An interventional study of SBIRT-PM in Substance Use Disorders and Pain, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Yale University · Not applicable, Interventional, and Screening
Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.
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.
This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.
During the two-years pilot trial, the team will prepare 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.
Exclusion Criteria:
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.
Non-Pharm Pain Treatment Modalities Received
A self-reported measure developed by the Pain Management Collaboaratory (PMC3). Questionnaire asks about the use of 13 different non-pharmacological pain treatments over the past 3 months. Below we present the mean number of non-pharmacological pain treatments received at baseline and then at week 12.
Time frame: Baseline, Week 12
Substance Use
Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). This self-reported assessment asks about the use of 10 classes of substances used over the preceding 3 months. In the below table, we present the number of participants that endorsed having used the indicated substance at baseline and week 12.
Time frame: Baseline, week 12
Change in Pain Severity
Measured by the pain severity subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain severity subscale consists of 4 items (worst pain, least pain, average pain, current pain) rated in the past 24 hours on a 0-10 scale- higher scores indicate higher pain severity. The four items are averaged to get a score. Below we present the mean, within-person change in pain severity from baseline to week 12. Minimally clinically important difference would be a 30% reduction in pain severity.
Time frame: Baseline to 12 weeks
Change in Pain Interference
Measured by the pain interference subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain interference subscale consists of 7 items rated in the past 24 hours on a 0-10 scale- higher scores indicate higher interference from pain. The 7 items are averaged to get a score. Below we present the mean, within-person change in pain intensity from baseline to week 12. Minimally clinically important difference would be a 1 point reduction in pain intensity.
Time frame: Baseline to 12 weeks
Veterans in catchment area of New England VA Medical Centers applying for C\&P disability benefits for a back, neck, knee, or shoulder condition
| Milestone | SBIRT-PM |
|---|---|
| Started | 40 |
| Completed | 36 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
A self-reported measure developed by the Pain Management Collaboaratory (PMC3). Questionnaire asks about the use of 13 different non-pharmacological pain treatments over the past 3 months. Below we present the mean number of non-pharmacological pain treatments received at baseline and then at week 12.
| non-pharm pain treatments | SBIRT-PM |
|---|---|
| # non-pharm pain treatments at Baseline | .93 ± 1.0 |
| # non-pharm pain treatments at week 12 | 1.3 ± 1.3 |
Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). This self-reported assessment asks about the use of 10 classes of substances used over the preceding 3 months. In the below table, we present the number of participants that endorsed having used the indicated substance at baseline and week 12.
| participants | SBIRT-PM |
|---|---|
| Baseline : Alcohol | 13 |
| Baseline : Nicotine | 16 |
| Baseline : Other Drugs | 7 |
| Baseline : Alcohol or drugs | 27 |
| Week 12 : Alcohol | 6 |
| Week 12 : Nicotine | 15 |
| Week 12 : Other Drugs | 8 |
| Week 12 : Alcohol or drugs | 22 |
Measured by the pain severity subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain severity subscale consists of 4 items (worst pain, least pain, average pain, current pain) rated in the past 24 hours on a 0-10 scale- higher scores indicate higher pain severity. The four items are averaged to get a score. Below we present the mean, within-person change in pain severity from baseline to week 12. Minimally clinically important difference would be a 30% reduction in pain severity.
| within-person change in score on a scale | SBIRT-PM |
|---|---|
| Change in Pain Severity | -.41 ± 1.3 |
Measured by the pain interference subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain interference subscale consists of 7 items rated in the past 24 hours on a 0-10 scale- higher scores indicate higher interference from pain. The 7 items are averaged to get a score. Below we present the mean, within-person change in pain intensity from baseline to week 12. Minimally clinically important difference would be a 1 point reduction in pain intensity.
| within-person change on a scale | SBIRT-PM |
|---|---|
| Change in Pain Interference | .08 ± 1.6 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SBIRT-PM | 0/40 (0%) | 0/40 (0%) | 8/40 (20%) |
| Event | SBIRT-PM |
|---|---|
| Suicidal ideationPsychiatric disorders | 8/40 |
| Age, Continuous(years) | SBIRT-PM |
|---|---|
| Mean | 40.2 (20 to 70) |
| Sex: Female, Male(Participants) | SBIRT-PM |
|---|---|
| Female | 6 |
| Male | 34 |
| Race/Ethnicity, Customized(Participants) | SBIRT-PM |
|---|---|
| White | 30 |
| Black | 3 |
| Other | 5 |
| Unknown | 2 |
| Hispanic | 6 |
| Region of Enrollment(participants) | SBIRT-PM |
|---|---|
| United States | 40 |
| Military Branch(Participants) | SBIRT-PM |
|---|---|
| Army | 18 |
| Marines | 5 |
| Navy | 7 |
| Airforce | 5 |
| Coast Guard | 2 |
| Army/Airforce | 2 |
| Army/Marines | 1 |
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Yale University