Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 3)

February 23, 2026 updated by: NYU Langone Health

Person-Centered Quality Measurement and Management (QM2) in a System for Addictions Treatment in New York State (Project 3)

The goal of this study is to implement Opioid Use Disorder Quality Measurement and Management (OUD-QM2) strategy by the Office of Addiction Services and Supports (OASAS) to drive change and improve treatment practices. Through a concurrent mixed methods approach that iteratively examines quantitative and qualitative data to inform the process, the investigators will examine the effects of the strategy on stakeholders-PWUD/patients, families, and providers-and outcomes. This comprehensive approach will allow for a "global" view of the perceived effects of the OUD-QM2 strategy for all stakeholders while allowing us to use administrative data to test the effects of the strategy on patient outcomes. Through qualitative interviews and focus groups conducted in years 1, 3, and 5 of the phase, the investigators will derive information from stakeholders about their perceptions and use of the quality measures. Through surveys conducted with all clinics, the investigators will elicit data on changes in provider use of quality measures, clinical practice, and use of measures for incentive-based contracting. Finally, the investigators will conduct a stepped wedge trial to examine the effects of performance coaching that guides clinics on use of the quality measures for clinical practice improvement. The trial will also benefit from a treatment as usual (TAU) condition of clinics not participating in the trial to examine secular trends in patient outcomes across the period of the OASAS QM2 strategy rollout. The overall aim is to build and test a science-based OUD-QM2 strategy for person-centered treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The NYULH research team in collaboration with OASAS will conduct surveys of all 550 outpatient clinics across the state at three time points, years 1, 3, and 5. The NYULH research team and collaborating sites will observe effects on outcomes for patients in Substance Use Disorder (SUD) treatment clinics using administrative data for all outpatient clinics in the New York OASAS system. The study team will test an organizational-level QM2 intervention by employing a stepped-wedged randomized controlled trial with 35 clinics receiving the performance coaching intervention and the remaining clinics in the system treated as usual (TAU). That is, the study team will be able to track change over time for all clinics throughout the system as well as test the marginal effect of the performance coaching on patient outcomes. The study will test whether the OASAS QM2 strategy increases retention in care and has any effect on adverse events (i.e., emergency department visits, hospitalizations, mortality). Clinics receiving the intervention will be randomized to one of five sequences reflecting different timing of the intervention between years 2 and 4. The examination of outcomes will benefit from access to the rich sources of data described above for phase 1. Qualitative data collection with staff and patients will be embedded within the trial to examine experiences with the intervention and to inform quantitative findings.

NYULH and OASAS will maintain stakeholder engagement throughout the implementation and evaluation of the OASAS OUD-QM2 strategy. The study team will seek input from the stakeholder groups on strategies for presenting quality data as well as providing technical assistance to each group. The stakeholders will also receive annual updates on emerging findings from qualitative interviews and focus groups, surveys, and analyses of administrative data to inform them as well as solicit feedback and support for broader dissemination efforts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Individuals 18 years of age, and older
  • Clients and clinicians of people attending substance use treatment programs in New York State with Opioid Use Disorder in the time interval 2020-2027

Exclusion Criteria:

  • There are no exclusion criteria related to sex/gender to increase the generalizability of the findings. Children will not be included in this study because the treatment system mostly includes adults.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Performance coaching
All clinics will receive the performance coaching intervention. There is only one arm to this study.
Other: Performance Coaching
Performance coaching will consist of working with clinic staff to understand and guide current quality measurement practices as well as improving quality measurement and implementing new measures and management practices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in number of substance use related emergency department visits
Time Frame: Baseline (6 months prior to intervention), 6 months post-intervention
Baseline (6 months prior to intervention), 6 months post-intervention
Change in number of substance use related hospitalizations
Time Frame: Baseline (6 months prior to intervention), 6 months post-intervention
Baseline (6 months prior to intervention), 6 months post-intervention
Change in mortality rate
Time Frame: Baseline (6 months prior to intervention), 6 months post-intervention
Baseline (6 months prior to intervention), 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Charles Neighbors, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-00896
  • 1RM1DA059377-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be shared but aggregated deidentified data will be available through publications post analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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