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CompletedNCT04632238Updated Jul 15, 2026

Coaching Performance Driven Practice Change in the Context of Value Based Purchasing Under New York Medicaid

An interventional study of Metrics-driven quality improvement (MDQI) in Opioid-use Disorder and Substance Use Disorders, sponsored by NYU Langone Health. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2020, registered Nov 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
7,950
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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. 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.

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Conditions studied

  • Opioid-use Disorder
  • Substance Use Disorders
03

In context

Opioid-Related Disorders

1,411 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's enrollment of 7,950 is above the median of 63 across 1,123 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • Patients who are not working/being treated at substance use disorder clinics with less than 50 clients per year.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
7,950 participants (actual)

Study arms

  • No intervention
    Control
  • Experimental
    Metrics-driven quality improvement (MDQI) intervention

    Behavioral: Metrics-driven quality improvement (MDQI)

Interventions

  • BehavioralMetrics-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.

06

What researchers measure

Primary outcomes

  1. 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.

  2. 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.

  3. Retention in Care

    Clinic rates of 6-month client 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

    Time frame: Assessed from the start of each clinic in the intervention to 1 year post-intervention

Secondary outcomes

  1. Cost of treatment

    Cost of the intervention to the clinic

    Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention

  2. 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

    Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention

  3. Change in clinic level-rates of clients identified as homeless

    As indicated in state administrative admission data

    Time frame: Assessed from commencement of the intervention at each clinic to 1 year post-intervention

  4. 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

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Study locations

4 sites
  • Samaritan Rockland - Outpatient Program
    Blauvelt, New York 10913, United States
  • Samaritan Queens - Jamaica IOP
    Jamaica, New York 11435, United States
  • Samaritan Daytop Village Harlem - Outpatient Program
    New York, New York 10027, United States
  • Upper Manhattan Addiction Treatment Services Program
    New York, New York 10031, United States
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References and documents

Publications

  • O'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 ↗

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04632238
Lead sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA), New York State Office of Addiction Services and Supports, UConn Health
Responsible party
Sponsor
First posted
Nov 17, 2020
Start date
Jul 1, 2020
Primary completion
Jun 30, 2025
Completion
Jun 30, 2025
Last update
Jul 15, 2026

Study contacts

Charles Neighbors, PhD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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