Pragmatic RCT of SBIRT-PM

NCT ID: NCT04062214

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2024-04-11

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.

Conditions

Substance Use Disorders; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

SBIRT-PM

Intervention Type: 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.

Usual Care

A Veteran who completes a Compensation examination ordinarily has no further treatment, referral or debriefing as part of the Compensation examination. Veterans will be advised that they should continue to pursue whatever counseling they need outside the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

US Department of Veterans Affairs

FED

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Rosen, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University/ VA Connecticut Healthcare System

Steve Martino, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University/ VA Connecticut Healthcare System

Locations

Yale University

New Haven, Connecticut, United States

VA Connecticut Healthcare System (VACHS)

West Haven, Connecticut, United States

VA Maine Healthcare System

Augusta, Maine, United States

Edith Nourse Rogers Memorial VA Hospital (VA Bedford)

Bedford, Massachusetts, United States

VA Boston Healthcare System

Boston, Massachusetts, United States

VA Central Western Massachusetts Healthcare System

Leeds, Massachusetts, United States

Manchester VA Medical Center

Manchester, New Hampshire, United States

Providence VA Medical Center

Providence, Rhode Island, United States

White River Junction VA Hospital

White River Junction, Vermont, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

4UH3AT009758-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1UG3AT009758-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000022664

Identifier Type: -

Identifier Source: org_study_id