PRoducing Outcome Measures for OTP Quality Improvement

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder

• Registration Number: NCT07214389
• Lead Sponsor: RTI International

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-03
• Study First Submitted: 2025-10-07
• Study First Submitted QC: 2025-10-07
• Last Update Submitted: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2027-08
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
OTP's 90-day treatment retention rate	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.

Secondary Outcome Measures

Name	Time	Method
OTP's 90-day retention rate of medications to treat OUD	90 days after treatment initiation	The secondary endpoint in the quantitative analysis will be the OTP's 90-day retention rate of medications to treat opioid use disorder.
ED visit or hospitalization for a substance use disorder (SUD)	Within 12 months after treatment initiation (claims-based outcome window)	the percentage of the OTP's patients who had an emergency department (ED) visit or were hospitalized for a substance use disorder (SUD)
ED visit or hospitalization for any cause	Within 12 months after treatment initiation (claims-based outcome window)	the percentage of the OTP's patients who had an ED visit or were hospitalized for any cause

Trial Locations

Locations (1)

RTI International; 🇺🇸 Research Triangle Park, North Carolina, United States