Pragmatic RCT of SBIRT-PM
Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (TRIAL)
3 other identifiers
interventional
1,101
1 country
9
Brief Summary
Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. The Investigators propose to test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM), designed to reduce pain and reduce risky substance use, in part by helping Veterans get comprehensive pain treatment. The study will involve clinicians at a single site contacting Veterans throughout New England by phone to deliver SBIRT-PM counseling in a pragmatic, randomized, clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedStudy Start
First participant enrolled
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2024
CompletedResults Posted
Study results publicly available
May 7, 2025
CompletedJune 8, 2026
May 1, 2026
4.5 years
August 13, 2019
March 4, 2025
May 14, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Pain Intensity Subscale of Brief Pain Inventory
Pain Intensity subscale of the Brief Pain Inventory uses a 0-10 numeric rating scale (0=no pain to 10=pain as bad as you can imagine) to measure four pain severity/intensity items: "worst" pain in the last 24 hours, "least" pain in the last 24 hours, "average" pain, and pain right "now". The pain intensity subscale is scored as a composite of the four pain items (mean intensity score).
36 weeks
Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) was developed to detect and manage substance use and related problems. Substance use will be measured over the last 3 months using Version 3.1.After a screening question focusing on substances ever used, the ASSIST consists of 7 questions about use of and consequences of use of each of 11 classes of substances over the preceding three months (including nicotine, THC and medical THC). Scores are generated for each substance that are mapped to a three-point ordinal score of severity: "no need for treatment", "need for a brief intervention" and "need for an intensive intervention". The number of problem substances are defined as the number of substances above the "no intervention" threshold \*only participants who had a problem substance reported at baseline were analyzed for this outcome
36 weeks
Secondary Outcomes (6)
Cost-Effectiveness Ratios (ICERs)
36 weeks
Cost-Effectiveness Acceptability Curves (CEACs)
36 weeks
Non-pharmacological Pain Service Utilization
36 weeks
Pain Interference Subscale of Brief Pain Inventory
36 weeks
Overall Health Measured by EQ-5D-5L
36 weeks
- +1 more secondary outcomes
Study Arms (2)
SBIRT-PM
EXPERIMENTALScreening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) was developed 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. 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. 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.
Usual Care
NO INTERVENTIONA Veteran who completes a Compensation examination ordinarily has no further treatment, referral or debriefing as part of the Compensation examination. Veterans will be advised that they should continue to pursue whatever counseling they need outside the study.
Interventions
SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes.
Eligibility Criteria
You may qualify if:
- Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filed claim,
- Reports a score of ≥4 (threshold for moderately severe pain) on the BPI's Pain Severity subscale (average of four pain intensity items);
- Availability of a landline or cellular telephone for SBIRT-PM.
You may not qualify if:
- Reports inability to participate during the study enrollment call
- Received three or more non-pharmacological pain treatment modalities within the last 12 weeks from VA.
- Participating in another PMC3 study as evidenced by a research protocol alert for that study at the time the study invitation letter is mailed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- US Department of Veterans Affairscollaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
Study Sites (9)
Yale University
New Haven, Connecticut, 06520, United States
VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, 06516, United States
VA Maine Healthcare System
Augusta, Maine, 04330, United States
Edith Nourse Rogers Memorial VA Hospital (VA Bedford)
Bedford, Massachusetts, 01730, United States
VA Boston Healthcare System
Boston, Massachusetts, 02301, United States
VA Central Western Massachusetts Healthcare System
Leeds, Massachusetts, 02053, United States
Manchester VA Medical Center
Manchester, New Hampshire, 03104, United States
Providence VA Medical Center
Providence, Rhode Island, 02908, United States
White River Junction VA Hospital
White River Junction, Vermont, 05001, United States
Related Publications (1)
Rosen MI, Gilstad-Hayden K, Lazar CM, Sellinger J, Mattocks K, Barnett PG, Brummett BR, Higgins DM, Holtzheimer P, Livingston NA, Ngo T, Reznik TE, Schimelman B, Semiatin AM, Solzhenitsyn C, Martino S. Motivational Interviewing Targeting Pain and Substance Use in Veterans Seeking Service-Connection Payments: A Multisite Randomized Clinical Trial. J Gen Intern Med. 2026 Feb 25. doi: 10.1007/s11606-025-10127-2. Online ahead of print.
PMID: 41741869DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marc Rosen, MD
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Rosen, MD
Yale University/ VA Connecticut Healthcare System
- PRINCIPAL INVESTIGATOR
Steve Martino, PhD
Yale University/ VA Connecticut Healthcare System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Research Assistants collect data from participant interviews at 12 and 36 weeks follow-up. They will be blind to randomization condition.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2019
First Posted
August 20, 2019
Study Start
October 23, 2019
Primary Completion
April 11, 2024
Study Completion
April 11, 2024
Last Updated
June 8, 2026
Results First Posted
May 7, 2025
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Access Criteria
- Data are available upon reasonable request. Datasets containing individually identifiable data will only be shared with a written assurance from the recipient that (1) the information will only be used for research purposes and will not be used to identify any individual participant; (2) the information will be secured using appropriate computer technology; and (3) the data will be destroyed or returned after analyses are completed.