Recruiting

Quality Measures & QI Toolkit

Sponsor:

RTI International

Code:

NCT07214389

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality Measures (Audit and Feedback)

Quality Improvement (QI) Toolkit

External QI Facilitation

Study Details

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.

Conditions

Opioid Use Disorder

Study ID

NCT07214389

Start date

Oct 3, 2025

Status verified date

Aug, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Only BayMark OTPs are eligible for participation.

Study Design

Enrollment

4500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

Interventions

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.

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.

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.

Primary outcome measure

  • OTP's 90-day treatment retention rate [ Time Frame: 90 days after treatment initiation (episodes initiating within the 12 months after intervention launch) ]

Central Contacts and Locations

Central contacts

Tami L Mark, PhD

301-816-4612tmark@rti.org

Emily C Costilow, MA, PMP

910-233-7508ecostilow@rti.org

Locations

RTI International

Recruiting

Research Triangle Park, North Carolina, United States, 27709

Contacts

Tami L Mark, PhD

301-816-4612tmark@rti.org

Emily Costilow

ecostilow@rti.org

More Information

Sponsor

RTI International

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Opioid Treatment Programs (OTPs)
  • Methadone
  • Buprenorphine
  • Quality Improvement (QI)
  • Treatment Retention
  • Addiction Services
  • Implementation Science

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by RTI International on 2026-08-27.