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NOT YET RECRUITING
NCT07214389
NA

PRoducing Outcome Measures for OTP Quality Improvement

Sponsor: RTI International

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

4500

Start Date

2025-10-03

Completion Date

2027-12

Last Updated

2025-10-09

Healthy Volunteers

No

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.

Locations (1)

RTI International

Research Triangle Park, North Carolina, United States