Pilot of Pragmatic SBIRT Study

NCT03307967 | Completed Results

• 2 other identifiers: 2000022664_aUG3AT009758
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Substance Use Disorders; Pain

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline to 12 weeks

Study Arms (1)

SBIRT-PM

EXPERIMENTAL

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

Interventions

SBIRT-PM BEHAVIORAL

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.

SBIRT-PM

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• US Department of Veterans Affairs: collaborator

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

Location

VA Connecticut Healthcare System (VACHS)

West Haven, Connecticut, 06516, United States

Location

Related Publications (2)

• Sellinger JJ, Martino S, Lazar C, Mattocks K, Rando K, Serowik K, Ablondi K, Fenton B, Gilstad-Hayden K, Brummett B, Holtzheimer PE, Higgins D, Reznik TE, Semiatin AM, Stapley T, Ngo T, Rosen MI. The acceptability and feasibility of screening, brief intervention, and referral to treatment for pain management among new England veterans with chronic pain: A pilot study. Pain Pract. 2022 Jan;22(1):28-38. doi: 10.1111/papr.13023. Epub 2021 Jun 26.

  PMID: 33934499 RESULT

• Rosen MI, Martino S, Sellinger J, Lazar CM, Fenton BT, Mattocks K. Access to Pain Care From Compensation Clinics: A Relational Coordination Perspective. Fed Pract. 2020 Jul;37(7):336-342.

  PMID: 32908339 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Pain

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Christina Lazar, Project Director
• Organization: Yale University

christina.lazar@yale.edu

203-932-5711

Study Officials

• Marc Rosen, MD

  Yale University/ VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

• Steve Martino, PhD

  Yale University/ VA Connecticut Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2017
• First Posted: October 12, 2017
• Study Start: January 15, 2019
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: February 15, 2024
• Results First Posted: May 16, 2022

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)