Health TrialsbyHealthPanel

PRoducing Outcome Measures for OTP Quality Improvement

ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRTI International

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

4,500 Participants
are divided into 3 treatment groups
Group A: Arm 1 - Title: Quality Measures + QI ToolkitExperimental treatment 2 interventions
Group B: Arm 2 - Title: Quality Measures + QI Toolkit + External QI FacilitationExperimental treatment 3 interventions
Group C: Arm 3 - Title: No Intervention: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

OTP's 90-day treatment retention rate

The primary endpoint in the quantitative analyses will be the OTP's 90-day treatment retention rate.

Time frame
90 days after treatment initiation (episodes initiating within the 12 months after intervention launch)

Secondary outcomes

1

OTP's 90-day retention rate of medications to treat OUD

The secondary endpoint in the quantitative analysis will be the OTP's 90-day retention rate of medications to treat opioid use disorder.

Time frame
90 days after treatment initiation
2

ED visit or hospitalization for a substance use disorder (SUD)

the percentage of the OTP's patients who had an emergency department (ED) visit or were hospitalized for a substance use disorder (SUD)

Time frame
Within 12 months after treatment initiation (claims-based outcome window)
3

ED visit or hospitalization for any cause

the percentage of the OTP's patients who had an ED visit or were hospitalized for any cause

Time frame
Within 12 months after treatment initiation (claims-based outcome window)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RTI International

Lead sponsor

University of California, Los Angeles

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

BayMark Health Services

Collaborator

Source ClinicalTrials.gov
Apply now