Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (TRIAL)
Phase: NA
Conditions: Substance Use Disorders, Pain
Sponsor: Yale University

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12 August 2024 
 
 
 
 
 
 
 
Engaging Veterans Seeking Service-Connection 
Payments in Pain Treatment 
 
NCT04062214  
 
8/12/24 
 
Study Protocol 
National Center for Complementary and Integrative Health 
      

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FULL PROTOCOL TITLE 
Engaging Veterans Seeking Service-Connection Payments in 
Pain Treatment 
  
Principal Investigators:   
Marc Rosen, MD, Professor of Psychiatry, Yale University; Director of 
Addiction Recovery Services, VA CT Healthcare System 
Steve Martino, PhD, Professor of Psychiatry, Yale University; Chief of 
Psychology, VA CT Healthcare System 
Supported by:  
The National Center for Complementary and Integrative Health (NCCIH) 
and The National Institute on Drug Abuse (NIDA)  
(NIH grant # UH3AT009758) 
 
Version 4.0 
 

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Tool Revision History 
Version Number: 1.0 
Version Date: 8/2/19 
Summary of Revisions Made: First Approved Version 
Version Number: 2.0 
Version Date: 4/27/20 
Summary of Revisions Made: Changes to protocol and questionnaires in response to COVID-19 
pandemic 
Version Number: 3.0 
Version Date: 12/14/20 
Summary of Revisions Made: Adding prepaid incentive and magnet to recruitment mailings to 
bolster recruitment and retention 
Version Number: 4 
Version Date: 8/12/24 
Summary of Revisions Made: Change to operationalization of substance use outcome 
 
 
 

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TABLE OF CONTENTS 
Page 
FULL PROTOCOL TITLE .......................................................................................................... 0 
Tool Revision History ............................................................................................................... 2 
TABLE OF CONTENTS ............................................................................................................. 3 
ABBREVIATIONS ....................................................................................................................... 6 
STUDY TEAM ROSTER ............................................................................................................. 9 
PARTICIPATING STUDY SITES ............................................................................................ 10 
PRÉCIS ........................................................................................................................................ 11 
1. STUDY OBJECTIVES .......................................................................................................... 12 
1.1 
Primary Objective ....................................................................................................... 12 
1.2 
Secondary Objectives ................................................................................................ 12 
2. BACKGROUND AND RATIONALE................................................................................... 12 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .................. 12 
2.2 
Study Rationale .......................................................................................................... 14 
3. STUDY DESIGN .................................................................................................................... 18 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ............................................... 23 
4.1 
Inclusion Criteria ......................................................................................................... 24 
4.2 
Exclusion Criteria ....................................................................................................... 24 
4.3 
Study Enrollment Procedures................................................................................... 24 
5. STUDY INTERVENTIONS ................................................................................................... 27 
5.1 
Interventions, Administration, and Duration ........................................................... 27 
5.2 
Handling of Study Interventions ............................................................................... 31 
5.3 
Concomitant Interventions ........................................................................................ 31 
5.3.1 Allowed Interventions ............................................................................................... 31 
5.3.2 Required Interventions .............................................................................................. 31 
5.3.3 Prohibited Interventions ............................................................................................ 31 
5.4 
SBIRT-PM Fidelity Assessment ............................................................................... 31 
6. STUDY PROCEDURES ....................................................................................................... 32 
6.1 
Schedule of Evaluations ............................................................................................ 32 

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6.2 
Description of Evaluations ........................................................................................ 33 
6.2.1 Screening Evaluation ................................................................................................ 33 
6.2.2 Enrollment, Baseline, and/or Randomization ........................................................... 34 
6.2.3 Blinding..................................................................................................................... 40 
6.2.5 Completion/Final Evaluation .................................................................................... 40 
7. SAFETY ASSESSMENTS ................................................................................................... 41 
7.1 
Specification of Safety Parameters ......................................................................... 41 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters .............................................................................................................................. 41 
7.3 
Adverse Events and Serious Adverse Events ....................................................... 42 
7.4 
Reporting Procedures ................................................................................................ 42 
7.5 
Follow-up for Adverse Events .................................................................................. 43 
7.6 
Safety Monitoring ....................................................................................................... 43 
8. INTERVENTION DISCONTINUATION .............................................................................. 43 
9. STATISTICAL CONSIDERATIONS ................................................................................... 44 
9.1 
General Design Issues .............................................................................................. 44 
9.2 
Sample Size and Randomization ............................................................................ 44 
9.3  
Definition of Populations ........................................................................................... 45 
9.4 
Interim Analyses and Stopping Rules ..................................................................... 46 
9.5 
Outcomes .................................................................................................................... 46 
9.5.1 Primary Outcome ...................................................................................................... 46 
9.5.2 Secondary Outcomes ................................................................................................ 46 
9.6 
Data Analyses ............................................................................................................. 47 
10.1 
Data Collection Forms ............................................................................................... 50 
10.2 
Data Management ...................................................................................................... 51 
10.3 
Quality Assurance ...................................................................................................... 51 
10.3.1 
Training ................................................................................................................. 51 
10.3.2 
Quality Control Committee ................................................................................... 52 
10.3.3 
Metrics .................................................................................................................. 52 
10.3.4 
Protocol Deviations ............................................................................................... 53 
10.3.5 
Monitoring ............................................................................................................ 53 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ...................................................... 54 
11.1 
Institutional Review Board (IRB) Review ................................................................ 54 
11.2 
Informed Consent Forms .......................................................................................... 55 
11.3 
Participant Confidentiality ......................................................................................... 55 

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11.4 
Study Discontinuation ................................................................................................ 57 
12. COMMITTEES ..................................................................................................................... 58 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 58 
14. REFERENCES..................................................................................................................... 58 
15. SUPPLEMENTS/APPENDICES ....................................................................................... 67 
I. Informed Consent Form Template ................................................................................... 67 
II. VA Central IRB reviewed and approved Protocol (v.11/8/18) .................................... 67 
 

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ABBREVIATIONS  
AE: 
 
 
 
Adverse Event 
ASSIST: 
 
 
Alcohol, Smoking and Substance Involvement Screening 
Test 
ATO:  
 
 
Authorization to Operate 
AUDIT-C: 
 
 
Alcohol Use Disorders Identification Test  
BPI: 
 
 
 
Brief Pain Inventory  
C&P:  
 
 
Compensation & Pension 
CAPRI: 
 
Compensation and Pension Record Interchange  
CBT: 
 
Cognitive Behavioral Therapy  
CDC: 
 
Centers for Disease Control and Prevention 
CEACs: 
 
Cost-Effectiveness Acceptability Curves  
CIDI: 
 
Composite International Diagnostic Interview  
cIRB: 
 
Central Institutional Review Board 
COVID-19 
 
Coronavirus Disease 2019 
CPT: 
 
Current Procedure Terminology  
CTSP: 
 
Centralized Transcription Service Program  
DBQ: 
 
Disability Benefits Questionnaire  
DSMC: 
 
Data and Safety Monitoring Committee 
EHR: 
 
Electronic Health Record 
ELISA: 
 
Enzyme-Linked Immunosorbent Assay  
ETG: 
 
Ethyl Glucuronide 
ETOH: 
 
Alcohol  
EQ-5D-5L: 
 
5 Level EuroQol: Instrument used to Describe and Value 
Health 
FDA: 
 
Food and Drug Administration  
HERC: 
 
Health Economics Resource Center  
HIPAA: 
 
Health Insurance Portability and Accountability Act 
HSR&D: 
 
Health Services Research & Development 
ICERs 
 
Incremental Cost-Effectiveness Ratios  
IMMPACT: 
Initiative on Methods, Measurement, and Pain Assessment 
in Clinical Trials 
IMPROVE: 
 
Improving Pain-Related Outcomes for Veterans  
IRB: 
 
Institutional Review Board 
ITRS: 
 
Independent Tape Rater Scale 
ITT: 
 
Intent to Treat 
JAMA: 
 
Journal of the American Medical Association 
MAR:  
 
 
Missing at Random  
MCAR: 
 
Missing Completely at Random  
MCID: 
 
Mean Clinically Important Difference  
MEDD: 
 
Morphine Equivalent Daily Dose 
MI: 
 
Motivational Interviewing 
MNAR: 
 
Missing Not at Random 
mPI: 
 
Multiple Principal Investigator 
MSD: 
 
Musculoskeletal disorders 
NCCIH: 
 
National Center of Complementary and Integrative Health 

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NDS: 
 
National Data Systems 
NIDA: 
 
National Institute on Drug Abuse 
NIH: 
 
National Institutes of Health 
NLP: 
 
Natural Language Processing  
NPCD: 
 
National Patient Care Database  
NPM: 
 
Non-Pharmacological Pain Modalities  
NRS: 
 
Numeric Rating Scale 
OEF: 
 
Operation Enduring Freedom 
OHRP: 
 
Office for Human Research Protections 
OIF: 
 
Operation Iraqi Freedom 
OI&T: 
 
Office of Information & Technology 
PACT: 
 
Patient Aligned Care  
PEG: 
 
Three-Item Scale Assessing Overall Pain Intensity and 
Interference 
PMC3: 
NIH-DoD-VA Pain Management Collaboratory Coordinating   
Center 
PHI: 
 
Personal Health Information 
PHQ-9: 
 
Patient Health Questionnaire 
PPV: 
 
Positive Predictive Values  
PRC: 
 
Protocol Review Committee 
PRIME: 
 
 
Pain Research, Informatics, Multi-morbidities, and Education  
Center  
PT: 
 
Physical Therapy 
PTSD: 
 
Post-Traumatic Stress Disorder 
QUERI: 
 
VA Quality Enhancement Research Initiative  
RCT: 
 
Randomized Controlled Trial 
REDCap: 
 
Research Electronic Data Capture  
SAE: 
 
Serious Adverse Event 
SAMSHA: 
 
Substance Abuse and Mental Health Services Administration 
SBIRT: 
 
Screening, Brief Intervention and Referral to Treatment 
SBIRT-PM 
 
Screening, Brief Intervention and Referral to Treatment for 
Pain   
  
 
Management 
SCAN-ECHO: 
 
Specialty Care Access Networks-Extension for Community  
Healthcare Outcomes 
SPACE: 
 
Strategies for Prescribing Analgesics Comparative 
Effectiveness 
SUD:  
 
Substance Use Disorder 
SVM: 
 
Support Vector Machine  
TAU: 
 
Treatment-As-Usual 
TBI:  
 
Traumatic Brain Injury 
TENS: 
 
Transcutaneous Electrical Nerve Stimulation 
UG3: 
 
Phase 1 Exploratory/Developmental Cooperative Agreement  
activity code 
UGH: 
 
Phase 2 Exploratory/Developmental Cooperative Agreement  
  
 
activity code 

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UC: 
 
Usual Care 
VA: 
 
Veterans Affairs 
VACHS: 
 
VA Connecticut Healthcare System 
VACO: 
 
VA Central Office  
VAMC: 
 
VA Medical Centers 
VBA: 
 
Veterans Benefits Administration 
VBMS: 
 
Veterans Benefits Management Software  
VERA: 
 
Veterans Equitable Resource Allocation  
Veterans’ Choice: 
 
Veterans Access, Choice and Accountability Act  
VHA: 
 
Veteran’s Health Administration 
VHA ORD: 
 
Veterans Health Administration Office of Research and  
Development 
VINCI: 
 
VA Informatics and Computing Infrastructure 
VISN: 
 
Veterans Integrated Service Networks  
VPN: 
 
Virtual Private Network 
VTT: 
 
Visual Tagging Tool  
 
 

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STUDY TEAM ROSTER   
Marc Rosen, MD (mPI), VA Connecticut Healthcare System, 950 Campbell Ave., West 
Haven, Connecticut, Tel: 203-932-5711 x2112, Email: marc.rosen@yale.edu 
Steve Martino, PhD (mPI), VA Connecticut Healthcare System, 950 Campbell Ave., 
West Haven, Connecticut, Tel: 203-932-5711 x7418, Email: 
steve.martino@yale.edu,  
William Becker, MD (Co-Investigator), VA Connecticut Healthcare System, 950 
Campbell Ave., West Haven, Connecticut, Tel: 215-514-8006, Email: 
William.becker@yale.edu 
Brenda Fenton, PhD (Co-Investigator), VA Connecticut Healthcare System, 950 
Campbell Ave., West Haven, Connecticut, Tel: 203-932-5711 x5174, Email: 
Brenda.fenton@va.gov, VACHS 
John Sellinger, PhD (Co-Investigator), VA Connecticut Healthcare System, 950 
Campbell Ave., West Haven, Connecticut, Tel: 203-932-5711 x3589, Email: 
John.sellinger1@va.gov, Yale/VACHS 
Kristin Mattocks, PhD (Co-Investigator), Central Western Mass VA, 421 North Main St., 
Leeds, MA, Tel: 413-584-4040 x2060, Email: Kristin.mattocks@va.gov 
Qing Zeng, PhD (Co-Investigator), Washington DC VA Medical Center, 50 Irving St. 
NW, Washington DC, Tel: 203-994-0477, Email: zengq@email.gwu.edu 
Tu Ngo, PhD (Site PI), Bedford VA, 200 Springs Road, Bedford, MA, Tel: 781-687-
2420, Email:  tu.ngo@va.gov 
Diana Higgins, PhD (Site PI), VA Boston, 940 Belmont St., Brockton, MA, Tel: 857-
3642221, Email: Diana.Higgins2@va.gov 
Bradley Brummett PhD (Site PI), Central Western Mass VA, 421 North Main St., Leeds, 
MA, Tel: 413-584-4040 x2489, Email: Bradley.brummett@va.gov 
Todd Stapley, DO (Site PI), VA Maine, 1 VA Ctr, Augusta, ME. Tel: 207-623-8411 
x5384, Email: todd.stapley@va.gov 
Christina Zimmerman, DO (Site PI), VA Maine, 1 VA Ctr, Augusta, ME. Tel: 207-623-
8411, Email: christina.zimmerman@va.gov 
Thomas Reznik, MD (Site PI), VA Providence, 830 Chalstone Ave, Providence, RI, Tel: 
401-273-7100, Email: Thomas.reznik@va.gov 
Alicia Semiatin, PsyD (Site PI), Manchester VA, 718 Smyth Rd, Manchester, NH, Tel 
603-624-4366 x6588, Email: Alicia.semiatin@va.gov  
Paul Holtzheimer, MD (Site PI), White River Junction VA, 215 North Main St., White 
River Junction, VT, Tel: 802-295-9363 x5951, Email: 
paul.e.holtzheimer@hitchcock.org 
Christina Lazar, MPH (Project Director), VA Connecticut Healthcare System, 950 
Campbell Ave., West Haven, Connecticut, Tel: 203-932-5711 x4833, Email: 
Christina.lazar@yale.edu 
Linda Adamczyk (Research Assistant), VA Connecticut Healthcare System, 950 
Campbell Ave., West Haven, Connecticut, Tel: 203-932-5711 x3972, x8124, 
Email:  Linda.Adamzczyk@yale.edu  
Katarina Bernice (Research Coordinator), Bedford VA, 200 Springs Road, Bedford, MA, 
Tel: 781-687-2420, Email:  Katarina.Bernice@va.gov 
Celia Butler (Research Coordinator), Providence VA, 830 Chalstone Ave, Providence, 
RI, Tel: 401-273-7100, Email: celia.butler@va.gov  

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Rebecca Jankowski (Research Coordinator), Central Western Mass VA, 421 North 
Main St., Leeds, MA, Tel: 413-584-4040 x2069, Email: 
Rebecca.Jankowski@va.gov 
Laurie Waterman (Research Coordinator), White River Junction VA, 215 North Main St., 
White River Junction, VT, Tel: 802-295-9363, Email: Laurie.Waterman@va.gov  
Cathy Lombardo (Research Coordinator), White River Junction VA, 215 North Main St., 
White River Junction, VT, Tel: 802-295-9363, Email: Cathy.Lombardo@va.gov  
Kate Gilstad-Hayden (Biostatistician), 300 George Street, Department of Psychiatry, 
Yale School of Medicine.  Tel: 203-764-5973,  Email:  Kathryn.Gilstad-
Hayden@Yale.edu 
Paul Barnett, PhD (Collaborator), Palo Alto Veterans Institute for Research, 591 Las 
Colindas Road, San Rafael, CA, Tel:  628-240-3930, Email:  
Paul@Barnettfamily.org 
Yijun Shao, PhD (software developer), Washington DC VA Medical Center, 50 Irving St. 
NW, Washington DC, Tel: 203-994-0477, Email: ychao@email.gwu.edu 
PARTICIPATING STUDY SITES 
Hub 
• Connecticut VA 
 
Spoke 
• Bedford VA 
• Boston VA 
• Central Western Massachusetts VA 
• Maine VA 
• Manchester VA 
• Providence VA 
• White River Junction VA 
Other Sites Involved in Data Analysis  
• Washington DC VA 
 
 
 
 
 
 

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PRÉCIS  
Study Title  
Engaging Veterans Seeking Service-Connection Payments in Pain Treatment 
Objectives  
Determine the effectiveness and cost-effectiveness of Screening, Brief 
Intervention and Referral to Treatment for Pain Management (SBIRT-PM) 
compared to Usual Care (UC) in reducing pain and risky substance use. 
Design and Outcomes   
In a pragmatic two-arm, parallel groups 36-week multi-site randomized 
controlled single blind trial, we will randomize 1100 Veterans applying for 
compensation related to musculoskeletal disorders to either SBIRT-PM or 
Usual Care (UC) across eight VA medical centers in New England.  
Outcome assessment by phone will occur at 12- and 36-week follow-ups and 
will be corroborated with other sources of information --- the electronic health 
record and toxicology testing of nail clippings.   
Primary outcomes will be change in pain severity as measured by the Brief 
Pain Inventory (BPI) and change in substances categorized as requiring 
intervention measured by the ASSIST.  Secondary outcomes will include non-
pharmacological pain management service utilization, NRS pain severity, pain 
interference with life activities as measured by the BPI, overall pain (PEG), 
overall health (EQ-5D-5L), use severity for individual substances generated 
by the ASSIST, and toxicology results for individual substances. The trial will 
include cost-effectiveness and budget impact analyses. 
Interventions and Duration  
Screening, Brief Intervention and Referral to Treatment for Pain Management 
(SBIRT-PM) aims to engage Veterans applying for compensation with pain 
conditions in multi-modal non-pharmacological pain care and to motivate 
those who misuse substances to change this problematic behavior. SBIRT-
PM will be delivered centrally by telephone throughout the New England VA 
Healthcare System’s (VISN1) eight medical centers. It involves an initial one-
hour session followed by up to three 20-minute calls in a 12-week period and 
an additional call in the 12-32 week period to support Veterans engagement 
in non-pharmacological pain care. 
Usual care (UC): A Veteran who completes a compensation examination 
ordinarily has no further treatment, referral or debriefing as part of the 
Compensation examination  
Sample Size and Population  
The study sample consists of 1100 randomized post-911 era Veterans 
applying for MSD related compensation. Participants will be randomized 
using a computerized urn randomization program within each site to increase 
the likelihood of balanced allocation of participants to the two interventions on 

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sex, race, ethnicity and self-reported illicit drug use within 90 days. 
1. STUDY OBJECTIVES 
1.1 
Primary Objective 
Our main objective is to test the effectiveness and cost-effectiveness of SBIRT-PM, 
compared to UC, when delivered within a VISN1-wide hub-and-spoke network. 
 
Objective 1: We will determine if SBIRT-PM is more effective than UC in 
reducing pain severity as measured by the Pain Severity subscale of the BPI (primary 
outcome). Secondary outcomes include non-pharmacological pain management service 
utilization, pain interference with life activities (BPI Interference Subscale), and overall 
health.   Hypothesis: SBIRT-PM will be more effective than UC. We will test the degree 
to which non-pharmacological pain management service utilization mediates pain 
outcomes. 
 
Objective 2: We will evaluate if SBIRT-PM, compared to UC, is more effective in 
reducing the number of substances categorized as requiring any intervention as 
measured by the ASSIST (primary outcome).  Secondary outcomes will include the use 
severity measure for individual substances generated by the ASSIST, and nail clipping 
toxicology results for individual substances.   Hypothesis: SBIRT-PM will be more 
effective than UC. We will separately test the degree to which non-pharmacological pain 
management service utilization and substance use service utilization mediates the 
effect of SBIRT-PM on substance use outcomes. 
 
Objective 3: We will assess the cost-effectiveness of SBIRT-PM relative to UC. 
Hypothesis: SBIRT-PM will be cost-effective relative to UC across a range of possible 
values of decision makers’ willingness-to-pay for minimal clinically important differences 
in pain severity and interference.  
1.2 
Secondary Objectives 
Our secondary objective is to determine if SBIRT-PM is more effect than UC in reducing 
overall pain as measured by the PEG, a common pain measure required across 
protocols funded by the NIH-DoD-VA Pain Management Collaboratory, which measures 
average pain intensity (P), interference with enjoyment of life (E), and interference with 
general activity (G).  Hypothesis: SBIRT-PM will be more effective than UC. 
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Many Returning Post-9/11 Veterans Have MSD and Could Benefit from Non-
Pharmacologic Pain Care.  
 
Military personnel carry heavy packs, move heavy equipment and undergo 
intense physical stresses; a high proportion of them will develop musculoskeletal 
disorders (MSD) involving chronic pain. Chronic pain is widely prevalent in Veterans 
and is one of the most common reasons for outpatient healthcare utilization.1 In recent 
years, returning Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) 
post-9/11 Veterans with injuries have faced the prospect of decades of chronic pain.2,3 

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By seven years after deployment, approximately 17.5% of post-9/11 Veterans in VA 
treatment were diagnosed with back disorders and 17.0% were diagnosed with joint 
conditions,4 higher rates than in comparable U.S. population cohorts.5 Back pain, 
followed by neck or joint pain, is the most common cause of chronic non-cancer pain in 
Veterans.6  
 
To decrease morbidity and mortality, a growing body of research and expert 
consensus support a multi-modal pain treatment strategy.7,8 In this bio-psycho-socially-
oriented model, evidence-based non-pharmacologic treatment modalities are 
incorporated alongside pharmacologic treatment.9 Multiple studies have demonstrated 
the effectiveness of non-pharmacological pain management in improving chronic pain 
outcomes, including, for example, physical therapy,10-12 cognitive behavioral 
therapy,13,14 yoga,15,16 and mindfulness based stress-reduction,17-19 and therefore 
guidelines now stress the importance of a multi-modal approach.7,20 In part to reduce 
prescribing of risky opioids, the availability of such multi-modal therapy at VA facilities 
was mandated by the 2013 Opioid Safety Initiative.21  
 
Veterans with MSD Are at High Risk for Substance Misuse and Need Early Intervention. 
Veterans22 and other people23 with painful MSD are at high risk for developing alcohol 
and other substance use disorders.24,25 Iatrogenic factors have contributed to the risk for 
substance use among Veterans. The opioids prescribed to treat painful MSD carry the 
potential for aberrant use and eventually misuse. A remarkably high proportion, 64%, of 
post-9/11 Veterans with chronic non-cancer pain have been prescribed opioids,6 and 
Veterans prescribed opioids have worse outcomes than those not prescribed opioids.26 
The base rate of substance use disorders in post-9/11 cohorts is high,27-30 and baseline 
substance use is a risk factor for going on to use more substances. The causality is 
bidirectional, in that substance use disorders predispose people to incurring injuries,31 
and are overrepresented in Veterans with pain-related comorbidities27,32,33  
 
Early intervention is needed for Veterans who have chronic pain and are at risk 
for substance misuse or are already engaging in it. Individuals with chronic pain and 
SUD have worse pain-related outcomes34 and worse addiction-related outcomes,35 than 
those without comorbid pain, supporting the need to intervene early to prevent this 
comorbidity. Restrictions on opioid prescribing may come too late to alter the 
neurobiological changes associated with long-term opioid treatment for chronic pain.36-38 
These neuroplastic changes endure long after opioid treatment is withdrawn and are 
thought to play a key role in facilitation of transition to chronic pain. Early engagement of 
Veterans with chronic pain into multi-modal non-pharmacological treatments has the 
potential to arrest the development of risky or disordered substance use and help those 
already misusing substances to reduce or stop this problem behavior. Furthermore, 
since substance use is strongly associated with treatment non-compliance in numerous 
settings, early interventions that reduce risky substance use have the potential to 
improve pain treatment outcomes by increasing Veterans’ pain treatment adherence.  In 
this proposal, although measured separately from non-pharmacological pain treatments, 
substance use treatment is facilitated because it is a component of pain treatment. 

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2.2 
Study Rationale 
Compensation Examinations as a Unique Opportunity to Engage Veterans in Multi-
modal Pain Care.  
As of 2015, there were 971,117 post-9/11 Veterans already receiving service-connected 
compensation. Many of these Veterans interact with service-connection examiners at 
VA facilities, but they interact as claimants, not as patients. When Veterans end their 
military service, and begin the transition to civilian life, they are encouraged to file 
claims for physical or psychological conditions that may be related to their military 
service. Veterans are encouraged to file claims during demobilization, at Veterans’ 
resource fairs to publicize services available to Veterans, and at Veterans Service 
Organizations that offer assistance with the claims process.39 The claim is processed at 
the VA but does not involve clinical care. 
Many of these claims are for MSD. As of 2015, there were 559,999 post-9/11 
Veterans being compensated for back or neck conditions, and 596,250 for limitation of 
flexion in joints (Veterans often have more than one involved body part).40 In 2015 
alone, 313,052 new Veterans began receiving disability compensation, of whom 
approximately 31% were under age 35.    
  
Examinations to determine Veterans’ compensation are important because: (1) 
they are often conducted when Veterans are in some degree of pain or crisis associated 
with their disorder; (2) significant financial remuneration is at stake; and (3) Veterans 
judged to have a service-connected condition will receive priority care at the VA for it, 
typically for life. The compensation examiner has a responsibility to the agency that 
decides claims, the Veterans Benefits Administration (VBA), to obtain information so the 
claim can be adjudicated. Therefore, as in forensic evaluations, compensation 
examiners are taught to tell Veterans that the purpose of the examination is to evaluate 
the disability claim and not to provide treatment. Although the examiner’s role might be 
complicated by him/her making a treatment recommendation, having another clinician 
explain available treatments is not. The failure to offer treatment can be alienating.41 
 
Considerable public pressure has developed to improve the process of 
evaluating compensation claims such that this process includes approaches to engage 
Veterans in treatment. In testimony to the House Committee on Veterans Affairs, Linda 
Bilmes called for early intervention approaches that interface with the compensation 
examination process for returning post-9/11 Veterans: “VBA should shift its focus away 
from claims processing and onto rehabilitating and reintegration of Veterans.”42 
Congressional hearings in June 2011 addressed “Bridging the Gap Between Care and 
Compensation for Veterans,”43 the very topic of this proposal. One of the witnesses 
cited our group’s editorial advocating engagement of Veterans in treatment when they 
apply for service-connection.44  
 
Motivational Interviewing to Engage Veterans with MSD in Non-Pharmacological Pain 
Treatment.  
Motivational interviewing,45 a person-centered, brief psychotherapeutic approach, helps 
people resolve ambivalence toward positive behavioral change and strengthen their 
commitment to it.46 Multiple meta-analyses have shown that MI improves treatment 
outcomes across a variety of behavioral domains in both medical and non-medical 
settings, including for substance use and treatment engagement.47-49 MI can be 

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delivered in person or by telephone. Telephone-based MI has been used successfully to 
address substance use and other risky behaviors in a variety of populations.50-56 It has 
been shown to significantly increase initiation and retention of post 9/11 veterans in both 
VA and non-VA mental health treatment, with a secondary effect of significantly and 
durably decreasing their marijuana use.57 
Notably, MI has been found to effectively improve chronic pain treatment 
engagement and outcomes, especially when more than one MI session is 
employed.58,59 Specifically, Habib et al59 found that a 2-session assessment and 
feedback intervention based on MI, in comparison to a standard 2-session assessment 
and educational control interview, significantly improved the rates in which patients with 
chronic pain attended a series of pain management workshops. Similarly, Friedrich et 
al58 showed that patients with chronic low back pain attended more physical therapy 
sessions and had reduced disability and pain levels when the physical therapists had 
been trained to use strategies consistent with MI during the patients’ visits. MI is well-
aligned with expert recommendations for patient-centeredness and shared decision-
making in chronic pain management.60-63 Furthermore, the VHA National Center for 
Health Promotion and Disease Prevention has endorsed the use of MI “to elicit and 
increase Veterans’ own intrinsic motivation to participate in healthcare decisions and 
change health behaviors that are key to improving health and maintaining their well-
being.”64 We propose to use MI to engage post-9/11 Veterans with MSD in multi-modal 
non-pharmacological pain management treatments. A recent meta-analysis of MI for 
chronic pain management concluded that MI is a promising approach for promoting 
engagement in treatments for chronic pain conditions and underscored the need for 
well-designed randomized controlled trials to determine the effectiveness of MI within 
musculoskeletal health.65 
 
MI-based SBIRT for Pain Management to Engage Compensation-Seeking Veterans 
with Chronic Pain. 
SBIRT is an approach to identify and briefly intervene with patients with risky substance 
use in settings not typically associated with addiction treatment.66,67 The Brief 
Intervention in SBIRT usually is based on MI. SBIRT is efficacious for reducing 
unhealthy alcohol68,69 and tobacco use,70-72 although less well established for 
decreasing illicit drug use73,74 or improving drinking outcomes for people with severe 
alcohol dependence.75,76 According to our pilot data, most Veterans meeting criteria for 
the proposed study are likely to have episodic risky drinking rather than drug use and 
are not likely to have alcohol dependence (see Preliminary Studies section).  
 
 
Our group developed SBIRT for Pain Management (SBIRT-PM) to promote 
engagement in multi-modal non-pharmacological pain management among 
compensation-seeking Veterans with chronic pain. In SBIRT-PM, a clinician meets with 
the Veteran after the compensation examination to address the presenting MSD 
complaint. A clinician rather than the compensation examiner delivers SBIRT-PM to 
allow the Veteran to engage in a confidential discussion without concern about how it 
will impact the compensation claim. The clinician addresses Veterans’ motivation for 
multi-modal pain care, and explains how pain can be managed using a variety of non-
pharmacological pain management services. The clinician spells out how those services 
can be accessed at VA. 

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Using permissive language about how pain is commonly self-medicated with 
substances, the clinician transitions to inquiries about use of prescription and non-
prescription substances. The clinician then attempts to motivate Veterans to change 
their behavior if they are misusing substances. Thus, SBIRT-PM addresses the 
Veteran’s presenting pain complaint first and nascent substance use subsequently.  
 
A Veterans Integrated Service Network Hub-and-Spoke Model of SBIRT-PM Delivery.  
The VA often employs the hub-and-spoke model to manage care across a 
geographically-dispersed healthcare system. The hub-and-spoke model allows for 
expertise concentrated in specific geographic areas to be available throughout the 
system. The Veterans Health Administration is divided into 18 geographical regions 
across the United States called Veterans Integrated Service Networks (VISN). VISNs 
are organized as hub-and-spoke networks in which a central administration oversees 
healthcare policy and service delivery of all medical centers in the designated region.77 
VISN 1 consists of eight VA medical centers and 50 outpatient clinics throughout the six 
New England states.  
We will adopt a VISN1-wide hub-and-spoke network implementation system in 
which VA Connecticut Healthcare System will serve as the hub for SBIRT-PM delivery 
in all eight VISN1 medical centers. The hub will be the site for screening and identifying 
individuals appropriate for SBIRT-PM, delivering the intervention via telephone to 
Veterans throughout New England, and referring Veterans to site personnel who make 
pain management service referrals. This approach has the advantage of fitting the way 
in which many other clinical interventions and areas of expertise are delivered within 
VA. One widely used example of a hub-and-spoke model in VHA is SCAN-ECHO 
(Specialty Care Access Networks-Extension for Community Healthcare Outcomes). In 
these programs, “hubs” with experts in a particular area arrange teleconferences, 
trainings, and case consultation for providers in “spokes” or satellite sites. VA 
Connecticut is the site for a SCAN-ECHO program for pain management, and this 
model appears to be effective. Suggestive evidence of its effectiveness is that providers 
who participate in the pain SCAN-ECHO program have been significantly more likely to 
use physical medicine, anti-depressants, and anti-convulsant treatments, but not 
opioids.78  Other examples are the VA Epilepsy Centers of Excellence to assure 
increased access to high quality of care for Veterans with epilepsy.79 A hub and spoke 
model has the advantage of being more cost-effective compared to no network from a 
hospital80 and societal perspective.81 Hub and spoke systems allow for full-time 
personnel to specialize in the intervention and serve multiple sites, rather than requiring 
training of larger numbers of personnel at many sites.  
 
 
The theoretical framework for implementation of SBIRT-PM in a hub-and-spoke 
model is Relational Coordination.82 Relational Coordination refers to the quality of 
communication and collaboration across sites and is predictive of a team’s or 
organization’s ability to provide high quality care.83-85 Hub-and-spoke networks function 
through collaborative relationships between individuals working across sites.86 
Information must flow effectively between members of the hub-and-spoke sites for care 
to be timely, coordinated and appropriate for the patient. In this study, we will first 
explore how relationships among clinical and administrative staff involved in pain care 
are coordinated at the sites during baseline semi-structured interviews early in the UG3 

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phase. Informed by what stakeholders tell us, we will then work to build Relational 
Coordination within our hub-and-spoke network to deliver SBIRT-PM. 
Within the VA, there are financial incentives for VISN-wide initiatives, such as the one 
proposed, that bring Veterans into VA care. The formula for funding each VISN is 
essentially a capitated model of payment per Veteran, called the Veterans Equitable 
Resource Allocation (VERA). Each additional patient in the New England VISN 
generates a mean of $650087 (the median is considerably lower) and Veterans whose 
conditions are judged to be connected to their military service are, understandably, the 
highest priority Veterans for VA facilities to enroll. The VA as an organization depends 
on enrolling new Veterans as those from prior wars die or move to other regions. 
Beyond having the potential to improve care for Veterans applying for compensation for 
MSD-related claims, to the extent SBIRT-PM results in new Veteran enrollment, it could 
increase revenue into VISN1 and its medical centers. Therefore, our proposal includes 
a budget impact analysis, with the prosaic but crucial information as to how SBIRT-PM 
impacts the VISN bottom line.  We will determine the cost and cost-effectiveness of 
SBIRT-PM because these data provide evidence for SBIRT-PM’s value. 
 

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3. STUDY DESIGN 
 
 
 
We will conduct a pragmatic two-arm, parallel groups 36-week multi-site randomized 
controlled single blind trial of SBIRT-PM. Drawing from VISN1 medical centers, we will 
randomize 1100 post-911 era Veterans applying for MSD-related compensation to 
either: 1) SBIRT-PM, a single phone-delivered session followed by up to three calls in a 
12-week period and an additional call in the 12-32-week period; or 2) usual care (UC). 
Primary outcomes will be change in pain severity (BPI Composite severity) and change 
in the number of substances categorized as requiring intervention (ASSIST).  The two 
primary outcomes will be measured by self-report at 12- and 36- week follow-ups.  The 
self-report BPI and ASSIST measures will be completed with the Research Assistant by 
SBIRT-PM Study Design Overview 
Obtain list of Veterans applying for Service Connection for Back, Neck, Knee 
and/or Shoulder conditions at 8 Study Sites  
 
Recruitment letters mailed to Veterans who served Post 911 
 
Follow-up battery of assessments  
administered between 12-16 weeks after baseline 
Nail Sample 
Research Assistant calls Veterans to explain study. Potential subjects are 
screened with inclusion/exclusion criteria within 6 weeks of letter mailing.  
 
Total N=1100: Obtain informed consent over the phone (audio-recorded). 
Collect contact information and administer Baseline battery of 
assessments. 
4 days  
Randomize 
SBIRT-PM 
(4 phone sessions 
administered over 12 
weeks) n=550 
No Additional 
Treatment 
n=550 
 
Baseline  
Follow-up 1  
Follow-up battery of assessments  
administered between 36-40 weeks after baseline 
Nail Sample 
Follow-up 2  
Prior to 
Enrollment  
EHR Data Collection 
Collect VA Staff Interviews and 
Survey Data Collection 
Analyze Study Data 
End of 
Study 

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telephone with the patient’s responses entered directly into REDCap. The Research 
Assistant conducting all study assessments will be blinded. Secondary outcomes will 
include non-pharmacological pain management service utilization, pain interference with 
life activities (BPI), overall pain (PEG), overall health (EQ-5D-5L), use severity for 
individual substances generated by the ASSIST, and toxicology results for individual 
substances. The trial will include cost-effectiveness and budget impact analyses. 
 
Study Settings.  
The study will occur within the eight VISN1 VA medical centers (VAMC) located across 
six New England States. Each site provides MSD-related compensation examinations, 
addiction/mental health treatment, and a variety of non-pharmacological pain 
treatments. 
 
The medical centers are:  
1. Bedford VAMC 
2. Boston Healthcare System 
3. Central Western Massachusetts 
4. Connecticut Healthcare System 
5. Maine Healthcare System 
6. Manchester VAMC 
7. Providence VAMC 
8. White River Junction VA 
 
Feasibility of Recruiting a Sufficient Number of Veterans Who Meet Inclusion/Exclusion 
Criteria:  
As noted in the completed SBIRT-PM RCT, in only 21 months of recruiting, 1017 
examinations (for 1014 unique Veterans) were scheduled for service-connection 
examinations for back, neck, knee, or shoulder. Over the 32 months of recruitment for 
the proposed study, this would come to 1448 potentially eligible Veterans at VA 
Connecticut. To extrapolate from these values to the number of eligible participants we 
could expect at each of the other seven sites within VISN 1, we used VBA reports of 
new service-connection examinations requested at each of the other sites for 
back/neck/knee/shoulder. We then assumed the same proportion at each site would be 
eligible as were at the Connecticut site. 
At VA Connecticut, 257/1014 Veterans met eligibility criteria and enrolled (a 
24.3% enrollment rate). The proposed study is likely to enroll at least as high a 
percentage, and probably higher because: (1) enrollment by phone asks less of 
Veterans than enrollment in person required in the prior study; and (2) there are fewer 
inclusion/exclusion criteria in the proposed study. Conservatively assuming the 18% 
enrollment rate in the UG3 pilot (with only one call to many participants) yields 1862 
exceeding the study’s randomization goal of 1100. The large sample allows for study 
completion should recruitment lag at one or more sites. 
The large numbers of readily recruitable Veterans in a single VISN speaks to 
how many Veteran are at risk and engageable at their service-connection examinations. 
  

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VISN 1 VA Medical Center 
Projected Number of Post-9/11 Veterans 
Scheduled for MSD Service-Connection 
Examination over 32 Months of Study 
VA Boston  
2478 
VA Connecticut  
1448 
Providence, RI 
1584 
Manchester, NH 
1275 
Togus, ME 
1493 
Bedford, MA 
744 
White River Junction, VT 
677 
VA Central Western Massachusetts HCS 
650 
Total 
10349 
 
Sources of Materials 
 
Veterans sources of materials: 
Information to be collected includes: 
1. Veteran questionnaire responses entered into VA REDCap 
2. Nail clipping toxicology tests 
3. Audio recorded SBIRT-PM sessions 
4. Information from the electronic health record (EHR), including the record of 
the Compensation examinations and service connection determination 
5. Service use data from central VA databases 
 
VA Staff sources of materials: 
Information to be collected includes: 
1. Responses to Relational Coordination Survey 
2. Digital recordings of interviews and transcriptions 
 
Assessment Procedures.  
A research assistant, blind to study condition, will conduct baseline, 12- and 36-week 
participant assessments by telephone. Veterans will be instructed during the 
assessments not to tell the research assistant if they are receiving study counseling. To 
determine if the blind was maintained, the research assistant will be asked in what 
condition each Veteran was assigned. In the initial RCT of SBIRT-PM reported in the 
Preliminary Studies, the accuracy of research assistants’ guesses about treatment 
condition assignment were almost exactly at chance (52%).  We will abstract data from 
the VA electronic health record (EHR) when possible.  
 
Procedures to Collect Self-Report Data from Veteran Participants.  
The self-reported assessment will be conducted by phone. Baseline assessment will be 
conducted as soon as possible after enrollment, and follow-up phone assessments will 
be conducted approximately 12 and 36 weeks after randomization. Participants will 
receive a reminder call or text/email message prior to study appointments (e.g., “your 
follow-up phone interview with our research study is Monday, December 11th at 1:30. 
Please call [Name] at xxx-xxx-xxxx if you need to reschedule”). If a participant misses a 
scheduled appointment, the research assistant will call to reschedule. Participants will 
be asked at the beginning of enrollment for the names and telephone numbers of three 

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people who can find them if the research assistant has difficulty reaching them. These 
people will be contacted if the research team is unable to reach the Veteran within a 
three-week period.  
 
Procedures to Collect Self-Report Data from VA Staff Participants 
Each Site-PI will identify a list of 7-10 stakeholders (providers in primary care clinics, 
pain service clinics, administration, and Compensation & Pension clinics) at their site. At 
the end of the study (after recruitment and follow-up appointments are complete), our 
qualitative expert and her team will contact stakeholders by email, inviting them to 
participate in a semi-structured interview designed to better understand how pain 
services are conducted at their site and how staff at each site communicate with other 
clinics regarding Veteran referrals for pain services. The qualitative expert and her team 
will place a follow-up phone call to stakeholders to schedule an interview. Interviews will 
last approximately 30 minutes, and will utilize a semi-structured interview guide. 
Interview responses will be audio-recorded and professionally transcribed by a VA 
approved transcription service for later qualitative analysis. 
 
Stakeholders will also be invited via email to complete a Relational Coordination 
survey, administered through VA REDCap. Survey responses will be collected 
confidentially and stored in VA REDCap in the secure VA environment. 
 
Procedures to Collect Data from the VA Electronic Health Record.  
VHA databases in the Corporate Data Warehouse hold patient demographics, 
diagnoses, and encounter information from all Veterans who have received services 
from anywhere in VHA. Veterans who are scheduled for a service-connection 
examination (all study participants) have a medical record with VHA. The encounters 
indicate a provider, service provider, diagnoses addressed, and clinic in which services 
were delivered (e.g. mental health, substance use, primary care, pain clinic). The 
diagnosis and service-use data are not comprehensive for Veterans who have not been 
receiving their care at VA, but positive findings such as treatment encounters and 
diagnoses reflect clinical care/evaluations and their charting by providers. 
 
Costs Estimation Procedures.  
We will use the customized Resource Allocation Worksheet to estimate the costs of 
delivering SBIRT-PM from the perspective of the providers (i.e., both the VISN and 
hospital). Cost estimation for VA services used by Veterans during the 36-week study 
period will be assessed using national VA administrative databases. Data on service 
use at the individual patient level will come from the VA National Patient Care Database 
(NPCD), which includes information on all inpatient and outpatient encounters at VA 
facilities. Costs for these services will be computed using the VA Average Cost 
Database, developed by the Health Economics Resource Center (HERC). The Average 
Cost Database assigns an average cost to each inpatient admission and outpatient visit 
in VA. Costs are based on Current Procedure Terminology (CPT) codes and can be 
linked to unique records in the NPCD.  
 
Costs for VA services used by Veterans during the 36-week study period will be 
assessed using national VA administrative databases. Data on VA service use at the 
individual patient level will come from the VA National Patient Care Database (NPCD), 

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which includes information on all inpatient and outpatient encounters at VA facilities. 
Costs for these services will be computed using the VA Average Cost Database, 
developed by the Health Economics Resource Center (HERC). The Average Cost 
Database assigns an average cost to each inpatient admission and outpatient visit in 
VA. Costs are based on Current Procedure Terminology (CPT) codes and can be linked 
to unique records in the NPCD.  Costs incurred by VA for community care will be 
obtained from databases tracking payments to community providers. 
 
Procedures to develop a new natural language processing (NLP) algorithm that 
identifies use of non-pharmacological pain management services  
To comprehensively identify pain-related treatment delivered to study participants, we 
will validate and extend existing natural language search algorithms, using previously-
described procedures, to identify current use of a comprehensive set of pain treatments 
including those not covered by the existing algorithms. Those modalities will be drawn 
from a review of modalities used by Veterans for pain treatment and those offered in 
VISN 1. Algorithm development will be informed by our prior experience with this study 
design. We will design algorithms to maximize positive predictive value (at the expense 
of sensitivity) to avoid the risk of including false positives that are not randomly 
distributed (e.g., refused treatment referrals). The NLP extraction target will be current 
use of the modality. Particular attention will be paid to excluding pain discussions that 
do not represent treatment because they were obtained in the course of routine medical 
history reviews. Algorithm development involves extracting relevant snippets that 
mention a particular pain treatment, establishing a valid classification system for current 
use of that pain treatment, and optimizing the machine learning algorithm to identify 
current use of that treatment. 
Extracting relevant snippets: In brief, terms related to each of the pain treatments 
(i.e. therapy keywords) will be generated by the investigative team. For example, for 
physical therapy, terms might include “physical therapy,” “PT,” or “physical therapist.” A 
simple algorithm will identify these terms, along with the 10 preceding and 10 following 
words. By our observation, a 20-word window is sufficient to capture most of the 
relevant context, and also allows for fast review of multiple records. The algorithm will 
be modified using Boolean terms (e.g. physical NOT physical exam). We will refine the 
search terms and extract 20+ word snippets using the Voogo clinical data search 
engine. 
Establishing a valid classification system for use of a pain treatment modality: 
The investigators will develop annotation guidelines for classifying snippets as 
representing current service use (e.g. of physical therapy services as no/yes/probably). 
One challenge is that the documentation of temporal information varies in specificity. 
We will classify the temporal information into several categories based on the onset and 
duration attributes. For instance, usage with a non-specific past start and end time (e.g. 
“patient used physical therapy before”) will be considered to be past usage, usage with 
no specific past start but no end time (e.g. “patient has been going to a physical 
therapist”) will be considered current for the time of documentation, usage with specific 
start and end time will be considered current for the time it specified, etc. The 
annotation guidelines will be revised and then tested on 100 snippet samples until a 
kappa of 0.75 is reached between the two experts. 

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Optimizing the machine learning algorithm to identify use of a pain treatment: We 
will then randomly select 500 text snippets containing terms per type of pain therapy 
from all retrieved notes from primary care and perform human review based on the 
annotation guideline described above. Annotation work will be carried out using the 
Visual Tagging Tool (VTT). This set of annotates data will be added to our existing set 
of annotated data (n=3000) and serve as the new gold/reference standard for machine 
learning and training. We will apply a machine learning algorithm, Support Vector 
Machine (SVM), to identify current use of pain therapy, optimizing for highest positive 
predictive values (PPV). Informed by our prior experience, we will use therapy 
keywords, n gram (n consecutive words), note type, and temporal information as 
features in the classification of current use. Temporal information will be extracted using 
a prior method developed and tested by Dr. Zeng.88  
To assess the NLP performance, we will perform 10-fold cross validation, which 
partitions the entire annotated sample into 10 random sets with equal size, uses 9 sets 
for training and 1 for testing, and repeats 10 times. Our target PPV is >=90%, which is 
very likely to be reachable because: 1) the specificity of the test has been set high (at the 
cost of sensitivity); 2) the usage level (prevalence) of the primary non-pharmacologic 
modalities for chronic pain treatment is high which increases PPV; 3) we achieved 89% PPV in 
our work on a small set of modalities. We will apply machine learning methods we trained 
using previously acquired annotated data such as Support Vector Machine and Random 
Forest, and will use an ensemble learning step called Stacking,89 in which a learning 
algorithm combines the results of several other learning algorithms, if the separate 
programs’ performance fails to reach the target positive predictive value.  In the unlikely 
event that the PPV is not reached for a particular CIH modality, that modality’s 
assessment will be conducted by the other two available methods (self-report and EHR 
codes). 
 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
 
For this pragmatic clinical trial, the study inclusion and exclusion criteria are broad.  
There are no specific evaluations of capacity to consent or complete study procedures.  
 
Participants must meet all the inclusion criteria to participate in this study.  
Consistent with the guidelines for pragmatic trials, we have taken a broad perspective to 
include all participants who have MSD-related conditions with moderately severe pain, 
regardless of the type of MSD, their anticipated responsiveness to SBIRT-PM, or 
psychiatric, substance use, or medical comorbidities or past compliance. Because 
SBIRT-PM targets pain, and is telephone-based, at baseline participants must self-
report moderate pain severity and have access to a telephone to test the effectiveness 
of the SBIRT-PM in this clinical trial. The other targeted outcome, substance use, is not 
an inclusion criterion. But rates of risky use in the completed RCT were high enough for 
an adequately-powered study without requiring baseline use as an inclusion criterion. 
 
Candidates meeting any of the exclusion criteria at baseline will be excluded 
from study participation. We are excluding people who are already connected to three 
or more VA nonpharmacological pain to minimize a ceiling effect, i.e., such participants 
have a lower likelihood of needing a referral. 
 

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4.1 Inclusion Criteria 
 
1. post-9/11 Veteran applying for MSD-related compensation (specified as back, 
neck, shoulder, or knee pain), as ascertained from filed claim,  
 
2. reports a score of ≥4 (threshold for moderately severe pain) on the BPI’s Pain 
Severity subscale (average of four pain intensity items);  
 
3. availability of a landline or cellular telephone for SBIRT-PM.  
 
4.2 
Exclusion Criteria 
 
1. reports inability to participate during the study enrollment call;  
 
2. received three or more non-pharmacological pain treatment modalities within the 
last 12 weeks from VA (modalities are: (1) acupuncture (2) rehabilitation 
therapies (3) Manipulation (4) Massage (5) Yoga (6) Tai Chi/Qigong (7) exercise 
(8) Biofeedback (9) Hypnosis/Hypnotherapy (10) Guided Imagery (11) Meditation 
(12) Psychotherapy/Counseling (13)Reiki (14) teaching about coping with pain  
(15) other treatment for pain);  
 
3. participation in another PMC3 study as evidenced by a research protocol alert for 
that study at the time the study invitation letter is mailed.  
  
4.3 
Study Enrollment Procedures  
Human Subjects Involvement. The proposed project will include two groups of human 
subjects, (1) Veterans and (2) VA staff (clinicians and administrators). 
 
Screening and Recruitment for Veterans.  
A waiver of Informed Consent and a waiver of HIPAA Authorization were obtained to 
review the Compensation and Pension Clinic’s schedule to determine when a MSD 
examination is scheduled for a post-9/11 Veteran. The waiver allows for the collection of 
basic demographic information concerning Veterans screened for study participation to 
determine if Veterans who consent to study participation differ systematically from those 
who do not. The proposed study will employ recruitment procedures used in 
Compensation Clinic-based studies by our group. There have been no adverse events 
associated with these recruitment procedures.  
The recruitment strategy involves first identifying Veterans scheduled for a 
compensation examination for a MSD by reviewing chart and Compensation Clinic 
information about Veterans scheduled for these evaluations. A research assistant at the 
hub site will exclude people whose records preclude post-9/11 military service and mail 
recruitment letters. These potentially eligible Veterans will be mailed a letter from the 

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research team explaining the basics of the study and that unless the Veteran opts out, a 
member of the research team will call to further explain the study. A toll-free phone 
number will be included in the letter that Veterans can call to opt out of receiving the 
phone call or to express their interest in participating. A magnet with study contact 
information and $1 USD will be included with the recruitment letter. All veterans who are 
identified as a potential participant and mailed a recruitment letter will receive the 
magnet and dollar regardless of whether or not they choose to enroll in the study. The 
magnet is a non-monetary incentive (valued at approximately $0.21) that will increase 
response rate, as potential participants can post the magnet in an easy to see location 
to remind them that the study personnel will be calling. It might also help with retention 
rates for enrolled participants as it can be a visual reminder of participation and the 
study team contact information will be readily available. The dollar is a monetary 
incentive designed to increase the rate at which people will take the study team call. 
One year into the study, we have found that we are unable to contact 45% of people 
who are mailed a letter after three contact attempts. Research has shown that pre-paid 
incentives are most effective at increasing response rate. However, the value of the 
incentive is nominal so as not to be coercive or to create an undue influence on people 
from a lower socioeconomic class. 
Veterans who opt out will not receive any more study-related phone calls. A copy 
of the Study Information Sheet describing the study will be included with the recruitment 
letter. 
At least four days after the recruitment letter is sent, research assistants will 
attempt to call Veterans up to three times to invite them to participate in the study. A 
four-day waiting period from the day the letter is mailed to the day of the call is sufficient 
to allow Veterans time to receive the letter in the mail and opt out if preferred. At that 
call, the research assistant will explain the study and further screen for eligibility. For 
eligible Veterans, the research assistant will conduct informed consent followed by 
baseline assessments during this phone call or subsequently. Although enrollment 
ideally occurs before the Compensation examination, Veterans will be allowed to enroll 
up to six weeks after recruitment letters are mailed.  If a Veteran misplaces or has not 
received the Study Information Sheet, the Research Assistants will offer to mail another 
copy to the Veteran. The Veteran can choose to continue with the recruitment call or to 
wait until they receive the copy of the Information Sheet before continuing. 
 
Informed Consent and Enrollment for Veterans: 
Voluntary informed consent will be obtained from all Veterans prior to participation. A 
waiver of Documentation of Informed Consent and a waiver of HIPAA Authorization has 
been obtained for this study.  
Participants will receive a Study Information Sheet detailing the study. In an 
audio-recorded telephone call, a research assistant will go over all aspects of informed 
consent with potential participants. At the start of the call, the research assistant will 
verify the identity of the participant. Veterans will be provided with information about the 
SBIRT-PM intervention, how long it will last, the nature of study assessments, 
information about the collection of biological specimens, the examination of their 
electronic health care and VA data, and potential risks and benefits of study 
participation. Veterans will be reminded that they can withdraw from the study at any 

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time without penalty. They will be given the opportunity to ask questions and then will be 
asked if they agree to participate.  
Veterans who agree to participate will state so for the audio-recording. Audio-
recorded consents will be stored in a restricted research investigator folder on VA 
Network computers behind the VHA firewall. Only research staff will have access to the 
recordings. 
Staff obtaining verbal consent will have completed a web-based course with 
post-test on Human Research Protections, and all will have had specific training by the 
mPIs in obtaining informed consent for this project. All staff obtaining consent will be 
authorized to do so by the VA Central IRB.  
Justification for obtaining a waiver of documentation of informed consent and 
waiver of HIPAA Authorization: These waivers are necessary to conduct the study. The 
purpose of this study is to test the usefulness of remotely delivered counseling. All 
counseling sessions and research assessments are conducted remotely. There is no 
face-to-face contact with participants and the study is considered minimal risk. It would 
be burdensome and impractical to have potential participants come in to the VA just to 
sign a study Consent Form and HIPAA authorization. This study could not practicably 
be conducted without the waivers due to the timing of study procedures. Baseline 
assessments and study counseling should occur before or within six weeks after the 
recruitment letter is mailed. Waiting for the Veteran to find time to come to the VA to 
sign a Consent Form and HIPAA Authorization or waiting for the Veteran to return a 
signed copy of the Consent Form and HIPAA Authorization by mail will likely push the 
timing of study assessments outside of this window, making a large proportion of 
eligible Veterans ineligible. 
Randomization: The unit of randomization is participant. Participants will be 
randomized to SBIRT or Usual Care using a computerized urn randomization program90 
within each site to increase the likelihood of balanced allocation of participants to the 
two interventions on sex, race (Caucasian, African American), ethnicity (Hispanic 
no/yes) and self-reported illicit drug use within 90 days. The research assistant will be 
blind to the assigned condition. For each participant, Research Assistants will 
communicate data needed for the urn to the Project Director, who will randomize the 
participant and assign a study therapist based on location, availability and work flow. 
Enrollment: Participants are considered enrolled after they complete the informed 
consent process and agree to study procedures. 
 
Informed Consent and Enrollment for VA Staff: 
A waiver of documentation of Informed Consent for VA Staff participants has been 
obtained for staff participants.  
 
Research staff will describe the purpose of the survey and interview prior to 
administering these assessments. Participating VA staff members will be encouraged to 
ask any questions and have the option to discontinue participation without prejudice. 
They will be approached by people other than their direct supervisors. 
 
After a brief reiteration of the study purpose, the interviewer will confirm consent 
to record the interview for transcription and analysis purposes before proceeding.  
 

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Screening for medical record review to develop the natural language processing (NLP) 
algorithm for pain-related treatments.  
A computer algorithm will be used to identify key terms (e.g. “physical therapy” along 
with the 10 preceding and 10 following words: a snippet. Snippets of chart data will be 
identified that contain pain-related treatment keywords and surrounding text will be 
identified from electronic medical records from up to 10,000,000 (approximately number 
of Veterans with medical records). As such, although not specifically queried for PHI, a 
snippet might contain some PHI such as a visit date and doctor’s name.  All of the work 
with the snippets is done in the VINCI data analysis environment behind the firewall in 
the VA. Access to the VA network and VINCI are password protected and only 
accessible at the VA or through remote access with an approved device. These 
snippets will be reviewed to identify approximately 700 snippets per pain treatment 
modality (100 for developing annotation and 600 for validating the algorithm using the 
developed annotation). 
5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
SBIRT-PM Intervention.  
SBIRT-PM involves a manualized, motivational interviewing-based 4-session telephone-
delivered intervention over a 12-week period to motivate Veterans to engage in multi-
modal non-pharmacological pain care and, for those with co-occurring risky substance 
use, also change this problematic behavior. SBIRT-PM also includes coordination 
between the SBIRT-PM counselors and the PACT nurse case manager or primary care 
provider after the initial session to support these patient outcomes. SBIRT-PM will be 
delivered centrally from the VA Connecticut hub to the VISN1 medical centers by 
counselors trained in the approach. All sessions will be audio recorded for the purposes 
of SBIRT-PM fidelity assessment and supervision. 
 
Initial Session.  
The initial session is conducted after the compensation examination for the presenting 
MSD complaint. The counselor begins by explaining the separation between any 
service-connection claim and the counseling, as we have done in prior studies. The 
counselor also explains the structure (4 sessions over 12 weeks), and focus 
(engagement in pain management services, changing risky substance use if it exists) of 
SBIRT-PM and then begins the interview by asking about the Veteran’s MSD condition 
and experiences with pain, conveying understanding and compassion for the Veteran’s 
experience.  Next, the counselor explains how pain can be managed using a variety of 
pain management services, and how these services can be accessed at VA. 
 
The counselor explains pain management consistent with guidelines issued by 
the American College of Physicians,91 calling for education, encouragement of self-
management, and judicious use of non-opioid medications. The explanation is in the 
spirit of providing information, not an exhortation. The counselor describes how the goal 
of pain treatment is improving function (“helping you get back to doing things that are 
important to you”) and that it may take a variety of different treatments to achieve this 

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goal. The counselor further describes how pain is commonly associated with decreased 
activity, which in turn can contribute to other problems.  
 
The counselor’s explanation of the role of opioid medications paraphrases 
messages that primary care providers deliver to Veterans as part of Dr. Becker’s safe 
prescribing approach.92 The counselor explains that medications, including both opioid 
and non-opioid medicines, have an important place in some Veterans’ pain treatment, 
and that Veterans benefit when pain medicines are prescribed and taken safely. The 
counselor reinforces the importance of taking opioid medicines as prescribed because 
there are risks of addiction and interactions with other substances (like alcohol). The 
counselor explains that judicious use of non-opioid medications improves pain treatment 
outcomes without these risks.  
 
The counselor introduces the idea that non-pharmacological treatments can help 
manage pain, and explains what they are and how they work. These services may 
include: (1) treatment for the underlying ailment, (2) physical therapy (both at VA and as 
home exercise and stretching programs), (3) behavioral treatments like Cognitive 
Behavioral Therapy for chronic pain, (4) treatments for depression, PTSD, and/or other 
mental health problems that chronic pain may have aggravated, and (5) complementary 
and integrative health interventions available including chiropractor services, 
acupuncture and yoga. 
 
Throughout these discussions, the counselor seeks opportunities to motivate the 
Veteran to engage in multi-modal pain care using a variety of MI consistent approaches.  
If the Veteran commits to engaging in pain management services, the counselor 
develops a plan with the Veteran to initiate this process. For Veterans not enrolled in VA 
services, the counselor explains the procedures to obtain eligibility for VA care.  
• After motivating Veterans for engagement in pain management services, the 
counselor transitions to screening for substance use.  The counselor explains that 
some people with chronic pain use various substances to help them cope with the 
pain, and obtains the Veteran’s permission to discuss this. The counselor then 
screens for substance use.  If the Veteran reports no risky substance use, the 
counselor summarized the session, reiterates the plan, and schedules the next 
session.  If the Veteran reports risky substance use, the counselor asks more about 
it and how the use is affected by the Veteran’s pain. The counselor provides 
feedback about the risky substance use, including evidence that people who don’t 
misuse substances have significant reductions in their pain compared to those who 
continue to do so.  As with efforts to address the Veteran’s interest in pain 
management services, the counselor uses MI consistent approaches to motivate the 
Veteran to stop or reduce risky substance use. Some Veterans will not want to 
pursue abstinence and, for them, a harm reduction approach will be taken, meaning 
the counselor and Veteran will negotiate a plan to use less of the problematic 
substance per occasion, or use on fewer days, but not necessarily strive for 
abstinence. The counselor will develop a plan with the Veteran about how to reach a 
goal of abstinence or reduced or less frequent use, including options for engaging in 
specialty addiction treatment services available at the VA. When mental health 
issues further complicate the Veteran’s pain management and risky substance use, 
the counselor will also discuss these issues with the Veteran.  In fact, some 
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treatment, and, consistent with MI, Veterans will receive information about preferred 
available treatments, including if the Veteran prefers to first talk with the primary care 
provider about his or her addiction or mental health concerns.   
  
Follow-up Sessions. 
After the initial session, the counselor will have up to three 20-minute, mutually 
scheduled phone counseling sessions with the Veteran (about once per month for 12 
weeks) to check on the Veteran’s status in achieving the goals of the plan, and to gauge 
his or her continued motivation to receive pain treatment and reduce risky substance 
use, as indicated. An additional call during the 12-32-week period is permissible to re-
motivate veterans to engage in available pain and substance use services in view of 
any healthcare system changes that occurred (see response to COVID-19 section 
below). These calls may be informed by information the counselor has obtained from 
the PACT providers or information in the electronic health record (e.g., seeing if a 
consult was placed, reviewing progress notes indicating engagement with services). 
Twelve weeks allows time for the Veteran to work with the counselor to resolve barriers 
to service engagement, consider other treatment options, and sustain motivation for and 
engagement in pain management and ancillary services. Moreover, meta-analyses and 
"dose-response" studies93,94 have suggested the benefit of several follow-up telephone 
sessions.  
 
Coordination with PACT Providers. The counselor will communicate with the 
PACT nurse case manager and primary care provider, or other point-of-contact about 
recommended pain treatment referrals primarily via the electronic health record. SBIRT-
PM counselors will write progress notes that indicate the SBIRT-PM encounter and 
outcome of each session, including asking the provider to consider placing a consult for 
the Veteran’s preferred services or discussing the Veteran’s interest in services at the 
Veterans next scheduled appointment. SBIRT-PM counselors cannot place consults for 
services directly; only PACT providers or other licensed professionals working with the 
Veterans at their VAs can do so. 
 
SBIRT-PM Clinician Supervision.  
Dr. Martino will provide competency-based supervision to support the counselors’ 
delivery of SBIRT-PM throughout the trial. This approach is consistent with the national 
VA Evidence-Based Practice training model,95 which emphasizes extended post-
workshop case-based supervision or consultation, including submission of audio 
recorded therapy sessions for treatment fidelity review, as an essential training 
component. Dr. Martino will meet with the counselors together on a 1-hour monthly 
basis to review their SBIRT-PM practice. For these supervision meetings, he will listen 
to and rate the counselors’ SBIRT-PM fidelity for two sessions per counselor (one initial 
and one follow-up call) using the Independent Tape Rater Scale 96 (see 3.C.3.8.10) for 
the purposes of feedback and coaching during supervision. In MI clinician training 
research, this approach and dose of supervision has been shown to sustain proficient 
practice.97  
 
Adaptations to intervention in response to COVID-19. 

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Because the intervention is delivered via telephone and involves no in-person contact, 
we are able to continue to deliver the intervention during the coronavirus pandemic. 
However, several adaptations will occur. 
1. Access to in-person pain and substance use treatment is extremely limited during 
the pandemic, while the VA has expanded telehealth/video-based visits and 
treatments. Therefore, SBIRT-PM counselors will advise veterans on available 
telehealth/video services and online resources for pain and substance use 
treatment that Veterans are being referred to. 
2. Counselors will make themselves as widely available as possible to 
accommodate tighter schedules. 
3. Empathy for the Veteran’s situation is a core feature of Motivational Interviewing 
and many Veterans’ situations are dominated by COVID-19. Therefore, empathy 
for COVID-19 related issues that Veterans raise is being incorporated into the 
counseling.  
4. Because of the changing availability of treatment services during the COVID-19 
period, the intervention will allow for one additional counseling session per 
veteran to occur between weeks 12 and 32. This session will be for the purpose 
of re-motivating veterans to engage in available pain and substance use services 
in view of any healthcare system changes that occurred. The additional session 
maintains the integrity of our intervention in that the counselor can fully influence 
veteran engagement in multimodal pain treatment and addiction services as 
those services’ availability changes. 
Counselors will determine on a case-by-case basis when to conduct this 
additional session based on when services become more available at each site 
and veteran preferences. Only one session will be permissible during this week 
12-32 period, regardless of the number of sessions completed during Weeks 1-
12. All participants in the SBIRT-PM condition currently are within 32 weeks post-
randomization and thus eligible to receive the additional session. The additional 
counseling session will remain part of the protocol for the duration of the trial. 
 
Usual Care.  
A Veteran who completes a Compensation examination ordinarily has no further 
treatment, referral or debriefing as part of the Compensation examination. Veterans 
assigned to the control condition will be contacted by the Project Director and will be 
told they were assigned to the condition without additional study counseling. Veterans 
will be reminded that they should continue to pursue whatever counseling they need 
outside the study. 
Justification for No Additional Referral Control Condition. No additional treatment 
is “treatment-as-usual” when a Veteran applies for service-connection. However, no 
treatment that a Veteran would otherwise get without participating in this study will be 
withheld. An active control group is important when an extensive intervention is being 
tested and it is important to determine if the intervention’s efficacy apart from non-
specific benefits from the time and effort expended by the clinician. However, the need 
for an active control group is less compelling when compared to a relatively brief 
intervention98 and when conducting a pragmatic trial where the emphasis is testing the 
effectiveness of innovations that improve upon usual clinical care.99  

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5.2 
Handling of Study Interventions  
Study counseling sessions will be administered over the telephone in accordance with 
the counseling manual. After a counseling session has occurred, study counselors will 
place a note in the Veteran’s electronic medical record indicating that a counseling 
session occurred and listing referrals the Veteran is interested in having placed. 
5.3 
Concomitant Interventions  
5.3.1 
Allowed Interventions 
 
N/A. Participation in this research study does not preclude use of any 
medications. 
5.3.2 
Required Interventions 
 
N/A.  
5.3.3 
Prohibited Interventions 
 
None 
5.4 
SBIRT-PM Fidelity Assessment  
SBIRT-PM fidelity assessment will involve tracking the number of counseling sessions 
conducted per participant and the adherence and competence with which counselors 
conduct the sessions.  All SBIRT-PM sessions will be recorded and counselors will 
maintain contact logs indicating all contact attempts made to participants, result of each 
contact, and duration of each counseling session.  
 
Adherence and Competence: We will randomly select 220 audio recorded 
SBIRT-PM sessions from the total number of sessions occurring in the trial (maximum = 
550 initial + 1650 follow-up sessions). Therefore, at a minimum we will have a 10% 
sample for validating that SBIRT-PM was delivered as intended. Specifically, the 
Independent Tape Rater Scale (ITRS) will be used to assess the degree to which 
SBIRT-PM sessions were delivered with fidelity to MI (i.e., with adherence and 
competence). The ITRS includes items that cover therapeutic strategies that are MI 
consistent (e.g. reflections) or inconsistent (e.g., unsolicited advice). For this trial, we 
added three general items that detail the extent to which strategies for pain and 
substance use occurred in the sessions. For each item, raters evaluate the counselors 
for adherence (i.e., the extent of intervention delivery) and competence (i.e., the 
skill/quality of intervention delivery) along 7-point Likert scales. We will: 1) calculate 
mean adherence and competence scores for the two factors (fundamental and 
advanced MI strategies) identified in prior psychometric analyses,96,100,101 and 2) 
determine if sessions achieve a criterion level for adequately performing MI, namely, at 
least half the MI consistent items rated average or above for both adherence and 
competence. In addition, we will evaluate the degree to which clinicians addressed pain 
and substance use during the session, based on our general items. We have 
documented experience training ITRS raters to perform reliable MI session process 
ratings in multi-site trials.102-106 

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For the data analyses, adherence to SBIRT-PM counseling will be dichotomized 
(“Having received counseling” Yes/No).  This approach is being taken because SBIRT-
PM’s duration and intensity is not hypothesized to relate to outcome; a Veteran might, in 
a single session, take steps to engage in non-pharmacological pain treatment that 
require minimal follow-up.  Conversely, a Veteran with more follow-up sessions might 
have more because the Veteran is more ambivalent about non-pharmacological pain 
treatments and is receiving more counseling because of more need for it.  After the 
completion of the intent-to-treat analyses, the adherence indicator will be added to 
examine it as a potential mediator of response in the primary outcome analyses.  
6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations 
RCT Assessments 
  Assessment Name/Domain 
Data Source 
Baseline 
12-wk 
36-wk 
 
Socio-demographic Characteristics 
Self-Report 
x 
 
 
Psychiatric and Substance Use 
Diagnoses 
VA EHR -structured data 
(e.g. clinic codes) 
x 
 
 
Characteristics of Musculoskeletal 
Disorders  
VA EHR, Service-
connection exam 
x 
 
 
Distance to nearest VA Facility 
VA EHR 
 
x 
 
Brief Pain Inventory  
Self-report 
x 
x 
x 
Numeric Rating Scale 
Self-report 
x 
x 
x 
Opioid Medications Dispensed in 
Morphine Equivalent Daily Dose 
VA EHR 
x 
x 
x 
Non-opioid Medications Dispensed 
VA EHR 
x 
x 
x 
Non-pharmacological Pain 
Management Service Use—VA 
services 
VA EHR -structured data 
(e.g. clinic codes) 
x 
x 
x 
Non-pharmacological Pain 
Management Service Use---VA and 
non-VA services 
VA EHR with Natural 
Language Processing  
x 
x 
x 
Self-reported VA and non-VA service 
use 
Self-report 
x 
x 
x 
ASSIST 
Self-report 
x 
x 
x 
Prescription Opioid Misuse 
Self-report 
x 
x 
x 
Nail clippings for drug/etoh use 
metabolites 
Biological 
x 
x 
x 
Substance Use Treatment Service 
Utilization – VA services 
VA EHR -workload data 
and clinic codes 
x 
x 
x 
Self-reported VA and non-VA 
substance use service use 
Self-report 
x 
x 
x 
PHQ-9 (depression) 
Self-report 
x 
x 
x 
EQ-5D -5L 
Self-report 
x 
x 
x 
PEG 
Self-report 
x 
x 
x 
Motivation for engaging in pain 
treatment 
Self-report 
x 
x 
x 

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High Impact Pain Questions 
Self-report 
x 
 
 
Audit-C 
Self-report 
x 
 
 
COVID-19 questionnaire 
Self-report 
x 
x 
x 
 
UG3 Preparation Assessments and End-of-Study Assessments 
Measures Described Earlier in 
UG3 Stage of RCT preparation 
Data Source 
UG3 
preparation 
phase 
End of 
Study 
Qualitative Interviews of 
Stakeholders 
Self-report 
x 
x 
Post-intervention Interview of 
SBIRT-PM-treated Veterans 
Self-report 
x 
 
Relational Coordination Survey of 
Key Stakeholders 
Self-report 
x 
x 
Treatment Fidelity Measure: 
Independent Tape Rater Scale  
audio recorded SBIRT-PM session 
ratings 
 
x 
 
6.2 
Description of Evaluations  
6.2.1 
Screening Evaluation 
A waiver of HIPAA authorization and waiver of informed consent have been obtained to 
access lists of Veterans applying for Compensation and Pension benefits for 
back/neck/knee/shoulder conditions at 8 study sites. Identified individuals who are post 
9-11 status will be mailed a letter explaining the study. Individuals will be eligible for 
enrollment for up to 6 weeks after the letter was mailed.  The SBIRT-PM intervention 
acts by engaging Veterans in pain treatment, and Veterans who have not engaged in 
three or more non-pharmacological pain treatment modalities (one of the inclusion 
criterion) still are at the stage of care that they could benefit from the proposed 
counseling.   
Four days after the mailing, research assistants will follow-up the recruitment 
letters with a telephone call to fully screen Veterans for inclusion in the study using the 
participant screening form. Screening forms will be saved in the research study folder 
on the VA secure network. The screening evaluation after the letters are mailed consist 
of a few questions about pain treatments received, pain severity, and availability of a 
phone.   
Individuals who meet all inclusion/exclusion criteria and are interested in 
participating in the study will be consented over the phone. 
Consenting Procedure 
A waiver of HIPAA authorization and a Waiver of Documentation of Informed Consent 
have been obtained to consent participants into the study. Research Assistants will 
consent eligible individuals into the research study by telephone call. Research 
Assistants will audio record the informed consent process for individual to enroll him/her 
into the study. Audio files of the informed consent process will be saved in the research 
study folder on the VA secure network. 
 

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6.2.2 
Enrollment, Baseline, and/or Randomization 
Enrollment 
The enrollment date is that day the individual has met all the screening criteria and has 
agreed to participate in the study by completing audio-recorded informed consent. 
Baseline Assessments 
Measures to Characterize the Sample. 
• Socio-demographic Characteristics. A research assistant will collect self-reported 
socio-demographics (age, sex, race, ethnicity, marital status, education, employment 
status, legal status, and military history) from Veterans during baseline assessment.  
• Medical Diagnoses. We will extract medical diagnoses from electronic health records 
and the VA Corporate Data Warehouse. We will identify psychiatric (e.g., 
depression, anxiety, Traumatic Brain Injuries,107,108  and PTSD109,110) and substance 
use disorders in the EHR and VA Corporate Data Warehouse by their ICD-9 and 10 
codes. We decided against more direct measures of psychiatric conditions (e.g. the 
PTSD Checklist) to minimize participant burden and reactivity.  To increase the 
sensitivity of our detection of psychiatric conditions, we will extract the service-
connection claims data from the Veterans Benefits Management System for study 
participants at the end of their study participation.  New recipients of service-
connection receive it for an average of 5.25 distinct claims,40 and many Veterans file 
both MSD and claims for mental conditions at the same time. This will identify 
Veterans with psychiatric disorders who were diagnosed during their service-
connection examinations but do not have a diagnosis in VA treatment records 
because they were not treated for their mental health condition.   
• Characteristics of Musculoskeletal Disorders. We will determine the diagnostic group 
of MSD assigned to participants in the EHR by using ICD-9 or 10 codes. Major 
groups are back pain, neck pain, and osteoarthritis.  Other categories will be 
combined as suggested by their frequency and co-occurrence with other MSD. 
These include non-traumatic joint disorders, osteoporosis, sprain and strain, 
traumatic joint disorder, spinal cord injury, fibromyalgia, rheumatoid arthritis, 
temporal mandibular disorder, lupus, gout, and MSD multimorbidity (more than one 
MSD diagnosed). The broad MSD groups will be considered as potential moderators 
of treatment effect in the analyses. In addition, compensation examiners complete a 
detailed, structured form, the Disability Benefits Questionnaire (DBQ), for each 
Veteran they evaluate. From these forms, we will extract structured notations of the 
examination findings.  Finally, we will obtain the final percentage service-connection 
awarded from the Veterans Benefits Administration System (VBMS) after the 
determination, and delineate service-connected conditions. 
 
Pain Measures: 
• Brief Pain Inventory (BPI). The Brief Pain Inventory111 (BPI) is a validated instrument 
to assess chronic non-cancer pain that yields two subscales.  One measures pain 
severity (4 items on a 0-10 scale) and the other assesses pain interference with life 
activities (7 items on a 0-10 scale), both using a 24-hour recall period.  BPI pain 

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severity will serve as our primary pain outcome for the trial; pain interference will 
serve as a secondary outcome. The BPI is a reliable measure and responsive to 
change.112 The BPI is endorsed by the Initiative on Methods, Measurement, and 
Pain Assessment in Clinical Trials (IMMPACT) group113 as a preferred measure of 
pain-related functioning. IMMPACT recommendations have specified score changes 
that would represent a minimally clinically important difference (i.e., 30% reduction in 
pain severity and 1-point reduction in pain interference), which will be used in our 
cost analyses.114   
• Numeric Rating Scale (NRS). The NRS115 is an 11-point (0 = no pain, to 10 = worst 
pain imaginable) scale for current pain. It is the only pain measure collected at point-
of-care for every Veteran as part of the vital signs assessment in Primary Care and 
entered into the EHR. The NRS has several shortcomings: a) Veterans may seek 
services when their pain levels are high, thereby masking longitudinal improvements 
in pain intensity; b) point-of-care contacts vary substantially among Veterans in 
Primary Care, rendering systematic analysis of changes in pain symptoms difficult to 
ascertain in a clinical trial; and c) point-of-care NRS significantly underestimates pain 
intensity compared to same-day paper-and-pencil NRS assessments.116 Balancing 
the ubiquitous use of NRS with its limitations, we will examine EHR-abstracted NRS 
ratings for participants as a secondary outcome. 
• PEG117. The PEG is a 3-item scale assessing pain intensity (P), interference with 
enjoyment of life (E), and interference with general activity (G) during the past week. 
It has good reliability, constructive validity, and sensitivity to change and has been 
required by the NIH-DoD-VA Pain Management Collaboratory Coordinating Center 
as a common measure across funded protocols. 
• High Impact Pain Questions. Three questions to determine the long-term impact of 
pain are being asked:  “In the past 3 months, how often did you have pain?”; “Over 
the past 3 months, how often did pain limit your life or work activities”; “Are you not 
working or unable to work due to pain or a pain condition? 
 Answer choices consist of “never”, “some days”, “most days” or “every day” for the 
first two questions and yes/no for the third question.  
 
 
Pain Treatment Services Received: 
• Opioid Medications Dispensed. We will extract dispensed opioid medications and 
dosages from the patient’s electronic medical record and convert them to morphine 
equivalent daily dose using the procedures from a published algorithm118 as adopted 
and operationalized by the PMC3 Phenotypes and Outcomes workgroup. 
Medications will be classified as opioids used to pain as follows: 
(1) All non-IV fills of: 
   a) Codeine 
   b) Fentanyl 
   c) Hydrocodone 
   d) Hydromorphone 
   e) Morphine 
   f) Oxycodone 
   g) Oxymorphone 
   h) Tramadol 

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(2) All non-IV, pill/tablet pills of: 
   a) Methadone 
(3) All transdermal or buccal fills of 
   a) Buprenorphine 
MEDD is calculated by assuming prescriptions were taken as directed. Total 
morphine equivalents are calculated by multiplying the quantity of each prescription 
by the strength of the prescription (milligram of opioid per unit dispensed). Standard 
conversion factors on the CDC website will be used to estimate the number of 
milligrams of morphine equivalents dispensed. Average daily morphine equivalent 
dose will be calculated by dividing total milligrams of morphine equivalents by days 
supplied. For prescriptions that apn a particular month, only dates during that month 
will be included.  
The PMC3 Collaboratory recommends the following be collected, and we will collect 
and analyze them per their recommendations: 
   a. Number of opioids supplied 
   b. Days supplied 
   c. a/b x conversion factor = milligrams morphine equivalent daily dose (MEDD) 
   d. Mg MEDD at enrollment 
   e. Mg MEDD monthly during enrollment and at study completion. 
• Non-opioid Medications Dispensed. We will extract dispensed non-opioid pain-
related medications from the medical record. These medications will include topical 
analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants, and 
antidepressants (specifically, selective serotonin and norepinephrine reuptake 
inhibitors and tricyclic antidepressants). The presence or absence of medications in 
each class will be the dependent measure. 
• Non-pharmacological Pain Management Service Utilization-VA Records. Dr. Goulet 
and the PRIME Center have an algorithm for identifying visits from the EHR 
involving non-pharmacological management using workload information entered at 
clinic visits (e.g. diagnosis treated, procedure performed) and the type of clinic 
providing the treatment.  
• Natural Language Processing-identified Non-Pharmacological Pain Management 
Service Utilization-VA and non-VA service use. This identifies dates at which the 
Veteran has reported “current use” of specific pain management modalities.  
• Self-Reported Use of Pain Treatment Services. The PMC3’s phenotype and 
outcomes workgroup developed the “Use of nonpharmacological and self-care 
approaches” questionnaire to collect information about patients’ use of 13 different 
pain treatments, including Acupuncture, Rehabilitation Therapies, Manipulation, 
Massage, Yoga, Tai Chi/Qigong, Exercise, Biofeedback, Hypnosis/Hypnotherapy, 
Guided Imagery, Meditation, Psychotherapy/Counseling. In addition to asking about 
whether each treatment category was used, the instrument also includes questions 
about the most important reason for use, whether the treatment was received from a 
practitioner, the type of setting of use, how the service was paid for, how often it was 
used, and how effective it was in relieving pain. The instrument was modified for this 
study to collect information over the past 3 months (instead of past year), and to 
include several additional categories: Reiki, Pain School, Pain Clinic, primary care 
services, emergency/urgent care services, opiate and non-opiate medications.  

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Substance Use Measures: 
• ASSIST. Substance use will be measured over the last 3 months using Version 3.1 
of the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). After 
a screening question focusing on substances ever used, the ASSIST consists of 
seven questions about use of and consequences of use of each of ten classes of 
substances over the preceding three months (including nicotine). Scores are 
generated for each substance that are mapped to a three-point ordinal scale of 
severity.119 As outlined in the World Health Organization’s Manual describing the use 
of the ASSIST to guide treatment recommendations, the ASSIST ratings are scaled 
to represent no need for treatment, need for a brief intervention, and need for an 
intensive intervention.  An advantage of the ASSIST is that these categories 
represent what clinicians consider a clinically important difference, in that they guide 
treatment recommendations. The items in the ASSIST have been shown to have 
good to excellent reliability for the substances assayed. The reliability of the 
individual ASSIST items,120 and the ASSIST’s concurrent validity compared to other 
more detailed assessments of substance use severity121 have justified its adoption 
by the World Health Organization.122 We will obtain additional specifiers for 
substances requiring further characterization: a specifier about use of vaping for 
tobacco products, a specification as to whether the Veteran is using legal or 
prescribed cannabis and specification about use of prescribed amphetamine. 
• Prescription Opioid Misuse. Two questions,123 adapted from the CIDI124 for use in a 
NIDA Clinical Trials Network study,125 will be used to describe misuse of prescribed 
opioid medications: “How often have you taken your pain medications in larger 
amounts than prescribed or for a longer period than prescribed?” and “How often 
have you used your pain medicines to get high, to relax, or to make you feel more 
alert?” The questions are asked about the preceding 4 weeks, with follow-up 
questions to clarify that the question refers to opioids only. 
• Nail Collection and Measurement. Nail clippings will be assayed for metabolites of 
alcohol (ethyl glucuronide i.e. ETG), cannabinoids (carboxy-THC, native-THC), 
opioids (6-MAM, codeine, hydrocodone, hydromorphone, morphine, oxymorphone, 
oxycodone), Amphetamines (amphetamine, MDA, MDEA, MDMA, 
methamphetamine), Cocaine (benzoylecgonine, cocaethylene, cocaine, norcocaine) 
and Phencyclidine (PCP).  The tests are highly specific.  Samples are analyzed 
using an immunoassay technique (ELISA) and non-negative specimens are 
subjected to a gold standard confirmation technique (GCMS or other method, 
depending on drug class). Nail, like hair, traps biomarkers in keratin but has higher 
concentrations of neutral and acidic biomarkers because it has thicker keratin. In a 
study of hair and nails collected from the same people, the rate of Carboxy-THC (an 
acidic biomarker for cannabis) positives for cannabinoid at the SAMHSA-
recommended cutoff was 46.7% for hair and 53.3% for fingernails and mean 
concentrations of the metabolite were five-fold higher in nails than in hair.126 In a 
study in the journal Addiction of 606 college students,127 nail ETG at the 8 pg/mg 
threshold proposed for this study detected high-risk drinking with a sensitivity of 1.0 
and a specificity of .63. Receiver operating characteristic curves were signiﬁcantly 
higher for ETG concentration in ﬁngernails than in hair for detecting risky drinking. 

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The biomarkers are incorporated throughout the nail plate from base to tip, by 
deposition of biomarkers from the capillary rich nail bed, thus allowing measurement 
by any nail clipping of sufficient weight. Biomarkers are thought to reflect 3-6 months 
of substance use history in fingernails, and toenails, which grow more slowly, reflect 
up to 9 months.  The detection window (3-6 months) is close to the timeframe of the 
ASSIST (90 days), making cross-validation by the two measures reasonable.   
Approximately 100 mg of nail is required for analysis, which can be obtained 
from 2mm (a quarter’s width) of nail from each of ten digits. Samples will be mailed 
from home and thus un-observed, and participants will be provided with kits for the 
nail clipping, and a financial incentive of $30 for providing each of the samples. We 
will also suggest Veterans set reminders to allow for growth before clippings are 
needed. 
To reduce the risk that Veterans pass off someone else’s fingernails as their 
own, they will be asked if the nails are theirs, and paid regardless of whether they 
are. Specimen substitution when there are contingencies for positive urines occurs, 
but there is no incentive for such false reporting when payment is provided 
regardless of the sample results. The samples will be mailed in coded envelopes 
addressed to our group, further reducing the likelihood of submitting someone else’s 
fingernails. 
 
• Samples will be processed at the United States Drug Testing Laboratories (Illinois). 
After processing, samples will be destroyed following a standard storage period. 
Sample analysis uses fully validated methods that have been inspected and 
approved by the College of American Pathologists Forensic Drug Testing Program 
and the New York State Department of Health. Substance Use Treatment Service 
Utilization-VA Records. Visits from the EHR involving substance use treatment will 
be identified conservatively, using an algorithm involving workload information 
entered at clinic visits (e.g. diagnosis treated, procedure performed) and the type of 
clinic providing the treatment.  The measure does not capture much substance 
abuse counseling in primary care settings, and in conjunction with other mental 
health treatment (i.e., PTSD treatment).  For this reason, self-reported substance 
use service utilization will be collected (see below).  
• Self-Reported Use of Substance Use Treatment Services: Using the same format as 
the pain treatment service use questions described above, we will inquire about 
whether each of a number of classes of treatments was received in the preceding 12 
weeks (substance use counseling, day program, residential, ER/hospital, self-help, 
counseling at a medical visit, counseling at a visit for a psychiatric condition, opioid 
substitution, smoking cessation counseling, nicotine replacement therapy 
prescribed).    
• Alcohol Use Disorders Identification Test (AUDIT-C)128.  This is an alcohol screen 
used to identify patients who are hazardous drinkers or have active alcohol use 
disorders (including alcohol abuse or dependence). It consists of three questions: 
“how often did you have a drink containing alcohol in the past year?”, “how many 
drinks did you have on a typical day when you were drinking in the past year”, and 
“how often did you have six or more drinks on one occasion in the past year”. It is 
scored on a scale of 0 (no use) through 12. In men, a score of 4 or more is 
considered positive and in women, a score of 3 or more is considered positive.  

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Other Measures: 
• Patient Health Questionnaire (PHQ-9). The PHQ-9 is a well validated screening 
measure for depression129 and will be used to identify probable depression as a 
covariate in analyses. It will also identify suicidal ideation, which if severe, will trigger 
the need for further assessment (detailed in Human Subjects). 
• EQ-5D-5L. The EQ-5D-5L is a standardized measure of health status designed to 
provide a single index value of health for clinical and economic appraisals. It 
consists of five questions in the domains of mobility, self-care, usual activities, 
pain/discomfort, and anxiety/depression. .130 
• Motivation for engaging in pain treatment131,132. Motivation for Change Scale to 
include 3 items (analogue scale coded from 1 to 100) tapping patient likelihood to 
engage in pain services, recognition of pain treatments as important, and pain 
treatment motivation. 
• COVID-19 questionnaire. These questions will assess participant infection status, 
adherence to COVID-19 safety regulations, and the effect that COVID-19 regulations 
have had on Veterans’ social determinants of health, access to pain treatment, and 
access to substance use treatment. 
 
Qualitative Measures Collected in UG3 Phase and then again at the end of the UH3 
Phase: 
• Relational Coordination Survey. This survey, will be administered post-trial to “hub” 
SBIRT-PM clinicians and “spoke” clinical and administrative staff in Compensation 
and Pension and Primary Care to examine how pain care was coordinated to meet 
the treatment needs of compensation-seeking Veterans. It includes seven 
dimensions: frequency of communication, timeliness of communication, accuracy of 
communication, problem-solving, shared goals, shared knowledge, mutual respect). 
Respondents indicate the frequency in which each dimension exists in their setting 
on a 5-point scale. The mean of the individual scores serves as the overall RC score 
for each dimension within each spoke site. 
• Post-Trial Semi-Structured Qualitative Interview. At the end of the trial, we will 
conduct in-depth interviews with “hub” SBIRT clinicians and “spoke” clinical and 
administrative staff in Compensation and Pension and Primary Care to assess the 
organization and coordination of pain management services, given their experiences 
with SBIRT-PM implementation.  
 
Randomization 
The urn randomization covariates are: site (8 sites of VISN1), sex (M/F), race (White, 
Black, Other), ethnicity (Hispanic/Non-Hispanic), and self-reported illicit drug use 
(Yes/No). Following enrollment and Baseline assessments, the Project Director will 
enter covariates into urn randomization program to determine intervention condition 
assignment. Randomization will occur within two weeks of the enrollment date.   
 

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6.2.3 
Blinding 
Research assistants who collect study data will be blind to participants’ treatment 
assignment. Veterans will be instructed during the assessments not to tell the research 
assistant if they are receiving study counseling. To determine if the blind was 
maintained, the research assistant will be asked to what condition each Veteran was 
assigned. The PIs and Project Director will not be blind to randomization, as they will be 
assigning study therapists to participants randomized to the treatment condition, 
reviewing counseling sessions for quality/fidelity, and conducting monthly supervision 
with study counselors. The statistician has no contact with the study veterans; she will 
not be blinded.  
  
6.2.4 Follow-up Visits 
 
Research assistants will schedule telephone follow-up interviews approximately 12 
weeks (+ 4 weeks) and 36 weeks (+ 4 weeks) after baseline visits. A 4-week window for 
follow-up appointments allows for flexibility in scheduling and provides sufficient time to 
complete assessments if an appointment is missed.  
 
Week 12 Follow-up 
See schedule of evaluations table and descriptions above. 
• Distance to nearest VA Facility. We will calculate the driving distance from the 
Veterans’ address to the nearest VA medical facility providing integrated pain 
services care services. Calculations will be done using google maps. 
 
Week 36 Follow-up 
See schedule of evaluations table and descriptions above. 
 
End-of-Study 
• Qualitative interview of stakeholders 
• Relational Coordinator survey of key stakeholders 
• Treatment fidelity: Independent Tape Rater Scale 
6.2.5 
Completion/Final Evaluation 
Participants’ final visit is the Week 36 follow-up. Participants will be contacted for week 
12 and 36 follow-up visits regardless of whether they engaged in study counseling. If 
the 12-week follow-up visit is missed and not completed within 4 weeks of the 
appointment date, that follow-up will be missed and participant will be contacted for final 
week 36 follow-up visit.  
 
Participation in study assessments and study counseling is voluntary. 
Participants can participate in study assessments and choose not to engage in 
counseling. Reasons for terminating a participant prior to week 36 are: 
• 
Participant is found to not be eligible for the study after enrollment 
• 
Participant withdraws consent for further contact 

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7. SAFETY ASSESSMENTS  
The risk to Veterans who participate in this study is minimal. Nevertheless, research 
staff will be trained in the detection and investigation of adverse events during the 
conduct of study assessments or other interactions with participants.   
Expected adverse experiences include: 
• Counseling session or study procedures upsets participant 
Criteria for management: Careful training of study staff and SBIRT-PM 
counselors will precede study initiation. If a participant complains about study 
procedures or counseling sessions, the complaint will be logged and will be 
brought to the attention of the mPIs. Depending on the nature of the complaint, 
mPIs will decide whether the complaint requires follow-up directly with the 
participant. 
• Suicidal ideation detected by the PHQ-9 or by counseling 
Criteria for management: item 9 in the PHQ-9 identifies potential suicidal ideation 
(the questions asks about “thoughts of being better off dead or of hurting yourself 
in some way”). It is collected at baseline and at 12- and 36-week follow-ups. Any 
positive response (response other than “none at all”) to this question will be 
further evaluated, as well as other expressions of suicidality to the research 
assistant or SBIRT-PM clinician. Positive responses will be evaluated by one of 
the mPIs, Site-PIs, or covering providers. The response to clinical emergencies 
will be delineated in the Service Use Agreements between the hub site and 
spoke for provision of SBIRT-PM. If the research team decides that the 
information must be reported, the person who spoke to the Veteran (clinician or 
research assistant) will contact the Site-PI from the relevant medical center, and 
if he or she is not available, the clinician designated by the spoke site for 
handling mental health crises at the sites. All VISN1 medical centers have 
emergency room facilities and a suicide prevention coordination team. If the 
participant’s situation precludes management by spoke personnel (e.g. the 
Veteran is not accessible to VA staff or the site PI), the Research Assistant will 
immediately consult with one of the mPIs about ways to handle the situation, 
including calling for a police safety check on the Veteran.  
7.1 
Specification of Safety Parameters 
NA. 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
Unanticipated problems will be recorded as they are discovered throughout the study. 
The Project Director will record all reportable events with start dates occurring any time 
after informed consent is obtained until the last day of study participation (approximately 
36 weeks after baseline).  At each study visit (Baseline, week 12, week 36), the study 
team will inquire about the occurrence of AE/SAEs since the last visit. 
Our group completed a randomized controlled trial of 101 participants to a face-to-
face version of SBIRT-PM or two control conditions in a very similar population to that 

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proposed in this application (Rosen et al., 2018).  There were no study-related adverse 
events in that study, and they are unlikely in this study as well.   
7.3 
Adverse Events and Serious Adverse Events  
An adverse event (AE) is any untoward medical occurrence in a subject during 
participation in the research study. Veterans with MSD have a high frequency of 
medical and psychiatric difficulties. Therefore, changes in medication regimen, the 
presence of medication side effects and symptom exacerbations are not untoward and 
do not constitute adverse events. 
Anticipated adverse events include complaints about the study procedures and 
the counseling intervention, and any occurrence in which the patient attributes 
discomfort, harm or disability to the study procedures. 
Serious adverse events (SAEs) are adverse events that result in: death, a life-
threatening experience, hospitalization, or the need for medical, surgical, behavioral, 
social or other interventions to prevent such outcomes. Any report that a patient 
required overnight treatment in any facility (emergency room, detoxification, and 
hospitalization) will constitute a SAE. Hospitalization or death of another individual due 
to direct action of patient will also be considered a SAE.   
7.4 
Reporting Procedures 
When an AE or SAE is reported by a participant, we will ask for clarifying information 
describing the event. Any SAEs will be immediately reported to Dr. Rosen and, if he is 
unavailable, to Dr. Martino. Reports to Dr. Rosen will include a description of the event 
and a summary of recent contacts with the patient. This summary will include any 
warning signs of the adverse event, the patient’s general state and any information 
suggesting a causal link between study participation and the event.  
 
SAEs that are unanticipated, serious, and possibly related to the study 
intervention will be reported to the Independent Safety Monitor(s), IRB, and NCCIH in 
accordance with requirements.   
• Unexpected fatal or life-threatening AEs related to the intervention will be 
reported to the NCCIH Program Officer, and Independent Safety Monitor(s) 
within 3 days of the investigator becoming aware of the event.   
• Other unexpected SAEs that are related or probably study related will be 
reported to the IRB, NCCIH Program Officer, and Independent Safety Monitor(s) 
within 5 days. 
• SAEs and AEs that do not meet criteria for reporting within five working days in 
accordance with VHA Handbook 1058.01 will be reported to the Central IRB and 
the Independent Safety Monitor(s),at the time of continuing review (overall total 
and summary of types of events that occurred) in accordance with their 
requirements. Such events will be reported to NCCIH on an annual basis.    
• All other AEs documented during the course of the trial will be reported to NCCIH 
on an annual basis by way of inclusion in the annual report and in the annual AE 
summary which will be provided to NCCIH and to the Independent Monitors.  The 
Independent Safety Monitor(s) Report will state that all AEs have been reviewed. 

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7.5 
Follow-up for Adverse Events 
The response to clinical emergencies will be delineated in the Service Use Agreements 
between the hub site and spoke for provision of SBIRT-PM. All VISN1 medical centers 
have emergency room facilities and a suicide prevention coordination team. If the 
participant’s situation precludes management by spoke personnel (e.g. the Veteran is 
not accessible to VA staff or the site PI), the Research Assistant will immediately 
consult with one of the mPIs about ways to handle the situation, including calling for a 
police safety check on the Veteran.  
 
7.6 
Safety Monitoring  
A Data and Safety Monitoring Committee (DSMC) will be appointed by NCCIH to review 
study progress, assess the adequacy of ongoing enrollment & site performance, ensure 
adequacy of data acquisition & protocol adherence and evaluate overall safety 
throughout trial implementation.  The DSMC will meet at least annually after trial 
initiation. A DSMC Charter Document outlining the operating guidelines for the 
committee, the frequency of planned meetings and the specific data presentation format 
will be agreed upon during the initial meeting of the DSMC. Study reports will be created 
by the study data center, following a standardized format, as directed by the DSMC. 
The DSMC will report directly to NCCIH.   
  
 
Study progress and safety will be reviewed annually during the RCT. Progress 
reports, including patient recruitment, retention/attrition, and AEs will be provided to the 
DSMB annually. This Annual Report will include a list and summary of AEs. In addition, 
the Annual Report will address (1) whether AE rates are consistent with pre-study 
assumptions; (2) reason for dropouts from the study; (3) whether all participants met 
entry criteria; (4) whether continuation of the study is justified on the basis that 
additional data are needed to accomplish the stated objectives of the study; and (5) 
conditions whereby the study might be terminated prematurely. The Annual Report will 
be sent to the Independent Monitor(s) and will be forwarded to the VA Central IRB and 
the NCCIH Program Officer within 1 month of each monitoring review.   
8. INTERVENTION DISCONTINUATION  
This study will be stopped prior to its completion if: (1) the intervention is associated 
with adverse effects that call into question the safety of the intervention; (2) difficulty in 
study recruitment or retention will significantly impact the ability to evaluate the study 
endpoints; (3) any new information becomes available during the trial that necessitates 
stopping the trial; or (4) other situations occur that might warrant stopping the trial. 

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9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
The pragmatic two-arm, parallel groups 36-week randomized controlled single blind trial 
design was selected based on findings from a completed pilot study (Rosen et al., 
2018).  The study design parameters---components of the intervention and its duration, 
duration of follow-up, and effect size estimates---were largely derived from that study.  
Treatment-as-usual was selected as a control condition because the question to be 
answered by this pragmatic trial is whether the intervention is more effective than the 
status quo. 
 
Our main objective is to test the effectiveness of SBIRT-PM, compared to Usual 
Care (UC), when delivered within a VISN1-wide hub-and-spoke network. 
 
Hypothesis 1: SBIRT-PM will be more effective than UC in reducing pain severity 
as measured by the Brief Pain Inventory (primary outcome #1).  
 
Hypothesis 2: SBIRT-PM will be more effective than UC in reducing the number 
of substances categorized as requiring any intervention (primary outcome #2) as 
identified by either self-report (ASSIST) or toxicological analysis of nail clippings.   
9.2 
Sample Size and Randomization 
 
Given there are two primary outcomes (change in pain severity from the BPI, 
change in the number of substances whose use requires intervention based on the 
ASSIST), Bonferroni correction was used to generate a p-value of .025 for the sample 
size calculations for each outcome. 
 
The planned (randomized) sample size is 1100 with sample selection at each site 
proportional to the size of the site. This sample size was based on power=.90 using 
alpha=.025, and an expected ES of d=.25 for pain severity. Breakdown as follows: 400 
per group divided by ‘1 – loss to follow-up’ (73%) = 548 x 2 groups= 1096. Clustering 
was removed from the calculation per the advice of the PMC3 Biostatistics workgroup 
leadership during our protocol review. Instead, site will be controlled in analyses and a 
site by treatment interaction effect tested. In addition, power was increased to 90% 
based on their advice.  
 
The planned sample size allows for 27% attrition. Values are based on previous 
related work and our 12-week pilot study. In Poisson modeling of our pilot data, SBIRT 
was associated with a baseline-adjusted relative rate of pain-related appointments 
attended (a proposed mediator of SBIRT-PM) of RR (Exp(B))=1.6. 
 
For substance use, the proportion converting to low risk on at least one 
substance in the treatment group was estimated as 27% and in UC as 10%. Attrition 
was set at 27%. For 90% power (alpha=.025), the calculations resulted in sample size 
of 128 per group divided by ‘1 – loss to follow-up’ (73%) = 176 x 2 groups= 352 as the 
total sample size.  Given the sample size required for the pain outcome, a small effect 
size (absolute value of 6% between groups) would be detectable for the substance use 
outcome with 90% power.  In the UG3 pilot study, 67% of the participants at baseline 
self-reported on the ASSIST a level of risky substance use (either alcohol, tobacco or 
other drugs) that would require intervention and 33% reported risky alcohol use.  
Projected to the full trial, this suggests 737 participants are likely to have a clinically 
significant problem with at least one substance and 357 will have a problem with 

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alcohol.  Thus, we will have an adequate sample in the UH3 RCT to detect changes in 
our primary substance use outcome. 
 
 
Treatment Assignment Procedures 
The unit of randomization is participant. Participants will be randomized to SBIRT or 
Usual Care using a computerized urn randomization program within each site to 
increase the likelihood of balanced allocation of participants to the two interventions on 
several covariates: sex (male/female), race (White, Black), ethnicity (Hispanic/Non-
Hispanic), and self-reported illicit drug use within 90 days (Yes/No). All randomization 
will be done by the Project Director. 
Urn randomization preserves randomization as the primary basis for assignment 
to treatment and is less susceptible to experimenter bias or manipulation of the 
allocation process by staff than is balancing. The urn randomization algorithm allows 
probability of assignment to fluctuate as a function of the degree of covariate imbalance.  
As a study's sample size increases, urn and simple randomization converge because 
the treatment assignment probabilities under urn randomization converge asymptotically 
to the simple randomization probabilities. 
 
Blinding  
Research assistants who collect study data will be blind to participants’ treatment 
assignment. Veterans will be instructed during the assessments not to tell the research 
assistant if they are receiving study counseling. To determine if the blind was 
maintained, the research assistant will be asked to what condition each Veteran was 
assigned.  
The PIs and Project Director will not be blind to randomization, as they will be 
assigning study therapists to participants randomized to the treatment condition, 
reviewing counseling sessions for quality/fidelity, and conducting monthly supervision 
with study counselors. The statistician has no contact with the study veterans; she will 
not be blinded.  
 
 
9.3  
Definition of Populations 
 
 
 
The study will occur within the eight VISN-1 VA medical centers (VAMC) located 
across six New England States. The medical centers are: Bedford VAMC; Boston 
Healthcare System; Central Western Massachusetts; Connecticut Healthcare System; 
Maine Healthcare System, Manchester VAMC, Providence VAMC, and White River 
Junction.  
 
Inclusion and exclusion criteria: 
 
Inclusion criteria: 1) post-9/11 Veteran applying for MSD-related compensation 
(specified as back, neck, shoulder, or knee pain), as ascertained from filed claim, 2) 
reports a score of ≥4 (threshold for moderately severe pain) on the BPI’s Pain Severity 
subscale (average of four pain intensity items); 3) availability of a landline or cellular 
telephone for SBIRT-PM.  

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Exclusion criteria: 1) reports inability to participate during the study enrollment 
call; 2) received three or more non-pharmacological pain treatment modalities within the 
last 12 weeks from VA, and 3) participation in another PMC3 study as evidenced by a 
research protocol alert for that study at the time the study invitation letter is mailed.   
 
 
Participants who complete the baseline assessment and are randomized to their 
treatment assignment will be the Intent to treat (ITT) population for analysis. The per-
protocol analyses will specify patients who participated the treatment and be conducted 
by including a variable indicating participation (Yes/No) in the ITT analyses. We will give 
precedence to the results of the ITT analysis over the PP analysis. 
 
9.4 
Interim Analyses and Stopping Rules 
 
No interim analysis is planned.  An in-person version of the proposed intervention was 
tested in a completed study by this team (Rosen et al., 2018).  There were no study-
related adverse events.   
 
There are no stopping rules. 
 
9.5 
Outcomes  
 
9.5.1 
Primary Outcome   
 
The two primary outcomes are pain severity as measured by the BPI and the number of 
substances above the “no intervention” threshold in the ASSIST. We initially planned 
that when a positive toxicology result disagrees with a self-report of no use, the middle 
value on the ordinal scale (the indication to receive brief intervention) would be derived 
and used as the primary substance use outcome. However, only 64% of participants 
returned nail samples at baseline, and this percentage dropped to 58% and 49% at 
week 12 and 36, respectively, among participants with completed ASSIST 
assessments. Further, depending upon the substance and timepoint, between 43% and 
48% of participants self-reporting a level of substance use that does not require an 
intervention, the group whose substance use classification would change with positive 
nail toxicology, did not have toxicology results. Given the amount of missing toxicology 
data and that nails do not measure intervention need directly like the ASSIST, we plan 
to base our primary substance use outcome on the ASSIST measure only. This change 
does not compromise our estimated power since the number of participants self-
reporting a level of risky substance use that requires an intervention on the ASSIST 
(N=571) exceeds our assumed total sample size for this outcome (N=352) used in 
power analyses.  The BPI and ASSIST are collected at baseline, week 12 and week 36. 
 
9.5.2 
Secondary Outcomes   
 
Secondary outcomes related to pain include non-pharmacological pain management 
service utilization, pain interference with life activities (BPI), overall pain (PEG), and 
overall health.   The non-pharmacological pain management service utilization will be 

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summed across 13 possible modalities (injection; physical therapy; chiropractic care; 
acupuncture; TENS; Spinal cord stimulator; cognitive behavioral therapy; 
mindfulness/acceptance and community therapy; treatment involving teaching about 
coping with pain; yoga, Tai chi or Reiki; massage treatment; other treatment not already 
mentioned) as well as examined by individual modalities where sufficient sample size is 
present.  
 
Secondary outcomes related to substance use will include severity measures for 
individual substances generated by the ASSIST, as well as toxicology results for 
individual substances.  
 
9.6 
Data Analyses  
 
 
All variables (Intervention, covariates and outcomes) will be described with the use of 
the approximate summary statistics (mean, median, interquartile range, and percent). 
Multivariate models will be used following the examination of bivariate tests of outcomes 
by intervention group. A successful outcome will be either a reduction in pain severity or 
number of substance use above the “no intervention” threshold in the ASSIST or 
toxicological analysis of nail clippings. The model type will be selected based on 
meeting of modeling assumptions including the outcome distribution; Potential models 
will include linear and non-linear mixed-effects (Poisson (with over-dispersion), negative 
binomial, binary outcome) regression modeling. If there is a large skew with many zeros 
(which is quite possible where the outcome is change in the number of substances no 
longer needing intervention), we will use a negative binomial. If the distribution is a 
combination of 0’s (no change) and 1’s (change to level of “no need for intervention” in 
one substance) with very few outcomes greater than 1, a binomial distribution will likely 
be used.  A Poisson model will be used if there are very few successes and they have a 
Poisson distribution.  
These common rules will be used for guidance: 
• 
Poisson distribution, if mean = variance 
• 
Binomial distribution, if mean > variance 
• 
Negative binomial distribution, if mean < variance 
The covariance structures will be explored to determine which (unstructured, compound 
symmetry, autoregressive) is the most appropriate in mixed models. Selection will be 
based on the lowest AIC. An intervention by time interaction will be tested in the models 
– this will show the effect of the intervention on the outcome compared to controls. 
 
Change in Pain: We anticipate using linear mixed-effects modeling to test the 
effect of SBIRT-PM on the 12-week value of the BPI, if it is a normally distributed 
outcome. We will in addition test simultaneously the unique effects of treatment on pain 
outcomes at week 12 and week 36, controlling for baseline differences, and test the 
equality of these parameters using the Wald test.  
Change in Substance Use: We anticipate using non-linear mixed-effects 
(Poisson, negative binomial, binary outcome as discussed above) regression modeling 
to test the effect of SBIRT-PM on the number of substances requiring intervention 
(according to the ASSIST), a count outcome.  One subset of analyses will use risk sets 

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(at least 1 substance at baseline, at least 2 substances at baseline, etc.) to analyze 
substance risk changes in substance users. We will also test the equality of treatment 
effects at weeks 12 and 36 as described above. 
 
We have identified stratification variables to account for error variance as a 
recommended good practice. Key covariates to be included in the model are 
depression, TBI, and mental health diagnoses (grouped into multiple more homogenous 
groupings, such as mood and psychotic disorders) as these are highly related to pain 
perception and substance abuse as well as the urn covariates– namely sex, race, 
ethnicity, self-reported illicit drug use and site. The strata used for the urn randomization 
are only to better ensure balance on key characteristics. Their main effects will not be 
interpreted in the analysis, though they will be examined as potential modifiers of the 
intervention effect. We will also consider as potential covariates: distance to nearest VA 
medical center, number of pain treatment modalities used at baseline, reasons patient 
might drop out of the study, and the probability of withdrawal. Opioid-use will be 
examined as a mediator as well as a tertiary outcome.  Actual participation in SBIRT-
PM (Y/N) will be examined as a mediator of response.   
Per NIH policy, because there is considerable data suggesting the importance of 
race, ethnicity and sex on the study outcomes (pain, substance use and service use), 
we will conduct an analysis that examines sex and race/ethnicity as moderators of 
treatment response. These analyses will be conducted through the inclusion of 
interaction effects in models so sex and race/ethnicity effects can be formally tested. In 
light of the differences in substance use, body habitus, and substance metabolism 
between men and women, we will include a sex interaction term for the analysis of the 
relationship between self-reported levels of substance use and levels of ETG found in 
nail clippings. While the use of subgroup analysis might be interesting to look at sex-
specific characteristics such as the influence of pregnancy or stage of menstrual cycle, 
we currently have no relevant covariates making the case for this type of sub-analysis. 
 
 
Sensitivity Analysis 
We anticipate some missingness will occur not completely at random. In general, more 
sensitive information such as use of illicit substances is less likely to be shared by 
participants when responding to an interviewer.  Based on our previous study (R34), we 
anticipate there might be a difference in the follow-up rate between Veterans in the two 
arms of the trial, with veterans in the usual care arm more frequently dropping out. We 
have created scenarios to minimize missing data through design considerations (i.e., 
increasing our payment scale as incentive, regular reminder calls), but our analytic plan 
includes the investigation of missingness. Patterns of missingness will be examined by 
each individual covariate in the data (univariate, monotone or non-monotone). Chi-
squares and t-tests will be run to see if missingness is related to other variables in the 
analysis (for example: intervention status, substance use). We intend to utilize multiple 
imputation in the case of variables missing either completely at random or at random. 
To reduce the likelihood of MNAR, the multiple imputation model will include “auxiliary 
variables” which are highly correlated with both the variable that has missing data and 
the probability that the variable is missing. Sensitivity analyses will be conducted as part 
of the multiple imputation procedure in SAS 9.4 (PROC MI).  
 

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Sources of data 
Data for the study are drawn from patient self-report, VA electronic medical records of 
VA and community care, and the C&P examination. Veterans requesting a 
Compensation & Pension evaluation for knee, shoulder, neck or back pain may or not 
be receiving services from the VA. Persons who get all their care outside of the VA will 
not have readily accessible medical records, while those persons who get some care in 
the VA but are sent out to community care for distinct services (such as non-
pharmacological pain management) will have medical records of both types of care. In 
addition, those veterans who had not used any VA services prior to their C&P request 
may then enter VA care following their C&P exam and will have EMR available only in 
the follow-up period. The lack of EMR data of non-users of the VA will affect both the 
intervention or control arms of the study, and there is no reason to believe its effect will 
be differential.   
Acknowledging the variability in availability of EMR information, all subjects will 
have self-reported and C&P data regarding service use as well as diagnoses. We will 
examine the concordance of self-reported and EMR-obtained information to estimate 
the impact of having no EMR data in the non-users of the VA. We will conduct a 
sensitivity analysis sub-setting the analyses only to those persons with available EMR 
(as well as self-reported and C&P data).  
 
 
Cost-Effectiveness Analysis 
The relative cost-effectiveness of SBIRT-PM will be assessed using both incremental 
cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves (CEACs). 
ICERs and CEACs will be calculated from the provider (i.e., VISN and medical center) 
perspective. Using the cost estimates described in the Assessment subsection, we will 
calculate ICERs for minimal clinically important differences (MCID) between baseline 
and week-36 assessments in three primary outcomes: self-reported pain, risky alcohol 
use, and morphine-equivalent doses of opioid analgesic medication use.  
• Pain. Self-reported pain severity and interference will be measured by the Brief Pain 
Inventory (BPI). A MCID in pain severity will be a 30% reduction in ratings on this 
BPI subscale from baseline to week 36. The MCID for pain functioning will be a 1-
point change in the BPI pain interference subscale. We have followed the guidelines 
Erin Krebs followed in the SPACE trial for selecting an MCID.  She states in her 
group’s 2018 JAMA report of the SPACE trial:  “Following consensus guidelines, this 
trial used a 1-point difference as the MCID for BPI interference and BPI severity, and 
used a 30% reduction from baseline as MCID for moderate improvement.” 
• Substance Use. As noted earlier, the ASSIST categories represent what clinicians 
consider a clinically important difference, in that a difference the differences in risk 
category guide treatment. Therefore, we will consider a net  decrease of one risk 
category (i.e. need for less overall treatment) across substances as the MCID.  
The ICERs will measure the incremental cost of using SBIRT-PM to produce a 
MCID in each of the outcomes. We will conclude SBIRT-PM’s cost-effectiveness for 
each outcome based on its ICER with respect to the threshold value placed by decision 
makers on the effect for that outcome. By using multiple outcomes, we can determine 

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the robustness of our cost-effectiveness findings and provide a more fine-grained cost-
effectiveness analysis to address different priorities that stakeholders may have.186, 187  
To illustrate the uncertainty associated with ICER point estimates, cost and effect 
estimates of SBIRT-PM will be bootstrapped (with 2,000 replicates) to produce 
confidence intervals around the ICERs and to produce CEACs for each outcome 
measure.188 CEACs quantify the uncertainty in the cost-effectiveness analysis by 
showing the probability that the intervention is cost-effective with respect to any given 
threshold value.188-190 Intuitively, as the threshold value of a MCID in a given outcome 
increases, the strategy that produces that effect most efficiently becomes increasingly 
more likely to be the most cost effective, even though incremental costs are incurred. 
Similarly, as the threshold value of a MCID in a given outcome decreases, the strategy 
that has the lowest cost becomes increasingly more likely to be the most cost-effective. 
Finally, sensitivity analyses will be conducted to determine the robustness of the cost-
effectiveness results to alternative assumptions about a wide variety of implementation 
parameters (e.g., cost of inputs).  
 
Budget Impact Analysis.  
 
To demonstrate the financial feasibility of adopting SBIRT-PM, a budget impact 
analysis will be conducted. The per-person cost of SBIRT-PM will comprise the cost of 
delivering the intervention plus the cost of the VA-funded services used by the 
participant in the SBIRT-PM condition over and above the cost of those used by 
individuals in UC, minus the yearly patient allocation (VERA dollars) assigned to that 
participant. The total projected yearly cost to a given medical center of SBIRT-PM will 
be the per-person cost times the total number of Veterans applying for compensation 
and pension for a musculoskeletal condition times the expected rate of uptake. 
 
Analyses of NLP Algorithms 
 
We will identify the use of non-pharmacological pain modalities through self-
report from the participants as well as two different approaches to the extraction of 
healthcare utilization data from electronic medical records.  Medical record extraction of 
1.)  Structured data - stop codes indicating use of these modalities, and 2.) Unstructured 
data - domains identified in the application of the NLP method to the medical record 
data of study participants. Two independent researchers will identify words/snippets that 
suggest use of specific non-pharma modalities and rate enough snippets to have 
software reliably generate an algorithm to rate all patients included in the study on each 
modality (machine learning). As we expect false positive reports of use of a modality to 
be unlikely, identification of use during an assessment period by any of the three 
methods (self-report, medical record stop codes and NLP) will be considered use.   The 
agreement between these different measures will be described by cross-tabs. 
 
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Research Assistants will screen and collect contact information for all study subjects on 
the “Participant Screening and Contacts Form”. Information will be collected by 

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Research Assistants over the telephone and entered directly into the electronic form. 
Forms are saved in a restricted research folder on secure VA networked computers. 
Research Assistants will collect all baseline and follow-up interview data by 
telephone interview with the participants. They will enter data directly into REDCap 
questionnaires. Research assistants are blind to participant’s randomization group. 
REDCap questionnaires and data are saved in VA REDCap and in a restricted research 
folder on secure VA networked computers. VA REDCap can only be accessed on the 
secure VA Network. 
Electronic medical record data will be accessed and stored on the VA Informatics 
and Computing Infrastructure (VINCI) platform and in a restricted research folder on 
secure VA networked computers. 
 
10.2 Data Management  
 
VA REDCap is a secure web application for building and managing online 
surveys that can be used for direct data entry by Research Staff. Project questionnaires 
will be created and used for data collection. After data are collected, REDCap provides 
automated export procedures for data to be downloaded to Excel and common 
statistical packages (SPSS, SAS, R) for data analysis. In these programs, filters flag 
data that needs to be re-checked by a person such as unclear characters, out-of-range 
variables and logical inconsistencies. The project director and project statistician will 
check files monthly so that errors can be readily corrected and consequential 
differences between treatment types (e.g., different levels of attrition) can be monitored 
closely.  
10.3 Quality Assurance  
10.3.1 
Training 
Training of Study Counselors  
Dr. Martino will provide competency-based supervision to support the counselors’ 
delivery of SBIRT-PM throughout the trial. This approach is consistent with the national 
VA Evidence-Based Practice training model,95 which emphasizes extended post-
workshop case-based supervision or consultation, including submission of audio 
recorded therapy sessions for treatment fidelity review, as an essential training 
component. Dr. Martino will meet with the counselors together on a 1-hour monthly 
basis to review their SBIRT-PM practice. For these supervision meetings, he will listen 
to and rate the clinicians’ SBIRT-PM fidelity for two sessions per counselor (one initial 
and one follow-up call) using the Independent Tape Rater Scale 96 for the purposes of 
feedback and coaching during supervision. In MI clinician training research, this 
approach and dose of supervision has been shown to sustain proficient practice.97  
The risk of angering or alienating Veterans is low because of the non-
confrontational nature of SBIRT-PM. The risk will be further minimized by hiring 
experienced counselors who have experience with the study population. Study 
counselors will be trained to adopt a collaborative approach. Study counselors will also 
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services available at each VISN1 medical center, as well as mandated reporting 
procedures for all sites.  
 
Training of Study Research Assistant  
Staff obtaining verbal consent will have completed a web-based course with post-test 
on Human Research Protections, and all will have had specific training by the mPIs in 
obtaining informed consent for this project. 
The research assistant will receive training in the study assessments from the 
Project Director and the two mPIs.  The research assistants will administer the study 
consent and assessments to other staff in role plays until they are administered 
correctly.  Research assistants will be asked to contact the PIs about participant 
responses that are not obvious to code within the offered choice options.   
The research assistant will also be knowledgeable about the emergency facilities 
(emergency rooms, VA Police, and crisis services) at each VISN1 medical center. The 
research assistant will also receive training in de-escalating agitated Veterans. 
COVID-19 response: the research assistants collecting self-report data about 
pain and substance use service utilization will prompt veterans to consider in-person 
and all telehealth/virtual and telephone-delivered services when responding to our 
service utilization assessment. 
 
10.3.2 
Quality Control Committee  
NA 
10.3.3 
Metrics 
Study progress and safety will be reviewed monthly by the mPIs and Project Director. 
An Annual Report will be sent to the Independent Monitor(s) and will be forwarded to 
the VA Central IRB and the NCCIH Program Officer within 1 month of each monitoring 
review. 
Data type 
Frequency of review 
Reviewer 
Subject accrual (including compliance 
with protocol enrollment criteria) 
Monthly 
PI, Project Director 
Annually 
DSMB 
Status of all enrolled subjects, as of 
date of reporting  
Monthly 
PI, Project Director 
Annually 
DSMB 
Data entry quality control checks on 
10% of charts 
 
These checks will consist of verifying 
that there is no missing data (except 
for patient refusals for specific items) 
and all assessments are completed. 
In REDCap, if a question is not 
answered, a box will pop up 
highlighting the unanswered 
questions before it allows the RA to 
“complete” the form. This will allow 
veterans to answer any missing items 
Monthly 
Project Director 

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10.3.4 
Protocol Deviations 
Protocol deviations will be reported to mPIs as they are discovered. mPIs will report 
protocol deviations to the VA Central IRB according to cIRB policies.  
10.3.5 
Monitoring 
The Project Director will create study checklists for each data collection point to ensure 
data is collected as outlined in the approved protocol. All self-reported survey data will 
be collected directly in VA REDCap. VA REDCap is a secure web application for 
building and managing online surveys that can be used for direct data entry by 
Research Staff. Project questionnaires can be created and used for data collection. 
After data are collected, REDCap provides automated export procedures for data to be 
downloaded to Excel and common statistical packages (SPSS, SAS, R) for data 
analysis. In these programs, filters flag data that needs to be re-checked by a person 
such as unclear characters, out-of-range variables and logical inconsistencies. The 
Project Director will check files monthly so that errors can be readily corrected and 
consequential differences between treatment types (e.g., different levels of attrition) can 
be monitored closely. Data quality will be monitored by random inspection of the 
completed forms monthly by the Project Director and any problems detected will be 
discussed with the mPIs. Recruitment and retention data will be reviewed and reported 
to study leadership monthly. 
 
We will collect data about SBIRT-PM implementation. Specifically, we will report 
the percentage of participants who received different “doses” of the intervention (i.,e., 0, 
1, 2, 3, or 4 sessions).  We also will track the percentage of each counselor’s assigned 
Veterans who receive counseling and the percentage whose first counseling session is 
during the same telephone call.  If a 
question is refused by the veteran it 
will be left blank and the RA will put a 
note in saying it was refused. 
 
Adherence data regarding study visits 
and intervention 
Monthly 
PI, Project Director 
Annually 
DSMB 
AEs and rates  
Monthly 
PI, Project Director 
Annually 
DSMB 
Annually 
NCCIH, VA Central IRB 
SAEs (unexpected and related) 
Per occurrence 
PI, DSMB, 
NIH/NCCIH 
SAEs (expected or unrelated) 
Per Occurrence 
PI, Project Director 
Annually 
DSMB, NIH/NCCIH  
Unanticipated Problems 
Per Occurrence 
PI, Project Director 
Per Policy 
VA Central IRB 

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followed by a second. In our pilot, 80% of participants received the assigned counseling, 
and 55% of those who received any counseling had at least two sessions. If a counselor 
falls below 70% of participants receiving any counseling within 12 weeks or below 50% 
of a second session among those with a first, we will take the following steps: 1) 
compare that counselor’s procedures to “best practices” by other counselors.  Such best 
practices might include time of day Veterans are called, and the negotiation around 
scheduling the calls; and 2) contact the site PI to determine if sub-optimal engagement 
is a site-specific issue.  Two examples of site-specific issues are cell phone reception 
and local VA hospital reputations.  In very rural areas, poor cell phone coverage makes 
participation more difficult, and it may be more difficult to engage Veterans when the VA 
facilities in their local communities have a damaged reputation.   
Clinicians will receive standardized training for SBIRT-PM, with their fidelity 
monitored by Dr. Martino using a competency-based supervision approach. We will 
independently rate a random sample of about 10% of the SBIRT-PM sessions (n = 220) 
for the counselors’ adherence and competence in delivering the intervention using the 
Independent Tape Rater Scale.  The ITRS has two factors - fundamental and advanced 
motivational interviewing strategies, as well as a clinical consensus-based benchmark 
of adequate proficiency, namely, half of the 10 motivational interviewing consistent 
items being rated > 4 for both adherence and competence.  We will report the mean 
factor scores for adherence and competence, as well as the percentage of sessions that 
meet adequate proficiency standards in the random sample as a reflection of our 
success in implementing SBIT-PM during the trial.  To support high-integrity 
implementation during the trial, Dr. Martino will review two sessions per counselor per 
month using the ITRS and provide feedback and coaching to the counselors in monthly 
supervision meetings.  Should a counselor fall below an adequate level of performance 
on two consecutive sessions reviewed by Dr. Martino, he will review one session per 
week from that counselor and meet with the counselor individually for more intensive 
supervision until the counselor’s proficiency reaches adequate or better standards once 
again. 
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
Subject confidentiality is strictly held in trust by the investigators, study staff, and the 
sponsor(s) and their agents.  This confidentiality is extended to cover testing of 
biological samples in addition to study information relating to subjects. 
 
The study protocol, documentation, data, and all other information generated will 
be held in strict confidence.  No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. 
The study monitor or other authorized representatives of the sponsor may 
inspect all study documents and records required to be maintained by the investigator, 
including but not limited to, medical records (office, clinic, or hospital) for the study 
subjects. The clinical study site will permit access to such records. 
11.1 Institutional Review Board (IRB) Review  
The VA Central IRB has approved the study application (containing a VA Central IRB 

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protocol, waivers, application forms, etc.). Any subsequent modifications will be 
reviewed and approved by the VA Central IRB and incorporated into this NCCIH 
protocol. 
11.2 Informed Consent Forms 
Veteran Participants 
Voluntary informed consent will be obtained from all Veterans prior to 
participation. Research assistants will conduct the informed consent process with 
participants over the telephone. The Informed consent process and the participant’s 
agreement to participate will be documented in an audio file.  
Veterans will be provided with information about the SBIRT-PM intervention, how 
long it will last, the nature of study assessments, information about the collection of 
biological specimens, the examination of their electronic health care and VA data, and 
potential risks and benefits of study participation. Veterans will be reminded that they 
can withdraw from the study at any time without penalty. They will be given the 
opportunity to ask questions and then will be asked if they agree to participate.  
Veterans who agree to participant will state so for the audio-recording. Audio-
recorded consents will be stored on VA Network computers behind the VHA firewall. 
 
VA Staff Participants 
 
Voluntary informed consent will be obtained from all VA staff interviewed for the 
study prior to participation. For the qualitative interviews, Research staff will describe 
the purpose of the interview prior to administering these assessments. Participating VA 
staff members will be encouraged to ask any questions and have the option to 
discontinue participation without prejudice. They will be approached by people other 
than their direct supervisors. After a brief reiteration of the study purpose, the 
interviewer will confirm consent to record the interview for transcription and analysis 
purposes before proceeding.  A waiver of documentation of informed consent for VA 
staff participants has been obtained.  No documentation will be obtained.  
 
For the survey, a survey invitation will be emailed to VA staff directly from 
REDCap. The invitation will explain the purpose of the survey and who will have access 
to the results. 
11.3 Participant Confidentiality  
Privacy and Confidentiality of Veteran Participant Data: 
Data Storage - All possible precautions will be taken to prevent a breach of 
confidentiality. 
1. Minimizing PHI in study databases: Research data will be identified by code 
number and will not include names, although enrollment records must also be 
kept and these records will include names. Our study forms have been designed 
to avoid collecting identifiable information; no Protected Health Information (PHI) 
will be collected on study forms. We collect only protocol session dates. These 
dates are changed to ‘number of sessions completed’ when data sets are 
anonymized and released to other investigators.  
2. Data with PHI: Personal identifiers will be retained to obtain VA service use data 
from central VA databases. The personal identifiers will be used to identify 

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service use by study participants from the VA central data repositories. Study 
data will be stored and analyzed on VA secure network computers and in the VA 
Informatics and Computing Infrastructure (VINCI). VINCI is a Department of 
Veterans Affairs (VA) Health Services Research & Development (HSR&D) 
resource center that provides a secure, central analytic platform for performing 
research and supporting clinical operations activities. It is a partnership between 
the VA Office of Information Technology (OI&T) and the Veterans Health 
Administration Office of Research and Development (VHA ORD). VINCI includes 
a cluster of servers for securely hosting suites of databases integrated from 
select national VA data sources. VINCI servers for data, applications and virtual 
sessions are physically located at the VA Austin Information Technology Center 
(AITC), located in Austin, Texas. This secure enclave with 105 high-performance 
servers and 1.5 petabytes of high-speed data storage has multiple layers of 
security and disaster recovery to prevent data loss. To ensure the protection of 
Veteran data, VINCI maintains compliance with the guidelines set forth by 
Veterans Health Administration (VHA) Handbook 1200.12, Use of Data and Data 
Repositories in VHA Research, and all other applicable VA and VHA policies and 
regulations. In addition, VINCI has undergone all security certification activities in 
support of obtaining an Authorization to Operate (ATO). Access to VINCI 
resources are approved in accordance with the requirements of National Data 
Systems (NDS), VHA Handbook 1200.12, Use of Data and Data Repositories in 
VHA Research, and all other applicable VA and VHA policies and regulations. All 
data transferred from VINCI is subject to audit for compliance. VA-credentialed 
research staffs are granted access to study-specific data along with tools for 
analysis and reporting in the secure, virtual working environment through a 
certified VHA network computer within the VA.  If not working within a VA or VHA 
hosted office environment containing VA network access, researchers may apply 
for and then access VINCI through an approved Virtual Private Network (VPN) 
and Remote Desktop application. The remote computing environment enables 
data analysis to be performed directly on VINCI servers, offering several 
advantages: uniform security standards for access; a common point of entry for 
all investigators who use the data; tools for analysis and reporting; tighter and 
more consistent control of data quality; and the ability to standardize and update 
terminology and format as technology and methodology improve. After the 
needed service use information is extracted, the identifiers will be removed to 
create files with de-identified data for subsequent analyses. At the conclusion of 
the study, all files with identifiers will be destroyed. The files with identifiers will 
be stored on VA secure network computers. Data Security will be insured by 
using servers which all reside completely behind the VA firewall. There is no 
public internet access. Another layer of protection for sensitive information is 
ascribed to the system by use of granular access privileges. Only authorized staff 
will have data access. Study managers have the capability of granting access 
and read-write privileges to users. All systems undergo daily backup and 24-hour 
security. 
3. Clinical enrollment records are kept separate from research data. Participants’ 
names will appear only on the consent form, HIPAA authorization form, and “key” 

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form kept by the mPIs. All paper forms will be stored and secured in a locked file 
cabinet under the jurisdiction of the Dr. Rosen.  
4. Presentation of Study Results: The research records will be used to prepare 
reports that do not allow for the identification of individual study participants. 
5. Communication by Research Staff: All computers used by research staff are 
password protected. All research staff and counselors receive annual Good 
Clinical Practice, Human Subjects Protection, HIPAA, and VHA privacy training 
through Yale and the VA. Our data collection and management procedures are 
fully compliant with HIPAA.  
 
Confidentiality of Digital Audio Recorded Counseling Sessions - To assure the 
confidentiality and protection of participants with respect to digital audio recording of 
SBIRT-PM sessions, the following steps will be taken: 
1. Participants will provide informed consent for digital audio recording. Participants 
will be allowed to participate in the study and refuse the audio recording. 
Participants who do consent to audio recording will be informed that they have 
the right to stop the audio recording at any time during the session.  
2. Digital audio recordings will be treated as confidential research records. They will 
be labeled with a unique study ID code and uploaded to a secure network VA 
server, separate from other study data. The audio file name will use study ID 
codes. 
3. Access to audio recordings will be limited to members of the investigative team 
including trained research raters who will rate the recordings according to the 
clinician adherence and competence rating system and only the research staff 
will have access to the recordings. A separate file will link the audio recording file 
code to the participant’s unique identification code, the clinician’s name, and the 
date of the session.  
 
Privacy and Confidentiality of VA Staff Participant Data: 
VA staff will have the right to stop the audio recording at any time during the interviews. 
These recordings will be treated as confidential research records, labeled with unique 
study ID codes, and uploaded to a secure network VA server. Recorded interviews will 
be transcribed by VA staff in the Centralized Transcription Service Program (CTSP) in 
Salt Lake City, UT. THE CTSP ensures VA privacy and security requirements are met 
by operating within the VA firewall. Both audio recordings and transcriptions will be kept 
behind the VHA firewall. Access to survey data and recordings will be limited to 
members of the investigative team in involved in managing, analyzing, and interpreting 
them. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the FDA, 
or other government agencies as part of their duties to ensure that research participants 
are protected.  

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12. COMMITTEES 
NCCIH Protocol Review Committee (PRC) is an external committee appointed by 
NCCIH to review clinical study documents and provide specific recommendations to 
NIH. 
 
Pain Management Collaboratory Coordinating Center (PMC3) Steering Committee 
provides administrative support, project management, quality management and 
communications between study projects. The committee will address issues that span 
all projects and provide input into the policies and processes of the NIH-DoD-VA PMC. 
This includes guiding the demonstration projects and work groups to develop best 
practices and tools to foster harmonization. Steering Committee Members include Bob 
Kerns (Chair), Cindy Brant, Peter Peduzzi (Co-PIs), PIs from each demonstration 
project, work group representatives, NIH, DoD, VA Program Coordinators, Program 
Officers/Project Scientists, and subject matter experts. 
13. PUBLICATION OF RESEARCH FINDINGS  
Publication of results from this study’s data will be overseen by Drs. Rosen and 
Martino.  Publications that result from data compiled across PMC3 studies will be 
subject to the PMC3 Collaboration Publication policy.   
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15. SUPPLEMENTS/APPENDICES 
I. Informed Consent Form Template 
VA Central IRB reviewed and approved Information Sheet (v. 11/8/18) 
VA Central IRB reviewed and approved Phone Script (v. 11/8/18) 
 
II. VA Central IRB reviewed and approved Protocol (v.11/8/18)