Equity Using Interventions for Pain and Depression (EQUIPD) - Phase 1
Phase: NA
Conditions: Chronic Pain, Depression, Health Equity
Sponsor: Indiana University

Cover Page 
 
Protocol 
 
Study Title: Equity Using Interventions for Pain and Depression (EQUIPD) - Phase 1 
 
NCT05695209 
 
Document Date: 11/11/2024 
 
IRB Approval Date: 11/14/2024 

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Equity Using Interventions for Pain and Depression 
(EQUIPD) – Phase 1 
 
Principal Investigator:  
Marianne Matthias, PhD 
Research Scientist, Regenstrief Institute 
Professor, Indiana University School of Medicine 
 
 
Support Provided by: 
National Institutes of Health 
 
 

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Table of Contents: 
1.0 
Background & Rationale 
2.0 
Specific Aims, Study Design, Recruitment, & Eligibility 
3.0 
Measures 
4.0 
Data Analysis Plan 
5.0 
Study Calendar 
6.0 
Reportable Events 
7.0 
Data Safety Monitoring 
8.0 
Study Withdrawal/Discontinuation 
9.0 
Data Management and Confidentiality 
10.0 
Follow-up and Record Retention 
11.0 
References from Grant 
 
 

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1.0 Background & Rationale 
Nonpharmacological pain treatments (NPTs) are increasingly supported by evidence and 
are widely recommended in treatment guidelines. However, these approaches remain 
underused. Even as access increases, several patient-related barriers remain, including lack of 
knowledge about NPT availability and effectiveness, poor patient-provider communication, and 
challenges to engagement and adherence. This last barrier is particularly important as NPTs 
typically require more commitment, time, and effort than taking medications. These patient-level 
barriers may be especially difficult for patients with comorbid pain and depression, since 
depressive symptoms can interfere with engaging in pain management. Such patients may 
require additional support and structure to successfully use and benefit from NPTs. These 
challenges are further exacerbated for Black patients, who continue to experience disparities in 
pain treatment, such as being offered fewer treatment options—including NPTs—compared to 
their White counterparts. Therefore, NPT use may be especially difficult for Black patients with 
comorbid pain and depression, given the unique challenges that depression adds to pain 
management and the persistence of racialized disparities in pain care. 
The overall goal of this proposal is to refine, test, and prepare to implement a novel 
approach to overcoming patient-related barriers to NPT use that is tailored to Black patients with 
comorbid pain and depression. EQUIPD (Equity Using Interventions for Pain and Depression) 
combines 1) a decision aid focused on NPTs to increase their use, and 2) a coach to foster 
patient engagement and NPT adherence. Drawing on a heuristic model of multi-level 
mechanisms of racial injustice in pain outcomes, EQUIPD is centered at the individual and 
interpersonal levels, while laying the groundwork for later intervention at the structural level (i.e., 
clinic/healthcare system) through subsequent system-wide implementation.  
The EQUIPD coaching manual and decision aid have been pilot tested with patients for 
acceptability, but not in the context of a randomized pilot. Procedures for a full trial, including 
recruitment strategies that may differ in a randomized controlled trial (RCT), need to be piloted. 
In addition, although the decision aid has been useful for patients, it is essential that we also 
learn from providers how it might better be used in the context of clinic visits. Finally, while we 
have incorporated patient perspectives throughout the development of EQUIPD, their continued 
involvement is critical for this next phase of our work in order to sustain use and achieve 
meaningful impact. This research will take place at Eskenazi Health, an urban safety-net health 
system that provides healthcare to underserved, socioeconomically disadvantaged patients.  
 
Chronic pain is prevalent, burdensome, and costly. Chronic pain affects tens of millions 
of Americans and is associated with depression, anxiety, reduced quality of life, and increased 
suicide risk.1, 2  Musculoskeletal pain is considered the most common, disabling, and costly of all 
pain complaints.3  
Depression is present in 30-50% of patients with pain and has additive effects on 
adverse health outcomes.4-6 Depression can increase pain and pain-related disability, 
ultimately reducing quality of life.1, 5 Depression can also interfere with effective pain 
management, especially nonpharmacological pain management approaches, which require 
active, consistent participation and engagement.7, 8 1 Indeed, depression has been identified as 
a significant barrier to engaging in pain self-management, with patients feeling overwhelmed by 
their pain, unable to focus on or engage in pain management activities, and feeling hopeless 
about being able to manage their pain.9 Clearly, depressive symptoms can reduce patients’ 
motivation to be active participants in their own care.10-12  
Non-pharmacological treatments (NPTs) for chronic pain are recognized as safe and 
effective. NPTs include both traditional (e.g., cognitive-behavioral therapy, exercise/movement) 
and complementary or integrative approaches (e.g., acupuncture, yoga).13 In response to high-
quality evidence supporting NPTs for chronic pain,13-16 the Centers for Disease Control and 
Prevention, the American College of Physicians, Department of Defense, and Veterans Health 

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Administration have released guidelines or adopted policies recommending multi-modal 
approaches that prioritize evidence-based NPTs.13, 17, 18 These guidelines are grounded in 
evidence from numerous studies and systematic reviews demonstrating safety and 
effectiveness.13, 14, 19-29 For example, the American College of Physicians strongly recommends 
that NPTs, including exercise, cognitive-behavioral therapy, yoga, and spinal manipulation, be 
considered as first-line treatments for chronic low-back pain.16  Thus, NPTs are a promising 
approach for patients seeking safe and effective pain treatment. Moreover, increasing NPT use 
is consistent with calls from the National Academy of Medicine and the National Pain Strategy to 
equip patients with tools to play an active role in managing pain.1, 30 
Despite the promise of NPTs, numerous barriers lead to their continued underuse.30-35 
Recent studies indicate notable gaps between patients’ interest in NPTs and actual use.34, 36 
Even in integrated healthcare systems such as Kaiser Permanente and the Veterans Health 
Administration, which have made concerted efforts to increase NPT access, patient-related 
barriers remain.31, 33, 36, 37 These barriers include (1) lack of knowledge about NPT options, (2) 
poor patient-provider communication about NPT options, and (3) challenges to 
engagement/motivation (because NPTs require more time and commitment than many other 
treatments, such as analgesics).13, 31, 33-35, 38, 39 Moreover, barriers such as skepticism and 
reduced motivation impact not just initial use, but long-term adherence—which is critical for 
NPTs to be effective.1, 13, 33  
Barriers to NPT use are exacerbated for Black patients. Disparities in pain treatment are 
well-documented and persist despite national priorities focusing on health equity. Minoritized 
groups, particularly Black patients, continue to experience greater pain severity, worse pain 
outcomes, and inadequate pain treatment.40-42 This includes being offered fewer treatment 
options—including NPTs—than their White counterparts.43-46 Racialized disparities in 
communication compound these disadvantages. Black patients report poorer quality 
communication with healthcare providers; they receive less health information and show 
reluctance to share health concerns and articulate their opinions and treatment preferences. 47-50 
These disparities have direct implications for pain care, particularly NPT use, which requires 
thoughtful evaluation of options and effective communication with providers to understand 
patients’ goals and preferences and find the NPT(s) that are the best fit for each patient.31, 33, 38, 
51, 52 Thus, the barriers to NPT use are intensified for Black patients compared to their White 
counterparts. 
In summary, NPTs represent a safe and effective—but underused—means to manage 
chronic pain. However, there are numerous barriers to NPT use, and these barriers are 
especially pronounced for Black patients and further exacerbated for patients with comorbid 
depression. Interventions are needed that address these disparities and provide tools for 
minoritized patients with comorbid pain and depression to benefit from NPTs. Notably, multi-
level factors, such as those at the structural and cultural levels, work together to create and 
maintain racial injustices, and these factors exert influence on individual experiences.53 
Therefore, to fully address these injustices, intervention at multiple levels is needed. EQUIPD 
begins this process by equipping individuals with tools to exercise autonomy and control over 
their pain care. Such patient-level empowerment is a necessary step in the multi-step process of 
achieving equity in chronic pain care. If effective, we will build on this work to effect change at 
the structural level in a follow-up project focused on implementing EQUIPD’s coaching and 
decision aid into everyday clinical practice at Eskenazi Health (see letter of support from 
Eskenazi leadership). 
Decision aids are promising tools for overcoming barriers to NPT use and improving 
pain-related outcomes. Decision aids (DAs) are evidence-based tools that help patients make 
choices among treatment options. They help facilitate discussions with providers and are often 
used prior to clinic visits to promote shared decision-making.54-56 DAs are typically used when 
there is no clear “best” choice, but rather when decisions are “preference-sensitive,” meaning 

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there is a need to weigh features of different options to evaluate how these options align with a 
patient’s own values and priorities.57 In other words, “patient decision aids may help clinicians 
and patients to come to quality decisions, grounded in patients’ values and taking into account 
the potential trade-offs in benefits and risks of different options.”56 
DAs can help overcome the barriers to NPT use described above. A 2017 Cochrane review 
of 105 studies56 found high to moderate quality evidence that DAs (1) improve patient 
knowledge about treatment options, including helping them to have more accurate treatment 
expectations; (2) engage patients by helping them clarify what goals and priorities are most 
important to them; (3) improve patient-provider communication by facilitating greater patient 
participation in decision-making; and (4) can be used in time-limited clinic visits. Of note, 
Cochrane review authors found that DAs added only 2.6 minutes, on average, to the clinic visit, 
indicating that these benefits are attainable without exacerbating existing clinic time constraints.  
Decision aids are especially well-suited for chronic pain and NPTs. First, as noted 
above, DAs are useful for preference-sensitive decisions and when different treatments may 
need to be tried. This is especially true for chronic pain because no single chronic pain 
treatment works for everyone, and frequently treatments must be used in combination (multi-
modal care).1, 58 Second, DAs facilitate communication, which is critical to foster shared 
decision-making.56, 57 This is especially important because minoritized patients experience 
poorer quality communication with providers,47-50 and because communication is often difficult in 
chronic pain care.59-62 Third, DAs provide a means to weigh different options, which is especially 
important when deciding among NPTs. Numerous NPTs are available, and they vary widely; 
consequently, patients and providers have indicated difficulty navigating NPT options.33, 38 
Moreover, unlike pharmacological treatments, such as pills or injections, NPTs require varying 
levels of patient participation and commitment, which patients need to consider as they choose 
among options. For example, a patient with long work hours might not have time for a series of 
chiropractor appointments, but might choose an NPT with flexible scheduling or that can be 
done on one’s own (e.g., walking). DAs help to make these tradeoffs explicit so patients can 
evaluate how different options fit into their lives. Fourth, DAs can help alleviate provider burden 
regarding informing, encouraging, and making decisions about NPT use with patients. By 
helping patients to define and state their goals and priorities for treatment, informing them of 
NPT options, and helping them to weigh these options against their own values and priorities, 
DAs equip patients to come to the visit prepared and primed to engage in a productive decision-
making process.  
Although some studies have trained physicians in shared decision-making for pain and a 
few have used DAs for patients with pain, these studies focused on specific conditions or clinical 
situations such as chest pain, orthopedic surgery, fibromyalgia, opioids, or medications for 
rheumatoid arthritis.63-67 Despite the importance of promoting NPT use for chronic pain and the 
demonstrated effectiveness of DAs, there have been no studies examining the effectiveness of 
a DA focused on NPTs for chronic pain.  
Patients need support to use and remain adherent to NPTs. In addition to the barriers to 
NPT use discussed above, once an NPT is selected, adherence can become challenging. In 
contrast to treatments such as analgesics, NPTs typically require considerably more time, effort, 
patience, and commitment.1, 13 Moreover, NPTs often take several months to show effects, 
which can be discouraging to patients.33 Indeed, challenges to adherence have been widely 
recognized in pain treatment, particularly those that are nonpharmacologic.1 Furthermore, these 
challenges are compounded for patients experiencing comorbid depression, who may need 
additional structure and support to maintain a treatment plan.9-12 In light of these challenges, the 
National Academy of Medicine recognizes the need to optimize adherence in pain management, 
especially for behavioral approaches such as NPTs.1 Our own work has highlighted the integral 
role of coaching to help patients in their daily efforts to manage pain. In multiple studies, 
including studies of patients with comorbid pain and depression, patients have noted that such 

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support is essential to their adherence to treatment regimens: coaching provides accountability 
toward goals and pain management activities, as well as encouragement to keep going when 
motivation is low.9, 68-71  Given the unique challenges associated with NPT uptake, which are 
compounded for minoritized patients with comorbid depression, additional support is needed to 
enhance the potency of the DA. Individual, tailored coaching can serve to (1) overcome initial 
barriers to NPT use, in conjunction with the DA; and (2) improve NPT adherence.  
 
Despite guidelines that encourage NPTs as first-line treatments, challenges to NPT use and 
adherence persist. These challenges are particularly resonant for minoritized patients with 
depression. This is the first study to tailor a patient-centered approach to empower Black 
patients with comorbid pain and depression to use and benefit from NPTs. EQUIPD’s approach 
takes an evidence-based tool – decision aid – pairs it with motivational coaching, and applies it 
to the problem of chronic pain. This is innovative for several reasons. First, although DAs are 
typically used in the context of one-time decisions, such as cancer treatment,56 DAs contain 
relevant features that have largely been overlooked in chronic pain. DAs facilitate side-by-side 
comparison of different options. This is essential for NPTs because they vary widely in delivery 
and what is expected of patients—including time commitment, flexibility, and delivery mode 
(self- versus provider-delivered). When patients are not given the opportunity to weigh these 
different features against what they prioritize as important—and what they are realistically able 
to accomplish—they are more likely to discontinue treatment. Second, DAs are typically 
designed only for use in a provider visit. This is a major constraint on their impact. By contrast, 
EQUIPD uses a DA in an innovative way—with a coach—who takes the time to explore the 
particulars of different NPTs and how they align with a patient’s values and lifestyle. Third, a 
DA-coaching model is novel and may be especially effective for patients with depressive 
symptoms. By using the DA with a motivational interviewing style, coaches help patients find 
treatments that best match their goals and lifestyle and work with them to build the self-efficacy 
to self-manage and adhere to treatment—thereby helping to overcome pain management 
barriers related to depression and ultimately leading to improved outcomes. 
 
Project Overview. This is phase 1 of a two-phase, 5-year project with the overarching goal 
of testing a decision aid/coaching intervention, tailored to Black patients with comorbid chronic 
pain and depression, to encourage use of and adherence to NPTs. Guided by the chronic care 
model and a heuristic model of multi-level mechanisms of racial injustice in pain outcomes, we 
begin by centering at the intrapersonal and interpersonal levels, while laying the groundwork for 
further intervention at the structural (i.e., clinic/healthcare system) level through subsequent 
system-wide implementation. Toward this end, we propose a Hybrid Type 1 trial99 , which will 
test for effectiveness while assessing factors relevant for system-wide implementation in a 
subsequent project.  
Conceptual Frameworks. Our overall approach is guided by a heuristic model of multi-level 
mechanisms of racial injustice (Figure 1).53 This model posits that injustice at the cultural, 
structural, interpersonal, and intrapersonal levels interact, thereby creating and maintaining 
racialized pain experiences and outcomes. As a result, intervention at multiple levels is needed 
to target the compounding injustices experienced by minoritized individuals. EQUIPD was 
developed with these levels in mind. EQUIPD begins at the intrapersonal and interpersonal 
levels, while laying the groundwork for moving into the structural level (i.e., clinic and healthcare 
system) as we make plans for system-wide implementation to change clinical practice.  
Figure 1 

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The 
intervention itself 
is guided by the 
Chronic Care 
Model (Figure 2), 
which 
emphasizes 
productive 
interactions 
between patients 
and providers 
within the larger 
context of the 
health system and community. Of particular relevance is collaborative management, which 
takes place when patients and providers have productive relationships, well-articulated goals, 
and shared understandings of their roles.100 With collaborative care, patients and providers work 
together through sharing information and decisions, to find treatments best aligned with patients’ 
needs and goals. This requires an informed, activated patient, who is aware of options, asks 
questions, and gives information that reflects their priorities.100, 101 The emphasis on patients’ 
roles in collaborative management is supported by evidence that patients who are informed and 
engaged are better equipped to participate in treatment decisions,87, 102 which leads to greater 
adherence and better patient outcomes.103 EQUIPD, with its focus on providing patients with 
tools for optimal NPT use, will help patients with chronic pain and depression to become better 
informed about NPT options and benefits, align these options with their goals, discuss with 
providers, and ultimately adhere to a mutually agreed upon NPT plan. 
The EQUIPD Intervention. The 
EQUIPD intervention includes two 
elements: (1) individual coaching and (2) 
a decision aid (DA) focused on NPTs for 
chronic pain. 
Coaching.  
Timing. The EQUIPD intervention 
consists of four sessions, lasting about 
30-45 minutes, over approximately 12 
weeks. Three sessions occur before the 
patient’s next scheduled PCP visit; the 
final session occurs after the visit. About 
3 months (+/- 1 month) before their next 
scheduled PCP visit, patients will be 
enrolled, and those randomized to the 
intervention will be scheduled for their 
first coaching session. Table 1 
summarizes the approximate timing and content of each session. Notably, flexibility is built into 
the coaching intervention to allow for potential missed sessions to be made up. In addition, 
coaches will schedule sessions on a more compressed schedule or combine content from 
sessions with the patient’s permission if sessions are missed. Attendance at all sessions will be 
tracked, and, if warranted, considered in further analysis (e.g., examining a dose effect within 
the intervention group). All efforts will be made to cover all content; however, if missing a 
session or part of a session is unavoidable, it will be documented and considered when 
examining dose effects within the intervention group. 
Figure 2 

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Table 1. EQUIPD Intervention Sessions 
 
Content. EQUIPD coaching is manualized and has been iteratively refined with local pilot 
funding. In these sessions, coaches elicit goals and priorities; discuss specific NPT options, 
including what is expected of patients; help patients align these options with their 
goals/priorities; and ultimately prepare patients for decision-making and long-term adherence. 
By eliciting and discussing what is important to patients, coaches can tailor the content and 
approach for each patient, allowing for variations in pain management goals, preferences, the 
impact of depression on pain and pain management, and sociocultural factors. The EQUIPD 
intervention uses a motivational interviewing (MI) approach in recognition that patients likely 
experience ambivalence about modifying their current treatment plan.104 MI techniques are 
associated with better treatment adherence among patients with chronic pain and reduced use 
of a variety of substances.105-107 This approach may be especially beneficial for patients 
suffering from comorbid depression, given that they may be more ambivalent about modifying 
their treatment plan and may require additional motivation and encouragement to adhere to a 
new plan.68 Specifically, coaches will (1) express empathy; (2) foster patient self-efficacy; (3) 
explore resistance to change; (4) discover discrepancies between patients’ current treatment 
plan and their stated values, goals, and preferences; (5) using the DA, help patients identify 
their goals and values and compare how different NPTs align with these goals/values; (6) using 
the DA, prepare the patient to discuss NPT preferences in the upcoming PCP visit (including 
role play); and, after the visit, (7) debrief about the PCP appointment and discuss treatment 
decisions; and (8) provide motivation and encouragement to adhere to the NPT plan, including 
Session 1 - Orientation (Build empathy, motivation, & look for discrepancies) 
Week 1 
1.  Ask patient how pain is problematic in life (i.e., interferes with daily activities and things patient finds important). 
2.  Understand current treatments and how they help. 
3.  Identify patient’s values and goals related to pain treatment & interference with function (including Section 1 & 2 
of Decision Aid)—to build empathy and explore discrepancies between values and current treatments. 
Session 2 - Review Life & Treatment Goals, Patient Values. Discuss Treatment 
Options and Expectancies (Look for discrepancies, enhance motivation & self-
efficacy) 
Week 3 
1. Discuss different treatments, including pharmacological treatments and NPTs. 
2. Introduce and begin discussing Section 3 of Decision Aid, which shows side-by-side comparison of 4 NPTs 
available at Eskenazi (study site). 
3. In this context, discuss expectancies for NPTs (e.g., may take longer to work than analgesics). Focus on 
exploring patients’ perspectives (empathy), looking for unmet needs (discrepancy), and helping patient identify 
ways to align treatment with their values, goals, and preferences (self-efficacy and motivation). 
4. Ensure primary care appointment is scheduled. 
Session 3 - Work on Connecting Goals and Values to Treatment Options and 
Preparing Patients to Discuss Preferences with Primary Care Provider (PCP) 
Week 5 
1. Revisit goals and NPT options. 
2. Discuss what options patients are leaning toward and why (Decision Aid Section 4). 
3. Prepare patient to discuss NPT preferences with provider (Section 5: Questions for PCP). 
4. Practice/role play of provider appointment. 
5. Have patients take a photo of the DA. 
PCP Appointment 
Weeks 5-10 
Session 4 - Reinforcement, Motivation, Self-Efficacy, Adherence 
Weeks 10-12 
1. Review patient goals and treatment preferences.  
2. Discuss recent PCP visit, including treatment decisions (using Section 6 of Decision Aid). 
3. Provide motivation and encouragement to stick with NPT plan, including reminding patient that NPTs may take 
more time. 
     OR 
4. If NPT was not chosen, revisit goals, values, current treatments, barriers and discrepancies between current 
treatment and values and goals. 

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reminding patients that NPTs often take time to work. If an NPT was not chosen, the coach 
revisits goals, values, current treatments, and barriers to NPT use, and encourages patients to 
continue these conversations with their PCP. This encouragement may be particularly effective 
for these patients, given that evidence shows that patients who receive recommendations for 
behavioral approaches to chronic pain are more likely to be interested in trying these 
approaches.34 
The DA is integrated into the first three coaching sessions in preparation for their primary 
care visit. After Session 3, the patient will attend their scheduled primary care visit. In addition to 
the preparation through coaching, we will also use the following strategies to encourage patients 
to bring and use their DA: (1) a research assistant will attempt to call patients the day before 
their visit to remind them to bring their DA (including a copy for the PCP) to the visit; and (2) in 
Session 3, coaches will ask patients to take a photo with their phones of the entire DA, as a 
backup, since they would be unlikely to attend the visit without their phone. After this visit, 
Session 4 will take place. In this session, the coach reviews patient goals and treatment 
preferences, and discusses what occurred during the patient’s appointment. The coach will also 
provide motivation and encouragement to stick with the NPT plan or encourage patients to 
continue considering NPTs if one was not chosen in their PCP visit.  
Delivery. Consistent with many of our other studies with patients with pain, all sessions 
will be delivered by phone. Consented patients deemed eligible and assigned to the intervention 
group will receive two copies of the DA (one to give to their PCP)  after they complete the 
baseline assessments. Consented patients deemed eligible and assigned to the wait-list control 
group will receive the DA after the final assessment at 6 months. See section 2.0, Aim 1.3 for 
more information. 
 
Table 2. EQUIPD Decision Aid 
Decision Aid Section 
Content 
1. What is Important to 
You 
Guides patients through important reasons (goals) related to improving 
their pain (e.g., better sleep, ability to work). 
2. What Matters Most to 
You about Choosing a 
Treatment? 
Patients answer questions about their priorities in choosing a treatment 
(e.g., how flexible their schedules are, whether they prefer to work on their 
own, with a provider, or in a group) to further help them align treatment(s) 
with their goals and lifestyles. 
3. Get the Facts 
Side-by-side comparison of 4 NPTs available at Eskenazi Health, the study 
site (walking, chiropractic treatment, physical therapy, and cognitive-
behavioral therapy) to see potential pros and cons, and what is expected of 
them for each treatment.  
4. Where are You 
Leaning Now? 
Lists all 4 NPTs, with spaces for additional treatments patients may write in, 
and asks patients to indicate on a continuum whether they are leaning 
toward, against, or are undecided on each treatment. Space is included 
after each treatment for them to note reasons for their inclinations. 
5. What Questions Do 
You Have for Your 
Doctor ? 
Provides space for questions related to each treatment option (plus space 
for additional treatments) that they can bring to their visit. 
6. Making the 
Decision/Plan with Your 
Doctor 
Provides space for patients to write down the specific treatment plan 
decided upon, including when, where, how long, and how often they will 
engage in the treatment, and plans for follow-up. 
 
Decision Aid (DA). According to the International Patient Decision Aids Standards (IPDAS) 
Collaboration, DAs are evidence-based tools that prepare patients to make informed, values-
based decisions with their providers.54 According to IPDAS, DAs (1) explicitly state the decision 
to be considered; (2) provide evidence-based information about treatment options; and (3) help 
patients to recognize the values-sensitive nature of the decision to help them align their values 

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with treatments being considered.54 The EQUIPD DA accomplishes this in 6 sections (Table 2) 
and is administered in a simple paper-and-pencil format with the coach. 
 DA Content and Development. Our DA was developed in consultation with research experts 
in chronic pain and treatment decision-making, clinical experts in chronic pain (including our 
grant Co-Is), and patients. In addition, we consulted systematic reviews and evidence-based 
practice guidelines. While numerous NPTs exist, it is not possible to include all potential options. 
Consequently, we focused on NPTs with high-quality evidence of safety and effectiveness that 
are readily available (at the study site in particular). We also sought to include a variety of 
options. For example, we chose both provider-delivered (e.g., chiropractic) and self-delivered 
(e.g., walking) approaches to accommodate different patient preferences. We also included 
more traditional NPT approaches (physical therapy) and psychological approaches (cognitive-
behavioral therapy) to accommodate a variety of preferences. We did not include some 
evidence-based complementary and integrative health therapies, such as acupuncture and 
yoga, as they are not yet widely available at Eskenazi Health (study site), but they can easily be 
added as availability changes.  
Moreover, choices do not have to be confined to the options on the DA. The purpose of a 
DA is not to limit options, but to facilitate discussions about treatments that are grounded in 
patients’ goals and values, helping “clinicians and patients come to quality decisions…and 
taking into account the potential trade-offs” of different options—even if some of these options 
are not included on the DA.56 That is why there is space on the DA for patient questions and 
consideration of other NPT options. Also of note, the DA is flexible. Treatment options can be 
modified according to (1) emerging evidence and (2) the needs/resources of individual health 
systems (in an implementation scenario), without changing the overall structure of the DA. This 
is important because it is likely that evidence will change as research on NPTs continues, and 
access to NPTs continues to expand.  
Supporting Data. Coaching: Thus far, through local pilot funding, we have iteratively 
developed and refined the coaching manual. We also have good evidence of adherence to 
coaching sessions, based on our COOPERATE study. Although COOPERATE’s coaching 
content was different, the study was conducted with 250 Black patients with chronic pain 
(almost half of whom had at least moderate depression) using 6 telephone-delivered coaching 
sessions. 85% of patients attended the majority of sessions, providing preliminary evidence that 
such coaching is feasible and acceptable. Aim 1.3 will facilitate further testing of this new 
coaching model for Black patients with comorbid depression.  
Decision Aid: We have 3 aspects of preliminary data from patients for the DA. The first 
involved obtaining and incorporating feedback from a 12-member Patient Advisory Board, half 
of whom are from minoritized groups. In the next, we pilot tested the revised DA with 12 Black 
patients, eliciting additional feedback and making changes as appropriate. Lastly, we conducted 
a larger pilot study (N=30, 21 of whom are Black) at the study site (Eskenazi). In this sample, 
91% indicated that the EQUIPD DA made them think more about using one of the listed NPTs; 
93% said they were likely or very likely to talk about one of the NPTs with their doctor; and 89% 
thought the DA would be helpful for other people with pain. Qualitatively, patients said: “This is a 
very good tool to identify and refine goals and give the patient vocabulary to speak to their 
doctor.” “It gives the patient power. It’s empowering.” “It gives you a plan for discussing chronic 
pain treatment with your doctor.” “This [decision aid] gives you hope—and actual solutions.” 
This preliminary work demonstrates high patient enthusiasm for the DA, indicating feasibility of 
use and acceptability of content/format. Our next step, which will be accomplished in Aim 1.2, is 
to elicit PCPs’ perspectives on the DA, including feasibility and acceptability of use in clinic 
appointments and adaptation where needed before the pilot RCT. 
PLANNING (Phase 1, Years 1-2). In preparation for a future fully powered clinical trial 
(phase 2), we have three specific aims. Each aim and associated activities are described below. 
 

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2.0 Specific Aims, Study Design, Recruitment, Eligibility 
 
AIM 1.1: Establish an engagement panel comprised of Black patients with lived 
experiences of chronic pain and depression to provide consultation . The objective of our 
engagement plan is to create a partnership between our team and patients with lived 
experiences of racialized pain treatment and depressive symptoms. This will ensure that our 
research is relevant to the needs of these individuals and will maximize the likelihood of positive 
outcomes. This panel will be formed during the beginning of the project, with plans to meet 
approximately quarterly . 
Recruitment. We will work with our consultant, Dr. Robles (or delegate(s)), who is the clinic chief 
at one of the Eskenazi Primary Care Clinics, to identify Black Eskenazi Primary Care patients 
with chronic pain and depressive symptoms to serve on this panel for our research team to 
recruit. Dr. Robles will facilitate recommendations from primary care clinicians throughout the 
health system. We have used a similar approach in prior studies. Eskenazi primary care 
patients who previously participated in a pain study with Dr. Matthias or other faculty research 
personnel may also be contacted for recruitment. We aim to recruit up to 6 patients (up to 12 
throughout the study to allow for replacements in case of withdrawals) to partner with us as 
stakeholders throughout our project.  
Engagement Panel Meetings. Members of the research team will meet with Patient 
Engagement Panel members up to 4 times annually for a total of up to 8 meetings during this 
study. Meetings may be held in person, by phone, or virtually depending on group preference 
and pandemic protocols and will last up to 90 minutes each. Meetings may be recorded (audio 
only if by phone or in person; audio and video if virtually). Recordings will only be used internally 
by research team members for those who missed meetings or to help draft notes from the 
meetings. Meeting materials may be sent to participants by mail or email. Participants may be 
contacted about scheduling meetings and for reminders of meetings by phone (including texts),  
email, and/or mail. If patients withdraw (actively or passively), they may be replaced during the 
study as needed. 
Eligibility Criteria for Engagement Panel Patient Participants. 
Eligible patients must (verified by self-report): 
• 
be at least 18 years old, 
• 
have chronic pain,  
• 
have depressive symptoms, 
• 
identify as Black, and 
• 
be willing and able to participate in Engagement Panel meetings.  
Compensation. Patient panel members will be paid $30 for each meeting attended for a 
potential total of $240.  
Collaboration with the Panel. We will elicit the panel’s input on the study’s decision aid and the 
feedback obtained from PCPs on the decision aid (Aim 1.2), including advising on proposed 
modifications. For our pilot RCT (Aim 1.3), we will consult with the panel on (1) recruitment 
strategies, including advertising materials, mode of contact (e.g., mail, email), and language 
describing the study; (2) data collection materials, including appropriateness of questionnaire 
items and length; (3) intervention materials (e.g., welcome material, decision aid); and (4) 
potential future modifications for the follow-up fully powered trial.  
 
AIM 1.2: Elicit primary care providers’ (PCPs) perspectives on the EQUIPD decision aid 
content and structure to optimize its use in PCP appointments. We will recruit up to 15 
PCPs to obtain their opinions on the DA. This sample size is consistent with published 
recommendations on qualitative sampling for a relatively homogeneous group (PCPs),108 as well 
as our team’s experience. In these one-time interviews, we will use a semi-structured interview 

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protocol for individual interviews or focus groups to elicit feedback on the DA, including content, 
structure, and use in clinic visits. Individual interviews or focus groups may be completed by 
phone, virtually, or in person and will be recorded. We expect the interview or focus group to 
last up to 30 minutes. We will conduct a rapid qualitative analysis with interview/focus group 
data to facilitate timely revisions in preparation for the pilot trial.109 Toward this end, the analytic 
team (comprised of research team members) will review each interview or focus group 
transcript and enter notes into a data matrix. The matrix columns will correspond to interview 
questions and elements of the DA. Each column will be comprised of summary points from each 
interview. We will seek input from our patient advisory panel during this process, particularly as 
we finalize the DA.  
Recruitment. We will work with our consultant, Dr. Robles (or delegate(s)), who is the clinic chief 
at one of the Eskenazi Primary Care Clinics, to identify potential participants for our research 
team to recruit.  
Eligibility Criteria for PCP Qualitative Interview Participants. 
Eligible PCPs must: 
• 
be a Primary Care Provider (prescriber), and  
• 
work in an Eskenazi Health Primary Care Clinic. 
Compensation. Participating PCPs be paid $150 for participating in an interview or focus group.  
 
AIM 1.3 Conduct a 2-arm pilot randomized controlled trial (RCT; N=40) to test and refine 
data extraction, recruitment, intervention delivery, and data collection protocols. 
Overview of Study Design. This 2-arm pilot trial will aim to enroll up to 40 Black patients with 
comorbid chronic musculoskeletal pain and depression in primary care from an urban safety-net 
health system (Eskenazi) with the end goal of at least 30 patients completing the trial. After the 
baseline assessment, patients randomized to the intervention will be asked to participate in 4 
coaching sessions over approximately 12 weeks. See Coaching Section and Table 1. Sessions 
will use Motivational Interviewing principles to foster openness to NPTs and self-efficacy by 
helping patients identify their goals and priorities, understand their NPT options, prepare them to 
discuss and choose options with their primary care providers (PCPs), and reinforce these 
choices to foster maintenance of these changes (Table 1). DA contents will be integrated into 
these sessions (Table 2), which will facilitate discussion of these options with their PCP. Ideally, 
the first 3 sessions will take place prior to the patient’s next scheduled PCP visit with the final 
session occurring after this PCP visit. Assessments will be conducted at baseline, 3 months 
(i.e., after completing the final coaching session), and 6 months. Coaching session and PCP 
visit attendance will be tracked; participants will not be withdrawn for non-attendance and 
missing either is not considered to be a protocol deviation. Participants may be contacted about 
scheduling/completing assessments and/or coaching sessions and for reminders by phone 
(including texts), email, and/or mail. 
Wait-List Control Group. Patients randomized to wait-list control will receive usual care (in 
addition to study assessments at baseline, 3 months, and 6 months). After completing the final 
assessment, they will then be given the DA along with a 20-minute coaching session to walk 
them through it (patients may decline the DA and/or coaching session or schedule for a future 
time). We are using this approach so that all patients have an opportunity to benefit from 
participation.  
Coach Training. Coaches have at least a Bachelor’s degree in psychology or related field. 
Training will involve didactics, demonstrations, and role-plays. All intervention and control 
sessions will be audio-recorded with participants’ permission, and a random subset reviewed for 
fidelity and quality control. During individual and group supervision, adherence scores and 
fidelity will be discussed. 
Intervention Fidelity. We will use treatment fidelity strategies consistent with the NIH 
Behavior Change Consortium recommendations,110 which include (1) using standardized 

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intervention protocols and training; (2) monitoring audio-recorded sessions; (3) using coach 
adherence checklists to track protocol deviations; and (4) holding regular meetings to address 
problems or concerns. Although there are no clear guidelines on the optimal level of adherence, 
80% integrity typically constitutes high fidelity.111-114 Thus, we will set a minimum threshold of 
80% on the coach adherence checklists used to evaluate the audio-recorded sessions (where 
adherence is the ratio of the number of required topics discussed to the total number of session 
topics). Ongoing corrective feedback will be provided, as needed, during supervision to maintain 
fidelity. 
Participant Recruitment. Similar to our other studies at Eskenazi, including Dr. Matthias’ 
NIDA-funded R21, eligible patients will be identified by Regenstrief Institute’s Data Core, which 
has agreements with Eskenazi to access patient data for research. Eskenazi PCPs may also 
refer patients who may be eligible to contact the study team or may provide the study team with 
patient referrals. Patients will be mailed or emailed a letter explaining the study, followed by a 
phone call approximately one week later.  
Eligibility Criteria for Patient Pilot RCT .  
Eligible patients must: 
• 
have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, 
shoulder) for ≥3 months,  
• 
have at least moderate pain intensity and interference with function, defined by a 
score ≥4 (possible range: 0-10) on the PEG, a 3-item measure of pain intensity, 
interference with enjoyment of life, and interference with general activity,115  
• 
have at least mild depression, defined as PHQ-8 score ≥5,  
• 
identify as Black,  
• 
have consistent access to a telephone, 
• 
indicate openness to new pain treatments, and  
• 
have a scheduled appointment with their PCP in the next approximate 2-4 months 
Patients are excluded: 
• 
if previously participated in Dr. Matthias’ past pilot study (IRB #12885) or 
participation as a Patient Engagement Panel member for this project (Aim 1.1), 
• 
if medical records indicate severe medical conditions likely precluding participation 
(e.g., NY Heart Association Class III or IV heart failure), or 
• 
if the eligibility screener reveals (1) active suicidal ideation, or (2) severe 
hearing/speech or cognitive impairment.  
Feasibility of Recruitment. According to a data pull by Regenstrief Data Core, Eskenazi has 
approximately 6,500 patients with chronic musculoskeletal pain (identified by ICD codes from 
our prior work), over half of whom (>4,000) are Black. Given that 30-50% of chronic pain is 
accompanied by depressive symptoms,5 we have a pool of 1,200-2,000 potential participants.  
Participant Compensation. Participants will be paid $30 for each assessment completed 
(baseline, 3 and 6 months), for a possible total of $90. 
 
3.0 Measures 
 
Measures are patient-reported, widely used in pain studies, and brief, creating low burden. 
They are also consistent with IMMPACT (Initiative on Methods, Measurement, and Pain 
Assessment in Clinical Trials) recommendations116 for key outcome domains in chronic pain 
trials. The baseline assessment will also gather socio-demographic data and review the 
patient’s history, particularly current and past pain treatments. Baseline assessments will be 
conducted prior to randomization. Outcomes will be assessed at baseline, approximately 3 
months (intermediate effects) and approximately 6 months (primary endpoint). Six months is our 
primary endpoint because NPTs typically take time to work.1, 13 Based on our prior studies, we 

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estimate the screening and baseline assessments to take about 1 hour and 3 and 6 month 
assessments to take about 45 minutes. 
 
Pain Interference (Primary Outcome) will be measured with the Brief Pain Inventory (BPI) 
Interference Scale, which is recommended for pain studies116 and has been validated in primary 
care.117 The pain interference score averages seven ratings, 0 (does not interfere) to 10 
(interferes completely), of interference with general activity, mood, walking ability, normal work, 
relations with other people, sleep, and enjoyment of life. The BPI is highly responsive to change 
in clinical trials118 and has strong internal consistency (Cronbach’s α = 0.77).117 
Satisfaction with the coaching sessions and coach will be measured by asking two 
satisfaction questions during the 3-month assessment (coaching group only). 
Pain Self-Efficacy will be measured using the Pain Self-Efficacy Questionnaire (PSEQ). The 
PSEQ is a 10-item questionnaire developed to assess the confidence people with ongoing pain 
have in performing activities while in pain.  
Pain Intensity will be measured with the Brief Pain Inventory (BPI) Intensity Scale which has 
4 items with ratings from 0 (no pain) to 10 (pain as bad as you can imagine). 
Depression (Secondary Outcome) will be measured with the PHQ-8,119 a widely-used, 
validated 8-item measure of depression severity. Notably, improvements in pain are associated 
with similar improvements in depression.6  
Anxiety (Secondary Outcome) will be measured with the GAD-7,120 which has demonstrated 
good reliability and validity.  
Pain catastrophizing (Secondary Outcome) will be measured with the Pain Catastrophizing 
Scale, a 13-item scale that assesses catastrophizing—a cognitive-emotional factor that predicts 
poor treatment response. Validation studies support its criterion, concurrent, and discriminant 
validity.121  
Patient engagement (Secondary Outcome) will be measured with the 12-item Altarum 
Consumer Engagement (ACE) Measure,122 which has 3 subscales: 1) commitment to manage 
one’s health, 2) informed choice, and 3) confidence to participate in treatment decisions. Items 
are assessed on a 5-point Likert scale. The ACE is internally consistent and has demonstrated 
convergent, predictive, and criterion validity.  
NPT Use (Secondary Outcome). We will use the NSCAP (Use of Nonpharmacological and 
Self-Care Approaches) to assess NPT use. This measure was developed by the NIH/DoD/VA 
Pain Management Collaboratory, comprised of national experts on NPTs and pain; two EQUIPD 
Co-Is (Taylor and Burgess) are members. The NSCAP asks about 9 NPT modalities, including 
the 4 that are in our DA, and assesses details of use such as frequency, location/source of 
service, and patients’ judgments of effectiveness. Space is also provided for other NPTs that 
are used but not listed. The number of modalities for which patients answer “yes” will be 
summed for descriptive purposes.  
Tobacco, alcohol, and drug use, as well as prescription medication misuse in the last year 
will be assessed using the 4-item screening tool, Tobacco, Alcohol, Prescription medications, 
and other Substance (TAPS) measure.  
Communication self-efficacy (Secondary Outcome) will be measured with the Perceived 
Efficacy in Patient-Physician Interactions Scale (PEPPI-5), a 5-item scale that measures 
patients’ self-efficacy in obtaining medical information and getting their most important health 
concern discussed in a clinic visit.  
Shared decision making (Secondary Outcome) will be measured with CollaboRATE, a 3-
item measure assessing provider effort from the patient’s perspective to engage in shared-
decision making during a recent appointment.  
Working Alliance (Secondary Outcome). The Working Alliance Inventory (WAI) Client Short 
Form assesses patient-provider agreement on treatment goals, collaboration to achieve these 
goals, and degree of emotional bond (liking and trust) between patients and providers. The WAI 

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has shown high reliability (α > .90 for WAI total) and demonstrated convergent, discriminant, 
concurrent, and predictive validity.139, 140, 
Perceived Discrimination. We will measure perceived discrimination in healthcare settings 
with the 7-item “Perceived Discrimination in Healthcare” Scale.42 Participants are asked, “When 
getting healthcare, how often do the following things happen to you because of your race or 
color?” Sample items include “You are treated with less respect than other people,” and “You 
feel like a doctor or nurse is not listening to what you were saying.” Response categories are 
Never, Rarely, Sometimes, Most of the Time, and Always. This measure has shown good 
reliability (Cronbach’s α=.89).141  
Physical functioning will be assessed with the PROMIS Physical Function Short Form 6b 
which assesses universal physical functioning with a 6-item, self-report scale. 
Sleep disturbance will be measured with the PROMIS Sleep Disturbance Short Form and 
sleep duration will be measured by asking about the number of hours and minutes of actual 
sleep in the last month.  
Patient-reported impression of change will be measured using the Patient Global Impression 
of Change (PGIC). This one-item measure reflects a patient’s perception of change after the 
start of an intervention. 
Opioid use will be assessed for enrolled patients taking prescribed opioids. Regenstrief 
Institute’s Data Core will extract opioid prescriptions from patients’ medical records, and daily 
doses will be described as morphine-milligram equivalent (MME), calculated with the Centers 
for Disease Control and Prevention’s conversion tables.142 Average daily doses will be 
calculated within 30-day windows. For each opioid prescribed within each window, the dose in 
MME will be multiplied by the number of pills dispensed, then divided by the number of days 
supplied. The average daily dose for each window will be the sum of the daily doses for all 
opioids dispensed during the window.  
 
4.0 Data Analysis Plan 
 
Data Analysis for Pilot RCT. Descriptive statistics such as proportions and 95% CIs will be 
estimated to assess milestones. Only descriptive statistics (N, mean, SD, median, minimum, 
and maximum or frequency and percent) will be estimated by study group and timepoint. This 
will allow us to test coding of instruments. 
 
5.0 Study Calendar 
 
 
Screening 
Baseline 
Coaching 
Sessions 1-3 
over 
approximately 5 
weeks 
Coaching 
Session 4 at 
approximately 
10-12 weeks 
3 Month 
Visit^ 
6 Month 
Visit^ 
Eligibility Checklist  
X 
  
  
 
  
 
Informed Consent and 
Authorization  
X 
  
  
 
  
 
Contact Information 
X 
  
  
 
  
 
Demographics 
 
X 
 
 
 
 
BPI (Interference + 
Intensity Scales) 
 
X 
 
 
X 
X 
Satisfaction^^ 
 
 
 
 
X 
 
PSEQ 
 
X 
 
 
X 
X 
PHQ-8 
  
X 
  
 
X 
X 
GAD-7 
  
X 
  
 
X 
X 

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Pain Catastrophizing 
Scale 
  
X 
  
 
X 
X 
ACE Measure 
  
X 
  
 
X 
X 
NSCAP 
  
X 
  
 
X 
X 
TAPS 
 
X 
 
 
X 
X 
WAI 
 
X 
 
 
X 
X 
PEPPI-5 
 
X 
 
 
X 
X 
CollaboRATE 
 
X 
 
 
X 
X 
Perceived 
Discrimination in 
Healthcare 
  
 X 
  
 
 
 
PROMIS Physical 
Function Short Form 
 
X 
 
 
X 
X 
PROMIS Sleep 
Disturbance Short Form 
+ Sleep Duration 
 
X 
 
 
X 
X 
PGIC 
 
 
 
 
X 
X 
Intervention* 
 
 
X 
X 
 
 
*For participants randomized to the intervention. Ideally, PCP visit (non-research) to occur between coaching sessions 3 
and 4.  
^Three-month assessments may occur at 10 weeks – 4 months so long as it is after coaching session 4. Six-month 
assessments may occur at 5-7 months (+/- 1 month). 
^^For participants randomized to the intervention (coaching group). 
 
6.0 Reportable Events 
We do not anticipate more than minimal risk to subjects who participate in this study and 
adverse events will not be systematically collected from participants. If a research team member 
becomes aware of any adverse events possibly related to study procedures, they will be 
assessed and reported to the Indiana University (IU) IRB according to the IU Standard 
Operating Procedures for Research Involving Human Subjects and to the study sponsor as 
required. Any unanticipated problems involving risk to participants or others will also be reported 
according to the IU Standard Operating Procedures for Research Involving Human Subjects.  
Suicidal Ideation. Participants will be screened for thoughts of suicidal ideation during 
assessment of eligibility to participate in the study by asking, “Over the last two weeks, have you 
thought that you would be better off dead or that you want to hurt yourself in some way?” If the 
participant responds with yes, the assessment continues with the P4 Suicidal Ideation Screener 
to assess risk level. 
• 
Based on the participant’s responses to this interview, they are characterized as: low to 
minimal suicidal risk or possible suicidal risk.  
o For possible suicide risk, the RA will provide the potential participant the Suicide 
Prevention Lifeline phone number as well as other relevant phone numbers (e.g., 
Suicide and Crisis Lifeline, Eskenazi Mental Health Emergency Line) and then 
will discuss with one of our two investigators who are licensed clinical 
psychologists (Hirsh, Rand) who will contact the subject and/or facilitate follow-up 
with their primary care or mental health provider as appropriate.  
 
Such a participant, per exclusion criteria, would then be ineligible for 
study participation.  
o For low to minimal suicidal risk, participants are likely eligible to participate.  

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Study coaches will have regular contact with enrolled subjects during the active (intervention) 
phase of the study. The PI and 2 co-investigators (Hirsh and Rand) will meet approximately 
monthly with study coaches during this time and will discuss any problems or concerns that 
arise and how to address them—this will include continued training to implement safety 
protocols as necessary. If any immediate concerns arise during the coaching sessions, coaches 
will contact the PI along with Dr. Hirsh and/or Dr. Rand, who will be available to address any 
instances of worsening mental health or suicidality. In addition, RAs will be in contact with 
subjects for screening/baseline, 3-, and 6-month assessments and will report concerns to the 
project manager and/or PI. If safety concerns arise (e.g., mention of self-harm or suicidality), Dr. 
Hirsh and/or Rand will be consulted and will contact the subject and/or facilitate follow-up with 
their primary care or mental health provider as appropriate. All personnel will be trained in study 
suicide assessment and referral protocols. 
 
7.0 Data Safety Monitoring 
 
We will use an Independent Safety Monitor (ISM), defined as a physician, nurse, or other 
appropriate expert who is independent of the study and available in real time to review and 
recommend appropriate action regarding adverse events and other safety issues. This role will 
be filled by Dr. Matthew Bair, M.D., M.S., who is a Professor of Medicine at Indiana University 
School of Medicine and Research Scientist at the Roudebush VA Medical Center. He is a 
primary care physician, general internist, and pain researcher who has led multiple clinical trials 
ranging from opioid management to use of nonpharmacological pain strategies 
 
Monitoring Schedule: Investigators will conduct continuous review of data and subject 
safety. Approximate quarterly review meetings with the PI, Project Manager (PM), grant co-
Investigators as available and appropriate, and ISM will take place during the pilot RCT while 
subjects are active in the intervention. Meeting summaries will be documented with notes and 
will include a review of data, number of subjects enrolled, and number of subjects who have 
completed the study. 
Requirements/conformance with informed consent documents: In preparation for 
these quarterly review meetings, the PM or delegate will randomly select study identification 
codes for approximately 5% of enrolled subjects to review. This review will include examining 
consent documentation for completion and accuracy, as well as ensuring all study materials are 
properly and securely stored (see data monitoring plan below).  
 
8.0 Study Withdrawal/Discontinuation 
Participants may withdraw from the study at any time and may communicate their intent to 
withdraw to the study team either verbally (in person, over the phone) or in writing. An attempt 
may be made to obtain their permission to complete any remaining assessments. Once the 
study team has been informed by the participant that they wish to withdraw (either just from the 
intervention or from the study entirely), a note will be made in the participant’s study record. If 
the participant chooses to withdraw from the study entirely, no further data will be collected. All 
data collected from the participant prior to their withdrawal from the study may continue to be 
used and stored by the study team. 
 
9.0 Data Management and Confidentiality 
 
All documentation will be stored on a secure university server, on Regenstrief’s secure network 
drive, or locked file cabinets behind locked doors. All electronic databases housing subject data 
will be password-protected with access limited to approved study personnel only. Identifying 
information will be separated from all data provided by subjects used in analysis through a 

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unique subject identification code assigned by study personnel with the linking file only 
accessible to research team members. 
All data entry will be done by trained personnel. Electronic databases will be constructed to 
include forms for data entry that mirror paper or computer-based questionnaires and have 
restricted field ranges and values to prevent errors as much as possible. In addition, quality of 
data entry will be monitored by the PM, who will attempt to ensure complete and accurate data 
is entered while addressing any potential interview or data entry problems promptly. The study 
statistician or delegate will periodically generate reports for the entire dataset to identify outliers, 
missing data, or other potential problems. All data will be imported into statistical analysis 
package (e.g., SAS, SPSS) data sets for analysis. Analyses will include only summaries of data; 
personal identifiers will be omitted. 
 
A data manager and/or delegate will create and maintain all databases. The data manager, PM, 
and RAs, supervised by the PI, will be responsible for data management. Each subject will be 
assigned a unique study ID number, and all data will be entered into a database only accessible 
to research team members, using these unique ID numbers.  
 
Primary data will be collected primarily by phone, directly entered and stored electronically in 
REDCap and/or statistical analysis software packages. If needed, data may also be recorded on 
paper (either by research staff using who interview participants or by a research participant who 
receives a paper copy of the data collection form by mail and sends back in a prepaid envelope) 
and then entered into REDCap and/or statistical analysis software packages. Enrolled 
participants may also complete REDCap surveys (invitation only, using unique links) for 3 
and/or-6-month data. The storage locations will be backed up automatically on a frequent and 
regular basis. Manual back-up copies may be made of data collection events (e.g., PDF of 
completed REDCap survey) and stored on a secure university server or Regentrief’s secure 
network drive. Other data sources may include paper data (recorded by research personnel 
when talking to a subject on the phone), audio/video recordings, and data extracted from 
medical records that will be stored using the study ID numbers in files on a secure university 
server or Regenstrief’s secure network drive. For qualitative data, transcribed interviews and/or 
focus groups will be checked for accuracy, de-identified, and may be entered into Atlas.ti or 
other appropriate qualitative data analysis program.  
 
10.0 Follow-up and Record Retention 
 
This study will last approximately 2 years. Records will be retained according to all applicable 
laws and regulations.  
 
 

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