NCT07214389 · RTI International
PRoducing Outcome Measures for OTP Quality Improvement
(PROMOTE-QI)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Quality Measures (Audit and Feedback)
Clinic-level reports/dashboards providing case-mix-adjusted retention and outcome measures with benchmarks and peer comparisons, derived from EHR and Medicaid claims; delivered periodically to guide quality improvement.
BEHAVIORAL
Quality Improvement (QI) Toolkit
A self-guided QI toolkit for OTPs with step-by-step change packages, PDSA templates, training materials, and case examples to improve retention. Provided together with the quality measures in Arms 1-2; designed for use without external facilitation.
BEHAVIORAL
External QI Facilitation
Structured facilitation based on the NIATx model. Facilitators provide training, coaching, and feedback to an OTP change team, using the measures and toolkit to guide retention-focused QI.
Primary outcome measures
OTP's 90-day treatment retention rate
Time frame: 90 days after treatment initiation (episodes initiating within the 12 months after intervention launch)
The primary endpoint in the quantitative analyses will be the OTP's 90-day treatment retention rate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Only BayMark OTPs are eligible for participation.
Where
- Research Triangle Park, North Carolina
Collaborators
University of California, Los Angeles, National Institute on Drug Abuse (NIDA), BayMark Health Services
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations