An interventional study of Quality Measures (Audit and Feedback) and Quality Improvement (QI) Toolkit in Opioid Use Disorder, sponsored by RTI International. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by RTI International · Not applicable, Interventional, and Health services research
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.
This cluster-randomized trial is part of an NIH/NIDA-funded program to advance quality measurement and management for opioid treatment programs (OTPs). PROMOTE-QI (Project 2) tests whether providing OTPs with retention/outcome quality measures and a quality-improvement (QI) toolkit, with or without additional QI facilitation, improves patient retention compared with usual care. The study is conducted in partnership with BayMark Health Services and academic/industry collaborators.
Design and setting. Forty-five BayMark OTPs in multiple states will be randomized in equal groups to three arms (≈15 sites/arm) in a parallel-group cluster design. We anticipate \~4,500 adult MOUD initiations across the 45 sites during the 12-month post-implementation observation window. Patients are not individually assigned; outcomes are derived from EHR and Medicaid claims.
Interventions. Arm 1: Quality measures + QI toolkit. Sites receive claims-based, case-mix-adjusted retention and outcome quality measures with benchmarks, plus a toolkit (evidence summaries, case studies, and "how-to" materials) to guide retention-focused QI efforts, delivered via a secure portal.
Arm 2: Quality measures + QI toolkit + QI facilitation (NIATx). Sites receive all Arm-1 components plus structured NIATx facilitation, including establishing a change team and running Plan-Do-Study-Act (PDSA) cycles to implement and test retention strategies.
Arm 3: Usual care. Sites continue existing practices; at study end they will be offered the quality-measure portal and toolkit.
Primary and secondary outcomes. The primary endpoint is the OTP's 90-day treatment retention rate. Secondary endpoints are the OTP's 90-day retention rate of medications to treat OUD, the percentage of the OTP's patients with an ED visit or hospitalization for a substance use disorder (SUD), and the percentage with an ED visit or hospitalization for any cause.
Data sources and analysis. Outcomes will be drawn from BayMark electronic health records (EHR) and Medicaid T-MSIS claims. Analyses use generalized linear mixed models that account for clustering at the OTP level; retention/discontinuation rules (e.g., ≥31-day gap) follow the study's measurement specifications.
Implementation outcomes. The study will document strategies adopted, barriers/facilitators, and costs of QI facilitation via surveys/interviews and cost tracking.
Rationale. Prior work shows audit-and-feedback is more effective when paired with actionable guidance; the trial therefore compares quality measures + toolkit with and without facilitation to determine the incremental benefit of NIATx support.
1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.
Browse Opioid-Related Disorders studies →RTI International is the lead sponsor of 84 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Only BayMark OTPs are eligible for participation.
OTPs in this arm receive clinic-level quality measures (claims-based, case-mix-adjusted retention/outcome measures with benchmarks and peer comparisons) plus a self-guided QI toolkit (evidence summaries, change packages, templates, and examples) to support retention-focused practice changes. No external facilitation is provided
Behavioral: Quality Measures (Audit and Feedback) · Behavioral: Quality Improvement (QI) Toolkit
OTPs receive the quality measures and QI toolkit as in Arm 1 plus structured external QI facilitation based on the NIATx model. Facilitators coach an OTP change team, review data, and guide PDSA cycles to implement retention-focused improvements
Behavioral: Quality Measures (Audit and Feedback) · Behavioral: Quality Improvement (QI) Toolkit · Behavioral: External QI Facilitation
OTPs continue usual practice without access to the quality measures or QI toolkit and with no external facilitation during the study. Outcomes are assessed from EHR and Medicaid claims.
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.
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.
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.
OTP's 90-day treatment retention rate
The primary endpoint in the quantitative analyses will be the OTP's 90-day treatment retention rate.
Time frame: 90 days after treatment initiation (episodes initiating within the 12 months after intervention launch)
OTP's 90-day retention rate of medications to treat OUD
The secondary endpoint in the quantitative analysis will be the OTP's 90-day retention rate of medications to treat opioid use disorder.
Time frame: 90 days after treatment initiation
ED visit or hospitalization for a substance use disorder (SUD)
the percentage of the OTP's patients who had an emergency department (ED) visit or were hospitalized for a substance use disorder (SUD)
Time frame: Within 12 months after treatment initiation (claims-based outcome window)
ED visit or hospitalization for any cause
the percentage of the OTP's patients who had an ED visit or were hospitalized for any cause
Time frame: Within 12 months after treatment initiation (claims-based outcome window)
Plan to share: No — Individual participant data (IPD) will not be shared because the study relies on de-identified Medicaid claims and electronic health records obtained through data use agreements, as well as site-level information from opioid treatment programs (OTPs). These data are protected by federal and state privacy regulations and cannot be shared at the participant level. Only aggregated results will be disseminated.
Started Oct 2025 (actual). Primary completion is estimated for Aug 2027, 21 months after the start.
Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 21 months is below that.
Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
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