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

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: Recruiting
• Conditions: Health Services Research
• Intervention / Treatment: Other: Performance Coaching

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: Interventional
• Enrollment (Estimated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Charles Neighbors, PhD; Phone Number: 646-501-3879; Email: Charles.Neighbors@nyulangone.org
• Study Contact Backup: Name: Sueun Hong; Phone Number: 646-501-3388; Email: Sueun.Hong@nyulangone.org

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change in number of substance use related emergency department visits	Baseline (6 months prior to intervention), 6 months post-intervention
Change in number of substance use related hospitalizations	Baseline (6 months prior to intervention), 6 months post-intervention
Change in mortality rate	Baseline (6 months prior to intervention), 6 months post-intervention

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Charles Neighbors, PhD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 6, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive
• Other Study ID 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