EMPOWER: Evaluating the Ability to Reduce Morphine Equivalent Dose for Chronic Pain Patients Receiving Opioid-therapy Through a Web-based E-Health Self-management Program: a Randomized Multi-site Clinical Trial in Primary Care
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Cincinnati

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1. 
 
EMPOWER 
 
EMPOWER:  
 
Evaluating the ability to reduce Morphine equivalent dose for chronic 
Pain patients receiving Opioid-therapy through a Web-based E-
Health self-management program:  
a Randomized multi-site clinical trial in primary care 
 
NIDA Grant Number: 1R01DA044248-01 
NCT Number:  NCT03308188 
Version: 2.1  
 
May 17, 2019 
 
Protocol & Statistical Analysis Plan 
 
 
 
 
 
 

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2. 
 
 
 
 
 
EMPOWER:  
 
Evaluating the ability to reduce Morphine equivalent dose for chronic 
Pain patients receiving Opioid-therapy through a Web-based E-
Health self-management program:  
a Randomized multi-site clinical trial in primary care 
 
NIDA Grant Number: 1R01DA044248-01 
Version: 2.1  
 
May 17, 2019 
 
 
 
 
 
 

EMPOWER Protocol Version 2.1 – 5/17/19  
 
 
 
3. 
 
 
CONTACT INFORMATION 
 
 
Principal Investigator: 
    
T. John Winhusen, Ph.D. 
 
 
 
 
 
 
University of Cincinnati College of Medicine 
 
 
Co-Investigator- Duke:  
 
Rowena Dolor MD, MHS; 
Duke University School of Medicine 
 
Co-Investigator- Washington:  
Marian Wilson, PhD, MPH, RN-BC 
Washington State University College of Nursing 
 
Co-Investigators- UC:  
 
Saundra Regan, PhD;  
Jeffrey Welge, PhD 
 
 
 
 
 
University of Cincinnati College of Medicine 
 
Project Implementation Director: Jeff Theobald, BS 
 
 
 
 
 
University of Cincinnati College of Medicine 
 
NIDA Program Official: 
 
David A. Thomas, Ph.D. 
 
 
 
 
 
National Institute on Drug Abuse 
 
 

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4. 
 
 
Table of Contents 
1.0 LIST OF ABBREVIATIONS ........................................................................................................................... 6 
2.0 STUDY SCHEMA............................................................................................................................................ 7 
3.0 STUDY SYNOPSIS ......................................................................................................................................... 8 
4.0 BACKGROUND AND SIGNIFICANCE ........................................................................................................ 9 
5.0 SPECIFIC AIMS ............................................................................................................................................ 10 
6.0 STUDY DESIGN............................................................................................................................................ 11 
6.1 Overview of Study Design .......................................................................................................................... 11 
6.2 Number of Sites and Participants ................................................................................................................ 11 
6.3 Study Duration ............................................................................................................................................ 11 
6.4 Participant Selection ................................................................................................................................... 11 
6.4.1 Inclusion Criteria ................................................................................................................................. 11 
6.4.2 Exclusion Criteria ................................................................................................................................ 12 
6.5 Outcome Measures ...................................................................................................................................... 12 
6.5.1 Primary Outcome Measure .................................................................................................................. 12 
6.5.2 Secondary Outcome Measures ............................................................................................................. 12 
6.5.3 Moderators and Mediators ................................................................................................................... 13 
6.5.4 Safety Measures ................................................................................................................................... 14 
6.5.5 Other Measures .................................................................................................................................... 14 
6.6 Randomization Plan .................................................................................................................................... 15 
6.7 Study Treatments ........................................................................................................................................ 15 
6.7.1 Treatment as usual (TAU) ................................................................................................................... 16 
6.7.2 E-Health ............................................................................................................................................... 16 
7.0 STUDY PROCEDURES ................................................................................................................................ 16 
7.1 Study Overview .......................................................................................................................................... 16 
7.2 Participant Recruitment and Consent .......................................................................................................... 16 
7.3 Screening/Baseline ...................................................................................................................................... 17 
7.4 Active Treatment Phase .............................................................................................................................. 17 
7.5 Follow-up .................................................................................................................................................... 17 
7.6 Trial Discontinuation .................................................................................................................................. 18 
7.7 Participant Reimbursement ......................................................................................................................... 18 
8.0 CHRONIC PAIN MANAGEMENT PROGRAM (CPMP) ........................................................................... 18 
8.1 Program Development and Description ...................................................................................................... 19 
8.2 Conceptual Model of E-health’s Mechanisms of Change .......................................................................... 20 
8.2.1 Hypothesized mediators ....................................................................................................................... 20 
8.2.2 Hypothesized moderators ..................................................................................................................... 21 
9.0 ANALYTICAL PLAN ................................................................................................................................... 22 
9.1 Statistical Hypotheses ................................................................................................................................. 22 
9.1.1 Primary Hypothesis .............................................................................................................................. 22 
9.1.2 Key Secondary Hypothesis .................................................................................................................. 22 
9.2 Intent-to-Treat Participant Population ........................................................................................................ 22 
9.3 Analysis Plan .............................................................................................................................................. 22 
9.3.1 Primary Outcome ................................................................................................................................. 22 
9.3.2 Secondary Outcomes ........................................................................................................................... 23 
9.3.3 Moderated Mediation Analyses ........................................................................................................... 23 
9.3.4 Safety Analyses .................................................................................................................................... 23 
9.3.5 Missing Data ........................................................................................................................................ 23 
9.4 Sample Size and Power ............................................................................................................................... 24 

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9.5 Descriptive Statistics ................................................................................................................................... 24 
10.0 REPORTING AND MONITORING ............................................................................................................ 24 
10.1 Informed consent ...................................................................................................................................... 24 
10.2 Financial Disclosure.................................................................................................................................. 25 
10.3 Clinical monitoring ................................................................................................................................... 25 
10.4 Study documentation ................................................................................................................................ 25 
10.5 Safety Monitoring ..................................................................................................................................... 25 
10.5.1 Data and Safety Monitoring Board (DSMB) ..................................................................................... 25 
10.5.2 Protocol Violations Reporting and Management ............................................................................... 25 
10.5.3 Confidentiality ................................................................................................................................... 26 
10.5.4 Adverse Events (AEs) ........................................................................................................................ 26 
10.5.5 Risk/Benefit Assessment ................................................................................................................... 26 
11.0 DATA MANAGEMENT.............................................................................................................................. 27 
12.0 PUBLICATION/DATA SHARING ............................................................................................................. 28 
13.0 SIGNATURES .............................................................................................................................................. 28 
14.0 REFERENCES ............................................................................................................................................. 29 
APPENDIX A: Goalistics Chronic Pain Management Program .......................................................................... 34 
 
 
 
 
 
 

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6. 
 
1.0 LIST OF ABBREVIATIONS 
 
Abbreviation 
Definition 
ACIC 
Assessment of Chronic Illness Care  
AE 
Adverse Event 
BPI 
Brief Pain Inventory 
COMM 
Current Opioid Misuse Measure 
CPMP 
Chronic Pain Management Program 
CRF 
Case report form 
CSQ-R 
Coping Strategy Questionnaire-Revised  
DASS-21 
Depression, Anxiety, and Stress Scales 
DSMB 
Data and Safety Monitoring Board 
EHR 
Electronic Health Record 
EOT 
End of Treatment 
IRB 
Institutional review board 
ITT 
Intent-to-Treat 
LOT 
Long-term opioid therapy 
MED 
Morphine Equivalent Dose 
NIDA 
National Institute on Drug Abuse 
PF 
Practice Facilitator 
PI 
Principal Investigator 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
PSEQ 
Pain Self-Efficacy Questionnaire  
SAE 
Serious Adverse Event 
RA 
Research assistant 
RCT 
Randomized controlled trials 
TAU 
Treatment as Usual 
TMT-B 
Trail Making Test B  
 

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7. 
 
2.0 STUDY SCHEMA 
 
Figure 1: Study Schema 
 
 
                                             Figure 1. Study schema 
 
Participant Recruitment 
1. Recruitment letter with “opt out” option sent to EHR-identified 
chronic pain patients with current opioid MED ≥ 20 mg 
2. For patients not opting out, Practice Facilitator attempts to contact 
and complete phone pre-screen 
3. If patient passes phone pre-screen, they are sent an email directing 
them to a website for informed consent 
Assessment of participating clinics to characterize treatment as usual 
(TAU)  
Randomization 
Patient is randomized: 
Randomized to TAU 
(N=200): 
-Patient sent an email 
notification that they were 
randomized to treatment as 
usual (TAU) 
End-of-treatment (EOT) and 6-months post-EOT assessments 
-Secure web-based self-report assessments  
-Completion of assessments earns the patient $30 at each time point 
Data extracted from EHR 
-Participants’ objective data (e.g., opioid dose) for pre-randomization 
through approximately 10 months post-randomization 
Primary outcome: Decrease ≥15% (Yes or No) in MED from 
Baseline to 6 months post-End-of-treatment 
End of Study 
Data sources merged and data analyzed 
EHR: Electronic 
Health Record  
MED: Morphine 
equivalent dose  
Compensation 
-Managed by 
Central 
research staff 
-Total potential: 
$110 
Screening/Baseline 
1. If patient signs informed consent, they are sent an email directing 
them to a website to complete screening/baseline assessments – 
patient earns $30 for completing  
2. Patients potentially eligible based on screening/baseline 
assessments are sent an e-mail with the link for the web-based 
neurocognitive assessment (WebNeuro) – patient earns $20 for 
completing WebNeuro  
Randomized to E-Health+ 
(N=200): 
-Patient sent an email with 
information about E-health  
-E-Health treatment is 4 months 
Assessment of clinics to characterize TAU  

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3.0 STUDY SYNOPSIS 
STUDY OBJECTIVES.  The primary objective of this study is to evaluate the impact of treatment as usual 
(TAU), relative to TAU plus access to a web-based chronic pain program (E-health+), in patients with chronic non-
cancer pain being treated with long-term opioid therapy (LOT). It is hypothesized that the E-health+, relative to 
TAU, group will have a significantly greater proportion of participants with a: 1) ≥15% reduction in daily 
morphine equivalent dose (MED) as assessed by the EHR (H1: primary), and 2) clinically significant decrease 
(i.e. ≥ 2 points) in Pain Intensity score as measured by the Brief Pain Inventory (H2: key secondary) at 6 months 
post-treatment. 
 
STUDY DESIGN.  This is a 10-month, intent-to-treat, 2-group randomized controlled trial. Eligible 
participants will be randomized to TAU or E-Health+, stratified by site. Participants will be assessed at baseline, 
at the end of the 4-month treatment period, and at 6 months following end-of-treatment through an electronic 
data capture system accessed by the participants. Other outcome data will be obtained from the participant’s 
electronic health record (EHR). 
 
STUDY POPULATION.  Approximately 400 participants, recruited from primary care and pain management 
practices within one of two healthcare systems (University of Cincinnati Health and Duke Health), will be 
randomized into the study. Each healthcare system will randomize approximately 200 participants. The study 
population will include individuals who are 25-80 years of age, being treated with LOT (≥3 months) for chronic 
pain with a MED ≥ 20 mg, and who have internet access.  
TREATMENTS. Participants randomized to TAU will receive treatment for chronic pain as typically provided 
by their clinician. Participants randomized to the E-health+ arm will receive treatment as typically provided by 
their clinician plus a 4-month subscription to an internet based chronic pain program (the Chronic Pain 
Management Program from Goalistics).  
ASSESSMENTS. Data to calculate MED will be derived from the participant’s EHR. The Brief Pain Inventory 
and other patient-reported assessments will be collected on-line using REDCap.  
 
PRIMARY ANALYSIS. The primary hypothesis is that a significantly greater proportion of E-health+, relative 
to TAU, participants will have a ≥15% decrease in MED between baseline and 10-month (i.e., 6-month post-
treatment) follow-up. The MED outcome may be prone to site effects in that the strategies used by the 
healthcare system to treat chronic pain may influence prescribing behavior; thus, the primary analysis will test 
for potential site (UC Health vs. Duke) effects. Specifically, a logistic regression will test for treatment (E-
health+ vs. TAU), site, and treatment-by-site interaction effects, with treatment being the effect of interest. 
 
 

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4.0 BACKGROUND AND SIGNIFICANCE 
 
An estimated 100 million Americans suffer from chronic non-cancer pain (referred to as chronic pain). The 
treatment of chronic non-cancer pain has largely fallen to physicians who often, due to healthcare system 
constraints, rely exclusively on long-term opioid therapy (LOT).1, 2 Gaps in policy, treatment, education and 
research have resulted in shortfalls in pain care and unintended deaths from opioids.3 In 2012, 259 million 
opioid prescriptions were written by U.S. health care providers -- enough for every adult to have a prescription. 
This trend has been blamed for the rise in opioid misuse and accidental overdose deaths.4 Nearly 46 Americans 
die from an overdose of prescription painkillers each day.5  A majority (60%) of the more than 15,000 annual 
opioid analgesic/painkiller overdose deaths in the U.S. occur in patients obtaining prescriptions within medical 
board prescribing guidelines.6 It has been estimated that opioid misuse behaviors occur in 1 of every 4 patients 
receiving opioids for chronic pain and addiction presents in 1 of every 10.7  Based on the adverse consequences 
of, and inadequate evidence of effectiveness for, LOT, the CDC recently developed recommendations designed 
to decrease the use of LOT and the morphine equivalent dose (MED) for patients receiving LOT.8 However, the 
majority of people receiving LOT report that opioid medication is significantly beneficial and even critical to 
managing their pain;9-11 thus, these patients may be resistant to having their medication reduced or 
discontinued.9  This discrepancy between the goal of many policy makers and providers to reduce or 
discontinue opioid medication for chronic pain treatment and the goal of patients to effectively manage their 
pain which, in their view, includes the use of opioid medication, will likely result in poor outcomes should 
opioid reduction be attempted in the absence of accessible, effective non-opioid medication treatment. Indeed, 
the importance of testing adjunctive therapies to reduce MED was noted in NIDA’s new strategic plan.12  
 
Due, in part, to the mounting adverse consequences associated with using LOT as the principal treatment for 
chronic pain, the question of whether there are viable alternative treatments has been asked frequently during 
the past few years, including by the Institute of Medicine1 and National Institutes of Health.2 In order to be 
viable, the treatment needs to be accessible – both in terms of availability and affordability – and effective. 
Unfortunately, many potential treatment alternatives, including effective multidisciplinary or interprofessional 
treatments, are associated with significant barriers, including limited availability in many areas, lack of 
coverage by many insurance plans, limited patient acceptance, and other limitations.13-15 Novel treatment 
approaches are needed to extend access to effective pain care. Self-management programs, which are designed 
to assist patients in mastering the tasks needed to live with a chronic condition, are promising in this regard. 
Based on concepts of self-efficacy, they aim to increase a person’s confidence and ability to exert control over 
troubling health symptoms. Self-management programs have been touted as an effective means to improve 
quality of life and health functioning while reducing health care resource utilization.16, 17 Pain self-management 
interventions are recommended as an essential component of evidence-based clinical practice for chronic 
pain.18, 19 Online and face-to-face group self-management interventions have demonstrated improved outcomes 
in small, specific populations of patients who suffer with pain such as patients with fibromyalgia, headaches, 
arthritis and angina.17, 20, 21 However, no such interventions have been accepted for widespread use in the 
general population of patients with chronic pain, and no consensus exists on the optimal means to engage 
patients in pain self-management strategies. Web-based interventions have the advantage of being more 
accessible than face-to-face interventions and these two treatment modalities have been found to have 
equivalent efficacy.22  
 
While there is evidence that web-based interventions can be effective for chronic pain, the majority of studies 
have failed to evaluate their impact on reducing reliance on LOT,23 with the exception of research on the 
Chronic Pain Management Program (referred to as E-health), which has been found to be efficacious in 
decreasing pain and medication use in two prior randomized controlled trials (RCTs). Of critical import, the E-
health intervention is particularly well-suited to address the sometimes discrepant goals of policy makers/ 
providers to reduce LOT and of patients to manage their pain, which, for them, includes LOT. Specifically, two 

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prior RCTs have found that the E-health program significantly decreased the use of prescription pain 
medications even though a desire to decrease dose was not an eligibility criterion nor were participants 
instructed to attempt a dose decrease. In an RCT, conducted with a sample of chronic pain patients 
heterogeneous for LOT use (N=305), E-health participants reported significantly greater decreases in 
prescription medication use compared to a wait-list control group.24 The second RCT, conducted with 92 people 
with chronic pain with a current opioid prescription found that, E-health, relative to wait-list control, 
participants evidenced significantly greater decreases in opioid misuse and a significantly greater proportion of 
E-health participants reported decreasing or discontinuing their opioid medication (21% vs. 7%).25  
 
In addition, the E-health participants experienced decreases in pain despite significant decreases in prescription 
medication use. In the RCT conducted with 305 chronic pain patients, participants randomized to the E-health 
intervention reported significantly greater decreases in pain severity, pain-related interference and emotional 
burden, perceived disability, catastrophizing, and pain-induced fear.26 The second RCT, conducted with 92 
people with chronic pain with a current opioid prescription found that 18% of E-health participants, compared 
to 6% of wait-list control, had a clinically significant decrease (i.e. ≥ 2 points) in Brief Pain Inventory Pain 
Intensity.25  
 
While these results are promising, they need to be replicated in a larger RCT and with patients from primary 
care and pain management clinics, where the majority of chronic pain patients are treated. In addition to 
identifying an effective intervention, it is important to identify therapeutic mediators and moderators which 
would allow for tailored interventions and delineation of therapeutic targets; such evaluation for E-health has 
been suboptimal due to the constraints of the small sample size of the pilot trial (N=92) and, in the first RCT 
(N=305), only data on prescription medication, rather than on opioid medication specifically, being collected.   
 
 
5.0 SPECIFIC AIMS 
 
Aim 1: The primary aim is to evaluate the impact of treatment as usual relative to treatment as usual plus access 
to a web-based chronic pain program, the Chronic Pain Management Program (E-health+), on daily MED in 
patients with chronic non-cancer pain being treated with LOT. It is hypothesized that the E-health+, relative to 
TAU, group will have a significantly greater proportion of participants with a: 1) ≥15% reduction in daily 
morphine equivalent dose (MED) as assessed by the EHR (H1: primary), and 2) clinically significant decrease 
(i.e. ≥ 2 points) in Pain Intensity score as measured by the Brief Pain Inventory (H2: key secondary) at 6 months 
post-treatment. 
 
Aim 2: Test our conceptual model of E-health’s mechanisms of change, including hypothesized mediators (i.e., 
pain self-efficacy, coping strategies, knowledge about pain/opioid therapy, and stress) and moderators 
(neurocognitive function: executive function and verbal learning ability) of E-health’s impact on decreasing 
MED and pain intensity. Moderated mediation analyses will be used to test our conceptual model.  
Our study will determine whether an innovative, accessible E-health intervention can assist with reduced opioid 
reliance in chronic pain patients, which can, ultimately, reduce risks of unintended opioid overdose and death. 
Importantly, we will better understand the mechanisms contributing to MED reduction while managing pain. 
Our findings may assist in developing treatment options for a population at risk for opioid adverse effects. 
 
 
 
 

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6.0 STUDY DESIGN 
 
6.1 Overview of Study Design 
The study schema is provided in Figure 1. This is a 10-month, intent-to-treat, 2-group randomized controlled 
trial. We will randomize 400 participants, recruited from primary care and pain management practices within 
one of two healthcare systems, in a 1:1 ratio to treatment as usual (TAU) or E-health plus TAU (E-Health+). 
Participants will be assessed at baseline, at the end of the 4-month treatment period, and at 6 months following 
end-of-treatment through an electronic data capture system accessed by the participants.  
 
It is possible that the standard practice at the participating sites will change during the course of the trial and, 
thus, an assessment of the clinics will be completed prior to the start of patient recruitment and after the end of 
data collection (see Figure 1); this will provide more accurate information about the study sites and, thus, about 
the sites to which the results are most likely to be generalizable. This is a particularly important consideration 
for this trial in that recent years have seen a significant increase in efforts to improve LOT prescribing practices. 
These include the CDC guidelines8 and the recommendation by an FDA Advisory Panel that Risk Evaluation 
and Mitigation Strategy training be made mandatory for all opioid prescribers.  
 
6.2 Number of Sites and Participants 
The two healthcare systems selected for this trial, University of Cincinnati (UC) Health and Duke, have 
successfully participated in primary care and chronic pain research and have a sufficient pool of potential 
participants to support this trial. Each health system will randomize approximately 200 participants (for a total 
N=400), with a target rate of approximately 5.1/month for 39 months. 
 
6.3 Study Duration 
An individual participant’s period of time for participation and study completion is approximately 11 months. 
This project will be completed over the course of approximately 5 years. 
 
6.4 Participant Selection 
 
6.4.1 Inclusion Criteria  
Potential participants must: 
 
1. be 25-80 years of age  
 
2. be able to understand the study, and having understood, provide informed consent in English 
 
3. have a daily average prescribed MED ≥ 20 mg over a recent three-month period 
 
4. have a chronic pain-related diagnosis  
 
5. self-report current use of opioid medication(s) to treat pain 
 
6. have a Brief Pain Inventory Pain Intensity score ≥3 
 
7. have internet access and a working email account 
 
 

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6.4.2 Exclusion Criteria  
 
Potential participants must not: 
 
1. be anyone who, in the judgment of study staff, would be unlikely to complete the study (e.g., planning to 
change to a different clinic for pain management, have a terminal illness, etc.)  
 
2. be unwilling/unable to complete the WebNeuro assessments 
 
3. be pregnant 
 
4. be a prisoner 
 
 
6.5 Outcome Measures 
 
6.5.1 Primary Outcome Measure  
The primary outcome measure is whether (yes/no) there was a ≥15% decrease in MED, based on the opioid 
prescribing information in the participant’s EHR, between baseline and 6-month post-treatment follow-up. 
There is no universally agreed upon method of calculating MED, which can result in inconsistent conversions 
among clinicians.27 For the proposed trial, the calculation of MED will use the Opioid Morphine Equivalent 
Conversion Factors table created by the CDC.28 There is also no standard definition for what constitutes a 
significant decrease in MED but a ≥15% decrease has been defined as a significant change in past research.29  
The impact of E-health on MED, as a continuous measure, will be evaluated in secondary analyses. 
 
6.5.2 Secondary Outcome Measures  
The secondary outcome measures are primarily self-report. Mobility can be an issue for individuals with 
chronic pain – to minimize participant burden, these data will be obtained through REDCap.30 REDCap is a 
web-based software toolset and workflow methodology for collection and management of clinical research data.  
 
1. Pain Intensity 
The key secondary outcome is whether there is a clinically meaningful decrease (yes/no) in pain intensity (≥ 2 
points) as measured by the Brief Pain Inventory (BPI)31 at 6-month post-treatment follow-up. The BPI is a well-
validated, reliable instrument that consists of a 4-item pain Intensity subscale and a 7-item pain interference 
subscale. The BPI has been used in more than 400 studies worldwide,32 including the pilot trial (N=92) testing 
the efficacy of E-health for patients receiving opioid therapy.25   
 
2. Pain-related Sleep Problems 
The 3-item Sleep Problems Index will be used to assess sleep interference resulting from pain; this measure has 
been found to have good construct validity and reliability (Cronbach's α > 0.90).33  
 
3. Global Health 
Global Health, which is a quality of life measure, will be assessed with the Patient-Reported Outcomes 
Measurement Information System (PROMIS) 10-item measure for Global Health, which briefly but 
comprehensively assesses physical, mental, and social health; this is a reliable (Cronbach's α > 0.80) measure 
with demonstrated construct validity.34  
 

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4. Current Opioid Misuse 
The Current Opioid Misuse Measure (COMM)35, 36 will be used to assess opioid misuse. The COMM is a 17-
item self-assessment used to monitor patients on opioid therapy and to assess whether patients are currently 
exhibiting behaviors indicative of misuse. The COMM has good predictive validity and reliability (Cronbach's 
α > 0.82).35, 36  Test-retest reliability has been established and construct validity demonstrated with positive 
correlations with urine toxicology results.37  
 
5. Healthcare Utilization 
The Stanford University Patient Education Research Center Health Care Utilization survey will be used to track  
health care utilization; the instrument has good test-retest reliability; validity has been established through chart 
audits.38   
 
6.5.3 Moderators and Mediators 
Our conceptual model of E-health’s mechanisms of change is described in section 8.1. The moderator and 
mediator measures are delineated below. 
  
6.5.3.1 Neurocognitive Moderators 
Obtaining the data for our hypothesized neurocognitive moderators (see Figure 2) requires a web-based 
neurocognitive assessment. WebNeuro, which is the most widely used and validated web-based neurocognitive 
assessment,39, 40 will be used for this purpose. WebNeuro, which takes 30 minutes to complete, assesses several 
functional domains including sensorimotor, attention, executive function, memory, and social cognition and 
also provides a measure of intelligence. WebNeuro reports raw scores and normative scores appropriately 
adjusted for the respondent’s age, gender, and education. While WebNeuro includes a number of tests in 
addition to our moderators (Trail Making B and Delayed Verbal Recall), we selected it for use in this trial 
because it is the only web-based, validated neurocognitive assessment that included these desired tests. The 
additional WebNeuro tests may be used in exploratory analyses to generate hypotheses to be tested in future 
research. For example, impulsivity has been found to be predictive of opioid misuse as measured by the COMM 
in chronic pain patients.41 We would attempt to replicate this finding by evaluating the relationship between the 
COMM and performance on WebNeuro’s Go-no-go test, a measure of impulsivity.40 
 
6.5.3.2 Mediators 
Each of the following measures will be evaluated as mediators of E-health’s treatment effect (see Fig. 2). 
 
1. Pain Knowledge Questionnaire 
A prior RCT of E-health found that it significantly increased knowledge about chronic pain and pain 
management.26 The Pain Knowledge Questionnaire includes questions about opioid medications and non-opioid 
treatment alternatives. 
  
2. Pain Self-Efficacy Questionnaire (PSEQ) 
The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item measure that has good construct validity and 
reliability (Cronbach's α = 0.92).42  Higher self-efficacy is associated with positive outcomes for pain coping, 
increased pain thresholds and tolerance,43 decreased fear of movement, emotional distress, depressive 
symptoms, and disability.44, 45  
 
3. Coping Strategies Questionnaire (CSQ-R) 
This 27-item Likert-scale questionnaire assesses the use of six pain-coping strategies: 1) catastrophizing; 2) 
coping self-statements; 3) ignoring sensation; 4) distancing; 5) distraction; and 6) praying. Participants rate their 
utilization of each strategy on a 7-point scale (0-“Never do that” to 6-“Always do that”). The CSQ-R has been 

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14. 
 
found to have adequate internal consistency and validity in several patient populations.46-49 The moderator to be 
tested in the proposed study is the use of passive coping strategies, calculated by combining the catastrophizing 
and praying subscales.50  
 
4. Depression, Anxiety, and Stress Scales (DASS-21).  
This 21-item Likert-scale questionnaire has established validity and reliability and assesses three constructs: 1) 
depression; 2) anxiety; and 3) stress.51-53 Participants provide past-week ratings using a 4-point scale (0-“Did 
not apply to me at all” to 3-“Applied to me very much or most of the time”). 
 
6.5.4 Safety Measures  
 
1. Adverse Events (AEs) 
An adverse event (AE) for this trial testing a low risk, internet-based, intervention is defined as > 30% symptom 
deterioration from baseline as indicated by any of the following: 
 Pain Intensity Score as measured by the Brief Pain Inventory 
 Pain Interference Score as measured by the Brief Pain Inventory 
 The Depression score from the Depression, Anxiety, and Stress Scales (DASS-21), and higher than 
Normal/Mild range 
 The Anxiety score from the DASS-21, and higher than Normal/Mild range 
 The Stress score from the DASS-21, and higher than Normal/Mild range 
Within REDCap, a report identifying participants with potential AEs (i.e., > 30% worsening on the measures 
listed above relative to baseline) will be generated on a weekly basis at minimum.  
 
 
6.5.5 Other Measures  
 
6.5.5.1 Participant Measures 
 
1. Demographics 
This assessment will include questions about the participant’s race/ethnicity, sex, marital status, education, and 
employment status. 
 
2. Pain-related Diagnoses  
Pain-related clinical characteristics will be assessed through both the participant’s EHR data (e.g., pain 
diagnoses, co-occurring diagnoses) and through self-report.  
 
3. Pain-related Treatment  
Information about the TAU that the participant receives (physician visits, referrals for other treatments, etc.) 
will be assessed with the participant’s EHR and through self-report. The self-report assessment will include 
questions about LOT, referrals received for nonpharmacologic treatment, and types of pain treatment utilized. 
4.  E-health program adherence 
E-health program completion will be measured as a continuous variable by the presence of “star ratings,” which 
are required when participants exit a learning activity in the E-health program.  Consistent with scoring used in 

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15. 
 
a pilot study evaluating the E-health program,25 an engagement level of “0” will be assigned if the pre-requisite 
activity in the initial “Understanding Pain” Learning Center was not completed; a “1” will be assigned if only 
the pre-requisite activity in the “Understanding Pain” module was completed; a “2” will be assigned if the 
Profile of Chronic Pain assessment is also completed, but there was no evidence of activity within any of the 4 
other Learning Centers; a “3” will be assigned if activities were completed in 1 of the 4 other Learning Centers 
and so on, up to the highest level of “6” assigned if the participant has completed activities in all 4 other 
Learning Centers.      
 
6.5.5.2 Clinical Practice Measures 
TAU at the participating practices will be characterized using three assessments, which will be completed by an 
administrative person from each clinical practice. An attempt will be made to have the same person complete 
the assessments at the pre-recruitment and post-data collection assessment time points; individuals will be 
compensated between $50 and $100 for completing these assessments at each time point. 
 
1. Clinical Practice Characteristics 
A questionnaire will be used to obtain information about the general characteristics of each practice, including 
size (e.g., number of full-time equivalent providers, staff, patients), geographic location, and provider types 
(e.g., family medicine, internal medicine, nurse practitioners, etc.). 
 
2. Practice-level Payer Data 
A questionnaire will be used to obtain information about the payer types for each practice. 
 
3. Assessment of Chronic Illness Care (ACIC) 
A modified version of the Assessment of Chronic Illness Care (ACIC, version 3.5),54 will be used to assess the 
practice’s approach to treating chronic pain. The ACIC assesses six elements that encourage high-quality care 
as outlined in the Chronic Care Model.55 The ACIC version 3.5 assesses: 1) health care organization (i.e., the 
degree to which the system focuses on chronic illness care); 2) community linkages (i.e., the degree to which 
linkages between the system and community resources have been established); 3) self-management support 
(i.e., the degree to which self-management by the patient is encouraged and supported); 4) decision support (i.e., 
the degree to which providers have access to evidence-based information); 5) delivery system design (this 
includes multiple aspects of the system including patient follow-up, encouraging a team-based approach etc.); 
and 6) clinical information systems (the degree to which providers and staff have timely information about 
individual patients and patient populations). In addition, the degree to which there is integration of these 
elements is assessed. The ACIC has been utilized in a number of quality improvement projects and has been 
shown to have adequate reliability and validity.56, 57 
 
6.6 Randomization Plan 
Eligible participants will be randomized in a 1:1 ratio to TAU or to TAU plus E-health (E-health+). 
Randomization will be at the level of participants and stratified by site. The number in each treatment group 
will never differ by more than a factor of b/2 where b is the block size, which will help ensure treatment 
balance. The randomization process will be performed within REDCap and the randomization sequence will be 
unknown to the research staff. 
 
 
6.7 Study Treatments 
 

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6.7.1 Treatment as usual (TAU) 
TAU will primarily consist of LOT. Opioid dose, physician visits, and referrals to non-pharmacological 
treatments (e.g., physical therapy, behavioral therapy, etc.) will be tracked through the EHR. Participant self-
report will also be used to assess whether the patient received referrals for nonpharmacologic treatment and the 
type of nonpharmacologic treatment(s) received. In addition, TAU will be characterized using three assessments 
(i.e., the ACIC and questionnaires about the general characteristics and payer types of the practice -see section 
6.5.5.2), which will be completed by an administrative person from each clinical practice.  
 
6.7.2 E-Health  
The E-health intervention is described in section 8. Participants randomized to the E-Health+ condition will 
receive a free, 4-month subscription to the on-line Goalistics Chronic Pain Management Program. E-health+ 
participants will receive e-mails outlining what activities they should be completing within the Chronic Pain 
Management Program during the course of their 4-month subscription and follow-up communications in the 
event of non-adherence. 
 
7.0 STUDY PROCEDURES 
 
7.1 Study Overview 
Table 1 provides an overview of the participant procedures and assessments. 
 
7.2 Participant 
Recruitment and 
Consent 
Potential participants 
will be identified 
through EHR queries. 
Our primary form of 
recruitment will be 
letters, which has 
been found to be an 
effective method of 
recruitment for trials 
testing online 
interventions in other 
conditions (e.g., 
obesity, etc.).58 The 
recruitment letters 
will use an “opt-out” 
strategy in which 
patients are asked to 
contact the clinic if 
they do not wish to be 
contacted by research 
staff. An RCT 
comparing opt-out 
and opt-in (i.e., 
patient needs to 
Table 1. Participant Procedures and Assessments 
Assessment/Procedure 
Scrn/ 
Base 
Active  
Tx 
Post-Randomization 
Follow-ups 
 
 
 
4-Month 
10-Month 
4-month subscription for E-health 
 
x 
 
 
Screening Assessments 
 
 
 
 
Informed consent 
x 
 
 
 
Demographics 
x 
 
 
 
Pain-related Diagnoses 
x 
 
 
 
Efficacy Assessments 
 
 
 
 
Morphine Equivalent Dose 
Electronic Health Record 
Brief Pain Inventory  
x 
 
x 
x 
Sleep Problems Index 
x 
 
x 
x 
Health Care Utilization Survey 
x 
 
x 
x 
Current Opioid Misuse Measure 
x 
 
x 
x 
PROMIS 10-item Global Health  
x 
 
x 
x 
Moderator/Mediator Assessments 
 
 
 
 
WebNeuro  
x 
 
 
 
Knowledge about pain/opioids 
x 
 
x 
x 
Pain Self-Efficacy Questionnaire  
x 
 
x 
x 
Coping Strategies Questionnaire  
x 
 
x 
x 
DASS-21  
x 
 
x 
x 
Safety Assessments 
 
 
 
 
Adverse Events  
 
 
x 
x 
Other Assessments 
 
 
 
 
Pain-related treatment  
x 
 
x 
x 
E-health Program Adherence 
 
x 
 
 
EOT=End of Treatment; DASS=Depression, Anxiety, Stress Scale 

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contact research staff if s/he is interested) strategies found the opt-out resulted in a significantly higher response 
rate and a more representative patient sample.59 The opt-out strategy shows consideration for the patients’ 
autonomy because it gives them ready access to more information about the study while also giving them the 
option to opt-out, whichever they decide.60 Practice Facilitators (PFs) will ensure that identified potential 
participants are sent a recruitment letter and a study brochure. For patients not opting out, the PF will contact 
patients to inform them about the study and offer to complete a phone pre-screen. Patients who do not opt out, 
but who are not reached by phone may be sent an additional recruitment letter. If the patient passes phone pre-
screen, they are sent an email directing them to a secure website for informed consent. Patients will be given the 
opportunity to discuss any questions or concerns with study staff prior to electronically signing the consent 
form. Patients who are interested in participating will sign the electronic consent form (e.g., using a mouse or 
touch screen). The time and date of signature is automatically recorded by the website. When a participant has 
signed the electronic consent, a secure e-mail notification will be automatically sent to research staff. Research 
staff will review the signed consent before sending an email with a link to the study screening assessments. 
Participants will be mailed a hard copy of their signed consent. Non-PHI information from all pre-screening 
interviews is retained to help track recruitment efforts and reasons for ineligibility. For individuals who do not 
qualify for the study, the other data collected during the pre-screening interview will be destroyed. 
 
7.3 Screening/Baseline 
After signing the informed consent form, the study participant will be sent an e-mail directing them to a website 
to complete the screening/baseline assessments. Participants who are potentially eligible based on the 
screening/baseline assessments will be sent an e-mail with a link for the web-based neurocognitive assessment 
(WebNeuro). Participants who meet study eligibility and complete screening/baseline (including WebNeuro) 
will be randomly assigned to the TAU or E-health+ condition. In some circumstances, the PI may allow 
individuals who do not complete WebNeuro to be randomized. 
 
7.4 Active Treatment Phase 
The active treatment phase is comprised of the 4 months during which E-health+ participants are provided with 
a free subscription to the Chronic Pain Management Program. 
 
7.5 Follow-up  
Because the primary outcome in this trial (MED calculated from opioid prescriptions) is contained in the site’s 
EHR, it is not dependent on participant retention in the study. Thus, primary outcome data will be complete 
unless the participant withdraws consent or is no longer being treated at the clinical site. The secondary 
outcomes for this trial (i.e., online surveys at months 4 and 10), however, will primarily be patient-reported 
outcomes. The present trial will utilize multiple strategies to help ensure a high rate of completion. A recent 
systematic review of methods for retaining participants for follow-up in healthcare research found that studies 
using multiple retention strategies had significantly higher retention rates.61 Accordingly, our retention plan 
includes several strategies identified by systematic reviews and meta-analyses to be associated with 
questionnaire completion in general research,62 healthcare research and randomized controlled trials,62-64 and 
trials of online interventions.63 The retention strategies we will use include: 1) financial incentives conditional 
on survey completion;63, 65 2) minimal participant burden (i.e., online short-form assessments that can be 
completed at the participant’s convenience over a 28-day period);62, 64 3) an established schedule of data 
collection windows provided to participants at the time of randomization;62 and 4) a retention “escalation plan”, 
which includes automated email reminders with links to complete surveys.62, 64 Each of the follow-up time-
points (4- and 10-months post-randomization) will have a 28-day data collection window during which the 
assessments can be completed. When the window begins, the participant will receive the initial assessment 

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invitation link via email. If the participant does not respond to the initial invitation, then the participant will 
receive up to 5 additional reminders, using a mix of emails, phone calls, and text messages, throughout the data 
collection window until it is completed. If a participant fails to respond to the 4-month follow-up survey within 
the allotted 28 days, then the participant will be sent a personalized retention letter via Certified Mail, 
approximately one week prior to the opening of the 10-month time-point’s data collection window. 
 
7.6 Trial Discontinuation  
The study sponsor has the right to discontinue the investigation at any time. 
 
7.7 Participant Reimbursement 
Participants will also be reimbursed up to $110 for their time. Payments will be provided via a prepaid debit 
card. 
 
Table 2: Reimbursement schedule  
Study Measures 
Estimated Time to 
Complete 
Payment 
Screening/Baseline 
40 minutes 
$30 
WebNeuro 
30 minutes 
$20 
4-months after randomization 
40 minutes 
$30 
10-months after randomization 
40 minutes 
$30 
Total 
150 minutes 
$110 
 
 
8.0 CHRONIC PAIN MANAGEMENT PROGRAM (CPMP) 
 

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8.1 Program Development and Description 
The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was 
developed from 
cognitive, behavioral, 
interpersonal, and 
self-management 
interventions with 
demonstrated efficacy 
in traditional face-to-
face or group settings. 
It is patient-centered, 
having been 
developed based on 
substantial input from 
people with chronic 
pain and chronic pain 
professionals. 
Specifically, in the 
initial project funded 
by the National 
Institute of 
Neurological 
Disorders and Stroke 
(NINDS), a prototype for the pain program was developed, reviewed, and twice revised. The second NINDS-
funded project included the final development of the program and an RCT to test its efficacy.26 The E-health 
program includes five learning centers - the order in which they are completed is customized for each user 
based on priorities identified from completing the Profile of Chronic Pain.66  Table 3 provides an overview of 
the content and therapeutic approach for each learning center. Developing new skills and integrating them into a 
patient’s life requires practice and persistence on the part of the patient and the E-health intervention was 
designed to promote both. A set of self-management tools are integrated into the learning centers to enhance 
tracking, troubleshooting, and attainment of program activities and goals; examples of these E-health tools are 
provided in Table 4. More in-depth information about the E-health program, including screen shots, can be 
found in Appendix A. 
 
Table 3. E-health learning center content and therapeutic approach 
1. Thinking Better-Derived from cognitive models of pain management, this learning 
center teaches the person with chronic pain how to recognize, interrupt, challenge, and 
replace dysfunctional thinking. Users create a custom plan to decrease self-defeating 
thoughts while increasing effective thinking.  
2. Feeling Better- Provides training in fundamental methods of emotion regulation, 
including identifying negative and positive emotional triggers, the role of relaxation 
training in emotion regulation, and incorporating positive emotional triggers into daily life. 
A set of relaxation sessions offer practice in using breathing as a trigger for relaxation, 
progressive muscle relaxation, guided imagery, and mindfulness meditation.  
3. Doing More-The primary goals are to increase activity and exercise and promote goal-
based activities. This learning center is based on behavioral and motivational models of 
pain self-management.  
4.  Relating Better- This is derived from interpersonal/transactional models of pain 
management. The user learns about types of social support and how to differentiate 
effective versus ineffective support. A personalized support plan is created.  
5. Understanding Pain-This learning center teaches basic concepts underlying the 
biopsychosocial perspective on chronic pain and its management. It consists of a series of 
videos covering such topics as medication management, the safe use of pain medication, 
reducing reliance on pain medication, relaxation, cognitive behavior therapy, biomedical 
treatment options, and hypnosis.  

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8.2 Conceptual Model of E-health’s Mechanisms of Change 
Evaluation of potential moderators and mediators of E-health’s effect on opioid medication use in chronic pain 
patients has been suboptimal due to the constraints of the small sample size of the pilot trial (N=92) and, in the 
first RCT (N=305), only data on prescription medication, rather than on opioid medication specifically, being 
collected. Thus, in addition to testing E-health’s effectiveness, the proposed trial will make an important 
contribution by 
allowing us to test a 
model of E-health’s 
mechanisms of 
change (see Fig. 2).  
 
8.2.1 Hypothesized 
mediators 
 
1) Knowledge about 
chronic pain/opioid 
treatment is 
significantly 
increased by E-
health.26 Knowledge 
about chronic 
pain/opioids has not, 
to our knowledge, 
been evaluated as a 
mediator of MED 
reduction; however, based on patient feedback, the information provided by E-health, particularly about the 
risks associated with opioids, decreases the perceived desirability of LOT.  
Table 4. E-health tools to promote and track lifestyle changes 
Navigator Calendar: Allows the user to schedule program activities and goals and send email and text-message reminders, 
with the ultimate goal that they will become automatic and self-sustaining.  
Self-Monitoring Tool: Allows the user to select a self-monitoring exercise (e.g., monitoring positive emotions), schedule 
it on the calendar, and send automated email or text alerts throughout the day.  
Pacing Tool: Used to create a custom plan to safely and slowly increase an activity over time. The user selects an activity 
to be paced (e.g., walking, swimming, meditating, etc.), identifies the amount of time it can be comfortably completed, and 
sets a target goal. The system creates a plan that increases the duration of the activity by 10% each week until the target 
time is reached. 
Daily Check-In: Assists the user in tracking progress over time. This is also linked to a separate set of program features: 
Mood Boosters, Pain Soothers, and Activity Boosters. These tools allow the user to create a set of activities or experiences 
to boost mood, decrease pain, and increase activity. These are brief and easy-to-implement. Low mood, pain management, 
or activity ratings over several days triggers a reminder to schedule a Mood Booster, Pain Soother, or Activity Booster. 
Self-Reward tool: Allows the patient to create a personalized list of inexpensive, easy-to-implement rewards to self-
administer for progress and completing activities. 
My Progress: Daily entries about what helps and interferes with activity completion are displayed, and compared to those 
of other program users to help the user understand his/her progress and to troubleshoot lack of progress. The system also 
displays progress in terms of Activity Completion Rate (the percentage of times that the user completed a scheduled 
activity). Each week, if the overall completion rate is reasonably high (e.g., ≥75%), a congratulatory message will be sent 
along with the suggestion that the user select a reward from his/her Self-Reward Menu.   

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21. 
 
2) Pain self-efficacy, as measured by the Pain Self-Efficacy Questionnaire (PSEQ), is significantly increased by 
E-health,25 and associated with positive outcomes including pain coping,44 increased pain thresholds and 
tolerance,43 and decreased fear of movement and disability.44, 45 In addition, in the pilot trial of E-health, PSEQ 
scores following treatment were positively associated with reduction in opioid medication use (r=.46, p=.03).67  
 
3) Passive coping strategies. E-health significantly decreases pain catastrophizing, which is a passive coping 
strategy.26  A role for passive coping strategies in pain outcomes is suggested by a recent trial evaluating the use 
of these strategies in the onset of chronic pain.50 In that study, passive coping strategies prior to surgery, as 
measured by the pain catastrophizing and praying subscales of the Coping Strategies Questionnaire, predicted 
chronic pain intensity 12-months post-surgery.50  
 
4) Stress. E-health significantly decreases stress, depression, and anxiety as measured by the Depression, 
Anxiety and Stress Scales (DASS) measure.26 A recent study testing an on-line chronic pain program in patients 
with back, neuropathic, and/or arthritis chronic pain found that the stress scale of the DASS mediated the effects 
of the intervention.52   
 
8.2.2 Hypothesized moderators 
No consistent moderators of psychosocial pain-management interventions have been found despite multiple 
attempts to define such factors.68  In their review of the literature, Day et al68 noted that neurocognitive function 
may be an important moderator of psychosocial pain interventions but that it had yet to be evaluated. Similarly, 
Solberg et al.69  hypothesized that a chronic pain patient’s ability to self-regulate thoughts and emotions and to 
engage in active coping strategies relies, in part, on executive functioning; the authors further hypothesized that 
psychosocial interventions could fail in patients with insufficient executive functioning/self-regulation 
capacity.69 Multiple studies have found cognitive impairment in chronic pain patients although the causal 
relationship between chronic pain and cognitive impairment is unclear. A recent meta-analysis of this literature 
revealed small-to-moderate effects in chronic pain patients for a subgroup of neurocognitive tests.70 These tests 
include the Trail Making Test B (TMT-B; Cohen’s d =-.38), a measure of executive functioning, and Delayed 
Verbal Recall (Cohen’s d=-.57), a  measure of verbal learning.70 To better evaluate the potential relationship 
between cognitive function and pain, a recent study evaluated patients a month before a scheduled surgery and 
followed them up for a year post-surgery; TMT-B performance prior to surgery predicted the presence and 
intensity of chronic pain at 6- and 12-months post-surgery.50 This finding is important in that it suggests that 
cognitive impairment may play a causal role in the development of chronic pain rather than being the result of 
pain or a side effect of medications used to treat pain. Consistent with Solberg et al.’s69 hypothesized 
relationship between executive functioning and ability to self-regulate, this study also found that worse 
performance on the TMT-B was significantly associated with the use of passive coping strategies and that 
passive coping strategies predicted chronic pain intensity 12-months post-surgery.50 Based on this literature, we 
hypothesize that participants with poorer executive functioning, as measured by the TMT-B, will have less 
capacity to learn self-regulation strategies from E-health (i.e., will moderate E-health’s effects), and hence, will 
evidence less improvement in pain self-efficacy, stress and coping strategies. Our findings will be useful for 
determining how treatment options may need to be customized for individual abilities. 
 
Another aspect of cognitive function that may moderate E-health’s treatment effect is the ability to learn new 
information. Verbal learning ability, as quantified by Delayed Verbal Recall, measures the respondent’s 
capacity to acquire, store, and retrieve verbal information.71, 72 Better Delayed Verbal Recall performance is 
associated with greater health literacy and medication adherence.73-75 Verbal learning test performance has also 
been found to be predictive of post-injury community integration,76 job performance and employment status,77, 
78 and ability to benefit from a cognitive/social group intervention for Alzheimer’s patients.79 While ability to 
learn could impact the effect of E-health on all 4 hypothesized mediators, the strongest/clearest signal will 

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22. 
 
likely be for obtaining knowledge about chronic pain/opioid treatment; to reduce the risk of a Type-I error we 
will test verbal learning as a moderator only for knowledge acquisition. 
 
Finally, there is a dearth of research evaluating the potential of MED as a moderator of treatment effect for 
chronic pain interventions. The participants in the present study will likely be on a wide range of MED at 
baseline (e.g., eligibility criteria require a minimum of ≥ 20 mg/day and do not set an upper limit). Baseline 
MED as a potential moderator of E-health’s effects will be evaluated.  
 
 
9.0 ANALYTICAL PLAN 
 
9.1 Statistical Hypotheses 
 
9.1.1 Primary Hypothesis  
The primary hypothesis is that a significantly greater proportion of E-health+, relative to TAU, participants will 
have a ≥15% decrease in MED between baseline and 10-month (i.e., 6-month post-treatment) follow-up.  
 
9.1.2 Key Secondary Hypothesis 
The key secondary hypothesis is that a significantly greater proportion of E-health+, relative to TAU, 
participants will have a clinically significant decrease (i.e. ≥ 2 points80) in Pain Intensity score at 6 month post-
treatment follow-up. 
 
9.2 Intent-to-Treat Participant Population 
The intent-to-treat population is defined as the participants who are randomized to treatment.  
 
9.3 Analysis Plan 
Each primary and secondary efficacy outcome measure will be analyzed for the intent-to-treat (ITT) population. 
While there is every intention to be complete in describing the analyses to be performed, it is not possible to 
anticipate every contingency, and some adjustments may be required to meet constraints posed by the structure 
of the data. Constraints such as non-linearity, non-normality, etc. may lead to different but more appropriate 
approaches to analysis. No interim efficacy analyses or adaptive features are planned. 
 
All statistical tests will be conducted at the 5% Type I error rate (two-sided). When multiple tests are conducted, 
the chance of finding a significant difference in one of the tests, when in fact no difference exists, is greater than 
the stated Type I error rate.  The investigators are aware of the multiple testing issues and will interpret results 
with caution and use confidence intervals where possible. 
 
9.3.1 Primary Outcome 
The primary hypothesis is that a significantly greater proportion of E-health+, relative to TAU, participants will 
have a ≥15% decrease in MED between baseline and 10-month (i.e., 6-month post-treatment) follow-up. The 
MED outcome may be prone to site effects in that the strategies used by the healthcare system to treat chronic 
pain may influence prescribing behavior; thus, the primary analysis will test for potential site (UC Health vs. 
Duke) effects. Specifically, a logistic regression will test for treatment (E-health+ vs. TAU), site, and treatment-
by-site interaction effects, with treatment being the effect of interest. 
 

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9.3.2 Secondary Outcomes 
The key secondary hypothesis, that a significantly greater proportion of E-health+, relative to TAU, participants 
will have a clinically significant decrease (i.e. ≥ 2 points80) in Pain Intensity score at 6 month post-treatment 
follow-up will be tested using logistic regression with treatment (E-health+ vs. TAU) as the effect of interest. 
For consistency with the primary analysis, models including site effects will be evaluated. 
 
Most of the secondary outcomes consist of baseline-endpoint longitudinal variables, which can reasonably be 
treated as continuous numeric values. These will be analyzed using random-intercept mixed model regressions 
including treatment, time, and treatment-by-time interaction as predictor variables. For consistency with the 
primary analysis, models including effects of site will be evaluated. The impact of utilizing non-study chronic 
pain treatments (i.e., as self-reported on the pain-related treatment assessment or EHR), other than LOT, on 
decrease in MED and pain intensity (yes/no) will be tested with logistic regressions including treatment (E-
health+ vs. TAU), use of other chronic pain treatment (yes/no), and their interaction. In the E-health+ group, the 
relationship between treatment adherence and outcome (e.g., MED, pain) will be evaluated with logistic 
regression with treatment adherence rating as the covariate.  
 
9.3.3 Moderated Mediation Analyses 
The purpose of the moderated mediation analysis is to explore the degree to which the model in Fig. 2 is 
consistent with the obtained study results. Using all ITT data, we will perform mediation analysis81 (empirically 
estimating 95% confidence intervals via bootstrapping) to test two mediation relationships: 1) knowledge about 
pain/opioids, pain self-efficacy, and passive coping strategies as joint mediators of the effect of E-health+ on 
MED reduction, and 2) pain self-efficacy, passive coping strategies, and stress as joint mediators of the effect of 
E-health+ on pain intensity score.  We will test three potential moderators of E-health’s treatment effect using 
linear regressions. One set of analyses will test whether executive function (as assessed by the Trail Making B) 
moderates E-health’s effects on pain self-efficacy, passive coping strategies, and stress. The second will test 
whether verbal learning ability (as measured by the Delayed Verbal Recall test) moderates E-health’s effects on 
knowledge about pain/opioids. The third will test whether baseline MED moderates E-health’s effects on 
knowledge about pain/opioids, pain self-efficacy, passive coping strategies, and stress. 
 
9.3.4 Safety Analyses 
It is anticipated that AEs and SAEs will have a low frequency of occurrence in this low-risk trial. AE/SAEs will 
be presented in tabular form as a function of treatment arm 
 
9.3.5 Missing Data 
For any participant dropping out, an attempt will be made to ascertain the reason for dropout. Since the primary 
outcome is based on the EHR, it will be complete unless the participant withdraws consent or is no longer being 
treated at the clinical site. However, many of our secondary outcomes are at greater risk for missing values. 
REDCap Survey will use hard stops as needed to ensure that key patient-reported outcomes are completed. Data 
that remain missing despite these measures will be accommodated in our analyses and their impact gauged 
through sensitivity analysis. The models we will employ can be estimated without bias under the missing at 
random (MAR) assumption. We will assess whether missingness depends on observed measures by creating 
indicators of whether each variable was missing at each occasion where it should have been recorded, use 
logistic regression to find predictors of missingness, and report on differences in groups with complete vs. 
truncated follow-up. For analyses involving missing data, we will use multiple imputation to generate multiple 
complete datasets. The analyses specified above will be performed on each of these data sets, and the results 
will then be combined using standard rules to produce single inferences that reflect uncertainty due to 
missingness.  
 

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24. 
 
9.4 Sample Size and Power 
The sample size calculation assumed an α level of 0.05 (two-tail). Study completion rates in the two prior E-
health RCTs were 92.4%26 and 79%.25 Data completeness for our primary outcome measure, which is obtained 
from the EHR, is expected to be higher than the completeness of participant-completed assessments. The pilot 
RCT, which required participants to have an opioid prescription in order to be eligible, found that 21% of E-
health, compared to 7% of wait-list control, participants reported decreasing or discontinuing their opioid 
medication;25 this difference equates to an odds ratio (OR) of 3.6. While the proposed trial uses a different MED 
reduction outcome (≥15%) than the pilot (any reduction), the data from the pilot is the most pertinent available 
for estimating power. The EMPOWER trial has a target sample size of 400 (200/arm) participants – using a 
conservative estimated completion rate of 75% yields 300 total completers (150/arm). Having 300 completers 
would provide 80% power to detect an E-health+ treatment effect if ≥18% participants have a meaningful MED 
reduction (i.e., of at least 15%) against 7% of TAU participants having a meaningful MED reduction; this 
equates to an OR of ≥2.77.  
 
9.5 Descriptive Statistics 
Using graphical and numerical techniques, we will inspect the data to identify potentially outlying or high-
leverage points, assess tenability of parametric assumptions, and evaluate the extent and pattern of missing data. 
Assessment of outliers and high-influence points will be conducted as residual analysis for specific statistical 
models, but data that appear extreme in preliminary analyses (e.g., boxplots; Q-Q plots) will receive particular 
attention in subsequent modeling. In models with continuous covariates, we will use scatterplots with non-
parametric smoothing to detect substantial non-linear associations. Descriptive checks and exploration will 
therefore be integrated through the entire modeling process. 
 
10.0 REPORTING AND MONITORING 
 
10.1 Informed consent 
The informed consent form is a means of providing information regarding the trial to a prospective participant 
and allows for an informed decision about participation in the study.  Each study site must have the study 
informed consent approved by their IRB(s). Every study participant is required to sign a valid, IRB-approved 
current version of the study informed consent form prior to the initiation of screening/baseline.  Every study 
participant should be given a copy of the signed consent form. 
Prior to signing the informed consent form, participants will be offered the opportunity to discuss the consent 
with research staff who are knowledgeable about the study.  In order to ensure that potential study participants 
understand the research study, a comprehension “quiz” (referred to as a comprehension tool) will be 
administered to potential participants.   
The informed consent form must be updated or revised whenever important new safety information is available, 
or whenever the protocol is amended in a way that may affect a participants’ participation in the trial.  The 
participant will be informed that their participation is voluntary and they may withdraw from the study at any 
time, for any reason without penalty. Individuals who refuse to participate or who withdraw from the study will 
be treated without prejudice.   
 
Health Insurance Portability and Accountability Act (HIPAA) 
Study sites may be required by their institutions to obtain authorization from participants for use of protected 
health information.  Sites will be responsible for communicating with their IRBs or Privacy Boards and obtaining 
the appropriate approvals or waivers to be in regulatory compliance. 

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25. 
 
Investigator Assurances 
Each site must file (or have previously filed) a Federal Wide Assurance (FWA) with the DHHS Office for Human 
Research Protection setting forth the commitment of the organization to establish appropriate policies and 
procedures for the protection of human research subjects, with documentation sent to NIDA or its designee.   
 
10.2 Financial Disclosure 
All investigators will comply with the requirements of 42 CFR Part 50, Subpart F to ensure that the design, 
conduct, and reporting of the research will not be biased by any conflicting financial interest.  Everyone with 
decision-making responsibilities regarding the protocol must comply with their Institution’s policy regarding 
conflict of interest. 
 
10.3 Clinical monitoring 
Each site will be responsible for implementing management and oversight activities during the pre-initiation, 
recruitment, enrollment, follow up, and close-out phases. These activities will be conducted by local project 
management staff/QA staff located at each site and aim to provide management support to the research team in 
order to ensure adherence to the protocol, SOPs, and regulatory requirements. The Lead Team will provide on-
going monitoring of study progress and will hold regular study management meetings to monitor any emergent 
problems or ongoing problematic trends, and may additionally hold individual meetings with site staff in order 
to assist in resolving any site-specific problems that impact the study. 
 
10.4 Study documentation 
Study documentation includes all case report forms, data correction forms, workbooks, source documents, 
monitoring logs and appointment schedules, sponsor-investigator correspondence, and signed protocol and 
amendments, Ethics Review Committee or Institutional Review Committee correspondence and approved 
consent form and signed participant consent forms. 
 
10.5 Safety Monitoring 
 
10.5.1 Data and Safety Monitoring Board (DSMB) 
A DSMB will examine accumulating data to assure protection of participants’ safety while the study’s scientific 
goals are being met. The DSMB will determine whether there is support for continuation of the trial, or 
evidence that study procedures should be changed, or if the trial should be halted, for reasons relating to the 
safety of the study participants, the efficacy of the treatment under study, or inadequate trial performance (e.g., 
poor recruitment). A Data and Safety Monitoring Plan for the trial has been approved by the study sponsor. 
 
10.5.2 Protocol Violations Reporting and Management 
A protocol departure is any departure from procedures and requirements outlined in the protocol.  Protocol 
departures may occur on two levels, deviation versus violation.  The difference between a protocol deviation 
and violation has to do with the seriousness of the event and the corrective action required.  A protocol 
deviation is considered an action (or inaction) that by itself is not likely to affect the scientific soundness of the 
investigation or seriously affect the safety, rights, or welfare of a study participant.  Protocol violations are 
departures that may compromise the participant safety, participant rights, inclusion/exclusion criteria or study 
data and could be cause for corrective actions if not rectified or prevented from re-occurrence. Each site is 

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responsible for tracking and reporting to their IRB as required.  Protocol deviations will be noted by 
participating sites and reported to their IRBs as required.   
 
10.5.3 Confidentiality 
To maintain participant confidentiality, study records and data will be stored in compliance with the 
International Conference on Harmonization (ICH) guidelines.  Participant records will be held confidential by 
the use of study codes in the study database, secure storage of any documents that have participant identifiers, 
and secure computing procedures for entering and transferring electronic data. No identifying information will 
be disclosed in reports, publications or presentations. Information collected for this study will be kept in a 
locked secure location accessible only to research staff and authorized personnel directly involved with this 
study.  
 
10.5.4 Adverse Events (AEs) 
An adverse event (AE) for this trial testing a low risk, internet-based, intervention is defined as > 30% symptom 
deterioration from baseline as indicated by any of the following: 
 Pain Intensity Score as measured by the Brief Pain Inventory, and greater than 4, indicating at least 
moderate pain intensity 
 Pain Interference Score as measured by the Brief Pain Inventory, and greater than 4, indicating at least 
moderate pain interference 
 The Depression score from the Depression, Anxiety, and Stress Scales (DASS-21), and higher than 
Normal/Mild range 
 The Anxiety score from the DASS-21, and higher than Normal/Mild range 
 The Stress score from the DASS-21, and higher than Normal/Mild range 
Within REDCap, a report identifying participants with potential AEs (i.e., > 30% worsening on the measures 
listed above relative to baseline) will be generated on a weekly basis at minimum. A Central Research Staff 
member will attempt to contact any participants experiencing an AE to obtain additional information; failure to 
make phone contact with a participant over 4 attempts, over a period of 1 month, indicates that the AE may be 
resolved by convention. During the process of obtaining additional information, the research staff will assess for 
potential SAEs. We will use FDA criteria for SAEs (i.e., an adverse event that results in any of the following 
outcomes: death, life threatening event, initial or prolonged hospitalization, disability, congenital anomaly, 
intervention to prevent permanent impairment or damage, or other significant medical event). All AEs/SAEs 
occurring during the course of the clinical trial will be collected, documented, and reported by the investigator 
or sub-investigators in accordance with reporting requirements. Drs. Winhusen and Wilson, for psychological 
AEs, and Dr. Dolor (or designated study physician), for SAEs, will manage all AEs/SAEs and make referrals 
for appropriate care, as necessary. All SAEs will be reported to the IRB of the participating sites and to the 
NIDA project officer within 72 hours of their discovery. All subject information will be de-identified when 
reporting SAEs. 
 
 
10.5.5 Risk/Benefit Assessment 
 
Risks:  
• Breach of confidentiality: As with any study, there is a potential risk of loss of confidentiality. To maintain 
participant confidentiality, study records and data will be stored in compliance with the International 

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27. 
 
Conference on Harmonization (ICH) guidelines. Participant-reported data will be collected through REDCap, 
which is HIPAA-compliant and 21 CFR Part 11- ready for audit trails for tracking data manipulation and 
exports. Neurocognitive assessment data will be collected through WebNeuro, which uses a secure website, 
with assigned unique user IDs and passwords, and no personally identifiable information will be collected by 
WebNeuro. EHR data will be transmitted by secure means to research staff.  Emails or text messages between 
researchers and participants, used in retention efforts, will be deleted after information exchange. We will train 
all study-related personnel to follow HIPAA regulations for research to ensure confidentiality of all data and 
that the rights of the patients are protected. All data will reside on password-protected computers, with only the 
investigators and key members of the research team having access. A variety of other measures will be taken to 
protect confidentiality, including: We will 1) assign a unique ID number to each patient to label all components 
of the protocol, instead of patient names, 2) restrict access to the key linking names and ID numbers to key staff 
and the PI at each site, 3) store any paper with data in a locked file cabinet. Participants will be told that agents 
of the IRB, QA monitors, and members of the DSMB will be allowed to inspect sections of their medical and 
research records related to this study, if requested.  
 
• Emotional Discomfort: The participants may experience some emotional discomfort from answering sensitive 
and/or personal questions. There is the possibility that the participant will feel bored. The patient’s ability to 
respond to study assessments in the privacy of his/her own home should help in reducing potential emotional 
discomfort. E-health is self-paced so patients can take breaks should any feelings of boredom arise.   
 
• E-health risks: There is little to no risk associated with the E-health program, which has been found to be safe 
and efficacious in prior studies. However, we will be monitoring for adverse events as noted above. 
 
Benefits: Previous research suggests that participants randomized to E-health+ may experience significantly 
greater decreases in pain severity, pain-related interference, perceived disability, depression, and pain-induced 
fear as well as significantly greater decreases in opioid misuse and MED. Other potential benefits include the 
chance to contribute to a scientific investigation which may benefit other patients like themselves in the future. 
The study will benefit society as a whole by potentially providing a low cost, accessible, multidisciplinary pain 
program to people with chronic pain that decreases opioid medication use and pain and improves pain self-
efficacy. The risk/benefit ratio is favorable and conduct of the research well justified. 
 
11.0 DATA MANAGEMENT  
Four data collection systems will be used in this project. The management and merging of these data will be 
overseen by our research team members who have many years of experience in coordinating data from multiple 
sources for large multisite trials.  
1) The vast majority of data will be patient-reported outcomes which will be collected through REDCap. This 
secure, flexible, web-based application provides: a) an intuitive interface for data entry and real time validation 
(e.g., automated data type and range checks); b) HIPAA-compliant and 21 CFR Part 11- ready audit trails for 
tracking data manipulation and exports; c) record locking and electronic signature functions; d) control of 
view/edit rights; e) a tool for reporting, monitoring and querying patient records; and f) automated export to 
common statistical packages. All participant-reported outcomes will be obtained via REDCap. In addition, the 
Central Research Staff will randomize participants to the E-Health+ or TAU-only arm, using REDCap’s 
randomization module. 
 2) The WebNeuro system will be used to assess neurocognitive functioning. WebNeuro’s vendor, Brain 
Resource Ltd., has an established history of providing valid, secure, web-based neurocognitive assessments for 
academic researchers. WebNeuro can be used on any computer that has an internet connection, a keyboard, and 
a mouse. Each participant will be assigned a unique user ID and password and no personally identifiable 
information will be collected. Upon completion of the tasks, participant data are transmitted via a secure 

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28. 
 
website to the Brain Resource Central Analysis Facility for rapid and standardized scoring. The WebNeuro data 
will be provided to the data managers by the Brain Resource Ltd. in a secure format, and participants will be 
identified in the dataset by their unique user ID.  
3) The sites’ EHR will be used to identify potentially eligible participants, and to provide study data for 
randomized participants. All EHR data will be transmitted in a secure manner. 
4) Participants randomized to E-Health+ will receive an email with: a link to the E-health tutorial videos and 
their study-assigned E-health username. Participant E-Health progress will be monitored by study staff via a 
secure, study-specific portal. When the study is complete, the E-health adherence data will be provided to the 
data managers by the E-health vendor (Goalistics) in a secure format, and E-Health+ participants will be 
identified in the dataset by their study-assigned E-health username.  
  
12.0 PUBLICATION/DATA SHARING 
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for publication. 
This study also follows the policy that requires that all clinical trials be registered in a public trials registry such 
as ClinicalTrials.gov, which is sponsored by the National Library of Medicine.   
 
 
13.0 SIGNATURES  
 
Statement of Compliance 
This trial will be conducted in compliance with the appropriate protocol, current Good Clinical Practice (GCP), 
the principles of the Declaration of Helsinki, and all other applicable regulatory requirements.  Participating sites 
must obtain IRB written approval of the study protocol, consent form, other supporting documents, and any 
advertising for participant recruitment in order to participate in the study. Any amendments to the protocol or 
consent materials must be approved before they are implemented. Annual progress reports and Serious Adverse 
Event (SAE) reports will be submitted to each IRB, according to its usual procedures. 
 
Typed Name      
 
Signature        
 
 Date  
  
T. John Winhusen        _________________________ __________________  
Principal Investigator  
  
_______________ 
 _________________________ __________________  
Sub-Investigator  
  
_______________ 
 _________________________ __________________  
Sub-Investigator  
  
_______________ 
 _________________________ __________________  
Sub-Investigator  
  

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29. 
 
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APPENDIX A: Goalistics Chronic Pain Management Program 
 
1.0 Overview of the E-health intervention 
Figure 1 depicts the two major components of the Goalistics Chronic Pain Management Program, referred to as 
the E-health program in EMPOWER. Program content is delivered via five Learning Centers. The Navigator 
contains the self-management tools, designed to help the user to move systematically through the program, set 
and track program goals, and monitor progress. This Appendix provides an overview of each of these program 
components. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1.1 Individually-tailored treatment plan 
Program participants traditionally begin the program by completing the Profile of Chronic Pain, a 
comprehensive battery that evaluates pain status and history, coping strategies, pain attitudes and beliefs, 
interference with daily activities, and social responses to pain. The participant’s scores are calculated and 
compared to national age- and gender-based norms. Based on this comparative analysis, a comprehensive report 
is provided and suggestions are made regarding the order of completion of the learning centers.  
 
1.2 Help/guidance for using the E-health program 
Program users vary in their computer abilities. A series of 13 Help Videos are available for the program user to 
assist with use of the program.  In addition, participants may utilize a Feedback button or email us for technical 
support.  
 
 

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2.0 Learning Center Functionality 
 
2.1 Features of Learning Centers 
Learning Centers are comprised of online learning activities and offline practice activities. Each type of activity 
is briefly described below. 
 
2.1.1 Online Learning Activities 
Each of the Interactive Learning Centers consists of a series of Online Learning Activities. Some are purely 
didactic and, in general, are presented as multimedia presentations to enhance interest and learning. Interactive 
learning activities may involve the presentation of basic concept(s) via text, pictures, diagrams, graphs, or 
video. The program user can interact with and practice the new material by answering questions or by creating 
personalized lists, journals, and/or plans. User data can be scored, graphed, tracked, reported, and sent to other 
parts of the program. Interactive activities are meant to increase the self-relevance of the program, hold the 
participant’s attention, and to keep the user engaged with display of actual, real-time data in a way that is visual 
and easy-to-comprehend. An Online Activity often results in the scheduling of an Offline Practice Activity as 
described below. 
 
2.1.2 Offline Practice Activities 
Offline Practice Activities are scheduled and tracked via the Goalistics Navigator Calendar. There are three 
types of Offline Practice Activities:  
1) Self-monitoring is an important component of behavior change, providing insight into problem areas at the 
outset, allowing for the prompt tracking of the nature and effectiveness of programmatic change, and for 
improving learning. A number of the learning centers employ self-monitoring as a means of gathering relevant, 
real-time information that the user will enter into the subsequent interactive activity. For example, in 
conjunction with the “Identify Positive Emotional Triggers” activity, the program user will use a program form 
to self-monitor positive emotions over a period of two days to identify experiences that trigger positive 
emotions. Each day, the user will receive 5 prescheduled reminders to implement the self-monitoring. 
 
 2) Practice of a new skill (e.g., social 
engagement) is an essential component of 
behavioral change programs.  
 
3) Having learned and practiced the underlying 
skills of the CPMP, the user will transition to 
the incorporation of lifestyle activities (e.g., 
exercise) into his or her daily life. A number of 
program objectives involve lifestyle changes, 
such as increased exercise, regular relaxation 
sessions, or more active social engagement. By 
scheduling and tracking such activities via the 
Navigator Calendar (see below), the ultimate 
goal is that these activities will become 
automatic and self-sustaining.  
 
Some of the offline activities utilize the Pacing 
Tool. The Pacing Tool is used to create a 
custom plan to safely and slowly increase an activity over time. The user selects an activity to be paced (e.g., 
walking, swimming, meditating, spending time socializing, time sitting at the computer), identifies the amount 
of time it can be comfortably completed (baseline), selects a target goal, and chooses weekly days/times to 

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complete the activity. The system then creates a plan that initially backs the patient off of baseline by 10%, then 
increases the duration of the activity by 10% each week until the target time is reached. Figure 2 shows 
screenshots of the Pacing Form; Figure 3 displays a sample Pacing Plan (showing weekly schedule and 
increases), and the paced activities that were automatically scheduled on the Calendar.  
 
 
 
3.0  Learning Center Content 
The five learning centers are described below. The content and interactive activities are derived from cognitive-
behavioral, interpersonal, motivational, educational, and self-management models of chronic pain and strategies 
for therapeutic change. Note that we did not “invent” new interventions; rather we transformed evidence-based, 
face-to-face strategies into an online format. 
 
 
 

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3.1 Thinking Better 
Derived from cognitive models of pain management, this learning center teaches the person with chronic pain 
how to recognize, interrupt, challenge, 
and replace dysfunctional thinking. 
Users create a custom plan to decrease 
self-defeating thoughts while increasing 
effective thinking. Figure 4 provides an 
annotated screenshot of the Thinking 
Better home page. Each of the learning 
centers is organized in the same way, as 
indicated in Figure 4. An overview 
video presents the underlying rationale 
and basic concepts to be learned in the 
center. The learning center goals and 
links to each of the interactive activities 
are included. A custom area on the 
bottom right of the page displays 
personalized content and links to 
custom plans.  
3.2 Feeling Better 
This learning center provides training in fundamental methods of emotion regulation, including identifying 
negative and positive emotional triggers, the role of relaxation training in emotion regulation, and incorporating 
positive emotional triggers into daily life. A set of relaxation sessions within the center, offer practice in using 
breathing as a trigger for relaxation, progressive muscle relaxation, guided imagery, and mindfulness 
meditation. See Figure 5 for an annotated screenshot.  
 
 
 
 

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3.3 Doing More 
The primary goals of Doing More are to increase activity and exercise and promote goal-based activities. This 
learning center is based on 
behavioral and motivational models 
of pain self-management. As shown 
in the annotated screenshot (Figure 
6), Doing More contains a tool to 
boost activity, a pacing tool, and a 
goal pursuit tool. The user creates a 
plan to pursue a personal goal each 
month and completes two activities 
that result in the creation of a 
personalized fitness plan involving 
both cardiovascular activity and one 
of our 15 flexibility/strength 
programs (created by a physical 
therapist and physical 
medicine/rehabilitation physician).  
 
 
 
 
 
 
 
 
 
 
3.4 Relating Better 
This learning center is derived from interpersonal/transactional models of pain management. The program user 
learns about types of social 
support and how to differentiate 
effective versus ineffective 
support. A personalized support 
plan is created. The importance 
of engaging in positive social 
engagement is discussed and 
the user creates a plan to 
increase social activities. See 
the annotated screenshot in 
Figure 7.  
 
 
 
 
 
 
 
 

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3.5 Understanding Pain 
This learning center teaches basic concepts underlying the biopsychosocial perspective on chronic pain and its 
management. It consists of a series of videos covering such topics as medication management, the safe use of 
pain medication, reducing reliance on pain medication, relaxation, cognitive behavior therapy, biomedical 
treatment options, and hypnosis. See the annotated screenshot in Figure 8. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
4.0  E-health Navigator 
The foundation of the Chronic Pain Management Program is goal setting and self-management. The learning 
activities of the E-health intervention focus on a consistent goal-based process of learning new information, 
practicing it online and offline, tracking progress, troubleshooting problems, and incorporating newly learned 
material into daily life. The Navigator (see Figure 9 for screenshot) delivers the self-management tools of the E-
health intervention including Activity Scheduling, Tracking of Daily Progress, and Tracking of Progress of 
Offline Practice Activities. A brief overview of each component follows. 
 
4.1 Activity Scheduling 
The Navigator Calendar allows the user to schedule program activities and goals, send email and text-message 
reminders, and use other basic calendar functions. The Self-Monitoring Tool is built into the calendar and 
allows the user to select a self-monitoring exercise (e.g., monitoring positive emotions), schedule it on the 
calendar, and send automated email or text alerts throughout the day.  
 
 
 

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4.2 Tracking of Progress via Daily Check-In 
 
Daily Check-In is a key capability of the Navigator designed to assist the user in tracking progress over time. 
Using a visual 5-star rating scale, the program user rates mood, pain management, and activity level. As 
displayed in Figure 9, the three ratings are displayed in a color coded, 30-day graph, allowing the user to track 
progress and to observe relationships among the variables. As users complete the learning centers, they will be 
able to visually track improvements.  
Note that the Daily Check-In is linked to 
a separate set of program features: Mood 
Boosters, Pain Soothers, and Activity 
Boosters. These tools allow the user to 
create a set of activities or experiences to 
boost mood, decrease pain, and increase 
activity. For example, a Mood Booster is 
defined as indicated in Figure 10 and 
mood boosters are created as shown in 
Figure 11. They can then be added to the 
calendar as needed. Pain Soothers and 
Activity Boosters are also easy-to-
implement, brief activities to provide a 
noticeable reduction in pain or increase 
in activity.  Low mood, low pain 
management, or low activity ratings in 
the Daily Check-In over several days will 
trigger a reminder to schedule a Mood 
Booster, Pain Soother, or Activity 
Booster. 
 
 
 
 
 
 
 
 
 

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4.3 Track Progress of Offline Practice Activities 
The user can monitor daily progress by recording whether scheduled program activities were completed or not 
completed. If the user completed the activity, s/he is asked to indicate how helpful it was and how much the 
activity helped the user move closer to the Learning Activity goal. In addition, the user will be asked what 
facilitated the completion of the activity. On the other hand, if the user is unable to complete a daily activity, 
he/she will be asked to indicate what specifically interfered with activity completion.  
All of the above information is automatically compiled on an Activity Detail Page in the My Progress section of 
the Navigator, a critical source of information to help the user stay on track. Daily entries about what helps and 
interferes with activity completion are displayed, and compared to those of other program users. This 
information will help the user to understand his/her progress and to troubleshoot lack of progress. The system 
also displays progress in terms of Activity Completion Rate, the percentage of times that the user completed a 
scheduled activity. Each week, if the overall completion rate is reasonably high (e.g., 75% or greater), a 
congratulatory message will be sent along with the suggestion that the user select a reward from his/her Self-
Reward Menu: a personalized list of rewards generated by the user. The tool is similar in structure to the Mood 
Boosters, Pain Soothers, and Activity Boosters tools. The Self-Reward tool allows the patient to create a 
personalized list of inexpensive, easy-to-implement rewards to self-administer for progress and success within 
the program. See Figure 12 for a sample My Progress report.  
 

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