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PRoducing Outcome Measures for OTP Quality Improvement

Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07214389
Acronym
PROMOTE-QI
Enrollment
4500
Registered
2025-10-09
Start date
2025-10-03
Completion date
2027-12-01
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Keywords

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

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.

Detailed description

This cluster-randomized trial is part of an NIH/NIDA-funded program to advance quality measurement and management for opioid treatment programs (OTPs). PROMOTE-QI (Project 2) tests whether providing OTPs with retention/outcome quality measures and a quality-improvement (QI) toolkit, with or without additional QI facilitation, improves patient retention compared with usual care. The study is conducted in partnership with BayMark Health Services and academic/industry collaborators. Design and setting. Forty-five BayMark OTPs in multiple states will be randomized in equal groups to three arms (≈15 sites/arm) in a parallel-group cluster design. We anticipate \ 4,500 adult MOUD initiations across the 45 sites during the 12-month post-implementation observation window. Patients are not individually assigned; outcomes are derived from EHR and Medicaid claims. Interventions. Arm 1: Quality measures + QI toolkit. Sites receive claims-based, case-mix-adjusted retention and outcome quality measures with benchmarks, plus a toolkit (evidence summaries, case studies, and "how-to" materials) to guide retention-focused QI efforts, delivered via a secure portal. Arm 2: Quality measures + QI toolkit + QI facilitation (NIATx). Sites receive all Arm-1 components plus structured NIATx facilitation, including establishing a change team and running Plan-Do-Study-Act (PDSA) cycles to implement and test retention strategies. Arm 3: Usual care. Sites continue existing practices; at study end they will be offered the quality-measure portal and toolkit. Primary and secondary outcomes. The primary endpoint is the OTP's 90-day treatment retention rate. Secondary endpoints are the OTP's 90-day retention rate of medications to treat OUD, the percentage of the OTP's patients with an ED visit or hospitalization for a substance use disorder (SUD), and the percentage with an ED visit or hospitalization for any cause. Data sources and analysis. Outcomes will be drawn from BayMark electronic health records (EHR) and Medicaid T-MSIS claims. Analyses use generalized linear mixed models that account for clustering at the OTP level; retention/discontinuation rules (e.g., ≥31-day gap) follow the study's measurement specifications. Implementation outcomes. The study will document strategies adopted, barriers/facilitators, and costs of QI facilitation via surveys/interviews and cost tracking. Rationale. Prior work shows audit-and-feedback is more effective when paired with actionable guidance; the trial therefore compares quality measures + toolkit with and without facilitation to determine the incremental benefit of NIATx support.

Interventions

BEHAVIORALQuality 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.

BEHAVIORALQuality 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.

BEHAVIORALExternal 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

RTI International
Lead SponsorOTHER
University of California, Los Angeles
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
BayMark Health Services
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

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.

Intervention model description

Parallel-group, cluster-randomized trial at the opioid treatment program (OTP) level. Forty-five BayMark OTPs (15 per arm) are randomized 1:1:1 to: (1) quality measures + QI toolkit; (2) quality measures + QI toolkit + external QI facilitation (NIATx); or (3) usual care. Patients are not individually assigned; outcomes are derived from routinely collected EHR and Medicaid claims. Enrollment reflects the expected number of adult MOUD initiations during the 12-month post-implementation window across participating sites (100 per site; total 4,500). Open-label; analyses account for clustering at the OTP level.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Only BayMark OTPs are eligible for participation.

Design outcomes

Primary

MeasureTime frameDescription
OTP's 90-day treatment retention rate90 days after treatment initiation (episodes initiating within the 12 months after intervention launch)The primary endpoint in the quantitative analyses will be the OTP's 90-day treatment retention rate.

Secondary

MeasureTime frameDescription
OTP's 90-day retention rate of medications to treat OUD90 days after treatment initiationThe secondary endpoint in the quantitative analysis will be the OTP's 90-day retention rate of medications to treat opioid use disorder.
ED visit or hospitalization for a substance use disorder (SUD)Within 12 months after treatment initiation (claims-based outcome window)the percentage of the OTP's patients who had an emergency department (ED) visit or were hospitalized for a substance use disorder (SUD)
ED visit or hospitalization for any causeWithin 12 months after treatment initiation (claims-based outcome window)the percentage of the OTP's patients who had an ED visit or were hospitalized for any cause

Countries

United States

Contacts

CONTACTTami L Mark, PhD
tmark@rti.org301-816-4612
CONTACTEmily C Costilow, MA, PMP
ecostilow@rti.org910-233-7508
PRINCIPAL_INVESTIGATORTami L Mark, PhD

RTI International

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026