PRoducing Outcome Measures for OTP Quality Improvement
NCT07214389 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4500
Last updated 2026-04-21
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.
Conditions
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.
Sponsors & Collaborators
-
University of California, Los Angeles
collaborator OTHER -
Los Angeles County Department of Public Health - Substance Abuse Prevention and Control (SAPC)
collaborator FED -
National Institute on Drug Abuse (NIDA)
collaborator NIH -
BayMark Health Services
collaborator OTHER -
RTI International
lead OTHER
Principal Investigators
-
Tami L Mark, PhD · RTI International
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-03
- Primary Completion
- 2027-08-31
- Completion
- 2027-12-31
Countries
- United States
Study Locations
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