A Feasibility Study of a Chronic Pain Self-management Intervention for Older Adults Incorporating Podcasts and Patient Priorities
Phase: NA
Conditions: Chronic Pain
Sponsor: University of Michigan

 
Cover Page for ClinicalTrials.gov 
 
Document: Study Protocol 
 
Study Title: A Feasibility Study of a Chronic Pain Self-
management Intervention for Older Adults 
Incorporating Podcasts and Patient Priorities 
 
Document Date: 1/11/2023 
 
NCT Number: NCT06185101 

 
 
A feasibility study of a chronic pain self-management intervention for older adults 
incorporating podcasts and patient priorities 
 
STEP-UP Pilot Trial 
National Clinical Trial Number (clinicaltrials.gov): NCT06185101 
Principal Investigator (Subproject of P30AG022845)  
Mary R. Janevic 
Research Associate Professor 
School of Public Health 
Department of Health Behavior and Health Education 
University of Michigan 
 
Supported by: 
National Institute on Aging 
Grant P30AG022845  
  
Title of Grant: Cornell Edward R. Roybal Center 
Translational Research Institute on Pain in Later Life (TRIPLL-III) 
MPIs of Grant: M. Carrington Reid, MD/PhD, Karl Pillemer, PhD, & Elaine Wethington, PhD 
Version Number v. 1.2 
Date: January 11, 2023 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
Protocol summaryct.gov 
4 
1 
Rationale & Background 
5 
1.1 
Study Rationale 
5 
1.2 
Background 
5 
1.3 
Specific Aims 
5 
1.4 
Risk/Benefit Assessment 
6 
1.4.1 
Known Potential Risks 
6 
1.4.2 
Known Potential Benefits 
7 
1.4.3 
Assessment of Potential Risks and Benefits 
8 
2 
OBJECTIVES & ENDPOINTS 
8 
3 
STUDY DESIGN 
9 
3.1 
Study Design 
9 
3.2 
Study flow 
10 
5 
Selection and enrollment of participants 
11 
5.1 
Inclusion Criteria 
11 
5.2 
Exclusion Criteria 
11 
5.3 
Recruitment 
11 
5.4 
Informed Consent & Enrollment 
12 
5.5 
Screen Failures 
13 
5.6 
Strategies for Recruitment and Retention 
14 
6 
STUDY INTERVENTIONS 
15 
6.1 
STEP-UP Intervention Overview 
15 
6.2 
STEP-UP Intervention Process 
15 
6.3 
Control Study Arm 
18 
6.4 
Measures to Minimize Bias: Randomization and Blinding 
18 
6.5 
Study Intervention Adherence 
18 
6.6 
Concomitant Treatment 
18 
6.7 
Lifestyle Considerations 
18 
6.8 
Intervention Discontinuation 
18 
6.9 
Treatment Fidelity 
19 
6.9.1 
Overall compliance 
19 
6.9.2 
Community Health Worker Training and Tracking 
19 
6.10 Withdrawal from the Study 
19 

 
 
STEP-UP Protocol, v1.2 
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6.11 Lost to Follow-up 
20 
7 
STUDY PROCEDURES 
21 
7.1 
Schedule of Activities 
21 
7.2 
Description of Activities 
22 
8 
SAFETY 
22 
8.1 
Potential Risks & Benefits - See Section 1.4 
22 
8.2 
Event Reporting Schedule 
22 
8.3 
Definitions for Events 
22 
8.4 
Classification of Adverse Events 
23 
8.4.1 
Severity of Event 
23 
8.4.2 
Relationship to Participation 
23 
8.4.3 
Expectedness 
24 
9 
Quality Control and Data monitoring procedures 
25 
10 Confidentiality and privacy 
27 
11 STATISTICAL CONSIDERATIONS 
28 
11.1 Sample Size 
28 
11.2 Data Analyses 
28 
11.2.1 General Approach 
28 
11.2.2 Primary & Secondary Endpoints 
29 
11.2.3 Other Pre-specified Analyses 
29 
12 Interim Analysis 
30 
13 Publications 
30 
14 protocol amendment history 
30 
 
 
STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
 
• 
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies 
(45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR 
Part 812)  
 
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 

 
 
STEP-UP Protocol, v1.2 
3 
 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the Institutional Review Board (IRB) for review and approval.  Approval of both 
the protocol and the consent form must be obtained before any participant is enrolled.  Any 
amendment to the protocol will require review and approval by the IRB before the changes are 
implemented to the study.  In addition, all changes to the consent form will be IRB-approved; a 
determination will be made regarding whether a new consent needs to be obtained from 
participants who provided consent, using a previously approved consent form. 
 
 

 
 
STEP-UP Protocol, v1.2 
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PROTOCOL SUMMARYCT.GOV 
Title: 
 
A pilot and feasibility study of a chronic pain self-management intervention 
for older adults incorporating podcasts and patient priorities. 
 
Study Description: 
This randomized pilot trial tests the feasibility of a community health worker 
(CHW)-delivered chronic pain self-management intervention for older adults 
("STEP-UP"; Support, Training, and Education for Pain Self-Management – 
Using Podcasts) in a primary care setting. 
Objectives*: 
 
We will conduct a randomized (waitlist) pilot trial (n=40) in a Federally 
Qualified Health Center.  
Endpoints*: 
Primary Endpoint: Improvement in pain interference at 8 weeks (post-
program)  
Secondary Endpoints: physical functioning and global impression of change, 
and participant engagement and satisfaction (secondary outcomes) at 8 weeks 
Study Population: 
We will recruit 40 adults from a FQHC who are age 50+ with high-impact 
chronic pain. 
 
 
Phase* or Stage: 
Stage 1 (Behavioral Stage Model) Pilot Trial 
Description of Sites/Facilities 
Enrolling Participants: 
Participants (N = 40) will be primarily recruited through Western Wayne 
Family Health Center’s clinic in Inkster, Michigan.  
 
Description of Study 
Intervention/Experimental 
Manipulation: 
The STEP-UP chronic pain self-management intervention (Support, Training, 
and Education for Pain Self-Management – Using Podcasts) will feature an 
educational podcast series teaching core pain self-management skills. 
Podcasts will be supplemented by sessions with a Community Health Worker 
taking place at designated times over a 7-week period. The Community Health 
Worker will guide participants in a modified Patient Priorities of Care (PPC) 
approach to help them identify their values and priorities and develop goals 
that reflect these.. 
Study Duration*: 
One year 
 
Participant Duration: 
Eight weeks 

 
STEP-UP Protocol, v1.2 
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1 
RATIONALE & BACKGROUND 
1.1 
Study Rationale 
Our overall objective in this pilot trial is to develop and test the feasibility and preliminary 
efficacy of a pain self-management intervention (STEP-UP, or Support, Training, and Education 
for Pain Self-Management – Using Podcasts) that combines educational podcasts with 
community health worker-led sessions eliciting participants’ values and related functional goals, 
and test its feasibility among primarily African American older adults at a Federally Qualified 
Health Center in a low-income community. STEP-UP is derived from the STEPS intervention, 
currently being tested in a large RCT (R01AG071511) but uses different educational tools (e.g., 
podcasts vs. videos in the original STEPS), includes a newly-developed component based on the 
Patient Priorities Care approach developed by Tinetti and colleagues, and is designed for 
delivery in a clinic-based (vs. community) setting. 
1.2 
Background 
African American older adults disproportionately face barriers to managing persistent pain, 
including multimorbidity, chronic psychosocial stressors, and suboptimal pain care--all of which 
are rooted in structural racism. Yet opportunities to learn chronic pain self-management (CPSM) 
skills that can improve functioning and quality of life are scarce in underserved communities. 
Moreover, typical CPSM interventions provide little guidance for how older adults can work 
with their providers to help ensure that their pain treatment plans reflect their values, priorities, 
and health goals. We propose to address these gaps by developing the novel STEP-UP 
intervention (Support, Training, and Education for Pain Self-Management – Using Podcasts). 
STEP-UP will feature a podcast series teaching core pain self-management skills in a culturally-
congruent manner. Podcasts will be accompanied by telephone sessions with a community health 
worker, who will guide participants in a modified Patient Priorities of Care (PPC) approach 
(originally developed for older adults with multiple chronic conditions) to identify their most 
important values and health outcome goals, and healthcare preferences. This information will 
inform self-management goals and will be shared with providers to promote patient-centered 
pain care.  
 
1.3 
Specific Aims 
1. Develop and beta-test the STEP-UP chronic pain self-management intervention. 
a) Create podcast episodes based on content from our existing STEPS and Positive 
STEPS CPSM interventions and lessons learned from podcast production in our 
ongoing RESET study.  
b) Design community health worker session protocols and adapt the PPC process for 
the pain care context with expert and provider input.  
c) Conduct a “beta” test of STEP-UP (n=5 participants) to refine content and 
processes. 
 
 
2. Conduct a pilot RCT of STEP-UP.  

 
STEP-UP Protocol, v1.2 
6 
 
a) Using a waitlist randomized control design, deliver the STEP-UP intervention to 
40 adults, age 50+ with high-impact chronic musculoskeletal pain, in a Federally-
Qualified Health Center. 
b) Assess baseline to post-program changes in pain interference (primary outcome) 
and global impression of change in pain and functioning and participant 
engagement (secondary outcomes). Use mixed methods to evaluate key processes 
and explore mechanisms of effect.  
Conduct qualitative interviews with clinic providers and administrators to: 1) identify factors 
affecting implementation, and 2) assess needs regarding a future provider-facing STEP-UP 
component. **JAN 11, 2023, NOTE: This will follow the pilot trial and the sampling plan will 
be informed by our experience during the trial; therefore, we will seek IRB approval for this 
element at a later date. *** 
1.4 
Risk/Benefit Assessment 
1.4.1 Known Potential Risks 
The risks of study participation are minimal, as we are testing an adaptation of a cognitive-
behavioral intervention for chronic pain self-management, which does not involve drugs or 
devices and is non-invasive.   
 
Below we list the potential risks, and in Section 1.3.b. we discuss how we will protect 
against/minimize each of these risks. 
 
1. Psychological distress (FREQUENCY: Infrequent. SERIOUSNESS: Mild). A plausible 
but unlikely risk to participants is psychological distress during the course of the baseline or 
follow-up assessments or telephone sessions.  
 
In the event of a participant expressing elevated distress as the result of an interaction, study staff 
will terminate the interaction (if deemed necessary) and/or offer psychological resources. We 
will have an updated list of Detroit-area resources for psychological support, which will be 
offered and mailed to participants as needed. Almost all of the survey questions (and all of the 
questions that are related to sensitive issues such as depressive symptoms) have been used in 
multiple prior studies, without noted problems. Participants will be informed as part of their 
informed consent process and immediately prior to each telephone interview that they can refuse 
to answer any of the questions or drop out of the study at any time. They will be asked if they 
would like to complete the interview over shorter sessions, if needed. 
 
2. Breach of confidentiality during study activities (FREQUENCY: Rare, SERIOUSNESS: 
Mild). 
 
Rigorous data security measures and staff training procedures will be put in place to minimize 
the risk of breach of confidentiality. 
 
As part of their consent process, participants will be informed about the small risk of a breach of 
confidentiality. Email and text messages will only be used to reply to or contact participants if 
they choose this mode. For example, a participant may request a reminder text or email for a 

 
STEP-UP Protocol, v1.2 
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scheduled survey or study visit, or they may indicate during enrollment that text or email is the 
best way to reach them to schedule telephone surveys or study visits. In this case, the study team 
may reach out to the participant via UM email or via text message. Survey responses or sensitive 
information will not be shared via email or text message. A secure UM email (Google) account 
will be created for the study and will be monitored by study staff. 
 
All participant study information will be kept in a secure, HIPAA-compliant REDCap database 
within the University of Michigan. Additional study files will be secured in a HIPAA-compliant 
University of Michigan team Dropbox account.  
 
Throughout the study, IRB guidelines and best practices in human subjects research will be 
followed to ensure the privacy and integrity of the information we collect. Any breach of 
confidentiality will be immediately reported to the PI and to the University of Michigan Health 
Sciences and Behavioral Sciences IRB. In addition, any complaints or concerns expressed to the 
study staff by participants, providers, or anyone else affected by this study will be immediately 
reported to the PI, and as appropriate, to the IRB.   
 
All study staff, including community health workers, and research assistants will complete the 
online Social and Behavioral Research Best Practices course (https://research-
compliance.umich.edu/hrpp-education-resources) which fulfills the NIH Good Clinical Practice 
requirement and the web-based University of Michigan's Responsible Conduct of Research 
Training Program, known as PEERRS (Program for Education and Evaluation in Responsible 
Research and Scholarship). Proof of their certification and completion of the training program 
will be kept on file. Training of staff will include information about the importance of privacy 
and confidentiality and specific techniques to maintain confidentiality of all information in the 
context of this study. Regular study team meetings will be used to ensure that all data quality and 
IRB policies and procedures are being followed.  
 
All research data presented in reports, presentations, or manuscripts will be in aggregate and/or 
de-identified form only. 
 
 3. Physical Injury (FREQUENCY: infrequent, SERIOUSNESS: Mild) 
 
Another possible risk is minor physical injury from doing physical activity that is encouraged by 
the STEP-UP program. Participants are encouraged to engage in physical activity of their choice, 
at a level that is comfortable for them. As with any physical activity, it is possible that 
participants could experience an injury while doing physical activity, like muscle strain. To 
minimize this risk, the STEP-UP Community Health Worker will guide participants in increasing 
activity levels slowly and will encourage them to check with their doctor if they do not know 
whether a specific activity is appropriate.  
 
1.4.2 Known Potential Benefits 
This intervention for chronic pain self-management will incorporate evidence-supported 
strategies to promote improved pain coping, and therefore has the potential for beneficial 
physical and/or psychological effects. 

 
STEP-UP Protocol, v1.2 
8 
 
  
1.4.3 Assessment of Potential Risks and Benefits 
This study is considered low risk to participants. It is non-invasive and offers a variety of 
resources for chronic pain management that are not commonly part of standard pain care. It 
incorporates evidence-based strategies that may improve health and functioning. If the program 
is effective, it has the potential to be a useful adjunct to clinical care. Overall, given that the 
potential risks of participation are minimal, the potential benefits outweigh the potential risks. 
 
 
 
2 
OBJECTIVES & ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR ENDPOINTS 
Primary 
 
 
To determine if 
participating in the STEP-
UP intervention leads to 
decreased pain interference 
with daily functioning. 
 
 
PROMIS Pain 
Interference 6a scale is 
the primary endpoint 
(pain interference is 
assessed at baseline, and 
8 weeks from baseline). 
A 2.5 point difference in 
T-score is considered 
clinically significant. 
Pain interference is a patient-centered 
outcome that indicates pain’s impact on 
valued and necessary activities. This 
intervention teaches skills such as goal 
setting to gradually increase engagement 
in daily activities.  
Secondary 
 
 
To determine if 
participating in the STEP-
UP intervention leads to 
greater improvement in 
Global Impression of 
Change in Pain and 
Functioning. 
Patient Global 
Perception of Change 
since baseline will be 
assessed at 8 weeks. 
Participants will be 
asked about pain and 
functioning in separate 
items. 
“Global impression of change” variables 
capture participants’ subjective 
perceptions of intervention benefit. 

 
STEP-UP Protocol, v1.2 
9 
 
To assess participant 
engagement in the 
intervention. 
Number of sessions (out 
of 7) completed at 8 
weeks from baseline. 
Given the novel nature of this intervention 
and the barriers that many participants 
may experience to engagement, it is 
important to assess whether the 
intervention as designed yields acceptable 
engagement levels. 
 
To assess participant 
satisfaction with the 
intervention. 
Items ask about overall 
satisfaction with the 
program, e.g., whether 
participation increased 
understanding of pain 
management (1= 
Strongly Disagree to 5= 
Strongly Agree). A 
higher score indicates 
higher patient 
satisfaction. 
 
These items will facilitate understanding of 
the intervention’s acceptability in the 
priority population as well as highlight 
potential areas for improvement prior to a 
larger trial or another future iteration of the 
intervention. 
 
 
3 
STUDY DESIGN 
3.1 
Study Design 
● 
NIH Behavioral Intervention Stage 1 randomized pilot trial to examine the acceptability 
and preliminary effects of the STEP-UP program on pain interference among older adults 
with chronic pain compared to a control group.   
● 
Participants will be allocated into the two study arms in a 1:1 ratio by block 
randomization with mixed block sizes. 
 
 
 
 
 
 
 
 
 
 
 
 

 
STEP-UP Protocol, v1.2 
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3.2 
Study flow 
4 
 
 
 
 

 
STEP-UP Protocol, v1.2 
11 
 
5 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
5.1 Inclusion Criteria  
Participants will be eligible if they:  
● Are 50+ years of age 
● Report high-impact chronic musculoskeletal pain (defined as pain in muscles or joints for 
>= 3 months “most days” or “every day” on a scale of never, some days, most days, or 
every day) AND their pain limited life or work activities over the past 3 months “most 
days” or “every day” 
● Have a cell or landline phone 
● Able to converse comfortably in English 
● Have not participated in another chronic pain self-management intervention in the last 5 
years. 
● Participants must be willing to meet by telephone with a Community Health Worker and 
listen to audio recordings (podcasts) to learn ways to manage pain and commit to the 
duration of the program. However, the study is voluntary, and participants may leave the 
study at any time.  
5.2 Exclusion Criteria 
● Hospitalization in the last month 
● Planned major surgery in the next three months that would interfere with program 
participation (e.g., knee or hip replacement) 
● Current or previous participation in either the STEPS or RESET interventions 
● Severe cognitive impairment or other severe physical or psychiatric disorder judged by 
the study team to pose a significant barrier to participation 
 
5.3 
Recruitment 
Recruitment for this study will take place through the Western Wayne Family Health Center 
(WWFHC). Several options for recruitment may be used: 1) By identifying potential participants 
age 50+ with specific diagnostic codes in the electronic medical record (EMR) system and 
sending them a letter and/or text message/portal message (sent out directly by WWFHC to 
patients; this process will be done in waves by zip code so that screening and enrollment can be 
done on a steady, “rolling” basis); 2) by making flyers available in clinic areas (either tables 
staffed by the UM study team or leaving flyers out for patients to pick up on their own - in the 
case of UM staffed tables, we will ensure that any screening that happens would take place by 
trained and IRB-approved UM study staff in a private location off the main clinic); and 3) direct 
referrals by WWFHC providers. In the case of direct referrals by WWFHC providers, the 
providers would give the patient a study flyer and/or the UM study team’s contact information so 
the patient can reach out to the UM study team for more information and next steps.  The UM 
study team will not receive any patient information directly from WWFHC. Potentially eligible 
patients will be informed about the study team by WWFHC and directed to contact the UM study 
team if they are interested in learning more.  
 

 
STEP-UP Protocol, v1.2 
12 
 
Three versions of the study flyers will be available; a simple version with the UM study hotline 
number and UM study email (used for tabling and recruitment events located at WWFHC and in 
the community; some WWHFC patients/providers may prefer the simpler version), a version 
with tabs so interested individuals can take the UM study team's contact information to contact 
later (for posting at WWFHC and in the community), and a QR code version where interested 
individuals can use their smartphone camera to scan the code and complete a brief interest form 
via UM Qualtrics (used for tabling and recruitment events located at WWFHC and in the 
community). The UM study team will receive automated emails when individuals leave 
voicemails on the study hotline number and when someone completes the UM Qualtrics interest 
form. The UM study team will add interested individuals to the REDCap database and reach out 
to them within one week of receiving their interest form and/or voicemail to follow up 
accordingly. 
5.4 
Informed Consent & Enrollment 
During recruitment contacts each patient will hear a brief description of the study before being 
asked if they wish to be screened for eligibility.  In addition to meeting eligibility criteria, 
participants must be willing to meet by phone with a community health worker and listen to 
audio recordings (podcasts) to learn ways to manage pain and commit to the duration of the 
program. Interested individuals will be screened by trained and IRB-approved UM study staff on 
site or by telephone to further assess eligibility and invite to participate, if appropriate.  
If a patient expresses interest in participating in the study by contacting the UM study team or at 
a tabling event, UM study staff will follow up with the patient by telephone (UM Zoom Phone) 
to see if the participant is interested and, if so, go through the eligibility screener with the patient 
using the study’s UM REDCap database. After this they will complete the verbal consent process 
over the telephone. This can be completed directly after the screening process, or the patient can 
schedule it for another time. 
In some cases, if there is time and private space available at the WWFHC clinic when UM study 
staff tabling and handing out flyers, UM study staff may go through the eligibility screener 
questions with the participant in-person at the clinic then schedule a telephone follow up to 
complete verbal consent process and next steps. If in-person, UM study staff would record the 
patient’s responses to the eligibility questions on a paper version and enter the responses into 
REDCap directly after the recruitment event. Paper versions of the eligibility questions will be 
kept securely in the UM study team’s locked office at the University of Michigan School of 
Public Health.  If the participant is eligible, the UM study staff will confirm a day and time to 
follow up with the participant and complete the verbal consent process over the telephone.  
For both, telephone and in-person screening, participant responses to the eligibility questions will 
be kept securely in the REDCap database.  
Participants who are eligible will be offered more details about the study. They will be told that 
those agreeing to participate in the research will be randomly assigned to one of two groups 
(with an equal chance of being in either), after completing informed consent and a baseline 
telephone survey.   

 
STEP-UP Protocol, v1.2 
13 
 
The intervention and control conditions will be described as follows. Individuals in the 
intervention group will meet with a community health worker for a 1-1.5 hour orientation session 
(typically in person but may be virtual in special cases described in Section 6.2) to get oriented to 
the program, receive a hard-copy workbook, and engage in a values-clarification and goal-setting 
exercise. Participants will then be asked to listen to one podcast episode per week for five weeks, 
each presenting a new pain self-management skill. Podcasts will be made available by both 
website and an IVR system. Each week, participants will receive a reminder text, voicemail, 
and/or brief telephone call from the CHW encouraging them to listen to that week’s podcast 
episode, complete corresponding tasks as described in the workbook, and continue to work on 
their goal. After completing the follow-up telephone survey at 2 months from baseline (see 
below), individuals in the control group will be invited to take part in the intervention. 
Participants in both groups will be asked to complete two data collection telephone interviews (at 
baseline and 8 weeks from baseline), each of approximately 45 minutes in length.  
Informed consent procedures: If an eligible individual expresses interest in participating, they 
will be asked to verbally consent over the phone, either right away or on a subsequent call, 
according to participant preference and whether the participant completes the eligibility screener 
in-person or over the phone as mentioned earlier in Section 5.4. Participants will have the option 
to have a copy of the consent document mailed or emailed to them to review beforehand, or they 
can choose to complete the verbal consent first and have a copy of the consent document mailed 
or emailed to them afterward. The consent document will be mailed in a packet that also contains 
survey scale options for the initial, baseline survey. These are the response options for each of 
the survey items so the participant can more easily follow along on the telephone.  
During the verbal consent process, the interviewer will read the informed consent document 
aloud, stopping to ask questions after each section. The verbal consent is documented in three 
ways. 1) With the participant’s permission, we will audiorecord the verbal consent interaction 
(using UM Zoom or UM Zoom Phone) and securely store the audiofiles in access-restricted UM 
Dropbox folders. 2) We write their full name, the date, and the interviewer's initials to document 
that verbal consent was obtained in REDCap. 3) We will also indicate in REDCap that verbal 
consent was provided and document the date. 
For participants who choose to have the consent document mailed to them first, research staff 
will call potential participants approximately one week after mailing the consent document to go 
through the verbal consent process over the phone and answer any questions. If the participant 
preferred an emailed copy of the consent document, research staff may call sooner based on the 
participants preferences.  
Upon completing verbal consent, the participants will be enrolled in the study and will be 
scheduled for a baseline interview. 
5.5 
Screen Failures 
Individuals who sign the consent document and who subsequently are deemed ineligible or 
inappropriate for participation (e.g., unable to participate meaningfully in study activities, 
discovery that diagnoses are not consistent with study criteria, etc.) will not be enrolled, but 
instead classified as “screen failures.” 

 
STEP-UP Protocol, v1.2 
14 
 
5.6 
Strategies for Recruitment and Retention 
Recruitment: We expect that the strategies outlined in Section 5.3 will yield enough participants 
for this pilot study, and we expect that most participants will be WWFHC patients. However, if 
needed, we will recruit from outside of the clinic, by working with the network of senior centers 
and senior housing facilities in the Detroit area with which we have developed relationships over 
several years, using flyers, information sessions, and word of mouth to advertise this study. 
Information sessions will be done by trained UM study staff. These would be done at WWFHC 
clinics or at a senior center/senior housing center. During the information sessions, UM staff 
provide an overview of the study and answer questions about study participation. Individuals 
who attend the information session will be invited to provide their contact information to the 
study team for follow up, if they are interested in participating. In some cases, if time and space 
allows, the study team may complete the study eligibility screener in-person with the participant 
and schedule them for a verbal consent over the telephone, as described in Section 5.4.  
Retention: We will follow detailed protocols that we have successfully used in past studies with 
older adults from vulnerable populations to try to retain participants once enrolled, including 
making a specific number of contact attempts at different times, with the goal of maximizing 
retention without being bothersome to participants or coercive. Specifically, these are the 
guidelines we will follow: 
● We will call each participant 10 times without answer or response before marking them as 
Lost to Follow-up (Unable to Contact). 
● If we call someone and the number is disconnected, we will arrange for a call-back one week 
later. If we call then and it is still disconnected we will arrange for a call-back two weeks 
later, and, if we have their address, mail them an “Unable to Contact” letter. If we call then 
and it is still disconnected, we will arrange for a call-back one month later.  If it still 
disconnected at that point, we will mark the participant as Lost to Follow-up (Unable to 
Contact). 
● We will reschedule a participant's baseline survey 5 times. We will reschedule the follow-up 
as many times as it takes to get the participant to complete it, until a one-month window from 
when the ideal follow-up date has passed (the ideal follow-up date is two months from 
baseline). 
● We will attempt to contact a person for their follow-up survey 5 times; then send an Unable 
to Contact letter. If we do not hear from them, we will contact them a total of 5 more times. 
● We will reschedule attendance at the orientation session (intervention participants only) a 
maximum of 3 times. 
● All contact attempts will be documented in REDCap.  
We will offer incentives for each data collection point. All incentives are provided in the form of 
gift cards from the Human Subjects Incentive Program at the University of Michigan. 
Participants will receive a $20 gift card incentive for the first data collection point and a $30 gift 

 
STEP-UP Protocol, v1.2 
15 
 
card incentive for the second data collection point. Participants will also be given an inexpensive 
pedometer to count their steps during the program, if they choose to, and as an additional 
incentive. The study team will not ask participants to report their step counts as part of the study 
data. 
In the STEP-UP intervention group, we will track session adherence. The CHW will be provided 
with guidelines for contact frequency. If participants do not respond back to the CHW, the study 
team will reach out to see if there are any issues that can be solved to increase engagement.  
 
6 
STUDY INTERVENTIONS 
Participants will be randomized to one of two study arms in a 1:1 ratio: Arm 1 will receive the 
STEP-UP intervention and Arm 2 will be in the control group and will be waitlisted to be invited 
to receive the intervention.  
6.1 
STEP-UP Intervention Overview 
STEP-UP will feature a podcast series teaching core pain self-management skills. Podcasts will 
be accompanied by regularly scheduled telephone sessions with a community health worker, 
who will guide participants in a modified Patient Priorities of Care (PPC) approach (originally 
developed for older adults with multiple chronic conditions) to identify their most important 
values and health outcome goals, and healthcare preferences. This information will inform self-
management goals and will be shared with providers to promote patient-centered pain care.  
 
6.2 
STEP-UP Intervention Process 
Orientation session: Intervention participants will meet in person with a CHW for a one-time 
study orientation (about 1-1.5 hours for most participants) to get oriented to the program, receive 
a hard-copy workbook, and respond to a brief social needs screener (PRAPARE), allowing the 
CHW to make referrals to any needed resources. The orientation session will typically be in 
person, but it may be completed virtually, via UM Zoom link, in special cases such as 
transportation barriers, scheduling challenges, patient mobility issues, and/or for public health 
reasons like COVID-19. The UM team will also try to provide transportation for participants to 
get from their home to the WWFHC clinic if that is a barrier to attending the orientation in-
person (like Green Cab or Uber/Lyft). The orientation will be completed in private location 
where the CHW and participant can speak comfortably. For the social needs screener, the CHW 
will read the PRAPARE questions out loud and record the participant’s answers to the questions 
in UM REDCap database. The participant can choose to decline answering any of the PRAPARE 
questions they prefer not to answer. Based on the participant’s responses, the CHW will provide 
community-based resource referrals (such as organizations serving seniors, senior centers, food-
related resources, local health department information, etc.). Contact information for referrals 
will be given to the participant at the orientation so they can follow up if they choose to.  

 
STEP-UP Protocol, v1.2 
16 
 
Participants will also engage in a values-clarification exercise (“What Matters Most”, in the 
domains of Connecting, Enjoying Life, Managing Health, Functioning) and goal-setting process, 
adapted from the Patient Priorities Care model. Participants will set meaningful activity goals 
that reflect their values. This process will include completing a “My Pain Priorities” summary 
sheet that can be shared with their provider, which includes information about care that they 
perceive as helpful or burdensome. The CHW will also complete a fillable form for each 
participant that states that they are taking part in the STEP-UP study and will include the 
information from the My Pain Priorities summary sheet. The CHW or study staff will fax this 
form to the WWFHC secure fax line for patient information and it will be uploaded by WWFHC 
into the patient’s Electronic Health Record (EHR). This is a way for the CHW to put information 
into the EHR without having to have their own access to the EHR system. By adding the 
participant’s My Pain Priorities summary sheet to their EHR, the participant’s healthcare 
providers can see what the participant’s goals and values are for a patient-centered approach to 
pain management. This may better facilitate conversations between the patient and the provider 
related to values and priorities. At this orientation, participants will also learn how to access the 
audio recordings (podcasts) and they will choose a time for weekly telephone sessions with the 
CHW. 
Subsequent sessions: Participants will be asked to listen to one podcast episode per week, each 
presenting a new self-management skill along with motivational elements to try out the new 
skill. Podcast audiofiles will be made available on a website or “dial in.” Each week, participants 
will receive a reminder text, voicemail, or phone call from the CHW (based on their preferences) 
encouraging them to listen to that week’s podcast episode, complete tasks as described in the 
workbook, and continue to work on their values-informed behavioral goal.  
During the final week, participants will have a 30-minute wrap-up session with the CHW. This 
final session can be done in-person or by telephone, depending on the participant’s preferences. 
At this final session, they will reflect on progress made, establish a goal to work on going 
forward, and receive encouragement to discuss their “My Pain Priorities” summary sheet with 
their provider if they haven’t already. See the table below for more details about the six weekly 
sessions. 

 
STEP-UP Protocol, v1.2 
17 
 
STEP-UP Intervention Content
 
Week 
Format/ 
CHW 
contact 
Main topics 
Week 1 
Orientation 
1-1.5 hr, in person 
with CHW (Zoom 
as back up option) 
-      How STEP-UP program will work 
-      Provide workbook, pedometer, and other materials (e.g., PPC) 
-      Podcasts: explain and practice accessing 
-      Chronic Pain 101: How body and brain process pain signals, holistic approach to 
managing pain and maintain quality of life 
-      Introduce Patient Priorities of Care approach (via video with discussion): Values 
identification and SMART goal 
-      Administer SDOH screener (PRAPARE) and provide resources 
Week 2 
Staying Active 
  
CHW 
30 
min 
phone 
session 
-      How physical activity helps with pain and fatigue 
-      Strategies for incorporating physical activity into daily routine 
-      Explore opportunities for physical activity and resources 
-      Problem-solve barriers and challenges 
-      Goal check-in 
Week 
3: 
Relaxing 
and 
Reducing Stress 
CHW 
15 
min 
phone session 
-      Explore how stress and pain are linked 
-      Introduce relaxation techniques (deep breathing, guided imagery, PMR) 
-      Goal check-in 
Week 
4: 
Partnering with 
Your Provider 
CHW 
30 
min 
phone session 
-      Review Patient Priorities Care approach; sharing worksheet with provider 
-      How to get the most out of healthcare visits and planning for visits 
Week 5: Doing 
What You Love 
CHW 
15 
min 
phone session 
-      Importance of making time for well-being, self-growth, and fun 
-      Identify ways to incorporate pleasant activities into daily life 
Week 6: Moving 
Forward 
30-min 
CHW 
phone 
or 
in-
person session 
-      Review of sessions and strategies presented 
-      Celebrate successes and progress 
-      Establishing long-term goals and plan for “relapse” 
-      Identify helpful resources moving forward 

 
STEP-UP Protocol, v1.2 
18 
 
 
6.3 Control Study Arm 
Participants assigned to the control condition will be administered the baseline and 8-week follow-up surveys. 
After that, they will be invited to take part in the STEP-UP intervention but will not receive any additional 
incentive for participating in the intervention, and they will not have additional outcome data collected 
(meaning the participants will not complete any additional study surveys when participating in the STEP-UP 
program after their 8-week follow up survey). Process intervention data will be tracked for all control group 
members who opt to do STEP-UP, such as completion of CHW orientation and subsequent telephone sessions.   
6.4 
Measures to Minimize Bias: Randomization and Blinding 
Participants will be randomized to intervention or control groups using a block randomization scheme with 
randomly selected block sizes. The study team member who randomizes participants will be blinded to 
participant responses on the baseline assessment and will only be informed if the assessments were completed. 
Participants will be informed by the study team of their study arm assignment and will be informed of next 
steps for their study arm. 
6.5 
Study Intervention Adherence 
Attendance of community health worker sessions (or responding to phone calls/texts during weeks where there 
is no session) will be the main mechanism of tracking adherence. Community health workers will also log 
information from participant reports about working towards their goals during their calls. We will assess self-
report of listening to podcast episodes (0 to 5).  
6.6 Concomitant Treatment 
This study will not restrict participation in other types of treatments. However, participants in the STEP-UP 
study will not be able to participate in our other ongoing R01 studies, Re-Engaging in Self-Care and Enjoying 
Today (RESET), and the original STEPS intervention trial. These two studies are recruiting from a similar 
population and have some overlapping intervention components. We will make this clear in the recruitment 
process.  
6.7 
Lifestyle Considerations 
This study does not have any restrictions regarding lifestyle and/or diet. 
6.8 
Intervention Discontinuation 
We will end a subject's participation upon their request. The research team may end a subject's participation 
from the study if they are too acutely ill to participate or have a change in disease severity in which the study 
team (in consultation with Dr. Reid of Weill Cornell Medicine) feels that they should not take part in the 
intervention. These instances will be recorded as adverse events, and all participants will be contacted to 
determine if they can complete outcome assessments if possible. We may also end a subject's participation if 
the research team deems that the participant is not a good fit for the program (e.g., belligerent with 
staff, too difficult to contact, or confused by study procedures). 

 
STEP-UP Protocol, v1.2 
19 
 
6.9 Treatment Fidelity 
6.9.1 Overall compliance 
See 6.5 Study Intervention Adherence above.  
6.9.2 Community Health Worker Training and Tracking 
The study CHW will complete the MiCHWA CHW Certification Training Program, a 126-hour course covering 
topics such as: communication skills and motivational interviewing, documentation and reporting, navigating 
community resources, and healthy lifestyles.   
STEP-UP-specific training will take place over a series of initial training sessions (the equivalent of 
approximately 4 full days) with ongoing training/feedback by the PI or other members of the study team or 
research staff throughout the study period. Our CHW training approach has been refined over a series of 
studies, and emphasizes role play and practice sessions with feedback. We focus on older adults’ needs, 
including multimorbidity and cognitive issues, as well as record-keeping, teaching goal-setting, managing 
common issues such as temporary increases in pain after activity, and knowing when to consult with a 
supervisor and the study team.  
All intervention sessions with participants will be audio recorded, with participants’ permission, and a checklist 
will be used to determine fidelity to the session protocol in the community health worker STEP-UP manual.  
We will test for CHW “drift” from the protocol by listening to all sessions for the first 3 participants, and a 
random 20% of recorded calls thereafter, and offer feedback and additional training as needed. Recording of 
session information in REDCap (e.g., information from phone sessions such as goals, also reminder calls/texts 
and whether response was received from participant) will also be audited, on the same schedule. The CHW will 
meet regularly (weekly or biweekly) with a research staff member for coaching and feedback. The duration of 
calls will also be recorded.  
6.10 Withdrawal from the Study  
If participants withdraw or decline to finish the intervention, every effort should be made to gather primary 
outcome data (pain interference) as well as a query about adverse events.   
● The goal is to collect the information as close to the designated follow-up assessment as possible (8 
weeks). Participants need to complete the assessment within one month of the follow-up date in order to 
be counted as non-missing. 
● For intervention group participants wishing to discontinue participation in the intervention, the study 
team member will ask to call them during the scheduled follow-up window. 
● Participants who state that they wish to withdraw completely from the study will not be contacted 
further. 
 
The reason for participant discontinuation or withdrawal from the study will be recorded in REDCap. Participants 
who sign the informed consent form and are randomized to the intervention but do not begin it will not be replaced, 
due to the short overall study period. Participants who sign the informed consent form, and are randomized and 
receive the study intervention, and subsequently withdraw, or are discontinued from the study, will not be 
replaced. 

 
STEP-UP Protocol, v1.2 
20 
 
6.11 Lost to Follow-up 
A participant will be considered lost to follow-up per the protocol presented in 4.6. 
 

 
STEP-UP Protocol, v1.2 
21 
 
7 
STUDY PROCEDURES  
7.1 
Schedule of Activities 
 
Activity 
Weeks 
 
Pre 
0 
1 
2 
3 
4 
5 
6 
7 
8 
Eligibility Screening 
 
X 
 
 
 
 
 
 
 
 
 
Consent Process 
X 
 
 
 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
 
 
 
Demographics 
 
X 
 
 
 
 
 
 
 
 
Chronic conditions and overall health 
 
X 
 
 
 
 
 
 
 
 
Pain Interference (PROMIS-43 6-item scale) 
 
X 
 
 
 
 
 
 
 
X 
PROMIS-29 +214,15 (except Pain Interference subscale) 
 
X 
 
 
 
 
 
 
 
X 
Pain Intensity (Numerical Rating Scale) 
 
X 
 
 
 
 
 
 
 
X 
Pain Self-Efficacy Questionnaire 
 
X 
 
 
 
 
 
 
 
X 
Pain Medication Use  
 
X 
 
 
 
 
 
 
 
X 
Communication with Provider 
 
X 
 
 
 
 
 
 
 
X 
Chronic Pain Acceptance 
 
X 
 
 
 
 
 
 
 
X 
Physical Activity 
 
X 
 
 
 
 
 
 
 
X 
Fear of Movement 
 
X 
 
 
 
 
 
 
 
X 
Patient Activation Measure 
 
X 
 
 
 
 
 
 
 
X 
Survey of Pain Attitudes (SOPA) - Control subscale 
 
X 
 
 
 
 
 
 
 
X 
Pain Catastrophizing Scale 
 
X 
 
 
 
 
 
 
 
X 
Life Control Scale 
 
X 
 
 
 
 
 
 
 
X 
PROMIS Meaning and Purpose (4-item) 
 
X 
 
 
 
 
 
 
 
X 
Global impression of change in pain, functioning, quality of life, 
and use of pain medication 
 
 
 
 
 
 
 
 
 
X 
STEP-UP Program Evaluation Questions  (intervention group only; 
both close- and open-ended) 
 
 
 
 
 
 
 
 
 
X 

 
STEP-UP Protocol, v1.2 
22 
 
STEP-UP: CHW sessions (intervention group only) 
 
 
X 
X 
X 
X 
X 
X 
 
 
 
Notes: 
*Shaded rows represent measures on the telephone data collection surveys (at baseline and/or 8 weeks). 
**Primary and secondary outcomes are bolded. 
***Allowable assessment windows: Participants need to complete the assessment within one month of the 
follow-up due date to be counted as non-missing. 
****If participant does not start intervention within one month of baseline assessment, they will be withdrawn 
from the study by the study team. If a participant drops out of the intervention, they will be invited to 
complete the surveys if they want to (intent to treat) or they can withdraw from the study. 
 
7.2 
Description of Activities 
● Telephone data collection surveys – participants will complete the validated measures tested as outcomes or 
mediators listed above as well as other measures to help characterize health and functional status, quality of 
life, and satisfaction with the intervention, at baseline and/or 8 weeks from baseline. Participants will be 
sent response options for each of the survey scales prior to their scheduled telephone survey appointment so 
they can see the response options and follow along. If participants do not have the survey scales, they can 
either reschedule or continue with the survey if they prefer (staff will read responses for each question/item 
on the survey).     
● Randomization – occurs after a participant completes their baseline telephone survey.  
● STEP-UP Program (Intervention) – See Table in Section 6.2 for details of intervention activities and flow..  
 
 
8 
SAFETY 
8.1 
Potential Risks & Benefits - See Section 1.4 
8.2 Event Reporting Schedule 
This study will use a study-specific reporting schedule for adverse events, protocol deviations, ORIOs and 
unanticipated problems. The reporting schedule can be found in eResearch, Section 32. 
8.3 Definitions for Events  
 
We will use standard definitions of AEs/SAEs as follows: 
Adverse Event (AE): Any untoward or unfavorable medical occurrence in a human study participant, 
including any abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease, 
temporally associated with the participants’ involvement in the research, whether or not considered 
related to participation in the research. The most likely example for the present pilot study is elevated 
psychological distress. 
 
Serious Adverse Event (SAE): Any adverse event that: Results in death; Is life threatening or places 
the participant at immediate risk of death from the event as it occurred; Requires or prolongs 

 
STEP-UP Protocol, v1.2 
23 
 
hospitalization; Causes persistent or significant disability or incapacity; Results in congenital anomalies 
or birth defects; Is another condition which investigators judge to represent significant hazards.  An 
example in the present study is a hospitalization. 
 
Unanticipated Problem (UP):   
Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets all the following 
criteria:  
• 
unexpected, in terms of nature, severity, or frequency, given (a) the research procedures that are 
described in the protocol-related documents, such as the IRB-approved research protocol and informed 
consent document; and (b) the characteristics of the study population;   
• 
related or possibly related to participation in the research (in this guidance document, possibly related 
means there is a reasonable possibility that the incident, experience, or outcome may have been caused 
by the procedures involved in the research);  
• 
suggests that the research places participants or others at a greater risk of harm (including physical, 
psychological, economic, or social harm) than was previously known or recognized. 
 
8.4 
Classification of Adverse Events 
8.4.1 Severity of Event 
We will use the standard grading scale in use by the University of Michigan Institutional Review Board - 
Health Sciences and Behavioral Sciences (UM IRB-HSBS) as follows: 
 
Grading scale: 
 
1. No adverse event 
2. Mild AE – No treatment needed 
3. Moderate AE – Resolved with treatment 
4. Severe AE – Inability to carry on normal activities, required professional medical attention 
5. Life-threatening or disabling AE 
6. Fatal AE 
8.4.2 Relationship to Participation 
We will use the standard relatedness scale in use by the University of Michigan Institutional Review Board 
- Health Sciences and Behavioral Sciences (UM IRB-HSBS) as follows: 
 
Relatedness scale: 
 
● Definitely related 
● Probably related 
● Possibly related 
● Unlikely to be related 
● Definitely not related 
Expectedness 
● Unexpected 
● Expected 

 
STEP-UP Protocol, v1.2 
24 
 
8.4.3 Expectedness 
For an event to be classified as “expected” it should have been addressed in at least one of the following 
sources: this document, the research application, literature, proposal document, informed consent, or associated 
with the characteristics of the study population. 
7.4.4. Process for identifying AEs and SAEs 
Given the low likelihood of adverse events in this study, and the short length of the active study period (8 weeks 
for an individual participant), passive monitoring for adverse events will be done by the PI, other research staff, 
and community health workers on an ongoing basis and will be reported to the IRB and other entities as 
described in the “AE/SAE Reporting” section below. 
It is possible that we will learn of adverse health-related events when conducting follow-up interviews; it is also 
possible that community health workers will learn of such events when speaking with participants or attempting 
to make contact. It is also possible that the study coordinator/research assistants providing technical or other 
support to participants will learn of such events. These staff will all be trained to recognize and immediately 
report anything that could potentially be an adverse event. 
 
AE/SAE Reporting: 
All AEs and SAEs will be collected on an Adverse Event form in the study’s REDCap database and will be 
reported immediately to the PI by the person learning of the event (generally, study staff, or community health 
workers).  
 
The PI or designated staff member will complete the UM IRB-HSBS Adverse Event Reporting form. Next 
steps will include the following: 
 
● For all expedited AE/SAE/UP reports, the Cornell Roybal Directors, and/or NIA PO may determine if 
full DSMB review is required. 
● All adverse events that are both serious (SAE) and unexpected (have not been defined as expected 
in the DSMP), should be reported to IRB, NIA PO and to Cornell Roybal Directors Reid and 
Wethington. 
● The summary of all other SAEs (i.e., expected or not related SAEs) will be reported to NIA Program 
Officer and to the Cornell Roybal Directors quarterly, or as requested by the Cornell Roybal 
Directors.  
● All unexpected deaths will be reported within 24 hours to the NIA PO, Cornell Roybal Directors, and 
IRB.  
● Unanticipated Problems (UP) will be reported to IRB, NIA PO and to the Cornell Roybal Directors 
within 48 hours of the study's knowledge of UP. The Unanticipated Problems report must include a 
corrective plan and measures to prevent reoccurrence. Reports of Unanticipated Problems, as defined 
above, should be forwarded to OHRP using ohrp@osophs.dhhs.gov, typically within two weeks of the 
event. 
● AEs will be reported per IRB policies. They should also be reported to the NIA Program Officer and 
to the Roybal Directors at minimum annually, or at a frequency requested by NIA and/or by the 
Cornell Roybal.  
 
No related AEs or SAEs are expected for this minimal-risk study of a behavioral intervention (i.e., 
events known to be associated with the intervention or condition under study, i.e., a cognitive-behavioral 

 
STEP-UP Protocol, v1.2 
25 
 
intervention for chronic musculoskeletal pain). Although participants will be encouraged to become more 
physically active, this will take the form of incremental increases in existing low to moderate intensity 
physical activities (e.g., walking) and trying the exercises in the NIA Workout To Go booklet that has been 
selected specifically to be done safely by older adults.  
 
However, we do expect unrelated AEs and SAEs, based on the high morbidity and multimorbidity of this 
population (i.e., adults who are 50+ years of age, most or all of whom will be from underserved and/or 
marginalized populations). These unrelated but expected AEs and SAEs could include hospitalizations, 
deaths, and/or other moderate to severe illness-related events during the study period that are related to age 
and pre-existing health conditions and unrelated to study participation. Nonetheless, if these occur, they will 
be reported as AEs or SAEs and the appropriate steps as outlined above will be taken. 
 
Below are the specific events that will trigger reporting to the parties described above: 
 
Acute Alerts/Serious Adverse Events 
● Hospitalization of Study Participant 
● Institutionalization of Participant 
● Emergency Room Visit of Participant 
● Death of Participant 
Safety Alerts/Adverse Events 
● Severe Medical Problem of Participant 
● Participant threatens to harm him or herself or others 
9 
QUALITY CONTROL AND DATA MONITORING PROCEDURES 
We will review study progress, and data and safety issues on a regular basis in the following ways: 
 
8.1. Training 
 
All study staff will complete PEERRS Human Subjects Research Protection course and Good Clinical Practice 
for Social and Behavioral Research training. They will also be trained on the project protocol, project data 
collection systems and other study-related topics by the Principal Investigator and/or Project Manager and 
Project Coordinator prior to beginning data collection. Additionally, the Project Coordinator will develop a 
detailed manual of procedures, which will provide step-by-step instructions on the conduct of the trial. The 
manual of procedures and other study documents will be reviewed in detail with the staff and student research 
assistants involved in data collection. Additionally, any staff who join the team after the project starts will be 
required to complete the standardized training prior to enrolling participants. Training will be documented in an 
electronic regulatory binder. 
 
  
8.2. Meetings 
 
● Study staff meetings: Drs. Janevic, the Project Manager, and the Project Coordinator will meet weekly 
throughout the course of the project to ensure that all data quality and IRB policies and procedures are being 
followed. This will include reviewing recruitment challenges, and monitoring data collection and quality. 
 
● Quarterly meetings with Cornell Roybal Executive Committee: Dr. Janevic will meet quarterly with the 
Directors and Executive Committee of the Cornell Roybal Center to report on study progress. These 
meetings will be either in Executive Committee sessions or in the Work-in-Progress seminar. She will also 

 
STEP-UP Protocol, v1.2 
26 
 
meet as needed with Cornell’s Roybal Center Director Dr. Cary Reid and Co-Director Dr. Elaine 
Wethington to provide updates and discuss any problems with implementation of this pilot study.  
 
● Meetings with Western Wayne Family Health Centers: Dr. Janevic and Ms. Lindsay and/or other staff 
members will meet at least monthly with Lisa Rutledge, Special Projects Manager at Western Wayne 
Family Health Centers, and/or other adminstrators as well as the Commmunity Health Worker, when hired. 
During the active intervention period, the Project Manager, Ms. Lindsay, or other designated staff member, 
will meet with the Community Health Worker weekly, to provide feedback to ensure optimal fidelity to 
protocols and to problem-solve as needed. Ms. Rutledge or another WWFHC representative will be invited 
to attend these meetings as well. 
 
 
8.3. Auditing 
 
● Conformance with Informed Consent Requirements. At approximately the study’s midpoint and end, the 
project manager and/or PI will also review all consent forms for participants. 
● Quality Control for Telephone Interviews: We will check a random 10% of all data from telephone 
interviews input into REDCap by listening to audiorecordings of the interviews and verifying that data 
was input correctly. Any deviations will be discussed at regular study staff meetings.   
To document adherence to this plan we will maintain a monitoring log and create accompanying monitoring 
reports for each review. The monitoring log will be kept in the electronic regulatory binder. 
 
8.4 Protocol Deviations 
 
This protocol uses the University of Michigan definition of a protocol deviation 
(https://az.research.umich.edu/medschool/glossary/deviation) which defines a protocol deviation as “an incident 
involving non-compliance with the protocol, but one that does not have a significant effect on the subject’s 
rights, safety or welfare, and/or on the integrity of the data. Deviations may result from the action of the 
participant, researcher or staff.” 
  
Reportable protocol deviations will be reported and tracked in the REDCap database and will be discussed at 
investigator and project staff meetings. 
  
The following events will not be reported as protocol deviations: 
 
● A protocol deviation will not be reported for participants who skip/do not complete telephone interview 
items or entire interviews. Participants can decline to answer any survey question for any reason. We 
expect in an intensive, long duration protocol like this that participants may miss some assessments. 
● A protocol deviation will not be reported for out-of-window assessments. Use of this data will be 
assessed by the study investigators for each study analysis; some analyses may need tighter compliance 
to the assessment window while others will not. 
● A protocol deviation will not be reported if an intervention group participant completes their 8-week 
survey before they have completed the final intervention session. 
● A protocol deviation will not be reported if a participant misses an intervention session. 
 
Reportable protocol deviations will be reviewed at the project staff and investigator meetings and submitted to 
the U-M IRB--HSBS and in other DSMB or NIH reports (if applicable). 
 

 
STEP-UP Protocol, v1.2 
27 
 
 
10 
CONFIDENTIALITY AND PRIVACY 
Overview 
A number of steps will be taken to ensure participant confidentiality and to protect against the potential risks 
related to stress from loss of confidentiality, or potential coercion. Participants will be encouraged to ask 
questions throughout recruitment/screening calls and informed that their participation is voluntary and that they 
can refuse to participate at any time without penalty. Participants also will be reminded that they can skip 
questions in surveys that they may not wish to answer. As part of their consent process, participants will be 
informed about the small risk of a breach of confidentiality.  All data collection will take place over the 
telephone, such that participants can choose a location with the level of privacy they desire. There will be a line 
in both the recruitment/screening script and the telephone survey script, “Are you in a comfortable place that 
has the privacy that you desire?” If the answer is no, we can reschedule the interview.  
Email and text messages will only be used to reply to or contact participants if they choose this mode. A secure 
UM email (Google) account will be used for the study and will be monitored by study staff. Throughout the 
study, IRB guidelines will be followed to ensure the privacy and integrity of the information we collect. Any 
breach of confidentiality will be immediately reported to the PI and to the University of Michigan Health 
Sciences and Behavioral Sciences IRB, as an ORIO. In addition, any complaints or concerns expressed to the 
study staff by participant participants, providers, or anyone else affected by this study will be immediately 
reported to the PI, and to the IRB as an ORIO.  All research data will be presented in reports, presentations, or 
manuscripts in aggregate statistics only. 
 
Training and Monitoring 
As noted above, all study staff, including community health workers, and research assistants will complete the 
web-based University of Michigan's PEERRS (Program for Education and Evaluation in Responsible Research 
and Scholarship) course in Human Subjects Research Protection and NIH-approved Good Clinical Practice 
Training (NCATS Social and Behavioral Best Practices). Proof of their certification and completion of the 
training programs will be kept on file. Staff will have signed a pledge of confidentiality, and we will ensure that 
all staff understand that a breach of confidentiality is grounds for dismissal. Training of staff will include 
information about the importance of privacy and confidentiality and specific techniques to maintain 
confidentiality of all information in the context of this study. Regular study team meetings will be used to 
ensure that all data quality protocols and IRB policies and procedures are being followed.  
 
Managing and Protecting Data  
All study participant information will be collected, stored and managed by trained study staff and research 
assistants in REDCap. REDCap is a secure, web-based application designed to support data capture for research 
studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation 
and export procedures; 3) automated export procedures for seamless data downloads to common statistical 
packages; and 4) procedures for importing data from external sources. It is HIPAA compliant and supported by 
the University of Michigan. This secure web application promotes high quality data collection; forced responses 
ensure that interviewers are not able to proceed with the survey if required data are missing; and each survey is 
designed so that only valid responses are entered. 
UM Qualtrics will be used to collect contact information for individuals interested in the study if they use the 
QR code available on the study flyer. UM Qualtrics is HIPAA compliant and secure. Qualtrics is a secure U-M 

 
STEP-UP Protocol, v1.2 
28 
 
contracted-for cloud service that can be used to maintain or share the university's sensitive unregulated data, as 
well as some kinds of sensitive regulated data. Only UM study team members will be able to access this data 
and manually transfer it to the study’s REDCap database for future contacts with potential participants. No 
other data will be collected or stored using UM Qualtrics.   
For telephone calls and telephone-based intervention sessions, we will use Zoom Phone to audio record calls 
and CHW sessions for quality assurance.   Zoom and Zoom Phone are HIPAA-compliant and supported by the 
University of Michigan. Audio recordings will be stored in the secure University of Michigan School of Public 
Health server or Dropbox at U-M, a HIPAA-compliant file storage system. 
On-site Access and Control: Users are instructed to lock their workstation and to never leave it unattended with 
an active desktop. This enables access control by allowing only the credentials of the validated user to unlock 
the workstation. This is especially true when a user is accessing study data. 
Remote Access: All connections from remote locations must use the University-configured Cisco VPN client, 
which encrypts all traffic to and from the servers. 
All databases will be maintained in access-restricted files throughout the study. Study personnel who leave the 
research team will have their access to study files revoked.  
The only paper records with identifiers will be the informed consent documents, and these will be kept in a 
locked office, in locked file cabinets in the University of Michigan School of Public Health. Access to the file 
cabinets will be restricted. 
We will report AEs/SAEs to the IRB, DSMB or ISM, and/or other parties in a blinded manner, using only the 
unique subject identifier to protect the participant’s identity. 
 
 
Certificate of Confidentiality  
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be issued by the 
National Institutes of Health (NIH).  This certificate protects identifiable research information from forced 
disclosure. It allows the investigator and others who have access to research records to refuse to disclose 
identifying information on research participation in any civil, criminal, administrative, legislative, or other 
proceeding, whether at the federal, state, or local level. By protecting researchers and institutions from being 
compelled to disclose information that would identify research participants, Certificates of Confidentiality help 
achieve the research objectives and promote participation in studies by helping assure confidentiality and 
privacy to participants. 
11 
STATISTICAL CONSIDERATIONS 
11.1 Sample Size 
This pilot study is not powered to determine the statistical significance of effects.   
 
11.2 Data Analyses 
11.2.1 General Approach 
We will collect outcome data at two time points: baseline and 8 weeks from baseline (post-program, for those in 
the intervention group). All quantitative process and outcome data will be collected in REDCap. Descriptive 
statistics will be used to summarize background variables for the overall sample and by treatment group. Prior 

 
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29 
 
to conducting primary analyses, descriptive analyses will be conducted to examine data distribution, outliers 
and potentially important covariates for inclusion in multivariate model diagnostics. We will evaluate normality 
using normal quantile plots and standard tests of normality incorporated in basic statistical packages, including 
SPSS and SAS.  
11.2.2 Primary & Secondary Endpoints 
We will calculate baseline descriptive statistics and compare groups using independent-sample t-tests for 
continuous variables and chi-squared tests for categorical variables. We will assess psychometrics of scales 
used (e.g., internal consistency reliability and concurrent validity). We will convert the PROMIS 6-item Pain 
Interference subscale score to T-scores (a standardized score with a mean of 50 and SD of 10) by summing the 
scales and using the conversion tables provided at HealthMeasures.net.  
 
To assess the effect of being in the intervention group, we will use a univariate analysis of variance model for 
continuous primary and secondary outcomes. The dependent variable in each model will be the value of the 
outcome at 8-week follow-up; the independent factor will be treatment group (intervention vs. control), with the 
baseline value of the outcome as a covariate. 
 
Effect size will be indicated by partial eta squared for the treatment group variable. In order to assess the 
potential clinical relevance of the intervention, we will use chi-squared tests to compare the percentage of 
participants in each treatment condition who achieved the Minimally Important Difference (MID) of ≥ 3 T-
score points in PROMIS pain interference.  
 
We will repeat this analysis with the secondary outcomes: Global Impression of Change in Pain and 
Functioning. Transformations for non-normality of outcomes will be performed as indicated. 
 
We will also assess the moderating effect of selected variables such as sex, age, baseline pain intensity, and 
degree of program engagement. Moderation analyses will use standard approaches to evaluate interactions 
between these covariates and treatment group.  
 
For patient engagement, the secondary outcome indicating feasibility that is composed of: 1) number of sessions 
completed out of 7; and 2) participant satisfaction on a 5-point Likert scale, we will calculate descriptive 
statistics. We will also explore differences by age group (under 65/65+) as well as gender. As an exploratory 
analysis, we will investigate whether satisfaction differs according to whether or not participants achieved the 
MID on the primary outcome of pain interference. 
 
11.2.3 Other Pre-specified Analyses 
To explore potential mechanisms, we will examine the association between: 1) participation in the intervention 
and the hypothesized composite meditator, Perceived Control Over Pain, as well as each of the 4 component 
scales (Survey of Pain Attitudes Control subscale, Pain Catastrophizing Scale, Life Control scale, and PROMIS 
Meaning and Purpose); and 2) between mediators and outcomes. Positive correlations in both cases will provide 
evidence for a potential mediating effect.  
 
Following intent-to-treat principles, we will include all participants randomized to the intervention group, with 
sensitivity analyses assessing whether different levels of participant engagement (i.e., session completion) 
impact results. 
 

 
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12 
INTERIM ANALYSIS 
This pilot study will not include interim analysis. 
 
13 
PUBLICATIONS 
This study will be conducted in accordance with the National Institutes of Health (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. 
 
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PROTOCOL AMENDMENT HISTORY