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Pilot of Pragmatic SBIRT Study

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ClinicalTrials.gov Identifier: NCT03307967
Recruitment Status : Completed
First Posted : October 12, 2017
Results First Posted : May 16, 2022
Last Update Posted : May 16, 2022
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders Pain Behavioral: SBIRT-PM Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (PILOT)
Actual Study Start Date : January 15, 2019
Actual Primary Completion Date : June 17, 2019
Actual Study Completion Date : June 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.




Primary Outcome Measures :
  1. Non-Pharm Pain Treatment Modalities Received [ Time Frame: 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.

  2. Substance Use [ Time Frame: 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.

  3. Change in Pain Severity [ Time Frame: 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.

  4. Change in Pain Interference [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307967


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
VA Connecticut Healthcare System (VACHS)
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Center for Complementary and Integrative Health (NCCIH)
National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs
Investigators
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Principal Investigator: Marc Rosen, MD Yale University/ VA Connecticut Healthcare System
Principal Investigator: Steve Martino, PhD Yale University/ VA Connecticut Healthcare System
  Study Documents (Full-Text)

Documents provided by Yale University:
Publications of Results:
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03307967    
Other Study ID Numbers: 2000022664_a
UG3AT009758 ( U.S. NIH Grant/Contract )
First Posted: October 12, 2017    Key Record Dates
Results First Posted: May 16, 2022
Last Update Posted: May 16, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders