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PRoducing Outcome Measures for OTP Quality Improvement

Study acronym: PROMOTE-QI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jan 12, 2027 → Aug 1, 2027
Enrollment reduced 89% 40194 → 4500 participants
See other at-risk trials from RTI International

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 12, 2027 to Aug 1, 2027
    • Enrollment reduced: 40194 → 4500 participants
    • Study completion pushed from Sep 1, 2027 to Dec 1, 2027
    • Start date: Jan 13, 2026 to Oct 3, 2025
    v4
  2. Enrollment increased: 4500 → 40194 participantsv3 Show 5 more changesShow less
    • Start date: Oct 3, 2025 to Jan 13, 2026
    • Primary completion moved earlier from Aug 2027 to Jan 12, 2027
    • Study completion moved earlier from Dec 2027 to Sep 1, 2027
    • Site contact updated
    • Collaborators: 4 to 3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Collaborators reordered
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Opioid Use Disorder
Related terms Opioid-Related Disorders
Enrollment 4,500 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov