Pragmatic RCT of SBIRT-PM (NCT04062214) | Clinical Trial Compass
CompletedNot Applicable
Pragmatic RCT of SBIRT-PM
United States1,101 participantsStarted 2019-10-23
Plain-language summary
Veterans seeking compensation for musculoskeletal (MSD) conditions often develop chronic pain and are at high risk for substance misuse. The Investigators propose to test the effectiveness and cost-effectiveness of Screening, Brief Intervention and Referral to Treatment for Pain Management (SBIRT-PM), designed to reduce pain and reduce risky substance use, in part by helping Veterans get comprehensive pain treatment. The study will involve clinicians at a single site contacting Veterans throughout New England by phone to deliver SBIRT-PM counseling in a pragmatic, randomized, clinical trial.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Post-9/11 Veteran applying for MSD-related compensation, as ascertained from filed claim,
* Reports a score of ≥4 (threshold for moderately severe pain) on the BPI's Pain Severity subscale (average of four pain intensity items);
* 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 within the last 12 weeks from VA.
* Participating in another PMC3 study as evidenced by a research protocol alert for that study at the time the study invitation letter is mailed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Subscale of Brief Pain Inventory
Timeframe: 36 weeks
2
Change in Number of Problem Substances Measured by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST)