Opioid Use DisorderPROMOTE-QINCT07214389
PRoducing Outcome Measures for OTP Quality Improvement
A study testing Quality Measures (Audit and Feedback), Quality Improvement (QI) Toolkit and External QI Facilitation in people with Opioid Use Disorder, run by RTI International at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Quality Measures (Audit and Feedback), Quality Improvement (QI) Toolkit and External QI Facilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,500 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Only BayMark OTPs are eligible for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
RTI International
Research Triangle Park, North Carolina, 27709
Tami L Mark, PhD, 301-816-4612, tmark@rti.org
Emily Costilow, ecostilow@rti.org
About this study
Official title: Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement
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.
Read the 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.
- Conditions
- Opioid Use Disorder
- Being tested
- Quality Measures (Audit and Feedback), Quality Improvement (QI) Toolkit, External QI Facilitation
- Keywords
- Opioid Treatment Programs (OTPs), Methadone, Buprenorphine, Quality Improvement (QI), Treatment Retention, Addiction Services, Implementation Science
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality Measures (Audit and Feedback)Behavioural
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) ToolkitBehavioural
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 FacilitationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Arm 1 - Title: Quality Measures + QI Toolkit | Experimental | 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 Receives: Behavioral: Quality Measures (Audit and Feedback); Behavioral: Quality Improvement (QI) Toolkit |
| Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation | Experimental | 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 Receives: Behavioral: Quality Measures (Audit and Feedback); Behavioral: Quality Improvement (QI) Toolkit; Behavioral: External QI Facilitation |
| Arm 3 - Title: No Intervention: Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OTP's 90-day treatment retention rate
The primary endpoint in the quantitative analyses will be the OTP's 90-day treatment retention rate.
Measured: 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
The secondary endpoint in the quantitative analysis will be the OTP's 90-day retention rate of medications to treat opioid use disorder.
Measured: 90 days after treatment initiation
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)
Measured: Within 12 months after treatment initiation (claims-based outcome window)
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
Measured: Within 12 months after treatment initiation (claims-based outcome window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start3 Oct 2025
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Drug Abuse (NIDA), BayMark Health Services
- Responsible party
- Principal investigator, Tami Mark, RTI International
- Investigators
- Tami L Mark, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214389
- Sponsor's protocol ID
- RTI-HEAL-OTP-P2
- Other IDs
- RM1DA059375
- Acronym
- PROMOTE-QI
- Status last verified
- Aug 2026
- First submitted
- 7 Oct 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
DeLisle DE, Mark TL, Katz C, Dowd WN, Barch D, Kluckman M. Opioid Treatment Programs' Medicaid Patient Retention Rates. JAMA Netw Open. 2026 Jan 2;9(1):e2553538. doi: 10.1001/jamanetworkopen.2025.53538.
PubMed 41575747
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research to Foster an Opioid Use Disorder Treatment System Patients Can Count On: Project 2 - Producing Outcome Measures for OTP Quality Improvement
- ClinicalTrials.gov ID
- NCT07214389
- Acronym / sponsor ID
- PROMOTE-QI / RTI-HEAL-OTP-P2
- Conditions
- Opioid Use Disorder
- Keywords
- Opioid Treatment Programs (OTPs), Methadone, Buprenorphine, Quality Improvement (QI), Treatment Retention, Addiction Services, Implementation Science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- University of California, Los Angeles, National Institute on Drug Abuse (NIDA), BayMark Health Services
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Title: Quality Measures + QI Toolkit | Experimental | Behavioral: Quality Measures (Audit and Feedback), Behavioral: Quality Improvement (QI) ToolkitOTPs 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 | Experimental | Behavioral: Quality Measures (Audit and Feedback), Behavioral: Quality Improvement (QI) Toolkit, Behavioral: External QI FacilitationOTPs 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 intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Arm 1 - Title: Quality Measures + QI Toolkit, Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation |
| Quality Improvement (QI) ToolkitA 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. | Behavioural | Arm 1 - Title: Quality Measures + QI Toolkit, Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation |
| External QI FacilitationStructured 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. | Behavioural | Arm 2 - Title: Quality Measures + QI Toolkit + External QI Facilitation |
Primary outcome
OTP's 90-day treatment retention rate
Time frame: 90 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.
3 secondary outcomes
OTP's 90-day retention rate of medications to treat OUD
Time frame: 90 days after treatment initiation
ED visit or hospitalization for a substance use disorder (SUD)
Time frame: Within 12 months after treatment initiation (claims-based outcome window)
ED visit or hospitalization for any cause
Time frame: Within 12 months after treatment initiation (claims-based outcome window)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Background: PubMed 41575747DeLisle DE, Mark TL, Katz C, Dowd WN, Barch D, Kluckman M. Opioid Treatment Programs' Medicaid Patient Retention Rates. JAMA Netw Open. 2026 Jan 2;9(1):e2553538. doi: 10.1001/jamanetworkopen.2025.53538.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tami L Mark, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality Measures (Audit and Feedback), Quality Improvement (QI) Toolkit and External QI Facilitation in people with Opioid Use Disorder, run by RTI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tami L Mark, PhD (301-816-4612, tmark@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07214389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.