**Transcript of Cyberseminar**

**The Hepatitis C Self‐Management Program**

**Erik J. Groessl, PhD**

**Kimberly R. Weingart, PhD**

**October 9, 2012**

**The Hepatitis C Self‐Management Program**

**October 9, 2012**

Moderator:We are just now almost at the top of the hour. So at this time, I would like to introduce our presenters. We do have Dr. Erik Groessl presenting for us and we also have Dr. Kimberly Weingart presenting for us. At this time, Dr. Groessl, are you prepared to show your screen? Dr. Groessl is an investigator for the HIV/Hepatitis QUERI and Dr. Kimberly Weingart is a Health Science specialist also at the VA San Diego Healthcare System. I apologize if I butchered either of those, but Dr. Groessl I’ll turn over to you now. Erik, go ahead and unmute yourself.

Dr. Erik Groessl:Sorry about that. I’d like to start by thanking everybody who is attending today and to provide a little bit of an overview, I’m going to start by providing a brief background on hepatitis C. I realize many of you already are familiar with much of this literature but wanted to review a little bit of that before talking about HCV care in the VA both past and present and I want to talk about the past because that’s when the self-management program was developed back in 2004, and then present with the new anti-viral medications and how we’re changing the self-management program.

Next, I’ll talk about what is self-management. There are probably many definitions, but I’ll provide some that provide the framework for our intervention here. Then, I’ll present the results of a little bit of pilot study results as well as the results of our randomized controlled trial then we’ll go into the self-management program itself and look at some of the details of the sessions and the modules before looking at future directions and where we’re going from here. 

So, hepatitis C infects about 1.8% of the US population that’s 3 to 4 million people but rates are triple that in the VA System. Hepatitis C leads to severe medical consequences such as cirrhosis, liver cancer and liver transplants, but there’s also evidence that although it can be a silent disease, there are functional limitations, physical and psychological symptoms, and reduced quality of life that result from hepatitis C.

The veterans often have a lot of other comorbidity as many of you know substance use, psychological comorbidity, homelessness and impoverishment are common and other comorbidity such as HIV so this makes them a challenging group to treat and to deliver good healthcare to. So in 2004 when we were developing this program, SVR rates were pretty low, that’s sustained viral response to the antiviral medications, and especially for genotype-1 patients. Rates were estimated in clinical trials to be 40% to 45% in genotype-1 but in reality in the VA System estimates were closer to 20% to 25% or about half that, just because our population was much harder to treat than people in a clinical trial. There were side effects from the Interferon based treatment, of course, same as there are now. Treatment rates were very low, about 10% of those in care in 2004 had ever been treated. So many veterans were either not good treatment candidates because of psychological comorbidity, substance use –they had failed treatments others refused treatment. They knew the chances of success and others many had low-grade fibrosis, watchful waiting was a much more viable option when the expected SVR rate among genotype-1 was 20% to 25%.

So, improving hepatitis C care back then we said how can we best help the 90% of hepatitis C patients not being treated? And a couple of people asked me well the treatment’s really tough, why don’t you design a program to help people on treatment?  And we thought about that. I think some people have developed programs to address that but I came from kind of a prevention and behavioral medicine background and I wanted to help the 90% of people who were not being treated and I wanted to help people prepare for treatment. So we kind of created this lists of things and it’s somewhat in order priority, we wanted to educate patients about hepatitis C, facilitate lifestyle change, improve quality of life, prevent transmission, and prevent progression of liver damage, we as I said wanted to prepare patients for treatment and increase treatment success.

So presently and in 2011, the percent ever treated had over doubled to 22% but there’s a lot of room for improvement still and the new triple therapies offer a much greater chance of being cured in addition to briefer duration of therapy, which increases the chance people complete treatment of course but slightly more side effects overall currently because of the third medication added. So in thinking about how we can best help hepatitis C patients now, experts and other people I work with said well it’s time to really focus on treatment. So we want to successfully treat more people. So we kind of reordered and reprioritized our goals of designing a self-management program. We wanted to prepare people for treatment, number 1, increase treatment initiation, maximize treatment efficacy through things like improved adherence yet we still want to educate patients about hepatitis C, prevent transmission, facilitate lifestyle change, and prevent progression of liver damage until they do get treated. 

So this slide, one of the realities of the new therapies is that they are very expensive and I wasn’t sure where to put this slide but I wanted to address a question upfront what happens in two or three years when these new Interferon free therapies come along? There will be much fewer side effects; some people are saying cure rates or SVR rates of 90% and are we even going to need self-management, is it going to have any purpose and what we believe the current therapies are maybe $30,000 per person and the next line of therapies may be $50,000 per person. So, our goal is to optimally prepare treatment candidates for antiviral therapy using low cost interventions. Our program cost may be about $200 per person to deliver and why not use that if you have any chance of increasing success at a $50,000 treatment.

So, next I’m going to talk about self-management. So in self-management, patients take an active role in managing their health. Self-management as a term used to be applied to programs that were more patient education where information was being distributed but kind of the model developed by Kate Lorig at Stanford University really advocates for going beyond patient education really teaching new skills, increasing self-efficacy, encouraging social support, and activating patients. We really believe that just giving them information is necessary but not sufficient for really improving their health. Self-management has been around for about 30 years at least, but more recently last 10 to 15 years self-management has been recognized as really an integral part of a good quality healthcare system and this is Wagner’s Chronic Care Model where self-management support is one of four major modalities for delivering quality health care. So some of the skills we try to improve through self-management are getting patients to take action as I said, to find and use resources that may be available to them, to improve decision making and problem-solving, and to develop and use supportive relationships.

So our self-management intervention and Kate Lorig’s model uses a blend of different approaches within it – it uses quite a few cognitive behavioral principles. It uses principles of motivational interviewing and empowerment approaches where patients are really encouraged to take ownership for their health and to kind of build these skills and really become confident in being a good patient and managing their own health. These interventions are also holistic and comprehensive. They use multiple modalities, address global well-being, not just hepatitis C so as you will see later, modules on exercise and diet and many different things that affect global well-being. These interventions emphasize the mind-body connection and reducing stress for example the connection between fatigue and depression or the cycle of pain and depression and another thing we really try to impact and improve through self-management is self-efficacy. This is Bandura’s Social Cognitive model and we see that self-efficacy here he postulates to impact behavior directly as well as impacting outcome expectations, directly impacting goals and facilitators and impediments to achieving those goals and then we see behavior affecting health outcome. There’s also some data and literature from Kate Lorig that shows self-efficacy alone can directly affect health outcome, so just being more confident in your own ability to handle your health can reduce worry and make one feel better especially psychologically. 

So in review, these programs have been very studied extensively. There’s lots of evidence that a wide variety of outcomes in many chronic diseases can be improved and impacted. The Stanford group has worked on arthritis, diabetes, asthma and cancer but there’s many other programs also that are not affiliated with the chronic disease self-management program in that model that are very efficacious as well. However, the CDSMP has been probably the most widely disseminated and implemented program – implemented almost nationwide in the UK, Australia, and British Columbia.

So, my preliminary work on this intervention started in 2004 with the Career Development Award from VA HSR&D and I started one of my early pilot projects was to conduct qualitative interviews with 16 VA patients with hepatitis C and eight hepatitis C care providers and what we really did was to ask them what it was like to live with hepatitis C and what it was like to treat patients with hepatitis C, what had they learned from treating those patients. I then attended the group leader training at Stanford and learned how to deliver this type of self-management program and I conducted two pilot groups of the self‐management program in I think it was more 2005-2006 and we also sought expert opinion from Hepatitis C clinicians mostly in the VA but also outside the VA on this developmental work and on the changes we made to develop the intervention. So, some of those changes we began with Lorig’s chronic disease self-management program as a base and we added basic hepatitis C education and there’s a set of VA power-points which is quite informative. We used that. We updated that a little bit, we added an alcohol and drug use module, we expanded the fatigue management module and we built a module about adherence to treatment recommendations so one thing we found is that hepatitis C patients face a large number of recommendations as far as getting laboratory tests, changing behavior, attending follow-up appointments, and that’s one of the most challenging things for a hepatitis C patient, and finally we added a discussion panel for vets who were treated so people attending the program get to hear the stories of two to three patients who were treated and what that’s like to be treated as well as they hear from a hepatitis C provider who’s treated many people.

Other changes to the chronic disease program, we took out a couple of modules, advance directives and distraction from pain. We reduced time spent on a number of other modules in order to fit this new material in and we added a health professional to co-lead the group in addition to a peer leader. The Stanford programs typically have two peer leaders leading the sessions and we felt though it was necessary with hepatitis C because it’s a complicated disease to have a health professional present. So, I’ll quickly take a look at some of the results from the pilot study. Our N was extremely small. We had two pilot groups and only eight people completed both the baseline and the follow-up assessments. It was an unfunded study and they didn’t, I guess, have enough incentive to come back and complete that assessment but despite the small N, we had significant improvements in self-efficacy and hepatitis C knowledge and many of the other outcomes moved in the direction we expected but are just not significant with that small of an N. Quality of life went up 0.02 points which is clinically important. Depression went from a mean of 18.6 which is pretty high to 15.4. Health distress went down. Self-reported exercise increased.

So in 2006, we were funded to conduct a four-year randomized trial of the hepatitis C self-management program and we randomized 134 VA patients with hepatitis C to either self-management or information only. The information only group got printed packets of the same hepatitis C information that we deliver in the in-person sessions. We also gave them a local resource guide and we encouraged them to study these materials at home. The hepatitis C self-management program, these were groups of typically 8-10 patients co-lead by a provider and peer leader. They meet once a week for six weeks for about two hours each time.

To be eligible for the study, they had to be eligible for VA Healthcare Services but not currently enrolled. They had to be confirmed hepatitis C positive. They could not be on treatment currently and we requested that they not start treatment for six months in order to complete our assessments, not terminally ill, and we recruited people primarily through providers at the VA Hepatitis C Clinic as well as the Alcohol and Drug Treatment Program and Primary Care. We also used flyers and in-person recruitment at Satellite Clinics of the VA, veteran’s organizations and other non-profit organizations, and one other strategy we used is to our clinic sends letters to everyone in test positive in the past year or two and we tacked on a paragraph onto that letter telling them about our study but I don’t think many people were recruited through that method. 

So, our health outcomes for the study: we did assessments at baseline, six weeks, 6 and 12 months. We were able to add the 12-month follow-up partway through due to a modification so that was not originally planned. Our primary outcomes were generic health-related quality of life as measured by the SF36 and QWB-SA as well disease specific quality of life the HQLQ. We had a variety of secondary outcomes and we also collected cost-effectiveness data.

So, here are our secondary outcomes – hepatitis C knowledge, self-efficacy, fatigue, depression, health distress and alcohol and drug usage. And we have some other secondary outcomes that were a little bit more exploratory, some health behaviors, such as attendance of health care appointments, medication and other utilization, rates of antiviral treatment, patient-provider communication, vaccination for hepatitis A and hepatitis B, dietary and exercise behaviors, and a number of other miscellaneous behaviors such as avoiding transmission – these were kind of open-ended questions.

To look at the patients enrolled in our clinical trial, the mean age was about 55 years old. The randomization did not work out with that. There was a significant difference with the information group being 3.4 years older. We had about 95% male, residence-wise about 14% to 15% were homeless, another 30% to 35% living in a group residence and we asked the question, have you been homeless in the past five years and there was also significant difference on this at baseline with 59% of our information group reporting may have been homeless in the last five years versus 38% but pretty high for both groups. It’s also worth noting over half the majority took public transportation to this intervention. The mean years since contraction, this is self-report since nobody is ever exactly sure, but 20 to 25 years and mean years since diagnosis 9.9 years. Other characteristics – our sample was about 25% African-American, 10% Hispanic, so fairly good representation of race and ethnicity here in San Diego. Education-wise, only about 14% were college graduates but another 50% had some college. Marital status, 55% were divorced or separated and we were really struck by the fact that so many of these veterans did not have much in the way of social support or support of others to kind of support of them in their efforts to deal with hepatitis C and unemployment-wise 43% of these veterans were disabled with another 30% unemployed and this is to be expected. These groups were held in the day so it is tough to attend a two-hour program if you’re employed.

Moderator:I apologized for interrupting. We do have a clarifying question before you go on, can you please define what HQLQ is?

Dr. Erik Groessl:Certainly. The HQLQ is the hepatitis quality of life questionnaire. I apologize for not stating that. It’s a measure that’s used in conjunction with the SF36 and it’s hepatitis specific, not hepatitis C specific, but we did not find much in the way of any movement on that measure. So on to our results, first I want to note that attendance was really pretty good once we got them to the first session, so of those who showed up, they attended 5.2 out of 6 sessions, 87%. At six weeks, the workshop improved more on hepatitis C knowledge, hepatitis C self-efficacy, and SF36 energy and vitality. At 12 months, effects were sustained for hepatitis C knowledge, energy, which is SF36, and global quality of life on the QWB-SA. At both of these time points, we found trends that were not quite significant for SF36 physical functioning, depression, and health distress. I should also note that these effects being sustained at 12 months were not a surprise but were impressive because they had not received any follow-up to the intervention since week 6, so 46 weeks later there were still benefits.

Here some more results. These are kind of some other secondary outcomes. The study wasn’t really powered to detect change on these utilization and behavioral outcomes. It also wasn’t really designed to focus on changing these variables but we thought they were interesting. Hepatitis C appointments attended, our workshop group increased from 1.8 to 2.5 sessions per year attended and this table looks at the one year prior to enrolling in the intervention versus the one year after and our information only group had no change in hepatitis C appointments attended. As far as no shows, our workshop group decreased slightly in no shows and the information group increased slightly, none of these are really significant here but they moved in the direction we expected. We looked at inpatient days and we subtracted out alcohol and drug treatments days because those tend to be 30 day or 28 day stay and we found the workshop group went from 3.4 to 2.0, a 40% decrease, while again almost no change in information only. For whatever reason, the workshop went to a few extra ER visits or had a few extra ER visits while the information group declined, they had started quite a bit higher at 2.6. Both groups had quite a bit fewer prescribed medications. It went from 5 to 3.9 and 3.9 to 2.9 in the year following enrolling in the study, but what’s interesting is we looked at the medication refill ratio of medications prescribed versus those filled and our workshop group went from 73% filled to 83% while the information only group went from 70% filled to 59% filled. 

Cost effectiveness results, so we delivered the intervention to 69 participants across nine groups or nine programs averaging about 7.7 participants per program. The mean intervention cost was $1,806 per program and which broke down to $235 per participant. At 12 months, we had a mean incremental increase in quality adjusted life years of 0.068 which is fairly significant in the workshop group, resulting in an incremental cost effectiveness ratio of $3,456 per QALY and I wanted to add that the Stanford programs actually enroll as many as 20 to 25 patients per group and they still find the same effectiveness and same effect sizes in their outcomes so there’s really no reason the 7.7 couldn’t double and that the cost couldn’t be cut in half if we could get enough hepatitis C patients to attend self-management groups. I don’t know if that’s possible but it could be more cost effective.

So now I’m going to talk a little bit about the program itself and provide some more details on that and I should start by saying, I’ve inserted the modules here of the revised group so we’re currently revising the group to focus much more on antiviral treatment. So, session one starts with introductions and identifying common problems. Here, people talk about what problems they have having hepatitis C, how does that cause problems in their daily life and people find common problems. Then, there's a workshop overview. It reviews the goals and treatments and this is where we now present the new treatment focus and we let people know right away our main goal of this session in this program is to help you get treated successfully.

We then go into the general hepatitis C information. This is presented in PowerPoint format with questions and discussion. We then have a module on acute and chronic conditions and discuss how hepatitis C is a chronic condition but it's different than most chronic conditions because it can be cured. We then have a module on basic information about antiviral treatment and this, as I note, has recently been updated. Then we have the introduction to action plans. Action plans are one of the core parts of this intervention. I'm going to turn it over Dr. Weingart who led these groups and she's going to tell you more detail on action plans.

Dr. Kimberly Weingart:Thank you very much. So, as Dr. Groessl mentioned, the action plan is a very important part. We discuss it and we go through the action plans at every session but the first session, of course, is important to really explain to the group, what to anticipate with an action plan. This is different from what they expect when they go into their doctor and the doctor says, “You need to lose weight.” Here in the self-management group, we want the patients and the participants to be one, most importantly, doing something that they want to do. It's important that when they set these goals for themselves, their goals that they are interested in makes them more likely to be successful each week. Keep in mind we ask them to do this every week, so it's something that they have to be excited about and encouraged to do. Most importantly, it's something that they want to do.

The goal also has to be reasonable, meaning if they say, “Well, I want to lose 25 pounds,” that’s wonderful. However, that’s not reasonable within the next week. These are all action plans that need to be completed within the next seven days or by the time they come to their next group because we ask them to report on those. So we ask that the plans are reasonable. We ask that the plans are behavior-specific. During my training at Stanford, they said it has to something that you can take a picture of yourself doing and that’s a wonderful way to really explain what we mean by behavior-specific. Can you take a picture of yourself doing it? I can't necessarily take a picture of you losing weight. However, I can take a picture of you walking around the block. So that’s what we mean by behavior-specific.

Additionally, we have set forth a few different criteria, so the action plan should answer the following questions: What, how much, when, how often? I’ll go through an example of that, a common example that we saw. Finally, we ask that each action plan have a confidence level that’s seven or more, zero meaning the participant is not confident at all and a ten, of course, means that they are totally confident that they’ll complete the entire plan in one week.  A common example as Dr. Groessl mentioned, many of our veterans had a comorbidity of either homelessness or impoverishment. So that, in and of itself, made them unlikely treatment candidates. So something that they often chose to work on were some of these comorbidities that we commonly see with this population. So of course putting themselves in a place where they're not homeless or where they're able to be contacted by the hepatitis C clinic or by their doctors makes them more likely or more eligible for treatment. That’s a common reoccurring goal that I saw frequently. And so, an example would be if we're looking at the what, how much, when, and how often, a lot of veterans would say, “I'm going to look for VA or VASH housing opportunity.” So that’s your what, but how much of the time? A common thing would be to review a VASH housing list. I'm going to pick two places in my location or in my desired location that I’d like to live from the housing list. I can take a picture of that. So it's behavior-specific. I can see you looking at the list.      

Then when. Well, they're going to do that on Saturday or Sunday or they're going to pick a day that they're going go through this list or that they're going to go to the two places that they’ve picked. The how often, they're going to do that just one time. They're going to see each place one time. So, we make it very specific and we let them choose what their action plans are going to be, what's going to be the most important for them. That’s what's so great about the self-management program, is that it’s led not only by a healthcare professional, but also a peer leader. So, we really allow them to manage themselves. We're not directing them as they would get in a normal medical or clinic type care. The action plan was really important and it was something that they were encouraged to do by themselves.

Dr. Erik Groessl:Okay, great. Thank you, Kim. Session two, there is more than one module in session two but it starts with action plan feedback and problem-solving. So, I'm going to send it right back to Kim to talk about how there's problem-solving around the problems that occur with action planning.

Dr. Kimberly Weingart:Right. So as I mentioned, each week when the participants come back to the group, we review how things went with their action plan. Remember, they have to have said that they were a seven out of ten in confidence, meaning they were confident that they were going to complete the entire action plan, they were confident that they were going to review say the VASH housing list, they were going to find two places and look at them. We certainly would never say, “Well, I'm going to find a house and move into it.” Of course, it would be outside of the goal. But for those people that maybe had a problem or could not complete their entire action plan, the problem-solving becomes very important. Now, we go through problem-solving for a number of different things, but it really is applicable and people can see the process when you apply it to their weekly action plan. 

So, problem-solving starts session two and we do this every single session. We review the action plan. We talk about successes and failures. The great part of that are the people in the group that were able to complete the action plan, they can talk about what works really well because as Erik has mentioned, many of the problems or the troubles that hepatitis C patients face are common. They're not always unique to one individual. So, looking at the successes, talking about those is helpful for the entire group and then we talk about the failures of the previous week’s action plan. So group members come together and brainstorm and discuss ways to help others be successful with action plans. Oftentimes in these groups, if say VASH housing was the action plan for the previous week, there's someone else in that group who has been through that process. There's someone else in that group who has had difficulty and found a way to overcome that difficulty. The brainstorming is a wonderful method to bring the group together, to create cohesiveness, and to really help members identify new ways, things that they may not have thought of in order to complete their action plan.

The seven steps to problem-solving include identifying the problem, which really is the most important. Oftentimes, people tend to identify the problem as something outside of themselves. The weather was bad. Sure, that could certainly be a problem if you're walking or you have a limited means of transportation. However, there may have been something else like I wasn’t motivated. That’s generally a common problem or I didn’t actually go get the list. I didn’t know where to find the list. So that’s where the group can come in and help. Once the real actual problem is identified, we can work together to find ways to then list ideas to solve the problem. Oftentimes, with the group coming up with ideas and ways to solve the problem, there may be multiple ideas that come up and what we do in the group is we’ll write them all on the board, good, bad, indifferent. We don’t judge on the types of ideas that people come up with for the problem-solving. We list everything and then we let the participants decide what it is that they would like to choose for that week. I think we lost the slide. I’ll keep going.

Then we select one method to try. From that list, we select the one method that we think might work the best and we let the participant choose. It doesn’t have to be something that I, as the healthcare leader, choose or the other peer leader. It's something that the participant chooses. Now the first three steps are what we do in the group. The last four steps are what the participant does on their own. They're going to try that one method. Perhaps they couldn’t find the list, maybe someone gave them a good idea of how to find the list for the VASH housing. The following week or throughout the week, they will then assess the results. They may or may not have to substitute another idea. Perhaps the ideas that we came up with in the group, they maybe wrote down two or three, selected one then the first idea they selected didn’t work. However, hopefully they wrote down multiples so they can go back and try other ideas. 

Utilizing other resources. As we mentioned, there is a resource guide that we give all the participants but there's also resources within the VA, there's resources in the community, resources maybe even within their immediate support group, whether that be friends, family, oftentimes AA group, things like that. So, utilizing other resources, reminding them to welcome other ideas and talk about the problems that they may be having with some of these action plans. Finally, accepting that the problem may not be solvable now. I know this is true for me, not just people in the group. It's hard to let go of an idea sometimes and understand that maybe I can't solve it now. However, I may be able to solve it in the future. I need to maybe work on a couple other things ahead of time. So, giving the veteran kind of the idea that they may not be able to solve it now, however, it doesn’t mean the problem is not solvable in general. It just means that maybe there needs to be some additional preliminary work.          

Dr. Erik Groessl:Thanks. So back to session two. We start with the action plan and feedback and problem-solving which Kim just described. The second module is antiviral treatment barriers and facilitators. This is a new module we developed to focus on anti-viral treatment. There's an intro module on cognitive symptom management. We then go into benefits of exercise and there's usually a break in here which I don’t think I mentioned. We don’t go two hours straight. We go for about an hour and five or ten and then take a 15, 20-minute break and then come back for an hour. Then we have an alcohol and drug usage and hepatitis C module. This is a new module. We're adding some brief interventions into that to strengthen that, I'm going to have Kim review that briefly in a second, and then making an action plan for the next week again. Kim?

Dr. Kimberly Weingart:So, as you mentioned, we added this alcohol usage and hepatitis C because it's such a predominant comorbidity with this population. Whether they're currently in some sort of rehabilitation program, maybe they're recently out of the ADTP, the Alcohol Drug Treatment Program, or maybe they're still using intermittently. Oftentimes, there's a continuum that we see for the veterans that come in to these programs. So it's a very important part of the self-management for a number of different reasons. We look at the pros and cons of alcohol consumption and we do this in the group as a brainstorm. Again, we have a white board and we write down what the veterans are saying and reporting as pros and cons. No judgment. We let them just -- whatever comes to their mind. Just an anecdotal story, I guess. As we would ask what are the cons of alcohol consumption, the list would be long. They had multiple reasons for why alcohol consumption was bad. The pros though, when you would ask, they would oftentimes look at me and say there's nothing good about it.  

Clearly though, there was a reason that they were using drugs or alcohol at some point. So we talk about that and they have to understand that it was functional for them at some point, what was it and how can they lead a better, healthier lifestyle without alcohol as that crutch or self-medicating or whatever it was for them. We let them really understand that and talk about it. Of course, we're not ADTP. If they're in the midst of having some struggles with that then they of course need to have that kind of referral and that, I think, is one of the benefits of having a healthcare professional in the group, is knowing where to refer people if they come up to you after the class. I don’t know what to do, I am struggling with this currently. We also bring them to the hepatitis.va.gov. That website is a wonderful website which includes things like change plans, drinking diaries. Those are actual forms that they can print and if they don’t have access to a printer, we can help them with that. We can send them to the Patient Education Resource Library where they can print these materials, things that help them really keep track of their alcohol use. It's interesting. The drinking diary, some people would use for soda as well because they're realizing that they have this exorbitant intake of sugar and soda. Sometimes they would use it for that as well.

But what we're trying to get them to do is really get a handle on how drinking is affecting their hepatitis C, how it's affecting their liver and why it's hindering them from becoming a treatment candidate. And that’s really the tie that we want to be able to make with them so that as we're preparing these people to be treatment candidates, they can see the link, they can make the change, and then they can become better treatment candidates. We talk a lot about that. We really try to get them engaged in that. Then we use brief interventions and motivational interviewing as a technique to help them to understand where they currently are versus where they want to be. If they want to be a hepatitis C treatment candidate, if they want to be in a place where they are free of the hepatitis C because they’ve gone through treatment, drinking, drugging, whatnot are the things that are going to hinder them from getting to that place. We use the motivational interviewing techniques, that sort of thing, in order to help them see the difference and to get to a place where they would be candidates for treatment.

Dr. Erik Groessl:Okay, thanks. We are going to have to go a little bit faster through the rest of our slides here. We got to wrap up in about eight or nine minutes to allow some time for questions. So, the highlights of session three, we do the problem-solving on the action plans, of course, dealing with difficult emotions, fatigue management. We have a new hepatitis C treatment adherence module as well as managing treatment side effects. They do learn muscle relaxation exercise and make their action plan for the next week. In session four, we start the usual action plan feedback. We then have this antiviral treatment discussion panel in which they get to hear from veterans who have been treated, some successfully, some sometimes not, some relapse with the virus. Kim is going to go over that really briefly.

Dr. Kimberly Weingart:Really briefly. It's just an opportunity for them to meet with a healthcare provider. So maybe it's someone from the hepatitis C clinic, whether it's a doctor, RN, whatnot, as well as two or three peers that may or may not have gone through treatment but it's a very informal atmosphere so they can ask a number of different types of questions. We ask that before they get to this session that they write down their questions ahead of time. This is something we encourage them to do when they get to their actual doctor’s appointment so it's a very good modeling experience for them. The parts of this module, the healthcare provider describes treatment developments, gives a brief synopsis of treatment where it is today. The peers describe their experience, symptoms that they commonly experience if they were able to be successful or not and then we allow the group to ask questions. This is a very informative module of this session and people look forward to it the entire time.

Dr. Erik Groessl:Great. Yeah, we found that many of these veterans, although some are well-informed, some were getting their information from some cellmate in jail, for example, and told them it was really horrible to get treated for hepatitis C. That came out in a number of qualitative interviews. Session four, the second module here is the antiviral discussion panel. I just talked about that. The other modules are informed treatment decisions, developing peer support. This is mainly in relation to developing peer support for getting through antiviral treatment. We then talk about communication skills and more on problem-solving. Session five, there's a module on medication usage and adherence. This is a more general module. It doesn’t focus only on antiviral treatment but it’s adherence to not just medications, but all treatment recommendations. We have modules on healthy eating and then depression management which dovetails into self talk and guided imagery.

Session six, some of the important new modules are informing the healthcare team. They work on patient-provider communication and collaboration with their healthcare professionals. They do some longer term goal setting because this is the last session, and there's a module on preparing for hepatitis C treatment where they really start to form a plan; do they need to change their work status or set aside time to work less or get more support or how are they going to go about this and when. Then it ends with looking back and planning for the future and Kim is going to describe that module.

Dr. Kimberly Weingart:So with this, we go through a brainstorm again where we talk about what have we learned in the last six weeks, what are some of the techniques we've learned, and as pointed out in some of the slides, it could be anything from communication, working with your healthcare provider, maybe it has to do with drugs and alcohol abstinence, a number of different things, self talk, whatnot. So we talk about the techniques that we've learned in the group and how the techniques can help with HCV antiviral treatment, meaning if self talk is something where you constantly are telling yourself, “I can't do it,” “I won't do it,” “I'm going to fail,” how do you change that so that as you're preparing for treatment you can realign with, “I'm going to be able to do this. I have a good team, I have a good support system, I'm ready,” that sort of thing.

We ask the group to share about their accomplishments, positive changes individually and the group as a whole, and we ask for the group to share what is it that they have accomplished. We take it back to the first week where they talk about the goals and what they hoped to accomplish with this class, and has it occurred for them, what they have learned along the way and what have they accomplished. Then we give a minute for the other group members to talk about what they think, not just about themselves but the group as a whole what has the group accomplished and oftentimes, there are small differences that one group member notices about another, which can be really a positive experience for the group as a whole.

Then, of course, we ask the group and remind them that they couldn’t have done it without one another and without sharing their experiences along the way and we thank the group members for their contribution and then we do a success visualization. Keep in mind that what we want them to really start thinking about is how they can be a treatment candidate, how they can get through treatment successfully. And so, the success visualization is where we ask them to think about what it looks like for them to be successful on treatment and oftentimes that can include things like I'm going to be able to hold a job, I'm not going to have this negative stigma, I'm going to be able to interact with my family without them thinking that something is wrong with me, I'm going to be able to have a sexual relationship. There's a number of different motivators but when we do that success visualization, we ask them to think about what they personally look like and what it is that makes them successful, and that’s different for everybody.

Dr. Erik Groessl:Thanks, Kim. So, a few lessons we learned with running this study and running the intervention that might be helpful for others to hear. Recruitment can be challenging. Some people are interested in attending in the day. Others work and want to come at night or on a weekend. So we kept different lists going. Some said, “I can do any day except Tuesdays,” but most people like Tuesdays. That was challenging. It took time. There were quite a few no shows. A lot of people expressed interest and we tried to stay in touch with them but a month or two later, they were no longer able to attend or were no longer interested. Transportation was an issue for a lot of these guys and women. So if you ever foresee running a group like this, think about transportation, think about any way you can facilitate that for people. We did find those who show for the first session, really attended well. Very few people came to that first session and didn’t come back and just said, “Wow, this is not for me.” I mean, one or two out of 69 or 70.

Good peer leaders can be hard to find. We often located these through nursing staff in the hepatitis C clinic who had interacted with these patients over the years and certain patients were really well-informed and seemed higher functioning and interested in helping others. We do pay them something for participating. The two-hour sessions are fairly long. A lot of these people traveled an hour or two to get there and have to travel the same to get home. So we did provide refreshments. We tried to make them healthy usually. Future directions for the hepatitis C self-management program, we recently received funding from the QUERI for a rapid response project to develop an Internet-based program and the group at Stanford they have about four or five internet-based programs, so we're using their platform. This can be accessed from any computer with Internet service so we can enroll people from across the country to attend a group at the same time over the computer.  Our study will officially probably start in January or February and we’ll be recruiting 40 to 50 VA patients nationally for the pilot Internet program in about a year from now. 

Next steps for the in person group, we recently submitted a service-directed project and reviewers really felt more evidence of impact on treatment outcomes was needed before implementation. I went into that submission thinking the same thing but it's really a hard dilemma because this field keeps changing so rapidly and we had to update. Six years later we had to start updating this intervention. If we piloted and do a randomized trial and then start implementing, it's going to be all different in another seven or eight years I think. We do plan to finish our revisions and pilot it. I think the last slide, some tips for starting hepatitis C self-management, contact us. We have to work with the Stanford Patient Education Center who own some of the rights to this program. You will need to find a health professional to be trained and co-lead the groups and one way to do that is through this site Stanford provides that lists everybody who’s been trained to deliver the chronic disease self-management program. If they're trained to deliver that, they can deliver the hepatitis C program. You need to find somebody to be a peer leader and locate space.

So in summary, this program has been shown to improve hepatitis C knowledge, self-efficacy symptoms, and quality of life. We're currently adapting it to focus a lot more on improving anti-viral treatment outcomes, we’re adapting it for the Internet and it is very low cost, $235 per person versus $30,000 for the current treatments and probably more for the next line of treatments. So that’s it. We’ll be fielding questions and thank you very much for attending.

Moderator:Thank you to the both of you for presenting. We do have about six questions pending and for those of you that joined us after the top of the hour, you can submit your question or comment in writing, just use the question function of the go to webinar dashboard located on the right-hand side of your screen. The first question is, “How was substance abuse addressed either as an exclusion criteria or comorbidity among individuals in the intervention?”  

Dr. Erik Groessl:Well, our exclusion criteria was not very clearly identified with substance use. Basically, we said if somebody was, by clinical judgment, impaired enough to interfere with the group process, they would be asked to not attend. We did have one person in the pilot group that came to the group intoxicated and they had cirrhosis, yellow eyes. It was an effort for them to get treated. They wanted to get treated but they were intoxicated and had severe alcohol problems. So they were referred to ADTP and we put a note in their chart. Otherwise, we accepted anybody and it was addressed through our alcohol and drug use module and it was discussed during slides and other discussions how they could work on that. But the intervention does not specify certain -- many people in our groups were 20 years clean and sober, so issues for them were maybe relapse prevention. But others still drank or occasionally used, others advocated and thought marijuana was great. We kind of took a harm reduction approach but there were so many other things to work on that it wasn’t a main focus.

Moderator:Thank you for that reply. The next question, “Can you talk about asking people not to start treatment for six months? Were there any ethical concerns in doing this?”

Dr. Erik Groessl:At the time, we didn’t feel that there were. Certainly if their provider -- we simply asked them to not start treatment for six months if they were going to participate in our study in order to get usable assessment data at six months. I don’t think we would do that currently. Currently the treatments are so much more efficacious and we did have one person at least, that de-enrolled from our study because they wanted to start treatment, which was fine. It was simply a request and we didn’t strong arm them and try and talk them out of it or anything like that.

Moderator:Thank you for that response. Next question, “Are the modules available to the attendees of this webinar?”

Dr. Erik Groessl:Probably not. Stanford owns some of that material, the manual in which these modules are broken out and really described in detail are mostly owned by Stanford so unfortunately I can't just send those out and distribute those. I'm happy to discuss certain things with people and a lot of it isn’t anything special. It's taken from general literature on behavior change so I'm happy to discuss with somebody and help somebody out in any way I can.

Moderator:Thank you. And as our attendees can see, you did leave your contact information on this slide so thank you for that. Next question, and these all kind of have to do with the Stanford licensing agreement, “How is permission gained to use the CDSMP format given the strict licensing agreement Stanford University requires for the module?”

Dr. Erik Groessl:Well, the CDSMP is being implemented almost nationwide in the VA through the PACT programs. I think it's rolling out at different sites at different times but I think it's part of PACT. There is an existing relationship with the VA nationwide to deliver the CDSMP. So, that’s in place and a very similar agreement will likely be in place for the hepatitis C program. I hope that answers the question and I'm happy to talk more on that. We don’t have a formal agreement in place right now for the hepatitis C program. Again, precedence has been set and we expect it to not be problematic. 

Moderator:Thank you. We only have three questions remaining. Do you both have time to stay on for just a few more minutes?

Dr. Erik Groessl:Sure.

Moderator:“Did all of the peer leaders get the Stanford training?”

Dr. Erik Groessl:Yes, they did. Well, let me check that. In the pilot groups, the peer leaders did not. In the randomized trial, we had one peer leader who delivered all nine programs with Dr. Weingart and that person was sent to Stanford for the training. I think we received a discounted cost because we were a research program. So that is a potential cost. But there are master trainers. So, master trainers can train other people. You don’t have to go Stanford. There are master trainers for the chronic disease program in the VA system at that location in the link in one of the slides we presented. And so, by contacting those people you can likely find someone in your area that can train a peer leader and a healthcare provider very nearby at very low cost.

Moderator:Great. Thank you. Next question, “I'm curious about the guided imagery and success visualization used during the session. What was the participants’ feedback? Was it useful?”

Dr. Erik Groessl:For guided imagery, the earlier module on guided imagery, there's a CD that we distribute. I don’t think I mentioned that in the slides. They get a CD and a book that comes from the chronic disease self-management program. But yeah, we read a script that has them imagine they're on a beach or on another -- I think we use the beach one. There used to be one called ‘in the woods’ or something and it's a walk down a lane through the woods in the country and we were told to not use that with veterans and combat veterans because it could produce PTSD-type reactions from walking through the woods and not knowing who’s looking at you or some combat scenario. So we avoided that imagery scenario. Kim, do you have anything to add?          

Dr. Kimberly Weingart:I would just say that especially with the success visualization at the end, it very much tied in to their ability to set goals and imagine what they would be like, kind of like an action plan, how confident were they when they would visualize what it was like to be successful in treatment. The veterans really liked it. After all of the visualizations, they would generally say, “Gosh, I feel so much more relaxed, more oriented, and productive for the group.” The success visualization was certainly one that they enjoyed at the end.

Dr. Erik Groessl:And I would just add that with a lot of these things, 10% like them and love them and use them all the time and the others don’t. They find something else they like. So we just had a veteran who’s still homeless and who went through our program and has no resources and he lost his CD. It's called ‘A Time for Healing’ and we happened to have some extras here, and it’s about three years after he attended, but he loved it and used it all the time despite being homeless. And so, we gave him a new copy.

Moderator:Thank you. We do have two quick questions to get through and then we’ll be all set. You might have covered some of this already, “What is your licensing agreement with Stanford and what is required to present this program? Can Stanford train facilitators, deliver the program on their existing licenses?”

Dr. Erik Groessl:I'm not sure how much more I can add. It depends if you're in the VA system or not in the VA system. If you are in the VA system, I think it can be easily delivered and I'm eager to help you work on that. If you're not in the VA system, we've got to work out a licensing agreement with Stanford and there will be some fees involved. It's not something to just offer once but as we further revise this and revise the treatment focus, I'm very willing to help work on that.

Moderator:The next question we have, the last question, “You mentioned computers. Have you also integrated these classes into Telehealth?”

Dr. Erik Groessl:I'm a little unclear on that question into Telehealth. We are adapting the modules for the Internet and so that people attend an online program that goes through one module per week, or I should say one module that goes through one session per week and there are discussion boards and there's a secure post office and there is a bunch of self-help tools and people read the information and then complete interactive tasks. That’s the direction that it's going. As far as delivering them over live conferencing or something, we haven't really considered that. It's possible and that’s something to explore. I think it's a good idea. Right now we're focused on the Internet program.

Moderator:Thank you. I do have one person that wrote in a comment. I believe he was asking about the licensing agreement. He says he is in the VA system and has a current license and is a master trainer. So it looks like there are opportunities to get that implemented in the VA.

Dr. Erik Groessl:Great.

Moderator:Well, I want to thank both of you for presenting today. Do either of you have any last minute comments you’d like to make to the audience?

Dr. Erik Groessl:No, thank you very much. This was great.

Moderator:Dr. Weingart?

Dr. Kimberly Weingart:No comments from me either. I thank everyone for listening and participating. It's wonderful.

Moderator:Great. Well, thank you both for your expertise. Thanks to our audience for joining us. And as you exit today’s session, a feedback survey will load on your web browser so please wait just a moment and fill out those questions. We do want to know what other sessions you’d be interested in. So thanks again. Everybody have a lovely day.

Dr. Erik Groessl:Thank you.

Dr. Kimberly Weingart:Bye.

[End of Audio]

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