Opioid-use DisorderNCT04632238
Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
A study testing Metrics-driven quality improvement (MDQI) in people with Opioid-use Disorder and Substance Use Disorders, run by NYU Langone Health at 4 sites in United States.
Trial summary
This project will develop and test quality measures for and a facilitation model to help addictions treatment clinics increase use of medicines for opioid use disorders, retain clients longer in care, and help more people move into successful recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-use Disorder, Substance Use Disorders
- What is being tested?
- Metrics-driven quality improvement (MDQI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,950 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jul 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Substance use disorder clinics in the regions surrounding New York City and the New York Capital Region with annual census of 50 or greater.
- All staff and patients from participating clinics will be eligible to participate in the study.
- Inclusion in the analyses using administrative data will be limited to those enrolled in Medicaid and not co-insured with Medicare (individuals ages greater than 64 and those with Federally determined disability).
Who cannot join
- Patients who are not working/being treated at substance use disorder clinics with less than 50 clients per year.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Samaritan Rockland - Outpatient Program
Blauvelt, New York, 10913
Samaritan Queens - Jamaica IOP
Jamaica, New York, 11435
Samaritan Daytop Village Harlem - Outpatient Program
New York, New York, 10027
Upper Manhattan Addiction Treatment Services Program
New York, New York, 10031
About this study
This project will develop and test quality measures for and a facilitation model to help addictions treatment clinics increase use of medicines for opioid use disorders, retain clients longer in care, and help more people move into successful recovery. At the end of the project, we will have developed specific training and coaching protocols as well as electronic clinical support tools to guide quality improvement that can be disseminated within New York and the rest of the country.
The study will test a clinic-level intervention that uses external facilitators to provide guidance to addictions clinics and contain three key components: 1) training on data driven management; 2) training and guidance on patient-centered care and OUD medication; and 3) electronic tools for shared decision making and patient progress monitoring.
Read the detailed description
There will be 4 sources of data examined in this study: 3 at the patient level and 1 at the staff level. The sources of patient data include: 1) State administrative data from all clients receiving treatment at the enrolled clinics (~7,950); 2) a subsample (1,200) who will be recruited directly from the clinics to complete patient-reported outcome assessments, and 3) treatment progress data for clients will also be collected.
For our administrative source of data, a final study population of approximately 7,950 individuals who are receiving treatment in the 30 enrolled outpatient treatment clinics for OUD is anticipated. Clinics will be located in the New York City metropolitan region (including Nassau, Westchester, and Rockland counties) and the Capital Region (including Albany, Rensselaer, Saratoga, Montgomery, Schenectady, and Schoharie counties). Staff at each enrolled clinic will also be interviewed and surveyed.
- Conditions
- Opioid-use Disorder, Substance Use Disorders
- Being tested
- Metrics-driven quality improvement (MDQI)
- Medical subject headings
- Opioid-Related Disorders, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metrics-driven quality improvement (MDQI)Behavioural
The intervention broadly consists of training and coaching to clinic staff and leadership on 1) clinical quality measure monitoring; 2) clinical practice process change management; and 3) use of tools for shared decision making and patient treatment progress monitoring.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Metrics-driven quality improvement (MDQI) intervention | Experimental | Not described Receives: Behavioral: Metrics-driven quality improvement (MDQI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinic-level rates of initiation to OUD medications
Measured: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in clinic-level rates of adherence to OUD medications
Measured: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Retention in Care
Clinic rates of 6-month client retention in care
Measured: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Incidence of Overdoses
Measured: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Incidence of Substance Use-Related Hepatitis C Infection
Measured: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Number of Emergency Room Visits
Measured: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Health Status
Change in health status is measured by the first item of the SF-12 Health Survey: "In general, would you say your health is: 1 - excellent, 2 - very good, 3 - good, 4 - fair, 5 - poor". Scores range from 1-5, with a higher score indicating worse health.
Measured: Assessed from the start of each clinic in the intervention to 1 year post-intervention
Secondary outcomes (4)
Cost of treatment
Cost of the intervention to the clinic
Measured: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic-level rates of clients with Severe OUD
As indicated by daily use and/or injection drug use as indicated in state administrative admission data
Measured: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic level-rates of clients identified as homeless
As indicated in state administrative admission data
Measured: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission data
Measured: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Jul 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- Stepped Wedge Cluster Randomized Trial (SW-RCT)
- Masking
- None (open label)
- Enrolment
- 7,950 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), New York State Office of Addiction Services and Supports, UConn Health
- Responsible party
- Sponsor
- Investigators
- Charles Neighbors, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632238
- Sponsor's protocol ID
- 20-00776
- Other IDs
- 1R61DA049252
- Status last verified
- Jul 2026
- First submitted
- 12 Nov 2020
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article resulting from surveys only, after deidentification (text, tables, figures, and appendices), will be available. Client outcome data from State administrative data files will not be available for sharing due to the nature of the data security agreements.
Publications
Hutchison M, Neighbors C, Hong S, Jordan AE, Lincourt P, O'Grady MA. How are substance use disorder treatment providers integrating harm reduction approaches into practice? Res Sq [Preprint]. 2026 Sep 15:rs.3.rs-10502518. doi: 10.21203/rs.3.rs-10502518/v1.
PubMed 42779935O'Grady MA, Lincourt P, Greenfield B, Manseau MW, Hussain S, Genece KG, Neighbors CJ. A facilitation model for implementing quality improvement practices to enhance outpatient substance use disorder treatment outcomes: a stepped-wedge randomized controlled trial study protocol. Implement Sci. 2021 Jan 7;16(1):5. doi: 10.1186/s13012-020-01076-x.
PubMed 33413493
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid
- ClinicalTrials.gov ID
- NCT04632238
- Acronym / sponsor ID
- 20-00776
- Conditions
- Opioid-use Disorder, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,950 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), New York State Office of Addiction Services and Supports, UConn Health
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 17 Nov 2020 (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 project will develop and test quality measures for and a facilitation model to help addictions treatment clinics increase use of medicines for opioid use disorders, retain clients longer in care, and help more people move into successful recovery. At the end of the project, we will have developed specific training and coaching protocols as well as electronic clinical support tools to guide quality improvement that can be disseminated within New York and the rest of the country.
The study will test a clinic-level intervention that uses external facilitators to provide guidance to addictions clinics and contain three key components: 1) training on data driven management; 2) training and guidance on patient-centered care and OUD medication; and 3) electronic tools for shared decision making and patient progress monitoring.
Detailed description
There will be 4 sources of data examined in this study: 3 at the patient level and 1 at the staff level. The sources of patient data include: 1) State administrative data from all clients receiving treatment at the enrolled clinics (~7,950); 2) a subsample (1,200) who will be recruited directly from the clinics to complete patient-reported outcome assessments, and 3) treatment progress data for clients will also be collected.
For our administrative source of data, a final study population of approximately 7,950 individuals who are receiving treatment in the 30 enrolled outpatient treatment clinics for OUD is anticipated. Clinics will be located in the New York City metropolitan region (including Nassau, Westchester, and Rockland counties) and the Capital Region (including Albany, Rensselaer, Saratoga, Montgomery, Schenectady, and Schoharie counties). Staff at each enrolled clinic will also be interviewed and surveyed.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped Wedge Cluster Randomized Trial (SW-RCT)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Metrics-driven quality improvement (MDQI) intervention | Experimental | Behavioral: Metrics-driven quality improvement (MDQI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Substance use disorder clinics in the regions surrounding New York City and the New York Capital Region with annual census of 50 or greater.
- All staff and patients from participating clinics will be eligible to participate in the study.
- Inclusion in the analyses using administrative data will be limited to those enrolled in Medicaid and not co-insured with Medicare (individuals ages greater than 64 and those with Federally determined disability).
Key exclusion criteria (1 listed)
- Patients who are not working/being treated at substance use disorder clinics with less than 50 clients per year.
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 |
|---|---|---|
| Metrics-driven quality improvement (MDQI)The intervention broadly consists of training and coaching to clinic staff and leadership on 1) clinical quality measure monitoring; 2) clinical practice process change management; and 3) use of tools for shared decision making and patient treatment progress monitoring. | Behavioural | Metrics-driven quality improvement (MDQI) intervention |
Primary outcome
Change in clinic-level rates of initiation to OUD medications
Time frame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in clinic-level rates of adherence to OUD medications
Time frame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Retention in Care
Time frame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Clinic rates of 6-month client retention in care
Change in Incidence of Overdoses
Time frame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Incidence of Substance Use-Related Hepatitis C Infection
Time frame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Number of Emergency Room Visits
Time frame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.
Change in Health Status
Time frame: Assessed from the start of each clinic in the intervention to 1 year post-intervention
Change in health status is measured by the first item of the SF-12 Health Survey: "In general, would you say your health is: 1 - excellent, 2 - very good, 3 - good, 4 - fair, 5 - poor". Scores range from 1-5, with a higher score indicating worse health.
4 secondary outcomes
Cost of treatment
Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic-level rates of clients with Severe OUD
Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic level-rates of clients identified as homeless
Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Change in clinic-rates of clients with co-existing psychiatric disorder as indicated in state administrative admission data
Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Derived from this study: PubMed 42779935Hutchison M, Neighbors C, Hong S, Jordan AE, Lincourt P, O'Grady MA. How are substance use disorder treatment providers integrating harm reduction approaches into practice? Res Sq [Preprint]. 2026 Sep 15:rs.3.rs-10502518. doi: 10.21203/rs.3.rs-10502518/v1.
- Derived from this study: PubMed 33413493O'Grady MA, Lincourt P, Greenfield B, Manseau MW, Hussain S, Genece KG, Neighbors CJ. A facilitation model for implementing quality improvement practices to enhance outpatient substance use disorder treatment outcomes: a stepped-wedge randomized controlled trial study protocol. Implement Sci. 2021 Jan 7;16(1):5. doi: 10.1186/s13012-020-01076-x.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article resulting from surveys only, after deidentification (text, tables, figures, and appendices), will be available. Client outcome data from State administrative data files will not be available for sharing due to the nature of the data security agreements.
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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. This study is not recruiting at the moment.
Charles Neighbors, PhD principal investigator
NYU Langone Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metrics-driven quality improvement (MDQI) in people with Opioid-use Disorder and Substance Use Disorders, run by NYU Langone Health at 4 sites 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?
The sponsor lists 3 inclusion and 1 exclusion criteria. 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: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinic-level rates of initiation to OUD medications (time frame: Assessed from commencement of the trial in Year 1 of the study to the conclusion of the trial in Year 4 of the study.). The study lists 7 primary outcomes in all. 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 NCT04632238, which also lists 2 linked publications.
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 15 Jul 2026.