Clinical trial NCT04062214: Pragmatic RCT of SBIRT-PM
Official title: Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (TRIAL)
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: 2019-08-20
Enrollment: 1101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants receive either usual care or study intervention
Primary purpose: PREVENTION

Brief 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.

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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain Intensity Subscale of Brief Pain Inventory
timeFrame: 36 weeks
measure: Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)
timeFrame: 36 weeks
measure: Cost-Effectiveness Ratios (ICERs)
timeFrame: 36 weeks
measure: Cost-Effectiveness Acceptability Curves (CEACs)
timeFrame: 36 weeks
Secondary outcomes:
measure: Non-pharmacological Pain Service Utilization
timeFrame: 36 weeks
measure: Pain Interference Subscale of Brief Pain Inventory
timeFrame: 36 weeks
measure: Overall Health Measured by EQ-5D-5L
timeFrame: 36 weeks
measure: Individual Substances of Misuse Generated by the ASSIST
timeFrame: 36 weeks
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
city: Augusta
country: United States
facility: VA Maine Healthcare System
state: Maine
city: Bedford
country: United States
facility: Edith Nourse Rogers Memorial VA Hospital (VA Bedford)
state: Massachusetts
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Leeds
country: United States
facility: VA Central Western Massachusetts Healthcare System
state: Massachusetts
city: Manchester
country: United States
facility: Manchester VA Medical Center
state: New Hampshire
city: Providence
country: United States
facility: Providence VA Medical Center
state: Rhode Island
city: White River Junction
country: United States
facility: White River Junction VA Hospital
state: Vermont
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: