NCT02049086

Brief Summary

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. 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. 2.To conduct a randomized clinical trial comparing SBIRT-PM to a no referral arm and a pain module only arm.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 29, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

3.8 years

First QC Date

January 24, 2014

Last Update Submit

June 14, 2018

Conditions

Pain

Keywords

SBIRTScreeningBrief InterventionReferral to TreatmentPain-ManagementVeterans

Outcome Measures

Primary Outcomes (9)

  • Risky substance use

    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

    The primary pain outcome will be the pain severity score form the Brief Pain Inventory

    baseline

  • Service Use

    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

    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

    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

    The primary pain outcome will be the pain severity score form the Brief Pain Inventory

    week 4

  • Pain

    The primary pain outcome will be the pain severity score form the Brief Pain Inventory

    week 12

  • Service Use

    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

    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

Study Arms (3)

SBIRT-PM

EXPERIMENTAL

Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)

Behavioral: SBIRT-PM

Pain Module Only

ACTIVE COMPARATOR

The pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)

Behavioral: Pain Module

No Additional Referral

NO INTERVENTION

No intervention.

Interventions

SBIRT-PMBEHAVIORAL

Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)

SBIRT-PM
Pain ModuleBEHAVIORAL

The pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)

Pain Module Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System (VACHS)

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • Rosen MI, Becker WC, Black AC, Martino S, Edens EL, Kerns RD. Brief Counseling for Veterans with Musculoskeletal Disorder, Risky Substance Use, and Service Connection Claims. Pain Med. 2019 Mar 1;20(3):528-542. doi: 10.1093/pm/pny071.

    PMID: 29800338DERIVED

MeSH Terms

Conditions

PainAgnosia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 29, 2014

Study Start

March 1, 2014

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

June 15, 2018

Record last verified: 2018-06

Locations

US(1)