PRoducing Outcome Measures for OTP Quality Improvement
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Quality Measures (Audit and Feedback), Quality Improvement (QI) Toolkit, External QI Facilitation.
- Who it may be relevant to
- Registry conditions: Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement
Overview
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.
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)]
Secondary outcome measures (3)
- OTP's 90-day retention rate of medications to treat OUD [Time frame: 90 days after treatment initiation]
- ED visit or hospitalization 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 [Time frame: Within 12 months after treatment initiation (claims-based outcome window)]
Eligibility criteria
Only BayMark OTPs are eligible for participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- RTI International — Research Triangle Park
Identifiers
NCT: NCT07214389 · RTI-HEAL-OTP-P2 · RM1DA059375