**Transcript of Cyberseminar**

**Spotlight on Pain Management**

**Patient Provider and Organizational Interventions for Managing Osteoarthritis in Veterans**

**Presenter: Marianne S. Matthias, Ph.D.**

**May 6, 2014**

*This is an unedited transcript of this session. As such, it may contain omissions or errors due to sound quality or misinterpretation. For clarification or verification of any points in the transcript, please refer to the audio version posted at www.hsrd.research.va.gov/cyberseminars/catalog-archive.cfm or contact**robin.masheb@yale.edu**.*

*Moderator:*Good morning, everyone.  This is Robin Masheb.  I’m the director of education at the PRIME Center and will be hosting our monthly team call entitled Spotlight on Pain Management.  Today’s session is Patient Provider and Organizational Interventions for managing osteoarthritis in veterans.  

I would like to introduce our presenter for today, Dr. Kelli Allen.  Dr. Allen is a research health scientist at the Durham VA Medical Center.  She’s also a research professor in the Department of Medicine’s Division of Rheumatology and Thurston Arthritis Research Center at the University of North Carolina at Chapel Hill.  Dr. Allen’s research focuses on improving care and outcomes for patients with osteoarthritis and other pain conditions.  

We will be holding questions for the end of the talk.  At the end of the hour there will be a feedback form to fill out immediately following today’s session.  Please stick around for a minute or two to complete this short form, as it is critically important to help us provide you with great programming.

Dr. Bob Kearns, director of the PRIME Center, will be on our call today and he will be around to take any questions related to policy at the end of our session.  Now I’m going to turn this over to our presenter, Dr. Kelli Allen.

*Dr. Matthias:*Well, great.  Good morning, everybody, from Durham, North Carolina.  It’s summer-like weather here and I’m glad to have the opportunity to talk with you today about some of the arthritis research we’re doing here at the VA Center of Excellence.

Okay, there’s my first slide.  We start out with one polling question, just mostly to give me an idea of who is on the line today.  The question is just for you to indicate your primary role in the VA.  I know most of you probably have multiple, but if you could respond your primary: student, trainee, fellow, clinician, researcher, manager or policy-maker or other.  Thanks, those of you that have responded already, some still coming in.  It looks like a lot of folks primarily clinicians, a lot of researchers.  

Okay, great, so about half of you clinicians, half or a little bit more.  Great.  That helps me a little bit in knowing how to gear this conversation.  We’ll go ahead on.

*Moderator:*I’m sorry to interrupt, Dr. Allen.  Bob, do you have your telephone unmuted?

*Dr. Matthias:*I did, I’m sorry.  It must’ve gone off. I’ll put it on mute.

*Moderator:*Thank you.

*Dr. Matthias:*Okay, no problem.  I just wanted to start off by talking a little bit about the burden of osteoarthritis, in general to set the stage for talking about this research area.  Osteoarthritis is highly prevalent.  You can see at the top of this slide some data from an actually large cohort study in North Carolina has shown that the lifetime risk of symptomatic knee osteoarthritis is 45 percent, meaning that about half of us will experience that sometime in our lives.  Then for hip osteoarthritis, the lifetime risk is 25 percent.

At the bottom of the slide you see some data showing that, like many other chronic diseases, we expect a big increase over the next several decades.  These are data from National Health Interview Survey.  They show data on all forms of arthritis.  

It’s something to keep in mind as I go through this presentation is that, as many of you know, osteoarthritis is by far the most common form of arthritis.  This shows a large and growing public health burden.

In addition to being highly prevalent, osteoarthritis is highly disabling.  This slide shows the number of adults in millions who have disability from different kinds of conditions.  You can see here, arthritis or rheumatism being the most highly common of those, followed by back or spine problems, which is a mix of things, but some also can be related to osteoarthritis.  It’s a high burden, in terms of disability.

I wanted to say a little bit, too, about the burden of osteoarthritis specifically in veterans.  Arthritis in general is the third most common health problem in veterans.  Some data have shown that the prevalence is higher in veterans than non-veterans, like again, many other chronic health problems.

Some data that we’ve looked at from the CDC have shown that arthritis affects 22 percent of non-veterans, 30 percent of veterans who are not VA users and then 43 percent of VA users.

Then if you look among veterans who have arthritis, activity-limiting joint symptoms are more common in VA users than non-users.  Again, common to what we see in other chronic conditions is the severity is greater in our VA users.  I think that statistic is particularly staggering in that people who have arthritis, well over half of them are having symptoms that are limiting their daily activities.

These forms of motivation for the research we’re doing, in addition to some things we know are gaps in the management of osteoarthritis.  There are, of course, things that go very well for a lot of patients, in terms of having their osteoarthritis managed, but I wanted to highlight on the next couple of slides some areas where research shows we have some gaps we probably need to be filling.

I want to start by talking about those at the patient level and then at the health system level.  In terms of patient behaviors related to OA management, we know that a lot of patients are symptomatic for a good while before they seek care.  It’s common to hear people talk about having joint aches and pains, but, “Oh, it’s because I’m getting older.”

The challenge behind that is that often what happens is that people get these aches and pains, they become more physically inactive, they become heavier, more overweight and so it’s this cycle that by the time patients often seek care or mention their symptoms to their health care provider, they’re kind of started on that trajectory of having the osteoarthritis progress, which makes it more challenging to manage.

We also know that a lot of patients have relatively limited knowledge about their arthritis and how they can manage it.  Physical activity is a key component of managing OA.  We know that most patients with OA are inactive.  Some days data showed 75 percent of them don’t meet physical activity recommendations.  Those are actually some of the lower numbers.  Some data show that that portion is a good bit higher.

Weight management is also really key for managing osteoarthritis symptoms, but we know that the majority of patients who have hip or knee osteoarthritis are overweight or obese.  Definitely a lot of challenges on the patient side.

Then what about our health care systems in managing OA?  One key is that detection and diagnosis often occur late.  Part of that is due to what I just mentioned is that patients often don’t report symptoms until they’re kind of far along in the course of their arthritis.  We don’t have any systematic ways to screen.

Now to be fair, there are no really good early markers of OA, like we have for some other conditions.  We do know risk factors, like, of course, age and overweight.  Some emerging data really show that prodromal symptoms, or just mild joint pain, is really a pretty good indicator of the likelihood of having osteoarthritis or developing it in the near future.  We probably can do something, in terms of screening more regularly for people who are known to be at risk.

Then what about care for people who we do know have osteoarthritis?  There are several sets of quality indicators out there in the literature for osteoarthritis management.  Across studies that have looked at pass rates, those have been between 22 and 57 percent pass rates.

One particularly important thing I think is that those studies have consistently shown that there’s relatively low use of conservative and non-pharmacological strategies that do have an evidence base for helping to manage osteoarthritis.  Some of those include exercise, weight loss, physical therapy and use of assistive devices or braces, canes and those types of things.

Before I start talking about our research here, I wanted to ask a question that I’m often curious about, is how familiar people are with osteoarthritis treatment guidelines?  My question is would you describe your familiarity with osteoarthritis treatment guidelines, any set of them, the choices being didn’t know there were any; I know they exist but I’m not familiar with the content; somewhat familiar with the content and very familiar with the content.  

I see lots of responses coming in.  Thank you.  So far looking like the most common response, somewhat familiar with content, followed by unfamiliar with content.  Okay, so poll closed.  Almost 70 percent of folks say they’re somewhat familiar with content, which is actually encouraging to me.  

There are four or five or so sets of osteoarthritis treatment guidelines that are published and always being updated and changed.  The thought out there is that a lot of them are not—perhaps not very well disseminated.  I’m always curious to what the level of familiarity is with those guidelines, so that’s very interesting and helpful information for me.

Moving on from there, I’m going to talk about one study that we’re doing here.  We actually have several trials ongoing, but in the interest of really focusing this presentation, I wanted to tell you about one that we recently completed.  It does have to do somewhat with those guidelines.  

The title of this project is Patient and Provider Interventions for Managing Osteoarthritis in Primary Care, which I’ll refer to from here on as PRIMO.  You see at the top of this slide our objective has been to examine the effectiveness of a comprehensive intervention involving both patients and providers for improving osteoarthritis outcomes in a real world VA clinical setting, so a very pragmatic clinical trial.

This has been a randomized controlled trial and there are two groups.  The first is assignment to a combined patient and provider intervention versus usual care.  Providers are actually our unit of randomization for this study.  We enrolled 30 primary care providers at the Durham VA and they were randomized either to the patient and provider intervention or usual care.  Then we aimed to enroll 10 each of their patients, five white and five non-white.

At the Durham VA we primarily, in terms of racial and ethnic minorities, we primarily serve African-American veterans, so we didn’t really have high enough representation of other groups to separate those out.

One challenge that you can probably imagine we encountered and that we anticipated is that some providers in our study left the VA during the study period.  Thankfully, none of them left our study specifically, but there was some general attrition of providers over the period in which the enrollment occurred, which was about a year and a half or so.

What we ended up with was a range of enrolled patients per provider that was between three and twelve.  To maintain our full sample size goal of 300, if a provider left the VA before we were finished enrolling their patients, we kind of distributed the remaining of their patients across other providers.  The range was three to twelve, but the majority of providers did have around that 10 range, but just one illustration of a challenge of a provider-based intervention in a pragmatic trial of this kind.

Participants in our study, they obviously had to be patients here, at the Durham VA.  They all had to have symptomatic hip or knee osteoarthritis by prior radiographic evidence or for knee there were also clinical criteria that we used.

Our patient intervention focused on a few things that I’ll describe in a little bit.  Two of those were weight management and physical activity.  All participants in this study had to be overweight, so BMI greater than or equal to 25, and they all had to be not currently already meeting physical activity recommendations from the Department of Health and Human Services.

Our primary outcome for the study was the Western Ontario and McMasters University Osteoarthritis Index, which I’ll refer to as the WOMAC.  That’s a self-reported measure of pain, stiffness and function.

Our two secondary outcomes are listed here, too.  The short performance physical battery, which is objectively assessed function, and that includes tests of balance, chair stand and a short walk.  Then depressive symptoms with the PHQ.  Today, in terms of the results that I will present, I’ll be showing you what we’ve looked at so far, which is the first two, the WOMAC and the SPPB.

Let me tell you a little bit about our interventions. The patient intervention is based on some work we’ve done here and that others have done in telephone-based osteoarthritis management.  It was a 12 month intervention.  Participants received calls every other week or twice a month for the first six months and then once a month for the last six months.

We focused this on three main areas that we felt had the best evidence base for treating lower extremity osteoarthritis from prior effectiveness studies.  Those are physical activities, weight management and then some cognitive behavioral management skills.  We had an emphasis in the intervention on goal-setting and the counselors used motivational interviewing approaches throughout the intervention.

I just wanted to show you some of the pages from our accompanying booklet.  We worked with a local firm to develop our relatively low literacy packet for patients.  These are just some example pages: our chapter on what is osteoarthritis, some stretching exercises that we had illustrated after we did some photo shoots here and this is just a page from our weight management section.  Again, they all received these booklets to accompany the phone-based intervention.

Now let me tell you about the provider intervention, which I think is really the most novel part of the intervention package.  The overall goal of our provider-based intervention was to enhance use of guideline-based osteoarthritis treatments, really with an emphasis on non-pharmacological therapies.  

We know, and you’ll see from some of our data later, that a lot of patients are already on medications for their osteoarthritis.  We really wanted to make sure we were emphasizing and getting in to providers hands some recommendations related to non-pharmacological therapies.  I’ll talk about this in more detail in just a moment.

How we did this was that we issued patient-specific treatment recommendations to providers at the point of care, optimally in conjunction with the routine visits.  You’ll see in a minute what these recommendations were, but we tried to get them in the medical record within a few days of an acute—I’m sorry, a non-acute visit.

The recommendations or the guidelines for osteoarthritis that were available at the time this study started, as well as the ones that are out there now, really don’t—I’m sorry, I don’t know if you all see that.  I just did something to my slide.  Here we go.

We really don’t offer a whole lot in the way of practical guidance of when a treatment might be most appropriate for a given patient.  What we did at the beginning of the study is work with some clinical experts, some content experts, to take those guidelines and put within them kind of some algorithms for when we might issue a recommendation to a provider.  

What are some criteria that indicate when a patient might be a good candidate for appropriate physical therapy, for example, the one I’m showing here at the top.  Let me go through this one, this example, for you.

The criteria were used for referral to physical therapy were first that a patient had to indicate that they would be interested in being referred, if their provider recommended it.  That criteria patient interest was common to all of our recommendations.

Second, the patient had to not be doing strengthening exercises regularly, more than twice a week, since that’s a main component of physical therapy, particularly for knee osteoarthritis, is home strengthening exercises.

The patient had to indicate that they were dissatisfied with some aspect of their daily function, since that’s another area that is a focus of physical therapy is restoring function.  Then finally, a patient had to have not seen a physical therapist for their OA in the past year.

Based on our baseline assessments of patients, we used these algorithms to determine which recommendations would go to providers for a given patient.  Not all patients got the same set of recommendations.  We really tried to tailor them as best we could to what seemed appropriate for each patient.

I’ve listed here for you too, the other recommendations we could issue for a given patient: knee braces, a referral to weight management, which in the VA that would be to MOVE!, most of the time, referral for physical activity programs, again MOVE!, as one example in the VA, joint injections, topical NSAIDs or capsaicin, adding a gastro protective agent, that would be for patients who are taking the NSAIDs but had GI bleeding risk, trying a new pain medication and then referral to orthopedist for consideration of a joint replacement.

Okay, so let me tell you about our study results, starting with just an overview of our participant characteristics.  The mean age was around 60 years.  As I mentioned before, by study design there were half white and half non-whites.  About 90 percent male, as you’d expect from a VA population.  The mean BMI was firmly in the obese category, at 34.  

Twenty percent of participants had hip osteoarthritis, almost 90 had knee osteoarthritis.  The mean self-reported duration of symptoms was about 14 years, with a standard deviation of 11.  That’s important to keep in mind.  I’m going to show you in a little bit what patients said they were doing or had done to manage their arthritis at baseline in this study.

Important to consider that these mostly were not patients who were newly diagnosed.  These are mostly patients who have had it for several years or more.  The mean WOMAC score at baseline for this group is 48, which is an indication of kind of moderate to severe symptoms.

Before I want to tell you about the study results, I wanted to talk a little bit about what participants were doing at baseline to manage their osteoarthritis or what they had done since they’ve had diagnosed arthritis.  You can see here that the large majority of them, almost 80 percent, were taking some kind of medication for their arthritis, almost 80 percent, which is not surprising.  You see the specific categories below, so a little over half were taking some kind of an NSAID, 19 percent acetaminophen, and a pretty high percent, 29 percent, were taking opioids.  That was something they said they were specifically taking to manage their osteoarthritis, not for another pain condition.

You can see that the categories below add up to more than 77, indicating that there were a number of patients who were taking more than one class of medication to try and manage their arthritis symptoms.

We also asked patients how well they thought their medications were controlling their arthritis pain, from zero, not at all, to ten, very well.  You can see the average score was about a five.  We’ve used this same question across probably three or four studies, VA, non-VA, and it inevitably is that same number.  It’s around five.  Really, patients are certainly being helped by their medications.  

This is not surprising, particularly to all you clinicians.  You know that medications help but particularly as symptoms get worse, they don’t completely take away the pain.  What that emphasizes to me is really the importance of trying to combine those medications with some non-pharmacological therapies that can help, as well.

We also asked patients if they’d be interested in talking with their provider about trying different pain medications.  You can see the vast majority said either yes or maybe.  That was one of the questions that fed into our provider intervention, in terms of selecting recommendations.

We asked about joint injections, specifically whether they’ve had—they’d had an injection for their arthritis in their knee.  That’s any kind of injection, viscosupplement or steroids.  About half had one for their knee and about 20 percent for their hip.  Not surprising that it’s less for the hip.  It’s just less commonly used and less evidence-based for that in the hip.

We also asked if they’d be willing or interested in having a joint injection, if their provider thought it might be appropriate.  Sixty percent said yes and 22 said maybe, so a fair amount of interest in that type of treatment.

We asked them if they had ever used a topical cream and a lot of them, almost 70 percent, said they had.  A lot of them also said they’d be interested in trying either a different one or a first one, if they hadn’t, if their provider recommended it.  Patients are very willing to try these non-oral kinds of pharmacotherapies.

We asked about brace use, if patients had been diagnosed with knee osteoarthritis.  A really high proportion, 81 percent, said they had.  I would say that’s most likely a lot higher than you would see outside the VA.  I think that one of the things, at least our VA, does pretty often is to issue various kinds of knee braces.

In those patients, only about half of them had used something other than an elastic sleeve.  A lot of them had just kind of gotten—had the kind that you could purchase at a drugstore, for example.  The vast majority, 92 percent, said they would be interested in trying a brace or a new kind of brace if their provider thought it might be appropriate for them.

Last slide on these kinds of data, related to physical therapy.  We asked if patients had seen a physical therapist for their knee and hip osteoarthritis.  For those who had knee osteoarthritis, only about half had ever seen a physical therapist and for hip, only about 30 percent.  

A relatively low number is not surprising for hip.  There’s less evidence base out there for effectiveness to date for hip osteoarthritis.  The evidence is pretty good, in terms of effectiveness for physical therapy for knee osteoarthritis.  

These data, to me, indicate that this is probably an area that we can generate some improvement, in terms of increasing referrals for physical therapy and veterans with knee OA.  Again, considering this is *[inaudible 23:08]* report of ever having seen a physical therapist in patients who have had, a lot of them, pretty longstanding knee osteoarthritis.  

If patients haven’t seen a physical therapist in the past year, we ask them if they’d be interested if their health care provider thought it would be appropriate; again, another question that fed into our provider recommendations.  In patients with hip osteoarthritis, 90 percent said yes or maybe, that they would be interested.  For hip osteoarthritis, about 85 percent said yes or maybe.

Those were some of our baseline data that I thought were interesting.  I want to move on to tell you about how things went with the delivery of our two interventions.  For the patient intervention, again, this was built on methods that we and others have used for phone-based self-management intervention, and overall it went well.  The mean number of calls completed, on average, was 12, with a standard deviation of 4.3, again, out of a possible 18 calls over that one year period.

The average call duration was about 17 minutes, so not a really long—and there was a good variability here, because during the first part of our study the second call of the month was just kind of a check in or brief call.  

We’ve done a preliminary cost estimate, just for the patient component intervention, and we have so far estimated that it costs about $300 per patient to deliver over that one year period.

I’m looking at our provider intervention.  We were able to successfully issue treatment recommendations for all but six participants within the study period, so we got those to a provider, the primary care provider in the medical record for almost all of our participants successfully.

Also importantly, 68 percent of them we were able to get them into providers’ hands or at their eyes, within a couple of weeks prior to a non-acute visit, which is our goal.  Definitely a challenge, but something we thought was really important, in terms of making the information available to providers when it’s most useful.

As you can imagine, there are challenges in terms of scheduled visits, missed visits.  We had to keep our eyes on those appointments, but again, for well over half of them, over 78 percent, we were able to get them in the medical record when we had aim to do that.

For the others, they were in the medical record but not necessarily right in that period immediately prior to a non-acute visit.  In some cases, we issued the recommendations and the visit was rescheduled, but it was rescheduled for several weeks or more later.

Okay, so I don’t know if you all have that—the slide that I see is a little bit kind of messed up on the treatment recommendations.  I don’t know if it is for you all too, but I’ll read through it in case you are seeing it like I am.  The next thing that I wanted to talk about was the treatment recommendations that we did issue for those in the intervention group.  

On the left column you see a list of the specific treatment recommendations.  In the middle is the proportion of intervention participants who had that recommendation issued to their provider.  Then the last column is the percentage of, at least for some of the rows, the percentage of patients for whom a provider did issue a consult associated with that recommendation.  That’s out of the denominator of those who were issued a recommendation.

Let me just start to go through these.  The top one, a knee brace, we issued that recommendation to providers for 41 percent of our intervention group participants.  Of those, 35 percent of the time a provider did a consult for a knee brace.  The next one is a referral to physical therapy for evaluation or exercise.  Then for that, 49 percent were issued a recommendation.  Of those, 20 percent of the time a provider did a consult for physical therapy.

The next one is weight management, which in this case would most likely be MOVE!  Eighty-two percent were issued that recommendation.  You saw our data on level of overweight and obesity.  The majority of patients in the study were in the obese category of BMI, so that was a very common recommendation we issued.

Of those who had that recommendation, 23 percent of the time a provider did a consult.  Physical activity, which was also MOVE!, could be a MOVE! consult.  Seventy-seven participants had that recommendation issued to a provider and of those, 23 percent of the time there is a consult issued.

The next slide is the remainder of our treatment recommendations.  Twenty-two percent of participants we issued a recommendation related to getting a joint injection.  Of those, 15 percent of the time the provider did a consult for a joint injection.  We don’t know how many times a provider may have done a steroid injection themselves.  I’ll talk in a minute about what we plan to do, in terms of looking at actual utilization of these services.

Looking down the road, 50 percent of patients had a recommendation for trying a topical NSAID or capsaicin.  Consults wouldn’t—there’s not a consult-related—that just doesn’t apply in this row. 

Eleven percent of patients had a recommendation related to adding a gastro protective agent or removing from NSAID.  That’s a safety issue and good that it’s low.  What we and others have found is that there often patients who are taking over the counter NSAIDs that their provider may or may not know about, but they have GI bleeding risk.  Hopefully this is an area we were able to inform providers when that might be going on, particularly if it was a non-prescription medication that they didn’t know about.

Eighty-three percent of participants had a recommendation issued to talk about a potential medication change.  Again, a consult’s not applicable in this situation.  Then lastly, referral to orthopedics, we’re discussing the potential joint replacement surgery.  That was issued to 12 percent of participants and of those, 11 percent received a consult.

That’s just kind of a snapshot of one way to look at what providers did in response to the recommendations that we issued.  Again, consults aren’t related to all of these recommendations and our next step is obviously to look at utilization, which will capture more of this and give us a better picture of what actually happened.  Did patients go to PT?  Did they get a knee brace?  Did they go to orthopedics?  Things like that.

One summary statistic here is that of patients in the provider intervention, 40 percent of them were issued at least one consult.  I actually thought that was rather encouraging.  We know that a lot of these patients have a lot going on, medically.  We know, again, that consults aren’t applicable for all of the recommendations we issued.  I was rather encouraged that 40 percent of the time there was something easy the provider could do, namely issuing a consult for some kind of typically non-pharmacological treatment.

Okay, so let me go on.  I want to tell you about our results so far.  These are kind of some preliminary data based on our models for the trial.  I’m starting off here telling you about our primary outcome, the total WOMAC score.  

On the X axis you see our measurement point.  Our primary outcome point is 12 months, so we also had an interim assessment at six months you see here, as well.  That was a phone-based assessment.  

You can see our treatment or intervention group in the blue and the usual care group in the orange.  What you see here is at six months both groups having some level of decline, which in the case of the WOMAC, that means improvement.  Not uncommon to see that in osteoarthritis clinical trials.  By our 12 month primary outcome point, the treatment group was doing better.  That was a statistically significant difference between the groups.

There are different data out there showing—to describe what a clinically meaningful difference is in total WOMAC score.  I would say based on the whole of those that these do meet the threshold for a clinically relevant treatment response.

Moving on, looking at a pain subscale of the WOMAC, again, same setup of the graph.  You see the time point on the X axis and the treatment group, again, in blue, usual care in orange.  You see a similar pattern here, but this was not significantly different between the groups at 12 months.

This is similar, actually, to what we found in a prior clinical trial of phone-based self-management for osteoarthritis in veterans, where effects of this type of intervention seem to be a little bit more robust for function.  I’ll show you that graph here.  This is the WOMAC function subscale.  Again, you see a very similar pattern to what we saw with the total WOMAC score and more robust differences at the 12 month time point and a significant and clinically meaningful difference between the two groups.

Related to that, we see kind of a green pattern here when we look at objectively assessed physical function in a short performance physical battery.  For this test, we only had two assessment points, baseline and 12 month follow up.  Since our six month time period was phone-based, we weren’t able to do the subjective functional test.  

You see our usual care group in orange declining over time, so a reduced function, poorer function over the 12 month period, whereas we see the opposite, an increase, not a huge increase, but somewhat of an increase and definitely not a decline in function, which is sort of the natural trajectory of osteoarthritis.  Improving in things like a short walk, chair standing and balance.

Some data that I don’t have yet to show you but that we’ve started to look at is self-reported physical activity data.  Those do appear to be different between the groups, with the treatment group having more—a greater increase in physical activity over the study period.  That is, I would say, most likely what is driving what we see here with improvements and function, is that we are able to do this intervention to get participants moving more, resulting in an increase of their function, which is hugely important in osteoarthritis.

Summary and conclusion here, we found that a combined patient and provider intervention improved key outcomes.  This intervention I would say is relatively inexpensive and really, it could be delivered centrally in the VA.  The patient intervention is all telephone-based and the things that we did in the medical record are also something that could be done centrally.

With all research, we have a lot of remaining questions.  Of course, we always want to know what the longer term outcomes are.  That’s a challenge to get participants with osteoarthritis and any other chronic condition to maintain their positive lifestyle changes.  We’d like to do some more follow up and see what’s happening over time.

Another important question I think is what’s the relative importance of the patient intervention versus the provider intervention.  For this study we delivered them as a package.  We also have an ongoing study in another health care system.  It’s going to be teasing out the patient intervention, provider intervention or a combination intervention to see is it—what’s most important, what has the biggest impact?

We certainly saw here, at least from looking at the consults, that providers did things.  They issued recommendations for evidence-based types of therapies.  My hope is that it is kind of an area where we can attack the problems on both fronts, both the patient and provider level, but hopefully our other study, even though not in a VA population, will help us to get a better picture of the relative importance and impact of intervening at those two different levels.

Another question really towards implementation is there a simple and automated way we can deliver the provider-based intervention?  You saw an example of the algorithm we used to deliver, or to choose specific recommendations.  They were based on not complex data, but four or five measures, probably, for each recommendation.  

These are not all data that you would necessarily collect at each clinical encounter.  However, I think those algorithms can most likely be simplified to a core set of a few things that would indicate whether a provider may at least want to have a discussion with the patient about things like physical therapy and whether that’s of interest.  I think that’s sort of a next step in moving towards implementation is what’s the easiest way to deliver this kind of intervention in a way that can be automated?

Then finally, I look forward to a Q&A session here and your suggestions for follow up we can do in this research and moving towards implementation.  I think I’ve ended a few minutes early, but hopefully that will allow time for good discussions.  I just thank all the people who have participated with us on our multiple osteoarthritis treatments at the Durham VA.

*Moderator:*Great.  Thank you so much, Dr. Allen.  Before I turn it over to Robin to moderate the Q&A, I just want to let those of you know that came in after the top of the hour, to submit a question or a comment just use the Q&A box that’s located in the upper right-hand corner of your screen.  Just type your question into a lower box and press the speech bubble and that will submit the question.  It looks like we have one pending now, so I’ll turn it over to you, Robin.

*Moderator 2:*Thank you, Molly.  I’m just waiting.  I don’t see any questions that have come in yet.

*Moderator:*Oh, up in the upper right-hand corner the Q&A box.  You may have to click on the presenter view, which is the icon just to the right of where it says Q&A.  It looks like a person with a little screen behind it.  Do you see that icon?

*Moderator 2:*Oh, great.  Thank you.  Oh, here’s a question.  Were referrals to occupational therapy ever made?

*Dr. Matthias:*That’s a great question.  We didn’t do occupational therapy primarily because we were focused on lower extremity hip and knee osteoarthritis.  Although that can certainly be a good treatment, there’s not a whole lot in the guidelines right now for hip and knee osteoarthritis related to occupational therapy, mostly because there’s not been literature on that from which the people developing the *[inaudible 37:58]* that.  

That’s a great question.  I think that that’s something worthy of consideration if we are able to move forward with some implementation phase.  Again, the reason we didn’t do that was because we tried to base our recommendations strictly on the guidelines, which didn’t have a solid recommendation for use of occupational therapy, either for hip or knee osteoarthritis.  That’s a great consideration for the future.

*Moderator 2:*Can you also share with us what practitioners were able to make the consult?

*Dr. Matthias:*Yeah.  Most of the time, that would’ve been the primary care provider who was enrolled in the study.  That was the best case scenario.  We enrolled the 30 providers and if they were assigned to the group, those providers would be the ones who would get the recommendations and then who would give the consult.

There were situations where maybe a patient was enrolled with a primary care provider who was enrolled, but for some reason they saw a different non-enrolled VA ambulatory care provider for a non-acute visit.  Either their provider was on vacation, they rescheduled, there was cover or something like that.  In those situations, we got permission for the treating ambulatory care provider to do the consult.

In either of those situations it was ambulatory care.  Most often it was the enrolled primary care provider, but in a few situations it was another ambulatory care provider who saw the patient for a non-acute visit.

*Moderator 2:*For example, could it have been nurse practitioners?

*Dr. Matthias:*It could have been, yes.  I think we may have enrolled one PA or nurse practitioner in our study.  The way we selected our ambulatory care providers actually was—it could be any of those.  We just selected people who had large enough patient panels that we thought we were likely to be able to enroll 10 patients of theirs with hip or knee osteoarthritis.  They were eligible to participate and give the treatment recommendations, yes.  Yes and if they were a covering provider, they would have been able to do that.  

*Moderator 2:*Great.  Can you talk a little bit more about how the cost analysis was done?

*Dr. Matthias:*Sure.  That’s just a preliminary cost analysis.  I’ll describe it to you in a minute.  We’re also planning to do a more formal cost effectiveness analysis. For this, all we did was we took the salary of the counselor, who was delivering the patient intervention and factored in training costs or the time that we spent with that counselor to do the training for the intervention and supervision and then looked at the average time for the calls per patient; and so just took that salary and basically looked to see how much time it took a person at that certain GS level to deliver the intervention, including the time of training, which was relatively minimal, but the time to deliver the intervention.

For our cost effectiveness analysis we were obviously doing much more robust than that.  It will include utilization of osteoarthritis related treatments and compare those between the groups.  I should say, the other cost included in the estimate that I gave, the $300 estimate, was some relatively minimal cost, but some materials that we gave patients.  

That was a booklet that I showed you a few pages *[inaudible 41:29]* and an exercise video that we gave them from the arthritis foundation.  I think that runs about 20 dollars and a Thera-Band that goes with it, which runs a few dollars.  Those are the main things.  It was the time with the counselor and then those, you know, probably 25 dollars-worth of materials that they received.

*Moderator 2:*Great.  We also have a question here about could you tell us exactly how the treatment recommendations were made to the providers?  Was this through some sort of note?

*Dr. Matthias:*Yes, it was a note.  It was a progress note that required a co-sign.  We went back and forth on different potential ways to do that and that was ultimately what we settled on.  We’re doing a similar project in, as I mentioned, in the Duke Healthcare Network and we’re doing that via the EMR, which has changed over time, so with different logistical ways of doing this.

It was nice in the VA system that we could do something like a co-signature, so we actually know what providers saw and what providers didn’t see.

*Moderator 2:*Can you tell us about what was the background or professional discipline of the counselor who delivered the recommendations?

*Dr. Matthias:*Sure. This was a master’s trained counselor.  She happens to be someone who’s worked in the VA for a number of years.  She is a licensed counselor who has done a lot of health educational intervention here with us at the Durham VA.  

That’s the type of level salary we’ve used in the cost analysis.  I think there are various kinds of folks who could deliver this kind of intervention.  A lot of people that I work with here have nurse delivered interventions.  We chose not to go that route, since we weren’t focused on anything related to medication changes in the patient intervention. This was someone with kind of a counseling background who has had a lot of experience with veterans, in particular.

*Moderator 2:*Did you consider or are you considering for the future, doing some sort of study of other CAM interventions, things like acupuncture?

*Dr. Matthias:*That’s a great question.  I haven’t ventured into that much.  It’s kind of a separate study, but I’ve been collaborating with researchers at Duke who are looking at massage therapy for knee osteoarthritis.  We were able to get a supplemental study through NCCAM, particularly to do a pilot at the Durham VA that took that massage intervention and specifically looked at it in the veteran population.  

We finished that pilot study and the results were excellent.  The feasibility, acceptability was excellent, which was something we were really interested in looking at because this was a very different population than maybe your typical massage or CAM users in the general population.  

That’s something that we’re hoping to move forward on with a larger study, not acupuncture, per se, but looking at massage as one complementary therapy to see a little bit more about its effectiveness and acceptability.  We’re hoping to do a larger trial to follow up on that, since it was not only great with it in terms of acceptability, but improvements in pain in that small pilot study were rather good.

*Moderator 2:*I’m just waiting to see if we get any more questions.  There were a couple of the first questions that came in that I missed.  If I didn’t get your question, if you can just write it in again, I would greatly appreciate it.

Here’s one.  How can we improve the disparity or difference between recommendations made and recommendations implemented by the primary care physician?

*Dr. Matthias:*Yeah, that’s a good question.  You saw that for some of the recommendations we issued a relatively high proportion did a consult and for some it was relatively low.  You know, to be honest, I don’t know what the right answer is, in terms of how many of those recommendations should be followed up on.

Our goal really was to kind of raise awareness of potential recommendations for providers to consider, but certainly we didn’t want providers to be overwhelmed with 14 different recommendations.  I think that’s a great question, but a little bit of a hard one, in terms of defining whether that disparity means something bad or not.  

We certainly want providers to be considering the range of potential, and particularly non-pharmacological therapies.  I think a challenge is that in *[inaudible 46:01]* arthritis 46:02 literature there are not really hard and fast appropriateness criteria.  For example, if a provider in our study chose not to give a referral for physical therapy, I don’t really have a good way to say whether that’s right or wrong.  I think our goal, again, is to have providers consider and talk with patients about potential treatment options so they know and have accessible to them the range of possibilities.

The physical therapy is of particular interest to me because of its low use and because in our study we saw relatively low proportions of providers who did act on that and make a consult.  That’s one thing that we’re going to be exploring in our follow up with providers.  

One of the things we’re starting to do with the study is to talk with providers who were involved and say, you know—well, first of all, get their feedback generally on the approach and the intervention but also to ask were there things that were barriers to you doing something, issuing a consult, that can help us understand this better?

My guess is that for physical therapy, researchers are just really limited and so it could be that you mentioned it to patients and patients said, “No, I really just don’t want to come back for another visit.”  It could be that providers know that the physical therapy visits are really limited.  

I don’t know if it’s common across VAs, but I know at our VA number one, the wait time is not huge and they’ll fee-based it out if they need to.  Patients for knee OA, they’ll probably get one outpatient visit, maybe two.  Just with talking to a couple of providers, I know that that’s sometimes a barrier to them feeling like it’s going to have a substantial benefit.

That’s one particular example that I think we can start to think through, what are some ways to deal with those disparities.  I think in terms of—the first step is to figure out why they might be there.  In our study in particular, we’ll have the opportunity to talk with providers through the different recommendations and get a sense of what went into their decision about whether to issue a consult or do some certain kind of treatment or not.

*Moderator:*Just so I can clarify then, if a provider started to talk to their patient about physical therapy and the patient was like, “No, no, no, I’m not going to do that,” and they didn’t make a referral, you wouldn’t have a way of documenting that there was actually a conversation about it, just the way you collected the data?

*Dr. Matthias:*That’s true.  The way we collected the data we would not have—we wouldn’t do that.

*Moderator:*Right, right.  It sounds like that would be in the next step, in terms of being able to get a better understanding from providers what kind of barriers they ran into?

*Dr. Matthias:*Yes, yes, right.  We’ll hopefully get a sense of that qualitatively, but in terms of data on all of the participants, no, we won’t be able to do that in particular.  You know, if you remember our baseline data, a lot of participants were really interested.  At least, they said at the beginning of the study that they’re interested in physical therapy.  

When that conversation actually happens may be a different story.  Maybe a provider brings it up and they’re interested, but does interested necessarily meant that they’re interested enough that they’re willing to come back and have a follow-up?

*Moderator:*We have some room for more questions, if people have.

*Dr. Matthias:*This is Bob Kearns.  Can I take my privilege and ask a question?

*Moderator:*Mm-hmm.

*Dr. Matthias:*Thanks, Kelli.  Great presentation.  I’m very interested from the research perspective on measurement issues, and particularly measurement of functioning, having just been at a combined Impact 49:45 OMERACT meeting focused on measurement of physical functioning and these are challenges, so I’m interested in your choice of measures, the WOMAC and this physical—this—

*Dr. Matthias:*SPPB?

*Dr. Matthias:*Yes, thank you.

*Dr. Matthias:*Yes, that’s a great question.

*Dr. Matthias:*You know, what have you learned about those measures in this context?  Even in the context relative to measuring pain?  They’re relatively, it looks like, in terms of pre, post, within the intervention group they’re relatively small sects.  They’re significant, it looks like, because the usual care condition maybe didn’t get better or got a little worse, even.

Anyway, just what have you learned about measures of functioning in this context or similar research?  Where does that take you in future research?

*Dr. Matthias:*Yes, that’s a great question.  Starting with the self-report, we used the WOMAC largely because that’s sort of the standard in lower extremity osteoarthritis.  Like any measure, there are pros and cons to it.  I feel like it does a reasonable job of measuring osteoarthritis-related function.

We also have been using, and I haven’t presented it yet here, a measure on satisfaction with function.  At just face value of it, I really like a lot.  We don’t have enough experience with it to know much about sensitivity to change in this kind of intervention, but we’re using it across several studies, several large clinical trials, including this one.

That’s one I’m looking forward to analyzing more and may hold some promise for really getting not just what people say their function is, but their level of satisfaction.  That’s a big deal, I think, in terms of patient-centeredness, is not only what they think they can do, because that’s the way WOMAC and a lot of other ones are structured, can you do this or how hard is it for you to do that, but how does that translate into their daily life?

Maybe they can’t get in and out of the bathtub, but they’re okay with that because they can walk to their mailbox.  I think that’s a construct that’s not been measured well or consistently, in terms of function, and one we are hoping to do more in.  That’s kind of on the self-report side.

The SPPB, we used that one for a number of reasons.  I mean, it’s validated.  It’s a measure that a lot of investigators in a group at Duke tend to use and so we are trying to do some sort of common measures and then we can then compare across studies.  Those are a couple reasons for our selection.

It definitely has validity in this kind of patient population.  We do see changes over time.  One of the things we will do with that is look at the separate measures, the separate components of that.

Balance, I think probably has a feeling effect in this population.  Chair stands are probably a little bit more where we’ll see differences and potentially in the walk, although the walk is short. It’s only an eight foot walk.

For another study we are doing and just completed on group versus individual physical therapy for knee osteoarthritis.  We’re doing a six minute walk.  That, I think, for this kind of population probably has more potential to show changes in the course of an intervention that deals with physical activity.

A short walk, I think there’s less chance of seeing a difference because people can kind of muster it together for a short walk, but a six minute walk is really different.  I think when you have opportunity to do those kinds of functional assessments to get more at longer duration, endurance kinds of things, and things that maybe really are relevant to life, like can you walk—can you spend six minutes walking around the grocery store or around the mall?  I think those are really valuable.

That said, they’re also challenging.  For us, just logistically, to find a space in our VA where we could have somebody walk for six minutes was really tough.  We didn’t do it for this study for those logistical reasons, but were able to manage for one of our other studies.  We’ll get to look in that study at changes in the different kinds of functional measures, the six minute walk, SPPB satisfaction.

*Dr. Matthias:*I’ll ask a follow-up.  Thank you.  That was a great response.  Maybe quickly, use of algometry or these other kinds of things, even you know, other technology solutions, even Fitbits were talked about at this meeting, the Impact OMERACT meeting.  Is that at all feasible in this kind of setting, in the VA, more broadly, when we do research?  Any thoughts?

*Dr. Matthias:*Yes, I think so.  I mean, we, again, not for this study but the physical therapy study that we just finished up, we have accelerometer data on a subset of participants.  I think that’s really valuable because you get to not only look at their self-reported activity, which we all know there are limitations to that but it’s still an important measure in some ways.

Using pedometers or Fitbits, accelerometers, I think gives us an opportunity to measure what people are actually doing.  Often we’ll look at specific exercise behaviors.  Are you doing what we asked you to do, which is important?  Are you now engaging in some kind of aerobic activity or strength training activity?  I think another really important component is are they just getting around more?

You can measure that somewhat physical activity questionnaire, but I think when there’s opportunity for that objective kind of assessment, it allows us to fine tune things more.  How much time are they spending in leisure activity, that kind of intensity?  I think they hold great value.  

There are certainly challenges to using them.  It makes a research study a little bit more cumbersome, but we like them.  I know a lot of *[inaudible 55:44]* again, in this other VA study we’re looking forward to being able to evaluate that alongside some of the functional measures.

*Dr. Matthias:*Thank you.

*Moderator:*Great.  I’ve got a couple more questions here.  Could you talk a little bit about the motivational interviewing training that was given to providers?

*Dr. Matthias:*Sure.  It was actually given to the counselor, not to the primary care providers, but it was a pretty standard motivational interviewing training by a certified motivational interviewing trainee or trainer we have locally.  That person came in and actually did a combined training session for a lot of interventionists in our HSR&D Center.  The counselor went through that training.

Then what we did was really as a study team, which included content experts in various areas, we had a content expert in more of the cognitive behavioral pain management, weight management and physical activity.  What we then did as a study team was really think through those motivational interviewing principles and how they applied to those aspects of our patient intervention.

We worked with the counselor on kind of integrating those and just did some training up front.  Then what we did throughout the intervention was those of us who were involved in kind of a fidelity check would listen to audio recordings of the intervention sessions and provide feedback to the counselor, not just on this, but on how things are going in terms of incorporating motivational interviewing approaches that were relevant for this particular intervention.

*Moderator:*Here’s another question.  What’s the current recommendation for the use of gastro protective agents in patients with osteoarthritis?

*Dr. Matthias:*That’s a good question and I probably cannot quote accurately all the specifics of that, but there are a list of GI bleeding risk factors, age among them, use of glucocorticoids and some others.  The recommendation basically is for people who meet those or have one of those risk factors, that they either not be on an NSAID or be on an NSAID with a gastro protective agent.  There are some specific concerns about NSAIDS in older adults that apply, as well.

*Moderator:*One more question, going back to the disparity between the recommendations made and the recommendations implemented.  Did you get the perception that the primary care providers might have been ignoring some of the recommendations or did you feel like there were other obstacles?

*Dr. Matthias:*That’s a good question.  I don’t know the answer.  I think we’ll be able to get more of the answer once we start looking at utilization and once we start talking with providers.  One thing, anecdotally, I will say, as we looked at the consults we have not done any formal analysis of it yet, but as we as a study team were looking at the situations where providers did and did not issue a consult, a pattern that we think we are seeing anecdotally is that for patients who were older, sicker *[inaudible 58:51]*, providers tended to be less likely to issue a consult.  Again, I don’t have any data on that yet, but it’s an analysis we will do.  That would not be surprising.  It would be completely understandable.

I suspect that that’s one thing that we have going on, is that when there are lots of things going on in a visit, there’s just simply often not time for bandwidth, either on the provider’s side or the patient’s side or just time in the visit to deal with those kinds of things.  Or it could’ve been that the patient just simply didn’t have the capacity to engage in those conversations.  I think that is something that we’ll pay particular attention to, in both our analysis and our qualitative interviews with providers.  That’s a good question and we’ll ask providers if they were ignoring us.

Actually, the 40 percent that I quoted, I was actually pretty pleased with that.  It’s obviously not 100 percent and there may have been things going on, but I was pleased that not quite half the time this very simple thing that we did generated providers doing something.

We know there are lots of other factors that can go into whether a provider chose to do something or not.  Those are all very well legitimate factors, ranging from patient interest or not to maybe something the patient’s already doing that we didn’t know about.  That’s a great question.

*Moderator:*Thank you.  Thank you, Dr. Allen.  This is a great presentation.  We really appreciate it.  Our audience had some great questions for you.  

Just hold on.  Everybody probably can see the feedback form right now.  If you can just take a minute or two to fill that out.  Our next cyber seminar will be Tuesday, June 3rd, by Dr. William Becker.  We will be sending registration information out to everyone around the 15th of the month.

I want to thank everyone for joining us at this HSR&D cyber seminar and we hope to see you at a future session.

*Moderator:*Thank you so much, too, Dr. Allen and also Robin, for moderating, and of course, to Dr. Kearns for being the champion of this series.  For our respondents, please do give us your feedback.  It is your responses that help guide what we have presented.  I will leave this up for a while, so feel free to take your time.  Once again, thank you everybody and have a great day.

*[End of Audio]*

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