PRoducing Outcome Measures for OTP Quality Improvement

Part of paid clinical trials in Research Triangle Park, North Carolina.

Sponsor
RTI International
Study ID
NCT07214389
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Quality Measures (Audit and Feedback) — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 3, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
4,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
RTI InternationalResearch Triangle ParkNorth Carolina27709
Tami L Mark, PhD
[email protected]
301-816-4612
Katherine Treiman, PhD
[email protected]
301-230 4645
Tami L Mark, PhD (PRINCIPAL_INVESTIGATOR)
Katherine Treiman, PhD (SUB_INVESTIGATOR)

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