N/A
Completed N=1,101
Pragmatic RCT of SBIRT-PM
Source: ClinicalTrials.gov NCT04062214 ↗Enrolled (actual)
1,101
Serious AEs
17.4%
Results posted
May 2025
Primary outcomePrimary: Change in Pain Intensity Subscale of Brief Pain Inventory — 5.39; 5.39; 5.02; 4.97 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Intensity Subscale of Brief Pain Inventory |
5.39; 5.39; 5.02; 4.97; 4.60; 4.86 | — |
| PRIMARY Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) |
1.47; 1.47; 1.32; 1.19; 1.26; 1.19 | — |
| PRIMARY Cost-Effectiveness Ratios (ICERs) |
-86925; -86925; 129527; 129527 | — |
| PRIMARY Cost-Effectiveness Acceptability Curves (CEACs) |
.83; .83; .73; .73; .29; .29 | — |
| SECONDARY Non-pharmacological Pain Service Utilization |
2.72; 2.49; 3.48; 3.31; 3.33; 3.00 | — |
| SECONDARY Pain Interference Subscale of Brief Pain Inventory |
5.15; 5.16; 4.93; 4.78; 4.35; 4.61 | — |
| SECONDARY Overall Health Measured by EQ-5D-5L |
65.13; 65.74; 66.72; 68.82; 68.61; 69.20 | — |
| SECONDARY Individual Substances of Misuse Generated by the ASSIST |
14.05; 13.35; 11.48; 11.97; 11.09; 10.80 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04062214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.