Pilot of Pragmatic SBIRT Study

Not Applicable

Completed

• Conditions: Substance Use Disorders; Pain
• Interventions: Behavioral: SBIRT-PM

• Registration Number: NCT03307967
• Lead Sponsor: Yale University

Brief Summary

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.

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.

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.

Study Timeline

• Study First Submitted: 2017-10-05
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-12
• Study Start: 2019-01-15
• Primary Completion: 2019-06-17
• Study Completion: 2019-06-17
• Results First Submitted: 2022-03-22
• Results First Submitted QC: 2022-04-27
• Results First Posted: 2022-05-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filed claim,
• Reports pain ≥4 on the pain Numerical Rating Scale (threshold for moderately severe pain);
• Availability of a landline or cellular telephone for SBIRT-PM.

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Exclusion Criteria

• Reports inability to participate during the study enrollment call
• Received three or more non-pharmacological pain treatment modalities (as previously categorized within the last 12 weeks from VA.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SBIRT-PM	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.

Primary Outcome Measures

Name	Time	Method
Non-Pharm Pain Treatment Modalities Received	Baseline, Week 12	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.
Substance Use	Baseline, week 12	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.
Change in Pain Severity	Baseline to 12 weeks	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.
Change in Pain Interference	Baseline to 12 weeks	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.

Trial Locations

Locations (2)

VA Connecticut Healthcare System (VACHS); 🇺🇸 West Haven, Connecticut, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States