karsh, an industrial engineer, and we're putting out a proposal to get out this team approach, where there would be a brief huddle before a patient comes to identify their history, the tests, and just have the MA, the nurse, the doc, all be on the same page about why the patient's there, and whether there might be a possible referral, just an attempt to get more people involved with identifying what the patient might be presenting with. So that brings us to the end. And as I mentioned, you might find, I think you will find some information about how to participant in research studies at our Web site, which is wren.wisc.edu. There are also links to our quarterly news letters here. 

And soon there will be links to greater things. The thing about Web site development is that it's never developed, it's just a continuing project. We're undergoing some changes, but the bulk of it's there right now. Any questions? 

- I was just going to say, I think the discussion about literacy and communication, usually people talk about it as health literacy, which doesn't just mean what kind of reading level you have, but how much you know about health and how you can process. So I think that helps the terminology a little bit, although I think communication is better than literacy. But the other thing I wanted to mention that when you talk about consent form and things, the biggest problem there is the IRB. It's not the people doing the studies. It's a kind of cover your butt mentality. Because I used to do recruiting for studies. 

And I did the advertising. And the IRB had to look at all the advertising. Instead of keeping it simple, like "free," this. We had to say, "at no expense to you." We had to take simple words and phrases and make them bigger and longer, with no improvement, because the IRB felt somehow this would be better. So I think some of this has to be done, you know, consent forms and all that sort of thing, some of that education process is not with the researchers, it's with the IRB and what they see as communication. And then we also had 14 pages-- 14 pages in our consent form. Nobody is going to read that. I don't care what kind of health literacy you have. I wouldn't read that. 

So in the interest of protecting themselves, and the university, they've actually done the opposite, and made it worse, because you're not protecting people if they never read it or they don't understand it. So that's my little soap box about that. So maybe there should be some work on that, as well as educating those folks. 

- IRB is aware of the reading level issues. And they are attempting to make it less legalese and more user friendly. Other questions? 

- You didn't mention very much about the dissemination of information through the train of the pharmaceutical reps. If you ask me, how do doctors find out-- pharmaceutical advertising, pharmaceutical reps, a good deal of their information. 

- That's very true. I think that, trying to recall our study. 

There's an increasing number of docs that have clinic policy or personal policy for not seeing Pharma reps. 

- An increasing number of doctors are saying we don't want to see that Pharma rep. 

- But you're right. A lot of them do rely on that. 

- As opposed to publications, or any other means of getting educated, to me that's the way the pharmaceuticals make money, is to give them free samples and tell them to use them. And then they use them, they work. And, plus dinners and free wine. 

- Yeah, that's a good point. We were contracted by Wisconsin Academy of Family Physicians to do this study. And they actually developed the questions. 

One question that I think should have been on there, per your comment, was how do you get information about health, about medical research, do you rely as much on Pharma reps, or do you read journals? But that's wasn't asked. I do know that across Wisconsin there is a fairly large number of docs that either have personal policy not to engage with Pharma reps, or have clinic policy. 

- Actually, there's research already out there about where they get their information. I can't remember exactly what it is. But a lot of them get it from not just the journals, like JAMA but they get it from what they call the throw-aways. Well, or like, instead of JAMA, it would be the AMA news. So it's one level down from the journals. And I don't remember where I saw that research. But there's another thing I wanted to raise too. 

We hit a nerve here. Another problem, this 17 years, is the whole grant process and publication process. It seems to me, I came into this from the business world. I thought, this is an ungodly long, slow process. First you apply for the grant. And that takes, who knows, how long, especially NIH, you've got three or four months for them to fool around looking at it, and then they send it back. Or I don't know, but anyway, it takes forever to get the darn grant. Then you do all the research and you write your papers. And then you send it off to these journals, okay. And then it takes another six months or more of fussing around with reviews or wording changes. 

And then you've got to get in the publication queue, which could take another God knows how much time. So there's a whole bunch of time lost there in that whole process. And I was at a meeting a few years ago. And it was from the Society for Nicotine and Tobacco Research. And they talked about developing a better structure to figure out what grants are out there, and what research is already being conducted. And then the second thing was, to figure out a way, maybe even publish all this stuff online, instead of waiting for six months or a year, or however much time it takes to get this stuff published in the journals. So, I mean, there's another place where there's a bottleneck between new information and the dissemination. And I don't know if there's more being done about that, because I've been out of it for a couple years, out of that end of it. But are they working on it? Because then they said it was like ten years between the time you get the grant and it's published. 

So somehow that's got to be fixed. 

- I agree. I think the NIH is getting a more real world vision on how to measure performance. Part of ICTR, we get points for building relationships. So in the past, it was number of publications in peer review journals. That still can earn you points. But we at WREN are not about publications. And they know that. And so many of our allied groups here at the UW are that way, too. Publications aren't what we're all about. 

So NIH is kind of coming around to having different measures. But I agree with you, the whole grant process, publication bottleneck is probably not the way to get information out. 

- There's an irony here that in order to get into med school, you've got to be some of the smartest people. And you have to be able to communicate with a whole range of people. You work has pointed this out. What is the UW School of Medicine and Public Health in specific, and what are the schools in general doing to divert time away from say, the sciences, and spend more time on communication skills. Or they're not doing that, even though you've got billions of dollars that are in healthcare costs due to lack of communication. Are people spending more time in medical school training on how to listen, how to talk across ranges of literacies? Or are they just spending more and more time, helping people go through biochemistry and anatomy? 

- Good question. 

I don't know is the short answer. The residency program in Family Medicine, the residents will get exposure to several WREN docs, and have the opportunity to hear more about the importance of communication there. But I don't know if there's any formal redirect at the classroom level in medical school. I can find that out. Yeah? 

- I have a question about the ethics associated with translational research. Like in the AZMATICS study, you have a theory, a drug that may help. Some people get a placebo. There are side effects. It actually relates to the question we've been talking about in terms the long times to put new research into practice. 

That isn't protective medicine, mechanism, for the patients. Over time, you would hope their problems would surface. So is this, are the ethics of the studies you can accept a big part of your work? Is there more concern because you've got a group of people you think this is going to help, and you only give it to some of them? You're doing it pretty fast. 

- When a patient enrolls in a study, they have one of two paths to go. And I didn't mention the other path. One path is the randomized study, where they have a 50-50 chance of getting placebo or drug. They know that has a chance that maybe their asthma is real bad, and they don't want to go down that path. Then we have a second informed consent for an arm of the study we call Open Label. 

And the open label patients can choose to knowingly get the antibiotic from the get-go. So there's no special provision by FDA to use this drug. The side effects are made available in an informed consent. We're tracking side effects. We also have a data safety and monitoring board that looks at our data routinely. They're unblinded. So they know the drug and placebo. We just had a data and safety monitoring board last week. They gave us the thumbs up. The side effects we're seeing, there's no alarm. 

There's no reason to stop the study. Does that? 

- I'm curious if those questions affect what you can accept as a study that you want to be a partner on. 

- What you can accept? 

- More than traditional research. 

- This is still pretty traditional, isn't it? I mean, you're still doing double blind research. 

- Yeah. 

- It isn't like it's any different. It's just recruiting differently. 

- I'm think about something like Covance, who would recruit people, pay them. You know, they sign up to take a medication. Sometimes they're actually healthy individuals who are looking at side effects first. Just by speeding it up, it doesn't seem to be an issue. 

- No, it's really different than the scenario you described. We're not going through Phase 1, 2 and 3 testing. These are drugs that have been tested. And we can communicate what we think, what is known, about the side effects. 

- Anything else? Thank you very much. 

(applause)

- Thank you.