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					                                                                          LIPMAN HEARNE
                                                                  Moderator: Tucker Warren
                                                            September 9, 2004/10:00 a.m. CDT
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                              LIPMAN HEARNE

                               September 9, 2004
                                10:00 a.m. CDT




Coordinator   At this time I’d like to thank all parties for holding. Your lines will

              remain on listen-only until the question and answer session of today’s

              conference. Today’s conference is also being recorded. At this time I’d

              like to turn the call over to Ms. Jeanne Brennan.



J. Brennan    Thank you. Hi, everyone. Thanks again for being on today’s call. Before

              we start I just want to restate who is speaking on today’s call and provide

              full titles and spellings of their names. First we’ll have Dr. Allen Dietrich

              who is Professor of Community and Family Medicine at Dartmouth

              Medical School and is the co-chair of the MacArthur Initiative on

              Depression and Primary Care at Dartmouth and Duke.



              We also have Dr. Charles Engel, who is Director of the Deployment

              Health Clinical Center at Walter Reed Army Medical Center, and is also
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              faculty at the Uniformed Services University. Dr. Engel is also a

              lieutenant colonel.



              We also have Dr. Laurie Garduque, who is the Director of Research for

              the Program on Human and Community Development at the MacArthur

              Foundation.



              Just let me know if you have any questions about the spellings after the

              call. You can reach me by e-mail. Again, it’s Jeanne Brennan. But at this

              point, I’ll turn the call over to Dr. Allen Dietrich.



A. Dietrich   Thank you, Jeanne, and good morning. I’m Allen Dietrich of Dartmouth

              Medical School, co-chair of the MacArthur Foundation Initiative on

              Depression and Primary Care. As Jeanne said, I’m joined here today by

              Dr. Charles Engel of the Walter Reed Army Medical Center and the

              Uniformed Services University, and Laurie Garduque, Director of

              Research for the Program on Human and Community Development at the

              John D. and Katherine T. MacArthur Foundation.



              We’re very pleased to be here today to discuss a paper that will be

              appearing in this week’s British Medical Journal. The paper describes a
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                                                    Moderator: Tucker Warren
                                              September 9, 2004/10:00 a.m. CDT
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clinical trial that we think represents a big step forward for patients with

depression, and for the clinicians who care for them.



You may know that the World’s Health Organization has estimated that

depression was the fourth highest cause of disability and premature death

worldwide in 1990, and will be the second highest cause by 2020.



Over the past two decades medical science has made great strides in

understanding depression. New drugs and therapies are more effective

than ever in treatment. Unfortunately, the stigma of mental illness

continues to influence attitudes toward this condition.



There’s a startling proportion of adults and children with mental illness

who do not receive treatment. Primary care is a prime portal to get people

into treatment, especially for those reluctant to access, or unwilling of

their need for mental health services. At this time few programs

nationwide are expressly organized to integrate mental health services and

primary care.



The MacArthur Foundation’s Initiative on Depression and Primary Care

has been charged with making a difference nationally in the primary care
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management of depression. To that end we have developed the Re-

Engineering Systems for Primary Care Treatment of Depression project,

known as RESPECT-Depression for short.



The components of the RESPECT approach of care are not unique but

rather the product of a wide range of recent research by many investigators

and institutions nationally and internationally. The essential components

include prepared primary care clinicians and practices, telephone care

management, and closer relationships between mental health and primary

care clinicians.



Professionals work together through these three components and provide

more systematic patient education, promotion of patient self-management,

and monitoring of suicide risk. Especially important is supporting

modification of the management plan if the patient’s symptoms are not

improving.



Starting in February 2002, we conducted a clinical trial of the RESPECT-

Approach. Five healthcare organizations in the United States - three large

medical groups and two health plans - and 60 of their affiliated practices

took part in the trial. Four hundred patients diagnosed with depression, in
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beginning or modifying treatment, were randomly assigned to either the

RESPECT- Depression Approach or to usual care.



Results: Sixty percent of patients responded to the RESPECT-Approach

within six months. Ninety percent rated their care as good or excellent.

Remission rates were up by almost 40% over usual care. Response rates

were up by nearly 30%, and patients who ranked their care as good or

excellent, was up over 20%.



Other studies have found benefits from enhanced care programs for

depression patients. However, many of the participating practices have

found that they can’t afford to continue these programs once the study is

over and the technical and financial support from the research team is

gone.



This study shows us how to better translate enhanced depression care from

the journal page to routine practice in the exam room. The RESPECT-

Approach relies on modest resources and the quality improvement

programs already available to many practices. The significance of all five

organizations participating in the trial has since taken steps to sustain and

expand their use of the approach.
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           In the interest of helping more practices to adopt this approach, the

           MacArthur Initiative is making the RESPECT- Depression materials

           available at no cost. These materials can be downloaded from our Web

           site, www.depression-primarycare.org. This is spelled out for you in the

           press release.



           Before I close, I think it’s important to note that the world today, as you

           all know, is filled with uncertainty and anxiety. We know there are real

           barriers such as perceived stigma to getting people the help they need to

           deal with depression. This approach breaks down those barriers by using

           the primary care clinician, the person in the front line of healthcare, to get

           people the help they need. Doing this now is more important than ever.



           At this point I’d like to call on Lieutenant Colonel Charles Engel, with the

           Walter Reed Army Medical Center in the Uniform Services University, to

           tell us about the development of a modified RESPECT model to help meet

           the post-war needs of returning soldiers and their families.



C. Engel   Thanks, Dr. Dietrich. As you may know, soldiers returning home from

           war sometimes struggle with depression, posttraumatic stress disorder, and
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              other mental health problems. They’re often reluctant or unable to seek

              the care of a specialist. This was a central finding among troops returning

              from Iraq and Afghanistan in a New England Journal of Medicine article

              published in July of this year.



              An approach based on the RESPECT-Depression model adapted for use in

              military primary care holds enormous promise. The RESPECT model

              could improve early access to needed services, improve the effectiveness

              of those services, and reduce stigma by locating the care in a primary care

              setting.



              Deployment Health Clinical Center, whose mission it is to improve post-

              deployment health care in the U.S. military, is actively working with the

              RESPECT team to tailor a modified program that will help meet the

              comprehensive post-war primary care needs of returning soldiers and their

              families. We’re also planning a feasibility project at Fort Bragg, North

              Carolina this fall.



A. Dietrich   Thank you, doctor. I’d also like you to hear a few words from Laurie

              Garduque, Director of Research for the Program of Human and
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              Community Development at the MacArthur Foundation. She will tell us a

              bit about why this work is so important.



L. Garduque   Thank you, Dr. Dietrich, and good morning. The MacArthur Foundation

              recognizes that mental health is critical to an individual’s healthy

              development and well-being and central to his or her ability to function in

              school, in the workplace, and in the community. Improving the quality of

              depression treatment and primary care is important for several reasons that

              extend beyond our concern for individuals and their families to the larger

              society.



              First, depression poses a major public health problem. Depressive

              disorders affect 19 million American adults; about seven percent of the

              population. One in five people will have an episode in their lifetime.

              Twice as many women as men are affected, and for half of the individuals

              depression will reoccur. Depressive disorders affect one in ten primary

              care patients, and most people with depression seek care in primary care.



              Depression exacts high personal and social cost. One of the more

              prevalent forms of mental illness, depression accounts for over half of all

              insurance claims. Effects include decreased functioning in everyday
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              activities, impaired work performance, increased mortality when it co-

              occurs with other medical conditions, and increased risk of suicide.



              In the workplace, depression is associated with decreased productivity,

              increased absenteeism, and increased disability. Yet, science has shown

              there are cost-effective treatments. The challenge is to close the gap

              between science and practice.



              The Foundation asked Dr. Dietrich and his colleagues to accelerate

              progress in closing the gap to develop a successful, replicable model of

              clinical care that would be available and sustainable in community

              healthcare settings and ready to take to scale nationally. Now we need to

              get the word out that the approach represented by RESPECT is practical

              and feasible in a variety of care settings, and that the tools are readily

              available.



A. Dietrich   Thank you very much, Dr. Garduque. I think we’re now ready to take

              some questions.



Coordinator   Your first question comes from Byron Spice from the Pittsburgh Post

              Gazette. Your line is open.
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B. Spice      Thank you. Dr. Dietrich, in this study you’re comparing the RESPECT

              model to usual care. Was usual care standardized in some way or did this

              vary depending on the provider?



A. Dietrich   Usual care was not standardized. It was what the provider usually did

              with a patient who was starting or changing their prescription dosage for

              medication or was being referred to counseling. It is worth noting that to

              participate in a study of this sort, the clinicians have to have a certain level

              of confidence in their care, and they have to be willing to cooperate with

              the rigors of informed consent and other things.



              So we found that our usual care physicians probably perform better than

              the national average in terms of providing services for depressive disorder.

              But even though this was a high-performing group to begin with, the

              RESPECT model was able to boost their outcomes in terms of patient

              depression and to achieve superior results in terms of remission, response

              to treatment, and patient satisfaction.



              These physicians, for the most part, did rely on medications with some

              proportion of patients getting counseling as well. They were clinicians
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              who had been taught about informed consent and had reviewed for them

              the criteria for diagnosing depression. But other than that there was no

              standard approach that they were required to take.



B. Spice      Is the effect with respect that they have more contact because of the

              follow-up calls, or is the number of contacts the same as with usual care

              but just different in kind?



A. Dietrich   That’s a great question, and I can direct your attention to table three in the

              paper and tell you some of the things that it reports. In particular, the

              clinicians in the prepared practices that were part of the RESPECT model

              were shown by independent evaluators to be more thorough about

              evaluating suicide risk, to be more likely to hand the patients patient-

              education material about depression, and to be more likely to promote

              self-management on behalf of the patient; that is seeking active

              opportunities for social contact, doing positive things like exercise and

              watching their diet. So those were some of the things that were different

              in terms of improved process of care for the clinicians that were working

              within the RESPECT model.
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              It’s also true that with the RESPECT model patients were much more

              likely to get a series of follow-up contacts from the clinician. They had

              both more follow-up visits over the three months following the index

              visit—following the first visit. And they were also much, much more

              likely to get a telephone support call. In this case these telephone support

              calls were provided by this telephone care manager who was based within

              each of the organizations and who was training to provide a supportive

              call to patients.



B. Spice      And the role of the psychiatrist, does the psychiatrist at some point step in

              if necessary, if the patient is not improving?



A. Dietrich   The psychiatrists functioned in several ways. They were in contact every

              week through a formal supervision call with the care managers, reviewing

              new cases and reviewing follow-up cases. For the most part they

              supported the care managers in what they were doing and made sure that

              they were following the protocol for care management.



              In some cases, although a modest percentage, they had an observation that

              they thought should be shared with the primary care clinician. This was
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              typically either suggesting an increased dose of the medication or perhaps

              a change in medication for patients that weren’t getting better.



              In some cases this was conveyed through the care manager in a written

              report, and in a few cases the psychiatrist reached out directly to the

              primary care clinician and said, “Oh, I see, Dr. Jones, that you’re helping

              Mrs. Smith. It looks to me like you might consider the following in terms

              of a change in management. What do you think about that?” So the

              primary care clinician was always in charge, but what the psychiatrist

              brought to the table was supervision for the care management and an

              informal resource for primary care clinicians to modify treatment to get a

              remission.



B. Spice      Thank you.



Coordinator   At this time we’re showing no questions.



A. Dietrich   Okay. Perhaps we’ll wait another minute or two to see if anybody comes

              up with a question that might be appropriate for Dr. Garduque or Dr.

              Engel. And I guess, if not, we’ll conclude the call.
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Coordinator   At this time I do have a question again from Byron Spice from the

              Pittsburgh Post Gazette. Your line is open.



B. Spice      Hello again. Dr. Engel, you mentioned something about a trial this fall, I

              think at Fort Bragg. Could you tell me more about that?



C. Engel      This is a feasibility study. As you know, people who return from war

              often develop challenges such as depression, post-traumatic stress

              disorder, and other mental health conditions, and primary care is an ideal

              place to de-stigmatize that care. They’re reluctant to seek specialty

              services in many cases. This was highlighted in the New England Journal

              paper published in the first of July.



              A lot of the data that was collected in that research was collected in Fort

              Bragg. This is a major place where troops are returning. So we’re

              interested in looking to see whether a modified version of the RESPECT

              model, applied to military primary care in a setting like Fort Bragg where

              there’s a high rate of people returning from the war, whether we can

              improve outcomes and improve access to services.
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              There are a number of unique aspects of military health care, one of which

              is that both patients and, in many cases, military providers are rotating in

              and out at a higher rate than one would see in civilian primary care

              practice. So we’re going forward cautiously.



              Right now we’re developing materials to report the intervention that

              describe the role of the care manager, the primary care doctor, and the

              psychiatrist, the tools that are used to screen for the relevant disorders, and

              we’re working with people at Fort Bragg to implement the feasibility

              study. And the plan is, in October, that we would implement the

              feasibility study at Fort Bragg.



A. Dietrich   That’s a great question, Byron. I think the thing that’s important to keep

              in mind is that this approach enables patients to obtain excellent

              management for depression and other mental health services in primary

              care. It enables primary care clinicians to provide it and it enables health

              care organizations, even organizations like the Department of Defense in

              the military to disseminate and support its use to benefit patients.



C. Engel      I would also add, Dr. Dietrich, that I think that it’s the overall flexibility of

              the RESPECT program model that makes it a fairly robust candidate to try
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              in an unusual and high-pace primary care setting such as the military,

              where troops are returning and going to war.



B. Spice      Dr. Engel, do you know what percentage of the returning troops are

              reporting symptoms of depression?



C. Engel      In the paper that was published by Charles Hoge and colleagues in the

              New England Journal of Medicine in July, what they found was that

              troops returning from Iraq were reporting post-traumatic stress disorder at

              about a rate of 17%, and that troops returning from Afghanistan were

              reporting post-traumatic stress disorder at a rate of about 13%, a much

              lower rate, so this is an important challenge for us.



              Again, I think the RESPECT-Depression model has the potential to be

              very adaptive and to improve the care of folks that we know will have

              these kinds of challenges when they come back. So we’re very

              enthusiastic about the use of the RESPECT model.



A. Dietrich   Byron, if you have any trouble putting your hands on that Hoge article,

              we’re happy to help, and I have to admit that article was an inspiration for

              us in RESPECT in getting together with Dr. Engel’s center to see what we
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              might do to address the problem that that study identifies so well, and we

              think the RESPECT model does offer at least one solution.



B. Spice      So you say, Dr. Dietrich, that all of the centers that were involved in this

              trial are now implementing this program, or in the process of

              implementing this program permanently?



A. Dietrich   Yes. They’re sustaining it or, the term is often used, “reinventing” it to

              move it out of a standard protocol that had to be similar across all five

              organizations to go on and evolve it to fit the particular cultures of the

              different organizations. But in all cases it relies on using a standard

              monitoring tool, this questionnaire called the PHQ9, that can help

              quantitatively assess the patient’s depression severity, and is sensitive to

              change over time. It also involves follow-up calls and promotion of self-

              management for patients, exercise and what have you, and the use of

              patient education materials.



              I think in all cases we see those elements continued. The particular way

              that the care management follow-up phone calls are provided vary a little

              bit across organizations and, actually, we would expect that. I think that

              for a program like this to be maintained over the long haul, it needs to be
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              modified. The rough edges need to be sanded to have them fit within the

              organization. Although, I think that all the places so far have done very

              well to maintain the essential elements that had been shown in other

              research to make a difference in helping patients get a remission.



B. Spice      Thank you.



Coordinator   I do have a question from Darrel Regier from the American Psychiatric

              Association. Your line is open.



D. Regier     Thanks very much. I’m delighted to see the study coming out, and I think

              one of the major questions that we would have is how this study and this

              protocol might be different than what has been experienced with other

              studies, like Juergen Unuetzer’s and the major study with the elderly

              population and others in primary care, that actually will make it

              sustainable over time, once the study is ended.



              I heard the previous discussion about that, but it seems like, in each of

              these places, the sites are going to have to maintain a care manager and the

              use of the PHQ9 as the essential element. And I was wondering how you

              saw the sites being able to deal with the financial issues and the
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              organizational issues of sustaining that in the absence of the research

              funding?



A. Dietrich   Well, excellent question, Dr. Regier. I’ll take a first crack at that and then

              I’ll see what Dr. Laurie Garduque would like to add. One of the unique

              things about this RESPECT study, Dr. Regier, is that we tried to build,

              within the quality improvement infrastructures of each of the five

              organizations, the ability to sustain the project over time.



              That is, we taught somebody within the quality improvement organization,

              who was paid by the organization, to know how to train new clinicians

              new practices in the RESPECT model, who knew how to train and support

              new care managers when there was turnover, and who knew how to train

              and support psychiatrists. So the skills to add new people and to maintain

              it over time were purposely built in to the infrastructures of these

              organizations.



              The organizations that we’ve worked with, for the most part, already have

              care management structures that are already dealing with conditions like

              diabetes and congestive heart failure. In some of these cases there’s pretty

              good data. At least the organizations have confidence that sustaining care
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management services saves money overall because it keeps people out of

the hospital, or keeps people out of trouble.



One of the ways that these organizations that we’re working with have

continued it has been to add the depression skills to these existing care

management programs so that for patients being followed already for

diabetes or congestive heart failure a depression screening and

management component gets added. And for patients that don’t suffer

from other conditions, there’s an infrastructure where the depression

support can get provided without creating something new. So that’s two

of the important things that are unique about this study.



Also the wonderful studies that had been done and recently reported, Dr.

Unuetzer’s study that you mentioned, Dr. Simon’s study, the studies of

Wells and Kayton and others, for the most part they involved more

intensive resources than we’re providing. For example, the Unuetzer

study that you mentioned, which was directed at an older population, had

built in the ability to get either low-cost or no-cost psychotherapy as part

of the plan.
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So, overall, I think that when you line them up those are much more

expensive projects to be able to sustain over time than the services of the

care manager providing a series of 10- to 20-minute calls to patients over

time than the services of an hour-a-week psychiatrist.



One of the studies that has the best economic analysis is the study of Dr.

Simon. He estimated that the cost of providing the kind of services that

we’re talking about here, in terms of telephone support, was on the order

of $80 a patient. Our own number-needed-to-treat studies—you’re

familiar with that concept—around the order of five or six patients need to

have the care manager services to get a remission, who otherwise wouldn’t

have gotten a remission.



So the organizations we’re working with have done the math and they’ve

concluded that supporting care management within their own resources is

feasible, appropriate, improves quality of care, improves patient

satisfaction, and improves clinician satisfaction. That’s not to say that this

is right for every organization at this time, but at least the five

organizations that we’ve worked with were able to sustain this project and

are disseminating it further. Laurie, would you like to add something?
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L. Garduque   Let me just add to what Dr. Dietrich has said. It was actually part of the

              challenge that the MacArthur Foundation posed for Dr. Dietrich and his

              colleagues was to come up with a model that would be likely to be

              replicated in a variety of different care settings, as well as in different

              regions of the country. So the fact that it demonstrated effectiveness in

              these five different healthcare settings in different regions is important in

              terms of thinking about how it might spread and be replicated.



              In addition, the model that RESPECT represents is not as discordant or

              discrepant to what you see, as Dr. Dietrich suggested, to other models that

              primary care practices use for managing other chronic conditions. So that

              gap between science and practice isn’t as great to close with the

              RESPECT model.



              I think that’s often why we see it as a failure to sustain or maintain

              innovative practices, because the infrastructure isn’t in place once the

              research team departs. But it’s also an empirical question and the

              foundation has provided funds to the initiative to follow the five

              healthcare organizations and to see, in fact, if the take up is sustained and

              maintained over time once the research team departs.
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A. Dietrich   Dr. Regier, I hope we’re answering your question. I might add that in one

              of our organizations, Intermountain Healthcare, there’s one care manager

              who’s actually received her 1,000th referral since we started the study back

              in 2002. So they’re clearly succeeding and maintaining it. And I think we

              can help any of you who are interested in making contacts with some of

              the organizations themselves, and clinicians, to find out from people on

              the front lines how it can be maintained and how it can work.



D. Regier     Yes, I think this is very responsive and I’m delighted that you’ve had the

              focus on an intervention that will be sustainable over time. Certainly

              integrating it into a care model for other chronic conditions like diabetes

              and hypertension and heart disease and the like is an excellent model to

              keep it from becoming just a separate effort that requires additional

              staffing beyond what might be available.



              I think that the major problem is probably disseminating it to the smaller

              office practices that don’t have additional staff available and that don’t

              already have a preexisting infrastructure of the type that your five

              organizations had. But if, in fact, this model can be demonstrated to be

              sustained, I think it will be a very nice contribution.
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A. Dietrich   Well thank you, Dr. Regier. I also don’t mean to say that there aren’t

              some changes in policy in the way healthcare financing is done that

              wouldn’t be very helpful in improving depression care, for example, the

              notion of primary care clinicians being informally able to consult with a

              psychiatrist and have the psychiatrist get paid for it; I think there’s

              excellent evidence that that’s justifiable and improves care. There’s no

              mechanism to do that yet, as I’m aware.



              Also, the notion of care management support calls. I think that, clearly,

              just about all the studies that we’ve been talking about over the last few

              minutes have included some component of care management and it really

              makes a difference in patient outcomes and it would be justified to be able

              to bill for it, and there’s no mechanism as of yet.



              The issue that you raised, Dr. Regier, about the solo practices: We’re in

              the midst of finalizing what I’m thinking of as kind of a do-it-yourself

              manual for somebody in an independent practice that does not have the

              support of a quality improvement project to institute at least a number of

              the elements of the RESPECT model.
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            A motivated clinician or practice now could go to our Web site, download

            the clinician manual, and could probably implement a half or two thirds of

            the RESPECT materials on their own if they wanted to take the time to go

            through it.



            And this do-it-yourself model that I’m talking about, we’re going to make

            it more streamlined so that a clinician or a practice manager could pick up

            the elements such as using PHQ9, having internal nursing staff make one

            or two follow-up calls, using patient education materials, and have that be

            something that clinicians who don’t have the benefit of a quality

            improvement program could do it on their own.



D. Regier   I would just add one other thing. At a time when there is such interest in

            monitoring the use of antidepressant medications, that the use of an

            instrument like the PHQ9 that has a specific mention of increases in

            suicidal ideation or increased activation, that, in fact, if physicians were

            using this kind of instrument on a routine basis they would be able to

            address the safety issues that have been raised and will now be raised

            again in the hearing at the FDA this coming week.
                                                                           LIPMAN HEARNE
                                                                   Moderator: Tucker Warren
                                                             September 9, 2004/10:00 a.m. CDT
                                                                                       Page 26

A. Dietrich   Indeed. Actually one of the more gratifying results that we got from the

              independent evaluation offices that were not aware of the point of the

              study, were not aware of people’s group assignments, is that patients cared

              for in RESPECT projects were much, much more likely to indicate at

              three and six months that they had been asked about suicide issues. And

              that is an important thing that I think the RESPECT model provides, and

              all of the data that we’re reading about, even in the paper over the last few

              days, the importance of suicide and monitoring for suicide can’t be

              overemphasized. So that’s a real strength of the program.



              I think we have time for a few more questions, if there are any.



Coordinator   I’m showing no questions at this time.



A. Dietrich   Well, we’ve had luck with waiting another minute before we sign off.

              Let’s do that again and see if there are any more questions that come to

              mind as people either look at the materials in front of them or reflect on

              the previous questions in the presentations.



              Well I think maybe it’s time to conclude. So I wanted to thank all of you

              for your interest and for your questions. We hope, by spreading the word
                                                                          LIPMAN HEARNE
                                                                  Moderator: Tucker Warren
                                                            September 9, 2004/10:00 a.m. CDT
                                                                                      Page 27

              about this trial and its related materials that are now available to clinicians,

              medical groups, health plans, and employers, more patients will get the

              care they need to lead happier, healthier lives.



              Thanks again. Have a good day, and if we can help you further, as you

              reflect on this call and look at the materials, please be in touch. Were you

              going to say any final words, Jeanne?



J. Brennan    No, I think we’re all set.



A. Dietrich   Thank you very much, everybody, and goodbye for now.

				
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