Pain Management for Veterans Filing Compensation Claims (SBIRT LBP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02049086
First received: January 24, 2014
Last updated: April 3, 2014
Last verified: March 2014
  Purpose

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.

Condition Intervention
Pain
Behavioral: SBIRT-PM
Behavioral: Pain Module

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Pain Management for Veterans Filing Compensation Claims

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Risky substance use [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Pain [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The primary pain outcome will be the pain severity score form the Brief Pain Inventory

  • Service Use [ Time Frame: baseline ] [ Designated as safety issue: No ]
    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.

  • Risky substance use [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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.

  • Risky substance use [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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.

  • Pain [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    The primary pain outcome will be the pain severity score form the Brief Pain Inventory

  • Pain [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    The primary pain outcome will be the pain severity score form the Brief Pain Inventory

  • Service Use [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    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.

  • Service Use [ Time Frame: week 12 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: March 2014
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SBIRT-PM
Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)
Behavioral: SBIRT-PM
Active Comparator: Pain Module Only
the pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)
Behavioral: Pain Module
No Intervention: No Additional Referral

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
    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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02049086

Contacts
Contact: Christina Lazar, MPH 203-932-5711 ext 4833 christina.lazar@yale.edu
Contact: Karen Ablondi, MPH 203-932-5711 ext 3972 karen.ablondi@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System (VACHS) Recruiting
West Haven, Connecticut, United States, 06516
Contact: Christina M Lazar, MPH    203-932-5711 ext 4833    christina.lazar@yale.edu   
Principal Investigator: Marc I Rosen, MD         
Sponsors and Collaborators
Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02049086     History of Changes
Other Study ID Numbers: R34 AT008318-01, R34AT008318-01
Study First Received: January 24, 2014
Last Updated: April 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Yale University:
SBIRT
Screening
Brief Intervention
Referral to Treatment
Pain-Management
Veterans

ClinicalTrials.gov processed this record on September 22, 2014