Clinical trial NCT02049086: Pain Management for Veterans Filing Compensation Claims
Official title: Pain Management for Veterans Filing Compensation Claims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: SBIRT
Screening
Brief Intervention
Referral to Treatment
Pain-Management
Veterans
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-01-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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. 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.


Eligibility 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.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.

Primary outcomes:
measure: Risky substance use
timeFrame: baseline
measure: Pain
timeFrame: baseline
measure: Service Use
timeFrame: baseline
measure: Risky substance use
timeFrame: week 4
measure: Risky substance use
timeFrame: week 12
measure: Pain
timeFrame: week 4
measure: Pain
timeFrame: week 12
measure: Service Use
timeFrame: week 4
measure: Service Use
timeFrame: week 12
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System (VACHS)
state: Connecticut
Study officials:
References:
citation: 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.