PRoducing Outcome Measures for OTP Quality Improvement
PROMOTE-QI
Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement
2 other identifiers
interventional
4,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 3, 2025
CompletedFirst Submitted
Initial submission to the registry
October 7, 2025
CompletedFirst Posted
Study publicly available on registry
October 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 21, 2026
April 1, 2026
1.8 years
October 7, 2025
April 16, 2026
Conditions
Keywords
Outcome Measures
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.
90 days after treatment initiation (episodes initiating within the 12 months after intervention launch)
Secondary Outcomes (3)
OTP's 90-day retention rate of medications to treat OUD
90 days after treatment initiation
ED visit or hospitalization for a substance use disorder (SUD)
Within 12 months after treatment initiation (claims-based outcome window)
ED visit or hospitalization for any cause
Within 12 months after treatment initiation (claims-based outcome window)
Study Arms (3)
Arm 1 - Title: Quality Measures + QI Toolkit
EXPERIMENTALOTPs 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
Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation
EXPERIMENTALOTPs 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
Arm 3 - Title: No Intervention: Usual Care
NO INTERVENTIONOTPs 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
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.
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.
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.
Eligibility Criteria
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
RTI International
Research Triangle Park, North Carolina, 27709, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tami L Mark, PhD
RTI International
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label, cluster-randomized implementation trial. OTPs, care providers, and investigators will be aware of arm assignment. Masking is not feasible because the interventions-provision of clinic-level quality measures and a QI toolkit, with or without external QI facilitation-are organizational changes visible to staff. Patient outcomes are obtained from EHR and Medicaid claims; the central analytic team may be masked to arm labels when feasible.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Distinguished Fellow, Health Policy
Study Record Dates
First Submitted
October 7, 2025
First Posted
October 9, 2025
Study Start
October 3, 2025
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared because the study relies on de-identified Medicaid claims and electronic health records obtained through data use agreements, as well as site-level information from opioid treatment programs (OTPs). These data are protected by federal and state privacy regulations and cannot be shared at the participant level. Only aggregated results will be disseminated.