Pain Management for Veterans Filing Compensation Claims (SBIRT LBP)

June 14, 2018 updated by: Yale University

This proposal will develop and test an indicated prevention strategy, Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM), in Veterans who have filed a claim for a (military) service-connected injury for which they have requested financial compensation. Although typically only an information-gathering, forensic-styled examination, the Compensation examination is a crucial point of entry to VA care. Objectives are:

  1. To finalize the procedures, manual, and training materials of SBIRT-PM. The goals of this stage will be (1) optimizing SBIRT-PM's appeal to Veterans concerned about their musculoskeletal conditions and their Compensation claims; and (2) finalizing the counseling materials and procedures.
  2. To conduct a randomized clinical trial comparing SBIRT-PM to a no referral arm and a pain module only arm.

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.

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 (Anticipated)

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.
120

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
      • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Veteran of OEF/OIF/OND
  • Scheduled exam for back, neck, knee, or shoulder. These four body parts were selected because they are classified as MSD by the VBA and are common causes of chronic non-cancer pain. Including other conditions (e.g. osteomyelitis, muscle injuries) would introduce more heterogeneity in illness course.
  • Able to participate psychologically and physically, able to provide informed consent, complete assessments, and participate in study procedures.
  • Self-reports peak pain of at least 2 on a numeric pain rating scale (0 "no pain" to 10 "worst pain imaginable" in the last 28 days in the joint that is the focus of the claim. This broad pain inclusion criterion may be narrowed after the Counseling Refinement Stage. Some Veterans apply for service connection for injuries that are not currently symptomatic, in case the injury recurs. This criterion will exclude these asymptomatic Veterans

  • Risky substance use within the last 28 days, defined as one of the following:

    1. Risky alcohol use: i.e. >14 drinks/week or>4 drinks/occasion for men 65 or younger; >7 drinks/week or >3 drinks/occasion for women. A standard drink will be 14 grams of absolute alcohol, equivalent to 12 oz of beer, 5 oz of wine, or 1.5 oz of 80-proof liquor
    2. Self-reported use of an illicit drug in the preceding 28 days. Use of opioids or sedative hypnotics not prescribed to the Veteran will be considered illicit drug use.Medical marijuana is legal in Connecticut but is illegal federally. Use of medical marijuana puts someone at some risk for future misuse of cannabis or other drugs and therefore will be treated as an illicit drug.
    3. Misuse of prescribed opioid medications in the preceding 28 days. Two questions adapted from the CIDI for use in a NIDA Clinical Trials Network study, were modified to describe misuse of prescribed opioid medications: "How often have you taken your pain medications in larger amounts than prescribed or for a longer period than prescribed?" and "How often have you used your pain medicines to get high, to relax, or to make you feel more alert?"

Exclusion Criteria:

  • Will not be able to attend the follow-up appointments.
  • Attended VA or non-VA substance abuse treatment during the three months prior to randomization. Veterans who are receiving mental health treatment but indicate it is not addressing substance use will be enrolled.
  • Physiological dependence on alcohol, illicit drugs, or non-prescribed opioids. People with more severe dependence have not benefited from SBIRT in prior studies.

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: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

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 with Pain-Management advice (SBIRT-PM)
Behavioral: SBIRT-PM
Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)
Active Comparator: Pain Module Only
The pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)
Behavioral: Pain Module
The pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)
No Intervention: No Additional Referral
No intervention.

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
Risky substance use
Time Frame: baseline
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
baseline
Pain
Time Frame: baseline
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
baseline
Service Use
Time Frame: baseline
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
baseline
Risky substance use
Time Frame: week 4
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
week 4
Risky substance use
Time Frame: week 12
A week will be defined as having had risky substance use if it had alcohol use at risky levels ( >14 drinks/week or 4 on an occasion for men or 7/week and >3/day for women), or illicit drug use. Weeks will be considered positive for illicit use if there is either a positive toxicology screen or self-reported use on that week.
week 12
Pain
Time Frame: week 4
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
week 4
Pain
Time Frame: week 12
The primary pain outcome will be the pain severity score form the Brief Pain Inventory
week 12
Service Use
Time Frame: week 4
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
week 4
Service Use
Time Frame: week 12
Service use will be coded for each week as whether the Veteran attended any pain related, substance abuse and/or mental health treatment. Attendance at treatment during a week will be defined as having any service use data (VA or self-reported use of non-VA services) indicating use. The difference in probability of attendance over time will be compared across treatment groups. Use of non-VA services, and whether substance abuse was addressed during a counseling session will be self-reported.
week 12

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 Center for Complementary and Integrative Health (NCCIH)

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

Helpful Links

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

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.
March 1, 2014

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.
January 1, 2018

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.
January 1, 2018

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).
January 24, 2014

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.
January 27, 2014

First Posted (Estimate)

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.
January 29, 2014

Study Record Updates

Last Update Posted (Actual)

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.
June 15, 2018

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.
June 14, 2018

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.
June 1, 2018

More Information

Terms related to this study

Keywords

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.
  • R34AT008318-01 (U.S. NIH Grant/Contract)

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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