Pragmatic RCT of SBIRT-PM

Last updated: May 6, 2025
Sponsor: Yale University
Overall Status: Completed

Phase

N/A

Condition

Opioid Use Disorder

Addictions

Mood Disorders

Treatment

SBIRT-PM

Clinical Study ID

NCT04062214
2000022664
1UG3AT009758-01
4UH3AT009758-03
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filedclaim,

  • Reports a score of ≥4 (threshold for moderately severe pain) on the BPI's PainSeverity subscale (average of four pain intensity items);

  • Availability of a landline or cellular telephone for SBIRT-PM.

Exclusion

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 forthat study at the time the study invitation letter is mailed.

Study Design

Total Participants: 1101
Treatment Group(s): 1
Primary Treatment: SBIRT-PM
Phase:
Study Start date:
October 23, 2019
Estimated Completion Date:
April 11, 2024

Study 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.

Connect with a study center

  • Yale University

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • VA Connecticut Healthcare System (VACHS)

    West Haven, Connecticut 06516
    United States

    Site Not Available

  • VA Maine Healthcare System

    Augusta, Maine 04330
    United States

    Site Not Available

  • Edith Nourse Rogers Memorial VA Hospital (VA Bedford)

    Bedford, Massachusetts 01730
    United States

    Site Not Available

  • VA Boston Healthcare System

    Boston, Massachusetts 02301
    United States

    Site Not Available

  • VA Central Western Massachusetts Healthcare System

    Leeds, Massachusetts 02053
    United States

    Site Not Available

  • Manchester VA Medical Center

    Manchester, New Hampshire 03104
    United States

    Site Not Available

  • Providence VA Medical Center

    Providence, Rhode Island 02908
    United States

    Site Not Available

  • White River Junction VA Hospital

    White River Junction, Vermont 05001
    United States

    Site Not Available

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