Pilot of Pragmatic SBIRT Study

Pain Clinical Trial

Official title:

Engaging Veterans Seeking Service-Connection Payments in Pain Treatment (PILOT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307967
• Other study ID #: 2000022664_a
• Secondary ID: UG3AT009758
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: June 17, 2019

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention.

Description:

In 2015 alone, 97,223 new Veterans under age 35 began receiving compensation for injuries related to their military service. In total, there are 559,999 post-9/11 Veterans being compensated for back or neck conditions, and a partially overlapping 596,250 for limitation of flexion in joints. Veterans seeking compensation for musculoskeletal conditions often develop chronic pain and are at high risk for substance misuse. Early intervention is needed to arrest worsening pain and risky substance use, particularly among post-9/11 Veterans for whom engagement in non-pharmacological pain treatment has the potential to improve their overall quality of life and spare them the complications of opioid treatments. The service-connection application is an ideal point-of-contact for initiating early intervention treatments for these at-risk Veterans. This study is designed to pilot test the Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM) intervention. SBIRT-PM is designed to reduce pain and reduce risky substance use among veterans applying for VA Benefits for a musculoskeletal condition, in part by helping Veterans get connected to comprehensive pain treatment. This pilot will involve a 2-year period to arrange for SBIRT Counselors at a single site to counsel Veterans throughout New England by phone with SBIRT-PM to test the acceptability and feasibility of the intervention. During the two-years pilot trial, the team will prepare SBIRT-PM for implementation by establishing communication (Relational Coordination is the theoretical framework) between the "hub" where the SBIRT-PM clinician is sited and the "spoke" sites, establishing study-related procedures, and piloting the intervention at each of the eight VA medical centers in New England.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filed claim,
• Reports pain =4 on the pain Numerical Rating Scale (threshold for moderately severe pain);
• Availability of a landline or cellular telephone for SBIRT-PM.

Exclusion Criteria:

• Reports inability to participate during the study enrollment call
• Received three or more non-pharmacological pain treatment modalities (as previously categorized within the last 12 weeks from VA.

Related Conditions & MeSH terms

• Pain
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• SBIRT-PM
SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes.

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
Yale University	National Center for Complementary and Integrative Health (NCCIH), National Institute on Drug Abuse (NIDA), US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

References & Publications (2)

Rosen MI, Martino S, Sellinger J, Lazar CM, Fenton BT, Mattocks K. Access to Pain Care From Compensation Clinics: A Relational Coordination Perspective. Fed Pract. 2020 Jul;37(7):336-342. — View Citation

Sellinger JJ, Martino S, Lazar C, Mattocks K, Rando K, Serowik K, Ablondi K, Fenton B, Gilstad-Hayden K, Brummett B, Holtzheimer PE, Higgins D, Reznik TE, Semiatin AM, Stapley T, Ngo T, Rosen MI. The acceptability and feasibility of screening, brief inter — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Pharm Pain Treatment Modalities Received	A self-reported measure developed by the Pain Management Collaboaratory (PMC3). Questionnaire asks about the use of 13 different non-pharmacological pain treatments over the past 3 months. Below we present the mean number of non-pharmacological pain treatments received at baseline and then at week 12.	Baseline, Week 12
Primary	Substance Use	Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). This self-reported assessment asks about the use of 10 classes of substances used over the preceding 3 months. In the below table, we present the number of participants that endorsed having used the indicated substance at baseline and week 12.	Baseline, week 12
Primary	Change in Pain Severity	Measured by the pain severity subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain severity subscale consists of 4 items (worst pain, least pain, average pain, current pain) rated in the past 24 hours on a 0-10 scale- higher scores indicate higher pain severity. The four items are averaged to get a score. Below we present the mean, within-person change in pain severity from baseline to week 12. Minimally clinically important difference would be a 30% reduction in pain severity.	Baseline to 12 weeks
Primary	Change in Pain Interference	Measured by the pain interference subscale of the Brief Pain Inventory (BPI). The BPI is a validated instrument to assess chronic non-cancer pain. The pain interference subscale consists of 7 items rated in the past 24 hours on a 0-10 scale- higher scores indicate higher interference from pain. The 7 items are averaged to get a score. Below we present the mean, within-person change in pain intensity from baseline to week 12. Minimally clinically important difference would be a 1 point reduction in pain intensity.	Baseline to 12 weeks