PRoducing Outcome Measures for OTP Quality Improvement (PROMOTE-QI)

RTI International

Status: Not yet enrolling

Conditions: Opioid Use Disorder

Treatments: Behavioral: External QI Facilitation; Behavioral: Quality Measures (Audit and Feedback); Behavioral: Quality Improvement (QI) Toolkit

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07214389

RTI-HEAL-OTP-P2

RM1DA059375 (U.S. NIH Grant/Contract)

Details and patient eligibility

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.

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.

Full 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.

Enrollment: 4,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Only BayMark OTPs are eligible for participation.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,500 participants in 3 patient groups

Arm 1 - Title: Quality Measures + QI Toolkit

Experimental group

Description:

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

Treatment:

Behavioral: Quality Improvement (QI) Toolkit

Behavioral: Quality Measures (Audit and Feedback)

Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation

Experimental group

Description:

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

Treatment:

Behavioral: Quality Improvement (QI) Toolkit

Behavioral: Quality Measures (Audit and Feedback)

Behavioral: External QI Facilitation

Arm 3 - Title: No Intervention: Usual Care

No Intervention group

Description:

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.