Pragmatic RCT of SBIRT-PM

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    1100
  • sponsor
    Yale University
Updated on 30 April 2021
analgesia
chronic pain
pain relieving

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.

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 and toxicology testing of nail clippings. 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.

Details
Condition Drug abuse, Pain, Acute Pain Service, Post-Surgical Pain, Pain (Pediatric), Substance Abuse, Drug use, substance use disorder, ache, substance use disorders
Treatment SBIRT-PM
Clinical Study IdentifierNCT04062214
SponsorYale University
Last Modified on30 April 2021

Eligibility

Yes No Not Sure

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
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