Pragmatic RCT of SBIRT-PM

Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (TRIAL)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Substance Use Disorders
• Intervention / Treatment: Behavioral: SBIRT-PM

Detailed Description

In 2015 alone, 97,223 new Veterans under age 35 began receiving compensation for injuries related to their military service. In total, there are 559,999 post-9/11 Veterans being compensated for back or neck conditions, and a partially overlapping 596,250 for limitation of flexion in joints. Veterans seeking compensation for musculoskeletal conditions often develop chronic pain and are at high risk for substance misuse. Early intervention is needed to arrest worsening pain and risky substance use, particularly among post-9/11 Veterans for whom engagement in non-pharmacological pain treatment has the potential to improve their overall quality of life and spare them the complications of opioid treatments. The service-connection application is an ideal point-of contact for initiating early intervention treatments for these at-risk Veterans. 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 risky substance use. In brief, the counselor explains that treating both physical and psychological aspects of pain leads to the best outcomes, outlines what VA (and non-VA if preferred) services are available to Veterans, explains that substances are sometimes used for pain relief, and segues into traditional SBIRT. SBIRT-PM's efficacy is supported by a completed clinical trial of 101 Veterans applying for service-connection for MSD, and by studies showing the efficacy of SBIRT for people with risky substance use and of Motivational Interviewing for engagement in non-pharmacological pain care.

During a two-years pilot study, the study team prepared SBIRT-PM for implementation by establishing communication (Relational Coordination is the theoretical framework) between the "hub" where the SBIRT-PM clinician is sited and the "spoke" sites, establishing study related procedures, and piloting the intervention at each of the eight VA medical centers in New England.

In this full clinical trial, investigators will randomize 1100 Veterans applying for compensation related to MSD 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. Investigators hypothesize that, compared to Usual Care, SBIRT-PM will be more effective and cost-effective in improving Veterans' pain and substance use. Investigators further hypothesize that a mediator of these improvements will be use of non-pharmacological services, as extracted from VA records from structured data fields and from narrative text in the medical record using an innovative natural language processing algorithm. Screening and referral to treatment at service-connection examinations can transform a widely-used point of entry to VA into a health promoting encounter.

• Study Type: Interventional
• Enrollment (Actual): 1101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System (VACHS)
  • Maine
    • Augusta, Maine, United States, 04330
      • VA Maine Healthcare System
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Edith Nourse Rogers Memorial VA Hospital (VA Bedford)
    • Boston, Massachusetts, United States, 02301
      • VA Boston Healthcare System
    • Leeds, Massachusetts, United States, 02053
      • VA Central Western Massachusetts Healthcare System
  • New Hampshire
    • Manchester, New Hampshire, United States, 03104
      • Manchester VA Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02908
      • Providence VA Medical Center
  • Vermont
    • White River Junction, Vermont, United States, 05001
      • White River Junction VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SBIRT-PM; Screening, 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.	Behavioral: SBIRT-PM; 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.
No Intervention: Usual Care; A 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost-Effectiveness Acceptability Curves (CEACs)	Probability that SBIRT is cost-effective compared to usual care over a range of monetary values that a decision-maker might consider the maximum acceptable to avoid to improve pain	36 weeks
Non-pharmacological Pain Service Utilization	Number of modalities of non-opioid pain services used will be assessed using a modified version of the Pain Management Collaboratory's "non-pharmacological and self-care approaches" questionnaire. This questionnaire asks about use of a list of 3 pharmacological and 23 non-pharmacological pain treatment modalities. For each modality, respondents indicate if the treatment was used in the past three months, if the treatment was delivered in an individual or group setting or if done on own (self-care), and the number of sessions/visits attended in the past 3 months. Number of non-pharmacological modalities will be summed.	36 weeks
Pain Interference Subscale of Brief Pain Inventory	Pain interference subscale of Brief Pain Inventory uses a 0-10 numeric rating scale (0=no interference to 10=interferes completely) to measure seven daily activities: general activity, walking, work, mood, enjoyment of life, relations with others, sleep. The pain interference subscale is scored as the mean of the seven interference items. This mean can be used if more than 50% (4/7 items) have been completed on a given administration.	36 weeks
Overall Health Measured by EQ-5D-5L	The Eq-5D-5L is a standardized measure of health status designed for clinical and economic appraisals. It includes a health scale which asks respondents to rate their health today on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).	36 weeks
Individual Substances of Misuse Generated by the ASSIST	Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) (Version 3.1) measures substance use risk over the last 3 months. It consists of 7 questions about use of and consequences of use for 11 classes of substances (including nicotine, THC and medical THC). Scores for each substance are summed and mapped to a three-point ordinal score of severity. Risk scores for alcohol range from 0-39, where a score of 0-10 indicates "no need for treatment", a score of 11-26 indicates "need for a brief intervention" and a score of 27+ indicates "need for an intensive intervention". Risk scores for tobacco range from 0-31, risk scores for all other substances range from 0-39, where a score of 0-3 indicates "no need for treatment", a score of 4-26 indicates "need for a brief intervention" and a score of 27+ indicates "need for an intensive intervention". Individual substances rated above the "no intervention" threshold will be analyzed here.	36 weeks
Cost-Effectiveness Ratios (ICERs)	The Incremental Cost-Effectiveness Ratio (ICER) was determined as the ratio of the difference in cost (mean cost in the treatment group less mean cost in the usual care group) divided by the difference in outcomes (QALYs in the treatment group less QALYs in the usual care group) Health care system perspective costs includes the intervention and services sponsored by VA. We limited these to care for musculoskeletal disorders. The societal perspective adds the cost of health services received outside of VA and costs incurred by participants, including the value of time spent seeking health services and obtaining self-directed care, and the value of the effect of disability on employment and normal activities.	36 weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); US Department of Veterans Affairs; National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Marc Rosen, MD, Yale University/ VA Connecticut Healthcare System; Principal Investigator: Steve Martino, PhD, Yale University/ VA Connecticut Healthcare System

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): April 11, 2024
• Study Completion (Actual): April 11, 2024

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Mental Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Substance-Related Disorders
• Other Study ID Numbers: 2000022664; 4UH3AT009758-03 (U.S. NIH Grant/Contract); 1UG3AT009758-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No