PRoducing Outcome Measures for OTP Quality Improvement

NCT07214389 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4500

Last updated 2026-04-21

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07214389 on ClinicalTrials.gov