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

NCT06408233 | Recruiting

• 2 other identifiers: 23-008961RM1DA059377-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Services Research

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Performance coaching

EXPERIMENTAL

All clinics will receive the performance coaching intervention. There is only one arm to this study.

Other: Performance Coaching

Interventions

Performance Coaching OTHER

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.

Performance coaching

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

• Charles Neighbors, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Neighbors, PhD

CONTACT

646-501-3879; Charles.Neighbors@nyulangone.org

Sueun Hong

CONTACT

646-501-3388; Sueun.Hong@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a stepped wedge design where clinics are randomized to onset of intervention in one of five time periods over the three years of the intervention rollout (years 2-4 of the phase) and tracked using administrative data. Data for all clinic clients during each of the seven six-month periods will be drawn from administrative data. All clinics will be in the control condition for the first six-month period. Seven clinics will be assigned randomly to one of five time periods for onset of intervention.

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 10, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)