Clinical Trial

PRoducing Outcome Measures for OTP Quality Improvement

Study acronym: PROMOTE-QI
Recruiting
View on ClinicalTrials.gov →
Summary
This study tests ways to help opioid treatment programs (OTPs) keep patients in care. Staying on methadone or buprenorphine is linked to better outcomes, yet many people leave treatment early. The project will compare two approaches that provide clinics with retention/outcome quality measures and a quality-improvement (QI) toolkit-either alone or with added facilitation-against usual care. Forty-five BayMark OTPs in multiple states will be randomly assigned to one of three groups: (1) quality measures + QI toolkit; (2) quality measures + QI toolkit + external QI facilitation; or (3) usual care. The primary outcome is 90-day retention in treatment, measured from OTP electronic health records and Medicaid claims. Secondary outcomes include emergency department visits, hospitalizations, overdoses, and mortality. Findings will identify practical, scalable strategies to improve patient retention in OTPs.
Protocol Amendment History 3 changes
notable Enrollment increased: 4500 -> 40194 participants 2026-08-14
notable Primary completion moved earlier: 2027-08 -> 2027-01-12 2026-08-14
minor Completion moved earlier: 2027-12 -> 2027-09-01 2026-08-14
Trial Details
NCT Number NCT07214389
Lead Sponsor RTI International
Collaborators: University of California, Los Angeles, National Institute on Drug Abuse (NIDA), BayMark Health Services
Conditions Opioid Use Disorder
Enrollment 40,194 participants
Start Date 2026-01-13
Primary Completion 2027-01-12 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-13