Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention
Phase: NA
Conditions: Chronic Pain
Sponsor: Minneapolis Veterans Affairs Medical Center

 
 
 
 
 
 
 
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole 
Health Telehealth Intervention (RAMP)  
 
IRBNet #1753168 
Grant Award # 1UG3NR020929-01 
National Clinical Trial (NCT) Identified Number: UG3 Pilot: NCT06568250; UH3: 
TBD 
Center for Veterans Research and Education (CVRE) #F10058 
Funding Mechanism: UG3/UH3 
Funding Agency: National Institutes of Health National Institute of Nursing 
Research (NIH NINR)  
Helping to End Addiction Long-term (HEAL) Initiative  
Minneapolis VA Multiple Principal Investigator (MPI): Diana J. Burgess 
University of Minnesota MPI: Roni Evans 
University of Iowa MPI: Katherine Hadlandsmyth 
Version 7 – 8/22/2025 
 
 

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Confidentiality Statement: This document is confidential communication. Acceptance of this 
document constitutes agreement by the recipient that no unpublished information contained 
herein will be published or disclosed without prior approval of the Principal Investigator or other 
participating study leadership and as consistent with the NIH terms of award. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Contents  
 
Revision History 
7 
1.0 Study Personnel Project Staff - Minneapolis VAHCS, CCDOR 
8 
Statement of Compliance 
11 
Abstract 
12 
List of Abbreviations 
14 
1.0 
Study Personnel 
17 
Multiple Principal Investigators (MPIs) 
17 
Co-Investigators 
19 
Consultant 
22 
Project Staff 
22 
Memoranda of Understandings (MOUs) and Subawards 
25 
2.0 
Protocol Summary 
25 
2.1 
Synopsis 
25 
2.2 Project Overview 
28 
2.3 Schedule of Activities (SOA) 
29 
2.4 Milestones 
29 
2.4.1 UG3/Phase 1 Milestones 
30 
2.4. UH3/Phase 2 Milestones 
30 
3.0 
Introduction 
31 
3.1 Study Rationale 
32 
3.2 Background 
32 
3.3 Risk/Benefit Assessment 
36 
3.3.1 Known Potential Risks 
36 
3.3.2 Known Potential Benefits 
37 
3.3.3 Assessment of Potential Risks and Benefits 
38 
4.0 
Objectives and Endpoints 
41 
5.0 
Study Procedures 
42 
5.1 Overall Design 
43 
5.1.1 Advisor Engagement 
43 

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5.1.2 Feasibility/Pilot and RCT 
43 
5.2 Recruitment Methods, Randomization Procedures and Blinding (for Feasibility/Pilot and 
RCT), Participant Enrollment, and Retention 
45 
5.2.1 Advisor Engagement 
45 
5.2.2 Feasibility/Pilot and RCT 
48 
5.3 Informed Consent Procedures 
50 
5.3.1 Advisor Engagement 
50 
5.3.2 Feasibility/Pilot and RCT 
50 
5.4 Inclusion/Exclusion Criteria 
51 
5.4.1 Advisor Engagement 
51 
5.4.2 Feasibility/Pilot and RCT 
51 
5.5 Study Evaluations 
52 
5.6 Discontinuation & Withdrawal 
54 
5.6.1 Discontinuation of Advisor Engagement 
54 
5.6.2 Discontinuation of Study Intervention (Feasibility/Pilot Study, RCT) 
55 
5.6.3 Withdrawal of Participants (Feasibility/Pilot and RCT) 
55 
5.7. Adverse Events & Serious Adverse Events 
56 
5.8 Data Analysis 
56 
6.0 
Reporting 
59 
6.1 
Minneapolis VA 
59 
6.2 
NIH 
60 
6.2.1 Framework and information monitored 
60 
6.2.2 Adverse Event Monitoring 
60 
6.2.3 Adverse events classification 
61 
7.0 
Privacy and Confidentiality 
62 
8.0 
Communication Plan 
65 
9.0 
Repository/Data Banking 
65 
10.0 References 
66 
Appendix A – DSMP 
80 
1 
Study Overview 
1 
1.1 
Purpose of Study 
1 
2 
Protocol Amendments 
2 

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3 
Multi-site Studies 
2 
4 
Confidentiality 
3 
4.1 
Protection of Participant Privacy 
3 
4.2 
Confidentiality During Adverse Event (AE) Reporting 
4 
5 
Expected Risks 
4 
5.1 
Advisors (Non-Feasibility/RCT) Expected Risks 
4 
5.1.1 
Advisors (Non-Feasibility/RCT) Protections Against Risks 
4 
5.2 
Research Participants Expected Risks 
4 
5.2.1 
Research Participants Protections Against Risks 
5 
6 
Adverse Event/ Unanticipated Problems 
8 
6.1 
Definitions 
9 
6.1.1 
Adverse Event (AE) 
9 
6.1.2 
Unanticipated problem involving risk to subjects or others (UPIRTSO) 
9 
6.2 
Time Period and Frequency for Event Assessment and Follow-Up 
9 
Characteristics of an Adverse Event 
9 
6.2.1 
Severity of Event 
9 
6.2.2 
Relationship to Study Intervention 
10 
6.2.3 
Expectedness of SAEs 
11 
6.3 
Reporting Procedures 
11 
6.3.1 
Serious adverse events (SAEs) and Unanticipated Problems. 
11 
6.3.2 
Other reporting 
12 
6.4 
Halting Rules 
12 
7 
Quality Control and Quality Assurance 
13 
7.1 
Subject Accrual and Compliance 
14 
7.1.1 
Measurement and Reporting of Subject Accrual 
14 
7.1.2 
Measurement and Reporting of Participant Adherence to Treatment Protocol 
14 
7.2 
Justification of Sample Size 
14 
a. 
UG3/Phase 1 – Aim 1 – Feasibility study 
15 
b. 
UH3/Phase 2 – Aim 1 – RCT 
15 
7.3 
Designation of a Monitoring Committee 
15 
7.4 
Safety Review Plan 
17 

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7.5 
Study Report Outline for the Data and Safety Monitoring Board (Interim or Annual 
Reports) 
17 
8 
Data Handling and Record Keeping 
18 
8.1 
Data Management Responsibilities 
18 
8.2 
Database Protection 
19 
8.3 
Source Document Protection 
20 
8.4 
Schedule and Content of Reports 
21 
8.4.1 
Interim Analyses 
21 
8.5 
Data Privacy and Data Breaches 
21 
9 
Informed Consent 
21 
9.1 
Feasibility/Pilot Study and RCT Participants 
21 
10 
Reporting Changes in Study Status 
22 
 

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Revision History  
 
Protocol 
Version 
# 
Revision 
Date 
Summary of Changes 
Rationale for change 
Protocol 
Section(s) 
2 
February 
2024 
Integrated IRBNet project 
“Stakeholder Engagement 
1754182” with IRBNet project 
“Feasibility and RCT 1753168” 
To best meet NIH funder 
protocol requirements, the lower 
risk, IRB- exempted protocol 
with “Advisors” as participants 
(IRBNet 1754182), has been 
integrated with the protocol with 
“Study Participants” (IRBNet 
1753168). Upon approval of new 
IRBNet 1753168, the previous 
IRBNet 1754182 will be closed. 
Throughout 
document 
2 
February 
2024 
Revised study acronym from 
RAMP-WH to RAMP 
Project team and external 
feedback decided RAMP is 
preferable acronym. 
Throughout 
document 
2 
February 
2024 
Added using Docusign for 
HIPAA authorization signatures. 
Electronic HIPAA signing 
necessary as little to no in-
person contact with participants 
and advisors 
5.3 Informed 
Consent 
Procedures and  
7.0 Privacy and 
Confidentiality 
2 
February 
2024 
Added using VA REDCap for 
data collection. 
Project team determined VA 
REDCap favorable tool for some 
data collection. 
5.5 Study 
Evaluations and  
7.0 Privacy and 
Confidentiality  
2 
February 
2024 
Added using Webex 
Previously stated using 
“approved VA videoconferencing 
program” but now specifying 
example of Webex. 
pp. 29, 35 
2 
February 
2024 
Added using ClinCard pre-paid 
debit cards from Greenphire for 
participant payment purposes; 
physical checks remain 
alternative/backup payment 
method 
When contract with Greenphire 
fully executed, the faster and 
more secure pre-paid debit 
cards will provide payment to 
participants. Slower-to-arrive 
physical checks will be used 
when ClinCard through 
Greenphire is not available.  
pp. 40, 41 
2 
February 
2024 
Changed use of word 
“stakeholder” to “advisor” 
Revised wording to best 
current practice. 
Throughout 
document 
2 
February 
2024 
Revise follow-up timepoints 
from 13 and 26 weeks to 16 
and 32 weeks 
Revised follow-up timepoints to 
account for feasibility/logistics. 
Throughout 
document 
2 
February 
2024 
Added 1 one-on-one 
intervention session at end of 
intervention period 
Based on Veteran feedback 
added post-group one-on-one 
session with facilitator. 
Throughout 
document 
 

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2 
February 
2024 
Revised inclusion and 
exclusion criteria 
Revisions made to ensure 
target population who can most 
benefit from study is reached 
while maintaining safety. 
5.4 
Inclusion/Exclusion 
criteria 
2 
February 
2024 
Revised screener, baseline, 
and follow-up measures 
Revisions made based on 
updated best practices and 
funder requirements 
2.3 Schedule of 
Activities 
2 
February 
2024 
Add Rose Degerstrom to 
study. 
Additional staff person needed. 
1.0 Study 
Personnel Project 
Staff - Minneapolis 
VAHCS, CCDOR 
 
3 
April 
2024 
Added Milestones. 
Not included in original 
protocol. 
2.4 Milestones 
3 
April 
2024 
Responded to informal 
feedback questions/comments 
from NINR. 
NINR is study sponsor. 
Throughout 
document 
3 
April 
2024 
Added possible RAMP VEP 
recruitment source is former 
LAMP study (IRBNet 1613709) 
participants 
Participants in a prior similar 
study have a relevant 
perspective on RAMP. 
5.2.1 Advisor 
Engagement 
3 
April 
2024 
Additional contacts with 
advisors and participants to 
share study results and/or other 
research opportunities. 
Based on previous studies, 
advisors and participants 
appreciate hearing about results 
and other research. 
5.1.1 Advisor 
Engagement and 
5.1.2 
Feasibility/Pilot 
and RCT 
3 
April 
2024 
Added saving data from 
feasibility and RCT participants 
in a secure repository/bank for 
other research studies in the 
future.  
We are required by our funder 
(NIH HEAL Initiative) to share 
data with an approved 
repository. 2)  
9.0 
Repository/Data 
Banking 
3 
April 
2024 
Added option to re-contact 
RAMP participants in the future 
(while the study is still open) if 
they say “yes” to the follow-up 
survey question, “We’d 
sometimes like to gather more 
information and opinions, or let 
you know about other 
opportunities. Are you willing to 
be contacted again in the 
future?” 
It can be advantageous to reach 
out to interested participants 
again (e.g., with more 
information, to ask follow-up 
questions, etc.). 
5.2.2 
Feasibility/Pilot 
and RCT 
4 
Novemb
er 2024 
Revised Appendix A- Data and 
Safety Monitoring Plan (DSMP) 
Revisions and additional details 
based on requests and 
recommendations from Data and 
Safety Monitoring Board 
(DSMB). 
Appendix A - 
DSMP 
4 
Novemb
er 2024 
Revised Lee Cross’s title role 
from Project Manager to Project 
Director 
“Project Director” was 
determined to be a better 
description of the role Lee has. 
Throughout 
document 

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4 
Novemb
er 2024 
Terminology revisions (e.g., 
procedure and protocol, project 
staff vs. study staff, health 
coach vs. Whole Health Coach) 
Revisions for consistency across 
project documents. For example, 
the current document is the 
protocol, and the project team 
also uses supplementary project 
procedure documents and a 
manual of operations that 
include additional detailed 
instructions and information. 
Throughout 
document 
4 
Novemb
er 2024 
Remove one-on-one 
intervention session at end of 
intervention period, which 
changes intervention to 12 
sessions rather than 13 for the 
pilot. 
Based on Veteran feedback and 
changes with VA Whole Health, 
the one-on-one sessions are not 
adding enough value. Removing 
them allows group sessions to 
work more cohesively together. 
Throughout 
document 
4 
Novemb
er 2024 
Revision of Mallory Mahaffey’s 
role. 
Mallory Mahaffey’s study role 
changed somewhat with her 
reduction of hours. 
1.0 Study 
Personnel 
4 
Novemb
er 2024 
Add Kimberly Behrens and 
Gloria Yang to protocol. 
Kimberly Behrens and Gloria 
Yang joined the study team and 
were added with Administrative 
Change documentation in 
September 2024. 
1.0 Study 
Personnel 
4 
Novemb
er 2024 
Add Sarah Schroeder. 
Sarah Schroeder joined the 
study team. 
1.0 Study 
Personnel 
4 
Novemb
er 2024 
Remove Rose Marie 
Degerstrom 
Ms. Degerstrom is leaving the 
study team due to retiring. 
1.0 Study 
Personnel 
4 
Novemb
er 2024 
Repository for data sharing 
named. 
As the study sponsor, NIH HEAL 
requires data sharing through a 
HEAL approved repository. The 
RAMP project will use the NIMH 
Data Archive (NDA). 
9.0 
Repository/Data 
Banking 
4 
Novemb
er 2024 
Add clinicaltrials.gov NCT. 
Pilot/feasibility study now 
registered with clinicaltrials.gov 
Title page 
4 
Novemb
er 2024 
Increase maximum IRB allowed 
number of participants enrolled 
in full RCT. 
The phase 2 RCT enrollment 
goal remains n=500.Asking for 
administrative approval to allow 
enrollment up to n=550. Our 
recruitment goal based on our 
power calculations remains set 
at 500, but we ask for approval 
to exceed this goal, since the 
way the study randomizes 
participants in large waves 
makes it difficult to perfectly hit 
recruitment numbers.  
5.8 Data Analysis 

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4 
Novemb
er 2024 
In addition to utilizing Docusign 
to email HIPAA forms to 
participants, we’d like to send 
physical letters along with 
HIPAA forms and return 
envelopes to non-signers. 
As our protocol states, we’ve 
used Docusign to email HIPAA 
forms to participants, and while 
many have signed, about 20 
have not (about 12% of our total 
baseline survey completers). As 
a result, we’re unable to pay 
these people for completing the 
baseline survey. We believe the 
Docusign process may be 
creating undue burden on these 
participants. We believe that 
alternative approaches, such as 
sending physical letters along 
with the HIPAA forms would 
place less of a burden on 
participants and make it easier 
to pay them for their time. 
5.3 Informed 
Consent 
Procedures 
5 
January 
2025 
Revise duties and data access 
description for Co-Investigator 
Stephanie Taylor and Marianne 
Matthias. 
Drs. Taylor and Matthias may be 
conducting interviews/data 
collection with VA employee 
partners. 
1.0 Study 
Personnel 
6 
February 
2025 
Add Raina Rooney to protocol. 
Raina Rooney joined the study 
team and were added with 
Administrative Change 
documentation in January 2025. 
1.0 Study 
Personnel 
6 
February 
2025 
Revisions to intervention: 
remove initial individual session 
and decrease number of group 
sessions to 9. 
Improvements to intervention 
based on pilot feedback and 
findings. 
Throughout 
document 
6 
February 
2025 
Revise description of follow-up 
time points to be in terms of 
months rather than weeks. 
More accurate to say follow-up 
timepoints will occur at 3 and 6 
months rather than particular 
weeks. 
Throughout 
document 
6 
February 
2025 
Remove framing RAMP in terms 
of how VA Whole Health works. 
RAMP can potentially be 
implemented in other areas of 
the VA beyond VA Whole 
Health. 
Throughout 
document 
6 
February 
2025 
Administrative updates 
Including revised phrasing of 
recruitment goal, adding missing 
abbreviations, revising “RAMP-
WH” to “RAMP” where not 
previously corrected, and fixing 
typos. 
List of 
Abbreviations, 
throughout 
document 
7 
August 
2025 
Terminology and clarification 
revisions.  
Revisions based on 
recommendations from DSMB 
and NINR. 
Throughout 
document 
7 
August 
2025 
Remove Mallory Mahaffey, 
Robin Austin, Gloria Yang. 
Updates due to regular staff 
turnover. 
1.0 Study 
Personnel 

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7 
August 
2025 
Increase incentive payment for 
each completed survey to $40.  
The surveys take more time to 
complete than originally 
estimated, so we’ve increased 
the incentive payment 
accordingly. 
5.2.2 
Feasibility/Pilot 
and RCT 
7 
August 
2025 
Add additional quality of life 
measures to surveys (EQ5D5L). 
Additional questions will aid in 
the budget impact analysis. 
 
2.3 Schedule of 
Activities (SOA) 
 
 
Statement of Compliance 
The trial will be carried out in accordance with International Council on Harmonisation Good 
Clinical Practice (ICH GCP) and the following:  
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 
completed Human Subjects Protection and ICH GCP Training. 
The protocol, informed consent procedure(s), recruitment materials, and all participant materials 
will be submitted to the Minneapolis VA Institutional Review Board (IRB) for review and 
approval. Approval of both the protocol and the consent procedure(s) must be obtained before 
any participant is enrolled. Any amendment to the protocol will require review and approval by 
the Minneapolis VA IRB before the changes are implemented to the study. In addition, all 
changes to the consent procedure will be IRB-approved; an IRB determination will be made 
regarding whether a new consent needs to be obtained from participants who provided consent, 
using a previously approved consent procedure. 
 
 

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Abstract 
Our long-term objective is to improve pain management and reduce opioid use among rural 
patients in the VA. To accomplish this, we will conduct a randomized clinical trial (RCT) to test 
the effectiveness of an innovative multi-component complementary and integrative intervention, 
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth 
Intervention (RAMP) delivered via group telehealth, at improving rural Veterans’ pain 
management, function, and wellbeing, within the VA healthcare system. This project addresses 
the significant challenge of implementing effective, non-opioid interventions for chronic pain 
management among rural Veterans, who experience a disproportionate share of the national 
pain burden, with more chronicity, opioid harms, comorbid mental health conditions and 
substance abuse, and are prescribed more opioids and have less access to evidence-based, 
chronic pain care that addresses their “whole-person” or biopsychosocial needs. The RAMP 
program strategically coalesces multiple evidence based CIH self-management strategies to 
address rural Veterans’ biopsychosocial needs and overcome existing barriers to 
implementation. Comprised of pain education, mindfulness, pain specific exercises, and 
cognitive behavioral strategies, the program is cohesive and scalable. Designed to meet the 
needs of VA interest holders, it uses health coaches as program facilitators. RAMP is a 9-week 
program comprised of group sessions with pre-recorded expert-led education videos, mind-body 
skill training and practice, and facilitated discussions. Participants will be rural dwelling VA 
patients with chronic pain, recruited through the electronic health record, and then screened 
through an online survey. For the preparatory phase (UG3/Phase 1) we will conduct 1) advisor 
engagement activities including identifying and developing new community partnerships and 
using mixed methods data collection from multiple levels of advisors (n=35-50 patients, 
community partners, VA healthcare system leaders and staff), guided by the established RE-
AIM/PRISM framework, to learn about key factors that can affect long-term adoption; and 2) 
conduct a feasibility study of 40 rural VA patients with chronic pain to assess the feasibility of 
delivering RAMP (pilot) in terms of recruitment and engagement, intervention fidelity and 
adherence, data collection, and other key metrics. For UH3/Phase 2, we will conduct a 
randomized pragmatic clinical trial of RAMP compared to Usual Care, among rural patients 
(n=500) in the VA healthcare system. Participants randomized to the Usual Care (UC) condition 
will not be asked to do anything besides complete the follow-up surveys. In keeping with our 
pragmatic approach, patients will not be asked to limit any other treatment. After completing the 
final follow-up survey, they will be mailed information about how to access the intervention 
materials online. UH3/Phase 2 Aim 1 will assess the relative effectiveness of RAMP in rural VA 
patients in terms of pain interference at 3 and 6 months (primary outcome) and secondary 
outcomes of opioid use and other HEAL recommended outcomes (e.g., pain intensity, pain 
impact, physical function, sleep disturbance, fatigue, anxiety, depression, post-traumatic stress 
disorder, participation in social roles and activities, global impression of change). We will ask 
intervention participants about their experience with the RAMP program. We will also perform 
additional exploratory analyses of women and minoritized Veterans’ primary and secondary 
outcomes. In UH3/Phase 2 Aim 2 we will work iteratively with multiple levels of advisors (from 
UG3/Phase 1) to evaluate intervention implementation strategies used in the trial and adapt 

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these strategies to scale up RAMP within the national VA healthcare system. This will include a) 
conducting mixed-methods assessments of advisor and randomized trial participant views of 
implementation-related barriers and facilitators, resource needs, and other RE-AIM/PRISM 
domains; b) working with advisors to co-create additional plausible strategies for overcoming 
barriers to implementation of RAMP; and c) conducting budget impact analyses using models 
informed by advisor views to inform future decision making. 
 
 

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List of Abbreviations 
AEs– Adverse Events 
ATLAS– Accessing Telehealth through Local Area Stations program 
BPS– Biophysical, Psychological, Social (factors of chronic pain) 
CAP – Community Advisory Panel 
CBOCs– The VA’s Community-Based Outpatient Clinics  
CCDOR – Center for Care Delivery and Outcomes Research 
CDW– Corporate Data Warehouse 
CIH– Complimentary and Integrative Health 
COIN – Center of Innovation 
CONSORT – Consolidated Standards of Reporting Trials framework 
CVRE – Center for Veterans Research and Education 
DART – Data Access Request Tracker 
DSMB – Data and Safety Monitoring Board 
DSMP – Data and Safety Monitoring Plan 
DUA– Data Use Agreement 
EHRs– VA Electronic Health Records 
HEAL – Helping End Addiction Long-term 
HRSA – Health Resources & Services Administration 
HSR&D – Health Science Research & Dissemination 
IMC – Independent Monitoring Committee 
JLV – Joint Legacy Viewer 
LATIS – Liberal Arts Technologies & Innovation Services  
MBIs– Mindfulness Based Interventions  
MOUs– Memoranda of Understandings 
MPI – Multiple Principal Investigator 

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NDA – NIMH Data Archive 
NDS – National Data Services 
NIH – National Institute of Health 
NIMH – National Institute of Mental Health 
NINR – National Institute of Nursing Research 
NPC – Non-Profit Research Corporation 
OCC– The VA’s Office of Connected Care 
OHRP – Office of Human Research Protections 
OPCC&CT– The VA’s Office of Patient Centered Care and Cultural Transformation 
ORH– The VA’s Office of Rural Health 
PHI– Protected Health Information 
PRISM– The Practical Implementation Sustainability Model 
PTSD– Post-Traumatic Stress Disorder 
RAMP – Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth 
Intervention 
RCT– Randomized Clinical Trial 
RE-AIM– Reach, Effectiveness, Adoption, Implementation, and Maintenance. 
RUCA – Rural-Urban Commuting Areas 
SAEs–Severe Adverse Events  
SMS – short message service (i.e., text messages) 
UAPs–Unanticipated Problems 
UC– Usual Care 
UCLA – University of California Los Angeles  
UMN – University of Minnesota 
UPIRTSO – Unanticipated Problems Involving Risk to Subjects or Others 
U-SAEs – Unanticipated Serious Adverse Events 

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VA– Veterans Healthcare Administration 
VAHCS – VA Healthcare System 
VINCI – VA Informatics and Computing Infrastructure 
VISN– VA Veteran Integrated Service Network 
 
 

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1.0 
Study Personnel 
Multiple Principal Investigators (MPIs) 
 
NIH Contact Multiple Principal Investigator, Minneapolis VA Healthcare System (VAHCS), 
Center for Care Delivery and Outcomes Research (CCDOR) 
Diana J. Burgess, PhD 
Minneapolis VA Healthcare System 
One Veterans Drive (mail code 152) 
Minneapolis, MN 55417-2309 
612-467-1591 
Diana.burgess@va.gov 
Duties: Dr. Burgess will provide oversight to the entire project, jointly with the other MPIs, 
including development and implementation of all policies, procedures, and processes related to 
the project and implementation of the scientific agenda, leadership plan, and all activities 
necessary to achieve the project aims. Jointly with the other MPIs she will ensure procedural 
mechanisms are in place to guarantee institutional compliance with US law and NIH policies 
including biosafety, human subject protection, data security, and facilities compliance. Dr. 
Burgess will serve as contact PI and will assume primary fiscal and administrative management 
including maintaining communication with NIH and among MPIs and key personnel. At the study 
level, Dr. Burgess will chair the Investigator Steering Committee and the Implementation 
Science Teams. She will be part of the Regulatory, Data & Technology, Data &Safety 
Monitoring and Intervention Effectiveness project teams. The MPIs will work closely together 
and with the Data & Technology and Regulatory Teams to prepare annual reports. Drs. 
Burgess, Evans, and Hadlandsmyth will work together with the Coordinating Center leadership 
regarding any changes in the direction of the research project and any reallocation of funds, in 
accordance with NIH policy and permissions. The MPIs will be responsible for ensuring that the 
research is conducted in compliance with all appropriate federal rules and regulations. They will 
jointly lead weekly videoconferences with the project teams, reach out and participate in 
collaborations with the Coordinating Center and investigators from the other study centers, 
attend annual research meetings with the Steering Committee (virtually or in person), and will 
share responsibility for interpreting and presenting research findings. 
Data access: Dr. Burgess will have access to protected health information (PHI). She will be 
involved in recruitment and obtaining informed consent. She will be involved in data analysis of 
coded and raw data. 
 
University of Minnesota School of Nursing Center for Spirituality and Healing  
Roni Evans, PhD, MS, DC 
612-301-9006 
Evans972@umn.edu 
Duties: Dr. Evans will provide oversight to the entire project, jointly with the other MPIs, 
including development and implementation of all policies, procedures, and processes related to 

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the project and implementation of the scientific agenda, leadership plan, and all activities 
necessary to achieve the project aims. Jointly with the other MPIs she will ensure procedural 
mechanisms are in place to guarantee institutional compliance with US law and NIH policies 
including biosafety, human subject protection, data security, and facilities compliance. Dr. Evans 
will Chair the Intervention Effectiveness Team. The MPIs will work closely together and with the 
Data & Technology and Regulatory Teams to prepare annual reports. Drs. Burgess, Evans, and 
Hadlandsmyth will work together with the Coordinating Center leadership regarding any 
changes in the direction of the research project and any reallocation of funds, in accordance 
with NIH policy and permissions. The MPIs will be responsible for ensuring that the research is 
conducted in compliance with all appropriate federal rules and regulations. They will jointly lead 
weekly videoconferences with the project teams, reach out and participate in collaborations with 
the Coordinating Center and investigators from the other study centers, attend annual research 
meetings with the Steering Committee (virtually or in person), and will share responsibility for 
interpreting and presenting research findings. 
Data access: Dr. Evans will have access to protected health information (PHI). She will be 
involved in conducting fidelity checks of health coaches. She will be involved in data analysis of 
coded and raw data. 
 
University of Iowa Carver College of Medicine and Iowa City VA Healthcare System 
(VAHCS) 
The current project has been approved for an exception to the single IRB rule. A separate IRB 
application will be submitted to the University of Iowa. The University of Iowa and the Iowa City 
VA Healthcare System are included in the HIPAA authorization form so identifiable data can be 
shared with both entities. Approved data sharing will be conducted via VA Box or another 
approved method. 
Katherine (Katie) Hadlandsmyth, PhD 
Katherine.hadlandsmyth@va.gov 
katherine-hadlandsmyth@uiowa.edu 
Duties: Dr. Hadlandsmyth will provide oversight to the entire project, jointly with the other MPIs, 
including development and implementation of all policies, procedures, and processes related to 
the project and implementation of the scientific agenda, leadership plan, and all activities 
necessary to achieve the project aims. Jointly with the other MPIs she will ensure procedural 
mechanisms are in place to guarantee institutional compliance with US law and NIH policies 
including biosafety, human subject protection, data security, and facilities compliance. Dr. 
Hadlandsmyth will chair the Advisor Engagement Team. The MPIs will work closely together 
and with the Data & Technology and Regulatory Teams to prepare annual reports. Drs. 
Burgess, Evans, and Hadlandsmyth will work together with the Coordinating Center leadership 
regarding any changes in the direction of the research project and any reallocation of funds, in 
accordance with NIH policy and permissions. The MPIs will be responsible for ensuring that the 
research is conducted in compliance with all appropriate federal rules and regulations. They will 
jointly lead weekly videoconferences with the project teams, reach out and participate in 
collaborations with the Coordinating Center and investigators from the other study centers, 

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attend annual research meetings with the Steering Committee (virtually or in person), and will 
share responsibility for interpreting and presenting research findings. 
Data access: Dr. Hadlandsmyth will have access to protected health information (PHI) for both 
advisors and pilot and trial participants. She will be involved in recruitment of advisors. She will 
be involved in data analysis of coded and raw data. 
 
Co-Investigators 
 
University of Minnesota (UMN) 
The University of Minnesota is included in the HIPAA authorization form so identifiable data can 
be shared with UMN project team members, including MPI Dr. Evans. Approved data sharing 
will be conducted via VA Box or another permitted method. 
 
School of Medicine and Minneapolis VAHCS, CCDOR 
Brent Taylor, PhD, MPH 
612-467-4941 
Brent.taylor2@va.gov  
Duties: Dr. Taylor will be the senior statistician and methods expert, overseeing both the Data 
and Statistics Teams (responsibilities described below). He will serve as the Chair of the 
Regulatory Team and the Data and Technology Team and will serve as a member of the 
Investigator Steering Committee. He will also serve on the Biostatistics and Study Design 
PRISM/Collaboratory Work Group. Dr. Taylor will also participate in the interpretation of 
quantitative and qualitative data, manuscript preparation and other dissemination activities. 
Data access: Dr. Taylor will be involved in data analysis of coded data. He will have access to 
protected health information only if necessary to maintain rigorous study methodology and/or for 
the safety of participants. He will not be recruiting, obtaining informed consent, or conducting 
surveys. 
 
School of Medicine Department of Rehabilitation Medicine 
John Ferguson, PhD 
612-625-2661 
Fergu170@umn.edu 
Duties: Dr. Ferguson will serve on the Regulatory and Data and Technology Teams. He will 
provide guidance on Qualtrics and website related technologies and will support the ongoing 
processes of adaptation, optimization, troubleshooting, and implementation of the intervention 
assets in an online environment. He will also offer expertise in interpretation of quantitative and 
qualitative data, contribute to manuscript writing, and participate in other dissemination 
activities. He will serve on the on the Regulatory and Ethics PRISM/Collaboratory Work Group. 
Data access: Dr. Ferguson will have access to protected health information (PHI). He will be 
involved in data analysis of coded and raw data. He will not be recruiting, obtaining informed 
consent, or conducting surveys. 
 

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Liberal Arts Technologies & Innovation Services (LATIS) 
David Olsen, Research System Engineer 
Duties: Mr. Olsen will develop code (e.g., API) to enhance communication between databases 
(e.g., Qualtrics FedRAMP and the internal VA participant tracking database) and with 
participants. Improving these lines of communication will assist in increasing participant 
retention, engagement, and maximizing data collection. 
Data access: Mr. Olsen will not have access to protected health information. He will not be 
involved in recruiting subjects, obtaining informed consent, administering surveys procedures, 
or performing data analysis. 
 
Sasha Zarins, Survey Methodologist and Project Designer 
Duties: Ms. Zarins will provide expertise in developing online surveys, online communication 
with study participants, and Qualtrics programming. 
Data access: Ms. Zarins will not have access to protected health information. She will not be 
involved in recruiting subjects, obtaining informed consent, administering surveys procedures, 
or performing data analysis. 
 
School of Nursing Center for Spirituality and Healing 
 
Alexander (Alex) Haley, JD, MBA, MS 
612-301-9006 
Haley045@umn.edu 
Duties: Mr. Haley will work with Dr. Evans and other investigators to further develop 
and adapt RAMP to include individual coaching sessions, and additional materials to bolster 
Veterans’ biopsychosocial health. He will also work closely with the investigators and staff to 
seamlessly integrate technology with intervention delivery to provide a user-friendly support 
resource for Veterans with pain. Mr. Haley will provide training and ongoing support to health 
coach Facilitators delivering the program; participate in the Intervention Effectiveness team; and 
conduct fidelity assessments of RAMP sessions. He will also work with investigators to make 
necessary adaptations of RAMP in preparation for the UH3/Phase 2 phase, and after its 
completion for implementation. Mr. Haley will also take part in the interpretation of study results 
and the preparation of scientific manuscripts and presentations. 
Data Access: Mr. Haley will have access to protected health information (PHI). He will conduct 
fidelity checks of health coaches. He will be involved in data analysis of coded and raw data. 
 
Brent Leininger, PhD, DC, MS 
612-301-9006 
Lein0122@umn.edu 
Duties: Dr. Leininger will share patient support resources (e.g., exercise videos, workbooks) 
from his on-going NIH funded trial (R34AT011209) and associated protocols which can be 
modified for Veteran use in the RAMP program. Dr. Leininger will assist with training of health 
coaches in pain-related competencies and in the development of fidelity forms. He will also work 
closely with the investigators to develop the effectiveness and implementation data collection 

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instruments, monitor, analyze, and interpret the UG3/Phase 1 related milestones and 
intervention experience data. He will work with Dr. B. Taylor and his team to further develop the 
methods and to conduct the budget impact analysis as part of the UH3/Phase 2 and contribute 
to the qualitative analyses. Dr. Leininger will serve on the Investigator Steering Committee, 
Implementation Science Team, Data & Technology Team, and Regulatory Team. He will also 
serve on the PRISM/Collaboratory Electronic Health Record Work Group. He will participate in 
the preparation of manuscripts describing the design and results of the study. 
Data access: Dr. Leininger will have access to protected health information (PHI). He will 
conduct fidelity checks of health coaches. He will be involved in data analysis of coded and raw 
data. 
 
 
Indiana University 
School of Medicine and Roudebush VAHCS 
Marianne Matthias, PhD 
317-278-2516 
mmatthia@iupui.edu  
Duties: Dr. Matthias will actively work with the team throughout each phase of the project. She 
will serve on the Implementation Science Team, and participate in advisor/partner data 
collection, interpretation of data, dissemination activities, and planning of next steps.   
Data access: Dr. Matthias will be involved in interviewing/data collection of advisors/partners, 
performing data analysis, and interpretation of data. She will be interacting with advisors. She 
will not have access to protected health information or have direct contact with pilot/RCT 
participants (e.g., she will not be recruiting, obtaining informed consent, or conducting surveys).  
 
 
University of California Los Angeles (UCLA) 
Schools of Medicine and Public Health and West Los Angeles VAHCS 
Stephanie Taylor, PhD 
310-941-0291 
Stephanie.taylor8@va.gov 
Duties: Dr. Taylor will provide her nationally recognized expertise to assist in examining the 
effectiveness and implementation of CIH for pain. She will be an active participant on the 
PRISM/Collaboratory Implementation Science Work Group and the project-level Implementation 
Science Team. She will be integral to analysis, manuscript writing, and dissemination efforts. 
Data access: Dr. Taylor will be involved in interviewing/data collection of advisors/partners,  
performing data analysis, and interpretation of data. She will be interacting with advisors. She 
will not have access to protected health information or have direct contact with pilot/RCT 
participants (e.g., she will not be recruiting, obtaining informed consent, or conducting surveys).  

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Consultant 
 
John G. Serpa Consulting and West Los Angeles VAHCS 
John (Greg) Serpa, PhD 
310-343-3459 
gregserpa@yahoo.com 
john.serpa@va.gov 
Duties: Dr. Serpa’s primary role will be to serve on the Intervention Effectiveness and 
Implementation Science Teams, helping to develop strategies for implementing the RAMP 
intervention successfully within VA Whole Health. He will provide guidance on refining the 
RAMP program and on developing a successful model for training health coaches.  
Data access: Dr. Serpa will be involved in performing data analysis and interpretation of coded 
data. He will not have access to protected health information or have direct contact with 
participants (e.g., he will not be recruiting, obtaining informed consent, or conducting surveys). 
 
 
Project Staff 
 
Minneapolis VAHCS, CCDOR 
 
Role: Project Director 
Lee Cross, MPH 
612-629-7568 
Lee.cross@va.gov 
Duties: Ms. Cross will work closely with Drs. Burgess, Evans, and Hadlandsmyth and the entire 
rest of the team. She will plan and organize meetings, including the project team meetings, and 
document decisions and action items. Ms. Cross will lead the efforts to ensure all logistical and 
human subjects protection matters are taken care of for success during all phases of data 
collection. This will include planning videoconferences, IRB approvals, informed consent, 
incentive payment, and budgeting. She will take the lead in documenting all study procedures 
(e.g., mailing protocols, recruitment staff training, recruitment instructions, randomization 
procedures, telephone support line procedures, mental health crisis management, and 
communication with participants). She will provide training and guidance to staff in these 
procedures as well as in the conduct of human subjects research, good clinical research 
practices, and data privacy and security. Ms. Cross will serve as the manager between all sites 
and will be in regular contact with health coaches. She will also cross-train on Intervention 
Coordinator and Study Coordinator duties. She will be an active member of the Regulatory, 
Intervention Effectiveness, Implementation Science, Data & Safety Monitoring and Data & 
Technology teams. She will participate in data analysis, manuscript preparation, and other 
dissemination activities. 

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Data access: Ms. Cross will have access to protected health information. She will be involved in 
recruiting subjects, obtaining informed consent, administering survey procedures, and will be 
involved in data analysis of coded and raw data.  
 
Role: Lead Intervention and Engagement Coordinator/Study Coordinator 
Kimberly Behrens, MPH 
612-467-1983 
kimberly.behrens@va.gov 
Duties: Ms. Behrens will be integral in the development of RAMP materials. In conjunction with 
Ms. Mahaffey, she will lead Health Coach training and day-to-day supervision, perform medical 
chart reviews as a step in determining participant eligibility, facilitate Patient Engagement Panel 
meetings, and be cross-trained on Project Director duties. She will coordinate and communicate 
with the Project Director, and provide regular progress reports, which will include required 
human subjects’ research documentation and ensuring all human subjects’ ethics regulations 
are followed. Ms. Behrens has extensive expertise in safety monitoring and crisis management 
and will be integral in developing and maintaining related protocols and procedures. She will be 
a member of the Intervention Effectiveness Team and actively participate in data analysis, 
manuscript preparation, and dissemination activities within traditional academic routes and 
without. 
Data access: Ms. Behrens will have access to protected health information. She will be involved 
in recruiting subjects, obtaining informed consent, administering survey procedures, and will be 
involved in data analysis of coded and raw data.  
 
Role: Intervention Coordinator/Study Coordinator 
 
 
Role: Health Coach & Support Assistants  
 
Raina Rooney, BS 
612-467-4391 
Raina.Rooney@va.gov 
 
Duties: The Health Coach and Support Assistants will be trained and then facilitate RAMP 
intervention sessions. They will coordinate and communicate regularly with the Project Director 
and Intervention/Study Coordinator. They will provide regular progress reports and receive 
feedback, which will include required human subjects’ research documentation and ensuring all 
human subjects’ ethics regulations are followed. 
Data access: They will have access to protected health information. They will be involved in 
recruiting subjects and obtaining informed consent. They may be involved in data analysis of 
coded and raw data. 
 
Role: Research Assistant  
Sarah Schroeder, MPH 

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Sarah.schroeder@va.gov 
Duties: The Research Assistant will to assist the Project Director and Intervention/Study 
Coordinator, including with generating and sending recruitment materials, conducting 
randomization over the phone, retention and engagement efforts, answering participant 
questions, and miscellaneous tasks related to qualitative data collection and organization. They 
will assist as needed with study close-out and coordinating manuscript submissions. 
Data access: The Research Assistant will have access to protected health information. They will 
be involved in recruiting and randomizing subjects, obtaining consent, and administering survey 
procedures. They may be involved in data analysis of coded and raw data. 
 
Role: Data Management Team  
Ann Bangerter, BS 
612-467-1384 
Ann.bangerter@va.gov 
Duties: The data team offers support in the following areas: study design; database design and 
development; administrative data extraction; survey design, development and support; 
scannable technology; design, development and implementation of custom applications and 
web sites; project management; and technical writing. The team maintains a balanced portfolio 
of permissions allowing them as a group to access the full scope of data that are necessary for 
project support. For this project, the CCDOR Data Management Team will: 1) create the secure 
SQL database; 2) extract patient data from CDW for identified facilities; 3) extract primary care 
provider data from the Primary Care Management Module for identified patients; 4) support the 
study staff in designing and using the Qualtrics FedRAMP and VA REDCap software, supervise 
the data quality assurance process, and ensure secure data transmission between FedRAMP 
and VA VINCI servers; 5) support the study staff in designing and maintaining the study 
website; 6) request special permission from National Data Systems to access patient name and 
address information in order to create a patient mailing list for project staff; 7) extract and clean 
administrative data, and create data files for analysis; and 8) assist with preparation of reports 
and dissemination of results. Dr. Brent Taylor leads the Data team and provides overall 
coordination and planning for team activities. The Data team, along with Dr. Taylor will take an 
active role in coordination and planning of data sharing efforts (including HEAL data sharing). 
Data access: Ms. Bangerter will have access to protected health information but will not have 
direct contact with participants (e.g., she will not be recruiting or obtaining informed consent). 
She will be creating coded data files for analysis. 
 
 
Role: Statistics Team  
Emily Hagel Campbell, MS 
612-467-7451 
Emily.hagelcampbell@va.gov 
Duties: Ms. Hagel Campbell will handle day-to-day data analyses under Dr. Brent Taylor’s 
supervision. Budgeted effort increases over the course of the 5-year project as data is collected 
and analysis needs increase. This includes time for clinical and data coordination to comply with 

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data sharing activities (including HEAL data sharing). Ms. Hagel Campbell will be involved in 
analyses for manuscripts and other dissemination products. 
Data access: Ms. Hagel Campbell will be involved in performing data analysis of coded data. 
They will have access to protected health information. They will have no direct contact with 
participants (e.g., she will not be recruiting, obtaining informed consent, or conducting surveys). 
 
Memoranda of Understandings (MOUs) and Subawards 
 
Center for Veterans Research and Education (CVRE)  
VA Non-profit Research Corporation (NPC) 
Grant award funds go through CVRE.  
- 
An MOU between CVRE and CCDOR will be created on an annual basis.  
- 
Subawards between non-Minneapolis VA sites will be created at the beginning of the 
study and amendments will be created in subsequent study years. 
- 
Authorization will be obtained before CCDOR study staff share any participant PII with 
CVRE staff. The reason for needing to share PII is to pay participants study incentives.  
 
Role: Executive Director 
Nadine Rogers 
Nadine.rogers@cvre.org 
 
Role: Grants Administration Manager 
Pamela Sharpe 
Pamela.sharpe@cvre.org 
 
 
2.0 
Protocol Summary 
2.1 
Synopsis 
This research is part of a two-phase project (UG3/UH3) supported through the National 
Institutes of Health’s Helping to End Addiction Long-term (HEAL) Initiative. The project is 
summarized below in Tables 1 and 2, and in Figure 1. 
The following provides a synopsis for the UG3 (Phase I) of the project: 
Table 1. UG3 (Phase 1) Synopsis 
Title: 
UG3 (Phase I) Reaching Rural Veterans: Applying Mind-Body Skills for 
Pain Using a Whole Health Telehealth Intervention (RAMP)  
 

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Study Description: 
The UG3/Phase 1 will prepare for the future UH3/Phase 2 trial. It focuses 
on advisor engagement activities (Aim 1) and a single arm pilot study (Aim 
2) to assess feasibility.   
Objectives/Aims: 
 
UG3/Phase 1 Aim 1: We will conduct advisor engagement activities 
including identifying and developing new community partnerships and using 
mixed methods data collection from multiple levels of advisors (n=35-50 
patients, community partners, VA healthcare system leaders and staff), 
guided by the established REAIM/PRISM framework, to learn about key 
factors that can affect long-term adoption.  
UG3/Phase 1 Aim 2: We will conduct a feasibility study of 40 rural VA 
patients with chronic pain to assess the feasibility of delivering RAMP (pilot) 
in terms of recruitment and engagement, intervention fidelity and 
adherence, data collection, and other key metrics.  
Endpoints: 
UG3/Phase 1 Aim 1: advisors named, panels established, assessments 
collected and analyzed (implementation-related barriers and facilitators, 
resource needs, etc.) 
UG3/Phase 1 Aim 2: rates of recruitment, engagement, intervention fidelity 
adherence and data collection, and other key metrics 
Study Population: 
UG3/Phase 1 Aim 1: 35-50 patients, community partners, VA healthcare 
system leaders and staff.  
UG3/Phase 1 Aim 2: 40 rural VA patients from the VA healthcare system.  
Phase or Stage: 
First phase (UG3) of two-phase project (UG3/UH3). 
Description of 
Sites/Facilities 
Enrolling Participants: 
UG3/Phase 1 Aim 1: Advisors found nationally within VA and advisors 
found locally including those in VISNs (Veterans Integrated Service 
Networks) 7 and 23 (representing the Southeast and Midwest regions of 
the US) 
UG3/Phase 1 Aim 2: rural VA patients including those in VISN 7, which is 
the VA Southeast Network including Georgia, Alabama, and South 
Carolina.   
Description of Study 
Intervention: 
RAMP (pilot) is a 12-week program; it includes an individual session with 
the Health Coach, plus 11 group sessions including pre-recorded expert-
led education videos, mind-body skills training and practice, and facilitated 
discussions. 
Study Duration: 
9 months from when study opens to enrollment until completion of data 
analysis 
Participant Duration: 
Each individual participant will take 8 months to complete all study-related 
tasks (enrollment to final follow-up data collection) 
 
The following provides a synopsis for the UH3 (Phase II) of the project: 
Table 2. UH3 (Phase II) Synopsis 

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Title: 
UH3 (Phase II) Reaching Rural Veterans: Applying Mind-Body Skills for 
Pain Using a Whole Health Telehealth Intervention (RAMP)  
Study Description: 
During the UH3/Phase 2 we will conduct a randomized hybrid type 2 
effectiveness-implementation pragmatic clinical trial of RAMP compared to 
Usual Care, enrolling 500 rural VA patients from the VA healthcare system, 
oversampling female and racial/ethnic minority patients.  
Objectives/Aims: 
 
UH3/Phase 2 Aim 1 (Effectiveness): To assess the relative effectiveness 
of RAMP in rural patients in terms of pain interference (primary outcome) at 
3 and 6 months and secondary outcomes of opioid use and other HEAL 
recommended outcomes. We will also perform additional exploratory 
analyses of women and minority Veterans’ primary and secondary 
outcomes.  
UH3/Phase 2 Aim 2 (Implementation): To work iteratively with multiple 
levels of advisors (n=35-50 patients, community advisors, VA healthcare 
system leaders and staff) to evaluate intervention implementation 
strategies used in the trial and adapt these strategies to scale up RAMP 
within the national VA healthcare system. This will include: 
a. Conducting mixed-methods assessments of advisor and 
randomized trial participant views of implementation-related 
barriers and facilitators, resource needs, and other RE-AIM/PRISM 
domains. 
b. Working with advisors to co-create additional plausible strategies 
for overcoming barriers to implementation of RAMP in the national 
VA healthcare system. 
c. Conducting budget impact analyses using models informed by 
advisor views to inform future decision making. 
 
Endpoints: 
UH3/Phase 2 Aim 1: analysis of primary and secondary outcomes, rates of 
recruitment, engagement, intervention fidelity, adherence, and satisfaction, 
rates of follow-up data collection, and other key metrics 
UH3/Phase 2 Aim 2: assessments completed and analyzed, 
implementation strategies created, and budget impact analysis completed. 
Study Population: 
UH3/Phase 2 Aim 1: 500 rural VA patients from the VA healthcare system.  
UH3/Phase 2 Aim 2: 35-50 patients, community partners, VA healthcare 
system leaders and staff.  
Phase or Stage: 
Second phase (UH3) of two-phase project (UG3/UH3). 
Description of 
Sites/Facilities 
Enrolling Participants: 
UH3/Phase 2 Aim 1: rural VA patients including those in VISN 7, which is 
the VA Southeast Network and includes Georgia, Alabama, and South 
Carolina, and VISN 23, which is the VA Midwest Network and includes 
North Dakota, South Dakota, Nebraska, Minnesota, Iowa, and part of 
Illinois. 
UH3/Phase 2 Aim 2: Advisors found nationally within VA and advisors 
found locally including those in VISNs (Veterans Integrated Service 
Networks) 7 and 23 (representing the Southeast and Midwest regions of 
the US) 
Description of Study 
Intervention: 
RAMP is a 9-week program comprised of weekly group sessions including 
pre-recorded expert-led education videos, mind-body skills training and 
practice, and facilitated discussions. 
Study Duration: 
30 months from when study opens to enrollment until completion of data 
analysis 
Participant Duration: 
Each individual participant will take 12 months to complete all study-related 
tasks (enrollment to final follow-up data collection) 
 

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2.2 Project Overview 
 
 
 
 
  
UH3/Phase 2 Aim 1 
(Effectiveness) 
Rural VA Patients (n=500) 
RAMP 
(n=250) 
Usual Care 
(n=250) 
Randomization 
9-week 
intervention 
Baseline data 
collection 
3 and 6 month follow up data collection 
Primary outcome: pain interference 
Secondary outcomes: opioid use and other 
HEAL recommended measures  
UH3/Phase 2 Aim 
2 
(Implementation) 
Rural VA Patients, community partners, 
VA leaders, staff (n=35-50) 
RAMP Trial participants (n=250) 
Mixed methods assessments of 
facilitators/barriers, RAMP use, etc. 
Co-creation of plausible strategies 
Budget impact analyses 
UH3 randomized hybrid type 2 trial 
Rural VA Patients (n=40) 
UG3/Phase 1 Aim 1 
(Partnerships, Advisors 
Input) 
RAMP  
(n=40) 
12-week 
intervention 
3 month follow up data collection 
Feasibility measures: recruitment and 
engagement; intervention fidelity and 
adherence; data collection rates; other  
UG3 advisor engagement & pilot study 
Rural VA Patients, community partners, 
VA leaders, staff (n=30-50) 
Identification/development of community 
partnerships 
Mixed methods assessment of needs, other 
key factors that could affect long-term 
implementation 
UG3/Phase 1 Aim 2 
(Feasibility) 
 
Figure 1. UG3/Phase 1 and UH3/Phase 2 Design Overview  
We have applied complementary models and frameworks to facilitate the project’s long-term objective (see C.2 
Guiding Theoretical Models and Frameworks). 
 
RE-AIM/PRISM: provides overall guidance for improving and measuring Reach, Effectiveness, Adoption, 
Implementation and Maintenance of the RAMP intervention. 
 
COM-B Model: provides guidance for assessing needs, facilitators and barriers and identifying intervention 
solutions aligned with desired outcomes. 
 
Dynamic Biopsychosocial (BPS) Model: provides insight into whole person needs and BPS risk and protective 
factors, including social determinants of health (SDH) 

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2.3 Schedule of Activities (SOA)  
 
 
2.4 Milestones  
Table 3. Schedule of Activities for 
UG3/Phase 1 Pilot/Feasibility (Aim 1) and 
UH3/Phase 2 RCT (Aim 2) 
Screen
er 
BL 
Enrollm
ent call 
Interven
tion 
Session
s 
3m to 
up to 
the 
start of 
6m 
assess
ment 
6m + 3m 
(UH3/Phas
e 2 only) 
Feasibility of recruitment, enrollment, 
intervention, and data collection rates (see 2.4 
Milestones for more detail) 
x 
x 
x 
x 
x 
 
Inclusion/Exclusion criteria 
x 
 
x 
 
 
 
Demographic (including core SDH measures) 
 
x 
 
 
 
 
Consent 
 
 
x 
 
 
 
Enrollment/randomization 
 
 
x 
 
 
 
Primary Outcome 
Pain interference (BPI) 
x 
x 
 
 
x 
x 
Secondary Outcomes 
Pain intensity (BPI) 
 
x 
 
 
x 
x 
Pain impact (GCPS-R) 
 
x 
 
 
x 
x 
Quality of life (WHO QOL 2 item & EQ5D5L) 
 
x 
 
 
x 
x 
Use of opioids (self-report, EHR) 
 
x 
 
 
x 
x 
Physical function (PROMIS) 
 
x 
 
 
x 
x 
Sleep (PROMIS) 
 
x 
 
 
x 
x 
Fatigue (PROMIS) 
 
x 
 
 
x 
x 
Anxiety (GAD2) 
 
x 
 
 
x 
x 
Depression (PHQ2) 
 
x 
 
 
x 
x 
PTSD (PC-PTSD-5) 
 
x 
 
 
x 
x 
Participation in social roles and activities 
(PROMIS) 
 
x 
 
 
x 
x 
Global improvement and satisfaction (PGIC) 
 
 
 
 
x 
x 
Use of CIH and non-pharmacological pain 
management  
 
x 
 
 
x 
x 
Adverse events 
 
 
 
x 
x 
x 
Mediation Measures 
Pain catastrophizing (PCS) 
 
x 
 
 
x 
x 
Pain management self-efficacy (PROMIS) 
 
x 
 
 
x 
x 
Perceived stress (PSS) 
 
x 
 
 
x 
x 
Body Awareness (MAIA) 
 
x 
 
 
x 
x 
Other Measures 
Substance Use Screener (TAPS) 
 
x 
 
 
x 
x 
Intervention-related measures* 
 
 
 
 
x 
x 
BL=baseline; 3m=3 months; 6m=6 months; SDH=social determinants of health; BPI=brief pain inventory; GCPS-
R=graded chronic pain scale-revised; WHO QOL=World Health Organization Quality of Life; EQ5D5L=5-level Euro 
Quality of Life-5D; PROMIS=patient-reported outcomes measurement information system; GAD2=generalized 
anxiety disorder; PHQ2=patient health questionnaire depression scale; PC-PTSD-5=PTSD checklist for DSM-5; 
EHR=electronic health record; PCS=pain catastrophizing scale; PSS=perceived stress scale; 
MAIA=multidimensional assessment of interoceptive awareness; TAPS=Tobacco Alcohol Prescription medications 
and other Substance; *Intervention related measures are also considered patient-level RE-AIM/PRISM measures. 

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2.4.1 UG3/Phase 1 Milestones 
UG3/Phase 1 Milestone Timeline (Years 
1-2 of Project) 
Year 1 
Year 2 
Month 
1 2 3 4 5 6 7 8 9 1
0 
1
1 
1
2 
1
3 
1
4 
1
5 
1
6 
1
7 
1
8 
1
9 
2
0 
2
1 
2
2 
2
3 
2
4 
Quarter 
1 1 1 2 2 2 3 3 3 4 4 4 5 5 5 6 6 6 7 7 7 8 8 8 
Agreements and Regulatory Approvals 
All necessary approvals received (IRB, 
NIH, DSMB) for all required protocols and 
plans (e.g., clinical protocol; 
accrual/retention plan, data and safety 
monitoring plans) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Advisor Engagement  
Community-based partners named 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Multi-level (patient, community, and VA) 
advisor/partner panels established 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Multi-level advisor assessments (of 
implementation-related barriers and 
facilitators, resource needs, and other RE-
AIM/PRISM domains) collected and 
analyzed (n = 35-50) 
 
 
 
 
 
 
 
 
 
 
     
 
 
 
 
 
 
 
 
 
 
X 
Pilot Study 
Recruitment and Enrollment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
40 rural-dwelling VA patients recruited 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
At least 35% female and 35% racial/ethnic 
minority patients recruited 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
 
 
 
 
 
Experimental Intervention 
75% satisfied with RAMP program  
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
75% of intervention participants 
attend/engage with recommended # of 
sessions (≥ 7/12)  
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Health Coach Facilitators deliver 90% of 
session activities 90% of the time 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Data Collection 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 >80% complete post-treatment data 
collection (at 3 months) 
     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X  
Key: DSMB=Data and Safety Monitoring Board; IRB=Institutional Review Board; NIH=National Institutes of Health; 
VA=Veterans Healthcare Administration.  
Successful completion of these milestones will establish the feasibility of our processes and 
ensure that we are prepared for the proposed UH3/Phase 2 randomized hybrid type 2 
effectiveness-implementation pragmatic clinical trial of RAMP. 
 
2.4. UH3/Phase 2 Milestones 
UH3/Phase 2 Timeline (Years 3-5 of Project).  
Quarter 
Administrative 
 
All staff hired and trained 
10 
Manual of Procedures (MOP) finalized 
12 
100% compliance with PRISM Program policies and practices, including workgroup participation 
(Annual) 
12, 16, 
20 

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100% compliance with Protocol (Annual) 
12, 16, 
20 
100% compliance with Data and Safety Monitoring Plan (Annual) 
12, 16, 
20 
Investigator Steering Committee meets monthly & project teams meet 1-4X/monthly (Annual) 
12, 16, 
20 
All staff maintain "trained" status each year including required human subjects training (Annual) 
12, 16, 
20 
Results submitted to clinicaltrials.gov  
20 
Final report submitted 
20 
UH3 Aim 1: Randomized Trial 
 
Recruitment and Enrollment 
 
Study Open to Enrollment 
10 
50% total sample enrolled (w/ completed baseline) per year (35% female; 35% racial/ethnic minority) 
13, 17 
Intervention delivery 
 
50% total sample participate in intervention per year (Annual) 
15, 19 
75% satisfied with RAMP program 
19 
75% of intervention participants attend/engage with recommended # of sessions (≥ 6/9) 
19 
15% of intervention sessions fidelity checked and Health Coach Facilitators achieve high fidelity rates 
(> 90%) 
18 
Data assessment and retention (Assess all participants at 3- and 6-month timeframes) 
 
Data collected at 3 and 6 months for 50% of participants per year 
15, 19 
 > 80% of participants each year retained for primary outcome at 6 months 
15, 19 
Data analysis 
 
Final dataset transferred to statisticians for data analysis 
20 
Aim 1 data analysis completed 
20 
UH3 Aim 2:  Implementation Aim 
 
Meet with patients and community advisors at least 3X/year 
12, 16, 
20 
Meet with VA advisors at least 1X/year. 
12, 16, 
20 
Aim 2a. Conduct mixed-methods assessments of advisor and randomized trial participant 
views of implementation-related barriers and facilitators, resource needs, and other RE-
AIM/PRISM domains 
 
Aim 2a data collection and data analysis completed 
20 
Aim 2b. Work with advisors to co-create additional plausible strategies for overcoming barriers 
to implementation of RAMP in the national VA healthcare system 
 
Aim 2b process plans and implementation strategies completed 
20 
Aim 2c: Conduct budget impact analyses using models informed by advisor views to inform 
future decision making 
 
Aim 2c budget impact analysis completed  
20 
Implementation and Dissemination 
 
Experimental intervention Adaptations 
 
Necessary intervention adaptations based on results completed 
20 
Dissemination and manuscript writing 
 
Design manuscript submitted 
11 
Main trial results manuscript submitted 
20 
Main implementation results manuscript submitted 
20 
Ongoing learnings disseminated via channels identified by multi-level advisors 
12, 16, 
20 
3.0 
Introduction 

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3.1 Study Rationale 
This project addresses the significant challenge of implementing effective, non-opioid 
interventions for chronic pain management in rural and remote dwelling Veteran populations. 
Pain is a complex biophysical, psychological, and social (BPS) condition and there is a growing 
evidence base to support several complementary and integrative health (CIH) approaches, 
which can address pain in a more holistic way. While the VA has become a leader in advancing 
CIH through its Whole Health Initiative, there remain many barriers, especially for rural patients. 
Our team has co-developed, with multiple-levels of VA advisors (including rural patients), an 
innovative telehealth evidence-based intervention that builds upon our team’s previous 
research. The Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole 
Health Telehealth Intervention (RAMP) project strategically coalesces multiple evidence-based 
CIH self-management strategies to address Veterans’ BPS needs and overcome existing 
barriers. Comprised of pain education, mindfulness, pain specific exercises, and cognitive 
behavioral strategies, the program is cohesive and scalable, and designed to meet the needs of 
VA interest holders. RAMP is a 9-week program comprised of group sessions including pre-
recorded expert-led education videos, mind-body skill training and practice, and facilitated 
discussions. For the preparatory phase (UG3/Phase 1) we will conduct 1) advisor engagement 
activities including identifying and developing new community partnerships and using mixed 
methods data collection from multiple levels of advisors (n=35-50 patients, community partners, 
VA healthcare system leaders and staff), guided by the established RE-AIM/PRISM framework, 
to learn about key factors that can affect long-term adoption; and 2) conduct a pilot study of 40 
rural VA patients with chronic pain to assess the feasibility of delivering RAMP (pilot) in terms of 
recruitment and engagement, intervention fidelity and adherence, data collection, and other key 
metrics. For the UH3/Phase 2, we will conduct a randomized hybrid type 2 effectiveness-
implementation multi-site pragmatic clinical trial of RAMP compared to Usual Care, among rural 
patients (n=500) in the VA healthcare system. UH3/Phase 2 Aim 1 will assess the relative 
effectiveness of RAMP in terms of the primary effectiveness outcome of pain interference at 3 
and 6 months and secondary outcomes including opioid use and other HEAL recommended 
outcomes. In UH3/Phase 2 Aim 2 we will work iteratively with multiple levels of advisors (from 
UG3/Phase 1) to evaluate intervention implementation strategies used in the trial and adapt 
these strategies to scale up RAMP within the national VA healthcare system. This will include: 
a) conducting mixed-methods assessments of advisor and randomized trial participant views of 
implementation-related barriers and facilitators, resource needs, and other RE-AIM/PRISM 
domains; b) working with advisors to co-create additional plausible strategies for overcoming 
barriers to implementation of RAMP; and c) conducting budget impact analyses using models 
informed by advisor views to inform future decision making. 
3.2 Background 
Chronic pain is a pervasive problem in the United States that disproportionately affects 
Veterans. 4 The Veterans Healthcare Administration (VA) is the nation’s largest integrated care 
system, serving over 9 million Veterans, including 2.7 million rural-dwelling Veterans. 3,34 Two-
thirds of all Veterans report chronic pain, resulting in significant functional limitations and high 
healthcare utilization. 4,35The most common chronic pain conditions among VA patients are 

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musculoskeletal disorders, with joint pain, back pain and osteoarthritis having the highest 
prevalence. 36 Despite reductions in overall opioid prescribing across the VA in recent years, 
there remains a significant subset who continue to receive long-term opioid medications for 
chronic pain. 37,38 VA patients are more likely than the general population to be treated with 
opioids, 39 and rural VA patients are disproportionately prescribed these medications. 8 Further, 
VA patients have nearly twice the rate of accidental fatal poisoning as US adults overall, and 
opioid analgesics are the drug class most commonly involved in these deaths. 5  
 
Pain in Rural America. Rural-dwelling individuals in the United States have increased 
prevalence of pain, less access to comprehensive chronic pain care, are more likely to be 
prescribed opioid medications, and experience greater harms from opioids compared to urban 
residents. 1,2,7,40-43 Rural VA patients receive over 30% more opioids than urban VA patients, 8 
are less likely to receive comprehensive and specialty pain care, 6,7 and are less likely to use 
self-management interventions for pain. 9 Compared to men, female VA patients have greater 
rates of pain, are more likely to experience multiple comorbid chronic pain conditions, 10,44 and 
rural-dwelling female VA patients receive more pharmacologic and less specialty pain care, 
relative to their urban counterparts. 6  
The Need for Whole Health Approaches to Pain Management. Pain, like most health 
conditions, has become widely recognized as more than a physical phenomenon. It is a 
complex condition influenced by interrelated biophysical, psychological, and social (BPS) 
factors. 18,19 Pain is frequently associated with psychological risk factors including poor cognitive 
and emotional coping strategies, depression, catastrophizing, and fear avoidance behaviors. 
45,46 There is also growing evidence that social determinants of health are associated with 
greater likelihood of chronic pain and poorer outcomes. 47-49 Lack of social support, 50-52 and 
occupation and related factors such as physical workload, education, injury compensation, and 
dissatisfaction can also have a negative effect on pain. 43,46 Poor quality relationships, social 
stressors (e.g., due to racism, ostracism, injustice, invalidation, isolation), and low income and 
education status also have been shown to contribute to poor outcomes. 43,53,54 Further, there is 
growing recognition of the important intersections among trauma, violence, substance use, and 
pain. 55 Veterans in the VA healthcare system are especially impacted by these factors; they 
have lower levels of income and education and higher levels of trauma exposure compared to 
non-Veterans and Veterans not enrolled in VA care. 56,57 Compared to men, female VA patients 
are more likely to report history of interpersonal trauma, military sexual trauma, mood disorders, 
and anxiety disorders, 10,44 all of which can adversely affect treatment outcomes. Rural-dwelling 
female VA patients are even more impacted, with a high probability (50%) of interpersonal 
and/or sexual traumas, 58 high rates of emotional distress, and low levels of social support. 10,11,58   
To reduce the burden of pain, patients require greater access to evidence-based care that 
addresses their “whole-person” or biopsychosocial needs. 59-61 There has been a growing 
recognition that pain, like other chronic health conditions, requires ongoing attention to lifestyle 
factors and engagement in effective self-management. 62,63 While patients recognize the need 

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for self-management strategies, they often need support and validation to initiate and maintain 
optimal self-care. 64,65  
The VA and Whole Health: In response to the opioid crisis which has disproportionately 
affected Veterans, 4 the VA has adopted policies and devoted resources to replace opioid-
centric models of pain management with multi-modal approaches that prioritize evidence-based 
non-pharmacological pain treatments, including evidence-based complementary and integrative 
health (CIH) approaches. 66-73 The VA’s Office of Patient Centered Care and Cultural 
Transformation (OPCC&CT) has significantly expanded the provision of CIH services over the 
last decade, supported by the passage of the Comprehensive Addiction and Recovery Act in 
2016. 33,74 Central to this has been the implementation of a Whole Health model of care which 
aligns with established BPS models of pain. In the U.S., the VA is recognized as a national 
leader in Whole Health and nearly one third of VA patients with pain engage in some Whole 
Health services. 33 Noteworthy is the threefold reduction in opioid use that has been observed 
among VA patients with chronic pain who engaged Whole Health services compared to those 
who have not. 33 
CIH and Non-Pharmacologic Self-Management Interventions: There are a range of 
evidence-based CIH and non-pharmacologic self-management modalities for improving 
pain outcomes, 20,76-81 including psychological strategies (e.g., behavioral or cognitive), mind-
body approaches (e.g., mindfulness practices, meditation, relaxation, guided imagery), physical 
activity (e.g., general and rehabilitative exercise, yoga, tai chi), lifestyle advice (e.g., for sleep, 
daily activities, social support), and pain education (e.g., pain neuroscience, and pain 
management tips). 82,83  
Mindfulness-Based Interventions (MBIs) are an especially popular CIH approach and central to 
the VA’s Whole Health model for promoting health. 75 MBIs have been shown to improve chronic 
pain through multiple pathways84-86 and have demonstrated effectiveness for improving 
conditions commonly co-occurring with chronic pain in VA patients, such as PTSD, sleep 
disorders, depression, and substance abuse. 87-89 MBIs have also demonstrated promise for 
improving opioid-related outcomes. 90 Results by our team have found a group telehealth MBI 
for pain can be safely delivered, is acceptable, engaging, and improved pain and other 
biopsychosocial outcomes among Veterans with chronic pain and high levels of psychiatric 
comorbidity. We have also found a similar group MBI to be significantly more satisfactory and 
effective in increasing mindfulness and social connectedness than an active control in older 
adults in a community-based setting. However, because of the complex biopsychosocial nature 
of chronic pain, as well as heterogeneous treatment responses and varied preferences and 
needs, MBIs alone (or any other single approach) are unlikely to meet the chronic pain needs of 
the majority of VA patients. 22,54 Indeed, this was the case in our prior group telehealth MBI for 
pain, in which 34% experienced a meaningful improvement (30% or greater) at 10 weeks, 
compared to those in Usual Care (16%).  Importantly, VA patients have expressed a desire for 
more integration of multiple modalities (e.g., mindfulness with more physical movement). 91 
Indeed, interventions integrating multiple evidence-based approaches are increasingly 
advocated to optimize pain management. 22 Multimodal approaches that support patients in 

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better self-managing their emotional reactions, unhelpful coping and thinking patterns, and 
maladaptive behaviors (e.g., activity avoidance, inactivity, substance over use) are especially 
promising, particularly for pain sufferers experiencing intersecting biopsychosocial challenges. 61 
Whole Person CIH Self-Management. There has been a growing number of multi-modal CIH 
self-management programs that address pain from a whole-person perspective (i.e., taking into 
account BPS factors), 92-94 including in our own research. 25 Evidence shows that such programs 
can lead to improved pain and health behaviors, self-efficacy, and overall health. 92,95-97 In much 
of the research, however, effect sizes are modest, and the research is limited by inattention to 
underlying theoretical frameworks that align individuals’ specific pain-related needs with 
appropriate program elements. 63,92,95,98 A major limitation of the existing research of multi-modal 
CIH self-management programs is that most of the study populations have been mainly White, 
highly educated, with relatively high levels of self-reported health. 92,95 96,97 This leads to 
questionable generalizability to Veterans and rural-dwelling populations, including those from 
racially diverse backgrounds, who are more likely to experience negative social determinants of 
health and poorer health outcomes. 56,57 
  
Barriers to CIH and Whole Health Care: Although the VA has made great strides in providing 
CIH approaches to pain, as part of its Whole Health model of care, these approaches remain 
underutilized, 99 particularly among rural VA patients. 6,7,9 Studies with VA patients, leadership, 
and frontline staff managers, including those conducted by our team, have identified key 
barriers and facilitators to widespread implementation of CIH in the VA, 64,72,73,100-107 including for 
rural populations. 6,24 Examples include difficulty traveling to the main VA medical centers where 
CIH services are offered, 24,108 need for a provider referral, 109,110 as well as lack of awareness 
and knowledge about CIH options for pain. 21-23 Additionally, some female VA patients are 
reluctant to go to the VA in person due in part to experiences of sexual harassment111 and 
history of military sexual trauma. 112  
Telehealth in the VA: Telehealth is an evidence-based approach for delivering healthcare, 
which can reduce some of the barriers to care and improve appointment attendance and patient 
satisfaction. 113-116 The VA is the largest federal provider of telehealth services, 117 which rapidly 
expanded with the onset of the COVID-19 pandemic. 118 In 2022, more than 2.3 million Veterans 
used VA telehealth services. 119 Recent studies have demonstrated the effectiveness of 
telehealth programs for rural Veterans, 113,120,121 including those with chronic pain. 24,108,122 The 
VA’s Office of Connected Care (OCC), which oversees the VA’s Telehealth Program, has 
developed multiple programs to facilitate remote access to telehealth care, in conjunction with 
the Office of Rural Health (ORH). These efforts include the OCC’s work to enhance telehealth 
options and provide mobile applications to support clinical services and overall patient health, 
with particular attention to the needs of rural Veterans, who experience greater barriers to 
accessing telehealth than urban Veterans. 118,123 The OCC has also developed innovative 
programs to increase access to telehealth such as the Accessing Telehealth through Local Area 
Stations (ATLAS) program, which offers convenient locations in communities to access the 
internet for telehealth services, 124 as well as programs that distribute tablets to VA patients. 125  

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This project is innovative in its comprehensive and rigorous assessment of a multi-component 
CIH telehealth intervention in the nation’s largest health system, the VA. Optimized to meet 
Veterans’ BPS needs, we will address critical barriers that currently exist to supporting rural 
Veterans’ pain care. Our approach will not only support larger scale implementation across the 
VA but will serve as a model for non-VA organizations to integrate novel solutions that promote 
equitable access to evidence-based non-opioid pain care across rural America. 
 
3.3 Risk/Benefit Assessment 
3.3.1 Known Potential Risks 
The risks across study phases and aims are summarized in Table 4.  
Table 4. Risks According to Study Phase and Aims 
Study Phase (Aims) 
Approach 
(Population) 
Risks 
Risk Level 
Phase I (UG3 Aim 1) 
Advisor engagement 
(patients, 
community partners, 
VA healthcare 
system leaders and 
staff) 
Breach of confidentiality/privacy 
Minimal 
Phase I (UG3 Aim 2) 
Feasibility/Pilot 
Study (Study 
Participants with 
Pain) 
Breach of confidentiality 
Completing health surveys 
Group education programs 
Natural history of pain 
Minimal 
Phase II (UH3 Aim 
1)  
Randomized Hybrid 
Effectiveness-
Implementation Trial 
(Study Participants 
with Pain) 
Breach of confidentiality 
Completing health surveys 
Group education programs 
Natural history of pain 
Minimal 
Phase II (UG3 Aim 
2) 
Advisor engagement 
(patients, 
community partners, 
VA healthcare 
system leaders and 
staff) 
Breach of confidentiality/privacy 
Minimal 
 

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Advisors: New information will be gathered from advisors and is not anticipated to place them 
at risk of criminal or civil liability or be damaging to their financial standing, employability, 
educational advancement, or reputation. 
Research Participants: The potential risks to study participants of the UG3/Phase 1 Pilot Study 
and UH3/Phase 2 Randomized Trial are considered minimal. They include: 
Breach of Confidentiality and Privacy. New information will be gathered from participants and is 
not anticipated to place individuals at risk of criminal or civil liability or be damaging to the 
subjects’ financial standing, employability, educational advancement, or reputation.  
 
Completing Health Surveys. Participants will be asked to complete health surveys as part of the 
screening and follow up data collection; they may feel uncomfortable answering questions they 
feel are too personal.  
 
Taking Part in Group Based Behavioral Interventions. Participants will be asked to take part in 
group behavioral interventions (via a VA-approved videoconferencing program, for example, 
Webex); the interventions are not physically invasive, embarrassing, or offensive, and not 
expected to have adverse lasting impact. Some participants may experience some anxiety or 
nervousness when participating in group activities. 
 
RAMP Program (Experimental Intervention).  Risks associated with the experimental 
educational intervention may occur in program sessions and practicing on one’s own. Expected 
risks are mild short-lasting physical discomfort (e.g., muscle and joint soreness) as a result of 
performing short periods of exercises (~5-10 minutes); participants might also feel emotional 
when doing the brief mind-body practices (~5-10 minutes) which include mindfulness and 
behavioral coping strategies (e.g., relaxed breathing, guided imagery, progressive muscle 
relaxation).  
 
See Appendix A – DSMP for additional detail about the known potential risks. 
 
 
3.3.2 Known Potential Benefits 
Advisors: We anticipate few direct benefits to advisors taking part in UG3/Phase 1 Aim 1 and 
UH3/Phase 2 Aim 2, although in similar studies we have found that participants find it valuable 
to be able to share their perspectives with researchers and with each other (for members of the 
Veteran Engagement Panel and Community Engagement Panel). 
 
Research Participants: The research participants taking part in the UG3/Phase 1 
Feasibility/Pilot Study and UH3/Phase 2 Randomized Trial (potentially both intervention and UC 
conditions) may benefit from learning new information about pain. They may experience health 
benefits, particularly improvements in their ability to self-manage their pain condition and 
improve related outcomes (decreased pain intensity and interference, impact, medication use; 
increased quality of life, function). Consequently, the benefits of participation are likely to 
exceed the risks.  

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It is possible that participants will experience no direct benefit from taking part in this research 
study (in particular, we believe this more likely to be the case for the UC condition). Still, the 
information participants provide from this study might help us treat future patients with chronic 
pain. This research will help guide the development of strategies to improve health care within 
the VA Healthcare system, particularly for patients with chronic pain and underserved 
subgroups (e.g., women, rural-dwelling, racial/ethnic minorities).  
3.3.3 Assessment of Potential Risks and Benefits 
This project addresses the significant challenge of delivering nonpharmacological treatment for 
chronic pain to a large number of rural-dwelling patients, many of whom have co-morbid 
conditions that contribute to and are exacerbated by their chronic pain. The proposed research 
poses “minimal risk” to subjects. There are no experimental procedures involved in this study. 
The potential risks to study participants include a negative reaction to all or parts of the 
intervention program, and loss of privacy and confidentiality. There are minimal economic and 
social risks with participating.  
 
Protections Against Risk 
Privacy, confidentiality, and data security. There is a very small risk of breach of 
confidentiality and privacy. Protections are in place to ensure a breach does not occur.  
 
Advisors: Study advisors will be assigned their position title or other general label instead of 
actual names in the field notes and file names. Other individuals referred to by participants will 
be assigned their position title or other general label instead of names. When disseminating 
results, whether oral or written, the research team will collapse information across advisors to 
ensure that no sensitive or identifiable information is included. 
 
Research Participants: Pilot/Feasibility and RCT participant confidentiality will be safeguarded 
by the use of password protected databases and locked file cabinets. Research databases will 
be stripped of all identifying information, with keys identifying individual subjects available only 
to the MPIs or selected designees.  
 
All Participants: All participants will have the option of skipping any interview or questionnaire 
questions they do not wish to answer. Further, access to identifiable private information from 
study participants will only be accessible to study related personnel who have met the training 
requirements for the responsible conduct of research, HIPAA and data security and have 
completed all initial and annual study specific training. See section 5.5 Study Evaluations – Data 
Collection and 7.0 Privacy and Confidentiality for more security details. 
 
Study Personnel Training. Prior to initiation of participant enrollment (and annually thereafter), 
all project personnel will undergo project specific human subjects training that addresses risks 
to subjects; protection against risks; potential benefits of research to subjects and others; and 
the importance of knowledge to be gained. Additionally, all study personnel will be required to 

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complete training in the Responsible Conduct of Research every three years. This includes 
online CITI training in responsible conduct of research, good clinical practice, and human 
research protections. 
 
Participant Screening. Potential research participants will undergo a baseline evaluation to 
ensure they meet eligibility criteria, and it is safe for them to participate. Adverse events will be 
minimized by identifying and excluding patients at high risk during the screening process 
(described in section 5.4 Inclusion/Exclusion criteria). 
 
Intervention. Participants will be monitored for side effects and adverse events during all study 
intervention sessions. The RAMP intervention is considered an introductory program and has 
been designed to minimize risks and meet the needs and skill level of participants. RAMP 
integrates mindfulness practices, pain education, pain-specific exercises, and cognitive and 
behavioral strategies. Based on our previous studies and the existing literature, we believe 
RAMP to be minimal risk. It is expected that some participants may experience limited and 
short-lasting physical and/or mental agitation. All participants will be provided health contact 
information as part of the study materials (e.g., workbook, website). Contact information will 
include the national Veterans Crisis Line (dial 988 and press 1) and local VA Healthcare System 
contacts. 
 
Intervention facilitators (health coaches) will be trained by investigators and monitored for fidelity 
to ensure they are implementing the interventions in a manner that optimizes patient safety. 
This will include how to monitor for potential emotional or physical discomfort during session 
activities and how to implement safety procedures if needed. 
 
Project Personnel Support. All participants will have access to the telephone support line and 
email address, staffed by trained team members, who will provide technical assistance and be 
able to answer basic questions related to intervention. We will continually update our 
procedures and manual of operations to reflect commonly asked questions.  
Our team has developed safety procedures to address any physical or mental issues in real-
time. Our aim is always to keep participants safe, give them resources they might need, and 
adhere to timely adverse event classification and reporting (e.g., severe adverse events (SAEs), 
unanticipated problems (UAPs), and adverse events (AEs)). If the participant endorses self-
harm ideation or is in emotional distress (e.g., in session, on the phone with a member of the 
study staff, via email), staff will follow a mental health protection for human subjects procedures, 
on which all study staff will be trained. This procedure has been used successfully in a similar 
study conducted by MPI Burgess (NH170001). 
All participants will be encouraged to contact the project staff (e.g., project director, an 
investigator) and their primary care physician regarding any side effects or adverse events that 
occur. Adverse events impacting participant safety may result in withdrawal from the study 
intervention. 

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Participants will be asked about potential adverse events in all self-report surveys. Participants 
will be asked to report side effects/adverse events related to the interventions by choosing from 
a list generated from the literature and the investigators’ experience (see below). In addition, we 
will query any new or worsening issues.  
 
Question: Since you started your participation in the study have you experienced any of the following? 
Check all that apply. 
 
• 
Worsening pain 
• 
Increased muscle soreness  
• 
Feeling more upset than usual when something reminded you of the past 
• 
Increased feelings of sadness 
• 
Increased feelings of anxiousness 
• 
Feeling more tired or fatigued than usual 
• 
Feeling more isolated or lonely 
• 
Other physical or mental symptoms (please describe) 
 
Please let us know if you think these symptoms were possibly related to the study 
• 
[Show selected items with yes/no for related to study] 
• 
[If yes] Please explain what happened: ________________ 
 
Question: Since your survey, have you experienced a NEW or WORSENING medical issue or event which 
resulted in any of the following? 
 
a. Required you to stay overnight in a hospital? 
No 
Yes 
• 
When did this occur?_________ 
• 
What happened?_____________ 
• 
Are you still being treated for this? 
• 
No 
• 
Yes 
• 
Anything else you want to share about this? 
 
 
 
 
b. Experienced a problem that resulted in a severe or permanent disability? 
No 
Yes 
• 
When did this occur?_________ 
• 
What happened?_____________ 
• 
Are you still being treated for this? 
• 
No 
• 
Yes 

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• 
Anything else you want to share about this? 
 
 
 
c. Experienced a life threatening injury or event? 
No 
Yes 
• 
When did this occur?_________ 
• 
What happened?_____________ 
• 
Are you still being treated for this? 
• 
No 
• 
Yes 
Anything else you want to share about this? 
 
 
4.0 
Objectives and Endpoints 
 
This project addresses the significant challenge of implementing effective, non-opioid 
interventions for chronic pain management in rural and remote dwelling Veteran patients. 1,2 The 
Veterans Healthcare Administration (VA) is the nation’s largest integrated healthcare system 
and serves an estimated 2.7 million rural Veterans. 3 Rural Veterans experience a 
disproportionate share of the national pain burden, with more chronicity, opioid harms, comorbid 
mental health conditions and substance abuse, compared to non-rural Veterans and non-
Veterans. 4,5 Rural Veterans are also less likely to receive comprehensive and specialty pain 
care, 6,7 are prescribed over 30% more opioids, 8 and are less likely to use self-management 
interventions for pain than non-rural Veterans. 7,9 Importantly, rural women and minority 
Veterans living in rural areas experience additional challenges that prevent equitable pain care. 
6,10-17 
Pain is a complex biophysical, psychological and social (BPS) condition10,11 and there is a 
growing evidence base to support several complementary and integrative health (CIH) 
approaches to manage chronic pain in a more holistic way. 18-20 While the VA has become a 
leader in advancing CIH through its Whole Health Initiative, there remain many barriers, 
especially for rural patients. This includes lack of awareness/knowledge about CIH, shortage of 
availability and accessibility of CIH/Whole Health pain care services, and absence of the 
necessary support to successfully engage in CIH self-management. 3,21-24  
Our long-term objective is to improve pain management and reduce opioid use among rural 
patients in the VA. Our multidisciplinary team has co-designed, with multiple levels of advisors, 
an innovative telehealth/virtual intervention that builds upon our team’s previous research. 6,25-32 
The Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health 
Telehealth Intervention (RAMP) project strategically coalesces multiple evidence based CIH 
self-management strategies to address Veterans’ BPS needs and overcome existing barriers. 
Comprised of mindfulness training, pain education, pain specific exercises, and cognitive 
behavioral strategies, the program is cohesive and scalable. RAMP is a 9-week program 
comprised of weekly group sessions with pre-recorded expert-led education videos, mind-body 

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skill training and practice, and facilitated discussions. To ensure long-term sustainability, we will 
collaborate with advisors including Veteran patients and an established network of VA health 
system partners including the Office of Rural Health; the Office of Pain Management, Opioid 
Safety, & Prescription Drug Monitoring (which has been investing in telehealth for pain); and the 
Office of Patient Centered Care and Cultural Transformation. We will also cultivate new 
community partnerships with the VA’s Community-Based Outpatient Clinics (CBOCs) and local 
and national Veteran organizations. There are two phases to the project, a UG3 and UH3.   
The specific aims for the UG3/Phase 1 and UH3/Phase 2 of the project are:  
UG3/Phase 1 Aim 1: We will conduct advisor engagement activities including identifying and 
developing new community partnerships and using mixed methods data collection from multiple 
levels of advisors (n=35-50 patients, community partners, VA healthcare system leaders and 
staff), guided by the established REAIM/PRISM framework, to learn about key factors that can 
affect long-term adoption.  
UG3/Phase 1 Aim 2: We will conduct a feasibility study of 40 rural VA patients with chronic 
pain to assess the feasibility of delivering RAMP (pilot) in terms of recruitment and engagement, 
intervention fidelity and adherence, data collection, and other key metrics.  
UH3/Phase 2 Aim 1: We will conduct a randomized hybrid type 2 effectiveness-
implementation pragmatic clinical trial (RCT) of RAMP compared to Usual Care, 
randomizing 500 rural VA patients from the VA healthcare system, oversampling female and 
racial/ethnic minority patients. The aim is to assess the relative effectiveness of RAMP in rural 
VA patients in terms of pain interference (primary outcome) at 3 and 6 months and secondary 
outcomes of opioid use and other HEAL recommended outcomes. We will ask intervention 
participants about their experience with the RAMP program. We will also perform additional 
exploratory analyses of women and minority Veterans’ primary and secondary outcomes.   
UH3/Phase 2 Aim 2:  We will work iteratively with multiple levels of advisors (n=35-50 patients, 
community partners, VA healthcare system leaders and staff) to evaluate intervention 
implementation strategies used in the trial and adapt these strategies to scale up RAMP within 
the national VA healthcare system. This will include: 
a. Conducting mixed-methods assessments of advisor and randomized trial participant 
views of implementation related barriers and facilitators, resource needs, and other RE-
AIM/PRISM domains. 
b. Working with advisors to co-create additional plausible strategies for overcoming 
barriers to implementation of RAMP in the national VA healthcare system. 
c. Conducting budget impact analyses using models informed by advisor views to inform 
future decision making. 
5.0 
Study Procedures  

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5.1 Overall Design 
 
This is a two-phase study with a UG3 phase in years 1-2 and a UH3 phase in years 3-5 (see 
Figure 1).  
 
5.1.1 Advisor Engagement  
We will ask the stakeholders to complete iterative qualitative assessments and use participatory 
research methods to collaborate and problem solve for implementing RAMP given the internal 
and external contexts that may be affecting the VA and Whole Health System initiatives at the 
time. Data collection will include a combination of primary data collection via surveys, qualitative 
interviews, and focus groups. Meeting times will be agreed upon ahead of time between 
facilitators and stakeholders. All reasonable efforts will be made to work with each stakeholders’ 
schedule and preference for meeting. Additional contact reasons, particularly towards the end of 
the study, may include alerting advisors to study results and other research participation 
opportunities. 
Advisor Population Characteristics 
This study will include Veteran, Community and VA stakeholders/partners who will help evaluate 
intervention implementation strategies within the trial and adapt these strategies to scale out 
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth 
Intervention (RAMP) to rural-dwelling patients in the national VA healthcare system. All advisors 
will be 18 years or older. We plan to specifically include advisors from diverse backgrounds 
(e.g., in terms of race/ethnicity, sex). 
 
Advisors involved in our study may require additional protection, either because they are from 
under-supported populations, minority populations, are women, and/or are employees of the 
VA. All study subjects are expected to be 18 years of age or older (no children will be included). 
We will follow all required protocols when working with VA employees as study participants, 
including communication with employee unions. Because our long-term goal is to provide 
evidence-based pain management to the many rural-dwelling patients in the VA healthcare 
system with chronic pain and under-supported populations are disproportionally affected by 
chronic pain, it is critical we include advisors from such populations in our study. In addition, 
because the program delivery and success are dependent on VA employees, they are also 
crucial to our study. 
 
5.1.2 Feasibility/Pilot and RCT  
 
Interventions 
RAMP (UG3/Phase 1 Aim 2 and UH3/Phase 2 Aim 1)  
Eligible participants will be enrolled in the RAMP intervention group and mailed (by 

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postal mail) tailored informational materials, including an introductory letter, copy of the 
information sheet, schedule with meeting dates/times, a workbook, and directions for accessing 
the intervention materials online. In keeping with our pragmatic approach, participants will not 
be asked to limit any other treatment. RAMP will take place over a 3-month period, delivered 
virtually via a VA-approved program (e.g., Microsoft Teams, Webex). For the UG3/Phase 1, the 
first session was a one-to-one session (60 minutes) with a health coach to complete a Personal 
Health Plan. This was followed by 11 weekly group sessions (90 minutes each) facilitated by the 
health coach. For the UH3/Phase 2, revisions were made, and all 9 weekly sessions will be held 
as a group (90 minutes each) facilitated by the health coach. Videos will be interspersed with 
workbook reflections and group discussions facilitated by the health coach. In session, group 
viewing of expert narrated videos will provide consistent education and training in content (e.g., 
pain education, mind-body skill training like mindfulness, physical movement, wellbeing). A 
range of customizable options and resources will be provided to meet Veterans' preferences, 
needs, and abilities. Email, SMS (using Qualtrics FedRAMP), and/or phone communication will 
provide reminders of sessions ahead of time. Participants will be asked to remain in close 
contact with health coaches and let them know of any need to miss a session. Study staff will 
follow-up with participants who do not attend session(s). Additional contact reasons, particularly 
towards the end of the study, may include alerting participants to study results and other 
research participation opportunities. 
 
Usual Care (UH3/Phase 2 Aim 1 only)  
Participants randomized to the Usual Care (UC) condition will not be asked to do anything 
besides complete the follow-up surveys. In keeping with our pragmatic approach, patients will 
not be asked to limit any other treatment. They will be mailed (by postal mail) an introductory 
letter, copy of the information sheet, and schedule of when they will be contacted to complete 
the follow-up surveys. After completing the final follow-up survey, they will be mailed information 
about how to access the intervention materials online. 
 
Follow-up 
Participants will be asked to complete follow-up surveys online at 3 months (UG3/Phase 1 and 
UH3/Phase 2) and 6 months (UH3/Phase 2 only) after the intervention period began. Survey 
invitations will be sent via email and SMS (using Qualtrics FedRAMP). Reminders will be sent to 
non-responders, including phone and mail follow-up if necessary. 
 
All recruitment and follow-up activities will be performed by project staff at the Minneapolis VA.  
 
Participant Population Characteristics 
In order to qualify for the US Military, and eventually become a Veteran, individuals must be at 
least 18 years old. Since children (less than 18 years of age) do not exist in the population of 
interest, they will not be included in the study. This is also consistent with NIH Policy and 
Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects. 
 

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People from under-supported populations requiring additional protection will be included in our 
study sample. This includes females, rural and varied heritage groups. These populations of 
Veterans are disproportionally affected by chronic pain. For our centrally managed recruitment 
strategy we will be using the VA (Veterans Affairs) Electronic Health Records (EHRs) to find VA 
Veteran Integrated Service Network (VISN) 7 and 23 patients who meet our selection criteria, 
including living in an area classified as rural. The U.S. is divided into 18 Veterans Integrated 
Service Networks or VISNs—regional systems of care. VISN 7 is the VA Southeast Network, 
which includes Georgia, Alabama, and South Carolina. It consists of 8 VA hospitals and 
affiliated community-based outpatient clinics or CBOCs. VISN 23 is the VA Midwest Healthcare 
Network, which includes North Dakota, South Dakota, Nebraska, Minnesota, Iowa, and part of 
Illinois. It consists of 9 VA hospitals and affiliated community-based outpatient clinics or CBOCs. 
We have chosen these two VISNs to obtain geographic diversity and because VISN 7 has a 
large percentage of rural racial and ethnic minorities, and a relatively large percentage of 
women compared to other VISNs. We will oversample Hispanic/Latino Veterans from VISNs 7 
and 23 who meet our study criteria (N = 3763), using the EHR, with the goal of having at least 
7.5% of our sample be Hispanic/Latino. This target is well above the current level of 
Hispanic/Latino Veteran representation in rural areas and will help provide more information for 
this important and growing demographic group.  
 
 
5.2 Recruitment Methods, Randomization Procedures and Blinding 
(for Feasibility/Pilot and RCT), Participant Enrollment, and Retention 
5.2.1 Advisor Engagement  
Patient Partners (n=15-20). 
RAMP Veteran Engagement Panel (VEP). We will establish a RAMP VEP comprised of rural VA 
patients with chronic pain from diverse backgrounds (e.g., geography, race/ethnicity, sex, age). 
Patients will be recruited to the VEP in collaboration with the Growing Rural Outreach through 
Veteran Engagement (GROVE) Center that has extensive experience recruiting rural VA 
patients for Veteran engagement activities. We will also reach out to prior LAMP participants 
(award W81XWH-18-2-0003, CIRB 18-21, IRBNet 1613709; led by Dr. Burgess) who expressed 
interested in being contacted again and who are rural-dwelling. 
Other Ongoing Veteran Engagement Panels and Expert Consultants. We will draw on other 
established Veteran Engagement Panels throughout the project to provide broader 
perspectives. These include the Center for Access & Delivery Research and Evaluation 
(CADRE) Veteran Engagement Panel comprised of rural VA patients; the Growing Rural 
Outreach through Veteran Engagement (GROVE) Midwest Veteran Engagement Panel, and the 
Pain/Opioid Care Veteran Engagement Panel, a diverse panel of patients with chronic pain, who 
meet regularly to provide feedback to VA research investigators involved in pain and opioid 

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research. We will also be in regular contact with our Expert Veteran Consultants, Vanessa 
Meade, Sean Green, and Adam Anicich.  
Community Partners (n=10-15). 
RAMP Community Advisory Panel (CAP). As part of the UG3 preparatory activities, we will 
identify and develop new community partnerships, and establish a RAMP CAP. The RAMP 
telehealth intervention is intended to reach rural Veterans, who are dispersed throughout 
different rural communities and receive care at different CBOCs. Because RAMP participants 
will be dispersed among rural communities in the Southeast (VISN 7) and the Midwest (VISN 
23), we will identify organizations serving Veterans in local communities in these regions, such 
as local branches of the American Legion and the Veterans of Foreign Wars (VFW). We will 
also identify organizations serving diverse Veteran communities such as women and racial, 
ethnic and sexual minority Veterans, which may be local or national, since those communities 
may not be represented by local organizations such as the VFW. Recruiting and successfully 
partnering with such community organizations that specifically serve rural-dwelling patients, will 
be facilitated via the GROVE center and other experts in partnering with organizations serving 
diverse Veteran communities. We will also ensure that our CAP includes individuals from 
diverse backgrounds (e.g., race/ethnicity, sex). We will accomplish this during the UG3 period, 
through our collaboration with the national Growing Rural Outreach through Veteran 
Engagement (GROVE) Center and our Veteran partners. We will also actively develop 
relationships with Veteran Service Organizations that serve under-supported communities. 
 
VA Healthcare System Partners (n=10-15). 
We will partner with leaders from national VA Program Offices who oversee VA policy and 
programs that will be key to implementing the proposed trial and to integrating RAMP into the 
VA healthcare system nationwide (Office of Patient Centered Care and Cultural Transformation; 
Pain Management, Opioid Safety, Prescription Drug Monitoring Program; the Office of Rural 
Health and the Office of Connected Care). We will also work with the VA Community Based 
Outpatient Clinics (CBOCs) leaders & staff in the Southeast (VISN 7) and the Midwest (VISN 
23) and VA Medical Center leaders and staff from “parent” facilities in those regions that provide 
in-person and virtual clinical care to affiliated, rural CBOCs (e.g., leaders: Pain Committee Lead, 
Telehealth hub lead, staff: Whole Health coach, Whole Health manager, Whole Health Flagship 
Site staff, primary care providers, integrative health providers). We will also ensure that our VA 
Healthcare System Partners include individuals from diverse backgrounds (e.g., race/ethnicity, 
sex). These employees will be recruited during the UG3 phase. 
To facilitate successful collaborations between the stakeholders/partners and researchers and 
optimize retention, we will develop a formative evaluation strategy for our engagement plan, to 
understand, refine, and continually improve our engagement activities. We also will be guided 
by the ConNECT Framework for advancing health equity in behavioral health. This framework 
provides actionable principles that can be infused throughout the entire research process. Use 
of ConNECT helps ensure greater and sustained consideration to how the researchers work 
with communities who experience health disparities, including giving greater attention to social 

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contexts (e.g., socioecological determinants, biological/physical and psychological influences). It 
also emphasizes processes that foster a norm of inclusion, ensure equitable diffusion of 
innovations, harness communication technology, and prioritize specialized training for project 
team members. 
 
Communication with Partners 
Study personnel will recruit and have continuous communication with partners via their 
preferred method of communication. We expect communication methods to primarily be email 
(see Table 5 below for allowed methods depending on partner type), secure messenger with VA 
healthcare system partners (e.g., Microsoft Teams chat), virtual meetings (e.g., Webex), phone, 
and in-person. We may also use postal mail. 
 
Table 5. Approved Communication Methods by Type of Stakeholder Partner Panel 
Advisor Partner 
Panel 
Approved Communication Methods 
Veteran patient 
partners (RAMP 
Veteran 
Engagement Panel 
and other ongoing 
Veteran 
Engagement Panels)  
● Shared VA email account (e.g., 
vhaminRAMP@va.gov) 
● Institutional study personnel email (e.g., 
diana.burgess@va.gov, evans972@umn.edu, 
katherine-hadlandsmyth@uiowa.edu, 
mallory.mahaffey@va.gov, mahaf016@umn.edu) 
● Qualtrics FedRAMP (email and text message/SMS) 
● Virtual meetings (e.g., Webex) 
● Phone 
● Postal mail 
Community partners, 
CAP, consultants 
● Institutional study personnel email (e.g., 
diana.burgess@va.gov, evans972@umn.edu, , 
katherine-hadlandsmyth@uiowa.edu, 
mallory.mahaffey@va.gov, mahaf016@umn.edu) 
● Shared VA email account (e.g., 
vhaminRAMP@va.gov) 
● Qualtrics FedRAMP (email and text message/SMS) 
● Virtual meetings (e.g., Webex) 
● Phone 
● Postal mail 
VA healthcare 
system partners (i.e., 
VA employees) 
● Institutional study personnel email (e.g., 
diana.burgess@va.gov, evans972@umn.edu, 
katherine-hadlandsmyth@uiowa.edu, 
mallory.mahaffey@va.gov, mahaf016@umn.edu) 
● Secure messenger (e.g., Microsoft Teams chat) 
● Shared VA email account (e.g., 
vhaminRAMP@va.gov) 
● Qualtrics FedRAMP (email and text message*) 
● Virtual meetings (e.g., Webex) 
● Phone 
● Postal mail 

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*We will send text messages to VA employees if they have a VA cell phone 
 
5.2.2 Feasibility/Pilot and RCT  
RECRUITMENT METHODS 
Veteran patients will be recruited and randomized to participate in the UG3/Phase 1 Aim 1 
Feasibility Study (n=40) and UH3/Phase 2 Aim 1 RCT (n=500). A proactive recruitment strategy 
will be used to contact potential participants. Rural-dwelling patients with chronic pain from the 
VA healthcare system (Veterans Integrated Service Networks (VISNs) 7 and 23, representing 
the U.S. Southeast and Midwest) will be recruited to participate. Trained project staff will identify 
patients by searching the VA Electronic Health Record (EHR) using an algorithm successfully 
used to identify patients with chronic pain. Specifically, patients must have documented in their 
VA electronic health record receipt of qualifying pain diagnoses within the same pain category 
on at least two occasions, at least 90 days apart during the previous 2 years. Pain categories 
were defined according to the International Classification of Diseases, 10th Revision, Clinical 
Modification diagnostic codes (ICD-10-CM) and include: Abdominal and bowel pain; Back pain; 
Bone infections; Fibromyalgia and wide-spread muscle pain; Fractures, contusions, sprains and 
strains; Headache; Infectious arthritic diseases; Limb extremity pain, joint pain and arthritic 
disorders; Musculoskeletal chest pain; Neck pain; Neuropathy; Orofacial, ear, and 
temporomandibular disorder pain; Other painful conditions; Systemic disorders or diseases 
causing pain; Urogenital, pelvic and menstrual pain.  
 
Patients will be required to have an email address in the EHR. We will use the Health 
Resources & Services Administration (HRSA) defined Rural-Urban Commuting Areas (RUCA) 
using zip codes to identify rural patients. The Data & Statistics Teams will then assign these 
patients a Study ID and create a crosswalk so that identifiable data is kept behind the VA 
firewall. Introductory postcards will be mailed to these patients. Patients will then be sent emails 
with a link to the study website, which will include information about the study, instructions for 
accessing the screener survey, an opt-out option, information about monetary incentives ($25 
per survey for the feasibility/pilot; $40 per survey for the RCT), and the study contact information 
(phone number and email address to contact for help). We anticipate needing to send postcards 
and emails to up to 30,000 (about 2,000 during the pilot and about 28,000 during the full RCT) 
people in order to reach our randomization goals. As of October 2022, there were over 50,000 
VA patients in the EHR who meet our initial eligibility criteria. Patients who go to the study 
website will be encouraged to review an information sheet and general introductory information 
as well as access the initial screener survey using a unique identifier (Qualtrics FedRAMP ID) 
via either a secure, unique or shortened URL. If participants screen eligible, they will then 
continue in Qualtrics FedRAMP to complete the baseline survey. This will be followed by a chart 
review by specially trained staff who will review VA EHR charts for mental health exclusions 
(see below). Project staff will call eligible participants to verify eligibility, availability, and interest. 
They will review information sheet details and provide the opportunity for participants to ask 

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questions before obtaining verbal consent and proceeding to randomization (UH3/Phase 2 
only)/full enrollment (both UG3/Phase 1 and UH3/Phase 2).  
 
To facilitate recruitment of patients who may not have reliable access to a device and/or 
broadband internet, the recruitment materials will: 1) Include instruction on the option to use a 
smartphone to access the website, and 2) encourage participants who do not have access to a 
device with internet or a smartphone to call the study phone number to discuss other means to 
connect and participate. Patients who call the study line will have this information reviewed 
verbally by project staff, who will then discuss options with interested patients. We will assess 
the utility of these approaches in the UG3/Phase 1 pilot study, via qualitative feedback. To 
facilitate recruitment and retention of racial/ethnic minority and female patients we will solicit and 
incorporate feedback on our recruitment materials and recruitment/retention strategies from 
patient and community partners/advisors from those groups. If goals for racial/ethnic minority 
and female patients are not being met, we will adjust our sampling strategy (e.g., increase the 
proportion of patients from under-supported groups in the subsequent recruitment waves) to 
achieve our goals, a strategy that was used successfully in the LAMP trial. 
 
RANDOMIZATION  
Allocation concealment methods were designed to maximize internal validity within the 
constraints of the study design.35,36  The computer-generated randomization list is concealed 
from the research team conducting eligibility assessments and participant enrollment using a 
centralized electronic randomization system. 
 
BLINDING 
For the UG3, blinding is not possible because of the design (single group). All enrolled 
participants are assigned to the RAMP intervention.  
For the UH3, upcoming treatment assignments will be concealed from study staff involved in 
screening and enrollment until after randomization through the electronic study application. All 
investigators will be blinded to the primary and secondary outcomes data until the study 
database is locked for analysis. Investigators are authorized to be unblinded when needed for 
safety-related processes (e.g., adjudication of serious adverse events, decisions to withdraw 
participants from the intervention following adverse events). 
 
RETENTION 
We will employ evidence-based retention strategies, which have been successfully used with a 
similar population of VA patients with chronic pain, participating in a similar trial (LAMP), which 
had an 86% follow-up rate at 12 months. These include 1) fostering participants’ commitment 
and sense of identification with the study through branded study materials with the study logo, 
2) a study newsletter, sent at the start of the study and before each survey, which includes 
updates about the study from the MPIs, as well as information shown to be motivating to 
participants (e.g., how they are contributing to research that will help Veterans with pain), 3) 
asking and using Veterans preferred means of communication (e.g., phone, SMS, email), and 4) 
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participants. Participants also receive monetary incentives ($25 per survey for the 
feasibility/pilot; $40 per survey for the RCT for each survey completed via pre-paid debit card or 
physical check) and are sent a reminder postcard shortly before each survey is emailed.  
 
RE-CONTACTING RAMP PARTICIPANTS N THE FUTURE 
The project team may re-contact RAMP participants in the future (while the study is still open) if 
they answer “yes” to the follow-up survey question, “We’d sometimes like to gather more 
information and opinions, or let you know about other opportunities. Are you willing to be 
contacted again in the future?” It can be advantageous to reach out to interested participants 
(e.g., with more information, to ask follow-up questions, to ask for testimonials, to inform of other 
research opportunities, etc.). Future amendment(s) will describe the specifics of these contacts 
(e.g., mode of contact, purpose, etc.). 
 
5.3 Informed Consent Procedures 
5.3.1 Advisor Engagement 
We requested approval for verbal informed consent and waiver of written informed consent from 
the Minneapolis IRB.  Study personnel will review contents of an information sheet with all 
advisors. The information sheets will explain information typically on a consent form including 
that the activity is research, participation is voluntary, permission to participate can be 
withdrawn, permission for use of data can be withdrawn for exempt research activities involving 
the collection and use of identifiable data, and contact information for the VA Investigator. The 
information on the sheets will be reviewed with advisors ahead of time, and advisors will have 
multiple opportunities to ask questions prior to and during study procedures. Advisors will be 
provided with a paper or electronic copy of the information sheet if they would like one. 
 
A signed HIPAA Authorization form will be obtained in order to 1) disclose the minimum 
necessary information to the Minneapolis VA Non-Profit Corporation, the Center for Veteran 
Education and Research (CVRE), for payment to eligible advisors for their time and 
contributions (VA employees will not be paid if on VA work time); 2) share basic and/or 
necessary advisor/partner contact information, qualitative data, and limited datasets with study 
personnel at the (e.g., University of Iowa/Iowa City VA Health Care System and the University of 
Minnesota); and 3) share required and approved data with study sponsor (e.g., NIH), Data and 
Safety Monitoring Board (DSMB), IRB, and other federal agency required to monitor or oversee 
research via VA Box or other approved methods. Signature on the HIPAA Authorization forms 
will be obtained via electronic signature using DocuSign or via a mailed physical HIPAA 
Authorization form and a pre-paid return envelope. A HIPAA waiver will be obtained in order to 
share identifiable information with DocuSign so that an individualized HIPAA form can be 
generated. 
5.3.2 Feasibility/Pilot and RCT 

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The IRB has approved our request for a waiver of HIPAA authorization for the initial recruitment 
search of EHRs for potential participants. The research meets all of the criteria for requesting a 
waiver of documentation of informed consent process, including involving no more than minimal 
tangible or intangible risk to the participants, the waiver will not adversely affect the rights and 
welfare of the participants, the research could not practicably be carried out without the waiver, 
and when possible, participants will be provided with additional pertinent information after 
participation. 
 
Potentially eligible patients will be mailed a postcard describing the study and informing them 
that the study is voluntary. The postcard will provide instructions for opting out, and at any point 
during the study, a participant can choose not to be contacted by project staff again. We will 
provide the study website which includes an Information Sheet (containing information that is 
typically including in an informed consent document). A hard copy of the Information Sheet will 
be mailed when a participant is enrolled/randomized into the study. 
 
We received an approval of verbal informed consent over the phone and waiver of written 
informed consent. We feel this is justified because the study poses minimal risks and waiving 
documentation of informed consent does not affect the wellbeing of the subject.  
 
A signed HIPAA Authorization form will be obtained in order to 1) disclose the minimum 
necessary information to the Minneapolis VA Non-Profit Corporation, the Center for Veteran 
Education and Research (CVRE) and Greenphire, for payment to participants for completing 
surveys; 2) share data with all approved project team members; and 3) share required and 
approved data with study sponsor, Data and Safety Monitoring Board (DSMB), IRB, and other 
federal agencies required to monitor or oversee research via approved methods. Signature on 
the HIPAA Authorization forms will be obtained via electronic signature using DocuSign or via a 
mailed physical HIPAA Authorization form and a pre-paid return envelope. The HIPAA waiver 
will include being allowed to share identifiable information with DocuSign so that an 
individualized HIPAA form can be generated. 
 
See section 4.1 Study Design for more information on personnel training and human subjects 
protections.  
5.4 Inclusion/Exclusion Criteria 
5.4.1 Advisor Engagement 
Participants will be interested and willing patients, community partners, and healthcare system 
leaders and staff. 
5.4.2 Feasibility/Pilot and RCT 
 
Inclusion criteria: 
• 
Veteran participants must be rural dwelling  

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• 
Email address in EHR. 
• 
Patient’s primary care provider is in VISN 7 or VISN 23 
• 
Report pain at least most days in the past 3 months (pain chronicity threshold) 
• 
BPI Pain Interference subscale of 4 or greater (scored by calculating mean of all 7 
items; can calculate as long as 4 of 7 are answered).  
• 
Willingness and ability to complete study activities including meeting remotely via 
videoconferencing when RAMP sessions are held (either at home or another location 
with internet access). 
 
Exclusion criteria: 
• 
Participated in LAMP study as a randomized participant or VEP member (Award 
W81XWH-18-2-0003, CIRB 18-21, IRBNet 1613709; led by Dr. Burgess) 
• 
Current RAMP VEP member 
• 
Requested no future follow-up during LAMP recruitment 
• 
Current enrollment in a research study for pain 
• 
Current enrollment in a similar facilitated, multi-week, multi-modal CIH program  
• 
Severe, poorly controlled psychiatric or substance use disorder (based on chart 
review using structured checklists, conducted by staff who are trained and 
supervised by a clinical psychologist). 
 
5.5 Study Evaluations 
 
Data Collection. Data will be collected using Qualtrics FedRAMP, VA REDCap, paper surveys, 
telephone, virtual or in-person meetings, and EHRs.  
 
Survey data will be collected using electronic data capture through Qualtrics FedRAMP or VA 
REDCap, secure web applications for building and managing online surveys. Qualtrics 
FedRAMP is VA-approved to collect data from VA patients and store data on VA cloud servers. 
Qualtrics is accredited by FedRAMP, a government-wide initiative to protect sensitive data in 
federal agencies, ensuring gold standard security for data collected through Qualtrics. It 
features data isolation, differentiated user roles and privileges, audit login, multi-factor 
authentication, single-sign-on and SSL encryption. VA REDCap has an authority to operate 
(ATO) from VA Office of Information and Technology (OI&T) and is hosted on the VA Enterprise 
Cloud (VAEC). Login requires a VA Network ID and is accessible only on the VA network, data 
is backed-up nightly, and audit trails and logging is captured using individualized user rights 
management. Surveys will contain a study ID number, time of data entry and limited individually 
identifiable information. Paper surveys will be carefully entered into the VA REDCap or Qualtrics 
FedRAMP system by project staff. Within the VA firewall, the project team at the VA will create a 
custom-built tracking app that will track each participant’s enrollment and study status. Data will 
be routinely extracted from Qualtrics FedRAMP and VA REDCap in the VA cloud and stored on 
secure VINCI, VA Box, and Minneapolis VA CCDOR servers, using SQL database connections.  

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Qualtrics FedRAMP and VA REDCap will contain the minimal identifying information needed to 
successfully conduct the study. This will include information that is self-reported by the 
participants (e.g., phone, email, which is best method of contact). No sensitive data will be 
stored outside of the VA protected environment. Once data are transferred for data analysis, 
data will be maintained on password-protected VA computers in the VA environment and on 
secure VA servers.  
Project staff will monitor the functioning of the Qualtrics FedRAMP and VA REDCap 
applications. Only staff affiliated with this research protocol will have access to Qualtrics 
FedRAMP and VA REDCap data collected for this study. The MPIs or their designees will be 
responsible for monitoring data storage location and transfer of data between the VA cloud and 
VA server.  
We will have dedicated research personnel at the Minneapolis VAHCS site to coordinate study 
data acquisition based on regularly updated reports. We will use several strategies to follow-up 
with participants who have not completed their assessments. These strategies were used 
successfully in the LAMP trial, which had an 86% follow-up rate at 12 months. To help decrease 
the number of participants who don’t complete their assessments, we will mail a newsletter 
between each survey and a reminder postcard shortly before each survey is emailed. After 
sending assessments, we will contact non-responders via their specified preferred method and 
using additional contact information they provided. We will encourage online completion but mail 
paper copies or complete surveys by phone as preferred. We will email, mail, call, and text/SMS 
participants with reminders to complete the surveys. The emails will be sent using the RAMP 
study email address or via Qualtrics FedRAMP. Text/SMS messages will be sent via Qualtrics 
FedRAMP. Participants will be contacted to follow-up on any missing data that doesn’t seem 
deliberate (e.g., if a couple of survey pages are completely blank but the rest of the survey is 
answered, it is likely the couple pages got stuck together rather than deliberately skipped). 
Participant flow data using the Consolidated Standards of Reporting Trials (CONSORT) 
framework118 will be collected, including recruitment, enrollment, intervention adherence, 
intervention fidelity, and data collection rates. 
 
All meeting notes will be stored on the VA network. 
 
Data coordination and management. Data collection and management will be overseen at the 
Minneapolis VA HSR&D Center of Innovation (COIN) by Dr. Brent Taylor. Regular meetings of 
investigators and project staff within and between sites will take place to routinely review data 
collection and management issues. To prevent improper use of any data collected for research 
projects conducted at the Minneapolis COIN we will use a combination of local Minneapolis VA 
secure servers as well as the national secure VA Informatics and Computing Infrastructure 
(VINCI) and the secure Qualtrics FedRAMP and VA REDCap systems in the VA cloud. The 
local VA secure servers facilitate data collection and provide a platform for the customized 
research tracking application, while the VINCI platform provides a robust environment for 
pooling the primary research collected data with direct connections to daily or weekly updated 

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mirrors of nearly the entire VHA EHR. VINCI also provides access to extensive storage area 
networks, drives, file shares, databases, SharePoint for collaboration and correspondence sites, 
SAS/Grid, and servers containing virtual machines with an extensive collection of software 
called the VINCI Workspace. We will request access to the Joint Legacy Viewer (JLV) in order 
to capture the highest follow-up response rate that is feasible. It is very important that we reach 
the participants in a timely manner; being able to access current address and phone numbers 
will help in tracking hard to reach participants. A secure link between local VA secure servers 
and Qualtrics FedRAMP and VA REDCap will be created. Limited study specific data will be 
collected on Qualtrics FedRAMP and VA REDCap and will contain a study specific participant 
ID code. VINCI allows individual researchers and their staff the means to securely conduct their 
research projects within a secure and well controlled technical environment. All of these VA 
systems undergo backups of the servers nightly and servers are updated when new security 
patches become available. All individuals with administrative privileges to the VHA servers have 
been screened and have been assigned security clearance putting them in trusted positions to 
work with patient-level data. 
Measures 
See 2.3 Schedule of Activities. 
 
5.6 Discontinuation & Withdrawal  
The reason for participant discontinuation or withdrawal from the study will be recorded in the 
study tracking database (SQL database) and participants will be notified. Subjects who consent 
and are randomized but do not receive the study intervention will not be replaced. Subjects who 
consent, are randomized and receive the study intervention, and subsequently withdraw, or are 
discontinued from the study, will not be replaced. 
We will not use a participant’s data if they request us not to, and we would reassure them, as is 
in the Information Sheet, that there are no penalties for discontinuing or withdrawing from the 
study.  
5.6.1 Discontinuation of Advisor Engagement 
At the point of discussing potential participation, advisors will be informed that this is a multi-
year study and asked whether this is a commitment that they want to make. Community 
organization representatives have the option of naming a second alternate to represent the 
community (i.e., some community organizations will be represented by only one person and 
some by two people who will take turns attending meetings and providing feedback). Although 
the panel meetings will be scheduled well in advance, there will likely be times when a Veteran 
or community advisor cannot attend a meeting and they will still be part of the panel if this is 
their preference. Advisors can also decline to provide feedback on any specific topic and remain 
on the panel. If an advisor no longer wishes to participate, they are of course free to withdraw at 
any time. Reasons for discontinuation will be recorded. Additional recruitment will be conducted, 
if necessary, to replace the expertise of advisor(s) that left the study. 

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5.6.2 Discontinuation of Study Intervention (Feasibility/Pilot Study, 
RCT) 
A study participant may discontinue from the study intervention (i.e., the RAMP program) but not 
from the research study. In such cases, remaining study procedures will be completed as 
indicated by the study protocol. If a significant finding (e.g., development of an exclusion 
criterion) is identified after enrollment, the investigator or qualified designee will determine if any 
change in participant management is needed. Any new significant findings will be recorded as 
an adverse event (AE). 
All efforts will be taken to facilitate study participants’ completion of the study intervention. 
However, participants may be discontinued from the intervention if, for example: 
• 
They develop an exclusion criterion (new or not previously recognized) that would make 
it unsafe for them to continue participation. 
• 
Any adverse event (AE), medical condition, or other situation occurs such that continued 
participation in the study would not be in the best interest of the participant. 
• 
The participant displays abusive behavior toward other participants and/or the project 
staff. 
• 
New evidence emerges which suggests it is unsafe for the participant(s) to proceed with 
the study.  
• 
The participant chooses to withdraw consent. 
 
The data to be collected at the time of study intervention discontinuation, and for the remainder 
of the study will include the following: 
• 
Reason for intervention discontinuation and methods for determining the need to 
discontinue. 
• 
Number of completed intervention visits. 
• 
AE/SAE information, if indicated. 
• 
If participant agrees, self-report surveys (to be administered as scheduled), even though 
the participant has discontinued attending the study intervention.  
5.6.3 Withdrawal of Participants (Feasibility/Pilot and RCT) 
Participants can initiate withdrawal from participation of the study overall, at any point, upon 
request. They can withdraw from the study and/or intervention at any time they feel 
uncomfortable or choose to do so. An investigator may also withdraw a participant from the 
study for reasons including, but not limited to, the following: 
• 
Participant develops an exclusion criterion (new or not previously recognized) that would 
make it unsafe for them to continue.  
• 
Participant exhibits significant study intervention non-compliance (e.g., disruptive or 
unsafe behavior). 
• 
Any adverse event (AE), medical condition, or other situation occurs such that continued 
participation in the study would not be in the best interest of the participant.  

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• 
New evidence emerges which suggests it is unsafe for the participant(s) to proceed with 
the study.  
• 
A major change occurs in the participant's life (e.g., incarceration, death). 
• 
Study closure by institute or oversight body. 
• 
Participant withdraws consent to continue. 
 
5.7. Adverse Events & Serious Adverse Events 
 
Refer to section 6.0 Reporting and to the Data and Safety Monitoring Plan (DSMP) (Appendix 
A) for adverse event handling information and details. 
 
Events of Special Interest 
Reporting of certain events is required by law (e.g., suspected child abuse, adult abuse or 
neglect, excessive use of alcohol or use of controlled substances for non-medical reasons 
during pregnancy) and may be discovered during the study. If information becomes available 
that may require mandated reporting, project staff will contact the PIs or Project Coordinators 
(also see https://mn.gov/dhs/general-public/licensing/maltreatment-investigations/mandated-
reporter-resources). 
Reporting of Pregnancy 
Pregnancy, current or planned, at the point of enrollment is not an exclusion criterion for the 
trial. Enrolled subjects who become pregnant will be monitored for safety and risks the same as 
all other study subjects.  
5.8 Data Analysis 
 
UG3/Phase 1 and UH3/Phase 2 Aim 1a – Advisor Engagement 
Quantitative data will be analyzed using descriptive statistics when appropriate (e.g., 
stakeholder characteristics). For the qualitative analysis, teams of 2-3 will perform rapid 
deductive, directed content analytic methods to interview notes and text from open-ended 
surveys; the coding structure and operational definitions will be guided by the study’s 
conceptual models to provide insights into barriers and facilitators to RAMP’s future 
implementation. Directed content analyses will allow for inductive gathering of important themes 
that might fall outside of our chosen models and frameworks.  
 
We will also apply traditional qualitative methods when more nuanced information would be 
helpful. In these instances, we will use semi-structured interview guides for individual advisor 
interviews and focus groups. Teams of 2-3 will perform in-depth, directed content analyses of 
the meeting notes, applying a codebook in qualitative software (e.g., NVivo). We will use 
deductive approaches aligned with the study’s models and frameworks, as well as inductive 
thematic coding to document other important information that falls outside the coding structure. 
Representative quotations will be identified; when useful (e.g., to gain insight as to theme 

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importance) we will also quantify themes by categorizing them as present or absent for each 
case and present descriptively as frequencies. 
UH3/Phase 2 Aim 1b – Advisor Engagement 
We will prepare summaries of the effectiveness and implementation analyses and present them 
to VA patient, community, and VA stakeholders. This will provide them with the necessary 
contextual information to meaningfully contribute to participatory research activities focused on 
problem solving, process mapping, to develop plausible strategies for remaining barriers to 
implementation of RAMP taking into account internal and external contexts affecting the VA and 
Whole Health System initiatives at the time. Examples include developing specific facilitation 
strategies, adapting information and patient-facing resources for particular groups to increase 
awareness and engagement (i.e., engaging Veterans), tailoring intervention process strategies 
and resources, identifying and preparing champions to lead, support and marketing 
implementation efforts, and developing training programs. 
 
UH3/Phase 2 Aim 1c – Advisor Engagement  
We will conduct a budget impact analysis synthesizing knowledge gained from stakeholder 
views/perspectives in Aim 2a, into analytic models that provide viewing of cost implications 
relevant to particular settings and contexts using recommended methods. This analysis will be 
performed by investigators with statistical and cost-analyses experience. We will develop 
models considering both the local facility and national VA perspectives. Model time horizons will 
be tailored to advisor needs for budget planning. RE-AIM/PRISM data will be used to inform 
values for model inputs and plausible ranges to consider (e.g., uptake by facilities and patients 
with chronic pain, training costs, impact on use of other chronic pain interventions, and related 
costs). Scenario analyses altering values of model inputs and model structure will be conducted 
to allow the consideration of plausible alternative scenarios. Models will be presented to 
advisors while in development to ensure face validity. 
UG3/Phase 1 – Aim 1 – Feasibility study 
The sample size for the proposed feasibility (n=40) was informed by previous feasibility studies 
by the investigators, who have found this number sufficient for informing the feasibility of larger, 
randomized clinical trials. The feasibility of recruitment, enrollment, intervention acceptability 
and credibility, and data collection activities will be assessed using designated feasibility 
measures and targets, described in. Section 2.4.1 UG3 Milestones, above. 
 
Mixed method analyses will be conducted. Quantitative data will be analyzed using 
descriptive statistics (e.g., participant characteristics, satisfaction, fidelity rates, etc.). Qualitative 
data analyses will use a rapid deductive, content analysis approach (directed and summative) 
informed by the study’s conceptual models. We will use the same qualitative methods described 
above for Advisor Engagement.  
 
UH3/Phase 2 – Aim 1 – RCT 

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Our randomization goal based on our power calculation is n=500 participants for our 
UH3/Phase 2 Randomized Clinical Trial. We have chosen a range of biopsychosocial (BPS) 
outcome measures relevant to Veterans, and which are likely to be affected by the experimental 
intervention, RAMP. BPS outcome measures will be collected at baseline, 3, and 6 months.  
 
Our power calculation uses the Brief Pain Inventory (BPI) interference scores over the entire 
follow-up period as the primary outcome measure. The primary outcome uses a repeated 
measures approach that takes into account assessments at 3 and 6 months with a single test of 
significance. Secondary outcomes will evaluate the time points separately. For our primary 
analysis we estimate up to 20% attrition, so at least 500 people will need to be randomized to 
obtain a sample of 400 people with complete data. 200 participants in each arm will yield 90% 
power, with an alpha of 0.05, to reject the null hypothesis of equal means over the repeated 
follow-up time points (i.e., 3 and 6 months) if the arms differ by an effect size of 0.3 or greater. 
This includes a conservative estimate that the repeated outcome measures are highly 
correlated (r=0.7) and even with only 1 time point there is power to detect effect sizes of 0.32. 
Analyses that are stratified by subgroups as small as 70 people per arm (i.e., equivalent to 
restricting to only women or minority Veterans) would have approximately 90% power to detect 
differences of 0.50. However, these would only be exploratory in nature and not adjusted for 
multiple comparisons. While our goal is to achieve 500 randomized participants, our intervention 
will roll out in large waves so precisely hitting a randomized sample number is difficult. 
Therefore, we asked for an administrative IRB approval to exceed this goal and enroll up to 550 
participants.  
 
We will use an intention-to-treat approach. Preliminary descriptive analyses will summarize the 
distributions of the baseline measures across treatment arms overall and will similarly assess 
the outcome distributions across assessment time points (i.e., baseline, 3, and 6 months). We 
will summarize the completeness of the self-reported outcome assessments and examine 
associations between completeness and baseline measures as well as the association with 
secondary outcome assessments that are collected from the electronic medical record (e.g., 
medications, health care utilization related to pain treatment). Initial analyses will use all 
available follow-up data and subsequent sensitivity analyses will examine the potential effect of 
response bias. For analyses of the primary outcome, all repeated measurements of the BPI 
interference score will be fitted in a mixed model for repeated measures as a function of the 
group assignment, while controlling for time points and baseline values of the outcome as fixed 
effects, with participants as random effects. Between-group differences over the entire follow-up 
period (average of 3 and 6 months) will be the primary test of treatment group differences. 
Between-group differences will be estimated for each of the individual time points as secondary 
outcomes. Similar to the methods described above for the primary analyses, weighted selection 
model analyses will examine the sensitivity of the initial results to response biases. To do this, 
we will fit a series of weighted selection model analyses. Each analysis will use an expectation-
maximization algorithm to estimate weights to assign to potential values of the missing 
outcomes for use in the regression model. The secondary outcomes will be similarly analyzed 

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using the same linear mixed effect models for normal continuous measures and appropriate 
generalized linear mixed effect models for non-normal measures. 
 
Subgroup analyses will explore treatment group effects for individual subgroups. For example, 
does there appear to be evidence of a benefit in each group (men and women, white and 
racial/ethnic minorities)? Potential interactions by subgroup type (e.g., sex, race/ethnicity) will 
also be explored to see if there is evidence that treatment effects depend on subgroup. Only 
moderately large subgroup differences would be able to be statistically detected, but exploration 
of subgroup differences is still important for understanding possible mechanisms and barriers. 
The models described above for the primary analysis will be modified for looking at these 
subgroup and interaction effects. Additionally, all of these variables can be explored in 
multivariable models to look at the relative independent relationships between these factors and 
the primary and secondary outcomes. 
 
Additional exploratory analyses involve the assessment of the extent to which pain 
catastrophizing, self-efficacy, perceived stress, mindfulness, and body awareness measures 
mediate the effects of the intervention. We will use the CAUSALMED procedure in SAS/STAT® 
14.3 to estimate mediation effects using a counterfactual framework approach (Robins, J. M., 
and Greenland, S. (1992). Identifiability and Exchangeability for Direct and Indirect Effects. 
Epidemiology 3:143–155). The overall (total) effect will be decomposed into four component 
parts. These components include: (i) the effect of the exposure in the absence of the proposed 
mediators (i.e., controlled direct effect), (ii) the interactive effect when the mediators are left to 
the levels they would hold in the absence of exposure (i.e., reference interaction), (iii) a 
mediated interaction, and (iv) a pure indirect (mediated) effect. Four-fold effect decomposition 
allows for the greatest insight into the causal mechanisms responsible for effect of RAMP on our 
outcomes by simultaneously assessing the portions of the total effect that are due only to 
mediation, only to interaction, to both mediation and interaction, and to neither mediation nor 
interaction. Separate analyses will be conducted pairing each mediator with each outcome. 
 
For the intervention experience responses from intervention participants, we will conduct 
descriptive analyses of quantitative data and explore differences that may emerge by sex. We 
will use Rapid Assessment Process (RAP) analyses to analyze open-ended responses.     
6.0 
Reporting 
6.1 
Minneapolis VA 
We will follow the Minneapolis VA IRB reporting requirements for all issues that must be 
reported (i.e., unanticipated serious adverse events (U-SAEs), unanticipated problems (UAPs), 
protocol deviations/violations/noncompliance, and any changes with respect to the protocol). 
The project staff will remain in regular contact (by phone, email, videoconference, and face-to-
face) to discuss study processes, progress, and any issues encountered. Any issues will be 
reported directly to the MPIs. Data will be reviewed regularly to ensure accuracy and data 

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privacy. In the case of problems, the project director will immediately discuss with the study 
MPIs. MPI Dr. Burgess will report any related or possibly related U-SAEs or Deaths to the 
Minneapolis IRB within 5 business days of learning of the event(s). If there are modifications or 
amendments to the study MPI Dr. Burgess will also complete the appropriate forms and wait for 
approval prior to implementation. As described below, IRB notification forms will be completed 
to notify Data and Safety Monitoring Board (DSMB) of findings.  
6.2 
NIH 
In addition, as guided by the NIH’s policy on data and safety monitoring, a detailed data and 
safety monitoring plan (DSMP) was developed and submitted to NIH program officials for 
approval prior to data collection. See Appendix A for current DSMP. The DSMP aims to ensure 
the safety of participants and the validity and integrity of the data collected. A Manual of 
Operations is also being developed, including standard procedures for protection of all subjects 
and data collected from participants in both hardcopy and electronic formats, from the point of 
collection to storage. 
NIH advised the project team that a Data and Safety Monitoring Board (DSMB) is required for 
the UG3/Phase 1 and UH3/Phase 2 of the project. The number of members and specific areas 
of content expertise for an appointed DSMB was agreed upon with NIH prior to funding. Safety 
and other data outlined in the DSMP (Appendix A) will be monitored by the MPIs on a monthly 
basis. The DSMB establishes the frequency of monitoring in the charter agreed upon by the 
board.   
6.2.1 Framework and information monitored 
The following information will be collected and monitored as part of the DSMP: participant flow 
(as per CONSORT recommendations); enrollment; allocation; data collection; findings from 
quality assurance and quality control procedures; safety (including adverse events described 
below and in Appendix A); and protocol deviations. No interim analyses are planned given the 
low expected risks with the study. 
6.2.2 Adverse Event Monitoring 
We will monitor and report adverse events and unanticipated problems involving risk to subjects 
or others (UPIRTSO) to our local IRB, DSMB, and the funding agency as required. Active and 
passive surveillance methods will be used to monitor for adverse events. We will ask about 
potential adverse events at all study visits and data collection events. Participants will also be 
asked to notify study personnel (outside of scheduled sessions and reporting) about serious 
adverse events that occur. Trained project staff will be responsible for documenting adverse 
events and notifying the principal investigators. The MPIs will have final determination regarding 
the classification and reporting of adverse events to applicable regulatory bodies (e.g., IRB, 
DSMB, funding agency). The MPIs will report serious adverse events and unanticipated 
problems to the appropriate regulatory bodies within 5 business days or other required amount 
of time. 

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6.2.3 Adverse events classification 
See the Data and Safety Management Plan (DSMP) Appendix A for additional details. The 
following table summarizes reporting plans. 
Table 6. Reporting for Adverse events, Serious adverse events, and Other events 
Event 
Report to… 
Reporting Time 
Deaths than are at least possibly related to 
the research 
Minneapolis 
VA IRB, 
ACOS-R, 
NINR, DSMB 
- 
Initial reporting to the Minneapolis IRB 
within 1 hour of learning of the event.  
- 
Follow up with submission of the 
“Minneapolis IRB Immediate Reporting of 
Serious Adverse Events or Deaths” 
written report form will occur within 1 
business day. 
- 
DSMB and NINR within 3 business days 
of learning of the event 
(non-death) Unanticipated Serious Adverse 
Events (U-SAEs) - unexpected and at least 
possibly related to the research 
Minneapolis 
VA IRB, 
NINR, DSMB 
- 
Within 5 business days in writing with 
submission of the “Minneapolis IRB 
Immediate Reporting of Serious Adverse 
Events or Deaths” 
- 
DSMB and NINR within 7 business days 
of learning of the event 
Serious Adverse Events (SAEs) – adverse 
event that is not unexpected and at least 
possibly related to the research 
Minneapolis 
VA IRB, 
NINR, DSMB 
- 
IRB - Summarized at Continuing Review 
- 
NINR – annual report 
- 
DSMB – annual report 
Unanticipated problem involving risk to 
subjects or others (UPIRTSO) 
Minneapolis 
VA IRB, 
NINR, DSMB, 
OHRP 
- 
IRB within 5 business days 
- 
NINR and DSMB within 14 business days 
- 
OHRP within 21 business days 
A summary of recommendations made by 
the DSMB or other monitoring entity as 
appropriate and (if applicable) the action plan 
for response. 
NINR 
- 
Within 14 business days 
Notice of any actions taken by the IRB or 
regulatory bodies regarding the research 
and any responses to those actions. 
NINR 
- 
Within 14 business days 
Abbreviations and acronyms: ACOS-R: Associate Chief of Staff for Research; DSMB: Data and Safety Monitoring 
Board; IRB: Institutional Review Board; NINR: National Institute for Nursing Research; OHRP: Office of Human 

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Research Protections; SAE: Serious Adverse Event; UPIRTSO: Unanticipated problem involving risk to subjects 
or others; U-SAE: Unanticipated Serious Adverse Event; VA: Veterans Health Administration 
 
 
7.0 
Privacy and Confidentiality 
 
● This study will utilize a combination of primary data collection via a study participant 
tracking application housed on secure VA CCDOR servers, Qualtrics FedRAMP, VA 
REDCap, and links to existing VHA administrative data using VINCI (a Health 
Services Research & Development (HSR&D) Resource Center). 
● For each research project, National Data Services (NDS) authorizes limited access 
to VA data via the Data Access Request Tracker (DART). After obtaining IRB 
approval, we will request as needed access to extracts of the Corporate Data 
Warehouse (CDW) that contains national data from several clinical and 
administrative systems in a common relational database. 
● Secure workspace will be allocated to the project for data extraction, processing, analyses 
and storage on a cluster of secure VINCI servers located at the Austin Information 
Technology Center (AITC). All access, processing, and analyses of VA EHR study data will 
be done within VINCI by the CCDOR Statistical & Data Group (CCDOR/SDG). Patient and 
provider identifiers will be used within VINCI when necessary to link records obtained from 
different files.  
● The entire study database (information retrieved from EHR data, recruitment outcomes) will 
be fully contained on secure VHA servers, behind the VA firewall (local CCDOR servers and 
National VA VINCI servers).  
● Initial screening and survey data will be securely stored on Qualtrics FedRAMP VA and VA 
REDCap cloud servers that are approved and fully compliant to house VA research data. 
Study participants have a study ID number will be used as the unique identifier for the 
Qualtrics FedRAMP and VA REDCap systems. The participant’s preferred method of 
communication will be collected along with their email and phone number, if they choose to 
provide it. All crosswalk files that link the study ID to other participant identifiable data will be 
kept securely within the VA firewall. Data will be securely transmitted from the secure 
Qualtrics FedRAMP VA and VA REDCap cloud servers to the local VA platform. 
● All typed field notes and analytic notes will be stored on VA servers. During the data 
gathering process in the field, all entries will be made onto VA-sanctioned devices.  
● VHA CCDOR servers will be used for running the customized tracking application software 
that contains participant contact information. EHR data will be extracted from within the 
VHA’s secure VINCI platform in an effort to robustly protect participant identifiable data 
throughout the project lifecycle within the VA firewall. 

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● Reminders to complete surveys will be sent to the participant’s preferred, allowed method of 
contact: phone, email, mail, SMS, or other secure messenger (e.g., Microsoft Teams chat). 
Continued non-response will activate reminders sent via other methods, including phone, 
email, mail, SMS, and secure messenger. Email will be sent using the RAMP study email, 
via Qualtrics FedRAMP, and/or study personnel email accounts (allowed advisors only). 
SMSs (text messages) will be sent via Qualtrics FedRAMP. 
● ORD Guidelines regarding using email and text messaging for communicating with VA 
research participants, as drafted in the following document, will be followed: 
https://www.research.va.gov/resources/policies/guidance/draft-electronic-mailtext.pdf. This 
includes: 
● No PHI or PII will be transmitted by study personnel through unencrypted email 
or text message. 
● The following text will be included in all emails and text messages so as to try 
and prevent participants from including PHI or PII in their responses: “Email and 
texting is not secure. Please do not reply back to this message with any personal 
information or personal health information. Please call 877-467-5079.” 
● Specific PHI or PII will not be shared in emails from VA staff, but if there is a 
concern for the participant’s immediate safety, and all other forms of 
communication (phone, emergency contact person’s phone) are not successful, 
emails with general statements like the following will be sent: “My role as your 
coach is to create a safe space to share and also to make sure you are safe. I 
have tried reaching you by phone during and after group tonight. To make sure 
you are safe and doing ok, please reach out to me. My VA cell is xxx-xxx-
xxxx. You can also contact the Veteran Crisis line directly by calling 988 and 
Press 1.” 
● If a participant sends PII or PHI as part of a response using the individual’s 
personal email or text messaging, project staff will either respond by telephone to 
the individual or respond using email or text messaging with redaction of any PII 
or PHI conveyed by the participant.  
● Email addresses of participants will be kept secure and not shared with other 
participants.  
● Emails and text messages sent and received for the RAMP study will be saved 
and maintained in accordance with the VHA Record Control Schedule. 
● CCDOR maintains strong protections for coded analysis datasets that will be stored on local 
VA server space. CCDOR provides protections for research data at least equal to that 
provided by the Minneapolis VA Health Care System for patients’ private health information 
(PHI). Access to data is on a “need to know” basis. For example, data analysts will not have 
access to project data unless they can demonstrate that they are somehow needed for a 
particular analysis.  
● Access to project data is obtained through Windows authentication (i.e., PIV card and 
password to the network). It is virtually impossible for any person without a login name, PIV 
card and password to the Minneapolis VA hospital’s domain network to access data on the 

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Center’s servers. Thus, all data housed on the CCDOR Server is extremely secure. Access 
by unauthorized persons is highly unlikely. 
● CCDOR maintains several secure servers that are located in the Minneapolis VA OIT server 
room. Physical access to the server room is limited to VA Office of Information and 
Technology staff. All individuals with administrative access privileges to the Center’s 
servers, including VA OIT personnel and CCDOR programmers, have been screened and 
assigned a security clearance putting them in trusted positions of the hospital with 
authorization to work with patient-level data. VA OIT’s access to the data is strictly limited to 
backing up server data, which prevents catastrophic loss of data. Backups are written to 
tapes that are stored in a secure location accessible only to OIT personnel. 
● To share data with non-VA entities, HIPAA authorization forms signed by participants and 
advisors and/or a Data Use Agreement (DUA) may be put in place and limited datasets will 
be created for this purpose. Necessary documentation will be determined by Minneapolis 
regulatory staff. 
● Docusign will be used to electronically obtain signed HIPAA authorization. The necessary 
identifiable information will be shared with Docusign in order for individualized HIPAA forms 
to be generated. 
● VA and NIH regulations require that all investigators and individuals who work on the study 
undergo comprehensive training annually in research integrity and protection of human 
subjects. Additionally, all study personnel will be required to complete training in the 
Responsible Conduct of Research every three years. This includes online CITI training in 
responsible conduct of research, good clinical practice, and human research protections. 
The CCDOR data group will ensure that all project staff have proper access to the VA 
network (i.e., will assist local OIT for project staff not in Minneapolis), so those who require 
access to study data will have permissions to the data they need.  
● Securing Other Physical Confidential Research Data: Primary data (e.g., survey responses, 
interview transcripts) are identified only by participant number. The original data sources 
(e.g., paper notes) will either be kept in locked cabinets within a locked room or stored in a 
secure folder stored on the CCDOR server. 
● Only individuals with a need to access the data, as vetted by the project’s Principal 
Investigator are granted access. Even then, only the absolute minimum number of data 
elements is released. This protects the integrity of the data as well as its confidentiality. 
● Study records, including data, will be maintained in a secure location and destroyed in 
accordance with VA Federal Records requirements in VHA Record Control Schedule (RCS 
10-1), currently at 6 fiscal years following the closure of the study. All records, including data 
will be handled in accordance with all VA and VHA privacy, confidentiality, and information 
security policies and procedures. 
● Dr. Brent Taylor and the CCDOR Data team are responsible for setting up access and 
creating a personnel list for access to the points on the VA network where documents and/or 
data are stored (i.e., VINCI, VA Box, local VA servers, VA REDCap, and Qualtrics 
FedRAMP). 

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● The current team and other VA investigators have used these procedures in previous 
studies, and they have proved both feasible to execute and acceptable to multiple 
Institutional Review Boards (IRBs). 
 
8.0 
Communication Plan 
 
MPIs Drs. Burgess, Evans, and Hadlandsmyth will meet regularly with Program 
Manager, Lee Cross. At these meetings the MPIs will check in with Ms. Cross to ensure 
that the following key communications occur: 
1. Ensure that required local site approvals are obtained and maintained. 
2. Notify the Director of any facility where the research in being conducted, but the 
facility is not engaged. 
3. Keep engaged sites informed of changes to the protocol, informed consent, and 
HIPAA authorization. 
4. Inform local sites of any SAEs, UAPs, or interim results that may impact conduct 
of the study. 
5. The project team will review relevant sections of the protocol periodically, so that 
we can make sure that the different phases of the study are conducted according 
to the IRB-approved protocol. 
6. Notify all local facility directors when the study reaches the point that it no longer 
requires engagement of the local facility.  
Drs. Burgess, Evans, and Hadlandsmyth have a history of prior collaboration. The 
governance and organizational structure of that project arrangement entails a clear 
division of the overall responsibilities for the research and frequent contact (weekly and 
often more frequently). The MPIs will continue to meet no less than weekly via 
videoconference to collaborate on the project’s overall planning, administration, 
implementation, management, and oversight. If a conflict arises, the MPIs will meet and 
attempt in good faith to settle any issues. If, in the unlikely event they fail to resolve the 
dispute, the disagreement will be referred to the Coordinating Center Steering 
Committee to reach consensus. If, in the unlikely event that the dispute remains 
unresolved, the Steering Committee will seek input from an arbitration group who are not 
affiliated with the study and comprised of individuals from CCDOR, the University of 
Minnesota, and the University of Iowa. No members of the arbitration committee will be 
directly involved in the research grant or disagreement. This panel will settle any conflict 
that arises in the performance of the study and the interpretation of the data. The 
decision of this panel will be final and binding. Publication authorship will be based on 
the relative contributions of participating research and community team members. 
9.0 
Repository/Data Banking 

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UG3/Phase 1 feasibility and UH3/Phase 2 RCT data will be shared with an external NIH HEAL-
approved data repository called National Institute of Mental Health (NIMH) Data Archive (NDA). 
The data will be anonymized as much as possible. All required documentation and agreements 
will be put in place prior to actually sharing any data.  
As with the rest of the RAMP data, the repository/data banking will be handled in accordance 
with all VA and VHA privacy, confidentiality, and information security policies and procedures. 
 
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Appendix A – DSMP 
 
 
 
Data and Safety Monitoring Plan 
(DSMP) 
 
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole 
Health Telehealth Intervention (RAMP) 
 
 
NIH Institute or Center: 
National Institutes of Health National Institute of 
Nursing Research (NINR) 
Grant Number: 
1UG3NR020929 
Version Date: 
February 2025 
NINR Approval Date 
 
IRB Approval Date 
 

 
1 
Study Overview 
1.1 
Purpose of Study 
This research is part of a two-phase project (UG3/UH3) supported through the National 
Institutes of Health’s Helping to End Addiction Long-term (HEAL) Initiative. 
In UG3/Phase 1, we will prepare for the future UH3/Phase 2 trial. This phase focuses on 
advisor engagement activities (Aim 1) and a single arm pilot study (Aim 2) to assess 
feasibility.   
In the UH3/Phase 2 we will conduct a randomized hybrid type 2 effectiveness-
implementation multi-site pragmatic clinical trial of RAMP compared to Usual Care, 
enrolling 500 rural VA patients from the VA healthcare system, oversampling female 
and racial/ethnic minority patients. 
1.1.1 Project Aims 
Phase I 
a. UG3/Phase 1 Aim 1: We will conduct advisor engagement activities including identifying and 
developing new community partnerships and using mixed methods data collection from multiple 
levels of advisors (n=35-50 patients, community partners, VA healthcare system leaders and 
staff), guided by the established REAIM/PRISM framework, to learn about key factors that can 
affect long-term adoption.  
b. UG3/Phase 1 Aim 2: We will conduct a feasibility study of 40 rural VA patients with chronic 
pain to assess the feasibility of delivering RAMP (pilot) in terms of recruitment and engagement, 
intervention fidelity and adherence, data collection, and other key metrics.  
Phase II 
UH3/Phase 2 Aim 1 (Effectiveness): To assess the relative effectiveness of RAMP in 
rural VA patients in terms of pain interference (primary outcome) at 3 and 6 months and 
secondary outcomes of opioid use and other HEAL recommended outcomes. We will 
also perform additional exploratory analyses of women and minority Veterans’ primary 
and secondary outcomes.  
UH3/Phase 2 Aim 2 (Implementation): To work iteratively with multiple levels of advisors 
(n=35-50 patients, community advisors, VA healthcare system leaders and staff) to 
evaluate intervention implementation strategies used in the trial and adapt these 
strategies to scale up RAMP within the national VA healthcare system. This will include: 

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a. Conducting mixed-methods assessments of advisor and randomized trial participant 
views of implementation-related barriers and facilitators, resource needs, and other 
RE-AIM/PRISM domains. 
b. Working with advisors to co-create additional plausible strategies for overcoming 
barriers to implementation of RAMP in the national VA healthcare system. 
c. Conducting budget impact analyses using models informed by advisor views to 
inform future decision making. 
The Data and Safety Monitoring Plan (DSMP) outlined below will adhere to the protocol 
approved by the Minneapolis VA IRB. 
2 
Protocol Amendments 
We have used the NCCIH Guidance on Changes in Clinical Studies in Active Awards to 
define protocol amendments. These include: 
● Any change that may affect patient safety (e.g., change in eligibility criteria; change 
in risk, regardless of whether risk is increased or decreased) 
● Any change that changes scientific intent or study design, or affects human subject 
protection 
● Addition/deletion of a site 
● Addition/deletion of key study personnel 
● A change of institution for key study personnel 
● A change in enrollment targets. 
Protocol amendments will be submitted to NINR and the IRB for approval prior to 
implementation except when necessary to protect the safety, rights, or welfare of 
participants. All protocol amendments will be provided to the DSMB in semi-annual 
reports (or sooner if directed by NINR, the IRB or other regulatory bodies).   
Protocol changes that do not meet the definitions described above are 
considered editorial or administrative and do not require approval. Protocol 
amendments not submitted for prior approval will be reported to NINR within 5 
business days. 
3 
Multi-site Studies 
This is a multi-site study with the Center for Care Delivery and Outcomes Research 
(CCDOR) at the Minneapolis VA Healthcare System serving as the Coordinating Center 
Institution. All screening, enrollment, intervention, and data collection procedures will 
occur using remote methods (e.g., videoconferencing). Trained personnel at CCDOR 
will conduct all screening, enrollment, intervention, and data collection activities during 
both phases of the project. 

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There are multiple responsibilities associated with serving in the capacity of a 
coordinating center.  The Coordinating Center will perform the following: 
● Design and develop the protocol and template informed consent documents (i.e., 
Information Sheets) 
● Review and approve all study-related documents 
● Ensure the protocol is reviewed and approved by the Minneapolis VA IRB prior to 
enrollment of participants 
● Collect and maintain critical documents from affiliated investigators (e.g. resume/CV, 
professional license, certification of completion of training, signed COI disclosure 
forms) 
● Store and/or manage data, data analysis, and data and safety monitoring activities  
● Comply with necessary protocols and maintain consistency with the HEAL Initiative 
Public Access and Data Sharing Policy.  
● Ensure informed consent is obtained and documented from each participant in 
compliance with federal regulations as described in the Minneapolis VA IRB-
approved protocol. 
● Maintain documentation of all IRB approvals for the protocol 
● Provide study specific training to the research personnel  
● Develop and provide protocol specific case report forms 
● Coordinate randomization as applicable  
● Register participants and track participant enrollment  
● Ensure use of the correct version of the protocol and consent document.  
● Ensure the use of quality control measures to assure data accuracy and 
completeness. 
● Track, report and maintain documentation of all serious adverse events and 
unanticipated problems and disseminating the information 
● Provide periodic updates to affiliated investigators on participant enrollment, general 
study progress, and relevant scientific advances 
● Assure that all relevant IRB correspondence (e.g., amendments) and study status 
changes are communicated 
● Protect participants’ rights in regard to research participation 
● Monitor protocol compliance, track protocol deviations and report as needed 
4 
 Confidentiality 
4.1 
Protection of Participant Privacy 
Participant confidentiality is strictly held in trust by the investigators, project staff, the 
sponsor and their agents. This confidentiality covers any study information relating to 
participants. All published reports will be of summary nature and no individual 
participants will be identified. Access to identifiable participant information will be limited 
to study personnel with authorized access.  

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To further protect the privacy of study participants, the Secretary, Health and Human 
Services (HHS), has issued a Certificate of Confidentiality to all researchers engaged in 
biomedical, behavioral, clinical or other human subjects research funded wholly or in 
part by the federal government. Recipients of NIH funding for human subjects research 
are required to protect identifiable research information from forced disclosure per the 
terms of the NIH Policy (see https://humansubjects.nih.gov/coc/index). It is the NIH 
policy that investigators and others who have access to research records will not 
disclose identifying information except when the participant consents or in certain 
instances when federal, state, or local law or regulation requires disclosure. NIH 
expects investigators to inform research participants of the protections and the limits to 
protections provided by a Certificate issued by this Policy. 
4.2 
Confidentiality During Adverse Event (AE) Reporting  
AE reports and annual summaries will not include participant identifiable material.  
5 
Expected Risks  
5.1 
Advisors (Non-Feasibility/RCT) Expected Risks 
New information will be gathered from advisors and is not anticipated to place them at 
risk of criminal or civil liability or be damaging to their financial standing, employability, 
educational advancement, or reputation.  
5.1.1 Advisors (Non-Feasibility/RCT) Protections Against Risks 
Study advisors will be assigned their position title or other general label instead of actual 
names in the field notes  and file names. Other individuals referred to by participants will 
be assigned their position title or other general label instead of names. When 
disseminating results, whether oral or written, the research team will collapse 
information across advisors to ensure that no sensitive or identifiable information is 
included. 
5.2 
Research Participants Expected Risks 
The potential risks are considered minimal for research participants in both the active 
and control groups. These include risks associated with the following: 
● Completing Health Surveys. Participants will be asked to complete health surveys 
as part of the screening and follow up data collection. The nature of the questions 
might be distressing to some individuals.  
● Breach of Confidentiality. There is a very small risk of breach of confidentiality and 
privacy. New information will be gathered from participants and is not anticipated to 
place individuals at risk of criminal or civil liability or be damaging to the participants’ 
financial standing, employability, educational advancement, or reputation.  
 

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The fluctuations associated with the natural history of pain and mental health conditions 
that co-occur with pain may be associated with some risk. 
● Natural History of Pain. People with pain that is chronic in nature often experience 
fluctuations in pain severity, location, character, and quality unrelated to study 
participation (e.g., aggravated by lifting at work or home).  
● Natural History of Mental Health Conditions in People with Pain: People with 
chronic pain often experience fluctuations in their levels of distress or aggravation of 
mental health conditions unrelated to study participation (e.g., stressful life events). 
 
Additional Risk Associated with RAMP Program (active intervention). 
The additional potential risks associated with the RAMP Program are considered 
minimal.  All Veteran patients in the VA health system have a primary health care 
provider; they will not be asked to limit any other treatment they might be receiving for 
their pain.  Participants will be asked to take part in a group behavioral intervention via a 
VA-approved videoconferencing program (for example, Webex). Minimal risks 
associated with the experimental educational intervention may occur in program 
sessions and practicing on one’s own. The intervention is not physically invasive, 
embarrassing, or offensive, and not expected to have adverse lasting impact. Expected 
risks include: 
● Experiencing some anxiety or nervousness when participating in group activities 
(e.g., discussions); mild short-lasting physical discomfort (e.g., muscle and joint 
soreness) as a result of performing short periods of exercises (~5-10 minutes); and 
feeling emotional when doing the brief mind-body practices (~5-10 minutes), which 
include mindfulness and behavioral coping strategies (e.g., relaxed breathing, 
guided imagery, progressive muscle relaxation).  
 
Additional Risk Associated with Usual Care (control group, UH3/Phase II only). 
The additional potential risks associated with being randomly assigned to Usual Care 
are considered minimal. As noted previously, all Veteran patients in the VA health 
system have a primary health care provider. Participants in the Usual Care condition will 
be instructed to do what they normally would, on their own. Patients will not be asked to 
limit any other treatment they might be receiving for their pain. After completing the final 
follow-up survey, they will be mailed information about how to access the intervention 
materials online, which they can use on their own if they wish.   
5.2.1 Research Participants Protections Against Risks 
The expected risks associated with this research have been deemed minimal by the 
Minneapolis VA IRB. All potential participants will be actively engaged in healthcare; 
they will have been identified through the electronic record in which they have had at 
least two visits with a provider in the past year. Also, as part of standard VA policy, 
Veteran patients complete annual suicidality screening. The project team has developed 

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plans for risk mitigation that meet or exceed what currently exists within the VA health 
system. See Table 1 for plans to protect participants against risks and Sections 5 and 6 
for monitoring and reporting plans.  
 
As part of the study, we will monitor safety after consent has been secured (e.g. 
screening, intervention, follow up). Safety concerns may be learned of actively (e.g. 
through querying at screening or in surveys) or passively (e.g. participant discloses 
during any communication at any point on Webex, by email or on phone).  
 
All participant facing staff will be trained, certified and monitored by investigators to 
ensure the satisfactory implementation of safety and monitoring procedures. In the 
event a staff member learns a participant is at risk of experiencing a serious adverse 
event (e.g., suicidality) they will implement safety procedures developed by our team’s 
clinical health experts (summarized in Table 1 and detailed in the manual of operations). 
 
MPIs and Co-Investigators will conduct, at least monthly, a review of safety data and 
meet with project staff to discuss any problems or concerns that arise; additional 
training to implement risk monitoring, documentation and implementation of safety 
procedures will occur as necessary.  
 
 
Table 1. Protection Against Risks  
Type of 
Risk 
Risk Mitigation  
Confidentiality and 
Data Safety 
● All staff receive HIPAA and data safety training that includes 
maintaining the confidentiality and security of research records and 
information.  
● Details regarding the protection of study databases and source 
documentation is provided in sections 8. 
Health Surveys 
(All) 
 
● All participants will have the option of skipping any interview or 
questionnaire questions they do not wish to answer.  
● All surveys will be prefaced by the following*: 
“Our first priority is your safety. The following questions relate to your 
emotional and mental wellbeing. We recognize that sharing this 
information can be challenging. Please remember while answering 
these questions to take care of yourself and if you are feeling upset and 

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would like help, please call the Veterans Crisis line by dialing 988 and 
pressing 1.” 
● All surveys will have the following message at the end*: 
“Our first priority is your safety. The previous questions relate to your 
emotional and mental wellbeing.  We recognize that sharing this 
information can be challenging. Please remember to take care of 
yourself, and if you are feeling upset and would like help, please call the 
Veterans Crisis Line by dialing 988 and pressing 1. 
*Language based on suggestions by our Veteran Advisors  
Health Surveys 
(Follow 
Up 
Only) 
● All participants will be queried for Serious Adverse Events.  
“Since your last survey, have you experienced a NEW or WORSENING 
medical issue or event which resulted in any of the following: 
a. Overnight stay in a hospital?” (no, yes with open fields to describe 
when it occurred, what happened, if still being treated) 
b. Problem that results in a severe or permanent disability?” (no, yes 
with open fields to describe when it occurred, what happened, if still 
being treated) 
c. A life-threatening injury or event? (no, yes with open fields to 
describe when it occurred, what happened, if still being treated) 
Screening 
procedures 
● Potential research participants will undergo baseline screening to 
ensure they meet eligibility criteria and it is safe for them to 
participate.  
● Baseline screening will be conducted by staff applying structured 
checklists to existing electronic medical records review  
● Screening staff will be trained and supervised by the clinical 
psychologist MPI and Co-Is responsible for data collection. The 
following is considered exclusionary: 
● Hospitalization for a severe mental illness-related issue in the 
past 6 months; active psychotic symptoms, suicidal ideation, or 
manic episodes; active substance use disorder that is poorly 
controlled. 
● Staff will be trained to actively monitor for potential emotional 
distress during baseline eligibility calls and to implement safety 
procedures if needed. The manual of operations details steps for 
assessing the nature of the situation, responding appropriately to 
ensure participant safety, documenting the event and notifying the 
Project Director and the MPIs (see Section 6). Participants in which 
imminent risk for suicidality is possible will be offered a warm 
handoff to the Veterans Crisis Line; if they decline, or disconnect, 
staff will immediately 1) contact the local police department to 
conduct a wellness check, then 2) contact the Veterans Crisis line to 
report event and 3) contact the participants’ local suicide prevention 
team. 
 

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Intervention 
● The RAMP intervention has been designed to include activities and 
exercises that are suitable for a range of abilities and preferences. 
The mind-body skill practices are short in duration (~5-10 minutes), 
lowering the risk of emotional discomfort or psychological events.  
● Participants will also be given the option to refrain from participating 
in activities that feel uncomfortable.  
● Facilitators will be trained and supervised by the clinical psychologist 
MPI, chiropractic MPI, and Co-Is with clinical pain management 
experience to actively monitor for potential emotional or physical 
distress during session activities and how to implement safety 
procedures. The manual of operations details steps for assessing 
the nature of the situation, responding appropriately to ensure 
participant safety, documenting the event and notifying the Project 
Director and the MPIs (see Section 6).  
● Participants in which imminent risk for suicidality is possible will be 
offered a warm hand off to the Veterans Crisis Line; if they decline, 
or disconnect, staff will immediately 1) contact the local police 
department to conduct a wellness check, then 2) contact the 
Veterans Crisis line to report event and 3) contact the participants’ 
local suicide prevention team. 
 
 
6 
Adverse Event/ Unanticipated Problems 
All project team members will undergo project-specific human subjects training that 
addresses risks to subjects; protection against risks; potential benefits of research to 
subjects and others; and the importance of knowledge to be gained. Additionally, all 
study personnel will be required to complete training in the Responsible Conduct of 
Research every three years. This includes online CITI training in responsible conduct of 
research, good clinical practice, and human research protections. Current human 
subjects training records are regularly updated by the Minneapolis VA IRB and checked 
annually at Continuing Review. 
All project team members will be trained in study specific protocols relevant to their role, 
including detailed safety procedures to mitigate risk to participants (see Section 5 and 
Table 1 above). We will use active and passive monitoring of adverse events and 
unanticipated problems in the study. Serious or possibly related adverse events and 
unanticipated problems can be learned about in the following ways: 
● From participants, who will be encouraged to contact the Project Director or an MPI  
● From direct queries in the self-report surveys 
● From observations by project staff during baseline screening calls, interventions, and 
other interactions with participants 
 

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Participants who experience possibly related serious adverse events and unanticipated 
problems will be contacted by the Project Director or delegate to gather information for 
adverse event reporting (see Section 6.1 below) and ensure safety procedures are 
followed (see Section 5 above).  
Events identified as serious adverse events or unanticipated problems will be 
adjudicated by the MPIs and Co-Is for: confirmation of severity, relatedness and 
expectedness based on the definitions below.  
6.1 
Definitions  
6.1.1 Adverse Event (AE) 
An adverse event (AE) is defined as any reaction or undesirable event that occurs while 
a subject is on the research protocol whether or not it is considered related to the study 
intervention. Such events could include illness, signs, symptoms, or abnormal 
laboratory tests that have appeared or worsened during the course of the trial, 
regardless of whether causal relationship to the study can be made.  
6.1.2 Unanticipated problem involving risk to subjects or others (UPIRTSO) 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or 
outcome that meets all of 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 participant population being studied; 
● Related or possibly related to participation in the research (“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); and 
● Suggests that the research places subjects or others at a greater risk of harm 
(including physical, psychological, economic, or social harm) than was previously 
known or recognized. 
6.2 
Time Period and Frequency for Event Assessment and Follow-
Up 
The Project Director or designee will record all adverse events or UPIRTSOs the project 
team is made aware of occurring any time after consent until 30 days after the last day 
of study participation. Study related SAEs will be followed to stabilization/resolution. 
 
Characteristics of an Adverse Event 
6.2.1 Severity of Event 

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The following scale will be used to grade adverse events: 
1) Mild: no intervention required; no impact on activities of daily living (ADL) 
2) Moderate: minimal, local, or non-invasive intervention indicated; moderate impact 
on ADL 
3) Severe: significant symptoms requiring invasive intervention; subject seeks medical 
attention, needs major assistance with ADL 
4) Serious: results in any of the following: 
Death – death due to any cause 
Life-threatening condition – the subject was at potential risk of dying at the time of the AE or 
if it is suspected that the use of the study interventions would result in the subject’s death. 
Hospitalization – this indicated the initial admission to the hospital or prolongation of a 
hospital stay that resulted from the AE. 
Disability – the AE has resulted in a significant, persistent or permanent change, 
impairment, damage, or disruptions in the subject’s body function/structure, physical 
activities, or quality of life. 
6.2.2 Relationship to Study Intervention 
To assess relationship of an event to study intervention, the following guidelines are 
used (see Table 2). 
 
Table 2. Relationship of Adverse Events to Study Procedures 
Relatedness 
Definition 
Definitely 
Related 
There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event, including an 
abnormal laboratory test result, occurs in a plausible time relationship to 
study procedures administration and cannot be explained by concurrent 
disease or other drugs or chemicals. The response to withdrawal of the study 
procedures 
should 
be 
clinically 
plausible. 
The 
event 
must 
be 
pharmacologically or phenomenologically definitive. 
 
Probably 
Related 
There is evidence to suggest a causal relationship, and the influence of 
other factors is unlikely. The clinical event, including an abnormal 
laboratory test result, occurs within a reasonable time after administration 
of the study procedures, is unlikely to be attributed to concurrent disease or 
other drugs or chemicals, and follows a clinically reasonable response on 
withdrawal. 

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Possibly 
Related 
There is some evidence to suggest a causal relationship (e.g., the event 
occurred within a reasonable time after administration of study procedures). 
However, other factors may have contributed to the event (e.g., the 
participant’s clinical condition, other concomitant events). Although an AE 
may rate only as “possibly related” soon after discovery, it can be flagged 
as requiring more information and later be upgraded to “probably related” 
or “definitely related”, as appropriate. 
Unlikely to be 
related 
A clinical event, including an abnormal laboratory test result, whose temporal 
relationship to study procedures administration makes a causal relationship 
improbable (e.g., the event did not occur within a reasonable time after 
administration of the study procedures) and in which other drugs or 
chemicals or underlying disease provides plausible explanations (e.g., the 
participant’s clinical condition, other concomitant treatments). 
 
Not Related 
The AE is completely independent of study procedures administration, 
and/or evidence exists that the event is related to another etiology. There 
must be an alternative, definitive etiology documented. 
6.2.3 Expectedness of SAEs 
An adverse event will be considered unexpected if the nature, severity, or frequency of 
the event is not consistent with the risk information previously described for the 
intervention.   
6.3 
Reporting Procedures 
6.3.1 Serious adverse events (SAEs) and Unanticipated Problems.  
These will be reported to the IRB, NINR, DSMB and others as described in Table 3. Reporting 
will include a detailed description of the event, incident, experience, or outcome; an explanation 
of the basis for determining that the adverse event, incident, experience, or outcome represents 
an unanticipated problem; a description of any changes to the protocol or other corrective 
actions that have been taken or are proposed in response. 
Table 3. Reporting of Serious Adverse Events and Unanticipated Problems 
Event 
Report to… 
Reporting Time 
Deaths that are at least 
possibly related to the 
research 
Minneapolis VA IRB, 
ACOS-R, NINR, DSMB 
- 
Initial reporting to the Minneapolis 
IRB within 1 hour of learning of the 
event.  
- 
Follow up with submission of the 
“Minneapolis IRB Immediate 
Reporting of Serious Adverse 
Events or Deaths” written report 

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form will occur within 1 business 
day. 
- 
DSMB and NINR within 3 business 
days of learning of the event 
(non-death) 
Unanticipated Serious 
Adverse Events (U-
SAEs) - unexpected 
and at least possibly 
related to the research 
Minneapolis VA IRB, 
NINR, DSMB 
- 
Within 5 business days in writing 
with submission of the “Minneapolis 
IRB Immediate Reporting of 
Serious Adverse Events or Deaths” 
- 
DSMB and NINR within 7 business 
days of learning of the event 
Serious Adverse 
Events (SAEs) – 
adverse event that is 
not unexpected and at 
least possibly related to 
the research 
Minneapolis VA IRB, 
NINR, DSMB 
- 
IRB - Summarized at Continuing 
Review 
- 
NINR – annual report 
- 
DSMB – annual report 
Unanticipated 
problem involving risk 
to subjects or others 
(UPIRTSO) 
Minneapolis VA IRB, 
NINR, DSMB, OHRP 
- 
IRB within 5 business days 
- 
NINR and DSMB within 14 
business days 
- 
OHRP within 21 business days 
ACOS-R: Associate Chief of Staff for Research; DSMB: Data and Safety Monitoring Board; 
IRB: Institutional Review Board; NINR: National Institute for Nursing Research; OHRP: Office 
of Human Research Protections; SAE: Serious Adverse Event; UPIRTSO: Unanticipated 
problem involving risk to subjects or others; U-SAE: Unanticipated Serious Adverse Event; 
VA: Veterans Health Administration 
6.3.2 Other reporting 
The following will be reported to NINR within 14 business days: 
● Summary of recommendations made by the DSMB or other monitoring entity as 
appropriate and (if applicable), as well as the action plan for response. 
● Notice of any actions taken by the IRB or regulatory bodies regarding the 
research and any responses to those actions. 
6.4 
Halting Rules 
The study may be temporarily suspended or prematurely closed if there is sufficient 
reasonable cause. Written notification, documenting the reason for study suspension or 

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termination, will be provided to study participants, investigators and study collaborators, 
funding agency, and regulatory authorities, including the IRB, by the MPIs or designee.  
In the event of any type of closure, the MPIs, or designee, will inform ongoing study 
participants, the IRB, and NINR and provide the reason(s) for the termination or 
temporary suspension within 14 business days. 
Circumstances that may warrant termination or suspension include, but are not limited 
to: 
● Determination of unexpected, significant, or unacceptable risk to participants 
● Insufficient compliance of project staff to the protocol (i.e., significant protocol 
violations) 
● Data that are not sufficiently complete and/or evaluable 
● Natural disaster, public health crisis 
  
The study may resume once concerns about safety, protocol compliance, and data 
quality are addressed and satisfy regulatory bodies (e.g., NINR, IRB, DSMB).   
7 
Quality Control and Quality Assurance 
Quality assurance and control procedures will be implemented as follows.  
Investigator and Staff Compliance: Research staff will undergo project-specific 
training in informed consent, screening and enrollment procedures, data collection, 
safety assessment, and adverse event protocols prior to study enrollment. Study 
intervention facilitators will undergo project-specific training, and safety assessment and 
adverse event protocols prior to study enrollment. Certification by a MPI (or designee) 
requires adherence to standard operating procedures outlined in the manual of 
operations. Training and certification will be logged. The Project Director will track all 
team members’ human subjects training to ensure it is current and will notify each 
person when renewal deadlines are approaching to ensure that they complete these 
renewals prior to expiration.  
Informed consent: The Project Director (and other team members, as required) will 
follow IRB guidelines when preparing for compliance audits of the study overall and 
informed consent documentation. The Minneapolis VA IRB reviews 100% of 
documentation of verbal informed consent and HIPAA authorization forms for 
completion and accuracy. Triennially the Minneapolis VA IRB reviews whether all study 
materials are properly and securely stored, IRB correspondence and approvals are up-
to-date, and personnel training is current. 
Outcome data collection: The primary method of data collection for participant self-
reported outcomes will be direct electronic entry through a survey interface with 
Qualtrics FedRAMP. Logic rules specifying the type and range of acceptable responses 
will be programmed into Qualtrics FedRAMP. Participants will receive an error message 

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if they enter an invalid response. The MPIs will review reports on data capture and 
quality on a monthly basis. Missing data reporting and other customized reports will be 
developed in order to facilitate efficient workflow and high-quality data capture. Data 
collection instrument specific follow-up rates will be tabulated and reviewed during 
meetings between the MPIs and project staff. Additional training will be provided as 
needed based on the findings. 
Intervention Fidelity: Consistent delivery of the study intervention will be monitored 
throughout the intervention phase of the study. Facilitators will use standardized 
checklists at each session to document the delivery of session activities. In addition, a 
total of 15% of intervention sessions will be assessed by an MPI (or designee) to ensure 
session activities are delivered as intended (goal: 90% of all activities are delivered). 
The MPIs will meet at least two times per month to review barriers to session activities 
and implement additional training as needed.  
Protocol Deviations: Protocol deviations will be documented by the Project Director 
and designees. The MPIs will review protocol deviations at least two times per month, 
and will implement corrective actions, as appropriate, or when the quantity or nature of 
deviations are deemed to be at a level of concern. Protocol deviations will be reported 
to NINR and the DSMB in the semi-annual reports. 
Verification of Source Documents: All project staff will engage in training related to 
proper documentation during the trial. Best practices of source document verification will 
be utilized. Original electronic copies of data will be saved where regular backups occur. 
Hard copy assessments and notes will be kept in locked cabinets in locked offices in 
locked buildings. At the triennial audit, the IRB Research Compliance Officer (RCO) will 
select and review 10-30 participant files. 
 
7.1 
Subject Accrual and Compliance 
7.1.1 Measurement and Reporting of Subject Accrual 
Review of the rate of subject accrual and compliance with inclusion/exclusion criteria will 
occur routinely (at least monthly) during the recruitment phase to ensure participant 
enrollment aligns with proposed recruitment projections and targeted diversity goals are 
met. 
7.1.2 Measurement and Reporting of Participant Adherence to Treatment Protocol  
Participant adherence to the RAMP Program intervention will be assessed through 
documentation of attendance/engagement in study sessions. Adherence is defined as 
attending/engaging in >6/9 session activities. These rates will be monitored routinely (at 
least monthly). Operating procedures will be reassessed and refined if the rates drop 
below study goals. 
7.2 
Justification of Sample Size  

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a. UG3/Phase 1 – Aim 1 – Feasibility study 
The sample size for the proposed feasibility study (n=40) was informed by previous 
studies by the investigators, who have found this number sufficient for informing the 
feasibility of larger, randomized clinical trials. 
b. UH3/Phase 2 – Aim 1 – RCT 
We plan to randomize n=500 participants for our UH3/Phase 2 Randomized Clinical 
Trial.  
Our power calculation uses the Brief Pain Inventory (BPI) interference score over the 
follow-up period as the primary outcome measure. For our primary analysis we estimate 
up to 20% attrition, so at least 500 people will need to be randomized to obtain a 
sample of 400 people with complete data. 200 participants in each arm will yield 90% 
power, with an alpha of 0.05, to reject the null hypothesis of equal means over the 
repeated follow-up time points (i.e., 3 and 6 months) if the arms differ by an effect size 
of 0.3 or greater. This includes a conservative estimate that the repeated outcome 
measures are highly correlated (r=0.7) and even with only 1 time point there is power to 
detect effect sizes of 0.32. Analyses that are stratified by subgroups as small as 70 
people per arm (i.e., equivalent to restricting to only women or minority Veterans) would 
have approximately 90% power to detect differences of 0.50. However, these would 
only be exploratory in nature and not adjusted for multiple comparisons. 
 
7.3 
Designation of a Monitoring Committee   
The composition of the Data and Safety Monitoring Board (DSMB) for this study is 
detailed in Table 4. DSMB members are not associated with this research project and 
work independently of the MPIs. They are not part of the key personnel involved in this 
grant. No member of the DSMB has collaborated or co-published with the Co-PIs within 
the past three years. They are qualified to review the patient safety data generated by 
this study because of their unique expertise and have been approved by NINR.  
 
Table 4. DSMB Membership 
Name, Credentials 
Institution 
Expertise 
DSMB Role 
Linda Hanson, DC, MS 
Assistant Research 
Professor and Assistant 
Director in the Integrative 
Health and Wellbeing 
Research Program, 
University of Minnesota 
 
Implementation and 
management of multi-
site, federally-funded 
clinical trials 
Executive 
Secretary, non-
voting member 

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Matthew Bair, MD, MS, 
FACP 
Professor of Medicine, 
Indiana University School of 
Medicine; Core Investigator, 
VA HSR&D Center for 
Health Information and 
Communication and Staff 
Physician, Roudebush VA 
Medical Center; Research 
Scientist, Regenstrief 
Institute 
Clinical trials, clinical 
aspects of the condition 
being studied, 
population being 
studied 
Voting member 
Beth Darnall, PhD 
Professor of Anesthesiology, 
Perioperative and Pain 
Medicine; Director of the 
Stanford Pain Relief 
Innovations Lab, Stanford 
University School of 
Medicine 
Ethics of clinical trials, 
clinical aspects of the 
condition being studied, 
work of DSMBs/IMCs, 
clinical trials 
Voting member 
Lynn DeBar, PhD, MPH 
Distinguished Investigator, 
Kaiser Permanente 
Washington Health 
Research Institute; Affiliate 
Professor at the Department 
of Psychiatry, University of 
Washington 
Clinical aspects of the 
condition being studied, 
work of DSMBs/IMCs, 
clinical trials 
Voting member 
Birgit Grund, PhD 
Professor, School of 
Statistics, University of 
Minnesota 
Biostatistician, work of 
DSMBs/IMCs 
Voting Member 
Sarah Krein, PhD, RN 
Research Career Scientist, 
VA Ann Arbor Center for 
Clinical Management 
Research (CCMR); Rensis 
Likert Collegiate Research 
Professor and Research 
Professor of Internal 
Medicine, University of 
Michigan; Adjunct Professor, 
School of Nursing, 
University of Michigan 
Clinical trials, clinical 
aspects of the condition 
being studied, 
population being 
studied 
Voting member 
Cynthia Long, PhD, 
PStat 
Dean of Research, 
Professor, Director, Office of 
Data Management & 
Biostatistics, Palmer Center 
for Chiropractic Research, 
Palmer College of 
Chiropractic 
Biostatistician, clinical 
aspects of the condition 
being studied, 
population being 
studied, work of 
DSMBs/IMCs 
Chair, Voting 
member 
 

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7.4 
Safety Review Plan  
One virtual review meeting with the DSMB will occur during Phase 1/UG3, and two 
virtual meetings per year will occur during Phase 2/UH3. Progress reports, including 
patient recruitment, retention/attrition, adverse events, and unexpected events will be 
provided to the DSMB and NINR annually during the UG3 phase and semi-annually 
during the UH3 phase. DSMB meeting summaries will include the progress reports and 
meeting minutes. Additional check-ins via email or virtual meetings will occur as needed 
at the direction of the DSMB. 
Progress reports, including patient recruitment, retention/attrition, and AEs will be 
provided to the DSMB semi-annually. An Annual Report will the items detailed in 
Section 7.5. The Annual Report will be sent to the DSMB and will be forwarded to the 
IRB and NINR, per each entities’ respective reporting guidelines. The IRB and other 
applicable recipients will review progress of this study on an annual basis. 
7.5 
Study Report Outline for the Data and Safety Monitoring Board 
(Interim or Annual Reports)  
The project team will generate Study Reports for the Data and Safety Monitoring Board 
and will provide information on the study parameters listed below. The Open Study 
Report tables will be generated only from aggregate (not by group assignment) baseline 
and aggregate safety data for the study population. The Closed Study Report tables will 
be presented by group (all reports including SAEs).  
Executive Summary 
● General Comments: Summary of the study status, enrollment, and any important 
developments since the last Data Safety & Monitoring Report. 
● Protocol Summary: Brief description of primary aims, primary hypothesis, 
inclusion/exclusion criteria, interventions, sample size, and primary statistical 
analysis. 
● Protocol Amendments: Description of protocol amendments since the last Data 
Safety & Monitoring Report. 
● Notes on Tables and Figures: Presentation of notable findings in the report and any 
limitations or other contextual information that may impact the interpretation of the 
tables and figures. 
Enrollment 
● Figure of cumulative enrollment over study time: plot with the projected enrollment 
set forth in the Study Accrual and Retention Plan (SARP). 
● Table(s) of screening and enrollment: Counts of screened, ineligible, eligible, and 
enrolled subjects. Reasons for ineligibility and reasons for not enrolling eligible 
subjects are also enumerated. 
● Table of baseline characteristics: Baseline characteristics including demographics 
and pain severity measures. 
Study Retention  

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● Table(s) of subject retention: Counts and rates of subject dropout. Timing relative to 
enrollment and reasons for dropout are also tabulated. 
Intervention Attendance 
● Table(s) of attendance: Rates of subject intervention attendance. 
Intervention Fidelity 
● Table(s) of quantitative and qualitative measures of intervention fidelity. Include total 
number of sessions completed, # observed, # of fidelity violations, etc. 
Data Quality and Timeliness 
● Table(s).  Follow-up rates. The follow-up rate for a study survey instrument is 
defined as the number completed within a specified time window divided by the 
number expected to be completed at the time of the report generation. Follow-up 
rates are presented for each data collection time point. 
Safety Summary 
● Table(s) of Serious Adverse Events and Unanticipated Problems. Includes counts 
and rates of adverse events, serious adverse events, and unanticipated problems. 
Protocol Deviations 
● Summary or listing of protocol deviations that have occurred since the previous 
DSMB report and over the course of the study. 
Quality Management 
● Summary or listing of quality management activities and findings completed since 
the last DSMB review, including frequency and any corrective actions taken to 
address the findings or issues. 
8 
Data Handling and Record Keeping 
The investigators are responsible for ensuring the accuracy, completeness, legibility, 
and timeliness of the data reported. All source documents should be completed in a 
neat, legible manner to ensure accurate interpretation of data. The investigators will 
maintain adequate case histories of study subjects, including accurate case report 
forms (CRFs), and source documentation. 
8.1 
Data Management Responsibilities 
Data collection and management will be overseen at the Minneapolis VA HSR&D 
Center of Innovation (COIN) by Dr. Brent Taylor. Data collection and accurate 
documentation are the responsibility of the project staff under the supervision of the 
investigators. All source documents will be reviewed by the project team and data entry 
staff, who will ensure that they are accurate and complete. 

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A history of CRFs and all fielded versions will be maintained. CRFs will be implemented 
as web-based eCRFs including checks for valid entry and incomplete responses. 
8.2 
Database Protection  
Data will be collected using Qualtrics FedRAMP, VA REDCap, paper surveys, 
telephone, virtual or in-person meetings, and EHRs. Survey data will be collected using 
electronic data capture through Qualtrics FedRAMP or VA REDCap, secure web 
applications for building and managing online surveys.  
Qualtrics FedRAMP is VA-approved to collect data from VA patients and store data on 
VA cloud servers. Qualtrics is accredited by FedRAMP, a government-wide initiative to 
protect sensitive data in federal agencies, ensuring gold standard security for data 
collected through Qualtrics. It features data isolation, differentiated user roles and 
privileges, audit login, multi-factor authentication, single-sign-on and SSL encryption. 
VA REDCap has an authority to operate (ATO) from VA Office of Information and 
Technology (OI&T) and is hosted on the VA Enterprise Cloud (VAEC). Login requires a 
VA Network ID and is accessible only on the VA network, data is backed-up nightly, and 
audit trails and logging is captured using individualized user rights management. 
Surveys will contain a study ID, time of data entry and limited individually identifiable 
information. Paper surveys are anticipated to be minimal in number and will be carefully 
entered into the VA REDCap or Qualtrics FedRAMP system by project staff. All access, 
processing, and analyses of VA EHR study data will be done within the Minneapolis VA 
analytical servers or the national secure VA Informatics and Computing Infrastructure 
(VINCI) by the CCDOR Statistical & Data Group (CCDOR/SDG). Patient and provider 
identifiers will be used only within these secure VA servers within the VA firewall when 
necessary to link records obtained from different files. 
The entire study database (information retrieved from EHR data, recruitment outcomes) 
will be fully contained on secure VHA servers, behind the VA firewall (local CCDOR 
servers and National VA VINCI servers). Within the VA firewall, the project team at the 
VA will create a custom-built tracking app that will track each participant’s enrollment 
and study status. Data will be routinely extracted from Qualtrics FedRAMP and VA 
REDCap in the VA cloud and stored on secure VINCI, VA Box, and Minneapolis VA 
CCDOR servers, using SQL database connections. Qualtrics FedRAMP and VA 
REDCap will contain the minimal identifying information needed to successfully conduct 
the study. This will include information that is self-reported by the participants (e.g., 
phone, email, which is best method of contact). No sensitive data will be stored outside 
of the VA protected environment. Once data are transferred for data analysis, data will 
be maintained on encrypted and password-protected VA computers in the VA 
environment and on secure VA servers.  
To prevent improper use of any data collected for research projects conducted at the 
Minneapolis COIN we will use a combination of local Minneapolis VA secure servers as 
well as VINCI, VA Box, and the secure Qualtrics FedRAMP system in the VA cloud. The 
local VA secure servers facilitate data collection and provide a platform for the 

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customized research tracking application, while the VINCI platform provides a robust 
environment for pooling the primary research collected data with direct connections to 
daily or weekly updated mirrors of nearly the entire VHA EHR. VINCI also provides 
access to extensive storage area networks, drives, file shares, databases, SharePoint 
for collaboration and correspondence sites, SAS/Grid, and servers containing virtual 
machines with an extensive collection of software called the VINCI Workspace. We 
requested and were provided access to the Joint Legacy Viewer (JLV) in order to 
capture the highest follow-up response rate that is feasible. It is very important that we 
reach the participants in a timely manner; being able to access current address and 
phone numbers will help in tracking hard to reach participants. A secure link between 
local VA secure servers Qualtrics FedRAMP will be created. Limited study specific data 
will be collected on Qualtrics FedRAMP and will contain a study specific participant ID 
code. VINCI allows individual researchers and their staff the means to securely conduct 
their research projects within a secure and well controlled technical environment. All of 
these VA systems undergo backups of the servers nightly and servers are updated 
when new security patches become available.  
CCDOR maintains strong protections for coded analysis datasets that will be stored on 
local VA server space. CCDOR provides protections for research data at least equal to 
that provided by the Minneapolis VA Health Care System for patients’ private health 
information (PHI). Access to data is on a “need to know” basis. For example, data 
analysts will not have access to project data unless they can demonstrate that they are 
somehow needed for a particular analysis. Access to project data is obtained through 
Windows authentication (i.e., PIV card and password to the network). It is virtually 
impossible for any person without a login name, PIV card and password to the 
Minneapolis VA hospital’s domain network to access data on the Center’s servers. 
Thus, all data housed on the CCDOR Server is extremely secure. Access by 
unauthorized persons is highly unlikely. CCDOR maintains several secure servers that 
are located in the Minneapolis VA OIT server room. Physical access to the server room 
is limited to VA Office of Information and Technology staff. All individuals with 
administrative access privileges to the Center’s servers, including VA OIT personnel 
and CCDOR programmers, have been screened and assigned a security clearance 
putting them in trusted positions of the hospital with authorization to work with patient-
level data. VA OIT’s access to the data is strictly limited to maintaining the server and 
backing up server data, which prevents catastrophic loss of data. Backups are written to 
tapes that are stored in a secure location accessible only to OIT personnel. Only 
individuals with a need to access the data, as vetted by the project’s MPIs are granted 
access. Even then, only the absolute minimum number of data elements is released. 
This protects the integrity of the data as well as its confidentiality. 
8.3 
Source Document Protection 
Electronic source documents will be stored on password protected VA computers. 
Participant IDs will be used to protect participants’ confidentiality. Hard copy 
assessments and notes will be kept in locked cabinets in locked offices in locked 
buildings which are only accessible to authorized study personnel. 

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8.4 
Schedule and Content of Reports 
Real-time reports of study conduct and progress will be available to the study steering 
committee and will detail subject accrual, enrolled subject demographics, current status 
of enrolled subjects, compliance with the intervention protocols, data collection, and 
adverse event rates. The DSMB will review reports outlined in sections 7.6-7.7 following 
the UG3 phase and semi-annually during the UH3 phase of the project.  
8.4.1 Interim Analyses  
There are no planned interim analyses of primary or secondary outcomes data 
(including futility analyses) before the study is complete. However, in the context of 
evaluating the safety outcomes, if the DSMB requests interim effectiveness estimates 
they will be provided. In the event this is required, a statistician independent of the 
project team will be assigned.  
The original unaltered data will be preserved in the electronic data capture system. All 
data alterations, recoding of variables, scoring of outcome measures, or data 
corrections will be clearly documented in a separate data file from the final, cleaned 
analysis-ready data set. For the purposes of preparing an analysis-ready data set, a csv 
file or statistical package format file will be exported from the original unaltered data 
provided directly from the electronic data collection and management system, with the 
result being an analysis ready data set. The analysis ready data set file will document 
and reproduce all analyses and study-monitoring reports and will employ detailed 
comments and time stamped output files. The analysis-ready data set will contain a 
coded variable for group allocation which will not be unmasked until after data analysis 
by the study statistician is complete. 
8.5 
Data Privacy and Data Breaches 
The Minneapolis VA has policies regarding data privacy (MCP IM-02M). Any data 
breaches need to be reported immediately to the VA Investigator’s facility’s OI&T 
Information Systems Security Officer (ISSO) and VHA’s Privacy Officer (PO), the 
investigator’s supervisor, and others as stipulated in VA, VHA, and local facility’s 
requirements. We will follow OHRP’s guidance for ‘prompt’ incident reporting, outlined 
here: https://www.hhs.gov/ohrp/compliance-and-reporting/guidance-on-reporting-
incident/index.html. 
9 
Informed Consent 
 
9.1 
Feasibility/Pilot Study and RCT Participants 

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The IRB has approved our request for a waiver of HIPAA authorization for the initial 
recruitment search of electronic health records (EHR) for potential participants. A signed 
HIPAA Authorization form will be obtained in order to 1) disclose the minimum 
necessary information to the Minneapolis VA Non-Profit Corporation, the Center for 
Veteran Education and Research (CVRE) and Greenphire, for payment to participants 
for completing surveys, and 2) share data with all approved project team members; and 
3) share required and approved data with study sponsor, Data and Safety Monitoring 
Board (DSMB), IRB, and other federal agencies to monitor or oversee research via 
approved methods. Signature on the HIPAA Authorization forms will be obtained via 
electronic signature using DocuSign or mailed a physical HIPAA Authorization form and 
a pre-paid return envelope. 
The IRB has also approved the use of verbal informed consent over the phone and a 
waiver of written informed consent. The rationale is that the research meets all of the 
criteria for requesting a waiver of documentation of informed consent process, including: 
involving no more than minimal tangible or intangible risk to the participants; the waiver 
will not adversely affect the rights and welfare of the participants; the research could not 
practicably be carried out without the waiver; and when possible participants will be 
provided with additional pertinent information after participation. 
The following outlines the informed consent process for Research Participants: 
1. The informed consent process begins at the point of first contact. Potentially eligible 
patients will be mailed a postcard describing the study and informing them that the 
study is voluntary. The postcard will provide instructions for opting out. Participants 
are provided the study website which includes an IRB approved Information Sheet 
(containing information that is typically including in an informed consent document 
including the activity is research, participation is voluntary, permission to participate 
can be withdrawn, permission for use of data can be withdrawn for exempt research 
activities involving the collection and use of identifiable data and contact information 
for the VA Investigator).  
2. Trained project staff will contact participants who have not opted out by telephone to 
secure verbal informed consent over the phone and waiver of written informed 
consent. This will be documented in the research record. 
3. A hard copy of the Information Sheet will be mailed when a participant is 
enrolled/randomized into the study.  
4. To complete the informed consent process at the end of study participation, project 
staff will inform the participant when their participation has come to an end and will 
document the notification in the study record. 
 
10 
Reporting Changes in Study Status 
During the funding of this study, any action by the IRB, DSMB, or one of the study 
investigators that results in a temporary or permanent suspension of the study will be 
reported to the NINR Program Official within 14 business days of notification. 

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