Pain Management for Veterans Filing Compensation Claims

Pain Clinical Trial

— SBIRT LBP  

Official title:

Pain Management for Veterans Filing Compensation Claims

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02049086
• Other study ID #: R34AT008318-01
• Secondary ID: R34AT008318-01
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: January 2018

Study information

• Verified date: June 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System (VACHS)	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain	The primary pain outcome will be the pain severity score form the Brief Pain Inventory	baseline
Primary	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
Primary	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
Primary	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
Primary	Pain	The primary pain outcome will be the pain severity score form the Brief Pain Inventory	week 4
Primary	Pain	The primary pain outcome will be the pain severity score form the Brief Pain Inventory	week 12
Primary	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
Primary	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

External Links

•   Financial Approaches to Behavior Change