Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06408233
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2024-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Person-Centered Quality Measurement and Management in a System for Addictions Treatment in New York State (Project 3)
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official Title:
Person-Centered Quality Measurement and Management (QM2) in a System for Addictions Treatment in New York State (Project 3)
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1RM1DA059377-01 | NIH | None | https://reporter.nih.gov/quic… | View |