Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- RTI International
- Enrollment
- 4,500
- Locations
- 1
- Primary Endpoint
- OTP's 90-day treatment retention rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Masking Description
This is an open-label, cluster-randomized implementation trial. OTPs, care providers, and investigators will be aware of arm assignment. Masking is not feasible because the interventions-provision of clinic-level quality measures and a QI toolkit, with or without external QI facilitation-are organizational changes visible to staff. Patient outcomes are obtained from EHR and Medicaid claims; the central analytic team may be masked to arm labels when feasible.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Only BayMark OTPs are eligible for participation.
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 3 - Title: No Intervention: Usual Care
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.
Arm 1 - Title: Quality Measures + QI Toolkit
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
Intervention: Quality Measures (Audit and Feedback) (Behavioral)
Arm 1 - Title: Quality Measures + QI Toolkit
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
Intervention: Quality Improvement (QI) Toolkit (Behavioral)
Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation
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
Intervention: Quality Measures (Audit and Feedback) (Behavioral)
Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation
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
Intervention: Quality Improvement (QI) Toolkit (Behavioral)
Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation
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
Intervention: External QI Facilitation (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- OTP's 90-day retention rate of medications to treat OUD(90 days after treatment initiation)
- ED visit or hospitalization for a substance use disorder (SUD)(Within 12 months after treatment initiation (claims-based outcome window))
- ED visit or hospitalization for any cause(Within 12 months after treatment initiation (claims-based outcome window))
Investigators
Tami Mark
Distinguished Fellow, Health Policy
RTI International