Pilot of Pragmatic SBIRT Study

February 13, 2024 updated by: Yale University

Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (PILOT)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University
      • West Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System (VACHS)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 12
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.
Baseline, week 12
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.
Baseline to 12 weeks
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.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)
US Department of Veterans Affairs
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Rosen, MD, Yale University/ VA Connecticut Healthcare System
  • Principal Investigator: Steve Martino, PhD, Yale University/ VA Connecticut Healthcare System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 12, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000022664_a
  • UG3AT009758 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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