Spotlight on Pain Management - 12 -Department of Veterans Affairs

September 4, 2012

**Department of Veterans Affairs**

**Spotlight on Pain Management**

**Evaluation of Stepped Care for Chronic Pain (ESCAPE) in Iraq/Afghanistan Veterans Trial**

**Matthew J. Bair, MD, MS**

**September 4, 2012**

Dr. Kerns:  Good morning and good afternoon everybody.  This is Dr. Kerns, National Program Director for Pain Management.  It’s my pleasure to invite you to this months’ spotlight on pain management.  Today’s speaker is Dr. Matthew J. Bair.  He’s a physician and a co investigator at the Center for Implementing Evidence-Based Practice and he’s an associate professor of medicine at the Indiana school—University School of Medicine and a research scientist at the Regenstrief Institute, Incorporated in Indianapolis, Indiana.

Dr. Bair is also importantly a member of our national pain management strategy coordinating committee as a representative of the primary care service in VA central office.  Dr. Bair’s research is focused in three interrelated areas, understanding the complex relationship between chronic pain and psychiatric co morbidity, especially depression and anxiety; developing and testing strategies to improve pain management in the primary care setting; and developing interventions that combine pharmacologic and psychological—excuse me, pharmacologic and non-pharmacologic treatments for chronic pain.

Today Dr. Bair will be speaking on evaluation of stepped care for chronic pain, the ESCAPE trial in Iraq/Afghanistan veterans.  Dr. Bair.

Matthew J. Bair:  Thank you, Dr. Kerns.  I just wanted to thank you for your tireless efforts to promote pain management research and your leadership of the national program in pain management.  I also want to thank CIDER and Molly for helping to make this opportunity possible and thank you all for attending the talk today.  I look forward to hearing your questions and feedback near the end.

So let’s get started.  The funding source for this work was funded by VA Rehabilitation Research and Development under a special solicitation called chronic pain treatment and management.  I’d like to send out a special thanks to Dr. Dorn and Dr. Pierce at the RR&D program office for their support of this work.

We all know that pain is a critical health problem nationwide.  According to the 2011 Institute of Medicine report, “Relieving pain in America: a blueprint for transformation, transforming prevention care, education and research” as many as 100 million Americans report chronic pain which exceeds the numbers affected by heart disease, cancer and diabetes.

Furthermore, the deleterious impact of chronic pain on individuals on their quality of life and function are well known.  And the economic burden of pain to society is really staggering and the IOM report suggests that the annual economic impact of pain represents between $560-$635 billion burden on US dollars.  Pain is also a critical problem among our veterans.  Pain was the most frequently reported symptom in Persian Gulf War veterans.  And other epidemiologic studies have shown the high prevalence of pain among veterans, ranging from 50 to as high as 75 percent of veterans.

The story is quite consistent in our latest cohort of veterans.  Pain is one of the most frequent presenting concerns among OEF/OIF veterans.  And the prevalence of musculoskeletal pain is found to be between forty and fifty percent.  Despite the high prevalence, the negative impact there have been relatively few intervention studies to address chronic pain and none among OEF/OIF veterans which is a concern.

There are some significant gaps in the pain literature.  While multidisciplinary pain clinics have been shown to improve pain outcomes the best, these clinics and services involved in them are not widely available.  While there is empirical evidence for individual pain treatments their individual effect is modest, and leads to modest improvements in pain outcomes.  Therefore research to combine effective approaches to pain treatment is needed and the rationale for the ESCAPE trial.

As a research group our long term goal is to test the effectiveness of a multi-modal, multi-disciplinary interventions and determine the best combination of non-pharmacologic and pharmacologic treatments for chronic pain that can be practically applied and used in VA primary care and other clinical settings.

So the ESCAPE trial objective is to determine if a stepped-care intervention reduces pain related disability, pain interference, and pain severity and to improve secondary outcomes in OEF/OIF veterans with chronic musculoskeletal pain.

Before moving forward, I’d like to take a step back and answer this question how we define a stepped-care intervention.  For us, stepped care involves starting with a lower intensity, less costly treatment initially, for example in step one, and then stepping up to more intensive, more costly and complex treatments in patients with an inadequate response in step two or three.

This model has been discussed and examined empirically by Von Korff in the context of chronic low back pain in primary care setting and Chuck Engel in Persian Gulf War Syndrome.  This table outlines the conceptual model for our ESCAPE intervention.  In this relatively simple framework, step one consists of optimizing analgesic medications coupled with pain self-management strategies in OEF/OIF veterans with disabling musculoskeletal pain of the spine or extremities.  This level of intervention is relatively brief, relatively simple to deliver. Our rationale is that analgesics are the most common and usually applied most frequently and the most pragmatic, at least in the initial steps; however, analgesics may be insufficient when used alone and therefore, we also tailor this treatment to consist of self-management strategies integrating some educational components as well as behavioral strategies in step one.

Step two involved brief cognitive behavioral therapy which we felt was an increased intensity intervention reserved for those who continue to have moderate pain-related disability and still limited by any improvement in their pain at twelve weeks during step one treatment.  For CBT as many of us know it identifies problems that patients experience, negative thoughts related to their pain and strategies to overcome these barriers and enhance their problem solving related to their pain experience.

The primary hypothesis for ESCAPE is that stepped care is more effective than usual care in reducing pain-related disability, pain interference with activities, and pain severity.  Our secondary hypothesis is that stepped care is more effective than usual care in reducing psychological distress and stepped care is more effective than usual care in improving secondary outcomes and these secondary outcomes included health related quality of life, self-efficacy to manage pain, and negative pain beliefs and coping strategies.

This figure represents our overall study design, so participants with chronic musculoskeletal pain were randomized to stepped care or usual care.  The stepped care intervention consisted of optimizing analgesics, coupled with self-management strategies and step two consisted of twelve weeks of brief cognitive behavioral therapy for those who failed to improve during step one.

The interviewers or our research assistant was blinded to study hypothesis and treatment assignment and conducted outcome assessments at baseline, three, six, and nine months.  Our study sites—ESCAPE was conducted at Roudebush VA Medical Center in Indianapolis and participants were recruited from our five primary care clinics as well as our post deployment clinic.  

This slide outlines the eligibility criteria for ESCAPE.  Participants were eligible if they were OEF/OIF veterans, if they had chronic musculoskeletal pain for three months or longer and that the pain involved the low back, the cervical spine or extremities including the shoulder, hip or knee.  Furthermore their pain had to be moderate—functionally moderately functionally impairing as defined as a Roland Morris Disability Scale Score of seven or greater.

The study exclusions are here on the slide and primarily are factors that may affect the performance of the study or study medications that might be used that could pose a study risk.  So participants with active suicidal ideation, current alcohol or substance use disorder dependant.  Prior surgery or back surgery for pain or pending surgery.  Pain-related disability claim under adjudication.  Severe cognitive impairment and bipolar disorder or schizophrenia.

Individuals were randomized on a one to one ratio to either stepped care or the usual care control group.  Randomization lists were computer-generated and treatment assignments were supplied in sealed opaque envelopes.  As I mentioned all our baseline and follow-up outcome assessments were conducted by research assistants blinded to treatment allocation and they were not involved in the care of ESCAPE patients.

A little more detail about the Stepped-Care intervention.  The first step, the first twelve weeks involved Analgesic Management guided by the World Health Organization Analgesic ladder and an evidence-based algorithm developed by Kurt Kroenke, Erin Krebs and myself.  Our main goals were to optimize the use of simple analgesics, acetaminophen and non-steroidal anti-inflammatory drugs and introduce co-analgesics, those medications such as skeletal muscle relaxants, anti-convulsants, and topical analgesics.  And lastly to address to either initiate or make adjustments to coexisting opiate regimens.

This depicts the WHO analgesic ladder and was the guiding framework for our analgesic choices and decisions.  And this takes into account the severity of an individual’s pain and tailoring of treatment in a stepped-care fashion.  This table outlines more of the specifics of our analgesic algorithm. For patients already taking analgesic at baseline we would make dose adjustments or medication changes considered because at baseline they had moderately severe pain severity as well as functional limitations and felt that their pain treatment was not working.  So for patients not taking an analgesic at baseline, this table really outlines kind of the steps that we took, the specific medications under each step and broadly, we go step one with our simple analgesics, step two, other non-steroidal anti-inflammatory medications; step three involves a variety of co-analgesics.  Step four involves the tri-cyclic antidepressants that have some evidence base for effectiveness in pain conditions.

Steps five and six were our latter steps where we would initiate or address our--the opiate regimens and our choices kind of fell into the combination opiates, hydrocodone acetaminophen and oxycodone acetaminophen and then we talked about sustained release opiates in the last step.

In step one, coupled with analgesic management our nurse care manager implemented a pain self management program that was really modeled after pioneering work by Kate Lorig and the Stanford Self Management program as well as our own Theresa Damush and low back pain.  Each session was actively managed by a nurse care manager and during each session the nurse care manager would introduce a new strategy for self-managing their pain. The nurse care manager would assist the patient in choosing a specific strategy and the nurse care manager would supervise them as they practiced the chosen strategy and here I’ve listed a few of the strategies that we addressed including some educational topics, we encouraged physical activity and trying to return to normal activities.  We talked about goal setting strategies, communicating with healthcare providers and specific techniques to manage stress better such as deep breathing.

In step two which was an additional twelve weeks this complemented the behavioral focus of our self management strategies in step one.  We adapted a manualized program of cognitive behavioral therapy developed by Dr. Paul Lysaker and Dr. Louann Davis here at our Indianapolis VA.  They had developed a treatment manual that was shown to effectively reduce negative beliefs related to work functioning in patients with schizophrenia.  

In the basic concept were CBT principles trying to help veterans identify and modify maladaptive or dysfunctional beliefs and cognitions related to their pain experience.  This step involved six sessions all delivered by the phone and by our nurse care manager.  So the treatment details all aspects of the stepped care approach were delivered by a nurse care manager who actually actively managed our patients.  All the patients were supervised by physician investigators during weekly case management meetings to discuss intervention patients.  And the nurse care manager had regular contacts on average every two to three weeks with participants to carry out the following tasks:  They would monitor the individuals pain, severity—their disability.  Would assess their response to the treatment choices that we recommended, assess for side effects, would ask the patient of their desire for a treatment change and also introduce a self-management strategies.

In the usual care arm, patients randomized to this group were recommended that they seek advice about their pain treatment from their primary care provider or other providers; otherwise we as a research team made no other attempts to influence or provide pain treatment or management unless a psychiatric emergency arose such as suicidal ideation.

In summary, ESCAPE is a randomized controlled trial.  Randomizing patients in either stepped care or usual care.  The sample included OEF/OIF veterans with chronic musculoskeletal pain of the spine—either the cervical spine or low back or extremities including the knee, hip or shoulder.  It involved our five primary care clinics as well as our post deployment clinic here at Roudebush VA and we conducted outcome assessments at baseline, three, six, and nine months.

The next couple of slides talk about our outcomes.  Our primary outcomes for pain related disability involve the Roland Morse Disability Scale.  The Roland Morse scale is a twenty-four item scale which was first validated in low back pain and subsequently validated in other pain conditions.  For the scale scores range anywhere from zero which represents no disability related to their pain through twenty-four representing severe disability.

Furthermore our primary outcomes included the brief pain inventory, pain interference scale which assesses seven items from zero, no interference, to ten severe interference.  The seven items are summed and then averaged to give an overall interference score.  And pain severity or intensity was assessed by the graded chronic pain scale with a range between zero representing no pain to 100 representing severe pain.

This depicts the specifics of the BPI—the Brief Pain Inventory interference scale which assesses the degree to which pain interferes with general activity, mood, a person’s walking ability, their sleep, their work functioning, relationships with others, and enjoyment with life.  We assess secondary outcomes in three large domains including psychological distress.  Primarily we looked at depression, anxiety, and PTSD symptoms.  We looked at health-related quality of life with the medical outcomes study SF-36.  Eight individual domains in the mental and physical component summary scores.  And we also evaluated pain beliefs and cognitions such as pain catastrophizing and centrality of pain.

Other measures we of course looked at demographics, their military history, medical co morbidity, pain treatments at baseline as well as during the course of the trial, their work functioning, pain beliefs and cognitions, their use of alcohol, somatization, psychosocial stressors, their cognitive function, degree of social support, deployment exposures, and physical activities.  Our analyses were based on the intention to treat method and all randomized participants.  The outcomes were assessed as the change scores from baseline to nine months between the stepped care arm and the usual care arm.  Missing outcomes during the follow-up were imputed using the last observation carried forward imputation method.  And to assess robustness of findings, we also examine the concept of complete [caged] findings as well.

For our power and sample size with a 100 individuals per group we had 80% power to detect a .4 or moderate effect size.  So enrolling a total of 240 individuals allowed a greater than 15% attrition rate, still giving us 80% power to detect this moderate treatment effect.

Recruitment was conducted from December 2007 to June 2011 and follow-up just concluded this last April 2012.  The next figure depicts our participant flow.  I want to highlight a couple of things.  242 patients were consented, half were randomized to stepped care and another half to usual care.  And I want to direct your attention down to the nine month interview where we had 108 subjects assessed with an attrition of 11% in the stepped care group and we only lost six in the usual care for an attrition of six percent.  So we were quite pleased with our retention and kudos to my research team for their fantastic recruitment and follow-up of these participants.

This depicts our overall sample characteristics of 241.  Mean age of the participants was roughly 37 years of age.  Most were men: 88%. More than half were married.  Here it depicts our racial breakdown.  About 77% were white.  13% black and most were employed or in a student status.  We also asked a single question about their income level whether they were they felt that their income was comfortable, just enough to make ends meet or not enough and here you see what they responded to their income status.  Two thirds were from the Army branch of the service.  Most had been deployed to Iraq.  Most were their duty status was in the retired or discharged state and the last bullet here is looking at their pain location most had chronic low back pain and you see the breakdown of other pain conditions, knee, neck, shoulder, and hip.

This slide shows the breakdown in their baseline analgesic medications.  Most common were the Non-steroidal anti-inflammatory medications.  Somewhat surprising, at least to me, was their frequent use of anti-depressants over a third to two out of five were on antidepressants at baseline.  Half were on—excuse me, a third were on opiates, a sizable minority were on muscle relaxants and you see the others on acetaminophen, anti-convulsants and topical analgesics.

In terms of other current treatments, non-pharmacologic treatments at baseline you see the number of that were currently being seen in the pain clinic across the two arms.  Who were actively being seen in the mental health setting, either seen by a psychiatrist or psychologist and those involved in active physical therapy at baseline.  

Here depicts our baseline pain measures of our three primary outcomes, the Roland Morse Disability scale, the BPI-Interference with activity scale and the [inaudible] Pain Scale Pain Severity.  What these numbers represent a Roland of thirteen or fourteen represents moderately severe disablement from pain.  Their interference with activities was also at a moderate level at baseline and their severity—again, the range for the pain severity was zero to a hundred scale again representing moderately severe pain severity at baseline with no differences across the two arms in stepped care versus usual care.

This table depicts baseline psychological measures for a few select scales including the PHQ-9 depression scale, the Primary Care Checklist for PTSD and the GAD-7 Anxiety scale.  Again I’d like to point out that depression at baseline was moderately severe yet equal across the two arms and moderately severe PTSD and Anxiety symptoms as well.  I think demonstrating the high degree of psychological co-morbidity at baseline in these veterans.

Here we get to the primary results and I’m going to walk you through this a little bit.  Here we have our baseline Roland Disability scale, our nine month Roland Disability and the change from nine month to baseline.  In the stepped care you see a change of a drop or improvement in disability of 3.4 points—in the usual care they improved but to a much lesser extent of 1.6 points.  And the change was clinically and statistically significant at a .0063 level. This is consistent with a moderate effect size in improving pain-related disability.  On the Roland, literature suggests that a drop of more than 2.5 is clinically significant in this measure.  

This table depicts the pain interference with activities at baseline both arms had moderately severe pain interference with activities.  You see the drop at nine months with a change in the intervention arm of 1.6 and in the usual care the arm dropped or the interference dropped to .86 and a clinically significant and statistically significant difference of .017.  This figure depicts the change over the course of the trial and pain severity or pain intensity.  Starting at month—or baseline, month three, month six and month nine.  And you see that it starts to differentiate from the red line which is the usual care the control arm and the blue line is the intervention arm.  It starts to separate at three months and continues to separate at six and nine months.  At this time, our second year outcomes and analyses are pending.  In fact we meet later today and hope to finalize those.  I wish I could present those. Hopefully at a later time.

Our study findings.  In OEF/OIF veterans they have received several pain treatments already at baseline which I think speaks to the complexity of pain management in this group.  Also they have moderate co-morbid psychological symptoms as well as their moderately severe pain.  Our ESCAPE trial showed that a stepped care intervention reduced pain-related disability, pain interference with activities, and pain severity.  I’d like to have two slides and discuss the ESCAPE trial in the context of two other important trials.  The first is the SCAMP trial conducted by our group and led by Kurt Kroenke here at Indianapolis VA and Indiana School of Medicine.  This was a trial that targeted primary care patients with co-morbid depression and pain.  The intervention was slightly different in that it involved anti-depressant treatment according to an algorithm combined with the pain self-management program, again in the context of a nurse care management intervention and this showed substantial improvements in depression severity as well as diagnosis for major depression.  It also showed moderate reductions in pain severity and disability.  The second trial that I think is quite important in the discussion of ESCAPE is Steve Dobscha’s collaborative intervention for chronic pain at the Portland VA.  Their intervention was slightly different and involved educating clinicians as well as assessing patients, educating patients, and activating them.  Facilitating specialty care, especially when patients had moderately severe psychological symptoms and then providing feedback and recommendations for pain treatment to primary care physicians.  The results of this collaborative intervention showed that there was modest improvements in pain as well as depression.  

So in summary ESCAPE was one of the first intervention studies for OEF/OIF veterans with chronic musculoskeletal pain.  It involved a complex intervention that included analgesics that were coupled with some self-management strategies and then cognitive behavioral therapy in step two in a nurse care management intervention showing moderate improvements in pain.  I think it shows that multimodal strategies, multidisciplinary strategies are needed to improve pain outcomes.  But I think that the impact could have been greater if we would have addressed the co morbid psychological symptoms head on and that I think this speaks to treatment models that you treat both psychological symptoms as well as pain concurrently for even better effect sizes and better outcomes for our veterans.

So I think this also speaks that we still have unique challenges in caring for our veterans with pain.  There is still much to be learned and finding the right combination of pharmacologic and non-pharmacologic approaches that can be practically applied in our VA primary care treatment settings and other clinical settings.

I had an amazing study team that I worked with and was very fortunate and I thank them for all their efforts in making this happen and this opportunity to present to you.  And I want to thank you for your attention and I’m happy to ask some questions if there are any.

Molly:  Thank you Dr. Bair.  We do have some questions that will come in or that have come in and I believe Dr. Kerns will be joining us momentarily to moderate some, but until then I can go ahead and get started.  We have about—just over half a dozen. The first question that came in are medications in step two added to those in step one or do they substitute those in step one?

Matthew Bair:  Thank you for the question.  In step two, medications are maintained.  It was unusual that we would add or initiate medications in step two.  We usually initiated and changed treatments, escalated doses in step one and then in step two generally maintained those doses and those medications and did not initiate unless a rare circumstances where their pain was still very poorly treated, very high pain scores, disability and severity scores.

Molly:  Thank you for that response.  The next question: are—can we get a copy of the Lysaker and Davis treatment manual?

Matthew Bair:  It is published.  I can send out the reference and talk with Dr. Lysaker and Dr. Davis about their treatment manual.  I am pretty sure they are open to sharing.  I can’t speak for them 100%.  But I’m fairly certain that they would share their treatment manual with interested members.

Bob Kerns:  This is Bob Kerns.  If we are able to get that manual, is there—I guess the question would be if it can be shared broadly with the participants or would people need to request it?  How do you think we could handle that?

Molly:  If it’s open access on the internet, then I’m happy to provide a link or the reference in the follow-up e-mail we’ll send tomorrow in which case all registrants will receive that directly.  If you feel that’s overkill, then they can e-mail Dr. Bair or myself and we can get that out.

Bob Kerns:  That sounds good.  And you’ll follow up with Dr. Lysaker?

Matthew Bair:  Yes, I will.

Bob Kerns:  And Molly Ann, the PowerPoint presentations will be available as well?

Molly:  Correct.  Everyone will receive a follow-up e-mail tomorrow with a direct link to the archived video of this and within that page is also a button to download the handouts.  So yes, the PDF will be available to anyone.

Bob Kerns:  And Molly Ann if you don’t mind will you continue with the questions for Dr. Bair that have already been posted.

Molly:  I’m happy to do so.  Thank you.  The next question: what did “treatment as usual” consist of?  Multidisciplinary care (behavioral health and physical health) or just one discipline?

Matthew Bair:  Good question.  So it could involve all of those.  It could involve, as you can see from the baseline treatments a lot of patients in the usual care were receiving pharmacologic treatments, smaller proportion were receiving active treatment in pain clinic, physical therapy or mental health.  They were also had been receiving treatments by a neurologist, orthopedics, rheumatologists, other specialists for pain conditions and we as a research team did not influence the treatment of their pain in the usual care.  So they could receive all of those different kinds of treatment and what we did was assess their treatments received at baseline as well as during the course of the trial.

Molly:  Thank you for that response.  We do have about five pending questions.  For those of you who joined us after the top of the hour, if you’re looking to submit a question, just please go to the goto webinar dashboard on the right hand side of your screen and you can submit your question under the question box and press send.  The next question that has been written in: were there any theoretical approaches applied to the hypothesis or clinical intervention?

Matthew Bair:  I’m hesitating a little bit, Molly because I’m not sure I understand the question.  Were there any theoretic can you repeat the question, please.

Molly:  Yes.  Were there any theoretical approaches applied to the hypothesis or clinical intervention and if need be we can request that that submitter further clarify.

Matthew Bair:  I think yes there was.  There was certainly—there was theoretically the stepped care model had been tested empirically by Van Korf and colleagues at University of Washington in the context of chronic low back pain and Chuck Engle at Walter Reed for Persian Gulf War Syndrome.  Stepped care has been used as a treatment approach in mental health treatment for years. The specific treatments that we use including analgesics, self-management strategies, and CBT all individually have an evidence base behind them as showing effectiveness in chronic pain treatment.  What hasn’t been shown is sort of their combination outside of a multidisciplinary pain clinic setting.

Molly:  Thank you for that response.  The next question: how difficult was it to recruit and retain participants?  What was the level of dropout?

Matthew Bair:  The level of dropout thanks to our research team was excellent. I showed a flow diagram, so in the intervention arm at nine months eleven percent had dropped out.  In the usual care arm, six percent had dropped out.  In terms of I think I have another slide here, we had to approach just over five hundred patients to obtain our 242 included in our study.  So of those 417 were ineligible most of the time because of a low or zero Roland Morse disability.  So they didn’t have moderately severe functional impairment.  108 were actually eligible but weren’t interested.  So recruitment is always the toughest part of any trial so I guess it was mild to moderately difficult.  It’s hard to say.  Retention thankfully was quite good.

Molly:  Thank you for that response. The next question: can you clarify what usual care was?

Matthew Bair:  Usual care was treatment as usual.  So that is quite varied.  So it could include analgesics prescribed by primary care providers.  It could involve non-pharmacologic approaches such as interventional pain treatment in our pain clinic, our physical therapy clinic.  It could involve our chronic pain CBT group.  It could involve physical medicine and rehab, being seen by a specialist for their pain such as a neurologist or rheumatologist or surgeon for their pain such as orthopedic surgeon.  It was quite varied and we assessed how varied that was at baseline as well as during the follow-up.  That there was—treatment as usual does not mean no treatment for pain.  They were receiving treatment that you can see from the baseline treatment and that we will look at throughout the course of this trial.  They were receiving; they being those in usual care were receiving several types of treatment for chronic pain.

Molly:  Thank you for that response.  We do have three more pending questions.  The next one: how would you recommend implementation of these interventions?  Do you think the clinicians performing the interventions should be meeting together regularly?  Or are clinic notes and alerts sufficient?

Matthew Bair:  Well, that’s such a difficult question.  I think it’s an excellent question; it’s just difficult how to best implement.  The latter part I don’t think alerts and reminders are sufficient.  From a practical standpoint I think time constraints limit you know limit the ability for all clinicians to get together to discuss and I think there needs to be some sort of special pain team within integrated within a primary care setting that complements what a primary care provider and the PACT teams are doing already for pain but can do some of the things that we did in our trial in terms of frequent assessment, monitoring, assessing for side effects, assessing treatment response, evaluating their patients desire for treatment change and then implementing that change with the AOK from the primary care provider.

Molly:  Thank you for that response.  People are continuing to write in questions, so we do have four more pending.  Did you track the patients who actually did any of the recommended interventions:  physical activity, stress management, etc, in addition to talking—analgesics?  If so, was there any intervention that showed benefits?

Matthew Bair:  We did track the use of analgesics during the course and we also did track the use of specific self-management strategies and the number of sessions attended and those sessions that were delivered by the nurse care manager and so we tracked the amount of time that the nurse care manager spent in individual session. The content of that session—the individual strategy that were introduced either during step one—the self-management strategy as well as the cognitive behavioral training techniques.  Unfortunately in a combined multicomponent trial such as this, it’s very difficult to disentangle the, I guess, the most active ingredient since it was kind of a bundled approach.  That problem has led to design of some of our subsequent studies where we do head to head comparative effectiveness and looking at these individual components to compared head to head and combined as well to see if there’s additive effects.

Molly:  Thank you for that reply.  The next question: was subsequent back or other orthopedic surgery tracked between the intervention and control groups?  Was there a difference in follow-up use of surgery?

Matthew Bair:  The only way we track that was self-report.  Self-report seeing a physical therapist since the last outcome assessment, the last visit with our research team.  So we did track that but we haven’t looked whether there’s been differences.  My anecdote is I think it’s very unlikely that there are any differences there—you know—we track the intervention patients very closely and they didn’t have any—as far as in the 121 didn’t have any subsequent back pain surgery during the nine month ESCAPE trial.

Molly:  Thank you for that response.  The next question: were the participants regularly screened for aberrant behavior with UDS and questionnaires?

Matthew Bair:  Good question.  No.  Not regularly.  We did some self-reported aberrant behavior and at-risk use of illicit and licit medications and drugs.  But we did not do systematic follow-up with urine drug screening.  We did in the participants who were on opiates we did have them sign an opiate agreement.  Yes.  An opiate contract so that if opiates were prescribed they would only be prescribed by the research team or the primary care provider involved.

Molly:  Thank you for that response.  The next question:  Can you provide us with additional details about CBT provided to the patients?

Matthew Bair:  I can do my best.  I think this kind of relates to the person’s whether Dr. Lysaker and Davis would be willing to share their treatment manual.  I think they would.  There was approach written by Emery the four A’s approaches which is sort of attempting to identify maladaptive thoughts, addressing those thoughts, and accepting that it’s perfection is not possible, and other than that I’m going to—it was based on CBT principles in terms of trying to identify maladaptive thoughts and helping participants identify those thoughts and helping them acknowledge that they’re probably not helping their pain experience and trying to restructure those thoughts to more adaptive and helpful pain thoughts.  And then finding ways to better cope and problem solve.

Molly:  Thank you for that reply.  We do just have another two questions pending.  What are the barriers and facilitators you foresee when thinking about implementing this type of approach within any given VAMC?

Matthew Bair:  Well, the biggest barriers I think are resources. The most valuable resources are people—people that can deliver this—I think all these treatments can be delivered in a primary care setting yet you need people that have the time so that they’re not burdened by some of the time constraints that are so common in primary care.  They’d need some specialized training but you know I think an algorithm approach to analgesic management is very feasible to do by—we showed it before a nurse care manager and other healthcare professionals.  I think self-management strategies have been delivered by not only healthcare professionals but peers as well, so those are feasible to be delivered in a primary care setting and I think the challenge is CBT which traditionally has been the more intensive on the order of ten to twelve sessions.  Can a much briefer more intense CBT type program be delivered in a primary care setting of three to six sessions and I think so, but it does require additional resources in primary care and in time.

Molly:  Thank you for that reply.  Questions do keep streaming in so we’ve got two more to go through.  Were mindfulness techniques included in your study and if not, have you any experience with these techniques and do you have an opinion on their ability to assist pain patients?

Matthew Bair:  Um.  In fact, Dr. Luann Davis is an expert in mindfulness-based stress reduction for pain as well as PTSD.  I am a strong proponent of mindfulness-based relaxation techniques for pain.  I do think that our current literature lacks some  empiric evidence for it and I think that provides a opportunity for us researchers to look at that—in the context of ESCAPE we did not explicitly implement or deliver mindfulness-based strategies, however.

Molly:  Thank you for that clarification.  Next question:  How often did the RN/CM provide the CBT?  Was it group or individual?

Matthew Bair:  Sorry I wasn’t clear on that.  Generally well, all the CBT sessions were conducted over the telephone.  So they were not done face to face. The protocol was for six CBT sessions delivered over the phone. Now that doesn’t mean that every patient received six sessions.  But that was what our goal was to deliver six CBT sessions for intervention patients.

Molly:  Thank you.  That is the remaining question we have at this point in time. I would like to give you the opportunity to make some concluding comments if you’d like to.

Matthew Bair:  Well, nothing mind-blowing.  Thank you for the opportunity to talk with you and discuss.  I really appreciate all the questions and I hope that’s a proxy for interest in the ESCAPE.  I hope to have the findings submitted for publication in the next two weeks and please my door is open per se.  Please e-mail me.  Matthew.bair@va.gov or mbair@iupui.edu.  And I’ll get back to you as soon as possible.

Molly:  Thank you Dr. Bair.  We do thank you very much for sharing your expertise and also Dr. Kerns, would you like to give any concluding comments?

Bob Kerns:  Yes.  Sure.  I’d really like to thank CIDER for their support and Molly Ann, your support today.  Thank you very much and special thanks to Dr. Bair for his excellent presentation.  I’m gratified by the strong interest in this.  Please if you’re new to the spotlight on pain management program, please know that this is held every month at this same timeslot, the first Tuesday of each month at 11 o’clock—11 a.m. eastern time, so stay tuned for further announcements and if you have specific questions of our national pain management program office, please send them in my direction.  I’ll be glad to try to help answer them.  Thanks again for your participation.  Bye bye.

Molly:  Excellent.  And I would like to thank our presenters and our attendees for joining us.  Please do check your e-mail tomorrow for a follow-up e-mail which will have the hyperlink to the archive where you will be able to view this at your leisure, pass it on to colleagues and download the PDF.  And I will be in touch with Dr. Bair and if we can get the manual out to you, then we will include that in a follow-up e-mail.  Thank you very much to everyone and this does formally conclude today’s HSR&D Cyber Seminar.  Have a wonderful day.

**[End of Recording]**