**Transcript of Cyberseminar**

**Spotlight on Pain Management**

**PROJECT STEP**

**Presenter: Robert Kerns, PhD**

**October 1, 2013**

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

**David Atkins, MD**I'm delighted to introduce Bob Kerns in making this call on the seminar on pain management.  Bob is in the unusual position of having held dual clinical and research appointments as the sort of pain czar for the VA, and I think his new title is now Chief of Pain Research in VA.  He is the director of a newly funded COIN in West Haven that has a focus on pain research and is also the lead on a CREATE project that is looking at ways to advance our understanding and management of pain.  There's no one who's in a better position to be giving this seminar, and I'm looking forward to hearing what he has to say.  Thanks.

**Robert Kerns, PhD:**Thank you, David.  First, let me do a check.  I hope that everybody will hear me.  I'm trying to use a headset.  If there's a problem with the audio, please put in your question or comment in the website so we can try to correct the problem. 

I'm going to try to cover a few different things today in this presentation and hopefully leave time for discussion and reflection on what I have to say.  Largely, I'm going to be trying to provide information about an important project that we've had the benefit of conducting at VA Connecticut Healthcare System in West Haven and Newington and actually over the whole state of Connecticut.  This project is funded through a partnership of two research foundations:  the Donaghue Medical Research Foundation, which is a Connecticut-based clinical and community health services research foundation, and the Mayday Fund, a New York-based education and research foundation focused on pain and pain management.  

The title of our project is Project STEP.  This takes off on the idea of—largely, this project is about studying, and evaluating, and trying to inform implementation of the VA stepped care model of pain management in our healthcare system at VA Connecticut.  

Today I'm going to talk—I'm going to place this project in the broader context of public health issues in the United States related to pain and pain management; talk about VA's national pain management strategy briefly; and give an introduction to the stepped care model that hopefully most, if not all of you, have heard about before; and then go through our project, including presentation of some results of both qualitative and quantitative approaches to inform and evaluate the implementation of our stepped care model at VA Connecticut. 

Hopefully, at the end of this presentation, the learner will be able to describe the public health significance of chronic pain; describe the VHA's stepped care model of pain management; describe several initiatives at the VA Connecticut Healthcare System to support implementation of this model; and describe the mixed methods approach that was employed. 

Here's a polling question for—actually, it doesn't—oh, yes, here we go—

**Moderator:**I'm opening it up.  It's not a problem. 

**Dr. Kerns:**Yes.  We'd like to get an idea of who's in the audience today.  This is a typical polling question that we use, so please respond to this question on your desktop or laptop, and I'll see the summary of the results in just a second.

It looks like the two largest proportion of responders are clinicians and researchers.  Let's just wait until the final results.  

*[Pause 04:05 - 04:12]*

**Dr. Kerns:**Looks like things are slowing down, Heidi.

**Moderator:** Yes, looks like things are slowing down here.  We're seeing about 41 percent VA clinicians, 31 percent VA researchers, and about 14 percent non-VA researchers, and then a few outliers beyond that in operations, non-VA clinicians, or in other designation.

**Dr. Kerns:**This is a typical mix of people that participate in these seminars.  I hope there'll be a little bit of something for everybody here.  It will be focusing on research but with a broader focus on the policy and  practice implications.  

I really like to start these kinds of presentations by placing all of this in the context of the work of an important committee on which I was privileged to serve:  an Institutes of Medicine Committee for Advancing Pain Research, Care, and Education.  In June of 2011, the committee published its findings and recommendations in book form, called *Relieving Pain in America:  A Blueprint for Transforming Prevention, Care, Education, and Research*.  

Importantly, this report was divided into several different sections.  It established the public health significance of this problem, but then it specifically focused in on issues related to the care of people with pain, research agenda, and an education agenda.  I'm going to focus here on just the recommendations or findings related to the care of people with pain.

There were several particular findings, but a couple that I'd like to highlight is that pain care should be tailored to each person's experience and that significant barriers to adequate pain care exist, including gaps in knowledge and competences of providers.  Some data to support that were highlighted, showing that at least about half of primary care providers feeling only "somewhat" prepared in terms of being able to address the care needs of the patients they serve, and ultimately that were were additional system and organization barriers to optimal pain care or quality of pain care as well.  

This next slide really highlights some of those barriers to effective pain care in more detail.  The comic is actually an interesting and important one, kind of a metaphor, if you will, for a problem that we have in the United States.  The physician is saying, "I'm going to prescribe something that works like aspirin but costs much, much more."  

In fact, in the United States there are multiple system, clinician-level, and patient-level variables.  Among those, particularly important system-level variables and barriers that have been highlighted, are really issues related to the way that we in the United States reimburse for pain care.  There are a number of evidence-based pain care strategies, including some that I've been promoting in my career, related to evidence-based psychological interventions, for example, or what we might call complementary health approaches, but those are often not well reimbursed, and even in VA, there are issues in terms of the availability or capacity for these kinds of services.  

On the other hand, there are enormous costs related to care of people with pain in the United States, including costs that are attributable to a variety of procedures or interventions that have limited evidence to support their efficacy and even some that have a growing body of evidence that suggests that they're not effective and, in fact, could be harmful.  Really, an important issue of the Institutes of Medicine committee was laying out some of the barriers to effective pain care that inform recommendations for system, clinician-level, and patient-level improvement.

Here are those recommendations that were specifically related to the care of people with pain.  Healthcare provider organizations should promote and enable self-management of pain as a starting point for management.  A population strategy described in a previous recommendation in this report related to the transforming of pain care in the U.S. should include developing strategies for overcoming these barriers to care that I just highlighted.  

Importantly, recommendation 3.3 was that health professions education and training programs, professional associations, and other groups should provide educational opportunities in pain assessment and treatment in primary care.  Pain specialty professional organizations and primary care professional organizations should support collaboration between pain specialists and primary care clinicians.  

Payers and healthcare organizations should revise reimbursement policies to foster coordinated and evidence-based pain care.  Finally, healthcare providers should provide consistent and complete assessments.  

Shifting to the VA, and with these recommendations about pain care in mind, we can talk about the public health significance of pain as a problem in the VA.  It's well recognized and frequently cited that as many as 50 percent of male veterans and perhaps as high as 75 percent of female veterans report chronic pain when they present to primary care or specialty women's health clinic settings.

Pain is widely acknowledged outside the VA and inside the VA as one of the most costly disorders treated in VA settings.  These are old data from the Health Economics Resource Center in Palo Alto that documented that the cost attributable to care of veterans with low back pain alone was 2.2 billion in FY 99 dollars.  

Actually, more recent data suggests that the number of veterans with chronic low back pain and, in fact, chronic pain more generally and particularly musculoskeletal pain, is growing steadily with each passing year.  It's expected that the costs of care have continued to accelerate as well. 

This slide reminds us that pain, as I'm sure most of you can appreciate, is essentially associated with all things bad.  Data from our group and others maybe as long as ten years ago documented that pain is associated with poorer self-rating of health status, which is, of course, a significant predictor of morbidity and mortality.  It's associated with greater use of healthcare resources.  

It's associated with health risk behaviors, such as tobacco use, alcohol use, and diet and weight concerns.  It's associated with significant functional limitations, particularly limitations in social role functioning.  It's associated with lower social support, a factor that can mitigate some of the stressors or challenges of pain.  

It's associated with higher levels of emotional distress and, in fact, is highly co-prevalent with significant mental health conditions, such as mood disorders, anxiety disorders, PTSD, and substance use disorders.  Among women, it's associated with high rates of military sexual trauma.

This slide is one of several figures, if you will, that are published about every three months in VA that show the cumulative prevalence of specific clusters of medical diagnosed conditions among veterans from Operation Iraqi Freedom, Enduring Freedom, and New Dawn.  Highlighted in red, the third from the bottom, are disorders of the musculoskeletal system, presumed to be painful, that reach close to 60 percent of all veterans from the era, surpassing the prevalence of all mental health disorders combined.

This slide cues us to think about or reflect a little bit about what we all know to be true, which is that the signature injuries of the wars in Iraq and Afghanistan are posttraumatic stress disorder and traumatic brain injury.  These data from what's called a level 2 polytrauma clinical setting at VA Boston Healthcare System in which veterans who had screened positive for the presence of traumatic brain injury were clinically evaluated by a multidisciplinary team.  

In this relatively small sample, in fact, the largest proportion, about 42 percent, of the sample had all three conditions—chronic pain, PTSD, and TBI—as co-prevalent conditions, with very few veterans in this sample either having PTSD alone or TBI alone or either combination of any of these two conditions.  Some would argue, and I would argue, that, in fact, the signature injury of the war in Iraq and Afghanistan is really chronic pain or at least we need to think about the veteran with multiple comorbidities that include chronic pain.

Let's turn now to the VA's National Pain Management Directive.  This is really an outgrowth of the vision of our former Undersecretary for Health, Ken Kizer, who in 1998 launched and chartered a VHA national pain management strategy.  By 2003 and then again in 2009, VHA published a pain management directive or policy guidance.  

In 2009, this policy guidance articulated objectives for our national pain management strategy.  It articulated a very detailed infrastructure to support the pain management strategy and its implementation.  For the first time, it articulated a single standard or model of care for VA called the stepped pain care model, which I'll talk about today, and it also promulgated specific standards for pain assessment and treatment, evaluations of outcome and quality, and clinician competence and expertise.  

This next slide shows the objective of the national pain management strategy.  If you look carefully,every word in this objective is important.  It talks about that this initiative needs to be multicultural in focus.  It needs to support integrated pain care and a system-wide approach to pain management that reduces not only pain but suffering and impact of pain associated with acute and chronic pain and also associated with a wide range of illnesses, including pain at the end of life.

There are multiple publications, both from outside the VA, that inform the model and this policy guidance, and then there are several publications highlighted on this slide that, in fact, serve to provide support, evidence-based, for this model and policy guidance.  In particular, there are several Kerns citations here.  The last four on this list actually are editorials or commentaries that were written in support of an entire issue of the journal that's focused on pain research in VA or at least significant special topic sections.

Before articulating or going over the stepped care model, I want to highlight what we all understand in the Institutes of Medicine committee.  This slide highlights some of the key principles of veteran-centered pain management that focuses on pain self-management as an adaptive strategy for managing pain.  This is the informed by the chronic illness model.  As we've already talked about, it places an emphasis on team-based interdisciplinary and integrated pain care.  

It really focuses on conservative use of analgesics and adjuvant medications, all in the context of a strategy that promotes reassurance, encouragement, and education of veterans and the encouragement of a maintenance or a sustaining of an active, healthy lifestyle, including regular exercise and avoidance of health risk behaviors.  Ultimately, though, and consistent with work that I've been doing throughout my career, it also emphasizes the development, potentially through interactions with the healthcare system but often on a person's own—the development of adaptive strategies for managing pain, things that we might call coping skills.  

Next slide:  This is a schematic of the VA's stepped care model.  Many of you have seen a similar slide or visual before.  What now has been added to ones that I've used previously is really that foundational base about pain self-management that I've just described.  Having said that, of course, most veterans do interact with the healthcare system, and we understand that there are primary or initial point of accesses through primary care with care being provided by patient-aligned care teams.  

It's in this setting that VA calls for the routine screening for presence and severity of pain:  the so-called "pain is the fifth vital sign."  When pain is present, it calls for assessment and management of most common pain conditions in the primary care setting by PACTs with support from a variety of integrated teams and a growing number of innovative structures and strategies to support primary care-based pain management, including support from mental health/primary care integration teams, OEF, OIF, and post-deployment teams, pharmacy pain care schools and clinics, and other strategies.

Of course, having built capacity for managing most common pain conditions in the primary care or PACT setting, we need to understand that there's an outer limit of the capacity of primary care to meet the needs of patients, and with increasing complexity, treatment refractoriness, comorbidities, and risks, primary care providers and patients need to know that they have timely access to specialty care and even sometimes tertiary care services.  At the secondary consultation level, this is not, of course, limited to pain medicine or pain clinic specialty teams but also rehabilitation medicine, mental health services, and behavioral pain management services, as well as complementary and alternative medicine services.  

VA is very serious about rebuilding what we used to have in the VA and in the United States, which were tertiary interdisciplinary pain centers.  For VA, this means that every VISN by September 2014, the end of the fiscal year that starts today, in fact, will have the capacity for delivering advanced pain medicine diagnostics and intervention and for providing commission for the accreditation of rehabilitation facility or CARF-accredited pain rehabilitation.  We're happy to say that just since this directive was published, VA has grown from having one to now nine CARF-accredited pain rehabilitation programs, with at least 14 more in the pipeline as far as we are able to monitor centrally.  

A polling question:   What is your involvement in efforts to implement the stepped care model of pain management in VHA?  Are you involved in national stepped care model pain management transformative efforts?  Are you a member of VISN or facility leadership teams responsible for these efforts?  

Are you an active participant in implementation efforts, for example, in the PACT?  Are you a researcher involved in evaluation of research related to this model, or you're not otherwise involved but interested in learning more or, in fact, not even aware of this model and efforts to implement it at your facility?

Take a minute to reflect on your current involvement and, in fact, look at these opportunities and consider whether there are opportunities for you to become involved, either at your local facility, or VISN, or, in fact, national efforts.

*[Pause 21:37 - 21:44]*

**Moderator:** It looks like the responses are slowing down a little bit here, so I will go through those.  We're seeing around 40 percent who are not currently involved but interested in learning more; about 19 percent a member of VISN and/or facility leadership responsible for implementation efforts; around 16 percent active participant in implementation efforts; 12 percent researcher involved in evaluation or research relevant to the SCM-PM; 14 percent not aware of this effort; and 2 percent involved in national transformative efforts.

**Dr. Kerns:**This is really wonderful.  First of all, for those of you who are involved nationally, at your VISN, or your facility, thank you.  It's for your efforts that we are seeing some really nice successes across the country in terms of building this capacity.  

For those of you who are not otherwise involved but interested in learning more, I'm glad you're participating in the seminar today, and I hope you will become engaged in these kinds of education and training opportunities in the future.  There's a saying, "Think globally; act locally," so if you are at a local facility, you almost certainly have a pain management committee or some other individuals who potentially are known to you as subject matter experts who potentially could help you become more engaged at your local facility level, if not at higher levels of the organization.  

I'm going to really turn now and use the rest of my time to talk about our Project STEP.  Pictured here is a picture of a very close colleague of mine, Patty Rosenberger, who many of you knew, but not all.  Patty, unfortunately, died just about a year ago from a rapid and progressive medical condition, and it was with great distress and considerable loss that we said goodbye to Patty.  Patty really was the linchpin of this project for several years, and I want to honor her and respect her contributions today as I present on this project and her contributions.  

This project was designed to evaluate processes of implementation to determine best practice models for broader dissemination and implementation in VA.  It was to encourage changes in group and organizational processes and evaluation of pain management and organizational outcomes.  It was to use qualitative and quantitative methods to both inform and evaluation our progress in implementing the stepped care model at VA Connecticut.  

There are multiple sources of data.  I'm going to very quickly go through some of those data and the results that we have to present today.  There were qualitative data from primary care providers and nursing staff, as well as pain management specialists, regarding their experiences caring for persons with pain.  

There was an entire strategy built from the ground floor up for manual extraction of indicators of quality of pain care from primary care provider progress notes.  The third data set was the development of metrics that could be applied to the automated electronic health record and administrative data to extract key dimensions of pain care consistent with the stepped care model, for example, indicators of guideline concordant care, opioid risk mitigation strategies.

In this context and, frankly, for the manual chart extraction as well, we looked at 2 cohorts of veterans in care in VA:  a pain cohort defined as having moderate to severe pain on the pain-as-fifth-vital-sign pain intensity rating; and an opioid cohort defined as receipt of longer opioid therapy, that is, opioid therapy for 90 consecutive days or longer.  

For the qualitative data from providers and nursing staff, we asked four questions.  These were presented in a written form and providers and nursing staff provided written responses—narratives—to each of these questions.  We conducted this, actually, at baseline early in our process a few years ago *[audio distortion 26:17]* have continued to survey providers and nursing staff ever since, and most recently included some follow-up questions that are on the slide here.

Basically, we asked about their experience in caring for patients with chronic pain and particularly tried to elicit from them their thoughts about barriers, positive aspects, and negative aspects of caring for people with chronic pain.  

From the primary care providers, actually 11 themes were identified using a method called Krippendorff's content or thematic clustering technique.  This was done with the support of Linda Pellico, a doctoral-level nurse in the School of Nursing here at Yale with particular expertise in qualitative analyses.  

You see here the list of several different barriers and facilitators.  I'd like to highlight a couple.  One, and really consistent with other reports, including those from a couple of people that are on this call today, inadequate training of providers was particularly highlighted, as well as organizational impediments, such things as time, but also just the infrastructure and limitations of the way primary care functions that can interfere with the ability, for example, to see patients more frequently who potentially need that kind of frequency or intensity of care.  

There was also highlighted the clinical quandaries and frustrations that accompany the care of people with pain, in this case veterans.  Particularly highlighted were issues related to the complexity of their chronic pain condition, it's subjective nature, and the presence of important medical and particularly mental health and substance use disorder comorbidities.  

There were issues highlighted about essentially conflict between primary care providers and specialists, and they also highlighted certain aspects of antagonistic aspects of provider-patient interactions, particularly highlighting conflict at the time of discussions about opioid therapy.  Finally, and this factor I would—among barriers, it was interesting that an entire theme of skepticism emerged:  skepticism about the credibility of patients' complaints; skepticism about the ability of pain specialists and the science that informs their clinical actions; and ultimately, interestingly enough, a general skepticism about the entire field of pain management.  

Importantly, several facilitators were identified, including the intellectual satisfaction of having solved a problem with diagnostic and management challenges.  It encouraged keener communication skills.  It really highlighted an important really aim of primary care providers, maybe all providers:  that is, the rewards of healing and building therapeutic alliances and relationships with patients.  

They thought that use of universal precautions as opposed to a stratified approach to risk mitigation was an important strategy.  They highlighted the importance of availability of complementary and alternative medicine, what some might call complementary health approaches that include evidence-based psychological and behavioral interventions, and they also highlighted the importance of multidisciplinary care.

Provider care providers, I should have said, included 45 providers of 60 at VA Connecticut across our 8 different sites of care, including 2 academic-affiliated sites and 6 rural community-based outpatient clinics.  We also surveyed providers from specialty care clinics and saw many of the same themes.  

Not surprisingly, they didn't highlight knowledge gaps, but they did highlight challenges about communication with patients, as well as with other providers, and coordination among clinics.  In particular, they highlighted coordination between primary care and the several specialty clinics that were surveyed, in this case, pain medicine, neurology, rehabilitation medicine, and chiropractic medicine, and highlighted what they saw as essentially a shotgun approach being used among primary care providers with sending off consults to multiple specialists in hopes that somebody would pick up a difficult or challenging patient.

They highlighted resource limitations, demands that exceeded their capacity, and they also particularly zoomed in on issues related to patient attitudes or beliefs about pain management.  They also highlighted the importance of a multidisciplinary team-based approach to pain management, and they highlighted the importance of good communication, again, between patients and providers and among providers.

For nursing staff, a similar set of questions were asked of the primary care nurses, as well as health technicians.  Again, there was about a 75 percent response rate.  In their narratives, eight themes were highlighted.  They particularly highlighted challenges related to opioid therapy and challenges really related to decision making about the use of opioid therapy, challenges in interpersonal aspects of caring for patients in this setting, and so forth.

They also highlighted system issues, such as those that were highlighted by the primary care providers.  They also highlighted personal barriers, such as their own limitations in terms of knowledge and competencies.  They highlighted some of the same clinical quandaries associated with the complexity of chronic pain and mental health comorbidities, and they highlighted the frustration of dealing with failure with patients really that are not benefiting from almost anything that is provided.  

Importantly, nurses really emphasized their interest in being particularly involved in integrated and coordinated, patient-centered, and team-based care, and the importance of multidisciplinary approaches was particularly highlighted, as was the availability of models of integrated care that include complementary and health approaches.  

This slide—I'm sorry it's—

**Moderator:**Just hit forward.  It gets a lot better.  There you go.

**Dr. Kerns:**Oh, there we go.  This is really an implementation timeline of things related to Project STEP at VA Connecticut.  The baseline qualitative data was particularly useful for us in identifying and informing some important initiatives.  

This is a very busy slide.  At the top of the slide, it starts with some of the national implementation and initiatives related to the stepped care model.  For example, publication of the directive that I've already highlighted that articulated the stepped care model, that was soon followed by actually a small funding stream that went to facilities to support the initial implementation of the model.  

I'd also highlight the publication of evidence-based practice guidelines for the management of opioid therapy for chronic pain, and it highlights a national pain management leadership conference and other PACT training initiatives that were begun in early 2011.  Then it brings us up to date now, and it's just this past summer and an important summer webinar series supported by primary care providers in particular and primary care champions, building on the successes of the post-deployment integrative care initiative and their efforts to focus on improvements in pain and pain management.  

Of course, our facility rests in VISN 1 or the VA New England Healthcare System.  It was actually in 2009, at the same time or about the same time of publication of the national strategy, that VISN 1 and particularly primary care and pain management leadership communities put together a strategic plan for pain management in our VISN.  

There were many primary care-led initiatives in both the VISN and at VA Connecticut that are highlighted on this slide.  For example, in our VISN, we had funding from an innovations initiative in VA that provided support for essentially a traveling road show of experts in communication and patient-centered care that went to each facility in our VISN to provide training in communication to providers to improve *[audio distortion 35:25]* to successfully engage patients in patient-centered approaches, including  complementary and integrated health approaches, CAM modalities, and evidence-based psychological treatments in particular.

At our local facility, a primary care pain workgroup was established, and it's about the same time our lead, Dr. Elizabeth Lincoln, put together a peer support group of volunteers from the primary care provider community, nursing community, and other disciplines, who actually met regularly to provide peer support but also to develop their own relative competencies in support of other primary care providers in their community of practice.  

One other thing I wanted to highlight here was actually a one-day workshop that specifically was an outcome of Project STEP and supported by the Project STEP grant.  That provided a full-day, really highly focused primary care survival guide to chronic pain management that was attended by primary care providers, nursing staff, and other providers in the primary care setting hosted in an all-day workshop at VA Connecticut.  That occurred in June, I think, or April of 2011.

In the context of Project STEP, we had many meetings really focused on primary care, but then we moved in year 2 of our project to specialty care clinic roundtable meetings that brought together specialists from the multiple groups that I already mentioned in the qualitative narrative review, to discuss improvements in their approach to pain care in specialty care settings.  This all culminated actually in a really wonderful what was called rapid process improvement workshop at the VA Connecticut, which brought together clinical leadership from the front office, as well as virtually every other clinical service stakeholder in our hospital, in a one-day workshop to develop a new organizational plan for pain management at VA Connecticut.  

Ultimately, it was decided to essentially turn pain management on its head and move the primary support or focus for pain management from secondary or specialty care and tertiary care into the primary care setting, acknowledging the importance and validity of the stepped care model and the value of really reinvesting our resources at VA Connecticut into primary care.  This really ultimately culminated in the development of a new integrated pain care clinic embedded in primary care.  

This is an interdisciplinary evaluation and treatment planning setting and care management clinic that now really takes the place of our previously long-standing tertiary pain care setting and puts really integrative pain care right into primary care, where it belongs.  Ultimately, we also began a new opioid reassessment clinic to identify and promote the optimal management of veterans receiving long-term opioid therapy who are challenging because of their mental health comorbidities, even potentially a history of substance use disorder.  

These two new clinics—integrative pain care clinic and opioid reassessment clinic—are continuing to grow, and I think there's continued opportunities for expansion and evaluation of these clinics in particular as we grow our capacity from improving pain care in the primary care setting, consistent with the stepped care model.  I've already mentioned our clinician education series on communication training that is now ongoing in primary care, really building on the earlier work at the VISN and zooming in on promoting really enhanced communication skills training in the primary care setting at VA Connecticut.

I want to zoom in and close with some snapshots of some of our quality of care data from both the manual chart extraction and electronic or automated extraction efforts.  With regard to the manual chart extraction, we looked at development of essentially a set of quality of care indicators focused on pain assessment, treatment planning, and reassessment— that is, outcomes—as well as patient education.  

We then took those ideas, if you will, and tried to operationalize them in an integrative process to be able to extract data from primary care provider progress notes to evaluate the extent to which these quality of care indicators were present in their documentation.  We created a data extraction tool, and this was developed through literature review and consideration of VA/DOD clinical practice guideline and policies and with input from multiple pain management stakeholders.  

We had a specific focus, as I said, on pain assessment, treatment planning, and reassessment.  The coding manual was developed with specific operational definitions of what would count as the presence, for example, a pain assessment, and examples of what wouldn't count in that regard.  Ultimately, we trained independent coders to at least an acceptable inter-rater reliability agreement of 0.75, and our initial Cohen's kappa for each of the 15 parameters or metrics in this tool were 0.78 to 0.91.  

Two cohorts of patients, as I previously described, were examined in each of four consecutive years.  A pain cohort—that is, those with a pain intensity rating of 4 or greater on the pain-as-a-fifth-vital sign rating—and an opioid cohort with pain for greater than nine—opioids prescriptions for greater than 90 days during that year.  There was a randomly selected sample of 200 patients in each cohort, and from those, the largest proportion—anywhere between 150 and 200 charts—actually met some additional inclusion/exclusion criteria.

Here are some results.  Again, these are for the—across the x-axis are the 15 parameters.  I'm not sure if all 15 on this slide—close to them; 12, I think.  These are presented for the two cohorts for the first year and fourth year of our analyses.  Asterisks show the results of these preliminary analyses of really significant differences between baseline and the follow-up year.  

Generally speaking, what you can see is a decrease in specific treatment plans for the pain management cohort.  This would seem to be moving in the wrong direction except that, in fact, the way that we looked at this was that pain treatment plans were a compilation of several individual parameters, including use of medications, pain-related consults, diagnostic interventions, and ordering tests and procedures, as well as pain education.  

In fact, the summary decline in specific treatment plan is accounted for by significant declines in use of medications, particularly opioids, and use of what we might call unnecessary diagnostic interventions and procedures.  Fortunately, the one domain that did show an increase for the pain cohort was in the domain of pain education and provision of information.

For the opioid cohort, we see some trends, again, in the right direction, in this case, again, a decline in the use of diagnostic interventions and ordering of tests, but in particular a decline in pain-related specialty care consultations.  The improvement in pain reassessment in this group is something that we're particularly happy about because this suggests that we're moving in the direction of encouraging providers to document the effectiveness of their plans of care and to take progress into account in further collaborating with patients in the design of refinements in their plan of care.  

We also, as I said, focused on electronic health record data extraction.  Again, we used a similar kind of strategy in extracting records for patients from 2008 to 2009 and then for the subsequent three years, again developing a large set of metrics that could be conceptualized as capturing evidence of guideline-concordant pain care, consistent with the stepped care model.  Again, two cohorts were examined.  

These next few slides give some trends in some of these data.  Over the four years of the study, we're showing an increase in physical therapy consults and physical therapy visits; an increase, actually, in pain medicine visits;  and an increase in both chiropractic consults and chiropractic visits.  Somewhat surprisingly, we see a decline in mental health consults, but, in fact, in looking more closely at these data, we know that this is accounted for an increase in these integrative pain services that include mental health and health psychology services in primary care that may be precluding the need to move toward the use of specialty mental health services.  

Also for the pain cohort, we see trends that are consistent with an evidence-based approach that would encourage the increased use of topical analgesics, nonsteroidal analgesics, at least for younger veterans, and increases in the use of anticonvulsants, which potentially are first- or second-line medications for neuropathic pain or mixed musculoskeletal/neuropathic pain conditions.  Fortunately, we're also seeing a significant decline in the use of sedative hypnotics, which are specifically discouraged for the management of most mental health conditions and also in the context of pain management.

For the opioid cohort, we saw a rapid uptake between 2008 and 2009 and then 2009 and 2010 in the use of these two important opioid therapy risk-mitigation strategies—the use of opioid agreements and urotoxicology screening—and these improvements have been sustained at VA Connecticut, so that our data suggest that about 80 percent of veterans who are receiving long-term opioid therapy have the benefit of an opioid pain care agreement and urotoxicology screening.  In the area of other medications, including co-analgesics for pain management in the opioid cohort, we see an increase in the use of topical analgesics but really no changes despite some appearance of changes in the use of other analgesic medications or co-analgesic medication.

One more slide about the consults for the opioid cohort:  we see, actually, increases again in physical therapy, both consults and visits in this cohort; a decline in pain consults and pain visits to the pain management specialty clinic; and an increase in chiropractic consults and chiropractic visits; and, again, that decline in mental health care for this cohort.

These are some publications that are attributable to our work here in the Project STEP.  These slides are available to you, so you may want to take a look at these publications.  With that, I'm going to close up, and thank you for your interest today, and try to spend the last ten minutes or even longer responding to questions if there are some, so thank you all very much.

**Moderator:**Thank you, Bob.  We actually do have one pending question out here, but I'm betting the audience is coming up with their own questions at this time.  For the audience, this is a great opportunity to get those questions answered.  Please submit them using the Q&A screen in the lower right-hand corner of your screen.

The first question that we have here:  is there any evidence-based pain differences between veterans of this era of different branches—Air Force, Navy, Army, Marines?

**Dr. Kerns:**Yes.  Actually, I don't know these data well.  One study that I know in particular that examined trends in musculoskeletal disorders and pain, and looked at different branches of the service, and has highlighted that the prevalence and severity of pain is reliably higher among veterans of the Army compared to the other three branches.  

That stands out even independent of other indicators like age; gender; race, I believe; and maybe even socioeconomic status, so that is a flag to consider—or a signal, if you will.  It may be intuitive that this may relate to issues of combat exposure or boots-on-the-ground exposure in the field, but really we can't go too far in speculating about those differences.  

I believe we also in a paper that's under review from our center now, that examined, in particular, mental health comorbidities, distinguishing veterans with no pain versus chronic pain over an extended period of time—and our sample was five years of persistent, chronic pain—we also found a similar difference in that sample.

**Moderator:** Great.  Thank you.  The next question that we have here:  did the pain levels of the two cohorts change?

**Dr. Kerns:**Actually, over the entire four-year period, in both cohorts the prevalence of—for example, in the electronic medical record data—the prevalence of people in the pain cohort continued to increase, and in the opioid cohort, the propensity to prescribe opioid decreased at VA Connecticut.  Pain intensity ratings for  both of those groups continued to decline with each successive year in a significant way.  

This is really consistent with data published by Sinnott and Wagner in the VA and with other data that have been published in the private sector and really highlighted in the Institute of Medicine report that identifies that the prevalence of pain and chronic pain among citizens of the United States and, frankly, around the world, seems to be continuing to grow with each passing year and, among those with pain, that reports of pain intensity and, in fact, things like functional disability, social role dysfunction, work-related disability, are also increasing with each year.  It's a really troubling scenario and certainly a challenge that many, like the Centers for Disease Control, have labeled as a significant public health crisis.

**Moderator:** Great.  Thank you.  The next question that we have here:  is the VA considering setting standards for the maximum daily dose of opioids, as has Washington State Medicaid?  Higher doses must have pain expert care.

**Dr. Kerns:**The bottom line is yes, but there are no specific formal discussions occurring at this time.  This is a common conversation among the leadership in the pain management community in VA that's well aware of the concerns about risks and harms related to opioid therapy, thus the highlighting of this in our efforts at VA Connecticut, and also quite aware of other legislative and other regulatory initiatives that are identifying risk mitigation strategies, including that that was just mentioned in this question:  that is, setting an upper dose limit, after which specialty pain care or pain medicine consultation would be required.  

VA is having these kinds of conversations.  At this time we haven't moved in the direction of some formal policy-level discussion about that.  It will surprise me if we don't move in that direction, but, at present, that's not the case.  

I can say that, in terms of other even federal interagency work groups that I'm involved in, this discussion is also occurring, and what the appropriate threshold would be remains a point of discussion as well.  There's probably consensus around a threshold as high as 200 milligram morphine equivalents a day, which is higher than many would think such a threshold would be, but, in fact, there are a growing number of publications and policy statements, if you will, that suggest a lower threshold might be a more appropriate target downstream.

**Moderator:**  Great.  Thank you.  The next question:  how did the study impact overall costs?

**Dr. Kerns:**We didn't specifically examine costs.  I could point to a few examples, though, in which we would suggest that this has been considered to be essentially a cost-neutral and, importantly, space-neutral proposition, so as I kind of implied, VA Connecticut historically—and maybe you know this—has invested heavily in pain management and interdisciplinary pain care for veterans.  For example, as early as 1981, I built, and directed, and for 30 years sustained an interdisciplinary, tertiary pain clinical research and education and training center for pain management at VA Connecticut.  

At the time of the rapid process improvement workshop at the VA Connecticut and a shift in our way of thinking about our organization's approach to pain management and the way we allocated resources, we really moved that entire enterprise into primary care.  Therefore, that building of the integrated pain clinic and the opioid reassessment clinic was really cost-neutral, if you will.  

Looking over a longer period of time, it's certainly true that people have come and gone, and resources have come and gone.  A more formal cost analysis would be an important thing to potentially add to this project in order to promote ideas about its value and ultimately promote its broader dissemination and uptake across VA, but we really haven't had the resources or expertise to be able to do that.

**Moderator:** Great.  Thank you.  I do want to mention:  we are just about at the top of the hour here, and I know a lot of our participants only are able to stay for the hour.  We do still have—it looks like—three pending questions that I'm hoping Bob is able to stay on to answer those, but for the audience, we realize that you are constrained on time.  We are recording today's call, and we will send that archive as soon as it is available so that you will be able to catch these last few questions that you're not able to stay on the call for right now.

The next question that we have here:  would the researchers be willing to share their extraction tool methods?

**Dr. Kerns:**The manual chart extraction tool paper on that tool is now in review in VA for publication, and so I don't think that we're ready yet to share it.  We're optimistic about that, and so when it is accepted for publication, we'd be happy to share it.  If, in fact, it doesn't, I guess, move in that direction, at some point we'll make it available, and put it into the public domain, and make it available. 

As for our metrics that we applied to the electronic health record, I think, similarly, we're interested in publishing these.  I guess the bottom line is, I'll consult with our team and see if we're willing and can make them more generally available.  

They actually were supported by private foundation funding as opposed to VA funding, so I think there are some concerns about that, but, ultimately, we hope to make these tools available.  We think that they are valuable tools that can serve important roles in promoting really identification of pain quality of care indicators, which, as many on this call will understand, are difficult to come by in the pain world, and ultimately can serve the purposes of promoting pain management performance efforts.

**Moderator:** Great.  Thank you.

**Dr. Kerns:**I guess I'm equivocating.  I'll check with my team, but I think the bottom line is we're going to wait until we publish our findings before broader dissemination.

**Moderator:** I think that's totally fair.  The next question that we have here:  where did nurse practitioners fit into the study?

**Dr. Kerns:**There were several nurse practitioners in primary care that were among the primary care provider group, as well as a few physician associates or physician assistants in that sample, so they were in the primary care provider group.  There were a couple of master-level advanced practice nurses or master-prepared nurses in the nursing sample who were not in primary care provider roles but were in roles as nurse leaders in primary care or nurse care managers, and they were included in the nursing sample.

**Moderator:** Great.  Thank you.

**Dr. Kerns:**I don't have the specific numbers in front of me, but if there's a specific question—for example, the paper on primary care providers is published.  The paper on the nurses is actually, again, under review right now, but I think, in confidence, we can share those papers and have those specific breakdowns.

**Moderator:** Fantastic.  Thank you.  The next question that we have here:  does pain management focus differ for female versus male veterans?  For example, pelvic pain versus chronic headache?

**Dr. Kerns:**This is a very interesting and timely question.  Right now, in the last few days, with our colleague, Sally Haskell—who many but maybe not all of you know, who's in the leadership community in women health services in VA and who herself is a pain researcher with a focus on gender differences and women in pain—is leading a discussion among our leadership group about just these issues.  

We know that women are a particularly vulnerable group.  The Institutes of Medicine highlighted them.  Women veterans are potentially particularly vulnerable, have higher prevalence of many pain conditions, including musculoskeletal conditions, but also, of course, disorders such as headache, but also have gender-specific problems, such as chronic pelvic pain, vulvodynia, vulvar vestibulitis, and so forth.  

It's certainly true that for some women with pain, with these gender-specific pain conditions, their pain care needs are distinct.  Fortunately, there is, for example, evidence-based psychological interventions specifically for chronic pelvic pain and vulvodynia that can be brought to bear on the management of pain among women veterans.  

The challenge is likely to be making these kinds of resources available, and so one strategy has that has been contemplated and may have some legs in VA is the use of telemental health or telebehavioral pain management to deliver evidence-based psychological services, for example, to women veterans with these particular problems face to face but at a distance.  The other strategy is building capacity for gender-specific pain assessment and management within specialized women health clinics, at least at those centers that have such clinics, and there are some pilot initiatives that are funded by the Office of Women's Health Services now that are important and can provide us some signals about where to move in the future.  

The bottom line is I think this is a very important challenge for VA.  Thankfully, we have the support from the Women's Health Service leadership and the expertise of Sally Haskell and a community of health services investigators who have focused on these issues to help inform and support future initiatives in this area.

**Moderator:**  Great.  Thank you.  That actually does wrap up all of the questions that we have received.  Bob, did you have any final remarks you wanted to make before we close *[cross talk 01:03:35]* today.

**Dr. Kerns:**No.  As usual, I want to, first of all, thank David Atkins for his generous introduction today.  I want to thank you, Heidi, and all of the team at the Center for Information Dissemination and Education Resources for their support of this webinar series.  

I want to thank all the participants today for your work in supporting our national pain management strategy and your interest in the research that we're doing here at VA Connecticut.  I want to encourage any of you that participated in today's call who are not otherwise regular participants in this cyberseminar series, Spotlight on Pain Management, to consider coming back.  This is held monthly the first Tuesday of each month at 11:00 Eastern Time, and we'd welcome your participation on future calls.  Thanks to everybody again, and have a good day.  Bye-bye.

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