A Proactive Walking Trial to Reduce Pain in Black Veterans
Phase: NA
Conditions: Musculoskeletal Pain
Sponsor: VA Office of Research and Development

 
 
 
 
 
 
 
 
 
 
Taking Action to Reduce Pain 
 
Funding Agency: VA HSR&D 
Principal Investigator/Study Chair: Diana Burgess, PhD 
June 9, 2020 
 
 
 
 

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Abstract 
Our long-term goal is to improve the quality and equity of pain treatment in order to improve 
pain outcomes for all Veterans. The objective of this application is to test the effectiveness of a 
multi-component intervention that specifically targets known barriers to effective pain care 
among black Veterans with chronic MSK pain. This project will result in a non-pharmacological 
intervention to reduce pain and improve functioning among Veterans in VA care suffering from 
chronic musculoskeletal (MSK) pain, by increasing walking. This intervention is specifically 
designed to address factors that contribute to MSK pain among black Veterans; however, we 
expect that it will also benefit non-black Veterans. 
The primary aim of this four-year project is to test the effectiveness of a non-pharmacological, 
self-regulatory intervention administered proactively by telephone, at improving pain outcomes 
and increasing walking among black Veterans. We will explore whether the intervention reduces 
service utilization and opioid analgesics and conduct a process evaluation. These aims will be 
pursued in three phases: intervention content refinement (Phase 1, year 1); intervention 
recruitment, implementation, and baseline data collection (Phase 2, years 2-3); and post-
intervention process and outcome data collection and evaluation (Phase 3, years 2-4).  
Our central hypothesis is that an intervention that uses Action Planning, motivational 
techniques, and a pedometer-based program to increase walking will improve chronic pain 
outcomes for black VA patients with MSK pain. We will also test the effectiveness of the 
intervention on Veterans with MSK pain who are not black, many of whom also experience 
suboptimal pain treatment and have similar contributors to pain as black Veterans. 
Our hypothesis is based on several lines of supporting research evidence. First, physical activity 
can reduce chronic musculoskeletal pain and improve function. Second, research demonstrates 
that proactive telephone outreach (in which a counselor reaches out to patients to offer them the 
intervention, rather than requiring the patients to seek out care) can address utilization-related 
and provider-related barriers that black Veterans experience. Third, pedometer-based walking 
programs are effective at increasing walking for various groups. Fourth, making an Action Plan 
(specifying when, where, and how the behavior will be performed) increases the likelihood that 
individuals will perform intended behaviors and overcome psychological and environmental 
barriers. Finally, black patients desire non-pharmacological approaches to pain treatment, such 
as including exercise.   

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List of Abbreviations 
CCDOR: Center for Chronic Disease Outcomes Research 
CDW: Corporate Data Warehouse 
COT:  Chronic opiate therapy  
EMR: Electronic Medical Record 
HSR&D: Health Services Research & Development  
IC: Intervention Condition  
IMMPACT: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials  
MED: Morphine equivalent dose  
MI: Motivational Interviewing 
MSK: Chronic musculoskeletal  
NEPEC: North East Program Evaluation Center  
OA: osteoarthritis 
OST: opioid substitution therapy  
PEG: brief pain intensity and interference scale 
PHQ: Patient Health Questionnaire 
PSEQ: Pain Self-Efficacy Questionnaire  
PTSD: Post Traumatic Stress Disorder 
RMD: Roland and Morris Disability Questionnaire  
TSK-R: Tampa Scale of Kinesiophobia   
UC: Usual Care VA: Veterans Affairs 
WOC: worker without compensation 
VINCI: VA Informatics and Computing Infrastructure 
 
 
 

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Contents 
1.0 
Study Personnel .............................................................................................................. 5 
2.0 
Introduction ..................................................................................................................... 6 
3.0 
Objectives ......................................................................................................................12 
4.0 
Resources and Personnel ..............................................................................................13 
5.0 
Study Procedures ...........................................................................................................17 
5.1 Study Design ...................................................................................................................17 
5.2 Recruitment Methods.......................................................................................................26 
5.3 Informed Consent Procedures .........................................................................................28 
5.4 Inclusion/Exclusion Criteria ..............................................................................................29 
5.5 Study Evaluations ............................................................................................................30 
5.6. Data Analysis .................................................................................................................30 
5.7 Withdrawal of Subjects ....................................................................................................35 
6.0 
Reporting ........................................................................................................................35 
7.0 
Privacy and Confidentiality .............................................................................................36 
8.0 
Communication Plan ......................................................................................................36 
9.0 
References .....................................................................................................................37 
 
 
 

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Protocol Title:  Taking Action to Reduce Pain  
1.0 
Study Personnel 
Principal Investigator:  
Diana Burgess, PhD; diana.burgess@va.gov, 612-467-1591; VA employee 
Minneapolis VAHS 
Co-Investigators: 
• 
Brent Taylor, PhD; Brent.Taylor2@va.gov; 612-467-4941; VA employee 
Minneapolis VAHS 
• 
Erin Krebs, MD, MPH.  Erin.Krebs@va.gov; 612-467-7558; VA employee 
Minneapolis VAHS 
• 
Steven Fu, MD, MSCE.  Steven.Fu@va.gov; 612-467-2582; VA employee 
Minneapolis VAHS 
• 
Laura Meis, PhD.  Laura.Meis@va.gov; 612-467-4516; VA employee 
Minneapolis VAHS 
• 
Robert Kerns, PhD. Robert.Kerns@va.gov; 203-932-5711 x3841; VA employee 
VA Connecticut Healthcare System 
• 
Alicia Heapy, PhD. Alicia.heapy@va.gov; 203-932-5711 x2299; VA employee VA 
Connecticut Healthcare System 
• 
Joseph Goulet, PhD. Joseph.Goulet@va.gov; 203-932-5711 x5325; VA 
employee VA Connecticut Healthcare System 
• 
Kelli Allen, PhD. Kelli.Allen@va.gov; 919.286.0411 Ext:7090; VA employee; 
Durham VAMC 
• 
Sarah Krein, PhD. Sarah.Krein@va.gov; 734-845-3621; VA employee; Ann Arbor 
VAMC 
• 
Patrick Hammett, PhD, Patrick.hammett@va.gov; VA employee; Minneapolis VAHS 
• 
Elizabeth Goldsmith, MD, MS, elizabeth.goldsmith2@va.gov; VA employee; Minneapolis 
VAHS 
Collaborators: 
a. Emily Hagel Campbell; Emily.HagelCampbell@va.gov; VA employee; Minneapolis 
VAHS 
b. Ann Bangerter; ann.bangerter@va.gov; VA employee; Minneapolis VAHS 
c. Sean Nugent; sean.nugent@va.gov; VA employee; Minneapolis VAHS 
d. Andrea Cutting; andrea.cutting@va.gov; 612-467-1881; VA employee; Minneapolis 
VAHS 
e. Tam Do, tam.do3@va.gov; VA employee; Minneapolis VAHS 
f. Lee Cross, MPH; lee.cross@va.gov; VA employee; Minneapolis VAHS 

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g. Mark Ackerman, PhD. Mark.ackerman1@va.gov. 404-321-6111; VA employee; Atlanta 
VA  
h. Michael Saenger, PhD. Micahel.saegner@va.gov. 404-321-6111; VA employee; Atlanta 
VA  
 
2.0 
Introduction 
 
Rationale for the proposed study 
Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans, 
affecting approximately 60% of those seen in VA primary care.31 As in the greater population, 
pain among Veterans is most often located in the back, hip, or knee.31 Since 2000, the 
prevalence of low back pain has been increasing at an annual rate of 4.8% among VA users.32 
This is particularly worrisome because chronic pain is associated with poorer self-reported 
health status, worse mental health, and lower levels of employment.33 Importantly, chronic pain 
is associated with lower satisfaction with VA care. Only 28% of patients receiving VA pain 
treatment report very good or excellent pain treatment effectiveness.31  
 
Numerous studies conducted over the past two decades, including studies conducted in 
the VA, have documented racial and ethnic disparities in pain and pain treatment.1,2,8,33   
Racial and ethnic minority groups report greater pain-related disability, physical and emotional 
impairment, and pain severity when compared to whites.1,2 In the VA, for instance, black male 
Veterans who reported receiving treatment for chronic pain perceived their pain treatment as 
less effective than white male Veterans and reported higher levels of pain interference (the 
extent to which pain interfered with their normal work over the past 4 weeks).8 
 
Contributors to racial and ethnic disparities in pain are complex and multi-level. One set 
of barriers involves utilization of healthcare.  Minority patients are more likely than whites to 
have unmet medical needs due to myriad factors, including discrimination and mistrust of 
healthcare (associated with avoiding and delaying care), poorly coordinated care, lack of a 
primary care provider, and logistical barriers (e.g., lack of childcare and transportation).2,14  
Many minority patients report experiencing pain for many years before receiving appropriate 
pain treatment.2 A second set of barriers (provider-related) involves how patients are treated by 
their providers within the healthcare system. Minorities are more likely to have their pain 
discounted and underestimated,4 to have poor quality communication with their providers,15 and 
are less likely to be screened for and given pain medication (including opioids) compared with 
whites.5-7  A third set of barriers (psychological) involves patient beliefs and attitudes that 
contribute to poor pain outcomes (e.g., pain-related fear of movement, low perceived control 
over pain), which members of minority groups are more likely to hold. 3,10-12 A fourth set of 
barriers (environmental) involves factors outside of healthcare in the patient’s “life space.”34  
These include life stressors disproportionately experienced by minorities that are associated 
with pain, such as racial/ethnic discrimination,13 and environmental barriers to engaging in 
physical activity (e.g., lack of time to walk, unsafe neighborhoods).12,35 

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Although the VA is a leader in pain management, minority Veterans continue to 
experience greater barriers to high quality pain care than white Veterans. For example, 
black VA patients are less likely to be screened for pain than white patients5 and are less likely 
to perceive their chronic pain treatment to be effective.8 There is also evidence of racial 
differences in prescription of pain medication in VA,7,36 suggesting that providers are using race 
in clinical decisions about pain treatment. Minority VA patients also report utilization barriers, 
such as dissatisfaction with the VA (which patients identified as a barrier to utilizing VA care),15 
provider-level barriers such as poorer quality communication with healthcare providers and 
greater dissatisfaction with interpersonal care compared with whites,15 environmental barriers, 
such as racial discrimination (which was associated with higher levels of pain among older black 
Veterans),13 and psychological barriers, such as lower levels of pain/exercise self-efficacy.3,10,11  
The proposed intervention addresses contributors to pain among Black Veterans that 
exist at multiple levels. This intervention takes a biopsychosocial approach to chronic pain, 
which acknowledges not only the physiological basis of pain but also the importance of 
psychological and environmental factors in contributing to and relieving pain.9 It consists of 6 
telephone-based coaching sessions over 10-12 weeks in which: 1) Motivational Interviewing 
(MI) and Cognitive/Motivational techniques will be used to increase patients’ motivation to walk 
and address anticipated barriers to walking (e.g., fear of movement, low self-efficacy), and 2) 
Action Planning will be used to help translate patients’ motivation and intention to walk into 
walking behavior. Below we describe how different classes of barriers will be addressed through 
specific components of the intervention. 
-Barriers related to utilization of VA care will be addressed through the use of proactive 
telephone outreach in which the counselor initiates the call to Veterans, who have been 
identified as having a diagnosis of chronic hip, back, or knee pain in their medical record, as 
compared to “reactive care,” in which the individual Veteran must initiate treatment. Additionally, 
the use of proactive, telephone-based care addresses barriers such as lack of transportation 
and negative healthcare experiences which have been associated with lower levels of 
healthcare utilization and unmet medical needs among blacks.14  
-Provider-related barriers will be addressed through the use of counselors trained in MI 
techniques, which emphasizes supportive and respectful care, reflective listening, and patient-
driven decision making. This addresses communication barriers that minority patients often 
experience within the VA healthcare system.15 These communication barriers are likely to be 
compounded for minority patients with chronic pain, as many providers view chronic pain 
patients as a major source of frustration37 and many chronic pain patients express feeling 
disrespected, distrusted, and dismissed by their providers.16  
-Psychological and environmental barriers. The intervention is specifically designed to address 
psychological barriers to effective self-management (e.g., lower levels of self-efficacy in coping 
with pain and greater levels of pain-related fear),3,10,11 and environmental barriers to engaging in 
physical activity (e.g., unsafe neighborhoods)12 that are greater among minority patients. This is 
important, as a large number of primary care providers do not feel adequately trained to treat 

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the non-biomedical aspects of chronic pain, and therefore do not address psychological and 
environmental barriers. A key component of the intervention is ---Action Planning (also called 
“Implementation Intentions”), a specific volitional technique (distinct from goal setting), which 
has been shown to increase the likelihood that individuals will translate their intentions into 
actions, and overcome psychological and environmental barriers to enacting the behavior.  
Action Planning works by creating “if-then” contingencies, so that cues in the environment 
trigger the desired behavior (e.g., “if it is nighttime and I haven’t walked, and I feel unsafe 
walking outside, I will walk inside my apartment before I go to bed”). Although there have been a 
number of studies that have used Action Planning to increase physical activity,26 we could 
locate only one study that used Action Planning to promote physical activity in chronic pain 
patients,38 and could find no studies targeting black or minority patients. 
There is growing consensus that chronic pain treatment should involve more than 
pharmacotherapy, and strong evidence to support the effectiveness of physical activity 
for MSK pain.17,18 Although studies have documented racial disparities in pain 
pharmacotherapy, especially in use of opioid analgesics,6 simply increasing the use of opioid 
analgesics to treat minority individuals with MSK pain would be a less than ideal solution. There 
is a lack of data on the long-term effectiveness and safety of opioids for this purpose and 
evidence of serious risks associated with opioids.39 Federal reports document rising incidence of 
emergency department visits, hospitalizations, and deaths related to opioid analgesic use that 
have paralleled the increasing use of opioids for chronic pain management. Moreover, our own 
research found that 84% of black and 79% of white MSK patients with opioid prescriptions 
reported substantial functional interference due to pain, pointing to the need for additional pain 
treatment modalities.7 
Physical activity has been shown to prevent recurrence or reduce pain, improve functional 
status, and decrease sick leave and disability for back pain and osteoarthritis pain.17,18,40  
Overall, members of racial/ethnic minority groups, including those with chronic pain,41 are more 
likely to be sedentary and less likely to engage in physical activity than whites.42 Moreover, 
many individuals are unaware of the beneficial effects of physical activity on MSK pain, and 
levels of physical activity among people with MSK pain are low.31 The documented challenges 
of increasing physical activity among the sedentary are compounded for patients with MSK pain, 
who often anticipate pain related to physical activity and so avoid it (“fear-avoidance behavior”) 
and who often do not believe that they will be able to engage in exercise (“low exercise self-
efficacy”).43 These challenges are greater among minority patients with MSK pain, who are 
more likely to experience these psychological barriers than whites.3,10-12 Nonetheless, despite 
these barriers to exercise, many minority patients desire non-pharmacological approaches to 
pain treatment, including the use of exercise,28 and prefer walking to other forms of exercise.44 
This gap between minority patients’ desire to exercise and actual exercise behavior represents 
an opportunity for our intervention to capitalize upon. 
 
Research and theory underlying the proposed project 
The conceptual framework shown in Figure 1 summarizes the key components of the 
proposed intervention and how they are expected to improve pain outcomes. The 

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intervention is based on the chronic pain and exercise literature and studies of physical activity 
and health behavior; it incorporates constructs from different theories of behavior change, most 
notably theories of self-regulation and Action Planning, and the Theory of Planned Behavior.45-48  
• 
Proactive Telephone Outreach and Motivational Interviewing (MI) techniques will be used to 
engage patients in the intervention and overcome barriers related to utilization of care and 
provider-related barriers (e.g., communication).   
• 
Action Planning will be used to translate intentions to walk into actual walking behavior (i.e., 
volition).45-48  
• 
Two Master’s level counselors will also use MI, Motivational/Cognitive techniques and Action 
Planning to help participants overcome environmental barriers to exercise through problem-
solving, coping skills coaching, and plan-making using the techniques of coping planning 
(i.e., making plans to overcome barriers),49 supportive/ facilitative planning (i.e., making 
plans to increase and strengthen helpful factors),45 and collaborative planning (i.e., making 
plans that involve friends and family members).50 Motivational and Cognitive techniques will 
be used to overcome psychological barriers to exercise (pain-related fear, low self-efficacy 
for exercise and coping with pain). Self-efficacy is particularly important, as a recent review 
identified self-efficacy as the strongest predictor of intentions to walk more.45  
• 
Pedometers will be used as a tool to promote walking through feedback, goal setting, and 
monitoring.20,51 
. 
The intervention is expected to improve pain outcomes through multiple mechanisms:  
Increased physical activity is expected to lead to improved emotional functioning, decreased 
sedentary time, reduced pain-related fear and self-protective behaviors associated with reduced 
muscle tone, and increased pain perceptions and functional disability. Reductions in pain-
related fear and improved self-efficacy are also expected to improve pain directly.10 Evidence for 
the key intervention components is discussed below and in Table 1, which summarizes prior 
studies that demonstrate the acceptability, feasibility, and potency of the proposed intervention 
in the target population.  
 
 

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Figure 1: Conceptual Model 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Description and Justification for the Key Intervention Components 
I. Proactive Telephone Outreach  
The proposed study will use Proactive Telephone Outreach to offer the intervention to patients. 
Specifically, the intervention will be offered “proactively” to patients from the Atlanta VA Medical 
Center with diagnoses of hip, knee, and back pain by counselors trained in MI. MI is a patient-
centered method whose main purpose is to help the participant explore and resolve 
ambivalence about a particular behavior change. The counselor avoids confrontation and takes 
advantage of opportunities to enhance self-efficacy by pointing out and reinforcing the patient’s 
strengths and successes. This approach addresses several contributors to racial/ethnic pain 
disparities. Proactive telephone outreach addresses barriers to healthcare utilization as the 
program does not require a medical care encounter and is delivered in the patient’s own home.  
The use of counselors trained in MI, which emphasizes collaboration with and respect for the 
patient also addresses provider barriers related to expectations of poor interpersonal treatment 
that prevent chronic pain patients and minority patients from seeking help from their usual 
provider. Importantly, a recent trial found a smoking cessation intervention that incorporated 
proactive outreach and MI (led by Co-I Dr. Steven Fu (VA HSR&D #05-303)) to be effective at 
reducing smoking among VA patients across several racial/ethnic groups, including black 
patients. Similarly, a telephone-based osteoarthritis (OA) self-management program (VA 
HSR&D IIR #04-016), conducted by Co-I Dr. Kelli Allen, in which a health educator delivered 
Physical activity 
Walking (steps/day) 
Chronic Pain 
Outcomes 
 
Primary 
outcome: Pain-
specific physical 
functioning  
 
Secondary 
outcomes (pain 
intensity, 
emotional 
functioning, 
perceived overall 
improvement, 
service utilization, 
use of opioid 
analgesics) 
 
Intervention  
i. Proactive 
Telephone 
Outreach 
Outreach 
materials and 
outreach calls 
using counselors 
trained in 
Motivational 
Interviewing (MI) 
 
ii. Coaching 
Intervention 
 
Action Planning 
 
Cognitive Behavioral 
and MI Techniques 
  
Pedometer program 
Psychological 
Barriers  
Pain-related fear,  
pain and exercise 
self-efficacy, 
motivation to exercise 
Enviro
nmenta
l 
Barrier
s   
Covariates (e.g., health 
status, SES, BMI) 
 
Healthcare 
Utilization Barriers  
Provider 
Barriers   

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treatment proactively to patients with OA, improved chronic pain outcomes among black OA 
patients in the VA system 52 and was viewed by black Veterans as helpful for improving their OA 
symptoms.53 
 
II. Pedometer-Facilitated Walking Intervention with Action Planning 
Pedometer-Facilitated Walking. The pedometer-facilitated walking program used in 
conjunction with Action Planning (described below) will be used to promote walking directly 
through goal setting, monitoring, and feedback. As in Dr. Sarah Krein’s and Dr. Alicia Heapy’s 
walking interventions, participants will be asked to increase their daily walking 10% over the 
previous week’s daily average. Walking is considered an ideal exercise as it is something that 
most people can do regardless of their health condition and does not involve the use of 
specialized equipment. The feasibility and safety of home-based walking programs for 
individuals with chronic health conditions, including chronic musculoskeletal pain conditions, 
have been previously demonstrated.54,55 Additionally, studies suggest that a majority of middle-
aged and older adults, including racial and ethnic minorities, prefer physical activity outside a 
formal setting,56 and that participation rates and maintenance of physical activity are generally 
better in home-based programs.57 Pedometer-based walking programs have been shown to 
increase walking across different patient populations.20 Moreover, a recent systematic review of 
pedometer interventions found significant decreases in systolic blood pressure and body mass 
index.20 This same systematic review found that setting a step goal and using a step diary were 
key components underlying the success of pedometer programs.20 Most pertinent to the current 
study is a recent trial conducted by Co-I Dr. Krein, in which a pedometer-mediated walking 
program improved pain outcomes among VA patients with chronic low back pain. Although the 
majority of individuals in pedometer trials are white, three recent trials found pedometer 
interventions to be effective at increasing walking and improving objective measures of health 
among blacks21-23 and a predominantly minority sample of low-income mothers,24 although 
these studies did not target patients with pain.  
 
Action Planning.  Forming an Action Plan —a tailored strategy that specifies when, where, and 
how the person will perform a specific behavior – has been shown to be a very effective self-
regulatory tool for translating intentions into action. Hundreds of studies have shown that 
forming an action plan increases the likelihood that one will engage in an intended behavior, 
compared with simply forming an intention to achieve a goal.25,26 A 2006 meta-analysis of 94 
independent trials, which included numerous studies of health-related behaviors, found medium-
to-large effects of implementation intentions on goal implementation.25 Action Planning has 
been successfully used to promote exercise (including walking) in clinical and nonclinical 
populations (including chronic pain patients), and has been shown to be more effective than 
motivational interventions consisting of goal-setting alone (see meta-analysis #7 in Table 
1).26,38,45-47 For example, in one study with chronic low back pain patients, those who 
participated in an intervention using Action Planning and motivational and cognitive techniques 
to increase physical activity had increased their physical capacity relative to controls.38  

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Action Planning works by using situational cues to automatically trigger an intended behavior 
(e.g., “After I eat dinner, I will go for a walk with my wife”) so that, over time, the behavior 
becomes a habit that is enacted in the presence of those cues (e.g., after dinner, with one’s 
wife). Action Planning has been shown to be particularly effective among patients with impaired 
self-regulatory capacity and for individuals in situations in which self-regulatory capacity is 
temporarily diminished, because it automates desired behaviors so that individuals do not have 
to exert conscious effort (or “willpower”) to engage in the behavior.58,59 Because pain has been 
shown to reduce self-regulatory capacity, Action Planning should be particularly beneficial for 
pain patients.48 Members of negatively stereotyped groups such as blacks also experience 
many situations that temporarily diminish regulatory capacity, such as social exclusion, racial 
discrimination, and stereotype threat (feeling that one is at risk of being negatively 
stereotyped).60,61 For this reason, Action Planning should be especially beneficial for black 
patients. Moreover, certain types of action plans-- Coping Planning49 and Facilitative Planning45 
--can help individuals overcome barriers and leverage supportive factors in their environment 
(e.g., “if I have a very busy day, I will walk around the block for 5 minutes after breakfast, lunch, 
and dinner,” “if the weather is bad, I will walk in the mall,” “if I am afraid of hurting myself, then I 
will remember that walking will help me with my pain”38).  Friends and family members have 
been shown to be important supportive factors that increase the likelihood that an Action Plan 
will be successful, and our intervention will explicitly guide participants to develop at least one 
Action Plan that incorporates friends or family members as part of the plan (i.e., Collaborative 
Planning).50 
Given that Black veterans with MSK pain are more likely to report lower self-efficacy for coping 
with pain and greater pain-based fear of movement, intervention counselors will be trained to 
address these barriers during Action Planning with specific cognitive techniques. Counselors will 
inquire about beliefs and thoughts that support fear of movement and diminish self-efficacy and 
challenge these thoughts using accepted cognitive/motivational methods such as Socratic 
questioning and reframing of negative thoughts with more realistic and positive ones. These 
techniques have been used successfully in combination with Action Planning in an intervention 
with chronic low back pain patients.38 Self-management approaches to chronic pain, which 
include self-efficacy building, goal-setting and action-planning, problem-solving, and partnership 
have been shown to be effective at improving pain among patients with arthritis. 
3.0 
Objectives 
Primary Aim: To test the hypothesis that the intervention will improve chronic pain-specific 
physical functioning—the primary outcome, improve emotional functioning, pain intensity and 
ratings of overall improvement and increase walking, compared to UC for black patients with 
chronic hip, back, and knee pain. 
Secondary Aim 1: To investigate whether key contributors to racial/ethnic disparities targeted 
by the intervention (motivation to exercise, pain/exercise efficacy, reduction of pain-related fear) 
mediate improvement in chronic pain outcomes and increases in walking.  

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Secondary Aim 2: To explore whether the intervention reduces service utilization and use of 
opioid analgesics.  
Secondary Aim 3: To determine if the intervention is effective for non-black VA patients and 
other subgroups of patients who may experience barriers to effective pain treatment.  
Secondary Aim 4: To explore whether the intervention reduces racial disparities in pain 
outcomes.  
4.0 
Resources and Personnel 
Research Sites 
1. Center for Chronic Disease Outcomes Research, Minneapolis VA, 
Minneapolis, MN. 
a. Data extraction will take place at the MPLS VA 
b. Intervention will be administered by counselors here, to participants 
over the telephone. 
c. The study coordinator, research assistant, and support staff at the 
MPLS VA, all trained interviewers, will collect survey data via phone 
and mail at the MPLS VA 
d. Data will be analyzed here 
2. Atlanta VA (not considered an engaged site requiring an LSI) 
a. Focus groups (Phase 1) will be conducted here 
Principal Investigator: Diana Burgess, PhD; diana.burgess@va.gov, 612-467-1591; 
VA employee Minneapolis VAHS;  
a. Will have access to protected health information (in the course of 
interviewing participants) 
b. Will be involved in recruiting subjects; obtaining informed consent; 
administering interview procedures/conducting interviews; and performing 
data analysis of de-identified qualitative data. 
Co-Investigators: 
1. Brent Taylor, PhD; Brent.Taylor2@va.gov; 612-467-4941; VA employee 
Minneapolis VAHS;  
a. Role: lead statistician 
b. Will not have access to protected health information 
c. Will be involved in performing data analysis of de-identified 
quantitative data. Will participate in manuscript writing. 
 
2. Erin Krebs, MD, MPH.  Erin.Krebs@va.gov; 612-467-7558; VA employee 
Minneapolis VAHS  

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a. Role: Co-Investigator  
b. Will be a part of the Intervention & Measures Subgroup, and will 
contribute her research expertise on chronic pain measurement and 
her clinical expertise in chronic pain management. Will participate in 
manuscript writing. Will not have access to protected health 
information. 
 
3. Steven Fu, MD, MSCE.  Steven.Fu@va.gov; 612-467-2582; VA employee 
Minneapolis VAHS;  
a. Role: Co-Investigator 
b. Will serve as a member of the Intervention & Measures and the 
Implementation/Dissemination subgroups. Will participate in 
manuscript writing. Will not have access to protected health 
information. 
 
4. Laura Meis, PhD.  Laura.Meis@va.gov; 612-467-4516; VA employee 
Minneapolis VAHS;  
a. Role: Co-Investigator 
b.  Will help train and supervise the counselors and participate as a 
member of the Intervention & Measures Subgroup. Will participate in 
manuscript writing. Will have access to protected health information 
only if a mental health crisis with a participant requires it. Will perform 
data analysis of de-identified qualitative data (for quality assurance 
checks). 
 
5. Robert Kerns 
a. Role: Co-Investigator 
b. Will play a key role in dissemination and implementation activities, 
within and outside the VA, as a member of the 
Dissemination/Implementation Subgroup, and provide consultation 
throughout the course of the project. Will participate in manuscript 
writing. Will not have access to protected health information. 
 
6. Alicia Heapy 
a. Role: Co-Investigator 
b. Will lead the intervention component of this project, and a member of 
the Intervention & Measures Subgroup. Will not have access to 
protected health information. Will perform data analysis of de-
identified qualitative data (for quality assurance checks). 
 

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7. Joseph Goulet 
a. Role: Co-Investigator 
b. Will provide guidance on use of ICD pain code measures by assisting 
our local programmer, Ann Bangerter Dr. Goulet will serve as a 
member of the Intervention & Measures Subgroup. Will not have 
access to protected health information or any of our data. We do not 
consider New Haven to be an engaged site because they will not 
have access to the data. 
 
8. Kelli Allen 
a. Role: Co-Investigator 
b. Will serve as a member of the Intervention and Measures Subgroup, 
where she will help refine intervention content and recruitment and 
retention strategies based on her extensive expertise in this area. Will 
participate in manuscript writing. Will not have access to protected 
health information 
 
9. Sarah Krein 
a. Role: Co-Investigator 
b. Will serve as a member of the Intervention and Measures Subgroup. 
Dr. Krein’s role will also be to provide implementation expertise and to 
participate in the Dissemination/Implementation Subgroup. Will 
participate in manuscript writing. Will not have access to protected 
health information. 
 
10. Patrick Hammett, Patrick.hammett@va.gov; VA employee; Minneapolis 
VAHCS 
a. Role: Co-Investigator 
b. Will not have contact with research participants 
c. Will have access to protected health information 
d. Will help with data analysis and manuscript writing. 
 
11. Elizabeth (Lizzy) Goldsmith; elizabeth.goldsmith2@va.gov; VA employee; 
Minneapolis VAHCS 
a. Role: Co-Investigator 
b. Will not have contact with research participants 
c. Will have access to protected health information 
d. Will help with data analysis and manuscript writing. 
 

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Collaborators: 
1. Emily Hagel Campbell; Emily.HagelCampbell@va.gov; VA employee; Minneapolis 
VAHS 
a. Role: statistician 
b. Will only have access to protected health information when creating a 
de-identified quantitative dataset 
c. Will not have contact with research participants 
d. Will be involved in performing data analysis of de-identified quantitative data 
 
2. Ann Bangerter; ann.bangerter@va.gov; VA employee; Minneapolis VAHS 
a. Role: programmer 
b. Will have access to protected health information 
c. Will not have contact with research participants 
 
3. Sean Nugent; sean.nugent@va.gov; VA employee; Minneapolis VAHS 
a. Role: programmer 
b. Will have access to protected health information 
c. Will not have contact with research participants 
4.  Andrea Cutting, andrea.cutting@va.gov; VA employee; Minneapolis VAHS 
a. Role: programmer 
b. Will have access to protected health information 
c. Will not have contact with research participants 
5. Tam Do, tam.do3@va.gov; VA employee; Minneapolis VAHS 
a. Role: Study Supervisor 
b. Will have access to protected health information  
c. Will be involved in recruiting subjects and obtaining consent, and 
conducting counseling sessions over the telephone  
6. Lee Cross, MPH, lee.cross@va.gov; VA employee; Minneapolis VAHS 
a. Role: Study Coordinator 
b. Will have access to protected health information  
c. Will be involved in recruiting subjects, obtaining consent, and conducting 
surveys over the telephone 
7. Mark Ackerman, mark.ackerman@va.gov; VA employee; Atlanta VA  
a. Role: consultant  
b. Will NOT have contact with patients or see any kind of data 

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c. Will help schedule rooms at Atlanta VA for phase 1 focus groups 
d. Will help with manuscript writing  
8. Michael Saegner, Michael.saegner@va.gov; VA employee; Atlanta VA  
a. Role: consultant  
b. Will NOT have contact with patients or see any kind of data  
c. will help with manuscript writing  
5.0 
Study Procedures 
5.1 Study Design 
 
Phase 1 Focus Groups: This is a 4-year study. In study month 2, we will conduct focus 
groups with black patients with hip, back and knee pain at the Atlanta VAMC, using algorithms 
derived from 14 ICD9 codes that capture the most commonly used chronic pain codes. ICD 
codes are grouped (e.g. connective tissue disorder) using AHRQ groupings. 
• 
We will use a brief telephone screener to select patients that meet the following criteria:  
1) presence of pain (using the three-item PEG, a brief pain inventory that measures 
average pain intensity, interference with enjoyment of life, and interference with general 
activity,80,81 2) lack of cognitive impairment (using the six-item Callahan screener that 
identifies cognitive impairment for potential research subjects)77. 
• 
We will use these focus groups to refine the recruitment materials (recruitment letter, 
brochure, and recruitment scripts), counselor communication strategies and pedometer 
instructions, and collect additional information on barriers to walking.  
• 
Veteran tips will also be sought for increasing likelihood of phone contact with potential 
candidates for the intervention and control groups.  
• 
We will use Rapid Assessment Process (RAP) methods to obtain the insights needed to 
modify these materials in a timely way.  
 
In study month 4, we will conduct two additional patient focus groups to obtain feedback on 
modified versions of these materials, based on input from the first two focus groups.  
This use of focus groups to refine intervention content is modeled on a process successfully 
used by Drs. Fu and Burgess in Dr. Fu’s Veterans Victory study. The moderator will use a semi-
structured interview guide, modified from one developed for the Veterans Victory study by 
nationally recognized focus group experts Dr. Mary Anne Casey and Dr. Richard Krueger. 
Veteran expectations of the counselor regarding communication will be elicited by prompting 
Veterans to recall past experiences with their health care providers, particularly during visits in 
which they sought treatment for pain and during visits in which they had negative experiences 
(as negative experiences have been shown to have outsize influence on individuals). 
 

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Phase 2 Pilot: We will recruit three African American Veterans from the Atlanta VAMC using 
the same methods for Phase 2 in order to pilot the counseling portion of Phase 2. (These will 
not be any participants from Phase 1 and these participants will be excluded from Phase 2.) 
 
Participants will receive the information sheet along with the recruitment letter. The participant 
will be called 7-14 days after the letter has been mailed and the interviewer will assess interest 
and conduct the phone screener to see if the participant fits eligibility criteria. If the participant 
meets eligibility criteria and is interested, research staff will confirm the mailing address and mail 
out a pedometer with the with the accompanying cover letter and information sheet, pedometer 
instructions and pedometer Q&A. While recruiting participants, study staff will be sure to 
emphasize to read the information sheet carefully, and that they are voluntarily choosing to 
consent by being willing to participate. The first counseling session will be 60-75 minutes. This 
allows 30-45 minutes for the counseling portion and 15-30 minutes for feedback following the 
intervention. The following session will be 45-60 minutes, allowing 30 minutes for counseling 
and up to 30 for feedback. Any questions regarding feedback will be asked by research staff 
other than the interviewer to allow the participant to give their full and honest opinion of the 
session.  
 
 
Phase 2:  Intervention recruitment, implementation, baseline data collection, 3 month outcome 
data collection, 6 month follow-up outcome data collection, (Phase 2) and post-intervention 
evaluation (Phase 3). We will identify 500 black and 500 non-black patients with diagnoses of 
hip, back, and knee pain from the Atlanta VAMC, using algorithms derived from the14 ICD9 
(and ICD10 code conversions) that capture the most commonly used chronic pain codes (data 
will be extracted at the Minneapolis VA and will not leave this site). We have chosen the Atlanta 
VAMC because it has a high percentage of black patients (43%). We have elected to focus on 
chronic hip, back, and knee pain as the literature supports the efficacy of walking for these 
conditions, and these are the most common chronic pain conditions in VA. After participants 
receive the recruitment letters, which provide an opt-out option, the interviewer (study 
coordinator/RAs) will call the veterans from a private office and state that all answers are kept 
private and confidential and remind them the study is completely voluntary before conducting 
the screening survey. If the participant fits the eligibility criteria and is interested in the study, the 
interviewer will explain the study again and the consent process by going over the information 
sheet that was mailed along with the recruitment letter. Study staff will be sure to read the 
information sheet carefully, and to emphasize that they are voluntarily choosing to consent by 
being willing to participate in the study. If the participant consents, the interviewer will confirm 
the mailing address and obtain height and weight (in order to setup their pedometer prior to 
mailing to the participant). The participant will be mailed a Baseline Survey, accompanying 
cover letter, pedometer, and pedometer Q&A. On day 14 after the initial mailing of the baseline, 
we will mail a reminder postcard. About 2 weeks later, we will make 1 final contact attempt via 
phone. Two or three weeks prior to the 3- and 6-month follow-up time points, a postcard 
reminder will be mailed to all participants. This postcard will remind participants to wear their 
pedometer so that step count data can be collected on the 3- and 6-month surveys. The 3- and 
6-month cover letters and surveys will be mailed to participants about a week prior to the 3 or 6 

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month date. A reminder post card to return the survey will then be sent to non-responders at 
about 14 days after the survey was mailed. At the 6-month time point, a second cover letter and 
survey will be mailed to non-responders about 3 weeks after the initial mailing. Study staff 
(study coordinator and/or RAs) will follow-up with phone calls to answer any questions and offer 
to do the survey over the phone if the participant prefers. The participant’s surveys (screening, 
baseline, 3 & 6 month) will only be identified by a subject ID number. Data from non-enrolled 
patients will be immediately stripped of personal identifiers and will not be used in any other 
analyses. (The screening data will allow for comparison of enrollees with those patients who 
were ineligible or refused participation, and will enable the detection of inclusion biases.)  
 
If randomization is delayed after receipt of completed baseline survey (e.g., due to staffing 
issues), participants may no longer eligible (e.g., their pain has diminished beyond the eligibility 
threshold), so these particular participants will be called again. Trained interviewers will use a 
script to 1) remind the participant about the study and review the purpose and what is involved; 
2) ask if they are still interested in participating; 3) go through the eligibility questions again if 
they are interested. If they are no longer interested, these people will not be contacted again. If 
they are interested and eligible so far, they will be mailed another baseline survey and will 
receive another $20 for completion. Upon baseline return, if originally contacted prior to 
Amendment 8 approval, which added a chart review step to determine eligibility, they will be 
randomized and treated the same as all other participants from pre-Amendment 8 approval for 
the duration of the study. Upon baseline return, if originally contacted after Amendment 8 
approval, a medical chart review will determine whether they are eligible, and they will be 
treated the same as all other participants from post-Amendment 8 approval for the duration of 
the study. If they are interested but no longer eligible based on their answers to the screening 
questions, study staff will apologize and explain the situation. These people will not be 
contacted again.  
 
After completing the baseline survey, study staff will conduct a chart review to determine 
eligibility (see 5.4 Inclusion/Exclusion criteria for more details), and eligible patients will be 
randomly assigned to the Usual Care (UC) or Intervention Condition (IC). We will continue to 
contact patients until we have our required sample of 500 eligible patients (250 in each arm); we 
are aware that we may need to contact more black than non-black patients due to the likelihood 
of lower response rates among blacks. Intervention participants will be invited to participate in 
the 6-session intervention, a pedometer-mediated walking intervention that incorporates Action 
Planning and MI and Motivational and Cognitive techniques. Patients in the UC condition will 
receive an informational brochure and a pedometer. The Primary Outcome, pain-related 
physical functioning, and other pain domains recommended by the Initiative on Methods, 
Measurement, and Pain Assessment in Clinical Trials (IMMPACT), psychological mediators, 
and measures of utilization, provider, and environmental factors, and current treatment for pain 
(pain related services and use of opioid analgesics) will be measured at baseline survey. 
Baseline data on utilization of health care services, prescription for pain medications, medical 
comorbidities, and demographic information will be obtained from the Corporate Data 
Warehouse (CDW) data.  We will survey patients by mail (at 3 months and 6 months post-
baseline) to assess the same pain measures and psychological mediators that we assessed at 

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baseline, and assess walking, in the form of daily step counts measured through patient logs of 
pedometer readings. We will also assess service utilization and opioid analgesics, using data 
from the CDW and survey data. Data analysis of primary aims will follow intent-to-treat 
methodology. During Phase 3, we will also conduct analyses of intervention processes using the 
RE-AIM framework. 
 
• 
Study Setting. The sample will be drawn from the Atlanta VAMC (the main facility 
and satellite clinics) which has about 19,146 black and 17,657 non-black patients 
(16,580 of whom are white) who have received a musculoskeletal diagnosis over the 
past 12 months. Race data will be collected on the brief screening survey. 
Recruitment (via the administration of a brief telephone screening questionnaire) and 
telephone coaching will be conducted at the Center for Chronic Disease Outcomes 
Research (CCDOR), at the Minneapolis VAMC. Participants randomized to the Usual 
Care control condition will receive pedometers and an informational brochure. They 
will be instructed to wear the pedometer throughout the study period and instructed 
(via a mailed postcard) to record their pedometer readings on logs over 7 days at the 
3-month and 6-month follow-up periods. They will report these step counts during the 
subsequent surveys, a procedure which has been used successfully in previous 
studies with similar populations. Although the pedometer is an enhancement beyond 
what is received in usual care, we decided to provide pedometers to the control 
condition because it is the only way to determine whether the intervention increases 
walking (as self-reported measures have not been shown to be reliable), and 
because past studies suggest that pedometers in isolation are unlikely to result in a 
sustained increase in walking among generally sedentary individual and that the use 
of pedometer self-monitoring in research does not lead to increased physical activity.  
 
• 
Intervention Condition. Participants assigned to the intervention group will receive 
personalized recruitment materials including a brochure describing the program and 
the benefits of walking for pain. Materials will include targeted messages to enhance 
persuasive appeal among this population and will be developed and modified using 
4-6 focus groups among VA patients at the Atlanta VA in phase 1. This approach to 
developing recruitment materials was successfully used by Fu et al. in the Veterans 
Victory study. The pedometer component of this intervention is based on the work of 
French et al. and Co-Investigators Krein and Heapy, in which patients will set modest 
goals to gradually increase their step count. Intervention participants will wear the 
pedometer and maintain a pedometer diary for the duration of the 6-month study 
using weekly pedometer diaries, a protocol that was demonstrated to be feasible in 
the “Fit for Life” and H.U.B. City Steps studies. The structure and intensity of our 
intervention was chosen to balance practical concerns about future dissemination 
while accommodating our intervention components and providing a sufficient dose of 
counselor time based on comparable prior interventions that successfully increased 
walking and improved pain. The intervention will be tailored to the specific population 
we are targeting through the Phase 1 focus groups and Phase 2 pilot.  
 

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• 
Telephone Sessions.  Intervention participants will complete six sessions of 
telephone coaching over a 10-12 week period (maximum of 14 weeks will be 
allowed). Participants are expected to receive approximately 180 minutes of total 
therapist time during the study. Sessions #1-4 occur weekly and sessions #5-6 occur 
with longer breaks in between. The Action Planning component of this intervention is 
based on a protocol and structured curriculum developed by French et al, which was 
effective at increased walking in several trials in a non-clinical population (healthy 
volunteers) and also incorporates techniques developed in an intervention that used 
Action Planning to promote physical activity among patients with chronic low back 
pain. Participants will be coached to create and write action plans for their proposed 
walking activity during the week(s) between coaching sessions, using a template, 
which prompts them to indicate when, where, and with whom they will walk. We have 
adapted this component for our target population, so that counselors will be trained 
to coach patients in developing plans to overcome common environmental barriers to 
walking experienced by members of racial minority groups (e.g., lack of time, 
neighborhood safety, lack of motivation to exercise during leisure time, and health 
concerns). We will specifically address fear of movement and promote self-efficacy 
for walking during the Action Planning process by incorporating these topics into the 
Action Planning sessions and, based on the pilot work of Allen, will design the 
materials for lower literacy levels.  
Evaluation of Intervention (Phase 2) 
Data Sources and Data Collection Data collection will occur by mail and telephone at baseline 
and at 3 and 6 months post-randomization. We will also include administrative data extracted 
from the CDW at these three timepoints (see Table 3).   
Description of the MSD.  Gender, birthdate, race, and zip code of residence will be gathered 
from the CDW. Medical and psychiatric diagnoses will be based on ICD-9 codes (and ICD-10 
code conversions). Only conditions noted in the year prior to cohort entry will be counted as 
baseline conditions, as they were likely to be active at the time of the incident musculoskeletal 
diagnosis encounter. Service utilization encounters will be defined using stop codes. Non-VA 
service paid for by VA will be assessed using fee-for-services data. 
Table 3: Table of Evaluation for Phase 2 (Data Sources, Constructs and Measures) 
Construct 
Measure 
0 
mo 
3 
m
o 
6 
m
o 
Baseline screening questions 
 
 
 
Race/ethnicity 
Standard measures of race and ethnicity 
X 
 
 
Pain intensity/interference  
Brief pain intensity and interference scale 
(PEG) 
X 
 
 

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Ability to walk a block 
Single-item screening question 
X 
 
 
Cognitive screener 
Callahan Measure 
X 
 
 
Anticipated back, knee or hip 
or other major surgery in next 
12 mo. 
Single-item question 
X 
 
 
 
 
 
 
 
Primary Outcome 
Disease-specific functioning 
Revised Roland and Morris Disability 
Questionnaire (RMD) 
X 
X 
X 
Secondary Chronic Pain 
Outcomes 
 
 
 
 
Pain intensity/interference 
Brief pain intensity and interference scale 
(PEG) 
X 
X 
X 
Emotional functioning 
 
Personal Health Questionnaire 
Depression Scale (PHQ-8) 
X 
X 
X 
Emotional functioning 
Generalized Anxiety Disorder 7 item 
(GAD-7) 
X 
X 
X 
Overall improvement 
Patient Global Impression of Change 
scale 
 
X 
X 
Average daily total steps  
Pedometer data recorded over past 7 
days on patient logs 
X 
X 
X 
Utilization and pain medication  
Service utilization  
Number of outpatient visits, emergency 
room visits, referrals for specialty care, 
and hospitalizations.  (from CDW) 
X 
X 
X 
Survey items 
X 
X 
X 
Use of opioid analgesics   
CDW – Pharmacy files (RXOutpatFill, 
RxOutpat, RxOutpatSig), Non-VA Meds 
(From CDW) 
X 
X 
X 
Survey items 
X 
X 
X 
Psychological mediators 
 
 
 
 
 
 
 
 
Exercise self-efficacy   
Exercise Regularly Scale  
X 
X 
X 
Pain management self-
efficacy  
Pain Self-Efficacy Questionnaire-8 item 
version (PSEQ-8). 
X 
X 
X 
 Pain-related fear avoidance 
Fear-Avoidance Beliefs Questionnaire 
(FABQ) Scale 1: Fear-avoidance beliefs 
about physical activity 
X 
X 
X 
Social support 
Social Support for Exercise: Marcus 
Social Support Questions 
X 
 
 
Social support 
Life Stressors Inventory (LISRES-A) 
X 
 
 
Environmental factors 
Neighborhood Environment Walkability 
Scale (NEWS)   
X 
 
 
Utilization factors 
 
 
 

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Experiences of discrimination 
Perceived Discrimination in Healthcare 
X 
 
 
Mistrust of medical Care 
Evaluation of VA Care scale 
X 
 
 
 
 
 
 
 
Demographic factors 
Standard measures of education, income, 
employment, height, weight, service 
connection  
X 
 
 
Walking Aid Question  
 
X 
 
 
RE-AIM Measures (open-
ended) * 
Open-ended questions assessing 
participants’ experience with the 
intervention and recommendations for 
improvement. 
 
*RE-AIM measures will only be 
assessed for intervention participants. 
 
 
X 
Note: Unless otherwise indicated, items are collected by survey self-report 
Patient telephone survey If participants do not return a paper mailed survey, data will be 
collected by phone by trained interviewers, (the study coordinator and research assistants 
located at CCDOR in MPLS), who are blinded to treatment condition. Patients will be assured 
that reports will not be shared with their counselor or healthcare provider, without their verbal 
permission, unless they indicate their safety or the safety of others is at risk. 
Description of measures 
• 
Screening Items:  Patients will be screened using: 1) two items assessing race and 
ethnicity, 2) the three-item PEG, a brief pain inventory that measures average pain 
intensity (P), interference with enjoyment of life (E), and interference with general activity 
(G),80,81 3) a single question asking them if they are able to walk a block, 4) the six-item 
Callahan screener that identifies cognitive impairment for potential research subjects,77 
and 5) a question asking them if they anticipate back, knee, or hip surgery or other major 
surgery within the next 6 months.   
• 
Chronic Pain Outcomes.  We will assess the following core chronic pain outcome 
domains and measures recommended by IMMPACT:29 1) The primary outcome will be 
a pain-specific measure of functioning, the revised version of the Roland and Morris 
Disability Questionnaire (RMD), widely used in studies of chronic musculoskeletal pain 
and included in the IMMPACT recommendations. Although the original version focused 
on low back pain,82 the revised version has been adapted for MSK pain more broadly, 
and has been validated with MSK patients.30 The scale has good internal consistency, 
discriminative validity and is sensitive to change.83 2) Emotional functioning will be 
assessed by items on Personal Health Questionnaire Depression Scale (PHQ-8)90, 99 
and Generalized Anxiety Disorder 7 item (GAD-7).105  3) Pain intensity/interference will 
be assessed by the brief pain intensity and interference scale (PEG).80,81  4) Participant 
ratings of overall improvement will be assessed by the Patient Global Impression of 

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Change scale, a single item measure assessing patients’ views of 
improvement/worsening in their pain.85  
• 
Average Daily Total Steps. Walking will be measured as the number of average daily 
steps using pedometer readings recorded in walking logs at three and six months, based 
on seven consecutive days of data. We will use the Omron HJ-321 pedometer, used in 
prior studies (including the Krein pedometer study). This pedometer can be worn in a 
pocket, around the neck, or on a belt clip (orientation does not matter) and has been 
shown to be highly accurate, including in obese populations.86 Patients will be instructed 
on how to use the pedometers, and we will conduct pilot tests (as part of the Atlanta 
focus groups) to assess whether these instructions are accurately understood.  
Participants in the intervention arm will have additional support for ongoing pedometer 
use as part of the intervention, but the walking outcome assessment protocol will be 
identical in both arms. 
• 
Psychological Factors (Mediators). Pain-related fear will be measured using the Fear-
Avoidance Beliefs Questionnaire (FABQ) Scale 1: Fear-avoidance beliefs about physical 
activity.106 Self-efficacy for exercise will be measured using the Exercise Regularly 
Scale, which includes questions asking respondents how confident they can do aerobic 
exercise such as walking three to four times each week and how confident they are they 
can exercise without making symptoms worse.87  Pain management self-efficacy will be 
measured using the Pain Self-Efficacy Questionnaire (PSEQ),88 which has been used in 
numerous studies of chronic pain patients. Service Utilization.  We will assess use VA 
services using administrative data from the CDW, which we will supplement with survey 
measures to assess health care utilization outside the VA.  Categories of VA service 
utilization will include the number of outpatient visits, emergency room visits, referrals for 
specialty care, and hospitalizations. These variables are defined using stop codes and 
encounter dates. Mental health visits are determined from stop codes devised using the 
VA North East Program Evaluation Center (NEPEC) algorithms. Because we have found 
that Veterans frequently receive care at multiple VA facilities and even multiple VISNs, 
site of care will be recorded for each encounter.  
• 
Use of Opioid Medication.  We will assess use of opioid medication using 
administrative data from the CDW which we will supplement with survey measures to 
capture medication received outside the VA.  Receipt of opioid medication will be 
defined as any dispense of VA formulary category CN101 drug. Because most 
methadone for opioid substitution therapy (OST) is in a separate VA table, we will 
assess OST by stop code 523. Chronic opiate therapy (COT) will be defined as >90 
consecutive days of medication dispensed. We will calculate average daily morphine 
equivalent dose (MED). A recent non-VA cohort study found that patients receiving 
medically prescribed opioids of 100mg or more per day MED had a 9-fold increase in 
overdose risk, that most overdoses were medically serious, and 12% were fatal.28 We 
will create indicator variables for average MED of 1-20, 21-49, 50-99, 100-124, and > 
125mg.  
• 
Environmental Factors: The baseline survey will include the Neighborhood 
Environment Walkability Scale (NEWS) in order to elicit information about access to and 
the use of equipment, facilities, and places where they can walk as well as 

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environmental barriers (e.g., safety concerns). Seasonal effects will be taken into 
account based on date of survey completion. Social influence/encouragement to 
exercise will be measured by the Social Support Exercise: Marcus Social Support 
Questions and the Life Stressors Inventory (LISRES-A). 
• 
Utilization Factors will include experiences of discrimination (associated with delay of 
healthcare and unmet medical needs), assessed using the Perceived Discrimination in 
Healthcare scale107, and the experiences with VA care, assessed by the Evaluation of 
VA Care scale, an 8-item scale measuring patient satisfaction with and perceptions of 
quality of VA healthcare.93 
• 
Socio-demographic characteristics: Participants will be asked to provide basic socio-
demographic information that is not available from the CDW, such as education level 
and income.  
• 
RE-AIM Measures Collected from Intervention Participants. Our process analysis 
will use the RE-AIM model73 and will include information about the participants’ 
experience of the intervention. We will collect this information as part of the 6-month 
survey, by asking intervention participants about their experience with the intervention 
and asking them for recommendations for improvement using open-ended questions. 
Power and sample size  
Our sample size calculation was based using the Roland Morris Disability Questionnaire 
(RMDQ) score as the primary endpoint. For our primary analysis we use a responder analysis, 
in which we define clinical significant changes as a 30% reduction in pain disability from 
baseline, using the RMDQ, and have powered the study to be able to detect this change.  This 
is the accepted threshold for clinically significant improvement in clinical trials and 
recommended by the IMMPACT guidelines and studies demonstrate that a 30% reduction on 
the RMDQ is a clinically important difference.96,97 Prior studies have shown that 15-20% of usual 
care patients will demonstrate a 30% reduction in pain function score (using the RMDQ and 
similar measures) from baseline to follow-up, so in order to detect an absolute difference to 20% 
in the primary outcome measure between treatment groups (i.e.15-20% in the usual care group 
compared with 35-40% in the intervention group), we estimate that we will need between 86-97 
people in each group with complete data. This estimate takes into account that we are setting 
the alpha error rate to look separately at both black and non-black patients. We will use the 
between-group change on the RMDQ as a secondary measure.   
We also need to factor in that up to 50% of the study sample may be non-black, since we want 
to be able to have power to detect meaningful effects in the subgroup that only includes black 
patients (~100/50%=200). To allow for up to 20% attrition, we would need to randomize 250 
patients for each arm of the study, for a total of 500 patients recruited, and 200 black patients 
with complete data for the final analyses. We estimate that in order to reach a total of 500 
patients randomized, we will need to enroll (i.e. participants who are eligible after the phone 
screener is completed and are thus mailed a baseline survey packet) as many as 1500 patients. 
Once we reach the goal of randomizing 500 participants, we will stop enrollment. 
 

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Risk vs. Potential Benefit 
The proposed research poses “minimal risk” to subjects. There are no experimental procedures 
involved in this study. The potential risks to study participants include loss of privacy and 
confidentiality. There are no economic and minimal social risks of participating in the study. The 
baseline survey will not ask very sensitive questions and subjects can refuse to answer any 
question(s). The potential risk associated with the focus group is psychosocial stress (any 
research project with direct contact with human subjects contains some risk of deleterious 
effects due to psychosocial stress). This is true for both usual care as well as intervention 
groups.  
The intervention group is expected to benefit from this study. It is hypothesized that this 
group will experience improvements in chronic pain-specific physical functioning, 
emotional functioning, pain intensity and will report overall. This group is also expected 
to increase their walking which has been shown to have a beneficial effect on health.  
 
5.2 Recruitment Methods 
• 
Phase 1 (Focus group): Potential participants will be sent a letter from the 
MPLS VA explaining the project and providing an opt-out option. Within two 
weeks the study coordinator and/or the research assistant will attempt to contact 
them by phone and asked if they would be interested in participating in a 60-
90minute group discussion on their opinions about a study on reducing pain 
through walking. The call will include reviewing information that will be contained 
in the consent form. The study coordinator and research assistant will attempt to 
call the participants for a maximum of 6 times at different times of the day. The 
recruitment sample focus groups will be restricted to black patients from the 
Atlanta VAMC, selected from the CDW (who will then be excluded from the study 
sample).  At the time of the focus groups the participant will be presented with 
the consent form. The participant will be given time to read the form. Key aspects 
of the form will also be reviewed verbally, including that (1) the focus group is 
expected to last 60-90 minutes (2) they will be audiotaped (3) the information 
they provide will be de-identified prior to analysis (4) they may skip any questions 
or terminate the interview at any time if they wish 5) and it will not affect their 
care at the VA if they choose not to participate.  Only participants signing an 
informed consent form will be interviewed. All focus groups will be conducted in 
the Atlanta VAMC by Dr. Burgess, PI.  
• 
In month 2 of the study we will conduct two patient focus groups to refine the 
recruitment materials (recruitment letter, brochure, recruitment scripts), the 
instructions related to use of pedometers, and counselor communication 
strategies, and to collect additional information on barriers to walking. In study 
month 4, we will conduct two additional patient focus groups to obtain feedback 
on modified versions of these materials, based on input from the first two focus 
groups.  
 

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• 
Initially we used Olympus digital voice recorders, which had been approved by 
MPLS ISO for use. Once the Olympus voice recorders were no longer supported 
by VA OIT, encrypted Philips DCM Digital Voice Recorders were purchased and 
used for recording. The voice recorders are VA equipment tracked via bar code 
by the MPLS facility inventory specialist. The ISO has worked with the PI to 
establish local procedures for use of the recorders, which are kept in a locked 
safe when not in use and are logged in and out prior to and after interviews.  
Once the interview is complete and a recording has been made on the device, 
the interviewers will promptly transfer the recording to the established secured 
VA server space and the recordings will be erased from the device. At the end of 
their life cycle the digital recording devices will follow electronic media sanitation 
procedures under the guidance of the MPLS ISO. This same procedure is used 
in C-IRB #12-28.  
 
• 
Phase 2 Pilot: Recruitment methods for the Phase 2 Pilot will be kept the same 
as Phase 2 recruitment methods, differing only in that we are recruiting and 
enrolling 3 participants for the Pilot.  
 
• 
Phase 2: We will use the 14 ICD9 (and ICD10 code conversions) that capture 
the most commonly used chronic pain codes to identify 1,000 patients with 
Musculoskeletal Diagnoses within the past 12 months, who are identified as 
Atlanta VAMC patients. Potentially eligible patients will be mailed a letter from the 
Minneapolis VAMC describing the study, providing an opt-out option, and 
informing them that they will be contacted by phone. Along with the letter will be 
an information sheet containing elements of informed consent. All patients will 
then be called by a trained interviewer, who will be the study coordinator and/or 
the RAs (from the Minneapolis VA) approximately a week or two after the letter is 
sent out, who will ask if they received the letter about the study and will briefly tell 
them about the purpose and the opportunity to participate. We will use the same 
call protocol described in phase 1. If they are interested, the interviewer will ask 
them 12 screening questions. If eligible, they will be invited to participate in the 
study and the interviewer will review the information sheet and obtain verbal 
consent. Eligible patients must meet the inclusion criteria.  
Participants who were found eligible and completed the baseline but were not 
immediately randomized (due to coaching staffing issues, randomization was 
putting on hold at the end of 2016 and beginning of 2017), will be given an 
additional call to see if they are still interested in participating. Trained 
interviewers will use a script to 1) remind the participant of about the study and 
review the purpose and what is involved; 2) ask if they are still interested in 
participating; 3) go through the eligibility questions again if they are interested. If 
they are interested and found eligible, they will be mailed a baseline survey and 
will receive another $20 for completion. Upon baseline return, they will be 

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randomized and be treated the same as all other randomized participants for the 
duration of the study.  
 
• 
If eligible, the participant will receive the baseline survey in the mail. Once they 
return the baseline survey, a chart review will determine if they are eligible, and if 
so, the subject will be randomly assigned to the Usual Care (UC) or Intervention 
condition. We will continue to contact patients until we have our required sample 
of 500 eligible patients (250 to each arm). Intervention participants will be mailed 
an introductory letter, informational brochure, and Veteran’s Workbook (to be 
used during coaching sessions) shortly before being called to schedule their first 
counseling session. Patients in the UC condition will receive an informational 
brochure. Recruitment (via the administration of a brief telephone screening 
questionnaire), baseline, 3 and 6-month surveys, and telephone coaching will be 
conducted at the Minneapolis VA. The study coordinator and/or research 
assistants will attempt to call the participants for a maximum of 3 times at 
different times of the day at each of the recruitment and data collection 
timepoints (eligibility, baseline, 3-month, and 6-month). 
• 
Describe materials that will be used to recruit subjects, e.g., 
advertisements.  Include materials as an appendix or separate 
attachment. 
See IRB supporting documents 
 
Subject payments:  
• 
Survey participants will be compensated for their time with $20 for each outcome 
assessment (baseline, 3 and 6 month) completed (for a total of $60, or potential 
$80 total if the participant is asked to complete the baseline a second time). 
Focus group participants will be compensated for their time with $50. Phase 2 
Pilot participants will be compensated $20 for session 1 and 6, and $15 for 
sessions 2, 3, 4 and 5. This payment amount is similar to those used in other 
studies, and is provided for the time and inconvenience of participating in 
research. The amount is not so much that subjects would feel coerced into 
participation.  
• 
The study coordinator will dispense payments for survey participants for all 
phases.  
• 
Phase 1 will consist of a onetime payment of a $50 check mailed 8-10 weeks 
after participation in the focus group.  
• 
In Phase 2, participants will receive a $20 check within 8-10 weeks of completing 
the baseline, 3 and 6-month follow-up survey.  
 
5.3 Informed Consent Procedures 
Phase 1 & 2: We are seeking a waiver for screening pain participants at the Atlanta 
VA so that we can identify our population and conduct future analyses for non-

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respondents. This waiver would only apply toward secondary data (i.e. data that 
has been collected and provided in VA records).  
 
Phase 1 (Focus group): We will provide a full written informed consent and HIPAA 
authorization form.  
 
Phase 2 Pilot: We will mail participants the recruitment letter and information 
sheet explaining that they can voluntarily consent by agreeing to participate in the 
study.  
 
Phase 2 (Intervention): We are requesting a waiver of documentation of informed 
consent as recruitment and consent will be obtained verbally over the phone. We 
will conduct a 12-question screening phone survey to determine eligibility status 
for recruitment with potential subjects, and once eligible and agree to participate, 
all contacts are done over the phone or by mail (screening survey, baseline, 3- and 
6-month follow-up survey).   
 
• 
Documentation: 
o Phase 1:  We will provide a full written informed consent and HIPAA 
authorization form.  
o Phase 2 Pilot: We have a waiver of documentation of informed consent, 
and a waiver of HIPAA authorization for the duration of the study 
o Phase 2:  We have a waiver of documentation of informed consent, and a 
waiver of HIPAA authorization for the duration of the study. The study and 
consent will be explained over the phone after the subject meets eligibility 
and is interested in participation.  
• 
Dr. Burgess will conduct the focus groups at the Atlanta VA. She will review the 
informed consent and HIPAA with participants and obtain consent at the time of 
the focus group.  
5.4 Inclusion/Exclusion Criteria 
• 
Phase 1 (Focus group participants): The recruitment sample for focus groups 
will be restricted to black patients from the Atlanta VAMC, with diagnoses of hip, 
knee, or back pain, using algorithms derived from 14 ICD9 codes (and ICD10 
code conversions) that capture the most commonly used chronic pain codes. 
They will then be excluded from the study intervention sample.  Focus groups are 
restricted to black patients because the study is designed to increase walking 
among this population and we want to make sure that our materials are culturally 
appropriate. Additionally, these veterans will help us refine the recruitment 
materials (recruitment letter, brochure, and recruitment scripts), counselor 
communication strategies and pedometer instructions, and identify additional 
information on barriers to walking.  
 

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• 
Phase 2 Pilot: The recruitment sample will be restricted to African American 
patients from the Atlanta VAMC with hip, knee, or back pain (using algorithms 
derived from 14 ICD9 codes and ICD10 code conversions), have pain duration of 
≥ 6 months, moderate-severe pain intensity and interference with function 
(defined as a PEG score of ≥ 5), self-reported ability to walk at least 1 block, and 
must be able to communicate effectively by telephone (no cognitive disability). 
We will not exclude patients who are on medication or receiving interventions to 
treat their chronic pain. We will exclude those who cannot obtain the threshold 
level of steps (400 steps per day) in 2 days of data collection. We will exclude 
Phase 2 pilot participants from the Phase 2 study.  
           
• 
Phase 2: The recruitment sample will include all patients from the Atlanta VAMC, 
regardless of race/ethnicity, with hip, knee, or back pain (using algorithms 
derived from 14 ICD9 codes and ICD10 code conversions), have pain duration of 
≥ 6 months, moderate-severe pain intensity and interference with function 
(defined as a PEG score of ≥ 5), self-reported ability to walk at least 1 block, and 
must be able to communicate effectively by telephone (e.g., no cognitive 
disability). We will not exclude patients who are on medication or receiving 
interventions to treat their chronic pain. We have chosen the Atlanta VAMC 
because it has a high percentage of black patients (43%). 
 
• 
We will include the approximately 10% of patients who have no race data; race 
data will be collected on the brief screening survey.  
 
We will not include any vulnerable populations or those who meet any of the following exclusion 
criteria that may interfere with the outcome assessment: a) moderately severe cognitive 
impairment defined as > 2 errors on a brief cognitive screener; b) anticipated back, knee, hip, or 
other major surgery within the next 6 months; c) patients who say they are unable to walk at 
least a block; d) patients who say they would be unavailable to participate in a 6 month study; e) 
patients with active psychotic symptoms, suicidality, severe depression, and/or active manic 
episode or poorly controlled bipolar disorder, as determined by chart review.  
5.5 Study Evaluations 
• 
Describe all evaluations to be conducted (including screening; 
tests/questionnaires that will be administered; any procedures that 
subjects will be required to complete) and data collection methods.  
Include materials as an appendix or separate attachment. 
• 
See IRB supporting documents  
 
5.6. Data Analysis 
Phase 1 

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• 
Analysis of focus group data. Our short timeline for refining the intervention 
content will require us to identify key insights from our focus groups quickly so 
that we can use them to guide our revisions on the materials. We will therefore 
employ rapid assessment process (RAP) methodology to analyze the data 
collected in this study. RAP is a team-based method that can be used to obtain 
rich qualitative results in a brief amount of time. A key feature of this method is 
iterative data collection and analysis where investigators analyze data after each 
interview. For our study, use of RAP methods will involve scheduling time 
immediately following each focus group for the investigators participating in data 
collection (Dr. Burgess and RAs) to identify and discuss key findings. The list of 
key findings will be updated and expanded with each subsequent focus group 
session. Investigator notes from each interview session will be amended to this 
list of key findings to create a running log of key interview data. The log will be 
periodically distributed to investigators and discussed during ongoing project 
meetings.  
• 
Phase 2 Pilot Data: There will be no data analysis for Phase 2 Pilot. Although 
we will be audio-recording the counseling sessions, we plan to use these 
recordings ONLY to accurately capture the Veteran’s reactions to the materials 
and counseling. We may refer back to the feedback from the Veteran in order to 
improve our training materials for our counselors, but will not be analyzing the 
recordings.  
Phase 2 
• 
The overall design of the study is a two-arm patient-level randomized trial. All 
analyses will take this design structure into account and will primarily follow an 
intent-to-treat analysis where patients are analyzed based on the group they 
were randomized to regardless of whether or not they actually receive the 
assigned intervention. Secondary analyses will assess the impact of the intensity 
of intervention compliance on outcomes and to test study outcomes among 
patients. 
 
• 
Primary Aim. To test the hypothesis that the intervention will improve chronic 
pain-specific physical functioning—the primary outcome (H1a), improve 
emotional functioning, pain intensity and ratings of overall improvement (H1b), 
and increase walking (H1c), compared to UC for black patients with chronic hip, 
back, and knee pain. 
 
• 
The primary analyses for these aims will be conducted in the sample of black 
patients, so the focus of much of the methods speaks to this primary sample. 
However, it needs to be clear that the study is designed to be adequately 
powered to detect effects separately in both the black and non-black groups. This 
is important from an implementation standpoint since if this intervention is 
successful it will be important to know whether the effects generalize to a non-
black population. 

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• 
General Analytic Approach. These analyses will proceed in three phases. In 
the first phase (data verification), we will examine the distribution of all study 
variables to assess extreme values, missing data, variances, skewness, and type 
of distribution. Frequency distributions and descriptive statistics for all study 
variables will be computed prior to conducting any analyses. Should normality 
tests indicate evidence of non-normality for any of our variables (e.g., pain 
severity ratings) we will compute necessary data transformations. In the second 
phase, we will evaluate bivariate associations between patients’ experimental 
condition and the outcomes, as well as between each covariate and the 
outcomes and between each covariate and intervention. These analyses will be 
done to determine unadjusted measures of effect and assess possible 
confounders. In the final phase, we will use generalized regression models to 
estimate the main effects of the intervention. Because of randomization of 
treatment assignment, we do not anticipate any imbalances in baseline 
characteristics between groups, but any differences between experimental arms 
in baseline characteristics will be included as covariates. Likewise, if we find 
differences in missing data, multiple imputation methods will be used to explore 
the impact of the missing data and attempt to adjust for its effects on the 
intervention’s effectiveness.  
 
• 
Aims 1a) and 1b) To compare the effects of the intervention to UC on the 
IMMPACT measures of pain outcomes. The primary measure for these aims is 
the RMDQ score (i.e. primarily a 30% reduction from baseline and secondarily 
mean change from baseline), and the other secondary measures are pain 
intensity, the Profile of Mood States, and the global rating of change scale. 
Analytic approaches for all of these measures will be similar with the exception 
that some of the measures are dichotomous (i.e. did the participant have a 30% 
reduction in RMDQ) while other outcomes are assessed on a continuous scale. 
For all of these outcomes we will use generalized linear regression fit using 
appropriate distribution and link functions (i.e. for the primary outcome of whether 
the patient’s RMDQ improved by 30% or more we will fit a binomial distribution 
and logit links, whereas for the comparison of mean differences between 
treatment groups we might fit a normal distribution). We expect the RMDQ score 
to decrease (indicating improvement) in the short term (3-month) as well as over 
the longer term (6-month) in the intervention group, while improving only slightly 
from baseline in the control group. For continuous outcomes in this model, for 
example the RMDQ, scores from both 6 months and baseline will be used as the 
dependent variable, and the independent variables will include the indicator for 
the intervention group and an interaction term of 6-month time by intervention 
group indicator. Each participant will be modeled as a random intercept to allow 
within-patient correlation of the repeated measures. The model can also include 
other baseline covariates such as age and pain intensity. The use of a mixed-
effects model, rather than using multiple linear regression or analysis of 

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covariance with change-scores or the 6-month values as the dependent variable, 
will allow us to use data from participants who may be missing either baseline or 
the 6-month data while giving an unbiased estimate of the outcome comparisons 
as long as missing-ness is approximately random. The 3-month effect will be 
similarly assessed.  
 
• 
We will assess the time-averaged effect of the intervention on pain-related 
functional interference and the outcome trends over time using the outcome 
measures at all three times (including the baseline) as repeated measures 
nested within patients and using a mixed-effects model. Prior to fitting the mixed-
effects model, we will explore the trends graphically by plotting the cross-
sectional means of the outcome measures at each measurement time separately 
by the two study groups. We will also graph the outcome measures by individual 
participants to assess the participant specific longitudinal pattern over time. The 
mixed-effects model will be guided by the results of the graphical analyses. For 
instance, we expect decreasing trends in the outcome measures over time in the 
intervention group and no particular trends in the control group. If such a pattern 
is indicated, linear time and an interaction of linear time by intervention group will 
be included in the model. In this model, if the time variable is not significant and 
the interaction is estimated with a significant negative coefficient, it would provide 
evidence for linearly decreasing outcomes (i.e., improvement in function) in the 
intervention group over the one follow-up period. If, on the other hand, the 
graphical analyses suggest that the outcomes in the intervention group decrease 
at 3 months with no noticeable change between 3 to 6 months, we will model this 
by including time as dummy categorical variables and interaction terms of 
intervention group by time dummy categorical variables. An appropriate contrast 
for the covariate adjusted difference in outcome means at 3 months and 6 
months between groups will be constructed to estimate and test for the 
intervention effect. Using this model, mean changes from baseline can also be 
estimated and tested for each group. If we find no difference in the intervention 
effect between 3 and 6 months using this model, we will model the post-
intervention time together to obtain a time-averaged intervention effect. The 
mixed-effects models will also include the baseline values of the outcome 
measure and other baseline covariates to adjust for potential baseline differences 
between the groups.  
• 
Aim 1c) To compare the effects of the intervention to UC on increasing walking 
behavior. Walking will be measured by step counts, which are reported based on 
readings from the Omron HJ-720 ITC pedometer. The effect of the intervention 
on step counts will be assessed by comparing average daily step counts (or 
appropriately transformed scores, if the distribution is shown to be skewed) 
measured over 7 days. We will use a mixed-effects model with the average daily 
step counts as reported on the baseline survey, during the last week of the 3 
month and 6 month measurement points as the dependent variables, with a 
similar analytic plan as described for Aim 1a.  

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• 
Secondary Aim 1: To investigate whether key contributors to racial/ethnic 
disparities targeted by the intervention (motivation to exercise, pain/exercise 
efficacy, reduction of pain-related fear) mediate improvement in chronic pain 
outcomes and increases in walking. The key measures for this aim include the 
Exercise Regularly Scale, the PSEQ-8, and the FABQ Scale 1. Each of these will 
be measured at baseline, 3- and 6-month, and each has continuous distribution, 
and therefore, analytic approaches for each of these measures will be identical to 
that of Primary Aim 1 with the primary objective of assessing the long-term (6-
month) effect of the intervention on these outcomes and secondary objective of 
exploring outcome trends over time. Indirect effects will be directly tested using 
the bootstrap approach to obtaining confidence intervals to avoid the often-
violated assumption underlying Sobel’s (1982) method that the sampling 
distribution of the indirect effect be normal.103 
 
• 
Secondary Aim 2: To explore whether the intervention reduces service 
utilization and use of opioid analgesics. Using similar analytical methods as 
described for the Primary Aims, we will use generalized linear models to explore 
whether service utilization and use of opioid analgesics measures are reduced in 
the intervention group compared to the UC group.  
 
• 
Secondary Aim 3: To determine if the intervention is effective for non-black VA 
patients and other subgroups of patients who may experience barriers to 
effective pain treatment. We will conduct the same analyses as for the Primary 
Aims and Secondary Aims 1-2 on the sample of non-black patients (most of 
whom are expected to be white) and subgroups based on key demographic 
factors (age, gender, education, and income) and psychological, environmental, 
and utilization, measured at the baseline survey, that we included because they 
were expected to constitute barriers to effective pain treatment, based on our 
theoretical framework. We will also explore whether treatment effects will be 
moderated by common psychiatric conditions (PTSD, anxiety, depression) and 
receipt of other forms of pain treatment, in order to see whether our intervention 
is effective for Veterans with these common psychiatric conditions and/or who 
are involved in other pain treatment. 
 
• 
Secondary Aim 4: To explore whether the intervention reduces racial disparities 
in pain outcomes, generalized linear regression models described above do 
allow for the incorporation of a race by intervention variable into the models to 
explore whether there might be evidence that the intervention is more or less in 
effective in black Veterans as compared with non-black Veterans. We expect that 
the intervention will be effective across racial groups and assume that the 
differences between racial groups receiving the intervention will be substantially 
smaller than the differences between the intervention and UC groups. Since the 
study is powered to detect the main effects that are assumed to be larger than 

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the interaction effects, this study may not be able to detect clinically important 
differences in the intervention’s effectiveness between racial groups. We will 
however explore tests of interaction for the key study outcomes and use any 
information to help craft a future study, if we find evidence that there might 
potentially be important race-specific treatment effects. 
• 
Describe how, where and by whom the data will be analyzed. 
The data will be analyzed at CCDOR by statisticians and Co-Investigators, including Dr. Brent 
Taylor, Emily Hagel Campbell, Elizabeth Goldsmith, and Patrick Hammett at the Minneapolis 
HCS.   
5.7 Withdrawal of Subjects 
Phase 1 (focus groups): Participants can withdrawal from the study (i.e. the one-time focus 
group) at any time they feel uncomfortable. We anticipate termination of participation if:  
1. The participant displays abusive behavior toward other participants in the focus 
             group and/or the study staff 
2.  The study is suspended or canceled.  
 
Phase 2 Pilot: Participants can withdraw or be terminated from the study at any point. We 
anticipate termination of participation if:  
 
1. The participant displays hostile or aggressive behavior to the counselor.  
2. The study is suspended or canceled.  
3. The participant chooses to withdraw consent.  
 
Phase 2: Participants can withdraw or be terminated from the study at any point for any reason. 
We anticipate termination of participation if:  
1. The study team believes that it is not in the participant’s best interest to stay in the 
study 
2. The participant becomes ineligible to participate 
3. The participant does not follow instructions from the researchers 
4. The participant loses three pedometers 
5. The study is suspended or canceled 
6. The participant displays hostile or aggressive behavior to the counselor or study 
staff 
7. The study team believes the participant cannot meaningfully participate in the study 
8. The participant chooses to withdraw consent 
6.0 
Reporting 
• 
We will follow the VA Central IRB Table of Reporting Requirements for all issues that 
must be reported (i.e. summary of adverse events, unexpected problems and any 
actions or changes with respect to the protocol). The research assistant (RA) and the 
counselors will meet weekly by phone with the project coordinator to discuss study 
processes, progress, and any problems encountered. The local RA and project 

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coordinator will also report directly to the local site PI regarding any problems with data 
collection. Data will be reviewed regularly to insure accuracy and data safety. In the case 
of problems, the project coordinator immediately discusses with the study PI. The PI in 
turn will report any problems to the central IRB. 
• 
Once learned of any SAEs, UAP, compliance issues, RCO, and/or protocol deviation the 
study PI will report these events as defined by the VA Central IRB Table of Reporting 
Requirements to the VA Central IRB. The study PI will complete the appropriate forms 
(i.e., 119 or 129) as listed on the VA Central IRB Table within 5 business days of 
learning of its occurrence. If there are modifications or amendments to the study the 
study PI will also complete the appropriate Central IRB form (i.e. 116) and wait for 
approval prior to implementation.   
7.0 
Privacy and Confidentiality 
• 
We will employ rigorous procedures to guard against loss of confidentiality and 
loss of privacy.  The CCDOR data group will manage all data collected during the 
study.  
• 
We will link data to a specific subject by a code rather than a direct identifier.   
CCDOR programmers Ann Bangerter and Sean Nugent, will maintain the code 
and have access to the link. All crosswalk files that link the study ID to other 
participant identifiable data will be kept securely within the VA firewall. 
• 
To prevent improper use of any data collected for research projects conducted at 
the Minneapolis COIN we will use a combination of local Minneapolis VA secure 
servers as well as the national secure VA Informatics and Computing 
Infrastructure (VINCI). The local VA secure servers facilitate data collection and 
provide a platform for the customized research tracking application, while the 
VINCI platform provides a robust environment for pooling the primary research 
collected data with direct connections to daily or weekly updated mirrors of nearly 
the entire VHA EMR. VINCI also provides access to extensive storage area 
networks, drives, file shares, databases, SharePoint for collaboration and 
correspondence sites, SAS/Grid, and servers containing virtual machines with an 
extensive collection of software called the VINCI Workspace.  
• 
VINCI allows individual researchers and their staff the means to securely conduct 
their research projects within a secure and well controlled technical environment. 
All of these VA systems undergo backups of the servers nightly and servers are 
updated when new security patches become available. All individuals with 
administrative privileges to the VHA servers have been screened and have been 
assigned security clearance putting them in trusted positions to work with patient-
level data.  
8.0 
Communication Plan 
P.I. Dr. Diana Burgess will meet regularly with the project coordinator.  At these 
meetings, Dr. Burgess will check in with the project coordinator to ensure that the 
following key communications occur: 
1. Ensure that required local site approvals are obtained  

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2. Notify the Director of any facility where the research in being conducted, but the 
facility is not engaged. 
3. Keep engaged sites informed of changes to the protocol, informed consent, and 
HIPAA authorization 
4. Inform local sites of any Serious Adverse Events, Unanticipated Problems, or 
interim results that may impact conduct of the study. 
5. Notify all local facility directors and LSIs when the study reaches the point that it 
no longer requires engagement of the local facility  
The study team will also review relevant sections of the protocol periodically, so that we 
can make sure that the different phases of the study are conducted according to the 
IRB-approved protocol. 
 
 
9.0 
References 
 
1.  
Anderson KO, Green CR, Payne R. Racial and ethnic disparities in pain: causes and 
consequences of unequal care. J Pain 2009;10:1187-204. 
2. 
Meghani SH, Polomano RC, Tait RC, Vallerand AH, Anderson KO, Gallagher RM. 
Advancing a national agenda to eliminate disparities in pain care: directions for health policy, 
education, practice, and research. Pain Med 2012;13:5-28. 
3. 
Shavers VL, Bakos A, Sheppard VB. Race, ethnicity, and pain among the U.S. adult 
population. J Health Care Poor Underserved 2010;21:177-220. 
4. 
Staton LJ, Panda M, Chen I, et al. When race matters: disagreement in pain perception 
between patients and their physicians in primary care. J Natl Med Assoc 2007;99:532-8. 
5. 
Burgess D, Gravely A, Nelson D, et al. A National Study of Racial Differences in Pain 
Screening Rates in the VA Health Care System. Clinical Journal of Pain Accepted. 
6. 
Meghani SH, Byun E, Gallagher RM. Time to take stock: a meta-analysis and systematic 
review of analgesic treatment disparities for pain in the United States. Pain Med 2012;13:150-
74. 
7. 
Burgess DJ. Unpublished data. In; 2012. 
8. 
Dobscha SK, Soleck GD, Dickinson KC, et al. Associations between race and ethnicity 
and treatment for chronic pain in the VA. J Pain 2009;10:1078-87. 
9. 
Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC, eds. The biopsychosocial 
approach to chronic pain: scientific advances and future directions; 2007. 
10. 
Allen KD, Oddone EZ, Coffman CJ, Keefe FJ, Lindquist JH, Bosworth HB. Racial 
differences in osteoarthritis pain and function: potential explanatory factors. Osteoarthritis 
Cartilage 2010;18:160-7. 
11. 
McCracken LM, Matthews AK, Tang TS, Cuba SL. A comparison of blacks and whites 
seeking treatment for chronic pain. Clin J Pain 2001;17:249-55. 
12. 
King AC, Castro C, Wilcox S, Eyler AA, Sallis JF, Brownson RC. Personal and 
environmental factors associated with physical inactivity among different racial-ethnic groups of 
U.S. middle-aged and older-aged women. Health Psychol 2000;19:354-64. 
13. 
Burgess DJ, Grill J, Noorbaloochi S, et al. The effect of perceived racial discrimination 
on bodily pain among older African American men. Pain Med 2009;10:1341-52. 

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14. 
Burgess DJ, Hargreaves M, Ding M, Phelan S, van Ryn M. Relationship between 
perceived discrimination and unmet physical and mental healthcare needs in a multi-ethnic 
community sample. Journal of Health Care for the Poor and Underserved 2008;18. 
15. 
Saha S, Freeman M, Toure J, Tippens KM, Weeks C, Ibrahim S. Racial and Ethnic 
Disparities in the VA Health Care System: A Systematic Review. J Gen Intern Med 2008. 
16. 
Upshur CC, Bacigalupe G, Luckmann R. "They don't want anything to do with you": 
patient views of primary care management of chronic pain. Pain Med 2010;11:1791-8. 
17. 
Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy 
for nonspecific low back pain. Ann Intern Med 2005;142:765-75. 
18. 
Chou R, Huffman LH. Nonpharmacologic therapies for acute and chronic low back pain: 
a review of the evidence for an American Pain Society/American College of Physicians clinical 
practice guideline. Ann Intern Med 2007;147:492-504. 
19. 
Fu SS, van Ryn M, Sherman SE, et al. Population-based tobacco treatment: study 
design of a randomized controlled trial. BMC Public Health 2012;12:159. 
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