Clinical trial NCT03307967: Pilot of Pragmatic SBIRT Study
Official title: Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (PILOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Pain
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: National Institute on Drug Abuse (NIDA)
name: US Department of Veterans Affairs
First posted: 2017-10-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Eligibility 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.

Primary outcomes:
measure: Non-Pharm Pain Treatment Modalities Received
timeFrame: Baseline, Week 12
measure: Substance Use
timeFrame: Baseline, week 12
measure: Change in Pain Severity
timeFrame: Baseline to 12 weeks
measure: Change in Pain Interference
timeFrame: Baseline to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: West Haven
country: United States
facility: VA Connecticut Healthcare System (VACHS)
state: Connecticut
Study officials:
affiliation: Yale University/ VA Connecticut Healthcare System
name: Marc Rosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University/ VA Connecticut Healthcare System
name: Steve Martino, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.