Opioid Use Disorder Clinical Trials

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Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Only BayMark OTPs are eligible for participation.

Locations
United States
North Carolina
RTI International
RECRUITING
Research Triangle Park
Contact Information
Primary
Tami L Mark, PhD
tmark@rti.org
301-816-4612
Backup
Emily C Costilow, MA, PMP
ecostilow@rti.org
910-233-7508
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 4500
Treatments
Experimental: 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
Experimental: 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
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA), Los Angeles County Department of Public Health - Substance Abuse Prevention and Control (SAPC), University of California, Los Angeles, BayMark Health Services
Leads: RTI International

This content was sourced from clinicaltrials.gov